Pakistan-U.S. Science and Technology Cooperation Program Annual Report Form Reports should be prepared jointly by the Pakistani and U.S. principal investigators and should cover all project-related activities carried out during the reporting period on both sides. Please expand the boxes below to accommodate all the information you need to include. Project Title: Capacity Building in Research Ethics and for Research in Ethics Pakistani Principal Investigator: Dr. Aasim Ahmad U.S. Principal Investigator: Dr. Adnan A. Hyder Reporting Period: October 2007- October 2009 Summary of Activities During Reporting Period: Please describe what has been accomplished under your grant during the reporting period, outlining the activities that were undertaken and specifically discussing achievements in relation to the milestones or targets set in the original work plan. For projectrelated events such as workshops, conferences, exchange visits, etc., please be sure to include exact dates and locations. Program Description It was a combined project between Aga Khan University (AKU) Karachi, Pakistan and Johns Hopkins (JHU) Bloomberg School of Public Health, USA. The goal of this project was to: i) improve the ethical conduct of human subject research in light of indigenous socio-cultural values in Pakistan; and ii) develop skills and capacity to conduct research in ethics in Pakistan. In this project, we had commitment to conduct 6 educational activities for research ethics with a plan of training at least 120 healthcare professionals across country. We also had a commitment to train 3 faculty members (Al-Razi fellowship) from AKU for research on ethics. The long term goal of this project is that these trained individuals would become resource persons in their respective institutes not only for ethical review of research but would eventually establish similar training programs. Approximately two-thousand (2000) healthcare and allied professionals applied for the six educational courses/workshops on research ethics across Pakistan and at the end of two years, this project has trained and certified one hundred and fifty-two (152) healthcare professionals across Pakistan in research ethics. Of these seventy-seven were men and seventy-five were women. Three faculty members were selected for Al-Razi fellowship (one year in duration) in research ethics through this project and developed three proposals (one each) with support of AKU and JHU faculty. These Al-Razi fellows also visited JHU for six weeks to further mature their research proposals and get expert feedback from renowned faculty in research ethics.
These 6 education courses/workshops and fellowship were based on a principle of equal opportunity and there was no discrimination for entry based on gender, religion or ethnicity. Females and minority groups were specifically encouraged to join these courses. The courses/workshops and the fellowship were aimed for mid-career professionals from diverse fields who play a direct or indirect role in health care and who desired an in-depth knowledge of bioethics. These included physicians, nurses, researchers, pharmacists, hospital administrators, health ministry officials, policy makers, lawyers, ethics committee (ERC/ERB/IRB) members, social scientists and others who wished to develop a fuller understanding of research ethics were encouraged to apply. In addition to the abovementioned broad category, we also gave preference to individuals with the following criteria while short listing candidates for selection: human subject researcher, publication in peer reviewed journals, potential to contribute in research ethics (from an institutional standpoint), members of ethics committees (ERB/ERC/IRB) and, postgraduate medical trainees. The project expectation was that after completion of the courses/workshops and fellowship, these participants would be able to play a role in research ethics; one of the examples is their vital involvement in ethics review committees in their institutions. Courses and Workshops Announcement The courses/workshops were announced through one of the leading newspaper (daily Dawn) of the country. Similarly, we circulated the announcement through AKU internal intranet and a national listserv. Four weeks were given for application submission. Applicants were encouraged to apply online where possible however, alternatively submission through post/fax was also available. Funding Available Courses/workshops were free to all participants. Travel funding was available