[Federal Register: March 17, 2008 (Volume 73, Number 52)]
[Notices]
[Page 14241-14242]
[DOCID:fr17mr08-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR08-17-000]

Bay Gas Storage Company, Ltd.; Notice of Petition for Rate
Approval

March 10, 2008.
    Take notice that on February 29, 2008, Bay Gas Storage Company,
Ltd. (Bay Gas) submitted for filing its proposal to charge a lost-an-
unaccounted-for (LAUF) reimbursement percentage of 0.96 percent.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate.

Such notices, motions, or protests must be filed on or before the date
as indicated below. Anyone filing an intervention or protest must serve
a copy of that document on the Applicant. Anyone filing an intervention
or protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll-free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 24, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-5231 Filed 3-14-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Proposed Rules]
[Pages 57907-57910]
[FR Doc No: 2023-18119]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1717; Project Identifier MCAI-2023-00728-A]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Embraer S.A. (Embraer) Model EMB-505 airplanes. This
proposed AD was prompted by analysis of certain monuments (the right-
hand refreshment center and left-hand forward cabinet) that identified
the need for installing structural reinforcements and replacing certain
floor support rivets. This proposed AD would require installing
structural reinforcements on certain monuments and replacing certain
floor support rivets, as specified in an Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC) AD, which is proposed for
incorporation by reference (IBR). The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this NPRM by October 10, 2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1717; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information that is proposed for IBR in this
NPRM, contact ANAC, Continuing Airworthiness Technical Branch (GTAC),
Rua Doutor Orlando Feirabend Filho, 230--Centro Empresarial Aquarius--
Torre B--Andares 14 a 18, Parque Residencial Aquarius, CEP 12.246-190--
S[atilde]o Jos[eacute] dos Campos--SP, Brazil; phone: 55 (12) 3203-
6600; email<EMAIL_ADDRESS>website: anac.gov.br/en/. You may find
this material on the ANAC website at sistemas.anac.gov.br/certificacao/
DA/DAE.asp. It is also available at regulations.gov under Docket No.
FAA-2023-1717.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-1717; Project Identifier
MCAI-2023-00728-A'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Jim
Rutherford, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590. Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    The ANAC, which is the aviation authority for Brazil, has issued
ANAC AD 2023-05-03, effective June 2, 2023 (ANAC AD 2023-05-03)
(referred to after this as ``the MCAI''), to correct an unsafe
condition on certain serial-numbered Embraer Model EMB-505 airplanes.
The MCAI states that analysis identified certain monuments (the right-
hand refreshment center and left-hand forward cabinet) that might not
withstand the loads expected for specific emergency landing conditions,
which may cause the detachment of mass items and result in injuries to
the airplane occupants. To address this unsafe condition, the MCAI
specifies installing structural reinforcements on certain monuments and
replacing applicable floor support rivets.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-1717.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed ANAC AD 2023-05-03, which specifies procedures for
installing structural reinforcements on certain monuments and replacing
applicable fasteners on the floor support.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop on other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in ANAC AD 2023-05-03 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD and
except as discussed under ``Differences Between this Proposed AD and
the MCAI.''

Differences Between This Proposed AD and the MCAI

    The service information specified in ANAC AD 2023-05-03 allows the
use of alternative or similar parts in place of the ones specified in
the kits, provided these alternative or similar parts are approved by
Embraer, but this proposed AD would require approval from either the
Manager, International Validation Branch, FAA; ANAC; or ANAC's
authorized Designee.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate ANAC AD 2023-05-03 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
ANAC AD 2023-05-03 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD and except as discussed under ``Differences Between
this Proposed AD and the MCAI.'' Service information required by ANAC
AD 2023-05-03 for compliance will be available at regulations.gov under
Docket No. FAA-2023-1717 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 208 airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                   Parts     Cost per
                Action                        Labor cost           cost      product     Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Airplane groups 1 and 2--install       21.50 work-hours x $85      $1,600    $3,427.50  $239,925 (70 airplanes).
 structural reinforcements.             per hour = $1,827.50.
Airplane groups 3, 4, 5, and 10--      13.50 work-hours x $85         600     1,747.50  $214,942.50 (123
 install structural reinforcements      per hour = $1,147.50.                            airplanes).
 and replace floor fasteners.
Airplane groups 6 and 8--install       25.50 work-hours x $85       2,000     4,167.50  $37,507.50 (9
 structural reinforcements and          per hour = $2,167.50.                            airplanes).
 replace floor fasteners.
Airplane group 7--install structural   19.50 work-hours x $85       1,600     3,257.50  $16,287.50 (5
 reinforcements.                        per hour = $1,657.50.                            airplanes).
Airplane group 9--install structural   13.50 work-hours x $85       1,600     2,747.50  $2,747.50 (1 airplane).
 reinforcements.                        per hour = $1,147.50.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs for operators that did the
actions in the original version of Embraer Service Bulletin SB505-25-
0046, dated March 31, 2021. The agency has no way of determining the
number of airplanes that might need these actions:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Inspect floor fasteners.......................  8.50 work-hours x $85 per hour =             $50         $772.50
                                                 $722.50.
Replace floor fasteners.......................  1 work-hour x $85 per hour = $85              50             135
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Embraer S.A.: Docket No. FAA-2023-1717; Project Identifier MCAI-
2023-00728-A.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by October 10, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Embraer S.A. Model EMB-505 airplanes, as
identified in Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil
(ANAC) AD 2023-05-03, effective June 2, 2023 (ANAC AD 2023-05-03),
certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2500, Cabin
Equipment/Furnishings.

(e) Unsafe Condition

    This AD was prompted by analysis of certain monuments (the
right-hand refreshment center and left-hand forward cabinet) that
identified the need for installing structural reinforcements and
replacing applicable floor support rivets. The FAA is issuing this
AD to address the unsafe condition. The unsafe condition, if not
addressed, could result in a monument not withstanding the loads
expected for specific emergency landing conditions, which may cause
the detachment of mass items and result in injuries to the airplane
occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as specified in paragraphs (h) and (i) of this AD: Comply
with all required actions and compliance times specified in, and in
accordance with, ANAC AD 2023-05-03.

