Good morning, ladies and gentlemen. Welcome to the Carnegie Endowment. My name is George Perkovich. I'm a vice president for studies here at the Endowment. And it's my pleasure to welcome you this morning for a discussion with Pakistan's relatively new ambassador to the United States, Dr. Majeed Khan, who, while he arrived in his ambassadorial position here in January, has long and deep experience, both in Washington and working on US issues back in the ministry in Islamabad. And then most recently, was serving as ambassador to Japan before coming here. So has an outstanding sense, not only of dynamics with the US, but globally, and in particular, Asian security affairs. So we're honored to have you with us, Ambassador. What we're going to do is I'm going to ask a few questions to get the discussion started. And then we're going to turn it into a broader discussion. And I also have invited the ambassador, if at any time he wants to ask you all a question or me a question about what's going on in this very predictable, rational environment in which we live in Washington that we're fair game. So everybody should understand that it's meant to be a truly a two-way conversation. Ambassador is a diplomat and a talented one at that. So I'm mainly going to focus on foreign policy issues. But as we get started, I suppose I should ask how you're finding the environment in Washington now compared to the years prior when you've served here. But I can imagine that you're too good at your job. To want to answer that in a really interesting way. But I want to leave it on the table to begin with, if there is a first kind of question or comment. Are the challenges like representing Pakistan now in mid-2019? Well, thank you very much, George. First of all, let me thank you and through you for giving me this opportunity to come and hear our perspectives and positions on issues of interest here in Washington, DC. I know the audience here is a very well-informed one. So I'm here as much as to say my piece as I am here to hear the positions and perspectives from the audience. Yes, I think I have a long association with your beautiful country. Not just in Washington, I served for over six years in New York as well with our permanent mission there. And having served as Deputy Chief of Mission as an acting ambassador here in DC. Yes, I think this city in particular, perhaps different from any other capital in the world, is defined by the incumbent at the White House. And the whole team that follows when the administration changes. So even if you know the place very well and you're well aware of the process also, the city is a different city when you come to a new and different administration. So I, of course, despite knowing the city very well, I'm trying to find my way around here in DC. And this position is as challenging as it can get, and particularly for Pakistani ambassadors. And clearly, I can also say that in our world, being accredited as ambassador to United States is as good as it can get for any diplomat. So I am very honored and feel very privileged to carry my country's flag in this very, very important country, which I believe is the center of the world. That's certainly the way people here see it. Let me then focus on South Asia, precisely because we're the center of the world, tend to think less about other parts of the world, even parts of the world that have many more people and many more challenges. So I want to turn to Pakistan. And in particular, kind of the underlying fundamental development, which is that Pakistan is reportedly going to receive another package of support from the IMF, the International Monetary Fund, for $6 billion. And I believe this is the 13th in the last 30 years of these bailouts. And so I guess a question is, or among the questions, is how do the repeated cycles of economic crisis and then IMF assistance, how do they affect the world's perceptions of Pakistan's importance and why and how to deal with Pakistan? And also, if you have a sense of how this affects the kind of dynamic within Pakistan and kind of the sense of priorities within Pakistan, that there's so often this kind of challenge of economic crisis and turning for help on the balance of payments. Well, I think a lot of attention has been off late given to Pakistan's resort to the IMF facility. I think as a member of IMF, we are entitled to have resort to that facility as and when we need to have. And then IMF carries out a professional and technical evaluation of the liquidity status of that particular country. And based on their technical evaluation, decides and determines the size of the package based on the history of that country. Yes, I think we face both structural and cyclical problems. We do face economic challenges. And coming to the IMF is not something very unusual. We have, as you just pointed out, done that many times in the past. But let me also say that Pakistan has never defaulted on its debt payments. Our debt to GDP ratio is still, if not better, it is as good as other countries at similar level of development. And therefore, coming to IMF should not, in fact, be seen as critically as it is really, I think, lately projected in some of the foreign media. As regards the steps that we need to take, that those steps in terms of expanding the domestic tax base, generating domestic resources, stopping the bleeding of state-owned enterprises, rationalizing the tariffs, expanding our exports, enhancing our competitiveness. Now, these are steps. And these are tough decisions that the government actually is determined to take, independent of what the IMF conditionalities might be eventually. Because these are the steps that we will require to basically enhance our productivity and competitiveness to basically be able to export more, because unless and until we are able to do that, I don't think we will be able to have the basis that would basically prevent us from repeatedly coming back to the IMF. So on that count, the budget and some of the steps that the government is taking are reflective of that determination that the government has to make those difficult choices and decisions that we need to make. And it's not just the IMF, actually. I think some of our friends and partners have also contributed to that, including yesterday, the Emir of Qatar was there. And they have also. So that is, again, I think a mark of confidence in Pakistan's economy. And Pakistan is no small country. And we are no small economy. So we still feel that this is a small part of what we owe. And once we are able to put our house in order, I think we will be able to meet our debt obligations, as we have done, 70 years of our existence. They, has the US been kind of pushing conditionality in ways that the government of Pakistan is aware and, if so, are some of the kind of conditions that the US is pushing any different than they would have been in prior years. Is there anything kind of new in that, or is it kind of the usual encouragement about expanding the tax base and so on? But I don't think that IMF has its own board. And it has its own technical teams and missions that go across to the countries, engage with the concerned people, and agree on the elements of the package. And that package then goes to the board, where this, the whatever package we have agreed to, has been agreed at the technical level, and it is still supposed to go to the board. I don't think that I can, I have heard of any specific conditionalities that the United States has particularly pushed for. It is so far a technical process that the IMF and the IMF personnel are leading and staring. Let me turn to the financial action task force. And in a sense, the logic of these questions really does focus on the economy and development and the challenges to Pakistan's building its strength, in a sense, and its well-being for its population with the idea as China showed over the decades and India has shown over recent decades that's also how you then project power and influence and protect your interests. And so the financial action task force, for those who don't follow it, Fatif it's often called, is an international body that sets standards and promotes effective implementation of legal, regulatory, and operational measures for combating money laundering, financing of terrorist activities and organizations and protecting the integrity of the financial, global financial system. And so this body, I believe 27 countries was meeting in Orlando, Florida last week. There was also a campaign event there, but I don't think they were related last week. It just occurred to me, but Pakistan was placed on the Fatif gray list a while back and the risk is that's a prelude to going on the black list, which you're put on for failure to take adequate or recommended steps to prevent money laundering and facilitation of terrorism. So in the media reported last week at the meeting in Orlando, that Pakistan was not put on the black list. Reports were that China, Turkey and Malaysia voted to prevent that and three out of the 27 are required, I believe, to prevent that. What I'm more interested in is that last week, right before the meeting or during the meeting, there were media reports that Pakistani security entities had shut down some terrorist training camps or militant training camps in the Pakistani part of Kashmir and taken other steps against some of the designated groups, Jaishi Mohammed, Luxury Taiba and others. And so while that was welcomed by a lot of people, some assume this was part of heading off the action in Fatah to put Pakistan on the black list. And but I guess the question is, a lot of people are curious about, I mean, have you been instructed that these actions have been taken and so that there were kind of new and more decisive actions taken against these groups in the recent days? First of all, let me say that the Fatah process is and the action plan that Pakistan willingly and voluntarily signed on to is a program that is work in progress. It is a tough set of conditions with rather short timelines, but actions that we are taking against, that's one part. And then there is this broad movement against extremist groups, against non-state actors, against anyone who is or is likely to abuse Pakistan's space, facilities or territory against anyone. That we are determined to act against all those elements. And this is part of our national action plan. And if you look at those 20 points covered in the national action plan, taking action against terrorist financing is an important part of that and against militant organizations. I can say that we have covered a lot of crimes a lot of crime.  