human subject would have been 3 years after the date of publication of
a final rule, the benefits and costs described below assume a start
date of 2020. In the absence of the proposed exemption for secondary
research studies, but taking into consideration the expansion to the
definition of human subject, we estimate that each year, all 250,000 of
these studies would undergo convened initial review. In subsequent
years, we estimate that 120,000 protocols would undergo convened
initial review, 89,700 would undergo convened continuing review, and
40,300 would undergo expedited continuing review based on the
distribution of reviews presented in Table 3. The estimated costs to
institution officials, IRB administrators, IRB administrative staff,
IRB chairs, IRB voting members, and investigators conducting these
reviews are based on the estimates presented in Table 3. The dollar
value of their time is calculated by multiplying hours by their
estimated 2017-2026 wages and adjusting for overhead and benefits.
c. Facilitating Research With Nonidentified Biospecimens Under the
NPRM: Seeking and Obtaining Broad Consent
    To facilitate secondary research using biospecimens and
identifiable private information, the NPRM also proposed an exemption
for storing and maintaining biospecimens and identifiable private
information for future, unspecified, secondary research activities.
Given the creation of this exemption, the NPRM envisioned that
institutions would need to develop tracking systems to monitor which
biospecimens or information could be used in secondary research by
investigators. Because both the exemption for secondary research use
described above, and the exemption required using the proposed
Secretary's broad consent, the NPRM assumed that a majority of
investigators and institutions would employ the Secretary's consent
template. Thus, the NPRM anticipated that minimal time would have been
spent updating consent forms or drafting new broad consent forms.
    We estimate that 6,428 FWA-holding institutions (80 percent) would
have stored and maintained clinical and nonclinical biospecimens and
identifiable private information for unspecified future research
studies in the manner prescribed under the NPRM. As also discussed
previously, extrapolations from 1999 data suggest that biospecimens are
collected from as many as 30 million individuals each year and stored
for both clinical and research purposes. Approximately 9 million
individuals' biospecimens (30 percent) are collected for research
purposes, and thus consent would be sought in the research context for
the secondary use of these biospecimens. For these 9 million
individuals per year, an investigator would spend an estimated 20
minutes per person conducting the consent process specific to seeking
broad consent, and the subjects would spend an estimated 20 minutes
engaging in the process of having their broad consent for future
research uses of their biospecimens or information sought. This
estimate of the investigator's time also includes the time for the
investigator to log the information into the appropriate database. We
note that the NPRM RIA estimated that it would take 5 minutes for an
investigator to seek broad consent in the research setting, and that
prospective subjects would spend 5 minutes having their broad consent
sought. Based on public comments, we have revised this estimate to
better reflect experience in the regulated community about how long it
takes to seek and obtain consent. We further estimate that
investigators would spend 10 minutes of time per protocol updating
their study specific consent form to include the language from the
Secretary's consent template.
    In the clinical setting, approximately 21 million individuals'
biospecimens (70 percent of the estimated 30 million individuals'
biospecimens collected each year) are collected for clinical purposes.
In the first year that the proposed changes would have been
implemented, as many as 21 million broad, secondary use consent forms
could have been collected from individuals. We anticipate 30 minutes of
a subject's time to engage in the consent process. We further
anticipate 30 minutes of an institutional employee's time at the IRB
Administrative Staff level to seek consent and put the information in
the appropriate tracking system. As with the estimate for seeking and
obtaining broad consent in the clinical setting, we have increased the
estimate of how long it would take institutional employees to seek
broad consent and how long prospective subjects would spend
participating in the broad consent process based on public comments.
    The NPRM proposed that once an individual gave broad consent to use
his or her biospecimens in future, unspecified research studies, that
consent could cover any biospecimen collected from that individual over
the course of a 10-year period. Note that an institution could retain
and use the biospecimens collected indefinitely. This provision merely
stated that every 10 years an institution must ask people whether or
not they may use newly collected biospecimens in research. Given that
an institution needed to seek

broad consent from an individual only once over the course of a 10-year
period, we assumed that after the first year the NPRM was implemented,
the number of individuals from whom an institution would seek broad
consent would decrease.
    To account for this, the RIA alternative approach assumes that
after the first year, a fraction of the clinical subjects from whom
broad consent was sought in year one would be sought in subsequent
years. We anticipate that in year two, secondary use consent would be
sought in the clinical context from 10.5 million subjects (50 percent
of the number of individuals involved in the year one estimates). We
anticipate that in year three and after, secondary use consent would be
sought in the clinical context from approximately 6.3 million subjects
each year (30 percent of the number of individuals involved in the year
one estimates). As in year one, we assume that a prospective subject
would spend 30 minutes of time undergoing the consent process and that
an institutional employee at the IRB Administrative Staff level would
spend 30 minutes of time conducting the consent process with an
individual and updating the appropriate tracking system.
d. Estimating the Cost of the Broad Consent Tracking System
    To appropriately track biospecimens or identifiable private
information for which broad consent had been sought and obtained on an
institutional level, an institution would need to develop an
institution-wide repository-like schema. The costs include the design,
implementation, and operation of the informatics system that would be
required to document and keep current thousands of consent documents
per year. In addition, the institution would have to come up with a
system to mark or otherwise flag which biospecimens and pieces of
identifiable private information could be used in future unspecified
secondary research studies.
    Under the NPRM proposal, we estimate that 80 percent of the 8,035
institutions with FWAs would develop these informatics systems (or
modify existing systems) to facilitate research with nonidentified
biospecimens. We estimate that under this proposal, institutions on
average would require 1.0 database administrator FTE to develop and
maintain these systems. We note that as this estimate is a nationwide
average, and we expect some institutions would require more database
administrators, and others would require fewer.
    For all of the estimates described above, the estimated costs to
institution officials, IRB administrators, IRB administrative staff,
IRB chairs, IRB voting members, database administrators, and
investigators of are based on the estimates presented in Table 3. The
dollar value of their time is calculated by multiplying hours by their
estimated 2017-2026 wages and adjusting for overhead and benefits.
    For the alternative proposal (i.e., the NPRM proposal to treat all
biospecimens regardless of identifiability as covered under the Common
Rule), present value costs of $19.7 billion and annualized costs of
$2.31 billion are estimated using a 3 percent discount rate; and
present value costs of $14.2 billion and annualized costs of $2.02
billion are estimated using a 7 percent discount rate. Table 20
summarizes the quantified and nonquantified benefits and costs of
amending the definition of human subject and obtaining consent to
secondary use of biospecimens and identifiable private information.

            Table 20--Alternative Proposal To Treat All Biospecimens as Covered Under the Common Rule
----------------------------------------------------------------------------------------------------------------
                                                Present value of 10  years by    Annualized value over 10  years
                                              discount rate  (millions of 2015   by discount rate  (millions of
                                                          dollars)                        2015 dollars)
                                             -------------------------------------------------------------------
                                                 3 percent        7 percent        3 percent        7 percent
----------------------------------------------------------------------------------------------------------------
BENEFITS:
Quantified Benefits:
    None....................................  ...............  ...............  ...............  ...............
----------------------------------------------------------------------------------------------------------------
Nonquantified Benefits:
    Increased protections for human subjects....................................................................
----------------------------------------------------------------------------------------------------------------
COSTS:
Quantified Costs:
    Increase in number of reviews; time to            19,670           14,214            2,306            2,024
     update consent forms; document and
     track permissible and impermissible
     secondary uses of information and
     biospecimens; and cost to develop and
     maintain tracking system...............
----------------------------------------------------------------------------------------------------------------
Nonquantified Costs:
    None........................................................................................................
----------------------------------------------------------------------------------------------------------------

F. Regulatory Flexibility Analysis

    As discussed above, the RFA requires agencies that issue a
regulation to analyze options for regulatory relief of small entities
if a rule has a significant impact on a substantial number of small
entities. HHS considers a rule to have a significant economic impact on
a substantial number of small entities if at least 5 percent of small
entities experience an impact of more than 3 percent of revenue.
    We calculate the costs of the proposed changes to the Common Rule
over 2017-2026 to institutions with an FWA. The estimated annualized
cost to institutions with an FWA, on average, is $2,516 using a 3
percent discount rate. The U.S. Small Business Administration
establishes size standards that define a small entity. According to
these standards, colleges, universities, and professional schools with
revenues below $27.5 million and hospitals with revenues below $38.5
million are considered small entities. It is not anticipated that a
majority of institutions with an FWA are in any of these categories.

XX. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

XXI. Paperwork Reduction Analysis

    This final rule contains collections of information that are
subject to review and approval by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act (PRA), as amended (44 U.S.C.
3501-3520). A description of these provisions is given in this document
with an estimate of the annual reporting and recordkeeping burden.
    Title: Federal Policy for the Protection of Human Subjects.
    Description: In this document is a discussion of the regulatory
provisions we believe are subject to the PRA and the probable
information collection burden associated with these provisions. In
general, the following actions trigger the PRA: (i) Reporting; (ii)
Recordkeeping.
    Description of Respondents: The reporting and recordkeeping
requirements in this document are imposed on institutions,
institutional review boards, and investigators involved in human
subjects research conducted or supported or otherwise subject to
regulation by any federal department or agency that takes
administrative action that makes the policy applicable to such
research.

Sec.  __.101(a)(1) Extending Oversight to IRBs-Not Operated by an
Institution Holding an FWA (OMB Control No 0990-0260)

    Section __.101 is amended, as described in Sec.  __.101(a), to give
Common Rule departments and agencies the authority to enforce
compliance directly against IRBs that, are not operated by an assured
institution. It is anticipated that institutions using an IRB that it
does not operate will be reassured because compliance actions can be
taken directly against the IRB responsible for the regulatory
noncompliance, rather than the institutions that relied on that review.
As a result of this change, we anticipate that FWA-holding institutions
will increase their reliance on IRBs not operated by an FWA-holding
institution when appropriate.
    The OHRP database of assured institutions and registered IRBs shows
that approximately 449 IRBs not operated by an institution holding an
FWA will now be subject to oversight. These IRBs will develop an
estimated average of 10 written agreements with other institutions each
year as a result of this rule. We further estimate that each agreement
will require an average of 10 hours of institution legal staff time and
5 hours of IRB administrator time to complete. We note that elsewhere
in the final rule (specifically Sec. Sec.  __.103(e) and __.115(a)(9))
requires that IRBs document the specific responsibilities that an
institution and an organization operating an IRB each will undertake,
when an institution relies on an IRB that it does not operate. The
impact of these provisions on FWA-holding institutions is described
below.