for selected participants from outside Karachi or Islamabad (locations where the workshops were held). Educational Activities During the time period, the following educational and training activities in research ethics were conducted: 1) Research ethics workshop: August 4 to 8, 2007, Karachi 2) Research ethics certificate course: April 1-30, 2008, Karachi 3) Research ethics certificate course July 20- August 20, 2008, Karachi 4) Research ethics workshop for ethics review committee members: August 21-22, 2008, Karachi 5) Research ethics certificate course: September 28- October 10, 2009, Karachi 6) Research Ethics workshop for academicians holding administrative responsibilities: October 14, 2009, Islamabad Curriculum These courses/workshops had two components: 1) a foundational module and, 2) research
ethics modules. The foundational module had three subcomponents: 1) Muslim ethics, 2) Western ethics and, 3) contemporary issues in bioethics. The main strength of this module was its contextual learning focused on Muslim philosophy and law and their influence on Islamic bioethical discourse. The research ethics module discussed the essentials for making human subject research ethical and examined different ethical issues raised by clinical trials, epidemiological studies and public health research, especially in the context of developing countries and international collaborative research. Group learning methodology was used with interactive case studies, presentations, mock exercises and faculty facilitation of all sessions. Program Faculty 1. Dr. Adnan Hyder- Johns Hopkins University, USA 2. Dr. Aasim Ahmed- Aga Khan University 3. Barrister Akmal Wasim- Hamdard School of Law 4. Dr. Anwar Siddiqui- Aga Khan University 5. Dr. Arshi Farooqui- Aga Khan University 6. Dr. Farzad Rafi Khan- Lahore University of Management Sciences, Lahore 7. Dr. Hilary Bok- Johns Hopkins University, USA 8. Mr. Kamaluddin Ahmad- Lahore University of Management Sciences, Lahore 9. Ms. Kausar S Khan- Aga Khan University 10. Dr. Khalid Zaheer- Al-Mawrid Institute of Islamic Sciences, Lahore 11. Dr. Nighat Khan- Reproductive Health Consultant 12. Dr. Murad Khan- Aga Khan University 13. Dr. Riffat Moazan Zaman: Aga Khan University 14. Dr. Robyna Khan- Aga Khan University
15. Dr. Rozina Karamaliani- Aga Khan University 16. Ms. R. Lynne Harris- Johns Hopkins University, USA 17. Dr. Sadaf Sheikh- Bioethics Consultant 18. Dr. Shabbir Ahsen- Lahore University of Management Sciences, Lahore 19. Ms. Shama Dossa- Aga Khan University Evaluation of courses/workshops from participants for quality improvement Both session-based and end-of-course/workshop evaluation was done for each course offered. These evaluations helped us in further tailoring and fine-tuning the subsequent course/workshop according to the evaluation received. Overall participants gave very positive feedback and the demand exceeded our expectations and capacity. Al-Razi Fellowship in Research Ethics Under this initiative, three faculty members from AKU, Karachi campus were selected after a university wide circulation for the opportunity. Each fellow developed a research proposal on an issue related to research ethics. These research proposals were supervised jointly from senior faculty members both at AKU and JHU. During this fellowship period, three fellows also visited JHU for approximately six-weeks and attended the ongoing activities in research ethics. Besides attending the educational activities at Johns Hopkins University, fellows had opportunities to improve their respective research proposals by direct feedback from experts in the field. The three Al-Razi fellows were: 1. Dr. Uzma Shamsi (Community Health Sciences Department- Aga Khan University) 2. Dr. Yousuf Memon (Community Health Sciences Department- Aga Khan University) 3. Mr. Syed Shamim Raza (Department of Pharmacy- Aga Khan University) The topics of their fellowship research proposals are as follows: 1. Informed consent in multicentre randomized clinical trials in Pakistan--are patients really informed? 2. An orientation to post clinical phase III trial need based treatment provision in Karachi, Pakistan: reflection from the subjects about treatment provision 3. Views of researchers conducting drug related trials towards the roles and functioning of ethical review committee in Karachi, Pakistan a qualitative Pilot Study These research proposals are now ready for implementation subject to availability of funding and are being processed for approvals at AKU.