We have taken over the facilities run by some of those proscribed entities. The state, the government has, we have proscribed about 11 new entities. And we also just in terms of the terrorist financing cases, the percentage, it has gone up by almost 95%. Similarly, there is a 175% increase in the arrests that have been made linked to that. So there is also almost 82% rise in conviction rates. So really, I think all of this is reflective of the will, the political will that the new government in Pakistan has to take on these challenges frontally. We are also as part of that political will putting in place the infrastructure, the legal frameworks, and that there is also this determination to see it through in terms of vigorously implementing those. And I think, George, this is a broad message that I would really like to share with you and through you with your audience here, that there is a new Pakistan, a Pakistan where the leadership is determined to make a difference in the lives of the common man. So this is a government with a people-centered development-focused and peace-oriented agenda. And there is a clear recognition that without peace within and peace without, the government will not be able to implement and execute its development agenda, would not be able to enable our people to realize their dreams and aspirations because folks in Pakistan as much want good jobs, better health, better education for their kids as folks here in the United States and your country do. So, and that is the new approach that we need to, and I think if you look at the security situation today in Pakistan, we had the lowest number of terrorist incidents in the last 12 years. Last year was the lowest. And we hope to actually take that further down this year. And this is really reflective of the ground that we have covered. And this also reflects the determination that we have in taking this fight to its logical conclusion. So FETF being a part of that wider effort that we are making, we are not making it because we are obligated to do it under FETF. We are doing it because it is part of our national action plan. We feel that what is really important because you alluded to the media reports and unfortunately most of those media reports come from India. And it's really, and I think that's where we need to be careful because we should not let any one country, you know, basically pursue its own political agenda vis-a-vis Pakistan through these international institutions and channels. As long as it is a technical process, we feel that we have done a lot. We are also clear and determined to do more but we would not want the jury to be reggae and where there are already predetermined positions be it the statements issued by the Indian Minister for Finance, be it statements issued by their other senior leaders publicly calling for the blacklisting of Pakistan. Now that's, and then ironically, ironically India is also the co-chair of the APG. So you put yourself in our position and you ask us as to what would our confidence level be in terms of the fairness of that jury which is sitting in judgment on our performance. But having said that, we are still taking it very, very seriously and we are determined to take it to the logical conclusion. The good news is I think China becomes the chair after India. So a few more months and you can breathe easier. But I wanted to pick, because what you said is extremely important and as you know, for people who followed developments in Pakistan and the region more broadly over the years, we'll remember President Musharraf said much the same in 2002 and then other civilian leaders have also emphasized the importance of peace within the country and fighting terrorism within the country as well as those groups that project violence outward. And yet things kept happening. And so the question that people always ask is, what about the military? Is the military on board? Do the military support these policies, including the ISI? And so in that regard, I wanna ask about a change that was reported in the Pakistani media and I think is true last week about the change in the leadership of the Inner Services Intelligence last week which came at almost exactly the same time as the thoughts of meeting in Orlando. And as I understand it, where the incumbent, the general who left had only been in the office for eight months and so it was somewhat unusual. So some people are saying this is an example or suggests the way in which the army leadership really does want to press hard on these groups and that was one of the reasons you made a change. Now, I don't want you to commit political suicide by jumping into these issues of personnel within the military, but is people in Pakistan take this as another example that the government actually is serious and that the army is serious about this time going after these groups? First of all, I think eight months should not be used as a measure or yardstick. I think the term of office for some of the senior officials in the United States perhaps is even shorter, so. Sometimes that's too long, but that's, you know, yes. But, and I would really, don't read too much into that and I mean, these are changes that are made depending on whatever the realities on the ground are and I think it is for you to see what follows. And I think, and I, it's about walking the talk and it's about doing things. Verbal commitments, assurances, aside, you know, obviously if one were to go by the descriptions that we keep hearing here about the influence that the military has in Pakistan, then whatever actions that we have taken over the past few years obviously would not happen without the active support of the military in Pakistan. So really I think even if I were to look at it in logical terms, really whatever is happening is happening with the active support of the military leadership and I can say this, you know, I think that national action plan and this consensus that we have in Pakistan because we have suffered more than anyone else. We have borne the brunt and faced the consequences and therefore there is this recognition that there are actions, of course, you know, there are situations and there are occasions where some of these actions cannot be made irreversible because of the legal constraints, you know, because some evidence that is would make perfect political sense or through intelligence sources may not be worth anything when brought before the court of law and is subjected to judicial scrutiny. And so these are the challenges and these are the things that we are trying to deal with. It's a tall order, but you can have my assurance and I think whatever is happening on the ground further confirms the ownership of all policies by all the stakeholders in Pakistan. Let me, I have just two more questions and again, foreign policy and then we'll open it up. So the next one I'm thinking of is Pakistan Indian relations because also last week, last week was a busy week, it seems because last week I believe Prime Minister Modi and Foreign Minister Jashankar sent letters to your Prime Minister Imran Khan and Foreign Minister Qureshi responding to earlier letters that your leaders congratulating them and in a sense kind of opening dialogue and at least as some reports held that these letters back were constructive. We know that Pakistan has, that generally seeks dialogue and wants India to reconstitute dialogue when it's cut but I wanna ask a different question which is what does Pakistan want from dialogue with India whether it would be through the foreign ministries or back channels, otherwise like right now what would be Pakistan's central ambition or objective in dialogue with India? You know, I think there has never been as big a vacuum in terms of conversation and dialogue with India as we have now. We are two nuclear powers. India is the second largest country in the world. We are the fifth or sixth largest country in the world. Both of us have huge military machines. So, you know, I think it is only natural that our two countries stay engaged and there are conflicts, there are disputes between our two countries that the new government and I'll come back to what I said earlier and I think there is a consistent pattern that you see in terms of our desire and our quest for peace with India and trust me don't take it in any way as a sign of weakness but it is born out of this recognition you know that these two countries whose people and populations have their aspirations have tremendous potential and prime minister even before taking oath as prime minister had very clearly said that you know and addressing prime minister Modi that lets we don't need to fight, we need to fight poverty. There are lots of people out there that are living below the poverty line. So we want and obviously we would want to resolve issues and of course, Kashmir has been the core issue that has been devil relations between our two countries. India believes that terrorism is another issue that we need to end that is what our prime minister and our leadership, the national security committee in some of our statements have clearly said that we are ready to address all issues. And then if you just look at the train of events you know like despite the fact, despite the fact that BJP and prime minister Modi ran a campaign which was in some parts directed at Pakistan our prime minister was one of the first foreign leaders to congratulate, it was followed by a letter. And so and we have of course, media has been speculating all kinds of things and I think on that our ministry of foreign affairs has actually because these congratulatory messages and exchanges take place between leaders, that's a normal thing. What we are not hearing back from India is the response to the peace gestures that we are making. And I think that is the challenge and that is the vacuum which is for a country of the size that we have and the challenges that we face. I think this is a, we would like India to respond to those gestures and to take the dialogue forward. So last question in my initial questions wanna turn to Afghanistan where Pakistan is, Pakistan has obviously borne the brunt of so much of the conflict for the last 40 years in Afghanistan and US Special Envoy Khalazad has been pushing for peace talks with the Taliban. And so I