(h) Exceptions to ANAC AD 2023-05-03

    (1) Where ANAC AD 2023-05-03 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The service information referenced in ANAC AD 2023-05-03
allows the use of alternative or similar parts in place of the ones
specified in the kits, provided that these alternative or similar
parts are approved by Embraer. This AD requires approval from either
the Manager, International Validation Branch, FAA; ANAC; or ANAC's
authorized Designee. If approved by the ANAC Designee, the approval
must include the Designee's authorized signature.
    (3) Where the service information referenced in ANAC AD 2023-05-
03 specifies discarding parts, this AD requires removing those parts
from service.
    (4) This AD does not adopt paragraph (d) of ANAC AD 2023-05-03.

(i) No Reporting Requirement

    Although the service information referenced in ANAC AD 2023-05-
03 specifies to submit certain information to the manufacturer, this
AD does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, mail
it to the address identified in paragraph (k) of this AD or email
to: [email protected]. If mailing information, also submit
information by email. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.

(k) Additional Information

    For more information about this AD, contact Jim Rutherford,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; email:
[email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil AD
2023-05-03, effective June 2, 2023.
    (ii) [Reserved]
    (3) For ANAC AD 2023-05-03, contact National Civil Aviation
Agency (ANAC), Continuing Airworthiness Technical Branch (GTAC), Rua
Doutor Orlando Feirabend Filho, 230--Centro Empresarial Aquarius--
Torre B--Andares 14 a 18, Parque Residencial Aquarius, CEP 12.246-
190--S[atilde]o Jos[eacute] dos Campos--SP, Brazil; phone: 55 (12)
3203-6600; email<EMAIL_ADDRESS>website: anac.gov.br/en/. You may
find this material on the ANAC website at sistemas.anac.gov.br/
certificacao/DA/DAE.asp.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on

the availability of this material at NARA, email:
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 17, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-18119 Filed 8-23-23; 8:45 am]
BILLING CODE 4910-13-P


comments:

1. It would be helpful if, somewhere near the beginning of the document,
there was a paragraph making it clear that the topics discussed in the
document are only a part of the rules that must be followed to assure
that research is conducted in an ethical manner, and that those other
rules (including local and state level regulations) are not being
discussed in this document. The paragraph could briefly list some of
those other rules, e.g., the need for appropriate study design, the
relationship of risks and benefits, the need to minimize risks to
subjects. It might also be appropriate to similarly mention the various
scientific issues that are not addressed in this report (e.g., exposure
and data collection methods and statistical issues), which issues may
often have a fundamental impact on whether or not a study is ethical.

2. Somewhere near the beginning of the document, it would also be
helpful to clarify that this guidance is specifically designed for
studies that fall under the definition of “intentional exposure”
studies as defined in the relevant sections of the federal regulations.

3. Also at the beginning of the document, there could be a clarification
of the extent to which this document is intended to apply to studies
conducted outside of the United States.

4. In the discussion of equitable subject selection (page 2), it would
be appropriate to note that some of the rules intended to protect
vulnerable subjects might in some cases lead to under-representation of
such subjects. The document should mention that to assure adequate
inclusion of subjects from all appropriate groups, random sampling may
be required.  Convenience sampling may not be appropriate.  Further,
lack of representativeness should not only be required to be justified,
but should be treated in the analyses in such a way as a) to determine
the biases so associated and their effects on the analysis and
conclusions, and b) adjusted or considered in analyses in such a way as
to determine what the conclusions might have been if the sample was not
biased and not representative.

5. In the discussion of recruiting subjects who do not speak English
(page 3), the document should highlight the need for recruiting such
subjects, given the fact that the agricultural work force includes a
high proportion of such individuals. The default should be that such
subjects are included.

6. An important element that should be added to the document is a more
extended discussion of the need for input, in the design and conduct of
the study, from the community representing the group of subjects being
recruited (e.g., agricultural workers), and especially the vulnerable
members of that group. The document should discuss specific ways in
which that input might be obtained and used. There is a substantial
literature on the topic of community participation in research, some of
which is discussed in the EPA National Exposure Research Laboratory’s
Report on the Workshop to Discuss State-of-the-Science Approaches for
Observational Exposure Measurement Studies.

7. If there is a possibility that genetic information will be collected
in these studies, the special issues relating to informing subjects
about the consequences to them from such collection should be mentioned
in the discussion of informed consent. There may also be state
regulations applicable to such studies, and those regulations vary
widely.

8. Under the heading Essential Elements of a Consent Document (page 6),
where it refers to the qualifications of an investigator, you might
consider being somewhat more specific about what details regarding those
qualifications should be included in the consent form.

9. In the discussion of Capacity to Make Decisions (page 6), it can be
noted that some state laws do not allow, under certain conditions,
enrollment of subjects who lack the capacity to make decisions.

10. In the last paragraph under Language of Informed Consent (page 7),
it would be helpful to include an example, or some discussion, of what
it means to include exculpatory language.

12. Under the heading Circumstances and Process (page 8), where the
second paragraph mentions the process of obtaining consent, it might be
helpful to give some details of what makes a good consent process, or
perhaps provide a brief case study highlighting key principles.

13. With regard to the first sentence under the heading Confirming
Understanding (page 9), the Board notes that the regulations do not
actually require that there be an investigator’s signature on a
consent form attesting to the subject’s understanding. However, this
is an excellent practice and it is welcome that the EPA wishes to adopt
it. It would be helpful if the line under the signature clearly states
what the signature means (e.g., “Signature of Investigator Confirming
that the Subject Appeared to Appropriately Understand the Information
Provided”).

14. On page 10, under the discussion of dependent relationships, the
standard that an employer should have “no” interest in the research
is a strict one. The Board merely points this out to the EPA.

15. In the discussion of Real Alternatives to Participation in Research
(page 11), the document asks a number of important questions, without
providing answers to most of them. It would be helpful, to the extent
possible, to state some ethical principles that might enable answers to
be provided in this document to many of these questions, and to provide
those answers if possible. For example, it might be noted that in
general, it would be inappropriate (and wrongly coercive) if, as a
result of the conduct of a study, a worker who chose not to participate
in the study would end up being worse off in any non-trivial manner
(e.g., he earns less money during the day the study is conducted than he
would have if the study had not been conducted).