Sec.  __.103(e) Documentation of IRB Oversight Reliance Requirement for
Institution and Organization Operating the IRB (OMB Control No 0990-
0260)

    To further strengthen the compliance enforcement authority
provision in Sec.  __.101(a) and provide a record for oversight and
compliance purposes, the final rule contains a requirement at Sec.
__.103(e), that for nonexempt research involving human subjects covered
by this policy (or exempt research for which limited IRB takes place
pursuant to Sec.  __.104(d)(2)(iii), Sec.  __.104(d)(3)(i)(C), Sec.
__.104(d)(7), or Sec.  __.104(d)(8)) that take place at an institution
in which IRB oversight is conducted by an IRB that is not operated by
the institution, the institution and the organization operating the IRB
shall document the institution's reliance on the IRB for oversight of
the research and the responsibilities that each entity will undertake
to ensure compliance with the requirements of this policy. This might
be accomplished through a written agreement between the institution and
the IRB, or by implementing an institution-wide policy directive
providing the allocation of responsibilities between the institution
and an IRB that is not affiliated with the institution, or as set forth
in a research protocol). In addition, a requirement is included at
Sec.  __.115(a)(9) that an institution include documentation of such
arrangements in the IRB records.
    Table 3 of the RIA section of the preamble shows that 5,164 FWA-
holding institutions do not have an IRB and 2,871 FWA-holding
institutions have an IRB. We assume that the 5,164 FWA-holding
institutions without an IRB have an average of 1 IRB authorization
agreement that will need to be modified as a result of the new
requirements for agreements between institutions and IRBs not operated
by the institutions in 2017. In addition, we assume that the 2,871 FWA-
holding institutions with an IRB have an average of 0.20 IRB
authorization agreements that will need to be modified in 2017. We
estimate that each agreement will require an average of 10 hours of
institution legal staff time and 5 hours of IRB administrator time to
complete. The dollar value of their time is calculated by multiplying
hours by their estimated 2017 wages and adjusting for overhead and
benefits.

Sec.  __.104(d)(5)(i) Posting of Information About Federally Funded or
Supported Demonstration Projects

    Section 104(d)(5)(i) requires each federal department or agency
conducting or supporting the research or demonstration projects covered
under this exemption to establish, on a publicly accessible federal Web
site or in such other manner as the department or agency head may
determine, a list of the research and demonstration projects that the
federal department or agency conducts or supports under this provision.
We estimate that under the pre-2018 rule, approximately 1,000
demonstration projects occurred each year. Under the modifications to
this exemption in the final rule, we estimate that an additional 3,376
studies will fall under this exemption. Thus, approximately 4,376
studies will be subject to this posting requirement each year. We
anticipate that investigators will spend approximately 15 minutes per
study submitting information about these studies to the federal Web
site.

Sec.  __.114 Cooperative Research (OMB Control No 0990-0260)

    The final rule requires any institution located in the United
States that is engaged in cooperative research to rely upon approval by
a single IRB for that portion of the research that is conducted in the
United States, as detailed in Sec.  __.114 (b)(1). The following
research is not subject to the requirements of this provision, as
described in Sec.  __.114 (b)(2): (1) Cooperative research for which
more than single IRB review is required by law (including tribal law
passed by the official governing body of a Native American or Alaska
Native tribe); or (2) research for which any federal department or
agency supporting or conducting the research determines and documents
that the use of a single IRB is not appropriate for the particular
study.
    The OHRP database of assurances shows that 8,035 institutions in
the United States have an FWA. We estimate that these institutions will

develop an average of 10 written joint IRB review agreements with other
institutions or organizations in 2019 before the first year of
compliance. We further estimate that each agreement will require an
average of 10 hours of institution legal staff time and 5 hours of IRB
administrator time to complete.
    We estimate that 202,617 annual reviews of multi-institutional
protocols take place, and an average of 5 reviews per multi-
institutional protocol, implying that 40,523 multi-institutional
protocols are reviewed each year. We further estimate that 16,209 (40
percent) of these multi-institutional studies are funded by NIH and
thus will already be subject to NIH's single IRB review policy.
Accordingly, we estimate that approximately 97,256 annual reviews of
protocols will no longer be conducted as a result of these proposed
changes. Of these reviews, 32,211 would have undergone convened initial
review, 14,472 would have undergone expedited initial review, 34,896
would have undergone convened continuing review, and 15,678 would have
undergone expedited continuing review based on the distribution of
reviews presented in Table 3 in the RIA section of the preamble.

Sec.  __.115(a)(3) Documenting the Rationale for Conducting Continuing
Review of Research That Otherwise Would Not Require Continuing
Review(OMB Control No 0990-0260)

    The final rule eliminates continuing review for many minimal risk
studies, as detailed at Sec.  __.109(f). Unless an IRB determines
otherwise, continuing review of research is not required if: (1) The
research is eligible for expedited review in accordance with Sec.
__.110; (2) the research is reviewed by the IRB in accordance with the
limited IRB review procedure described in several of the exemption
categories (specifically, Sec.  __.104(d)(2)(iii), Sec.
__.104(d)(3)(i)(C), Sec.  __.104(d)(7), or Sec.  __.104(d)(8)); or (3)
the research has progressed to the point that it involves data analysis
(including analysis of identifiable information or identifiable
biospecimens) or access to follow-up clinical data from procedures that
subjects would undergo as part of clinical care. If an IRB chooses to
conduct continuing review even when these conditions are met, the
rationale for doing so must be documented according to a new provision
at Sec.  __.115(a)(3).
    We estimate that 40,773 reviews will require documentation of the
rationale for doing so (as required under Sec.  __.115(a)(3)). We also
estimate that IRB voting members will spend 1 hour per review providing
the necessary documentation.

Sec. Sec.  __.116(a)(5), (b)(9), (c)(7)-(9) and __.117(b) Changes in
the Elements of Consent, Including Documentation (OMB Control No 0990-
0260)

    The final rule imposes a new requirement at Sec.  __.116(a)(5)(i)
informed consent must begin with a concise and focused presentation of
the key information that is most likely to assist a prospective subject
or legally authorized representative in understanding the reasons why
one might or might not want to participate in the research. This part
of informed consent must be organized and presented in a way that
facilitates comprehension. This requirement applies to all informed
consent process, except for broad consent obtained pursuant to Sec.
__.116(d), which may warrant a different presentation.
    The final rule includes a new element of consent at Sec.
__.116(b)(9) that requires one of the following statements be included
for any research that involves the collection of identifiable private
information or identifiable biospecimens: (1) A statement that
identifiers might be removed from the identifiable private information
or identifiable biospecimens and that after such removal, the
information or biospecimens could be used for future research studies
or distributed to another investigator for future research studies
without additional informed consent from the subject or the legally
authorized representative, if this might be a possibility; or (2) a
statement that the subject's information or biospecimens collected as
part of the research, even if identifiers are removed, will not be used
or distributed for future research studies.
    The final rule's three additional elements of consent are in Sec.
__.116(c)(7), (8), and (9). These require that a subject be informed of
the following, when appropriate:
     That the subject's biospecimens (even if identifiers are
removed) may be used for commercial profit and whether the subject will
or will not share in this commercial profit;
     Whether clinically relevant research results, including
individual research results, will be disclosed to subjects, and if so,
under what conditions;
     For research involving biospecimens, whether the research
will (if known) or might include whole genome sequencing (i.e.,
sequencing of a human germline or somatic specimen with the intent to
generate the genome or exome sequence of that specimen.
    These additional elements of consent will promote respect for
persons and greater transparency in the research enterprise.
Additionally, including the information referenced in these provisions
in a consent form will help ensure that prospective subjects are given
information necessary for understanding why one might choose whether to
participate in a research study.
    The language at Sec.  __.117(b)(1) in the final rule was modified
to reference Sec.  __.116(a)(5)(i) and state that if a short form
consent process is used, the key information required by Sec.
__.116(a)(5)(i) must be presented first to the prospective subject,
before other information, if any, is provided.
    We estimate that 246,382 new protocols annually will use
identifiable private information. For each protocol, we estimate that
investigators will spend an average of 15 minutes in 2017 updating
consent forms to comply with the new requirements found in the final
rule at Sec.  __.116(a)(5), (b)(9), (c)(7), (c)(8), or (c)(9) (in Table
3 in the RIA section).
    We assume that few additional investigators will elect to offer the
second option at Sec.  __.116(b)(9), and that the investigators who
currently offer equivalent options already track the permissible and
impermissible uses of information in line with the requirements
discussed above. As a result, we estimate that tracking will have no
additional associated impacts.

Sec.  __.116(h) Requirement for Posting of Consent Forms for Common
Rule Department or Agency-Supported or Conducted Clinical Trials (OMB
Control No 0990-0260)

    A new provision in the final rule, Sec.  __.116(h), requires that,
for each clinical trial conducted or supported by a federal department
or agency, one IRB-approved informed consent form used to enroll
subjects must be posted by the awardee or federal department or agency
component conducting the trial on a publicly available federal Web site
that is established as a repository for such informed consent forms.
The informed consent form must be published on the federal Web site
after the trial is closed to recruitment, and no later than 60 days
after the last study visit by any subject, as required by the protocol.
    If the federal department or agency supporting or conducting the
clinical trial determines that certain information should not be made
publicly available on a federal Web site (e.g., confidential commercial
information), such Federal department or agency may permit or

require redactions to the information posted.
    We believe that public posting of consent forms will increase
transparency, enhance confidence in the research enterprise, increase
accountability, and inform the development of future consent forms,
possibly resulting in future savings in time for investigators
developing consent forms.
    According to queries of ClinicalTrials.gov, an estimated 5,270
clinical trials are conducted or supported by Common Rule agencies, of
which an estimated 575 are regulated by provisions in the FD&C Act and
Trade Secrets Act based on the information presented in Table 3 in the
RIA section of the preamble. We assume that each clinical trial is
associated with one consent form that must be submitted to the HHS
system by an investigator. We estimate that investigators will spend an
average of 15 minutes submitting each consent form. In addition, for
the 575 clinical trials regulated by provisions in the FD&C Act and
Trade Secrets Act, we estimate that investigators will spend an average
of 30 minutes redacting information before submission.

                                                       Table 21--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
             Sec. description                   Description of burden        Number of     responses per   Total annual    Average hours    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
101(a)--Extending Oversight Authority to    Develop agreements..........             449              10           4,490              15          67,350
 IRBs not operated by an FWA-holding
 institution.
103(e)--IRB Reliance Documentation          Modify agreements...........           5,164               1           5,164              15          77,460
 (institutions without an internal IRB).
103(e)--IRB Reliance Documentation          Develop agreements..........           2,871            0.20          574.20              15           8,613
 (institutions with an internal IRB).
104(d)(5)(i)--Posting information about     Posting information.........           4,376               1           4,376            0.25           1,094
 demonstration projects.
114--Cooperative Review...................  Time to create agreements              8,035              10          80,350              15       1,205,250
                                             for all institutions
                                             involved in a study will
                                             rely on one IRB of record.
115(a)(3)--Continuing Review Rationale      Provide rationale...........          40,773               1          40,773               1          40,773
 Documentation.
116(a)(5), (b)(9), (c)(7)-(8) & 117(b)--    Updating IC forms with new           246,382               1         246,382            0.25          61,596
 Changes in elements of informed consent,    elements.
 including documentation.
116(h)--Requirement for posting consent     Posting consent forms for              5,270               1           5,270            0.25           1,318
 forms for Common Rule department or         new clinical trials.
 agency-supported clinical trials.
116(h)--Requirement for posting consent     Redact information from                  575               1             575            0.50             288
 forms for Common Rule department or         consent forms.
 agency-supported clinical trials.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.................................  ............................  ..............  ..............  ..............  ..............       1,422,968
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total estimated burden imposed by these information collection
requirements is 1,422,968 burden hours.
    It should be noted that the burden estimates for the Common Rule
include approved information requirements in OMB No. 0990-0260,
Protection of Human Subjects: Compliance with Federal Policy/IRB
Recordkeeping/Informed Consent/Consent Documentation, approved through
May 31, 2018. As such, it will be amended and submitted to OMB as
revisions to currently approved collections once the rule is finalized
and the collections are due for renewal.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the information collection provisions of this rule will be
submitted to OMB for review. These requirements will not be effective
until OMB approves them.