think one of the central questions in all of this is whether and how Pakistan can help. And for a long time there's been a view at least by some in this town that Pakistan could fix it if they really wanted to. So I think people know the situation, always doubted that it's that easy. But nonetheless, there is this abiding question about whether and how Pakistan is prepared to facilitate push towards a peaceful resolution or otherwise. And I know that you can't speak for the Taliban but on the basis of Pakistan's longterm interactions with the Taliban, do you have a sense of what kind of settlement Taliban leaders are looking for within Afghanistan? In other words, if there are intra-Afghan talks, what is it that the Taliban are seeking as kind of a way to move forward at an internal modus vivendi? And then in that case, what can Pakistan and others do to help bring that about? So if you could shed light on those, it would be great. First of all, I think Pakistan has consistently believed that there is no military solution to the conflict in Afghanistan. And it is, as you just said, a very complicated issue. It has a long history, unfortunately. There are at least three generations in Afghanistan who have not seen anything but conflict and war. And clearly now in terms of what the Taliban wants, I would say that Ambassador Khalilzad is perhaps better informed than I am or many folks in Pakistan by virtue of the six or seven rounds of consultations that he has had. But I can tell you that we have made a serious and sincere effort in facilitating in whatever way we can the peace process, the reconciliation process. We also believe that this is not just for us. It is a shared responsibility where other countries in the region and players also need to contribute. And we also believe that violence is something that our prime minister, we've been saying this privately. We've already made a very clear statement, condemning violence urging Taliban to this spring offensive and all sides to avoid violence and to engage in dialogue. We also believe that without there being a comprehensive intra-Afghan dialogue, we will not have a peace, a sustainable peace in Afghanistan. And that is why only yesterday in Pakistan we hosted quite a large number of Afghan leaders. And in the foreign minister's statement, I invite you to look at that statement. I think it really comprehensively lays out what our expectations are. Obviously the gains that Afghanistan has made over the last 20 years, I think need to be preserved, be it on the human rights front, be it on the women empowerment front, be it on the democracy front. And there are those four elements that they are looking at. We will continue and we have made it clear that we will not let no one use our territory. And we expect that no one else would use the Afghan territory against Pakistan. And we would not want to basically bring the Afghan war into Pakistan. And so these are really the broad principles that we are looking at and we are adhering to. And we are really, because if you had asked me this question about six months or eight months ago, frankly, I could never have actually guessed that there will be a day where U.S. and Taliban will spend 16 days in the room talking about peace. And then someone said the other day that, and I think Ambassador Khalilzad publicly praised Pakistan and I was telling some friends that if Ambassador Khalilzad is praising Pakistan for Pakistan's cooperation, then we must have earned it very hard. I think you're right. This is one of those examples where a Republican administration can do things that a Democratic administration can't. So Zal's interaction with the Taliban, I think, is, I just want to follow up. Without mentioning India, you alluded to the importance of other countries in a sense using Afghanistan to project violence into Pakistan. And so is kind of the future of Afghanistan, is that something where you think India and Pakistan can have productive engagement to if you get the diplomatic process rolling again? You know, again, I think what is really important is for the world to be wary of the spoilers. Spoilers who, you know, when in a country you have seen conflict for too long, you have rent-seeking groups that built around perpetual conflict and therefore they are the ones who get to lose if that conflict is over. And then there are those who perhaps benefit indirectly from the conflict. So it is very important that all these factors are and all those who are part of those conversations are aware of that, are mindful of that. I don't think there should be any priory conclusions from the process and whosoever is in it in good faith and seriously needs to be given the opportunity to contribute. So what we're going to do is I'm going to ask you all who would like to ask a question or make a comment to raise your hand. Then I'll call on you. And then when my colleagues bring you the microphone, please introduce yourselves. And let's start. Let me see your hands to start with. Okay. Why don't you start with this gentleman and then we'll work over there and then we'll do it this way. Hi Ambassador, it was great listening to you. I'm a visiting fellow at the Simpson Center and I teach international relations in India. You know, to a common man, after events happen like the Mumbai attack or for instance the Pulwama attack, we are caught in these web of allegations and counter allegations and Pakistan it seems always says that provide us the dossier and then what happens after that? You know, it seems to a layman that's kind of stuck after that that probably India doesn't respond or it doesn't anticipate the kind of invitation that Pakistan gives. So where do you think the problem lies in this series of events that happen after every unfortunate incident? Thank you. You know, and then to be able to address this and it's a fair question, it's an important question. And I think for that we are saying that it is very important for our two countries to sit across the table. And post Pulwama, we even offered to have a dialogue on terrorism only. So, you know, and we offered India that we are ready to, you provide intelligence, you provide evidence. We are going to work with you in following up and to track and trace those who may have been responsible for that. But unfortunately, the government wanted to make a political point and instead they chose to send their aircrafts across to Pakistan. You know, and when I speak to you today here, I also have the advantage of hindsight. And so look at those claims that a terrorist camp taken out, 300 terrorists killed, one F-16 down. And it's not what we say. You look at these are independent reports. There are independent observers who say that none of that was true. So really, I think at the dossier that India shared, we have examined that. We have given our considered views back to India. We have yet to hear back from them on Mumbai also. You know, look at the train of events and the sequence of events and where things got stuck, you know, because as an attorney, I can tell you that I cannot present any evidence which the defense does not have the right to cross-examine. It will not be admissible as evidence in the court of law. And for this precise plea, the Samjhotha Express, where you actually had confessions, our citizens were killed there. And I think lives, be it Indian lives or Pakistani lives are precious lives, you know, and we must hold people to account for whenever those lives are lost. So the same argument was used in equating those. We have at least not equated the Mumbai trial. We may not have concluded the trial because we have not been able to basically get the evidence. I mean, Ajmal Kasab was executed right away. Had he been basically made to appear before the judicial tribunals in Pakistan, that would have actually enabled our people and our defense and everybody else to cross-examine and then cross-check the evidence that was available. Really, I think it's your right. I mean, it's my statement versus someone else's statement. And we are in this vicious cycle of throwing back the ball is in our court, ball is in their court, and it keeps going back and forth, you know. And that's why, and I think in Prime Minister Imran Khan, there is somebody who is consistent. And this is like even before it took over. And as you said that maybe the military was not on board. They are definitely on board now. Then what is it that is stopping India from reciprocating the initiative that Pakistan is consistently taking? Look at Kartarpur. I mean, we practically did it unilaterally. So, you know, these are, and we have suffered from terrorism and we understand the pain of those who suffer from terrorism anywhere.  And then gentlemen, kind of the orangeish shirt or coral. Where is that? There you go. All right. Yeah. Thank you. And I love summons. Yeah, I will. Yes. Indeed. Thank you very much for your time. It's extremely interesting. I'm Piotra. I'm a student just graduated from SICE. And during my studies, I was looking at China and a bit of Indian South Asian international affairs. And something that I'm interested to hear your opinion on about is Pakistan obviously has a large amount of investment and input from China and what we were talking about with China taking over the association. I forgot the acronym. And I was just interested to know how you think that's going to influence potential Pakistani-Indian relationships as we go ahead further with... Pakistani and whose relationship? Indian relationship. And China or over Kashmir and generally about the Belt and Road and where we think that's going to go in the next few months or even years. Thank you. I can tell you that Pakistan's trade relationship with China is much smaller than what Indian trade relationship with China is. And the investments that you are alluding to are investments that started since 2014. And we are grateful and thankful because China came to us when no one else was frankly looking at us. But if you look at the total portfolio of investments in Pakistan, it is just part of several, you know, many other investments coming from other countries. So we, of course, it is Pakistan is open not just to China. We are open to investments from all other friendly countries. And some of these economic zones, you know, are there and they are open for countries to invest with. I don't know how because frankly, you know, in the world today, I mean, this notion that kind of dates back