16. It might be helpful to provide a conclusion or summary at the end of
the document.

In addition, with regard to possible sources of guidance that might be
useful to an investigator who is designing a process for recruiting and
enrolling subjects in handler exposure research (the second charge
question), here are some suggested web sites, listed by topic. In
addition, note that the web site for the Office of Human Subjects
Research, at http://www.hhs.gov/ohrp, contains information on all of the
topics listed below, in addition to the Institutional Review Board
Guidebook, at   HYPERLINK
"http://www.hhs.gov/ohrp/irb/irb_guidebook.htm"
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm .

Ethical Principles

	The Belmont Report, available at   HYPERLINK
"http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm"
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

	Archival Documents relating to the Belmont Report, available at
HYPERLINK "http://www.hhs.gov/ohrp/belmontArchive.html"
http://www.hhs.gov/ohrp/belmontArchive.html

Informed Consent Process

	A Brief Introduction to Informed Consent, available at   HYPERLINK
"http://poynter.indiana.edu/sas/res/ic.pdf"
http://poynter.indiana.edu/sas/res/ic.pdf

	An Informed Consent Bibliography, prepared by the Department of
Veterans Affairs, available at   HYPERLINK
"http://www.research.va.gov/resources/pubs/informed_consent/"
http://www.research.va.gov/resources/pubs/informed_consent/

Capacity to Make Decisions

	A volume from a report by the National Bioethics Advisory Commission
containing papers relating to Research Involving Persons with Mental
Disorders That May Affect Decision-Making Capacity, available at
HYPERLINK
"http://www.georgetown.edu/research/nrcbl/nbac/capacity/volumeii.pdf"
http://www.georgetown.edu/research/nrcbl/nbac/capacity/volumeii.pdf

Language of Informed Consent

	Guidelines for writing informed consent documents prepared by the
Office of Human Subjects Research, National Institutes of Health,
available at   HYPERLINK "http://ohsr.od.nih.gov/info/sheet6.html"
http://ohsr.od.nih.gov/info/sheet6.html

Complexity of Consent Materials

 	Simplification of Informed Consent Documents, prepared by the National
Cancer Institute, available at   HYPERLINK
"http://www.cancer.gov/clinicaltrials/understanding/simplification-of-in
formed-consent-docs/page2"
http://www.cancer.gov/clinicaltrials/understanding/simplification-of-inf
ormed-consent-docs/page2

With regard to textbooks on some of these topics, the following books
are suggested:

Ethical Principles

	Principles of Biomedical Ethics (5th edition). Tom L. Beauchamp and
James F. Childress. Oxford University Press 2001

Informed Consent

	A History and Theory of Informed Consent. Ruth R. Faden and Tom L.
Beauchamp. Oxford University Press 1986

	Informed Consent: Legal Theory and Clinical Practice (2nd Edition).
Jessica W. Berg, Paul S. Appelbaum, Charles W. Lidz and Lisa S. Parker.
Oxford University Press 2001.

Capacity to Make Decisions

	Assessing Competence to Consent to Treatment. Thomas Grisso and Paul S.
Appelbaum. Oxford University Press 1998.

Follow-up on Agricultural Handler Exposure Task Force and Antimicrobial
Exposure Assessment Task Force Protocols

Charge to the Board

Recognizing that protocol-specific science and ethics issues will be
addressed in later HSRB meetings, EPA has attempted to explain the basis
for its conclusion that additional information on exposure for people
who mix, load, and apply pesticides (handlers) would be useful in EPA's
regulatory decision-making and therefore new research would be valuable.
 Do the materials provided by EPA regarding the quality of the
scientific data currently available for assessing exposures for handlers
contain useful information to establish the societal value of proposed
new handler exposure research, assuming individual protocols would
generate scientifically valid information?

Board Response to the Charge

The Board found that the joint U.S. EPA – California EPA – Health
Canada background document provided an excellent review of existing
handler data, and identified important limitations of these data. The
report from the January 2007 meeting of the EPA FIFRA Scientific
Advisory Panel (SAP) extended this analysis, and provided an excellent
rationale for the collection of new occupational handler exposure data
for use by EPA and other regulatory agencies. In summary, the materials
provided by EPA regarding the quality of the scientific data currently
available for assessing exposures for handlers provide a sound
justification for the societal value of proposed new handler exposure
research. The challenge as the Agency moves forward with the AHETF study
is to ensure that the study is designed and conducted in a way that
produces high quality exposure data suitable for use in Agency risk
assessments.

Charge to the Board

What additional information, if any, would the Board want with respect
either to handler research in general or to individual protocols?

Board Response to the Charge

The Agency brought the AHETF study to the Board’s attention because it
considered this study to fall within the boundaries of “intentional
exposure” as defined in the EPA’s Human Studies Rule. Substantial
discussion occurred at the June 2006 meeting and again at this meeting
regarding the Agency’s decision process for classifying human studies
as intentional or observational. The Board would appreciate the
opportunity to learn more about the Agency’s approach to this issue,
and contribute to this discussion at a future HSRB meeting, particularly
in regard to occupational exposure studies.

The Board praised EPA’s decision to obtain a review and report of
worker exposure methods from the EPA FIFRA SAP. The Board found the
meeting presentations by Drs. Heeringa and Popendorf of the EPA SAP
particularly helpful in providing guidance on the AHETF task force
study.

The Board commended EPA’s response to its questions regarding use of
diazinon in the AHE37 protocol.  The Board understands that the Agency
will require AHETF to identify a pesticide other than diazinon to use in
this protocol to assess exposures associated with open pour activities,
and that EPA will ensure that future protocols comply with the most
current risk mitigation measures.

Overarching Concerns

At its June 2006 meeting, the Board recommended development of a
“governing document” that would frame the entire study in regard to
its purpose, general methodological approach, and general analytical
plan. Agency and SAP presentations at the April 2007 meeting indicated
that substantial progress had been made in this regard, both within the
Agency and within the Task Force. The Agency indicated that additional
information to address this concern would be presented at the June 2007
HSRB meeting.

More specifically, the Board recommended development of a clear and
appropriate plan for the collection and handling of the data being
collected, including sample size and statistical analysis. The Board
recognized that this is a complex and iterative task. It would be most
helpful to have a timeline for development of the analytical and
statistical plan.

At the April 2007 meeting, the Board indicated that there will be two
tiers to its evaluation of submitted protocols: (1) whether the model
and general plan are scientifically and ethically valid, and (2) how the
protocol will be implemented at each site, i.e., how issues such as
compliance with data collection and entry will be managed, subject
safety, and monitoring of recruitment.