XXII. Tribal Consultation Statement

    We are committed to consulting with AI/AN tribes and tribal
leadership to the extent practicable and permitted by law before
promulgating any regulation that has tribal implications. As we
developed this rule, we engaged with tribes through tribal consultation
and the public comment process. The requirements in this final rule
were informed by consultations with and comments from tribal
representatives.
    On January 5, 2016, HHS conducted a tribal consultation through
conference call in accordance with the HHS Tribal Consultation Policy
\61\ with tribal representatives to obtain comments on

the proposed changes to the Common Rule. This conference call was
moderated by Elizabeth Carr, a Tribal Affairs Specialist within HHS and
a federal representative of HHS's American Indian and Alaska Native
Health Research Advisory Council. Tribal leaders and other interested
parties were informed of this consultation through written
communication. The written invitation included a solicitation for
formal comments and information on how to submit a formal comment to
the public docket. Public comments were also solicited during the
consultation conference call. A transcript of this call was posted to
the Regulations.gov public docket for the Common Rule on January 13,
2016.
---------------------------------------------------------------------------

    \61\ U.S. Department of Health and Human Services Tribal
Consultation Policy. Retrieved from https://www.hhs.gov/sites/default/files/iea/tribal/tribalconsultation/hhs-consultation-policy.pdf.
---------------------------------------------------------------------------

    During the tribal consultation conference call, participants
discussed:
     Concern about the NPRM not acknowledging the role of
tribal governments in research oversight of research occurring on
tribal land or with tribal citizens;
     Concern about the pre-2018 rule and the NPRM not
explicitly acknowledging tribal sovereignty. HHS representatives
acknowledged an outstanding legal question about whether rules created
by tribal governments were encompassed by the provision in the pre-2018
rule and the NPRM's statement that the policy does not affect any state
or local laws or regulations that may otherwise be applicable and that
provide additional protections for human subjects;
     Concern about the NPRM not acknowledging the unique and
significant impact that the proposed changes would have on American
Indian and Alaska Native populations;
     Concern that the NPRM does not address risks of research
to communities and only addresses individual risks;
     Concern that the NPRM proposals seem to reduce
institutional responsibility but increase investigator responsibility.
This presents a unique challenge when institutions have entered into
agreements with tribal governments or tribal representatives, as
opposed to individual investigators entering into these arrangements.
The exemption decision tool was cited as an example of the proposals
placing more responsibility on the investigators while perhaps reducing
responsibility on the institutions; and
     Concern about the single IRB review mandate for multi-
institutional studies affecting the ability of tribal communities to
conduct local reviews of research involving tribal citizens or research
that takes place on tribal land. One commenter noted that a one size
fits all approach to addressing American Indian and Alaska Native
concerns in human subjects protections might not be appropriate as
needs and concerns might vary from tribe to tribe.
    HHS reiterated its commitment to engaging in an ongoing dialogue
with tribal communities and tribal representatives, and welcomed
ongoing discussion and comment on how the Common Rule affects these
groups.
    In addition to the January 2016 tribal consultation, we reviewed
public comments from tribal representatives, and individuals and groups
representing tribal interests to the ANPRM and NPRM. We received one
comment on the ANPRM from a group representing tribal interests. This
group noted ``the long and challenging history'' of research involving
AI/AN populations, and how this history informs current research
activities involving these groups. This comment argued that, for
research involving AI/AN populations:
     Continuing review should be required;
     IRBs, not investigators or other parties, should determine
whether a prospective study is exempt or excluded from the Common Rule;
     IRBs should be required to consider potential harms to
populations or groups, not just individuals, when reviewing research
activities;
     Incorporating tribal IRBs into the process for multi-
institutional studies is a crucial aspect of respecting these
populations and ensuring human subjects protections;
     Study-specific informed consent forms should be required,
and general, multi-purpose consent forms should be avoided;
     Mandated information and biospecimen privacy safeguards
would be a welcome improvement to the current research landscape and
would help prevent harm to human subjects; and
     Consultation with tribal representatives would be crucial
should a proposed rule or final rule mandate single IRB review for
multi-institutional studies.
    We received approximately 15 comments on the NPRM from groups
representing tribal interests. As described in Section II.E of this
preamble, overarching concerns raised by these groups in comments to
the NPRM included:
     Lack of group consent requirements proposed in the NPRM;
     Concern about the allowance for broad consent for future
unspecified research uses;
     Lack of consideration for research activities involving
research with biospecimens or information from individuals who are no
longer alive;
     Mandating the use of single IRB review in multi-
institutional research activities undermining the ability of tribal
groups to conduct local review of studies; and
     Concern about the breadth and depth of exclusions and
exemptions proposed in the NPRM exempting or excluding activities that
tribal populations might find sensitive and requiring IRB review.
    Commenters also raised concerns about the timing of the tribal
consultation call and noted that the tribal consultation call occurred
one day before the closing of the extended comment period for the NPRM.
When HHS received notice that tribal representatives desired to consult
on this proposed rule, a consultation was immediately scheduled in
accordance with HHS policy.
    The final rule includes a modification to the provision requiring
single IRB review, and several clarifications specifying that
regulatory references to state and local law are intended to include
tribal law, in response to concerns raised during the tribal
consultation and in the NPRM public comments. As described in this
preamble, the final rule clarifies in Sec.  __.101(f) that tribal
governments can develop laws related to the protection of human
subjects that are more protective than the Common Rule, and that these
laws must be followed by federally funded researches in activities
involving these populations. Section __.114 now provides that if a
tribal government requires review by more than one IRB by law in multi-
institutional research, the single IRB review requirement in Sec.
__.114 does not apply. Additional clarification has also been made to
Sec.  __.116(i) that tribal governments can develop their own informed
consent standards that provide additional protections to subjects and
that investigators conducting research involving populations under the
jurisdiction of the tribal governments would have to follow these
rules. Finally, additional language has been added to Sec.  __.116(j)
noting that nothing in Sec.  __.116 is intended to limit the authority
of a treating physician to the extent the authority is granted by
tribal law.
    Additional details of public comments from individuals representing
tribal interests are included above in the relevant public comment
summaries for the various final rule provisions discussed in Sections
II through XVIII of this preamble.

    For the reasons set forth in this preamble, the Federal Policy for
the Protection of Human Subjects is amended.

Text of the Final Common Rule

    The text of the final common rule appears below:
    1. Part/subpart __is amended/revised/added to read as follows:

PART __--PROTECTION OF HUMAN SUBJECTS

__.101 To what does this policy apply?
__.102 Definitions for purposes of this policy.
__.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
__.104 Exempt research.
__.105 [Reserved]
__.106 [Reserved]
__.107 IRB membership.
__.108 IRB functions and operations.
__.109 IRB review of research.
__.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
__.111 Criteria for IRB approval of research.
__.112 Review by institution.
__.113 Suspension or termination of IRB approval of research.
__.114 Cooperative research.
__.115 IRB records.
__.116 General requirements for informed consent.
__.117 Documentation of informed consent.
__.118 Applications and proposals lacking definite plans for
involvement of human subjects.
__.119 Research undertaken without the intention of involving human
subjects.
__.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
__.121 [Reserved]
__.122 Use of Federal funds.
__.123 Early termination of research support: Evaluation of
applications and proposals.
__.124 Conditions.

Sec.  __.101 To what does this policy apply?

    (a) Except as detailed in Sec.  __.104, this policy applies to all
research involving human subjects conducted, supported, or otherwise
subject to regulation by any Federal department or agency that takes
appropriate administrative action to make the policy applicable to such
research. This includes research conducted by Federal civilian
employees or military personnel, except that each department or agency
head may adopt such procedural modifications as may be appropriate from
an administrative standpoint. It also includes research conducted,
supported, or otherwise subject to regulation by the Federal Government
outside the United States. Institutions that are engaged in research
described in this paragraph and institutional review boards (IRBs)
reviewing research that is subject to this policy must comply with this
policy.
    (b) [Reserved]
    (c) Department or agency heads retain final judgment as to whether
a particular activity is covered by this policy and this judgment shall
be exercised consistent with the ethical principles of the Belmont
Report.\62\
---------------------------------------------------------------------------

    \62\ The National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research.- Belmont Report.
Washington, DC: U.S. Department of Health and Human Services. 1979.
---------------------------------------------------------------------------

    (d) Department or agency heads may require that specific research
activities or classes of research activities conducted, supported, or
otherwise subject to regulation by the Federal department or agency but
not otherwise covered by this policy comply with some or all of the
requirements of this policy.
    (e) Compliance with this policy requires compliance with pertinent
federal laws or regulations that provide additional protections for
human subjects.
    (f) This policy does not affect any state or local laws or
regulations (including tribal law passed by the official governing body
of an American Indian or Alaska Native tribe) that may otherwise be
applicable and that provide additional protections for human subjects.
    (g) This policy does not affect any foreign laws or regulations
that may otherwise be applicable and that provide additional
protections to human subjects of research.
    (h) When research covered by this policy takes place in foreign
countries, procedures normally followed in the foreign countries to
protect human subjects may differ from those set forth in this policy.
In these circumstances, if a department or agency head determines that
the procedures prescribed by the institution afford protections that
are at least equivalent to those provided in this policy, the
department or agency head may approve the substitution of the foreign
procedures in lieu of the procedural requirements provided in this
policy. Except when otherwise required by statute, Executive Order, or
the department or agency head, notices of these actions as they occur
will be published in the Federal Register or will be otherwise
published as provided in department or agency procedures.
    (i) Unless otherwise required by law, department or agency heads
may waive the applicability of some or all of the provisions of this
policy to specific research activities or classes of research
activities otherwise covered by this policy, provided the alternative
procedures to be followed are consistent with the principles of the
Belmont Report.\63\ Except when otherwise required by statute or
Executive Order, the department or agency head shall forward advance
notices of these actions to the Office for Human Research Protections,
Department of Health and Human Services (HHS), or any successor office,
or to the equivalent office within the appropriate Federal department
or agency, and shall also publish them in the Federal Register or in
such other manner as provided in department or agency procedures. The
waiver notice must include a statement that identifies the conditions
under which the waiver will be applied and a justification as to why
the waiver is appropriate for the research, including how the decision
is consistent with the principles of the Belmont Report.
---------------------------------------------------------------------------

    \63\ Id.
---------------------------------------------------------------------------

    (j) Federal guidance on the requirements of this policy shall be
issued only after consultation, for the purpose of harmonization (to
the extent appropriate), with other Federal departments and agencies
that have adopted this policy, unless such consultation is not
feasible.
    (k) [Reserved]
    (l) Compliance dates and transition provisions:
    (1) For purposes of this section, the pre-2018 Requirements means
this subpart as published in the 2016 edition of the Code of Federal
Regulations.
    (2) For purposes of this section, the 2018 Requirements means the
Federal Policy for the Protection of Human Subjects requirements
contained in this subpart. The compliance date for Sec.  __.114(b)
(cooperative research) of the 2018 Requirements is January 20, 2020.
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  __.101(i), or for which a determination
was made that the research was exempt before January 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after January 19, 2018, may instead
comply with the 2018 Requirements if the institution determines that
such ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
    (4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  __.101(i), or for which a

determination was made that the research was exempt on or after January
19, 2018, shall comply with the 2018 Requirements.
    (m) Severability: Any provision of this part held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this part and shall not affect the
remainder thereof or the application of the provision to other persons
not similarly situated or to other dissimilar circumstances.