to the Cold War days where you would only, you know, trade with your allies and partners and that you would not trade with your competitors is no longer relevant or true, you know. Countries are trading with the so-called allies as well as with their competitors and even adversaries, you know. Look at some of the biggest trading relationships in the world today. Look at some of the biggest investment relationships in the world today. So really, I think Pakistan is fortunate to receive investments from China, but that does not mean that we are close to others. And we would welcome that and no one needs to basically decide their sovereign options of having relationships with other countries based on what they are doing with the other countries, you know, mutually. These are not mutually exclusive relationships. So and and really, and I would like to push that point a little bit further also in terms of our relationship with the United States also. I mean, we would not. I mean, Pakistan for us, our relationship with the United States is a very important and consequential relationship. Our economic relationship is much older apart from the security relationship that we have. So we don't want this to be seen through the Afghan prism or through the India prism or through the we think that we are an important country in our own right. So similarly, our relationship with China, even when we were the most allied of allies of the United States, we were still friends with China. So I really don't think that it needs to be seen that way and India or any other country should actually look at that. This is a I'm glad you asked the question and I agree with what the ambassador said. And I think it's it's a point that really needs to be emphasized as especially as kind of politics and discourse in the US focus is more and more on competition with China. And then people mentioned Belt and Road as an example. And the ambassador was saying is what people in many of the other countries where China is investing in doing the Belt and Road, which is we would like other people to be investing in our infrastructure too. And we would actually like to diversify and more is better. It's not like people are kind of willingly limiting themselves to Chinese investment. And we tend to lose that perspective here in part because, you know, kind of investment doesn't flow from government policy as as directly, but I just to emphasize the importance of what the ambassador was saying, I think I want to switch sides right in front of you. Aaron, we'll take a couple and then we're going to move to the front. Thank you. It's a wonderful program. I want to. My name is Sufi Lagari with the Cindy Foundation. Hafiz Said is a declared terrorist by United Nations and United States of America. Do you think will Pakistan hand over Hafiz Said to India or international code and how Pakistan will manage political and economic crisis? Thank you. So far as I understand, he is listed under 1267 and Pakistan is fulfilling all its legal obligations under the UN sanctions regime, which does not involve handing over anyone to anybody. And about the economic challenges, as I have just responded to George earlier about the cyclical and structural aspects of the challenges that we face and how the government is determined to deal with those in terms of putting our house in order. Gentlemen there and then we're going to move up here. Thank you so much, sir. This is Jahan Sabali, a Washington correspondent for AIY News TV. It's about Pakistan, United States, diplomatic relations. So many things are going on like suspension of security aid and strict visa restrictions. But I just wanted to ask about the travel restrictions of Pakistani diplomats. Pakistani diplomats, including you, are facing travel restrictions and you guys cannot travel more than 25 miles. So can you tell us the reason what is going on and is it still active that travel restriction? And secondly, sir, Pakistan is a free media society. I myself working for the Pakistani media channel for the last many, many years. Can you tell us the reason of suspending the services of Vice of America Urdu and Vice of America Prashto services in Pakistan? Thank you. What was the first question? Are you restricted? No, yeah, 25 miles. These are ongoing conversations that we have with the U.S. government. And there are issues on both sides that we are trying to resolve in terms of dealing with this 25-mile limit that we have on the movement of diplomats. And we hope to resolve this and some of the other issues that you alluded to in terms of our diplomatic engagements. On the Vice of America Urdu and Prashto service, I am frankly, I would not want to comment on something that I am not aware of in terms of the restrictions. But I can tell you, and being the ARY correspondent here, I think you know it better than many in this room in terms of the freedoms that our media has in Pakistan, you know. And the channels, the range of subjects, the extent of criticism, and we have been on, you know, in the government as civil servants, as bureaucrats, you know, we basically experienced that on a daily basis. So it's really, I think sometimes when I hear about the challenges in regard to the media, I say this, that you compare the freedoms that we have and some of the most important stories that are normally broken in Pakistan are basically broken by Pakistani media. And there are no bounds in terms of the extent to which the subjects can be covered on the national network.  Gary, come up here, this lady here in the second row. Thank you, George. Thank you, Ambassador, for the wonderful talk. My name is Sitaranur and I'm a visiting fellow here at the Stimson Center from Pakistan. My question is that notwithstanding the risks associated with outsourcing crisis management to a third party, India and Pakistan has largely been dependent on a third party intervention to resolve the bilateral conflicts, be it 2001, 2008, and the recent one. And traditionally, the United States had been that third party who had played a larger role in depusing the tension. How do you see that role has evolved, particularly in the recent crises post-Pulwama? How the U.S. role had been different from before and was it really late? And are there new contenders for the third party which were visible in the recent crises? Particularly, I ask this question considering the relatively lesser interest of the current U.S. administration in events happening in South Asia. That's an interesting question. I think, first of all, we are looking forward to a day where India and Pakistan don't really have to depend on a third party for crisis management. And that was the whole spirit of Simla Accord, you know. But unfortunately, we had crises one after the other. And there are occasions and there have been several where our friends and partners had to intervene because those conversation tracks fail to deliver. And that is precisely what we want to do, what we are trying to do, and all the urges that government of Pakistan has made and the Prime Minister of Pakistan is making are basically consistent with that desire to be able to sit face to face across the table and be able to address all the challenges that we face. And you are also right that depending on each administration's world view, depending on each president's personal priorities and preferences, and depending on the broader regional dynamic, the size, scale and level of U.S. involvement has varied, you know. For instance, during President Clinton's time or President Senior Bush's time, it was different. But I can tell you that even in the Pulwama crisis also, I think U.S. played an important role in diffusing the situation. And I think that is where what is really important is for the international players and consequential powers and the consequential power like United States to maintain that objectivity and neutrality in terms of assessing and evaluating the situation on the ground. And to not do things that would be construed in India or elsewhere as endorsement of the choices that they are making because clearly, you know, sometimes you have a duty to speak and the right to remain silent, you know. So when you don't say or speak, it is construed as an endorsement. And for in Pulwama crisis, some of the earlier statements did, I would say, give that impression that as if, you know, U.S. is and at least the Indian media gave that spin, even if the U.S. government and the state did not do that. So that's where I think there are situations where international community must come out and say it very clearly so that there is no confusion and no one construes it as an endorsement of a call for, you know, escalation. And that's where I believe that still there is more that, you know, United States and other countries should do. This lady back here. Hi, Becky Van Doren. I used to be State Department. I'm interested in two questions. One of them is, can you give us some insight into what's happening with Zardari and Sharif in the future? But their current situations are complicated. And then the second situation is, do you have insight into how the government is going to approach repatriating all of the ample Pakistani assets outside of Pakistan? What steps it might take to claw some of that back? On the first one, I really don't know. I wish I had a crystal ball to tell you what will happen. There are these. Ambassador, for those who don't follow Pakistani soap opera, basically you're asking about the legal moves against both former civilian leaders? Yeah, I know. I know. No, no, no, I'm talking about the Russian people getting those out in television.  