The Board recommended that the Agency and AHETF develop a clear
narrative regarding the uses to which the data would be applied. The
Agency and SAP reports submitted to the Board for this meeting provided
substantial additional information regarding the use of data.
Articulation of these plans in a short draft document would likely move
this process forward.

The Board also recommended that the Agency consider development of
protocols for repeated measures to appropriately estimate exposures
within individuals. Such studies on at least a small subset of the study
population would allow adjustment for this source of variability in
statistical analysis. The SAP report addressed this issue in some
detail, and has provided the Agency with very useful guidance on this
issue.

The Board discussed the potential value of examining the ways in which
the agency has used the Agricultural Reentry Task Force (ARTF) database
in its risk assessments. This database has a similar scenario-based
structure as the databases under review, and used similar methods to
measure dermal exposure. The Board suggested that the agency share with
the board its experience with the ARTF database to identify “lessons
learned” and possible pitfalls in the use of such databases.

Methodological Concerns Issues

The Board reaffirmed its interest in two recommendations from the June
2006 HSRB meeting:

The Board recommended additional validation studies to determine the
extent to which dermal exposure measurements may underestimate true
exposure. The Board would appreciate an update on plans, if any, to
address this recommendation.

The Board recommended that the Agency consider broadening participation
in its discussions of the Agricultural Handler Exposure Database,
including additional members of the scientific community, as well as
parties with a direct interest in the database project, such as the
labor community. The Board would appreciate an update on plans, if any,
to address this recommendation.

At the April 2007 meeting, the Board also recommended that the following
methodological issues be considered in the development of documents and
protocols:

A description of how EPA will evaluate its linear model assumption
(exposure vs. amount of active ingredient handled), given the SAP’s
recommendations;

Information on sampling frame and where to focus data collection, based
on usage patterns for products; how sample size would be determined;
strategies for replacement of missing or partial data;

A statistical analysis plan including identification of covariates to be
collected and a rationale for emphasis on some covariates versus others;

Whether the Agency plans to include biomonitoring data in the task force
activities as a means of evaluating the validity of passive dosimetry
measurements;

How the protocols represent, as closely as possible, the conditions of a
true work day including documented reasons for and proposed duration of
the study.

Plans to meet the requirements established in 40 CFR part 26, subparts K
and L.

HSRB Consensus and Rationale

The HSRB concluded that the materials provided by EPA regarding the
quality of the scientific data currently available for assessing
exposures for handlers provide a sound justification for the societal
value of proposed new handler exposure research. In addition, the review
and recommendations of the EPA FIFRA SAP provide an excellent starting
point for some methodological decisions and for the identification of
issues still to be addressed. The challenge as the Agency moves forward
with the AHETF study is to ensure that the study is designed and
conducted in a way that produces high quality exposure data suitable for
use in Agency risk assessments.

The Board recommended development of a “governing document” that
would frame the entire plan for the collection and statistical analysis
of the data, and a clear narrative regarding the uses to which the data
would be put. The Board also recommended that studies be conducted as a
part of this project to determine the accuracy of dermal exposure
measurements. The Board further recommended that the agency consider
broadening participation in its discussions of the agricultural handler
exposure database, including additional members of the scientific
community, as well as parties with a direct interest in the database
project, such as the labor community. Finally, the Board recommended
that the Agency draw upon its experience with the Agricultural Reentry
Task Force database to clarify how such data are used in its risk
assessments, to capture the key “lessons learned” from this
experience, and to avoid possible pitfalls in the use of such databases.

REFERENCES

Carley, J.M. 2007a. Ethics Review of EMD-003.3 Report of Completed
Efficacy Study for Aerosol Tick Repellent Containing IR-3535. Dated
March 14, 2007.  Unpublished document prepared by Office of Pesticide
Programs, United States Environmental Protection Agency.

Carley, J.M. 2007b. Ethics Review of EMD-004.3 Report of Completed
Efficacy Study for Aerosol Mosquito Repellent Containing IR-3535. Dated
March 14, 2007.  Unpublished document prepared by Office of Pesticide
Programs, United States Environmental Protection Agency.

Carroll, S. 2007a. Test of Personal Insect Repellents: Study EMD-003.3
(Aerosol) – Revised. Dated February 5, 2007.  Unpublished document
prepared by Carroll-Loye Biological Research.

Carroll, S. 2007b. Test of Personal Insect Repellents: Study EMD-004.3
(Aerosol) – Revised. Dated February 5, 2007.  Unpublished document
prepared by Carroll-Loye Biological Research.

Carley, J.M. 2007c . Ethics Review a Completed Human Study of Dermal
Irritation of Two Repellent Products. Dated March 15, 2007.  Unpublished
document prepared by Office of Pesticide Programs, United States
Environmental Protection Agency.

Carley, J.M. 2007d . Ethics Review a Completed Human Repeated Insult
Patch Test (RIPT) of Two Repellent Products. Dated March 15, 2007.
Unpublished document prepared by Office of Pesticide Programs, United
States Environmental Protection Agency.

EMD 003.3 (Aerosol).  2007.  EMD Chemicals.

EPA HSRB. 2007. January 24, 2007 EPA Human Studies Review Board Meeting
Report. Washington, DC: Environmental Protection Agency.  April 16,
2007.  EPA-HSRB-07-01

Georgeian K and Dosik JS. 2007a. Primary Irritation Patch Study
[redacted] Supplemented with Additional Supporting Materials Satisfying
40 CFR 26.1303 for [redacted] [Repellent Code] 1000718-008, concentrate
of 1000718-009. Volumes 1 and 2. Unpublished document prepared by
toXcel, LLC. February 1, 2007.

Georgeian K and Dosik JS. 2007b. Primary Irritation Patch Study
[redacted] Supplemented with Additional Supporting Materials Satisfying
40 CFR 26.1303 for [redacted] [Repellent Code] 1004006-005. Volumes 1
and 2. Unpublished document prepared by toXcel, LLC. February 1, 2007.

Georgeian K and Dosik JS. 2007c. Repeated Insult Patch Study [redacted]
Supplemented with Additional Supporting Materials Satisfying 40 CFR
26.1303 for [redacted] [Repellent Code] 1000718-008, concentrate of
1000718-009. Volumes 1 and 2. Unpublished document prepared by toXcel,
LLC. February 1, 2007.