Sec.  __.102 Definitions for purposes of this policy.

    (a) Certification means the official notification by the
institution to the supporting Federal department or agency component,
in accordance with the requirements of this policy, that a research
project or activity involving human subjects has been reviewed and
approved by an IRB in accordance with an approved assurance.
    (b) Clinical trial means a research study in which one or more
human subjects are prospectively assigned to one or more interventions
(which may include placebo or other control) to evaluate the effects of
the interventions on biomedical or behavioral health-related outcomes.
    (c) Department or agency head means the head of any Federal
department or agency, for example, the Secretary of HHS, and any other
officer or employee of any Federal department or agency to whom the
authority provided by these regulations to the department or agency
head has been delegated.
    (d) Federal department or agency refers to a federal department or
agency (the department or agency itself rather than its bureaus,
offices or divisions) that takes appropriate administrative action to
make this policy applicable to the research involving human subjects it
conducts, supports, or otherwise regulates (e.g., the U.S. Department
of Health and Human Services, the U.S. Department of Defense, or the
Central Intelligence Agency).
    (e)(1) Human subject means a living individual about whom an
investigator (whether professional or student) conducting research:
    (i) Obtains information or biospecimens through intervention or
interaction with the individual, and uses, studies, or analyzes the
information or biospecimens; or (ii) Obtains, uses, studies, analyzes,
or generates identifiable private information or identifiable
biospecimens.
    (2) Intervention includes both physical procedures by which
information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are
performed for research purposes.
    (3) Interaction includes communication or interpersonal contact
between investigator and subject.
    (4) Private information includes information about behavior that
occurs in a context in which an individual can reasonably expect that
no observation or recording is taking place, and information that has
been provided for specific purposes by an individual and that the
individual can reasonably expect will not be made public (e.g., a
medical record).
    (5) Identifiable private information is private information for
which the identity of the subject is or may readily be ascertained by
the investigator or associated with the information.
    (6) An identifiable biospecimen is a biospecimen for which the
identity of the subject is or may readily be ascertained by the
investigator or associated with the biospecimen.
    (7) Federal departments or agencies implementing this policy shall:
    (i) Upon consultation with appropriate experts (including experts
in data matching and re-identification), reexamine the meaning of
``identifiable private information,'' as defined in paragraph (e)(5) of
this section, and ``identifiable biospecimen,'' as defined in paragraph
(e)(6) of this section. This reexamination shall take place within 1
year and regularly thereafter (at least every 4 years). This process
will be conducted by collaboration among the Federal departments and
agencies implementing this policy. If appropriate and permitted by law,
such Federal departments and agencies may alter the interpretation of
these terms, including through the use of guidance.
    (ii) Upon consultation with appropriate experts, assess whether
there are analytic technologies or techniques that should be considered
by investigators to generate ``identifiable private information,'' as
defined in paragraph (e)(5) of this section, or an ``identifiable
biospecimen,'' as defined in paragraph (e)(6) of this section. This
assessment shall take place within 1 year and regularly thereafter (at
least every 4 years). This process will be conducted by collaboration
among the Federal departments and agencies implementing this policy.
Any such technologies or techniques will be included on a list of
technologies or techniques that produce identifiable private
information or identifiable biospecimens. This list will be published
in the Federal Register after notice and an opportunity for public
comment. The Secretary, HHS, shall maintain the list on a publicly
accessible Web site.
    (f) Institution means any public or private entity, or department
or agency (including federal, state, and other agencies).
    (g) IRB means an institutional review board established in accord
with and for the purposes expressed in this policy.
    (h) IRB approval means the determination of the IRB that the
research has been reviewed and may be conducted at an institution
within the constraints set forth by the IRB and by other institutional
and federal requirements.
    (i) Legally authorized representative means an individual or
judicial or other body authorized under applicable law to consent on
behalf of a prospective subject to the subject's participation in the
procedure(s) involved in the research. If there is no applicable law
addressing this issue, legally authorized representative means an
individual recognized by institutional policy as acceptable for
providing consent in the nonresearch context on behalf of the
prospective subject to the subject's participation in the procedure(s)
involved in the research.
    (j) Minimal risk means that the probability and magnitude of harm
or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations or
tests.
    (k) Public health authority means an agency or authority of the
United States, a state, a territory, a political subdivision of a state
or territory, an Indian tribe, or a foreign government, or a person or
entity acting under a grant of authority from or contract with such
public agency, including the employees or agents of such public agency
or its contractors or persons or entities to whom it has granted
authority, that is responsible for public health matters as part of its
official mandate.
    (l) Research means a systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute
to generalizable knowledge. Activities that meet this definition
constitute research for purposes of this policy, whether or not they
are conducted or supported under a program that is considered research
for other purposes. For example, some demonstration and

service programs may include research activities. For purposes of this
part, the following activities are deemed not to be research:
    (1) Scholarly and journalistic activities (e.g., oral history,
journalism, biography, literary criticism, legal research, and
historical scholarship), including the collection and use of
information, that focus directly on the specific individuals about whom
the information is collected.
    (2) Public health surveillance activities, including the collection
and testing of information or biospecimens, conducted, supported,
requested, ordered, required, or authorized by a public health
authority. Such activities are limited to those necessary to allow a
public health authority to identify, monitor, assess, or investigate
potential public health signals, onsets of disease outbreaks, or
conditions of public health importance (including trends, signals, risk
factors, patterns in diseases, or increases in injuries from using
consumer products). Such activities include those associated with
providing timely situational awareness and priority setting during the
course of an event or crisis that threatens public health (including
natural or man-made disasters).
    (3) Collection and analysis of information, biospecimens, or
records by or for a criminal justice agency for activities authorized
by law or court order solely for criminal justice or criminal
investigative purposes.
    (4) Authorized operational activities (as determined by each
agency) in support of intelligence, homeland security, defense, or
other national security missions.
    (m) Written, or in writing, for purposes of this part, refers to
writing on a tangible medium (e.g., paper) or in an electronic format.

Sec.  __.103 Assuring compliance with this policy--research conducted
or supported by any Federal department or agency.

    (a) Each institution engaged in research that is covered by this
policy, with the exception of research eligible for exemption under
Sec.  __.104, and that is conducted or supported by a Federal
department or agency, shall provide written assurance satisfactory to
the department or agency head that it will comply with the requirements
of this policy. In lieu of requiring submission of an assurance,
individual department or agency heads shall accept the existence of a
current assurance, appropriate for the research in question, on file
with the Office for Human Research Protections, HHS, or any successor
office, and approved for Federal-wide use by that office. When the
existence of an HHS-approved assurance is accepted in lieu of requiring
submission of an assurance, reports (except certification) required by
this policy to be made to department and agency heads shall also be
made to the Office for Human Research Protections, HHS, or any
successor office. Federal departments and agencies will conduct or
support research covered by this policy only if the institution has
provided an assurance that it will comply with the requirements of this
policy, as provided in this section, and only if the institution has
certified to the department or agency head that the research has been
reviewed and approved by an IRB (if such certification is required by
Sec.  __.103(d)).
    (b) The assurance shall be executed by an individual authorized to
act for the institution and to assume on behalf of the institution the
obligations imposed by this policy and shall be filed in such form and
manner as the department or agency head prescribes.
    (c) The department or agency head may limit the period during which
any assurance shall remain effective or otherwise condition or restrict
the assurance.
    (d) Certification is required when the research is supported by a
Federal department or agency and not otherwise waived under Sec.
__.101(i) or exempted under Sec.  __.104. For such research,
institutions shall certify that each proposed research study covered by
the assurance and this section has been reviewed and approved by the
IRB. Such certification must be submitted as prescribed by the Federal
department or agency component supporting the research. Under no
condition shall research covered by this section be initiated prior to
receipt of the certification that the research has been reviewed and
approved by the IRB.
    (e) For nonexempt research involving human subjects covered by this
policy (or exempt research for which limited IRB review takes place
pursuant to Sec.  __.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8))
that takes place at an institution in which IRB oversight is conducted
by an IRB that is not operated by the institution, the institution and
the organization operating the IRB shall document the institution's
reliance on the IRB for oversight of the research and the
responsibilities that each entity will undertake to ensure compliance
with the requirements of this policy (e.g., in a written agreement
between the institution and the IRB, by implementation of an
institution-wide policy directive providing the allocation of
responsibilities between the institution and an IRB that is not
affiliated with the institution, or as set forth in a research
protocol).

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.104 Exempt research.

    (a) Unless otherwise required by law or by department or agency
heads, research activities in which the only involvement of human
subjects will be in one or more of the categories in paragraph (d) of
this section are exempt from the requirements of this policy, except
that such activities must comply with the requirements of this section
and as specified in each category.
    (b) Use of the exemption categories for research subject to the
requirements of subparts B, C, and D: Application of the exemption
categories to research subject to the requirements of 45 CFR part 46,
subparts B, C, and D, is as follows:
    (1) Subpart B. Each of the exemptions at this section may be
applied to research subject to subpart B if the conditions of the
exemption are met.
    (2) Subpart C. The exemptions at this section do not apply to
research subject to subpart C, except for research aimed at involving a
broader subject population that only incidentally includes prisoners.
    (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6),
(7), and (8) of this section may be applied to research subject to
subpart D if the conditions of the exemption are met. Paragraphs
(d)(2)(i) and (ii) of this section only may apply to research subject
to subpart D involving educational tests or the observation of public
behavior when the investigator(s) do not participate in the activities
being observed. Paragraph (d)(2)(iii) of this section may not be
applied to research subject to subpart D.
    (c) [Reserved.]
    (d) Except as described in paragraph (a) of this section, the
following categories of human subjects research are exempt from this
policy:
    (1) Research, conducted in established or commonly accepted
educational settings, that specifically involves normal educational
practices that are not likely to adversely impact students' opportunity
to learn required educational content or the assessment of educators
who provide instruction. This includes most research on regular and
special education instructional strategies, and research on the
effectiveness of or the comparison among instructional techniques,