So we will let the courts decide. And I really don't have anything to speculate on that in terms of, I would say, rather than repatriating, I would say co-opting our diaspora in our national development effort. And I think that is something that is a very high priority with the Prime Minister of Pakistan. And I think this government in a way is unique in terms of its popularity and its acceptability with the Pakistani diaspora overseas. And the Prime Minister himself is very keen to involve them, to co-op them in our national development efforts. So we are looking at various ways in which, you know, and in this country in particular, I can tell you that we have a very vibrant Pakistani-American community here close to a million. Many of them are actually professionals, doctors, around 20,000 doctors. Then IT specialists and others, you know, and people who have had productive lives and now ready and willing to go back and contribute, you know, occasionally. And those are the people that we would like to engage. And then similarly, Pakistani-American diaspora is also looking at investment possibilities in Pakistan. Because I can tell you that, you know, with improved security, with better energy supplies, the crisis of energy. And since you track Pakistan, you would know the kind of outages that we used to suffer. The infrastructure, the internal connectivity through roads and rail has improved tremendously. So that really, I think, prepares or has prepared Pakistan to go to the next level of industrialization. And that's where these special economic zones that we are building in Pakistan would welcome investments from overseas Pakistanis and particularly from the United States. And already I can also, I'm happy to share this with you that companies like Argel, companies like Axon Mobile, even IHOP has gone to Pakistan, you know. And not just that, I think another very important step that the government has taken is to focus on tourism. As I was saying, you know, like, for instance, travel advisory, the reality on the ground has changed. And I say this and I can support my statement by presenting to you empirical data showing that Islamabad perhaps is the safest city in the wider neighborhood. So we want those peaceful piecemeal revisions of the travel advisory that would enable people from overseas because, you know, we really need to debunk. The problem here is that people either don't know about Pakistan. I mean, in many cases, when I go to meet some businessmen and I tell them that we are the third or the fourth largest English speaking country. We are the fifth or the sixth largest country in the world with a huge middle class.  They really do. And those who know they only know the bad things about Pakistan. So that information deficit needs to be plugged. And for that, what we are doing is that we are focusing on promoting tourism. We have completely liberalized our visa policies. So a US citizen, not Pakistani American, all US citizens can actually apply. And then for if up to a five year multiple visa, the US businessman can actually get 30 days visas on arrival business visas on arrival. And we have about 57 countries that are now part of the visa on arrival system and all countries are now part of the visa system. So we want to promote religious tourism, which is again a reflection of the greater religious tolerance that we want to project and promote in Pakistan, including the celebrations for the 550th anniversary of Guru Nanak. So these are the ways in which so it is education, it is investment. It is bringing professionals who can basically contribute to leading universities because medium of instruction is not an issue in Pakistan. Most of our universities have English as a medium of instruction.  They really don't know about these things. So these are the ways in which we would want to promote greater awareness about the possibilities and opportunities in Pakistan. Let's come to this gentleman here and then we'll work our way back. Hello, my name is Alexey Bogdanovsky, I'm a reporter with RIA Novosti Russian News Agency. Russia has signed memorandums of understanding with Iran and Pakistan about possible construction of natural gas pipeline from Iran to India through Pakistan. I imagine such a pipeline would raise a double red flag in Washington being a Russian and an Iranian project at the same time. As we know, in other regions of the world, the United States are usually concerned about any Russian pipeline projects. Sometimes in the case of the North Stream too, they are openly advocating cancelling such projects and threaten sanctions. Has this issue come up in your conversations in Washington with your American colleagues? And if so, what are you hearing from them? Thank you. It has not come in our conversations here. I regret that. I wrote about this, you know, 15 years ago. I thought it was a great idea. Anyway, let's go to the back, Garrett, and this gentleman with a green shirt that's kind of very energetic in the back. This is Ali. I'm a visiting fellow at the Stimson Center. Thank you, Ambassador, for an excellent talk. You've rightly talked about Pakistan and any other world country not pandering to a zero-sum game while conducting their ties with other countries. So this brings us to the point of how can park-America relations be dehyphenated from the Afghan Prism and the Indian Prism. So our Prime Minister Imran Khan, he has a great deal of focus on resetting park-US relations in a manner which allows both countries to have mutual respect for each other. And also his vision of economic diplomacy, as you touched upon briefly during one of your answers. My main question is, we have oftentimes seen the US meddling into things which are not theirs. Like we saw their debates about tactical nuclear weapons or frankly this question about why did we change our ISI commander. That's our internal matter. So are we treading towards, given that you hold the DC place, are we treading towards some kind of a reset where this mutual respect and non-interference in some matters which pertain to Pakistan or to the US, are we treading towards such kind of a relationship where both two governments can actually develop a very cordial investment-friendly, business-friendly relationship that is, you know, away from the Afghan and the Indian lenses that we have normally had our relationship in. That's where we want to be. And I think I see good tidings, one very important convergence because obviously I have spent a lot of time in the city and I am aware of the deep skepticism also in several quarters. About things we do or we don't. But at the same time I think the convergence where the President of the United States want to see peace in Afghanistan where Prime Minister, we have a Prime Minister who has been a long-standing advocate of the resolution of that conflict through peace. So, you know, it's really important to start by working on things where you do have that convergence. And I think the other area where we see a lot of potential, although, you know, when unfortunately a terrorist incident takes place or a soldier gets killed, it gets a lot of media attention and coverage. When a major US company goes to Pakistan, it doesn't really get the kind of attention in the news. So it doesn't sell that well. But in reality, what that contributes to the relationship is much more than the image-related challenges that we face. So our job really is, while security peace has been an important part of this relationship, we really need to move out and look at all other and business and investment. And there are, as I said, tremendous possibilities and opportunities. And then, you know, we may look as small because we are, we happen to be sandwiched between China and India. But we are a significant country, you know, and there are tremendous possibilities and opportunities with the access that we have to Central Asia, to the Middle East, the strategic location that we have. So that gives, and then, and I say this to the American government, you know, because even our diaspora, I can't think of a family worth any influence in Pakistan that does not have at least one blood relation as a US citizen. Every other or third civil servant in Pakistan is either educated or trained in this country. Every third or fourth military man in Pakistan is either educated or trained in this country.  And I say this, the value of this is not really appreciated because as someone who has served in a country where they don't speak English, you know, the blessing of speaking English and to be able to communicate is so that these are the natural. I would say anchors that we have and there is skepticism, but I think what unites us is much more than what divides us. And then there is this will and determination, because we think that this is an important and consequential relationship. So we want to get to that point and and in all interstate relations. I think the basis has to be mutuality of benefit and mutual respect. And then that's where we want to go. They've expressed concern about the ISIS movement or their shifting from Syria and Iraq to Afghanistan. And they fear that in future ISIS will be a great threat to South Asia, not only Afghanistan, but Pakistan as well. How concerned or prepared is the new Pakistan, new government in Pakistan to the challenge of ISIS in South Asia? I think that is something that makes everyone join heads in terms of trying to deal with these ungoverned spaces, wherever they are, and particularly in Afghanistan. Because if you look at the ideology that ISIS sells and the narrative that they have. I have a feeling that their narrative resonates more in places and in countries where Muslims are in minority and there is this, you know, perception of their persecution in countries like for instance in Pakistan. There is very limited scope for them to basically find a toe hold, because the already the view, the narrative that they are building and projecting would not hold any ground. And the other is those ungoverned spaces that might exist that will give them the option of setting up their shops there. And that is one reason why everyone in the broader region is very keen to see peace return in Afghanistan.  