Educational Impacts: Please provide information on the numbers of students and other junior collaborators (graduate and undergraduate students, healthcare workers, laboratory technicians, data collectors, etc.) involved in the projects, and discuss new courses or degree programs created (if any) or changes to existing course curricula as a result of your project. 1) RESEARCH ETHICS WORKSHOP (AUGUST 4 TO 8, 2007) Details of number of application and participants are as below: Total Applications received: 150 Total participants: 27 From AKU: 12 From Karachi: 10 1. Sir Syed College of Medical Sciences: 01 2. Defence Forces: 01 3. HOPE NGO: 02 4. Karachi Medical & Dental College: 01 5. Pakistan Medical Research Council: 01 6. University of Karachi: 02 7. Liaquat National Hospital: 01 8. Ziauddin University: 01 From Outside Karachi: 5 1. Government of Sindh Health Department: 02 2. Liaquat University of Medical Sciences: 01 3. Social Welfare Officer, Children Hospital Complex Multan: 01 4. PIEAS, Islamabad: 01 City Distribution: 1. Hyderabad: 03 2. Multan: 01 3. Islamabad: 01 2) RESEARCH ETHICS CERTIFICATE COURSE (APRIL 1-30, 2008) Total Applications received: 500 Total Participants: 31 From AKU: 12 From Karachi: 11 1. Jinnah Post Medical College: 01 2. National Institute of Child Health: 01 3. Novartis Pharma (Pakistan) Ltd: 01 4. Aga Khan Health Services Pakistan: 01 5. Hamdard College of Medicine & Dentistry, Hamdard University Karachi: 03 6. Ziauddin Hospital: 01
7. Liaquat National Hospital: 01 8. Dow International Medical College: 01 9. Research Psychologist-Pakistan Association for Mental Health: 01 From Outside Karachi: 08 1. Medical Institute, Khyber Medical University, Peshawar: 01 2. Free lancer: 01 3. Pakistan Medical Research Council Lahore: 02 4. ADB funded project, Delivery of Primary Health Care and Preventive Services: 01 5. Bolan Medical Complex Quetta: 01 6. Department of Pharmacology, Nawabshah Medical College: 01 7. Doctors Hospital & Medical Center, Lahore, Pakistan / Lahore Medical & Dental College, Ghurki Hospital Trust, Lahore, Pakistan: 01 City Distribution: 1. Lahore: 04 2. Hyderabad: 01 3. Nawabshah: 01 4. Peshawar: 01 5. Quetta: 01 3) RESEARCH ETHICS CERTIFICATE COURSE JULY 20 (AUGUST 20, 2008) Total Applications received: 600 Total Participants: 27 From AKU: 12 From Karachi: 12 Institutional Affiliation: 1. FIGO SOGP: 01 2. Civil hospital: 01 3. High Court of Sindh: 01 4. Dow University of Health Sciences: 02 5. Sanofi-Aventis, Pakistan: 01 6. Dow University of Health Sciences: 01 7. HANDS: 01 8. Jinnah Post Medical College: 01 9. Pharm Evo (Pvt.) Ltd: 01 10. Aga Khan Health Services Pakistan: 01 11. Baqai Medical University, Baqai Dental College Karachi: 01 From Outside Karachi: 03 Institutional Affiliation: 1. SRSP (Sindh Rural Support Program) it s an NGO: 01 2. Anatomy section at Shifa College of Medicine, Islamabad: 01 3. NUST Electrical & Mechanical Engineering College (EME): 01
City Distribution: 1. Hyderabad: 01 2. Islamabad: 01 3. Multan: 01 4) RESEARCH ETHICS WORKSHOP FOR ETHICS REVIEW COMMITTEE MEMBERS (AUGUST 21-22, 2008) Total Applications received: Members were nominated by the Institutes with functioning ERC/IRB Total Participants: 14 From AKU: 06 From Karachi: 08 1. Dow University of Health Sciences (DUHS): 05 2. Ziauddin University: 01 3. HOPE NGO: 01 4. Jinnah Post Medical College: 01 5) RESEARCH ETHICS CERTIFICATE COURSE (SEPTEMBER 28- OCTOBER 10, 2009) Total Applications received: 750 Total Participants: 28 From AKU: 11 From Karachi: 10 1. Institute of professional psychology, Bahria University: 01 2. Pfizer Laboratories Pakistan: 01 3. Liaquat National Hospital: 01 4. Macter International (Pvt.) Limited: 01 5. Karachi Medical & Dental College: 01 6. Pakistan Navy & Pakistan Armed Forces: 01 7. Ziauddin University College of nursing: 01 8. PMRC: 01 9. GlaxoSmithKline Pakistan: 01 10. Hamdard University, Karachi: 01 From Outside Karachi: 7 1. Pakistan Anti TB Association: 01 2. Quaid-i-Azam University: 01 3. Army Medical College/ NUST: 01 4. King Edward Medical University/Mayo Hospital Lahore: 01 5. PAEC (Pakistan Atomic Energy Commission): 01