curricula, or classroom management methods.
    (2) Research that only includes interactions involving educational
tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior
(including visual or auditory recording) if at least one of the
following criteria is met:
    (i) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects cannot readily be
ascertained, directly or through identifiers linked to the subjects;
    (ii) Any disclosure of the human subjects' responses outside the
research would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial standing,
employability, educational advancement, or reputation; or
    (iii) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects can readily be
ascertained, directly or through identifiers linked to the subjects,
and an IRB conducts a limited IRB review to make the determination
required by Sec.  __.111(a)(7).
    (3)(i) Research involving benign behavioral interventions in
conjunction with the collection of information from an adult subject
through verbal or written responses (including data entry) or
audiovisual recording if the subject prospectively agrees to the
intervention and information collection and at least one of the
following criteria is met:
    (A) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects cannot readily be
ascertained, directly or through identifiers linked to the subjects;
    (B) Any disclosure of the human subjects' responses outside the
research would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial standing,
employability, educational advancement, or reputation; or
    (C) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects can readily be
ascertained, directly or through identifiers linked to the subjects,
and an IRB conducts a limited IRB review to make the determination
required by Sec.  __.111(a)(7).
    (ii) For the purpose of this provision, benign behavioral
interventions are brief in duration, harmless, painless, not physically
invasive, not likely to have a significant adverse lasting impact on
the subjects, and the investigator has no reason to think the subjects
will find the interventions offensive or embarrassing. Provided all
such criteria are met, examples of such benign behavioral interventions
would include having the subjects play an online game, having them
solve puzzles under various noise conditions, or having them decide how
to allocate a nominal amount of received cash between themselves and
someone else.
    (iii) If the research involves deceiving the subjects regarding the
nature or purposes of the research, this exemption is not applicable
unless the subject authorizes the deception through a prospective
agreement to participate in research in circumstances in which the
subject is informed that he or she will be unaware of or misled
regarding the nature or purposes of the research.
    (4) Secondary research for which consent is not required: Secondary
research uses of identifiable private information or identifiable
biospecimens, if at least one of the following criteria is met:
    (i) The identifiable private information or identifiable
biospecimens are publicly available;
    (ii) Information, which may include information about biospecimens,
is recorded by the investigator in such a manner that the identity of
the human subjects cannot readily be ascertained directly or through
identifiers linked to the subjects, the investigator does not contact
the subjects, and the investigator will not re-identify subjects;
    (iii) The research involves only information collection and
analysis involving the investigator's use of identifiable health
information when that use is regulated under 45 CFR parts 160 and 164,
subparts A and E, for the purposes of ``health care operations'' or
``research'' as those terms are defined at 45 CFR 164.501 or for
``public health activities and purposes'' as described under 45 CFR
164.512(b); or
    (iv) The research is conducted by, or on behalf of, a Federal
department or agency using government-generated or government-collected
information obtained for nonresearch activities, if the research
generates identifiable private information that is or will be
maintained on information technology that is subject to and in
compliance with section 208(b) of the E-Government Act of 2002, 44
U.S.C. 3501 note, if all of the identifiable private information
collected, used, or generated as part of the activity will be
maintained in systems of records subject to the Privacy Act of 1974, 5
U.S.C. 552a, and, if applicable, the information used in the research
was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C.
3501 et seq.
    (5) Research and demonstration projects that are conducted or
supported by a Federal department or agency, or otherwise subject to
the approval of department or agency heads (or the approval of the
heads of bureaus or other subordinate agencies that have been delegated
authority to conduct the research and demonstration projects), and that
are designed to study, evaluate, improve, or otherwise examine public
benefit or service programs, including procedures for obtaining
benefits or services under those programs, possible changes in or
alternatives to those programs or procedures, or possible changes in
methods or levels of payment for benefits or services under those
programs. Such projects include, but are not limited to, internal
studies by Federal employees, and studies under contracts or consulting
arrangements, cooperative agreements, or grants. Exempt projects also
include waivers of otherwise mandatory requirements using authorities
such as sections 1115 and 1115A of the Social Security Act, as amended.
    (i) Each Federal department or agency conducting or supporting the
research and demonstration projects must establish, on a publicly
accessible Federal Web site or in such other manner as the department
or agency head may determine, a list of the research and demonstration
projects that the Federal department or agency conducts or supports
under this provision. The research or demonstration project must be
published on this list prior to commencing the research involving human
subjects.
    (ii) [Reserved]
    (6) Taste and food quality evaluation and consumer acceptance
studies:
    (i) If wholesome foods without additives are consumed, or
    (ii) If a food is consumed that contains a food ingredient at or
below the level and for a use found to be safe, or agricultural
chemical or environmental contaminant at or below the level found to be
safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection
Service of the U.S. Department of Agriculture.
    (7) Storage or maintenance for secondary research for which broad
consent is required: Storage or maintenance of identifiable private
information or identifiable biospecimens for potential secondary
research use if an IRB conducts a limited IRB review and makes the

determinations required by Sec.  __.111(a)(8).
    (8) Secondary research for which broad consent is required:
Research involving the use of identifiable private information or
identifiable biospecimens for secondary research use, if the following
criteria are met:
    (i) Broad consent for the storage, maintenance, and secondary
research use of the identifiable private information or identifiable
biospecimens was obtained in accordance with Sec.  __.116(a)(1) through
(4), (a)(6), and (d);
    (ii) Documentation of informed consent or waiver of documentation
of consent was obtained in accordance with Sec.  __.117;
    (iii) An IRB conducts a limited IRB review and makes the
determination required by Sec.  __.111(a)(7) and makes the
determination that the research to be conducted is within the scope of
the broad consent referenced in paragraph (d)(8)(i) of this section;
and (iv) The investigator does not include returning individual
research results to subjects as part of the study plan. This provision
does not prevent an investigator from abiding by any legal requirements
to return individual research results.

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.105 [Reserved.]

Sec.  __.106 [Reserved]

Sec.  __.107 IRB membership.

    (a) Each IRB shall have at least five members, with varying
backgrounds to promote complete and adequate review of research
activities commonly conducted by the institution. The IRB shall be
sufficiently qualified through the experience and expertise of its
members (professional competence), and the diversity of its members,
including race, gender, and cultural backgrounds and sensitivity to
such issues as community attitudes, to promote respect for its advice
and counsel in safeguarding the rights and welfare of human subjects.
The IRB shall be able to ascertain the acceptability of proposed
research in terms of institutional commitments (including policies and
resources) and regulations, applicable law, and standards of
professional conduct and practice. The IRB shall therefore include
persons knowledgeable in these areas. If an IRB regularly reviews
research that involves a category of subjects that is vulnerable to
coercion or undue influence, such as children, prisoners, individuals
with impaired decision-making capacity, or economically or
educationally disadvantaged persons, consideration shall be given to
the inclusion of one or more individuals who are knowledgeable about
and experienced in working with these categories of subjects.
    (b) Each IRB shall include at least one member whose primary
concerns are in scientific areas and at least one member whose primary
concerns are in nonscientific areas.
    (c) Each IRB shall include at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate
family of a person who is affiliated with the institution.
    (d) No IRB may have a member participate in the IRB's initial or
continuing review of any project in which the member has a conflicting
interest, except to provide information requested by the IRB.
    (e) An IRB may, in its discretion, invite individuals with
competence in special areas to assist in the review of issues that
require expertise beyond or in addition to that available on the IRB.
These individuals may not vote with the IRB.

Sec.  __.108 IRB functions and operations.

    (a) In order to fulfill the requirements of this policy each IRB
shall:
    (1) Have access to meeting space and sufficient staff to support
the IRB's review and recordkeeping duties;
    (2) Prepare and maintain a current list of the IRB members
identified by name; earned degrees; representative capacity;
indications of experience such as board certifications or licenses
sufficient to describe each member's chief anticipated contributions to
IRB deliberations; and any employment or other relationship between
each member and the institution, for example, full-time employee, part-
time employee, member of governing panel or board, stockholder, paid or
unpaid consultant;
    (3) Establish and follow written procedures for:
    (i) Conducting its initial and continuing review of research and
for reporting its findings and actions to the investigator and the
institution;
    (ii) Determining which projects require review more often than
annually and which projects need verification from sources other than
the investigators that no material changes have occurred since previous
IRB review; and
    (iii) Ensuring prompt reporting to the IRB of proposed changes in a
research activity, and for ensuring that investigators will conduct the
research activity in accordance with the terms of the IRB approval
until any proposed changes have been reviewed and approved by the IRB,
except when necessary to eliminate apparent immediate hazards to the
subject.
    (4) Establish and follow written procedures for ensuring prompt
reporting to the IRB; appropriate institutional officials; the
department or agency head; and the Office for Human Research
Protections, HHS, or any successor office, or the equivalent office
within the appropriate Federal department or agency of
    (i) Any unanticipated problems involving risks to subjects or
others or any serious or continuing noncompliance with this policy or
the requirements or determinations of the IRB; and
    (ii) Any suspension or termination of IRB approval.
    (b) Except when an expedited review procedure is used (as described
in Sec.  __.110), an IRB must review proposed research at convened
meetings at which a majority of the members of the IRB are present,
including at least one member whose primary concerns are in
nonscientific areas. In order for the research to be approved, it shall
receive the approval of a majority of those members present at the
meeting.

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.109 IRB review of research.

    (a) An IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all research
activities covered by this policy, including exempt research activities
under Sec.  __.104 for which limited IRB review is a condition of
exemption (under Sec.  __.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and
(8)).
    (b) An IRB shall require that information given to subjects (or
legally authorized representatives, when appropriate) as part of
informed consent is in accordance with Sec.  __.116. The IRB may
require that information, in addition to that specifically mentioned in
Sec.  __.116, be given to the subjects when in the IRB's judgment the
information would meaningfully add to the protection of the rights and
welfare of subjects.
    (c) An IRB shall require documentation of informed consent or may
waive documentation in accordance with Sec.  __.117.
    (d) An IRB shall notify investigators and the institution in
writing of its decision to approve or disapprove the proposed research
activity, or of modifications required to secure IRB

approval of the research activity. If the IRB decides to disapprove a
research activity, it shall include in its written notification a
statement of the reasons for its decision and give the investigator an
opportunity to respond in person or in writing.
    (e) An IRB shall conduct continuing review of research requiring
review by the convened IRB at intervals appropriate to the degree of
risk, not less than once per year, except as described in Sec.
__.109(f).
    (f)(1) Unless an IRB determines otherwise, continuing review of
research is not required in the following circumstances:
    (i) Research eligible for expedited review in accordance with Sec.
__.110;
    (ii) Research reviewed by the IRB in accordance with the limited
IRB review described in Sec.  __.104(d)(2)(iii), (d)(3)(i)(C), or
(d)(7) or (8);
    (iii) Research that has progressed to the point that it involves
only one or both of the following, which are part of the IRB-approved
study:
    (A) Data analysis, including analysis of identifiable private
information or identifiable biospecimens, or
    (B) Accessing follow-up clinical data from procedures that subjects
would undergo as part of clinical care.
    (2) [Reserved.]
    (g) An IRB shall have authority to observe or have a third party
observe the consent process and the research.

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in approved
research.

    (a) The Secretary of HHS has established, and published as a Notice
in the Federal Register, a list of categories of research that may be
reviewed by the IRB through an expedited review procedure. The
Secretary will evaluate the list at least every 8 years and amend it,
as appropriate, after consultation with other federal departments and
agencies and after publication in the Federal Register for public
comment. A copy of the list is available from the Office for Human
Research Protections, HHS, or any successor office.
    (b)(1) An IRB may use the expedited review procedure to review the
following:
    (i) Some or all of the research appearing on the list described in
paragraph (a) of this section, unless the reviewer determines that the
study involves more than minimal risk;
    (ii) Minor changes in previously approved research during the
period for which approval is authorized; or
    (iii) Research for which limited IRB review is a condition of
exemption under Sec.  __.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and
(8).
    (2) Under an expedited review procedure, the review may be carried
out by the IRB chairperson or by one or more experienced reviewers
designated by the chairperson from among members of the IRB. In
reviewing the research, the reviewers may exercise all of the
authorities of the IRB except that the reviewers may not disapprove the
research. A research activity may be disapproved only after review in
accordance with the nonexpedited procedure set forth in Sec.
__.108(b).
    (c) Each IRB that uses an expedited review procedure shall adopt a
method for keeping all members advised of research proposals that have
been approved under the procedure.
    (d) The department or agency head may restrict, suspend, terminate,
or choose not to authorize an institution's or IRB's use of the
expedited review procedure.