And that again is basically designed to bring all our citizens into the mainstream, into the economic mainstream, into the legal mainstream, into the political mainstream. And in terms of the cross-border movement also, you know, Pakistan has already built a 1000 wall is a sensitive issue in the city but we have actually built a 1000 kilometer fence on our border with Afghanistan from our own resources. And we are determined to basically take it to, it's basically to complete it. The idea really is to address our concerns or movement from the other side and the concerns that perhaps there were elements going from our side. So we would like border management will be a challenge and we would like to, you know, deal with that effectively and then also help Afghanistan achieve peace because once they have peace within, you know, that will also help them take care of those spaces and places where there may be this possibility of, because already, you know, even statistically also, and some of the recent attacks that we have, you know, had in Pakistan could be basically traced back to some of those elements were spread around the border on Pakistan and Afghanistan. Yeah, hi. I'm also a Stimson visiting fellow. So I have a question on Iran. What is Islamabad's view on the ongoing tension between the U.S. and Iran? And if the situation escalates in the future, how will Islamabad approach the whole issue considering it's this balancing Saudi-Iran ties? It seems like a foreign policy issue for Pakistan. So how do you see what is your take on that? I don't think that is an issue. Prime Minister was in Tehran. The foreign minister was in Pakistan. We have always had very good ties with Saudi Arabia and we always had good ties with Iran as our immediate neighbor. And then like most other countries in the region, of course, we are concerned with any possible escalation and we've been urging all concerned, you know, to find and resolve the issues within the framework of international law, you know, and then through dialogue and consultation. So yes, we are concerned and we would like to see it resolved sooner than later. And we have our hands full already, you know, I mean on at least two fronts, you know, Eastern border and Western border. So that is another one area where we would like to see peace continue. Avi Kirkbacker from Partnership for Secure America. So since partition, there's been tensions between Muslims and Hindus in the region. And, you know, with the rise of the BJP in power since 2014, and as the party of self-proclaimed Hindu nationalists, how does the Pakistan approach to dealing with members of the BJP change as, you know, they've becoming increasingly a Hindu nationalist and there's been, you know, more and more conflict between Hindus and Muslims in the region. You know, obviously, it is not for me to speak about how India or the people of India or BJP, you know, their choices that they make the democratic choices that they make in terms of the political ideology or leaders that they elect, you know, it is really for the Indian people. I can though say that, you know, India is a huge country. It's a very diverse country. And when you seek to frame it in any particular way, then that creates the stress that will be felt by those who are not part of that framework, whatever framework is being advocated and pushed. And in Pakistan, we, I can say that we are coming back from that point where we are determined to create a deal with extremism. We are taking measures to deal with fundamentalism, and we are trying to go back to the plural society, accepting society and embracing society that we were the society that I grew up in. So these divisions will create consequences for us in Pakistan, sometimes what is of consequence is the fact that sometimes, you know, extremism across the border provides oxygen to our own extremists also. And that's where our concern would be. But I think besides that it is really for the people of India to make those choices and I'm sure they will make those choices in a democratic way. Or if there is, I'll say, yes sir, hold on one second, there's a microphone, there you go. Thank you for the opportunity. I represent Pakistan-American Congress. This organization has been working in the last 20 plus years to promote a good relationship with the U.S. and Pakistan. Having said that, I would like to ask the ambassador, what are the latest moves or plans to increase U.S. and companies improve their investments in Pakistan? Thank you. This is one of the highest priorities that I have as ambassador frankly. And we are going out to other states, to other cities in informing people. As I said that what I have now realized is that there is a clear lack of awareness on information, on possibilities and opportunities in Pakistan. People are looking at it in an open mind and so far I have received a lot of good response. There is a USPBC delegation going to Pakistan next month. We will also be working on organizing the business opportunities conference. In September, we are organizing a Pakistan tech summit in the Silicon Valley with the support and cooperation of some U.S. companies and some leading Pakistani companies active in Silicon Valley. We are also planning to do one here in Washington D.C. just to sensitize people about the possibilities in Pakistan. So obviously this is just one part of what we can do. The real action is on the ground where Prime Minister has personally committed to steer and oversee the ease of doing business. Improving the ease of doing business in Pakistan. Enhancing Pakistan's competitiveness where we have already gone up by about 20 notches. We are determined to basically improve for instance for 47 tech streams. Government has actually brought them down to 16 already. Similarly, if you wish to register a company in Pakistan you can do it in one day. So these are the things that would make it easier for people to go and see for themselves because and I say this again. You know one of the most effective way of debunking those myths about Pakistan and which is obviously our biggest strength is the warmth, hospitality and generosity of our people.  And then obviously that will because then one of the reasons why we are emphasizing tourism is that that helps us open that window. Because clearly you know like for instance Vietnam was a tourist destination much before it became an investment destination. Thailand was a tourist destination much before it became so we would like the US franchises to come also because everything else is there. And then that's what and how I propose to move here and I will need the support of particularly the Pakistani American diaspora who are well placed and well resourced. And that hopeful note I want to conclude and I want to thank all of you for coming and I want to ask you to join me in thanking Ambassador Khan.


Hello. Good morning everybody. Let me introduce myself. My name is Danyek. Can you hear me well? So the goal of this presentation is to show you how to develop the USB application with the QMX. Are you anybody familiar with this solution? Or are you developers of the applications? More or less. So what is the most boring part when you develop the application? When you start to develop the application, you have to first configure the peripherals, configure the core clocks and so on. It's time consuming, isn't it? So this could be a solution for you and we call it Qube. So the purpose of the Qube is to ease developers' lives by developing efforts. It reduces your efforts' time and therefore even the cost because time is money. The Qube part of the Qube is Qube MX. Qube MX is an application on the PC. It's a graphical wizard which allows you to initialize the microcontroller. It generates the initialization C code which you can download then to the application. This is a solution for all our microcontrollers through the performance microcontrollers which are F4 through to the low-power devices. This Qube you can download it for free from the st.com slash stm32Qube. The Qube is based on the HAL. It's a hardware abstraction layer. It's a set of the driver for peripherals. It includes the middlewares for USB and Ethernet, graphics and so on. I will be talking about USB. Do you plan to develop the USB application? Is it your goal? Do you know how to use the USB? Are you familiar with USB? If you are not, what is your expectation? How much time do you need to develop the USB application? 3-4 weeks. Now you will be able to do it in 10 minutes. Do you believe that it's possible? I tried. I will show you how to create the USB mouse. This USB mouse will be this board. We will connect this board to the PC and it will behave as a USB mouse. It will be moving with your cursor over the PC. The Qube includes drivers. It's a layer approach. The first layer is HAL. It's a hardware abstraction layer. These are drivers for peripherals. Above these are middlewares. Middleware is several stacks. The first is Ethernet solution, USB, graphics, file system and freeRTUS. If you want, you can develop even the USB flash stick. On this board, it can behave as a USB mouse, USB flash or something else.  Inside of the Qube, there are examples. You can open them in your working environment. You can compile it and download it. How it works? On your PC, after the download and installation on your PC, you will create the initialization code. In the working environment, you have to finish only the application. For the USB mouse, it's just one function, which is called or used. You will see later. Then, this complete solution with initialization code, you have to download it to your hardware. In our case, we will use the discovery board. This discovery board will be connected to the PC. It will be moving with the mouse. For those of you who know the USB, I don't think that there are USB experts. If there is someone over there, he can tell us how this USB mouse works. Basically, if you want to implement the USB mouse, you need a data structure, which is called a scriptor. This is the structure of the scriptor. If you want to send to the PC information about the mouse, you need to send the x-axis, y-axis and the wheel or the buttons. There are information which button is pressed. That's all what you have to send to the PC if you want to move your cursor. You should remember this structure because we will use it in writing of the code. How it works between the PC and the device? On the USB, PC as a host always asks for the data. If the device doesn't have the data, it will send not a knowledge. It indicates to the PC that the host doesn't have the data. And twice versa, if the application as a device has a data, it will send back the scriptor. The function which we will use in our application is only one. Send report. That's all what you have to write in your application. The rest is created by the QPMX. Is there any volunteer who wants to create this application? I will guide him. Together we can create this application. Nobody wants to try it. It's easy. Don't worry. You can win something. The board for volunteers. Or two boards for volunteers. Okay, I will try it. So now I'm going to open the QPMX. This is first window which you will see when you open the QPMX. Of course it has a help. It allows you to open the old project if you have one already created. Now I will start with the new project. The second window which you will see is configuration. Here you can select the device. We will use L0 device. In the second box you can select subfamily. So it's 0x3 and the package. As