International Research Ethics

Attitudes and Experiences of U.S. and Developing Country Investigators- This project was the first large-scale study of researchers’ experiences with the ethical issues and human subjects regulations encountered while conducting research in the developing world. The study collected qualitative data from focus groups and interviews, as well as quantitative data from a survey distributed to investigators from the US and developing countries in a wide variety of contexts, including academic, commercial, and governmental institutions. Major findings related to informed consent, trial design, and oversight led to the development of recommendations regarding research in developing countries, presented in a paper commissioned by the National Bioethics Advisory Commission. The project was a collaboration between Nancy Kass and Adnan Hyder. NBACreport

International Perspectives on Protecting Human Research Subjects – This project examined the influence of U.S. human subjects protections on investigators and the conduct of U.S.-funded research in foreign countries. Interviews with investigators and oversight officials from eight countries around the world and visits to research sites were used to develop recommendations for investigators, IRB members, regulators, and sponsors regarding ways to enhance human subjects protections in international collaborative research. These recommendations appear in a paper commissioned by the National Bioethics Advisory Commission, written by Jeremy Sugarman and his co-investigators from Family Health International. NBACreport

Barsdorf, N., Maman, S., Kass, N., Slack, C. Access to Treatment in HIV Prevention Trials: Perspectives from a South African Community. Developing World Bioethics, in press.

Masiye, F., Kass, N., Hyder, A.A., Ndebele, P., Mfutso-Bengo, J. Why Mothers Choose to Enroll Their Children in Malaria Clinical Studies and the Involvement of Relatives in Decision Making: Evidence from Malawi. Malawi Medical Journal 2008; 20(2):50-56.

Elsayed, D.E.M., Kass, N.E. Attitudes of Sudanese researchers on obtaining informed consent from study subjects involved in health research. Sudanese Journal of Public Health April 2007; 2(2): 95-102.

Hyder, A.A., Harrison, R.A., Kass, N.E., Maman, S. A Case Study of Research Ethics Capacity Development in Africa. Academic Medicine July 2007; 82 (7):675-683.

Sugarman J. Ethical oversight of multinational collaborative research: lessons from Africa for building capacity and for policy. Research Ethics Review 2007;3: 84-86.

Kass, N.E., Hyder, A.A., Ajuwon, A., Appiah-Poku, J., Barsdorf, N., Elsayed, D.E., Mokhachane, M., Mupenda, B., Ndebele, P., Ndossi, G., Sikateyo, B., Tangwa, G., Tindana, P.O. The Structure and Function of Research Ethics Committees in Africa: A Case Study. Public Library of Science January 2007; 4(1): e3 1-6.