Sec.  __.111 Criteria for IRB approval of research.

    (a) In order to approve research covered by this policy the IRB
shall determine that all of the following requirements are satisfied:
    (1) Risks to subjects are minimized:
    (i) By using procedures that are consistent with sound research
design and that do not unnecessarily expose subjects to risk, and
    (ii) Whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes.
    (2) Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects, and the importance of the knowledge that
may reasonably be expected to result. In evaluating risks and benefits,
the IRB should consider only those risks and benefits that may result
from the research (as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the
research). The IRB should not consider possible long-range effects of
applying knowledge gained in the research (e.g., the possible effects
of the research on public policy) as among those research risks that
fall within the purview of its responsibility.
    (3) Selection of subjects is equitable. In making this assessment
the IRB should take into account the purposes of the research and the
setting in which the research will be conducted. The IRB should be
particularly cognizant of the special problems of research that
involves a category of subjects who are vulnerable to coercion or undue
influence, such as children, prisoners, individuals with impaired
decision-making capacity, or economically or educationally
disadvantaged persons.
    (4) Informed consent will be sought from each prospective subject
or the subject's legally authorized representative, in accordance with,
and to the extent required by, Sec.  __.116.
    (5) Informed consent will be appropriately documented or
appropriately waived in accordance with Sec.  __.117.
    (6) When appropriate, the research plan makes adequate provision
for monitoring the data collected to ensure the safety of subjects.
    (7) When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
    (i) The Secretary of HHS will, after consultation with the Office
of Management and Budget's privacy office and other Federal departments
and agencies that have adopted this policy, issue guidance to assist
IRBs in assessing what provisions are adequate to protect the privacy
of subjects and to maintain the confidentiality of data.
    (ii) [Reserved.]
    (8) For purposes of conducting the limited IRB review required by
Sec.  __.104(d)(7)), the IRB need not make the determinations at
paragraphs (a)(1) through (7) of this section, and shall make the
following determinations:
    (i) Broad consent for storage, maintenance, and secondary research
use of identifiable private information or identifiable biospecimens is
obtained in accordance with the requirements of Sec.  __.116(a)(1)-(4),
(a)(6), and (d);
    (ii) Broad consent is appropriately documented or waiver of
documentation is appropriate, in accordance with Sec.  __.117; and
    (iii) If there is a change made for research purposes in the way
the identifiable private information or identifiable biospecimens are
stored or maintained, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
    (b) When some or all of the subjects are likely to be vulnerable to
coercion or undue influence, such as children, prisoners, individuals
with impaired decision-making capacity, or economically or
educationally disadvantaged persons, additional safeguards have been
included in the study to protect the rights and welfare of these
subjects.

Sec.  __.112 Review by Institution

    Research covered by this policy that has been approved by an IRB
may be subject to further appropriate review and approval or
disapproval by officials of the institution. However, those officials
may not approve the research if it has not been approved by an IRB.

Sec.  __.113 Suspension or Termination of IRB Approval of Research

    An IRB shall have authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's
requirements or that has been associated with unexpected serious harm
to subjects. Any suspension or termination of approval shall include a
statement of the reasons for the IRB's action and shall be reported
promptly to the investigator, appropriate institutional officials, and
the department or agency head.

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.114 Cooperative Research

    (a) Cooperative research projects are those projects covered by
this policy that involve more than one institution. In the conduct of
cooperative research projects, each institution is responsible for
safeguarding the rights and welfare of human subjects and for complying
with this policy.
    (b)(1) Any institution located in the United States that is engaged
in cooperative research must rely upon approval by a single IRB for
that portion of the research that is conducted in the United States.
The reviewing IRB will be identified by the Federal department or
agency supporting or conducting the research or proposed by the lead
institution subject to the acceptance of the Federal department or
agency supporting the research.
    (2) The following research is not subject to this provision:
    (i) Cooperative research for which more than single IRB review is
required by law (including tribal law passed by the official governing
body of an American Indian or Alaska Native tribe); or
    (ii) Research for which any Federal department or agency supporting
or conducting the research determines and documents that the use of a
single IRB is not appropriate for the particular context.
    (c) For research not subject to paragraph (b) of this section, an
institution participating in a cooperative project may enter into a
joint review arrangement, rely on the review of another IRB, or make
similar arrangements for avoiding duplication of effort.

Sec.  __.115 IRB Records

    (a) An institution, or when appropriate an IRB, shall prepare and
maintain adequate documentation of IRB activities, including the
following:
    (1) Copies of all research proposals reviewed, scientific
evaluations, if any, that accompany the proposals, approved sample
consent forms, progress reports submitted by investigators, and reports
of injuries to subjects.
    (2) Minutes of IRB meetings, which shall be in sufficient detail to
show attendance at the meetings; actions taken by the IRB; the vote on
these actions including the number of members voting for, against, and
abstaining; the basis for requiring changes in or disapproving
research; and a written summary of the discussion of controverted
issues and their resolution.
    (3) Records of continuing review activities, including the
rationale for conducting continuing review of research that otherwise
would not require continuing review as described in Sec.  __.109(f)(1).
    (4) Copies of all correspondence between the IRB and the
investigators.
    (5) A list of IRB members in the same detail as described in Sec.
__.108(a)(2).
    (6) Written procedures for the IRB in the same detail as described
in Sec.  __.108(a)(3) and (4).
    (7) Statements of significant new findings provided to subjects, as
required by Sec.  __.116(c)(5).
    (8) The rationale for an expedited reviewer's determination under
Sec.  __.110(b)(1)(i) that research appearing on the expedited review
list described in Sec.  __.110(a) is more than minimal risk.
    (9) Documentation specifying the responsibilities that an
institution and an organization operating an IRB each will undertake to
ensure compliance with the requirements of this policy, as described in
Sec.  __.103(e).
    (b) The records required by this policy shall be retained for at
least 3 years, and records relating to research that is conducted shall
be retained for at least 3 years after completion of the research. The
institution or IRB may maintain the records in printed form, or
electronically. All records shall be accessible for inspection and
copying by authorized representatives of the Federal department or
agency at reasonable times and in a reasonable manner.

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.116 General Requirements for Informed Consent

    (a) General. General requirements for informed consent, whether
written or oral, are set forth in this paragraph and apply to consent
obtained in accordance with the requirements set forth in paragraphs
(b) through (d) of this section. Broad consent may be obtained in lieu
of informed consent obtained in accordance with paragraphs (b) and (c)
of this section only with respect to the storage, maintenance, and
secondary research uses of identifiable private information and
identifiable biospecimens. Waiver or alteration of consent in research
involving public benefit and service programs conducted by or subject
to the approval of state or local officials is described in paragraph
(e) of this section. General waiver or alteration of informed consent
is described in paragraph (f) of this section. Except as provided
elsewhere in this policy:
    (1) Before involving a human subject in research covered by this
policy, an investigator shall obtain the legally effective informed
consent of the subject or the subject's legally authorized
representative.
    (2) An investigator shall seek informed consent only under
circumstances that provide the prospective subject or the legally
authorized representative sufficient opportunity to discuss and
consider whether or not to participate and that minimize the
possibility of coercion or undue influence.
    (3) The information that is given to the subject or the legally
authorized representative shall be in language understandable to the
subject or the legally authorized representative.
    (4) The prospective subject or the legally authorized
representative must be provided with the information that a reasonable
person would want to have in order to make an informed decision about
whether to participate, and an opportunity to discuss that information.
    (5) Except for broad consent obtained in accordance with paragraph
(d) of this section:
    (i) Informed consent must begin with a concise and focused
presentation of the key information that is most likely to assist a
prospective subject or legally authorized representative in
understanding the reasons why one might or might not want to
participate in the research. This part of the informed consent must be
organized and presented in a way that facilitates comprehension.
    (ii) Informed consent as a whole must present information in
sufficient detail

relating to the research, and must be organized and presented in a way
that does not merely provide lists of isolated facts, but rather
facilitates the prospective subject's or legally authorized
representative's understanding of the reasons why one might or might
not want to participate.
    (6) No informed consent may include any exculpatory language
through which the subject or the legally authorized representative is
made to waive or appear to waive any of the subject's legal rights, or
releases or appears to release the investigator, the sponsor, the
institution, or its agents from liability for negligence.
    (b) Basic elements of informed consent. Except as provided in
paragraph (d), (e), or (f) of this section, in seeking informed consent
the following information shall be provided to each subject or the
legally authorized representative:
    (1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and
identification of any procedures that are experimental;
    (2) A description of any reasonably foreseeable risks or
discomforts to the subject;
    (3) A description of any benefits to the subject or to others that
may reasonably be expected from the research;
    (4) A disclosure of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the subject;
    (5) A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be maintained;
    (6) For research involving more than minimal risk, an explanation
as to whether any compensation and an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they
consist of, or where further information may be obtained;
    (7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom to
contact in the event of a research-related injury to the subject;
    (8) A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled; and
    (9) One of the following statements about any research that
involves the collection of identifiable private information or
identifiable biospecimens:
    (i) A statement that identifiers might be removed from the
identifiable private information or identifiable biospecimens and that,
after such removal, the information or biospecimens could be used for
future research studies or distributed to another investigator for
future research studies without additional informed consent from the
subject or the legally authorized representative, if this might be a
possibility; or
    (ii) A statement that the subject's information or biospecimens
collected as part of the research, even if identifiers are removed,
will not be used or distributed for future research studies.
    (c) Additional elements of informed consent. Except as provided in
paragraph (d), (e), or (f) of this section, one or more of the
following elements of information, when appropriate, shall also be
provided to each subject or the legally authorized representative:
    (1) A statement that the particular treatment or procedure may
involve risks to the subject (or to the embryo or fetus, if the subject
is or may become pregnant) that are currently unforeseeable;
    (2) Anticipated circumstances under which the subject's
participation may be terminated by the investigator without regard to
the subject's or the legally authorized representative's consent;
    (3) Any additional costs to the subject that may result from
participation in the research;
    (4) The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by the
subject;
    (5) A statement that significant new findings developed during the
course of the research that may relate to the subject's willingness to
continue participation will be provided to the subject;
    (6) The approximate number of subjects involved in the study;
    (7) A statement that the subject's biospecimens (even if
identifiers are removed) may be used for commercial profit and whether
the subject will or will not share in this commercial profit;
    (8) A statement regarding whether clinically relevant research
results, including individual research results, will be disclosed to
subjects, and if so, under what conditions; and
    (9) For research involving biospecimens, whether the research will
(if known) or might include whole genome sequencing (i.e., sequencing
of a human germline or somatic specimen with the intent to generate the
genome or exome sequence of that specimen).
    (d) Elements of broad consent for the storage, maintenance, and
secondary research use of identifiable private information or
identifiable biospecimens. Broad consent for the storage, maintenance,
and secondary research use of identifiable private information or
identifiable biospecimens (collected for either research studies other
than the proposed research or nonresearch purposes) is permitted as an
alternative to the informed consent requirements in paragraphs (b) and
(c) of this section. If the subject or the legally authorized
representative is asked to provide broad consent, the following shall
be provided to each subject or the subject's legally authorized
representative:
    (1) The information required in paragraphs (b)(2), (b)(3), (b)(5),
and (b)(8) and, when appropriate, (c)(7) and (9) of this section;
    (2) A general description of the types of research that may be
conducted with the identifiable private information or identifiable
biospecimens. This description must include sufficient information such
that a reasonable person would expect that the broad consent would
permit the types of research conducted;
    (3) A description of the identifiable private information or
identifiable biospecimens that might be used in research, whether
sharing of identifiable private information or identifiable
biospecimens might occur, and the types of institutions or researchers
that might conduct research with the identifiable private information
or identifiable biospecimens;
    (4) A description of the period of time that the identifiable
private information or identifiable biospecimens may be stored and
maintained (which period of time could be indefinite), and a
description of the period of time that the identifiable private
information or identifiable biospecimens may be used for research
purposes (which period of time could be indefinite);
    (5) Unless the subject or legally authorized representative will be
provided details about specific research studies, a statement that they
will not be informed of the details of any specific research studies
that might be conducted using the subject's identifiable private
information or identifiable biospecimens, including the purposes of the
research, and that they might have chosen not to consent to some of
those specific research studies;
    (6) Unless it is known that clinically relevant research results,
including individual research results, will be