you can see here in the MCU list, we selected or we filtered the devices. In our example I will use this L0538T. Okay, now we have selected the device. What next we have to do? So we have selected the device. And now we want to configure the peripheral. I'm going to select the USB peripheral. Here in this tab, the first tab is the pinout which we will use. And I want to use the USB. So I will select the USB. Immediately in this pinout view in this package you see which pin are assigned to the USB. For the USB there are two pins, data plus and data minus. Between the middle there I will select which stack I want to use. It's USB. And as you can see we have several solutions for the USB. The one which we are going to use is a human interface device. It's the class for the USB mouse. If you want to implement USB mouse, it's this one. Because I want to download this application, I have to select the serial wire debugger. It's the interface for debugging and downloading application to the hardware. That's it. And now I see where is it. In the second tab is a clock tree. So here you can select the clock configuration. In this example we will use the two clocks. The first one will be 16 MHz internal RC. This clock will be multiplied in the PLL. So I'm going to choose the multiplication by 4. And I will get 32 MHz for the core. It's the maximum for this device. And for the USB I need 48 MHz. It's given by the USB standard. So that's all what I need to do if I want to configure the microcontroller for the USB mouse. Shall I do something else? Any idea? So what do you expect? What will happen if I have this configuration? So that's all what I need to do if I want to create the USB mouse. Maybe one last point is the project configuration settings. I have to create the name of the project. So let's call it USB mouse. This tool allows you to choose between three working environments. Here we have IAR, KYLE and TRUE Studio. I use the TRUE Studio. So for this example, two chains selected is TRUE Studio. Okay, this problem already exists. So I will call it mouse A. And the last action in the QPemix is the generate project. Now the QPemix generates the code, initialization code. And immediately it will open your working environment. So in a few seconds you will have a complete project with zero teams. Okay, now I'm asked to open the project. And this is my project. I created mouse A. So it's the empty project with all routines. In the main, I have all functions necessary for the USB mouse. Hardware abstraction layer is initialized. The clock system is ready. This function sets the requirement or configuration for the clock. GPOs are initialized. USB stack is initialized. Only action which I have to do now is to find the function which will send the data as a mouse. Do you remember which function is it? Pardon? Right, exactly. Correct answer and the winner price is... U, as B, D. How was the name of the function? Yeah, HID. HID is the name of the class. And what else? Which data we want to send? Do you remember the report descriptor structure? How many bytes it was? Eight. We want to send one byte with button four. And two bytes about the position of the mouse. And one byte about the wheel. Okay? You said it first. Four bytes. So I'm going to create the structure which will have the eight bytes. I didn't say that. The QPMX in the main create the user section. These sections are sections where you can write your code. So I have to create the structure of four bytes. In the user section, too, I will use this structure and I fill it. So here, in the first position, I don't want to send information about the buttons pressed. So the first byte will be zero. The second byte is X position. So I want to a little bit move with the mouse. So let's put here 10 value. The third byte is Y position. I don't want to move in the Y axis. And the last byte is the wheel. Again, I do want to turn with the wheel. So that's all what I need to do. I will get some errors because the centerport function... Where is the mistake? Semi-colon. I don't see it. Sorry. You need here a semicolon instead of a colon. And here, too. That's a semicolon. Ah, thanks. Thanks for your help. There is a semicolon. It's okay. Are you sure? In the function, there are no parameters. Now it's better. So I want to see which parameter are required by this function. The first function is a handler. It's the device handler. It's already defined, specified in this USB underscore device. And I have to publish this in the main. So it's this variable. So I have to extend. So now this handler for the USB device is visible in the main. And I will use it as a parameter in the function centerport. The second parameter is the buffer which I want to send. And the last parameter is the number of the bytes which I want to send. I want to send complete buffer, so I put there four bytes. So this function is not known in the main. Therefore, I have to include another module. It's USB, I guess, FDE. USB HID. This function is in this module. And now it should be all what I need. Okay, this function requires the pointer. And that's it. Now it will work. I don't want to move too fast, so I will use the function how. How delay, how delay. So each 100 milliseconds, the mouse will send the information about the change of the position. So I'm going to program this device. And after this, you will see how this board moves with the cursor on my PC. This board has embedded debugging stealing. So I will use this one. So what I need is just the connection of the USB cable for programming. Now this board is programmed with the mouse application. So, and if I will use the second USB interface, you will see the moving of the cursor over my screen. Now you see I'm not moving my PC and the cursor is moving. Okay, now you have a USB mouse. So was it easy? So now you have a solution. If you want to implement your USB application, it takes approximately 10 minutes. So what do you think about this solution? Is it okay? Is it fancy? So now all of you are USB experts. You can go home and say, I'm a USB expert. I know how to create the application in 10 minutes. If you want to homemade mouse, here it is. So that's all. Thank you for your attention. Thank you.


This is the DeHousie Health Law Institute's Health Law Primers electronic module series. This module, which is broken down into two parts, provides an overview of the regulation of human biomedical research in Canada. I am Michael Haskus, a professor at the Schulich School of Law and School of Health Administration at DeHousie University. This module is not intended to serve as legal advice. It is for educational purposes only. This module will examine the regulation of human biomedical research in Canada. It will begin by addressing the need to distinguish research from clinical practice. Next, the documents that directly or indirectly regulate Canadian biomedical research will be outlined. With that as a backdrop, the procedural and substantive aspects of the research ethics review process established by these instruments are then discussed. The module will end with a few concluding remarks. It is important to distinguish human biomedical research from clinical practice. This is sometimes difficult to do because research and clinical practice frequently occur in conjunction, since many medical interventions are delivered by physician researchers and form the subject of formal research projects into the intervention's safety and efficacy. Despite this difficulty, it is necessary to make this distinction because the application or non-application of regulatory instruments can turn on whether an activity is considered clinical practice or research. In the context of this module, research will be defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. This is the definition that is used in a document that plays a central role in the regulation of biomedical research in Canada. Namely, the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans, which I'll refer to in this module by the abbreviation TCPS. The Canadian regulatory landscape for biomedical research involving humans consists of a complex patchwork of diverse forms of regulatory instruments. Let's have a look at some of these instruments. The first instrument we will look at is the TCPS. It establishes an ethical framework for the conduct of human participant research, including studies involving living human participants and research involving human biological materials, whether or not this material is derived from living or deceased persons. It also addresses research involving identifiable personal information collected from participants through various means such as interviews, questionnaires, and access to health records. The TCPS requires research institutions to establish or appoint multidisciplinary research ethics boards, which I'll refer to as REBS, to review and make decisions about the ethical acceptability of research involving humans that takes place within the institution's jurisdiction or under its auspices. These boards are empowered to approve, propose modifications to, or reject proposed studies. REBS may also require ongoing studies to be altered or terminated. If a particular activity meets a definition of research that we looked at earlier, this activity may be captured by the TCPS. If not, the TCPS does not apply to it. However, even if the activity constitutes research under that definition, it does not necessarily follow that the TCPS will apply. Being a policy statement, the TCPS lacks the inherent legal authority of legislation. On the other hand, the scope and extent of its regulatory impact rests on other factors. One such factor is that in order to be eligible to receive and administer funding from the tri-agencies, institutions must agree to abide by the TCPS. Additionally, the tri-agencies grant applications require applicant researchers to certify compliance with the TCPS. As a result, tri-agency funded researchers and their institutions must comply with the TCPS. The regulatory impact of the TCPS is not necessarily dependent on the presence of public funding for research. Members of some professional organizations may be required to seek ethics review of the TCPS-compliant REB before conducting human research or risk being subject to disciplinary action by their regulatory bodies. For instance, the College of Physicians and Surgeons of Alberta requires that this be done. There is also legislation that requires researchers