6. PNC & PNF (Pakistan Navy): 01 7. FMH College of Nursing Lahore: 01 City Distribution: 1. Bahawalpur: 01 2. Faisalabad: 02 3. Rawalpindi: 01 4. Lahore: 03 6) RESEARCH ETHICS WORKSHOP FOR ACADEMICIANS HOLDING ADMINISTRATIVE RESPONSIBILITIES (OCTOBER 14, 2009) Total Applications received: 33 Total Participants: 25 From Karachi: 08 1. Dow University of Health Sciences: 02 2. Sindh Aids Control Program, Health Department, Government of Sindh, Karachi: 01 3. Altamash Institute of Dental Medicine, Karachi, Pakistan/PNS Shifa hospital, DHA, Karachi, Pakistan: 01 4. Ziauddin University Karachi: 01 5. Bahria University Medical & Dental College: 01 6. Karachi Medical and Dental College /ANNALS Abbasi Shaheed Hospital: 01 7. COMSTECH: 01 From Outside Karachi: 17 1. Nur foundation Centre for Health & Social Policy at the Fatima Memorial System, Lahore: 01 2. PGMI Peshawar: 01 3. University of Wah, Wah Cantt: 01 4. CANADA-PAKISTAN HIV/AIDS Surveillance Project (HASP) Punjab AIDS Control Program: 01 5. University of Veterinary and Animal Sciences, Lahore: 01 6. Khyber Medical University, Peshawar: 01 7. Liaquat University of Medical & Health Sciences Jamshoro: 01 8. Department of Environmental Sciences/Director P&D, University of Peshawar: 01 9. School of Humanities, Social Sciences & Law/ Lahore University of Management Sciences (LUMS): 01 10. Kabir Medical College, Gandhara University, Peshawar: 01 11. Quaid-i-Azam University, Islamabad: 01 12. Pakistan Medical & Research Council: 02 13. Pakistan Medical & Dental Council: 01 14. Hayatabad Medical College: 01 15. KRL General Hospital: 01 16. Health Services Academy: 01
City Distribution: 1. Hayatabad: 01 2. Lahore: 06 3. Peshawar: 04 4. Wah Cantt: 01 5. Faisalabad: 01 6. Jamshoro: 01 7. Islamabad: 03 Infrastructure Development: Please list any equipment acquired during this reporting period with grant funds and discuss the impact the new equipment will have on research and educational activities. The grant supported the following supplies: 1) Four desktop computers; 2) Two laptops 3) One multimedia 4) One printer These were vital to establish and run this program as they were no dedicated supplies or equipment for this program at AKU. We used these for course material preparation, printing of reading material and classroom presentations. Publications: Please provide citations for any papers published or conference presentations made as a result of your project. 1) Ahmad A, Farooqui A, Hyder AA. Health ethics in Eastern Mediterranean Region: Case Study from Pakistan. UNESCO/ISESCO/WHO Workshop on Health Ethics in the Arab world, Morocco, April 13-15, 2009 2) Farooqui A, Ahmad A, Harris L, Hyder AA. Current and Desired Role and Function of National Bioethics Committees in EMR. WHO/EMRO Second Regional Meeting of National Bioethics Committees: Ethics of New Biotechnologies, Damascus, Syria, June 24-25, 2009 3) Farouqui A, Ahmad A, Bok H and Hyder AA. Status of Bioethics Education in Pakistan. Presentation at research seminar organized by COMSTECH, March 2008, Islamabad 4) Farooqui A, Ahmad, Bok A, Hyder AA. Capacity development for ethics in Pakistan: a North-South partnership. Manuscript in preparation for submission to Journal of Medical Ethics in 2010 Additional Funding: Please list any additional funding applied for or received to help support your project during this reporting period. While no additional funding was received directly to support this program, it is important to note that AKU also received an award from the Fogarty International Center of the US National Institutes of Health for research ethics capacity development. The grant (P.I. Dr.