Georgeian K and Dosik JS. 2007d. Repeated Insult Patch Study [redacted]
Supplemented with Additional Supporting Materials Satisfying 40 CFR
26.1303 for [redacted] [Repellent Code] 1004006-005. Volumes 1 and 2.
Unpublished document prepared by toXcel, LLC. February 1, 2007.

APPENDIX A

Draft Framework for Developing Best Practices

for Recruiting, Screening, and Informing, and Consenting

Human Subjects of an  Obtaining Consent from Human Subjects for
Occupational Exposure Studies with Pesticides

March 15, 2007

Introduction

	One of the fundamental protections for people who participate as
subjects in human research is embodied in the requirement that their
choice to participate be both fully informed and fully voluntary.
EPA’s regulation governing the conduct of third-party research
involving intentional exposure of human subjects for pesticides contains
provisions that require that all subjects provide written informed
consent before participating in a covered study.  See 40 CFR
§§26.1116, 26.1117.  These sections, which closely parallel provisions
in the Common Rule, also require that informed consent documents contain
certain basic information (§26.1116(a) and (b)) and that investigators
document each subject’s consent to participate (§26.1117).  These
provisions, however, contain broad directions which must be interpreted
and applied in the context of specific research proposals to achieve
their intent.

Two industry task forces–the Agricultural Handlers Exposure Task Force
(AHETF) and the Antimicrobial Exposure Assessment Task Force
(AEATF)–are preparing to conduct research to measure exposure received
by professional pesticide handlers who mix, load, or apply pesticides in
representative agricultural or antimicrobial use scenarios.  The Agency
believes that investigators undertaking this kind of research need to
interpret the general requirements of the regulations and apply them to
the specific circumstances associated with this kind of research.   To
help ensure that people who consider participating in these studies are
treated ethically, EPA plans to compile guidance on best practices that
investigators could employ to recruit and enroll subjects into this kind
of research.

This paper addresses the major elements of ethical recruitment and
enrollment and the issues that typically arise during these processes.
For each element, EPA discusses broad principles which should be
considered in the course of research design.  In the future, through a
participatory process involving investigators, workers, and other
stakeholders, EPA intends to add to the document specific best
practices, and to identify publicly available resources that contain
additional discussion and guidance relevant to the application of
general ethical principles in occupational exposure research.

Overarching Concerns

This The remainder of this paper presents a conceptual framework for
considering and organizing best practices in occupational exposure
studies for pesticides under four broad headings:

Equitable Subject Selection

Fully Informed Choice to Participate

Fully Voluntary Choice to Participate

Respect for Prospective and Enrolled Subjects

Equitable subject selection

As a condition for approval of proposed research, the IRB must determine
that subject selection is equitable.  (40 CFR §26.1111(a)(3)).  This
passage continues:

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
and should be particularly cognizant of the special problems of research
involving vulnerable populations, such as prisoners, mentally disabled
persons, or economically or educationally disadvantaged persons.

Much of the available guidance on the interpretation and application of
this requirement focuses on the potential for inequitable exclusion from
research of subjects who might benefit from participation in it.  This
concern is clearly important in the context of medical research which
may offer therapeutic benefit to subjects.  But in pesticide research
with human subjects, participation in the research typically offers the
subjects no prospect of direct benefit, so exclusion of potential
beneficiaries is unlikely to weigh heavily.  In pesticide research the
greater concern is usually for the potential for inequitable reliance on
subjects from vulnerable populations—especially those who are
economically disadvantaged or in a dependent or subordinate relationship
to the investigators or others involved with the research.

The essence of equity in selection of research subjects is that the
burden of bearing the risks of research be fairly distributed.  There
are several aspects of fair distribution.

Representativeness of sample

The Common Rule defines “research” as “a systematic investigation
. . . designed to develop or contribute to generalizable knowledge.”
(40 CFR 26.1102(d)).  Research which is more broadly generalizable is of
greater societal value than other research.  The representativeness of
the sample is thus directly related to the justification for the
research.

Ideally, the population selected for research participation would be
randomly sampled from the target population to which the study results
will be generalized.  This ideal cannot often be attained, but it should
guide the design of recruitment and selection processes in three ways.

First, the target population should be identified and characterized
demographically.  Second, a sampling frame should be defined, and its
relation to the target population should be characterized.  Differences
between the characteristics of the population in the sampling frame and
those of the target population—i.e., the extent to which the sampling
frame is unrepresentative of the target population to which the study
results will be generalized—should be justified.  Third, the sample
should be selected from the sampling frame in a way that preserves its
representativeness of the target population.  To be equitably selected,
the sample must be selected to serve the scientific purposes of the
research, and not for the convenience of the investigators or for other
arbitrary reasons.

Appropriate use of inclusion/exclusion factors

Selection of potential subjects from a sampling frame entails
application of appropriate inclusion and exclusion factors to screen
candidates.  These can serve both to preserve the representativeness of
the selected sample and to provide extra protections for potentially
vulnerable subjects.  In the regulatory sense, “vulnerability” means
that some or all of the subjects may be overly susceptible to coercion
or undue influence when being enrolled into the research.

For example, in a study of agricultural worker exposure to pesticide
residues in previously treated orchards, it might make the research
easier to conduct if candidates who could not read and understand
English fluently were excluded.  But since a significant proportion of
orchard workers are of limited English language proficiency, such an
exclusion would diminish the representativeness of the sample, thereby
reducing the generalizability—and the societal value—of the
resulting data.

As another example, EPA’s regulations (40 CFR §26.1203) prohibit the
use of human subjects in research involving intentional exposure to
pesticides, if those subjects are pregnant or nursing women, or children
under age 18.  Compliance with these prohibitions and protection for
potentially vulnerable subjects can both be ensured with appropriate
exclusion factors.

Special considerations for vulnerable populations

Special consideration is needed to ensure protection of vulnerable
subjects.  Many potentially vulnerable populations should simply be
excluded from research involving pesticides.  The absence of any
potential direct benefit and the possibility of potentially harmful
dosing greater than that of normal occupational exposure to potential
harm to them makes it fundamentally unethical to consider using
prisoners, children, pregnant or nursing women, or mentally disabled
people as subjects in research with pesticides.  Some other examples of
appropriate exclusions are discussed above.