to have their projects approved by TCPS-compliant REBs. This is required under Nova Scotia's Personal Health Information Act and Newfoundland and Labrador's Health Research Ethics Authority Act. In addition to the circumstances already outlined, other factors may serve to promote compliance with the TCPS. Ethics review of the kind provided for in the TCPS is often a condition of publication in peer-reviewed journals. As well, courts may invoke non-legal instruments such as the TCPS when determining the common law liability of researchers, REB members, and research institutions in tort actions arising from personal injuries. Now, let me talk a bit about a couple of documents that regulate drug research in Canada. The first is Part C, Division 5 of the Food and Drug Regulations, which I'll refer to as the Clinical Drug Trial Regulations. And the second document is the Good Clinical Practice Consolidated Guidelines, more commonly referred to as the GCP Guidelines. The Clinical Trial Regulations, passed pursuant to the Federal Food and Drugs Act, established legal requirements concerning the conduct of clinical drug trials. This slide sets out the definition of a clinical trial contained in these regulations. The Clinical Trial Regulations apply to all clinical trials in Canada, irrespective of how this research is being funded. The sponsor of the clinical trial must obtain approval of the REB at each clinical trial site. The REB must attest that it reviewed and approved the protocol and informed consent forms, and that it carries out its functions in a manner consistent with good clinical practices. The term good clinical practices is defined on the present slide. Health Canada has endorsed the principles and practices provided for in the GCP Guidelines. These international guidelines were developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The GCP Guidelines provide greater detail than the clinical trial regulations respecting the duties and responsibilities of REBs, investigators, and sponsors. And, to some degree, reflect the substantive and procedural norms in the TCPS. There are also relevant international documents. The growing involvement of Canadian researchers in multinational health research requires these researchers to familiarize themselves with the relevant regulatory frameworks adopted by other countries. The United States is one such country. In the US, the Code of Federal Regulations establishes legal standards for the protection of human research participants that apply to research funded by the United States Department of Health and Human Services, abbreviated DHHS. Other parts of the Code of Federal Regulations fall under the auspices of the United States Food and Drug Administration. And they apply to human research that uses drugs, medical devices, and biological products, regardless of whether the research is federally funded. A multitude of other federal and state laws may also be relevant depending on the research activities being pursued. These US regulatory instruments are relevant to Canadian researchers who carry out research supported by DHHS funding. Since the research must comply with the Code of Federal Regulations, even if the research is conducted outside the United States. Two international documents, the Nuremberg Code and the Declaration of Helsinki, have played a fundamental role in the formulation and evolution of international, regional, and national regulatory instruments for the protection of human research participants. They have expressly shaped other important international instruments, such as the international ethical guidelines for biomedical research involving human subjects, prepared by the Council for International Organizations of Medical Sciences in collaboration with the World Health Organization. The regulatory instruments I have described in the last few minutes are by no means the only instruments that impact the conduct of human biomedical research. The present slide mentions some additional regulatory instruments. Having had a quick look at some of the principal regulatory instruments for human biomedical research, we now turn our attention to the research review process that many of these instruments rely on. REBS are the workhorses of the governance regime. REBS are charged with a number of roles and responsibilities. The principal mandate of REBS is to approve the initiation of and conduct periodic reviews of biomedical research involving human subjects in order to ensure the protection of their rights, safety, and well-being. Our discussion of REBS is divided into two sections. The first section will focus on procedural features of research ethics review. Procedural matters include the process of research review, including the way in which REBS function as a committee and how research proposals make their way through the review process. The second section will examine some of the substantive aspects of the review. By this I mean the principles or criteria used by REBS to assess the ethical acceptability of research protocols. So let's begin our examination of the procedural aspects of REBS by looking at who sits on these boards. The regulatory instruments typically set parameters around the number of REBS members and they set the kinds of backgrounds and expertise the REBS membership needs to collectively possess. The TCPS requires that, for biomedical research, a REBS must consist of at least five members, including both men and women, of whom at least two members have expertise in relevant research disciplines, fields, and methodologies covered by the REBS. At least one member who is knowledgeable in ethics, another who is knowledgeable in the relevant law, and at least one community member who has no affiliation with the institution. The stated rationale for this membership requirement is to ensure the necessary basic background, expertise, and perspectives to allow informed independent reflection and decision making on the ethics of research involving humans. Prior to participant recruitment, access to data, or the collection of human biological material, researchers must have their research proposals, including pilot studies, approved by the relevant REBS. Therefore, the researcher will need to identify the REBS or REBS from which he or she will need to seek approval. The application or submission materials that researchers must provide to REBS can vary according to the specific demands of the relevant REBS and the particular type of research being proposed. The required documentation can include research summaries, consent forms, participant recruitment tools, questionnaires, interview guides, contracts entered into with sponsors, including confidentiality agreements, and the researchers curriculum fee type. What types of reviews do REBS conduct? The TCPS puts forward two levels of REBS review, full board review and delegated review. Full board review is the default requirement on the TCPS. That is, unless it is appropriate to proceed by way of delegated review, a full board review is necessary. Under the TCPS, full board reviews normally involve regularly scheduled, face-to-face REBS meetings during which each research project before the REBS is discussed with the aim of reaching a decision as to whether to approve, reject, or propose modifications to proposed research, or to terminate any ongoing research. On completing its discussion of a research proposal, the REBS must reach a reasoned, well-documented decision in accordance with the decision-making process that it has adopted. Delegated review usually involves the REBS delegating the research ethics review to one or more members of the REBS. In practice, this may well mean that those conducting the delegated review will not possess the full range of expertise and experience that exists within the REBS as a whole. Pursuant to the TCPS, decisions about the level of review required for particular study are to be made in accordance with the concept of proportionate review. This requires consideration of the level of foreseeable risks to participants. The lower the level of risk, the lower the level of scrutiny. The lowest level of scrutiny, of course, being a delegated review. On the other hand, the higher the level of risk, the higher the level of scrutiny, which will ultimately call for a full board review. If the research involves no more than minimal risk, it should normally receive delegated review, whereas above minimal risk research shall receive full board review. This raises the question of what constitutes, quote-unquote, minimal risk. Minimal risk research is defined as research in which the probability and magnitude of possible harms implied by participation in research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research. In the context of biomedical research, any risk of harm that participants would have been exposed to as a consequence of undergoing medical treatment, irrespective of their participation in the study, is not considered in the minimal risk calculus. However, those interventions that serve only the needs of the study are included. The TCPS identifies several potential categories of harm that need to be considered in terms of their probability and magnitude. These include physical, psychological, behavioral, social, and economic harms. This slide provides some examples contained in the TCPS of research that may qualify for delegated review. Delegated reviews are inappropriate for clinical drug trials, with the possible exception of minor changes in ongoing trials. Once a research project has received REB approval and is underway, there is a continuing need to safeguard research participants. Researchers are required to report to the REB any unanticipated issue or event that may increase the level of risk to participants, or has other ethical implications that may affect participants' welfare. In its chapter on clinical trials, the TCPS requires researchers to promptly report new information that may affect the welfare or consent of participants to the REB and to others. Furthermore, researchers must promptly inform all participants to whom the information applies, and this includes former participants. This concludes Part 1 of the module. I will see you at Part 2, which deals with the substantive aspects of research ethics review. Before I leave you, I want to quickly thank the Dehousey Health Law Institute for generously supporting the development of this module. Thank you so much for your attention.