disclosed to the subject in all circumstances, a statement that such
results may not be disclosed to the subject; and
    (7) An explanation of whom to contact for answers to questions
about the subject's rights and about storage and use of the subject's
identifiable private information or identifiable biospecimens, and whom
to contact in the event of a research-related harm.
    (e) Waiver or alteration of consent in research involving public
benefit and service programs conducted by or subject to the approval of
state or local officials--(1) Waiver. An IRB may waive the requirement
to obtain informed consent for research under paragraphs (a) through
(c) of this section, provided the IRB satisfies the requirements of
paragraph (e)(3) of this section. If an individual was asked to provide
broad consent for the storage, maintenance, and secondary research use
of identifiable private information or identifiable biospecimens in
accordance with the requirements at paragraph (d) of this section, and
refused to consent, an IRB cannot waive consent for the storage,
maintenance, or secondary research use of the identifiable private
information or identifiable biospecimens.
    (2) Alteration. An IRB may approve a consent procedure that omits
some, or alters some or all, of the elements of informed consent set
forth in paragraphs (b) and (c) of this section provided the IRB
satisfies the requirements of paragraph (e)(3) of this section. An IRB
may not omit or alter any of the requirements described in paragraph
(a) of this section. If a broad consent procedure is used, an IRB may
not omit or alter any of the elements required under paragraph (d) of
this section.
    (3) Requirements for waiver and alteration. In order for an IRB to
waive or alter consent as described in this subsection, the IRB must
find and document that:
    (i) The research or demonstration project is to be conducted by or
subject to the approval of state or local government officials and is
designed to study, evaluate, or otherwise examine:
    (A) Public benefit or service programs;
    (B) Procedures for obtaining benefits or services under those
programs;
    (C) Possible changes in or alternatives to those programs or
procedures; or
    (D) Possible changes in methods or levels of payment for benefits
or services under those programs; and
    (ii) The research could not practicably be carried out without the
waiver or alteration.
    (f) General waiver or alteration of consent--(1) Waiver. An IRB may
waive the requirement to obtain informed consent for research under
paragraphs (a) through (c) of this section, provided the IRB satisfies
the requirements of paragraph (f)(3) of this section. If an individual
was asked to provide broad consent for the storage, maintenance, and
secondary research use of identifiable private information or
identifiable biospecimens in accordance with the requirements at
paragraph (d) of this section, and refused to consent, an IRB cannot
waive consent for the storage, maintenance, or secondary research use
of the identifiable private information or identifiable biospecimens.
    (2) Alteration. An IRB may approve a consent procedure that omits
some, or alters some or all, of the elements of informed consent set
forth in paragraphs (b) and (c) of this section provided the IRB
satisfies the requirements of paragraph (f)(3) of this section. An IRB
may not omit or alter any of the requirements described in paragraph
(a) of this section. If a broad consent procedure is used, an IRB may
not omit or alter any of the elements required under paragraph (d) of
this section.
    (3) Requirements for waiver and alteration. In order for an IRB to
waive or alter consent as described in this subsection, the IRB must
find and document that:
    (i) The research involves no more than minimal risk to the
subjects;
    (ii) The research could not practicably be carried out without the
requested waiver or alteration;
    (iii) If the research involves using identifiable private
information or identifiable biospecimens, the research could not
practicably be carried out without using such information or
biospecimens in an identifiable format;
    (iv) The waiver or alteration will not adversely affect the rights
and welfare of the subjects; and
    (v) Whenever appropriate, the subjects or legally authorized
representatives will be provided with additional pertinent information
after participation.
    (g) Screening, recruiting, or determining eligibility. An IRB may
approve a research proposal in which an investigator will obtain
information or biospecimens for the purpose of screening, recruiting,
or determining the eligibility of prospective subjects without the
informed consent of the prospective subject or the subject's legally
authorized representative, if either of the following conditions are
met:
    (1) The investigator will obtain information through oral or
written communication with the prospective subject or legally
authorized representative, or
    (2) The investigator will obtain identifiable private information
or identifiable biospecimens by accessing records or stored
identifiable biospecimens.
    (h) Posting of clinical trial consent form. (1) For each clinical
trial conducted or supported by a Federal department or agency, one
IRB-approved informed consent form used to enroll subjects must be
posted by the awardee or the Federal department or agency component
conducting the trial on a publicly available Federal Web site that will
be established as a repository for such informed consent forms.
    (2) If the Federal department or agency supporting or conducting
the clinical trial determines that certain information should not be
made publicly available on a Federal Web site (e.g. confidential
commercial information), such Federal department or agency may permit
or require redactions to the information posted.
    (3) The informed consent form must be posted on the Federal Web
site after the clinical trial is closed to recruitment, and no later
than 60 days after the last study visit by any subject, as required by
the protocol.
    (i) Preemption. The informed consent requirements in this policy
are not intended to preempt any applicable Federal, state, or local
laws (including tribal laws passed by the official governing body of an
American Indian or Alaska Native tribe) that require additional
information to be disclosed in order for informed consent to be legally
effective.
    (j) Emergency medical care. Nothing in this policy is intended to
limit the authority of a physician to provide emergency medical care,
to the extent the physician is permitted to do so under applicable
Federal, state, or local law (including tribal law passed by the
official governing body of an American Indian or Alaska Native tribe).

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.117 Documentation of informed consent.

    (a) Except as provided in paragraph (c) of this section, informed
consent shall be documented by the use of a written informed consent
form approved by the IRB and signed (including in an electronic format)
by the subject or the subject's legally authorized representative. A
written copy shall be given to the person signing the informed consent
form.

    (b) Except as provided in paragraph (c) of this section, the
informed consent form may be either of the following:
    (1) A written informed consent form that meets the requirements of
Sec.  __.116. The investigator shall give either the subject or the
subject's legally authorized representative adequate opportunity to
read the informed consent form before it is signed; alternatively, this
form may be read to the subject or the subject's legally authorized
representative.
    (2) A short form written informed consent form stating that the
elements of informed consent required by Sec.  __.116 have been
presented orally to the subject or the subject's legally authorized
representative, and that the key information required by Sec.
__.116(a)(5)(i) was presented first to the subject, before other
information, if any, was provided. The IRB shall approve a written
summary of what is to be said to the subject or the legally authorized
representative. When this method is used, there shall be a witness to
the oral presentation. Only the short form itself is to be signed by
the subject or the subject's legally authorized representative.
However, the witness shall sign both the short form and a copy of the
summary, and the person actually obtaining consent shall sign a copy of
the summary. A copy of the summary shall be given to the subject or the
subject's legally authorized representative, in addition to a copy of
the short form.
    (c)(1) An IRB may waive the requirement for the investigator to
obtain a signed informed consent form for some or all subjects if it
finds any of the following:
    (i) That the only record linking the subject and the research would
be the informed consent form and the principal risk would be potential
harm resulting from a breach of confidentiality. Each subject (or
legally authorized representative) will be asked whether the subject
wants documentation linking the subject with the research, and the
subject's wishes will govern;
    (ii) That the research presents no more than minimal risk of harm
to subjects and involves no procedures for which written consent is
normally required outside of the research context; or
    (iii) If the subjects or legally authorized representatives are
members of a distinct cultural group or community in which signing
forms is not the norm, that the research presents no more than minimal
risk of harm to subjects and provided there is an appropriate
alternative mechanism for documenting that informed consent was
obtained.
    (2) In cases in which the documentation requirement is waived, the
IRB may require the investigator to provide subjects or legally
authorized representatives with a written statement regarding the
research.

(Approved by the Office of Management and Budget under Control
Number 0990-0260)

Sec.  __.118 Applications and proposals lacking definite plans for
involvement of human subjects.

    Certain types of applications for grants, cooperative agreements,
or contracts are submitted to Federal departments or agencies with the
knowledge that subjects may be involved within the period of support,
but definite plans would not normally be set forth in the application
or proposal. These include activities such as institutional type grants
when selection of specific projects is the institution's
responsibility; research training grants in which the activities
involving subjects remain to be selected; and projects in which human
subjects' involvement will depend upon completion of instruments, prior
animal studies, or purification of compounds. Except for research
waived under Sec.  __.101(i) or exempted under Sec.  __.104, no human
subjects may be involved in any project supported by these awards until
the project has been reviewed and approved by the IRB, as provided in
this policy, and certification submitted, by the institution, to the
Federal department or agency component supporting the research.

Sec.  __.119 Research undertaken without the intention of involving
human subjects.

    Except for research waived under Sec.  __.101(i) or exempted under
Sec.  __.104, in the event research is undertaken without the intention
of involving human subjects, but it is later proposed to involve human
subjects in the research, the research shall first be reviewed and
approved by an IRB, as provided in this policy, a certification
submitted by the institution to the Federal department or agency
component supporting the research, and final approval given to the
proposed change by the Federal department or agency component.

Sec.  __.120 Evaluation and disposition of applications and proposals
for research to be conducted or supported by a Federal department or
agency.

    (a) The department or agency head will evaluate all applications
and proposals involving human subjects submitted to the Federal
department or agency through such officers and employees of the Federal
department or agency and such experts and consultants as the department
or agency head determines to be appropriate. This evaluation will take
into consideration the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research
to the subjects and others, and the importance of the knowledge gained
or to be gained.
    (b) On the basis of this evaluation, the department or agency head
may approve or disapprove the application or proposal, or enter into
negotiations to develop an approvable one.

Sec.  __.121 [Reserved]

Sec.  __.122 Use of Federal funds.

    Federal funds administered by a Federal department or agency may
not be expended for research involving human subjects unless the
requirements of this policy have been satisfied.

Sec.  __.123 Early termination of research support: Evaluation of
applications and proposals.