Others, however, who may ethically be included as subjects in pesticide
research may also be vulnerable and require special considerations.  For
example, individuals with limited English language proficiency may
appropriately participate in some research, but require translations of
recruiting and informed consent materials into language they can
understand, and assistance in communicating with investigators in the
consent process and during the conduct of the research.   Here the
“vulnerability” is due to the possibility that potential harms, or
the directions to avoid them would not be correctly understood.

In studies of occupational exposure to pesticides, subjects are quite
appropriately drawn from among those who are occupationally exposed to
pesticides.  But great care must be taken in recruiting them to ensure
that their decisions to participate in the research are made freely,
without any coercion or undue influence from their employers or
supervisors or the investigators.  One prerequisite to a free choice to
participate in occupational exposure studies is a clear understanding of
a real alternative to participation.

In some past pesticide studies, subjects have been drawn from among the
employees of the sponsor or the students of the investigators or
sponsors of the research.  It is very difficult to ensure either that
such subjects are representative of the target population or that their
choice to participate is made freely and without any undue influence
(intended or unintended); thus as a practical matter, the best course is
not to involve use them as research subjects.

Appropriate recruiting strategy

To ensure that a selected sample is as representative and equitable as
possible, the recruiting strategy must be appropriate to the design of
the research.  Fliers or advertisements or other recruiting efforts may
or may not reach the intended audience, depending on where and when they
appear.  In order that no individual or group bears an undue burden of
research, it is important to use a recruiting strategy that will extend
the opportunity to participate to the widest possible a wide population
consistent with research design.

Because of the potential for privacy infringement, recruiting procedures
that involve one person providing information about another person or as
a potential subject without his/her permission are discouraged.
Information about the study should be provided to potential subjects
through flyers, advertisements or other means initiated by the
investigators.  Potential subjects may then actively express interest in
study participation by contacting the investigator directly.

Prospective subjects may be recruited via advertisements, announcements,
flyers or other means. All recruitment materials—advertisements,
flyers, postcards, brochures, press releases, telephone scripts, or
postings on the internet—should need to be reviewed by the IRB for
accuracy in presentation of information that the prospective subject
needs to determine his/her eligibility and interest.  The IRB review
should considers content, language, and design.

Fully informed choice to participate.

The second over-arching concern is to ensure that subjects’ choices to
participate in research are fully informed.  The Office for Human
Research Protections (OHRP) states that “informed consent is one of
the primary requirements underpinning research with human subjects; it
reflects the basic principle of respect for persons.”

Informed consent is the knowing consent of an individual or his/her
legally authorized representative, obtained without undue inducement or
any element of force or coercion.  Obtaining informed consent doesn’t
end with a signature on a piece of paper.  It is a process in which the
subject receives enough information about a study to make an informed
decision about initial entry and continuing participation in the
research.  The process involves reading, understanding and signing an
informed consent document as well as discussing the details of study
participation with a knowledgeable member of the research team.

By signing the consent form, the project representative—the principal
investigator or study coordinator—who obtains consent is documenting
that the consent process is complete.  The project representative is
responsible for ensuring that everything is done to enhance prospective
subjects’ comprehension of the information and their ability to make
free and voluntary choices.  The project representative must be
knowledgeable about the study, able to present information clearly in
plain language, fluent in the preferred language of the prospective
subjects, and able to understand and resolve questions.

The subject who signs the consent form acknowledges having read the
information in the consent document and having had a chance to discuss
it, to and ask questions about the study, and to have those questions
answered.  The subjects’ signatures also indicate agreement to
participate in the study, and understanding that they are free to change
their minds at any time and withdraw their consent to participate.

The primary purposes of the informed consent process are is to
communicate to prospective subjects :adequate information, expressed
clearly in plain and understandable language, to make an informed
decision about participating in the proposed study.  This information is
outlined in the required elements of consent (40 CFR §26.1116)
including:

Adequate information, expressed clearly in plain and understandable
language, to make an informed decision about participating in the
proposed study.

The purpose, risks, and benefits of the research.

The procedures involved and what would be expected of participants.

That he/she retains the right to decline to participate or to withdraw
from the study at any time without penalty.

In addition, the informed consent process should:

Confirm the prospective subject’s understanding of the information
provided.

Answer any questions the prospective subject may have about the study.

Provide the subject with a copy of the completed consent form(s).

Essential Elements of a Consent Document

Basic and additional elements of an acceptable informed consent document
are specified in regulations at 40 CFR §26.1116(a), (b), and (e).  The
list below is based on these regulations, but is rearranged for clarity.
 In case of any perceived conflict between this list and the
regulations, the regulations are authoritative.

A consent document for occupational exposure studies for pesticides
should include:

A statement that the subject is being asked to participate in research
on a pesticide, and the identity and pesticidal function of the
pesticide(s) to which he or she will be exposed.

Identification of all the investigators involved in the study by name,
qualifications, and affiliation, and disclosure of any conflicts of
interest.

A plain-language, jargon-free explanation of the purposes of the
research.

An explanation of the eligibility criteria used to identify prospective
participants, and the number of subjects being recruited.

A description of where the research will be conducted and the expected
duration of the subject’s participation.

A description of all the procedures that the subject will be asked to
follow, identifying any procedures that are experimental.

A description of the nature and likelihood of any risks or discomforts
the subjects might encounter as a result of participation, and of the
actions taken to minimize these risks or discomforts.

Aa statement about compensation for injury, if any, and whetherif
medical treatment or other arrangements are available.

A statement that participation in the research will offer no direct
benefit to the subjects.

A discussion of statement about potential benefits to society of from
the knowledge that may result from this research.  This should
realistically identify both the nature and magnitude of expected
benefits and how they will be distributed—that is, who will receive
them.  This should not be exaggerated because it would then become a
source of undue influence.

A description of the extent, if any, to which records identifying the
subject will be held confidential, explaining the procedures for using
and storing data and who will have access to it.

Information about any payment or other incentive offered to
participants, describing what it is and what the subject must do to
obtain it. If there is a payment, a statement of the amount, the formula
for proration should the subject or investigator chose to discontinue
participation, and when and how payment will occur.  If no payment or
other incentive is offered, a statement that the participant will not be
paid to participate in this study. (Note: payments for participation are
not should not be described as individual “benefits” fromof the
researchparticipating in the study.)