Aasim Ahmad) is supporting a Masters program in Bioethics at AKU with JHU on the Advisory Committee (Dr. Hyder). Linkages with Government or Private Industry: Please describe any linkages developed with government agencies or companies interested in implementing the results of your project. The courses/workshop offered through this grant gained countrywide popularity (please see above the number of applicants) and included both public and private health institutes. Most of the major public institutions participated in the workshops and especially the high level workshop in Islamabad received participation from a dominant group of health institutions in the public sector. Deans, Directors and Heads of departments from various private and public health institutions have been reaching out to AKU now for support in furthering their ethics missions within their institutions. One other measure of our influence is that 2 course participants are now enrolled in Masters of Bioethics at AKU. Problems Encountered: Please provide information on any problems you may have encountered in making progress on your project objectives and describe steps you are taking to resolve the problems. 1) Due to delay in release of funds in 2007, courses offered were six months late which contributed in overall delay in program implementation; 2) 2009 funds have still not been received by AKU from the Pakistani funding agency; 3) Lodging funds were declined by the Pakistani funding agency therefore resulted in less than expected number of applications from up-country; 4) The security situation in Pakistan between 2007 and 2009 made the holding of workshops very challenging and thrice we had to change dates due to bombs and security threats in Karachi; 5) Travel of Pakistani fellows (AKU faculty) to USA was very challenging and difficult due to delays and problems with accessing US visas; and 6) Travel for US faculty to Pakistan as challenging due to security issues. Plans for Activities During the Coming Year: Please provide details on project activities during the next year, including planned exchange visits, training events, and ongoing research efforts. This program ended 30 Nov 2009. However, it is important to note that AKU is still waiting for the second year installment of the allocated grant from the Pakistani funding agency. Supplementary Information: If applicable, please attach copies of project-related workshop or conference agendas, course curricula developed, summaries of research data collected in the course of the project, or articles about the project appearing in newspapers, journals, or Web sites. Please note that your report will be posted on the program Web site, so please do not include any data you do not wish to make publicly available at this point in your research.
Indicators Reporting Period: 1. Number of higher education partnerships between Pakistani and U.S. institutions (see note below) 1 2. Number of journal articles, technical reports, books, or book chapters 1 (published or accepted for publication) resulting from your project during the reporting period 3. Number conference presentations resulting from your project during 3 the reporting period 4. Number of training events (courses, workshops, seminars, 6 conferences, stakeholders meetings) conducted on your project during the reporting period 5. Total number of Pakistanis making exchange visits on your project 3 during the reporting period Number of women 1 Number of men 2 6. Total number of Americans making exchange visits on your project 3 during the reporting period Number of women 2 Number of men 1 7. Total number of exchange visits overall during the reporting period 9 8. Total number of Pakistani PhD students involved in the project 0 Number of women 0 Number of men 0 9. Total number of American PhD students involved in the project 1 Number of women 1 Number of men 0 10. Total number of all other Pakistanis not listed above who 152 participated in your project during the reporting period (Include in this total those who were involved as researchers, MS or undergraduate students, technicians, or data collectors, as well as those who received formal training in workshops or courses or participated in conferences or stakeholders meetings organized as part of the project.) Number of women 75 Number of men 77 11. Total number of all other Americans not listed above who 0 participated in your project during the reporting period (Include in this total those who were involved as researchers, MS or undergraduate students, technicians, or data collectors, as well as those who received formal training in workshops or courses or participated in conferences or stakeholders meetings organized as part of the project.) Number of women 0 Number of men 0 Note on Question 1: For the number of higher education partnerships, please count the partnership between your institution and your Pakistani counterpart s institution as one. If your project also involves collaboration with other Pakistani institutions / US institutions (universities, research institutes, government agencies, or non-governmental organizations), please add each such additional institution to your total.