    (a) The department or agency head may require that Federal
department or agency support for any project be terminated or suspended
in the manner prescribed in applicable program requirements, when the
department or agency head finds an institution has materially failed to
comply with the terms of this policy.
    (b) In making decisions about supporting or approving applications
or proposals covered by this policy the department or agency head may
take into account, in addition to all other eligibility requirements
and program criteria, factors such as whether the applicant has been
subject to a termination or suspension under paragraph (a) of this
section and whether the applicant or the person or persons who would
direct or has/have directed the scientific and technical aspects of an
activity has/have, in the judgment of the department or agency head,
materially failed to discharge responsibility for the protection of the
rights and welfare of human subjects (whether or not the research was
subject to federal regulation).

Sec.  __.124 Conditions.

    With respect to any research project or any class of research
projects the department or agency head of either the conducting or the
supporting Federal department or agency may impose additional
conditions prior to or at the time of approval when in the judgment of
the department or agency head

additional conditions are necessary for the protection of human
subjects.

Adoption of the Common Rules

    The adoption of the common rules by the participating agencies, as
modified by agency-specific text, is set forth below.

DEPARTMENT OF HOMELAND SECURITY

List of Subjects in 6 CFR Part 46

    Human research subjects, Reporting and record-keeping requirements,
Research.

0
For the reasons stated in the preamble, the Department of Homeland
Security adds 6 CFR part 46 as set forth at the end of the common
preamble of this document.

PART 46--PROTECTION OF HUMAN SUBJECTS

Sec.
46.101 To what does this policy apply?
46.102 Definitions for purposes of this policy.
46.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
46.104 Exempt research.
46.105 [Reserved]
46.106 [Reserved]
46.107 IRB membership.
46.108 IRB functions and operations.
46.109 IRB review of research.
46.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
46.111 Criteria for IRB approval of research.
46.112 Review by institution.
46.113 Suspension or termination of IRB approval of research.
46.114 Cooperative research.
46.115 IRB records.
46.116 General requirements for informed consent.
46.117 Documentation of informed consent.
46.118 Applications and proposals lacking definite plans for
involvement of human subjects.
46.119 Research undertaken without the intention of involving human
subjects.
46.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
46.121 [Reserved]
46.122 Use of Federal funds.
46.123 Early termination of research support: Evaluation of
applications and proposals.
46.124 Conditions.

    Authority:  5 U.S.C. 301; Pub. L. 107-296, sec. 102, 306(c);
Pub. L. 108-458, sec. 8306.

Reginald Brothers,
Under Secretary for Science and Technology, DHS.

DEPARTMENT OF AGRICULTURE

List of Subjects in 7 CFR Part 1c

    Human research subjects, Reporting and record-keeping requirements,
Research.

0
For the reasons stated in the preamble, the Department of Agriculture
revises 7 CFR part 1c as set forth at the end of the common preamble of
this document.

PART 1c--PROTECTION OF HUMAN SUBJECTS

Sec.
1c.101 To what does this policy apply?
1c.102 Definitions for purposes of this policy.
1c.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
1c.104 Exempt research.
1c.105 [Reserved]
1c.106 [Reserved]
1c.107 IRB membership.
1c.108 IRB functions and operations.
1c.109 IRB review of research.
1c.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
1c.111 Criteria for IRB approval of research.
1c.112 Review by institution.
1c.113 Suspension or termination of IRB approval of research.
1c.114 Cooperative research.
1c.115 IRB records.
1c.116 General requirements for informed consent.
1c.117 Documentation of informed consent.
1c.118 Applications and proposals lacking definite plans for
involvement of human subjects.
1c.119 Research undertaken without the intention of involving human
subjects.
1c.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
1c.121 [Reserved]
1c.122 Use of Federal funds.
1c.123 Early termination of research support: Evaluation of
applications and proposals.
1c.124 Conditions.

    Authority:  5 U.S.C. 301; 42 U.S.C. 300v-1(b).

Ann M. Bartuska,
Acting Under Secretary for Research, Education, and Economics, USDA.

DEPARTMENT OF ENERGY

List of Subjects in 10 CFR Part 745

10 CFR Part 745

    Human research subjects, Reporting and record-keeping requirements,
Research.
0
For the reasons stated in the preamble, the Department of Energy
revises 10 CFR part 745 as set forth at the end of the common preamble
of this document.

PART 745--PROTECTION OF HUMAN SUBJECTS

Sec.
745.101 To what does this policy apply?
745.102 Definitions for purposes of this policy.
745.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
745.104 Exempt research.
745.105 [Reserved]
745.106 [Reserved]
745.107 IRB membership.
745.108 IRB functions and operations.
745.109 IRB review of research.
745.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
745.111 Criteria for IRB approval of research.
745.112 Review by institution.
745.113 Suspension or termination of IRB approval of research.
745.114 Cooperative research.
745.115 IRB records.
745.116 General requirements for informed consent.
745.117 Documentation of informed consent.
745.118 Applications and proposals lacking definite plans for
involvement of human subjects.
745.119 Research undertaken without the intention of involving human
subjects.
745.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
745.121 [Reserved]
745.122 Use of Federal funds.
745.123 Early termination of research support: Evaluation of
applications and proposals.
745.124 Conditions.

    Authority: 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b).

Elizabeth Sherwood-Randall,
Deputy Secretary of Energy.

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

List of Subjects in 14 CFR Part 1230

14 CFR Part 1230

    Human research subjects, Reporting and record-keeping requirements,
Research.
0
For the reasons stated in the preamble, the National Aeronautics and
Space Administration revises 14 CFR part 1230 as set forth at the end
of the common preamble of this document.

PART 1230--PROTECTION OF HUMAN SUBJECTS

Sec.
1230.101 To what does this policy apply?
1230.102 Definitions for purposes of this policy.
1230.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
1230.104 Exempt research.
1230.105 [Reserved]
1230.106 [Reserved]
1230.107 IRB membership.
1230.108 IRB functions and operations.
1230.109 IRB review of research.
1230.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
1230.111 Criteria for IRB approval of research.
1230.112 Review by institution.
1230.113 Suspension or termination of IRB approval of research.
1230.114 Cooperative research.
1230.115 IRB records.
1230.116 General requirements for informed consent.
1230.117 Documentation of informed consent.
1230.118 Applications and proposals lacking definite plans for
involvement of human subjects.
1230.119 Research undertaken without the intention of involving
human subjects.
1230.120 Evaluation and disposition of applications and proposals
for research to be conducted or supported by a Federal department or
agency.
1230.121 [Reserved]
1230.122 Use of Federal funds.
1230.123 Early termination of research support: Evaluation of
applications and proposals.
1230.124 Conditions.

    Authority: 5 U.S.C. 301;42 U.S.C. 300v-1(b).

James D. Polk,
Chief Health and Medical Officer, NASA.

DEPARTMENT OF COMMERCE

List of Subjects in 15 CFR Part 27

15 CFR Part 27

    Human research subjects, Reporting and record-keeping requirements,
Research.

0
For the reasons stated in the preamble, the Department of Commerce
revises 15 CFR part 27 as set forth at the end of the common preamble
of this document.

PART 27--PROTECTION OF HUMAN SUBJECTS

Sec.
27.101 To what does this policy apply?
27.102 Definitions for purposes of this policy.
27.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
27.104 Exempt research.
27.105 [Reserved]
27.106 [Reserved]
27.107 IRB membership.
27.108 IRB functions and operations.
27.109 IRB review of research.
27.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
27.111 Criteria for IRB approval of research.
27.112 Review by institution.
27.113 Suspension or termination of IRB approval of research.
27.114 Cooperative research.
27.115 IRB records.
27.116 General requirements for informed consent.
27.117 Documentation of informed consent.
27.118 Applications and proposals lacking definite plans for
involvement of human subjects.
27.119 Research undertaken without the intention of involving human
subjects.
27.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
27.121 [Reserved]
27.122 Use of Federal funds.
27.123 Early termination of research support: Evaluation of
applications and proposals.
27.124 Conditions.

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

James Hock,
Chief of Staff, Department of Commerce.

SOCIAL SECURITY ADMINISTRATION

List of Subjects in 20 CFR Part 431

20 CFR Part 431

    Human research subjects, Reporting and record-keeping requirements,
Research.
0
For the reasons stated in the preamble, the Social Security
Administration adds 20 CFR part 431 as set forth at the end of the
common preamble of this document.

PART 431--PROTECTION OF HUMAN SUBJECTS

Sec.
431.101 To what does this policy apply?
431.102 Definitions for purposes of this policy.
431.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
431.104 Exempt research.
431.105 [Reserved]
431.106 [Reserved]
431.107 IRB membership.
431.108 IRB functions and operations.
431.109 IRB review of research.
431.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
431.111 Criteria for IRB approval of research.
431.112 Review by institution.
431.113 Suspension or termination of IRB approval of research.
431.114 Cooperative research.
431.115 IRB records.
431.116 General requirements for informed consent.
431.117 Documentation of informed consent.
431.118 Applications and proposals lacking definite plans for
involvement of human subjects.
431.119 Research undertaken without the intention of involving human
subjects.
431.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
431.121 [Reserved]
431.122 Use of Federal funds.
431.123 Early termination of research support: Evaluation of
applications and proposals.
431.124 Conditions.

    Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).

Carolyn W. Colvin,
Acting Commissioner of Social Security.

AGENCY FOR INTERNATIONAL DEVELOPMENT

List of Subjects in 22 CFR Part 225

22 CFR Part 225

    Human research subjects, Reporting and record-keeping requirements,
Research.

0
For the reasons stated in the preamble, the Agency for International
Development revises 22 CFR part 225 as set forth at the end of the
common preamble of this document.

PART 225--PROTECTION OF HUMAN SUBJECTS

Sec.
225.101 To what does this policy apply?
225.102 Definitions for purposes of this policy.
225.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
225.104 Exempt research.
225.105 [Reserved]
225.106 [Reserved]
225.107 IRB membership.
225.108 IRB functions and operations.
225.109 IRB review of research.
225.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
225.111 Criteria for IRB approval of research.
225.112 Review by institution.
225.113 Suspension or termination of IRB approval of research.
225.114 Cooperative research.
225.115 IRB records.
225.116 General requirements for informed consent.
225.117 Documentation of informed consent.
225.118 Applications and proposals lacking definite plans for
involvement of human subjects.
225.119 Research undertaken without the intention of involving human
subjects.
225.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
225.121 [Reserved]
225.122 Use of Federal funds.
225.123 Early termination of research support: Evaluation of
applications and proposals.
225.124 Conditions.

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless otherwise
noted.

Irene Koek,
Acting Deputy Assistant Administrator for Global Health, U.S. Agency
for International Development.

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

List of Subjects in 24 CFR Part 60

24 CFR Part 60

    Human research subjects, Reporting and record-keeping requirements,
Research.

0
For the reasons stated in the preamble, the Department of Housing and
Urban Development revises 24 CFR part 60 as set forth at the end of the
common preamble of this document.

PART 60--PROTECTION OF HUMAN SUBJECTS

Sec.
60.101 To what does this policy apply?
60.102 Definitions for purposes of this policy.
60.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
60.104 Exempt research.
60.105 [Reserved]
60.106 [Reserved]
60.107 IRB membership.
60.108 IRB functions and operations.
60.109 IRB review of research.
60.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
60.111 Criteria for IRB approval of research.
60.112 Review by institution.
60.113 Suspension or termination of IRB approval of research.
60.114 Cooperative research.
60.115 IRB records.
60.116 General requirements for informed consent.