Contact information for study personnel and the responsible IRB, in case
subjects have questions or concerns about the research, about their
participation in it, or about their rights as subjects.

A statement that the subject’s participation is voluntary, and that if
the subject decides to participate, they can change their mind and stop
their participation at any time without penalty.

A clear statement of alternatives to participation, specific to the
context of the research, should subjects decide not to participate or to
withdraw.

.

CompetenceCapacity to Make Decisions

Like the Common Rule that governs research with human subjects conducted
or supported by the federal government, EPA’s regulations governing
third-party research involving intentional exposure of human subjects to
pesticides provide that “[n]o investigator may involve a human being
as a subject in research . . . unless the investigator has obtained the
legally effective informed consent of the subject or the subject’s
legally authorized representative.”  (40 CFR §26.1116)

But because research involving intentional exposure to pesticides is
unlikely to be of direct benefit to subjects, it is equally unlikely
that it would ever be ethically appropriate to obtain consent from a
representative of a subject rather than from the subject him- or
herself.

In short, for these types of studies, it is essential to fully informed
consent that the consenting subjects be competenthave the capacity to
understand the information provided, and to make a free choice to
participate or not to participate.  If there is any question about the
decisional competence capacity of a prospective subject, that person
should not be enrolled in research.

Language of Informed Consent

The first regulatory requirement for the language of informed consent
documents—and for the entire informed consent process—is that
“[t]he information . . . given to the subject . . . shall be in
language understandable to the subject.”  (40 CFR §26.1116)

That means, first, that the language used in the consent documents and
throughout the consent process should be selected for the benefit of the
potential subjects, not for the convenience of the investigators.  If
subjects with limited English proficiency are expected to be enrolled,
all consent materials should be translated into the language(s) in which
prospective subjects are comfortable, and the accuracy of the
translation should be confirmed, through back-translation or other
means.  Translated consent materials must also be approved by an IRB
before use.  An interpreter fluent in the languages of both the
investigators and the prospective subjects may be needed to ensure that
the information provided in the consent process is fully understandable
to the subjects.

Understandability also requires that consent materials be written in
plain language, avoiding technical jargon.  Most authorities recommend
writing consent materials at a 6th to 8th grade reading level, using the
second person (i.e., addressing the subject as “you.”)
Understandability of consent materials should be verified before they
are used. A helpful web site is:
http://www.plainlanguage.gov/howto/index.cfm.

Finally, regulations forbid inclusion in consent materials of “any
exculpatory language through which the subject . . . 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.”  (40 CFR §26.1116)

Complexity of Consent Materials

It is easy to overwhelm subjects with too much information.  The quality
of consent materials is not measured by their bulk, but by the accuracy
and clarity with which they present what subjects need to know to make a
decision to participate.  Many details contained in the protocol itself
are unnecessary in good consent materials, and careful editing should
exclude them.

One important element, however, that should be described in detail is
the procedures involved in the research, from the point of view of the
subjects.  The goal in developing consent materials should be to discuss
all the procedural elements in the research in one place, as much as
possible in the sequence they will occur, and in clear, plain language.

Circumstances and Process

The entire consent process and the circumstances in which it takes place
are critical components of fully informed and fully voluntary decisions.
 Most authorities consider the consent process to begin with the
potential subject’s initial contact with the research—whether
through advertisements, flyers, phone calls, or other means.  The
regulations require investigators to seek consent “only under
circumstances that provide the prospective subject . . . sufficient
opportunity to consider whether or not to participate and that minimize
the possibility of coercion or undue influence.” (40 CFR §26.1116)

The process should be designed to enhance the prospective subject’s
comprehension of the information and his or her ability to make a
choice.  It should take place in circumstances designed to minimize the
possibility of coercion or undue influence, and toan in an area and in a
manner that protects the privacy and integrity of both prospective and
selected subjects.

Particular care is needed to ensure that the process is free from any
element of coercion or undue pressure when When third parties other than
the investigators and subjects play a role in the recruiting, informing,
and consent processes particular care is needed to ensure that the
processes are free from any element of coercion or undue pressure.  If,
for example, pesticide handlers are recruited through their employers,
care must be taken to ensure they have a legitimate free choice not to
participate, and that their employers do not influence their decisions,
intentionally or unintentionally.

Communicating Risks

Unless prospective subjects understand the risks associated with
participation in research, they cannot make a rational decision to
participate.  Risk should be addressed in consent materials from the
point of view of the subjects, rather than from the point of view of the
investigators.  If the discussion of risk in the informed consent
document is the same as the discussion in the protocol, it almost
certainly needs revision.

Three aspects of risk need to be addressed in consent materials:

  The first aspect of risk is Iits qualitative nature.  Risks may be
physical risks of harm or discomfort; they may also be psychological,
social, economic, or legal.  For example, a prospective female subject
who learns she is pregnant as a result of a pregnancy test associated
with eligibility screening may experience psychological harm.  If the
news of her pregnancy is not communicated to her with care and
discretion, she may experience economic or social harm as well.  Risks
and harms may also involve others such as family members and future
children.

  The second aspect of risk that must be addressed in an adequately
informative consent document is Iits likelihood.  An informed choice to
participate in research depends on a clear understanding of the
distinction between likely and unlikely risks.  Each risk identified in
an informed consent document should also be characterized in terms of
its likelihood of occurrence.

  The third and final aspect of risk that must be discussed is the
Ssteps taken by the investigators to minimize riskit.  This should
include telling potential subjects how injuries or other adverse effects
resulting from participation in the research will be managed, what
treatment will be available, and who will pay for it.

Communicating Benefits

Occupational exposure studies for pesticides do not offer any direct
benefit to participants.  This must be clearly stated in consent
materials.

 explicit discussion of the nature and distribution of benefits is
essential to a fully informed decision by a subject to participate in
the research.

Potential societal benefits of from the information expected to result
from the research should be described to potential subjects.  If, for
example, a study of pesticide handler exposure is expected to provide
information which EPA will use to define the minimum personal protective
equipment required for safe handling of pesticides in the relevant
exposure scenario, this could affect a potential subject’s decision to
participate.  If the beneficiaries of the research are likely to be
pesticide registrants, this, too, should be stated clearly.  Care should
be taken to not over-state potential benefits.

Compensation must not be described as a benefit to subjects.

