The Mentored Scientist Developmental Award in Research Ethics (PAR-01-144) application will support the career development of the candidate in research ethics-related issues pertaining to vulnerable study populations under the primary mentorship of Dr. Larry Churchill with the Center for Health Ethics and Policy, and secondary mentorship of Dr. Nancy King with the Department of Social Medicine, The University of North Carolina at Chapel Hill. This award will provide the needed mentoring and training for the candidate to a) develop her knowledge in research ethics, particularly with respect to clinical research, b) develop her skills in quantitative methods in clinical research, and c) become a more competent and established investigator in research ethics. The research plan will be guided by recommendations made by the National Bioethics Advisory Board (NBAC) to better conceptualize what is meant by vulnerability in the context of AIDS clinical trials and to evaluate the effectiveness of a consent monitoring protocol as a means to improve the informed consent process in AIDS clinical trials. The proposed training program to address the main objective of this award will contribute to an area of research ethics that has not been well explored: The concept of vulnerability in research, and the ethical considerations involved in devising specific protections to safeguard those who are seen as vulnerable. The research plan will involve two studies. Study 1 will be a pilot study to gather information on how AIDS Clinical Trial investigators see their study populations as vulnerable, and what they currently are doing to protect their study populations. Study 2 will have two components. Information from Study 1 will inform Study 2 by exploring what types of special protections subjects have experienced in AIDS Clinical Trials. Secondly, Study 2 also will examine the effectiveness of consent monitoring as one type of special protection to improve the informed consent process in AIDS Clinical Trials. The pilot work in this research plan will engender preliminary findings to apply for an RO1 that will explore the concept of vulnerability and special protections in different research settings and with different study populations. Other career development activities proposed will be to take short courses and attend seminars/meetings in research ethics to further advance understanding of issues concerning informed consent and vulnerability in clinical research ethics.
|Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P et al. (2011) Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials. AIDS Care 23:1382-91|
|Sengupta, Sohini; Banks, Bahby; Jonas, Dan et al. (2011) HIV interventions to reduce HIV/AIDS stigma: a systematic review. AIDS Behav 15:1075-87|
|Sengupta, Sohini; Strauss, Ronald P; Miles, Margaret S et al. (2010) A conceptual model exploring the relationship between HIV stigma and implementing HIV clinical trials in rural communities of North Carolina. N C Med J 71:113-22|
|Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P et al. (2010) How researchers define vulnerable populations in HIV/AIDS clinical trials. AIDS Behav 14:1313-9|