Confirming Understanding

It is the responsibility of the research team to confirm subject
understanding, and the investigator’s signature on a consent form
attests to this confirmation.  It is not sufficient to obtain signatures
on forms worded so as to put the responsibility on the subjects.
Statements such as “I understand . . .” in informed consent
documents represent such an unacceptable transfer of responsibility.  As
with consent itself, subject understanding is an ongoing process, which
needs to be confirmed and enhanced if the project occurs over time.

Fully voluntary choice to participate

Recruitment must be conducted without any element of coercion or undue
influence to participate.  Principal potentialPotential sources of undue
influence are from dependent relationships and from social pressure from
peers.  Is the consent process adequate to ensure that the subject’s
agreement to participate is informed, rational and voluntary?  What
safeguards could be implemented to improve the consent process?  Do
candidates have a legitimate free and real option alternative to
participating?

Compensating for Managing Dependent Relationships

In many occupational exposure studies for pesticides, the
subjects—whether they are pesticide handlers or re-entrant
workers—are recruited for the research through their employers.  In
such cases, great care is needed to ensure this does not compromise the
voluntariness of the subjects’ choices to participate.  The employer
must have no compelling interest in the research, or in whether an
individual chooses to participate in it, and this must be clearly
communicated to potential subjects.  They Subjects must understand that
their decision either to participate in research or not to participate
will have no impact on their job, their pay, or any other aspect of
their relationship to their employer.

In some past studies for pesticides, the employers of the subjects have
had a direct interest in the research.  Some Also, some companies who
that sponsor or conduct exposure studies have recruited subjects from
among their own employees.  This practice is inconsistent with ensuring
that subject choices to participate are entirely voluntary.

In some exposure studies, subjects have been recruited as a crew,
through a crew leader or labor contractor.  This introduces a clear
potential for undue influence, especially since because some members of
agricultural work crews may be in the U.S. illegally, and thus
particularly vulnerable.

Minimizing Peer Pressure

It may be essential to fully voluntary choice to design the
circumstances and process for discussing the research, addressing
questions about it, and seeking consent of potential subjects so that
each candidate has the privacy to act without any pressure from a peer
group.  Since Because it is often obvious whether someone is
participating in research—as, for example, when participants are all
wearing whole-body dosimeters—it is important to ensure privacy for
individual choices and discretion concerning reasons for
nonparticipation.  If each candidate is interviewed and makes a
participation decision in private, for example, non-participation could
result from application of the exclusion factors by the investigators or
from personal choice by the candidate.  A well-designed process would
leave it entirely up to the individual subject whether to disclose the
true reason for non-participation.

Real Alternatives to Participation in Research

It is common practice to include in the consent materials for
non-therapeutic research such as that conducted with pesticides a
statement to the effect that “this study is not associated with any
therapeutic treatment, so your only alternative to participation is not
to participate.”  This simple statement is a carryover of habits
associated with biomedical research, where consent materials are
required to discuss alternative treatments may not be available to
potential subjects of research.  But it such an unexplained statement is
inappropriate for occupational exposure studies for pesticides.
Potential subjects in occupational studies must be told in some detail
what they would do if they decide not to participate in the research, or
if they decide later to withdraw from the research.  This must be
thought through in the course of study design and spelled out in the
consent materials, so subjects can understand their options more fully.

For the following example, assume mixer/loaders and aerial applicators
are recruited from among the employees of a commercial pesticide
application service to participate in a study of agricultural handler
exposure.  The study coordinators have identified a particular farmer
who is a client of the application service, and arranged with him to
make his fields available for pesticide treatment in the course of the
research.  What does it mean to tell an aerial applicator employed by
the service that his only alternative to participating in the research
is not to participate?  What would he do that day if he did not
participate in the research?  Would he apply the same pesticide to the
same field, but with no measurement of his exposure?  Would he be
reassigned to service another client?  Would he get an unscheduled day
off?  Would he get paid?

To extend the example, what does it mean to tell an aerial applicator
that he is free to withdraw from the research at any time?  If he
decides to withdraw in the middle of the study, will someone else step
up and fly the plane?  What would he do for the rest of the day?  How
will the cooperating farmer’s field get treated?  Would anyone’s
income—his own, his employer’s, perhaps the farmer’s—be affected
by the pilot’s decision to withdraw from the research?

For another example, consider a study of re-entrant agricultural worker
exposure, for which subjects were recruited through a crew boss.  If one
member of the crew chose not to participate in the research, what would
that individual do that day?

Respect for potential and enrolled subjects

Fully informed, fully voluntary participation in research is required by
the principle of respect for persons.  But research subjects are
sometimes treated in ways that undermine this principle.

Incentive Payments forCompensation of Subjects

To assist in subject recruitment, an incentive may be offered.  Any
incentive should be reasonable, taking into account the burden or
inconvenience incurred by study participants.  The amount and type of
incentive should not unduly influence prospective subjects to
participate.  Subjects should understand what incentives will be offered
before they agree to participate in the study.  The terms of the
incentive should be described in the consent form.  Incentives may also
be described in general terms in recruitment materials, but should not
be emphasized. All incentives and methods of communication (e.g.,
fliers) to prospective subjects need to be approved by the IRB before
use.

It is particularly important in research on occupational exposures to
explain clearly to potential subjects how any incentive compensation
payments for their participation in research relates to their normal
compensation for doing their job.  Will they be paid above and beyond
their usual pay?  How will their pay be affected if they decide to
withdraw from the research?

Privacy and Confidentiality

The protection of a prospective or enrolled subject’s privacy must be
considered in the design and conduct of research.  A breach of
confidentiality or a perceived invasion of privacy may result in harm to
the individual.

To maintain confidentiality of research data, the investigator should
protect information obtained from the subject to avoid unintentional
access by others. Subjects should understand the procedures used to
protect confidentiality.

Guidelines for developing procedures to address confidentiality include:

Limit the personal information recorded to that which is essential to
the research;

Store personally identifiable data securely and limit access to the
principal investigator and authorized staff;

Code data as early in the research as possible and dispose of the code
linking the data to individual subjects when data have been processed;

Do not disclose personally identifiable data to anyone other than the
research team without the written consent of the subjects. (Exceptions
may be made in case of emergency need for intervention or as required by
regulatory agencies).

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1116.E

Impact on EPA/IRB is not relevant to the discussion on subject consent.