Descriptive Project Title:

The Role of Community Consultation in Promoting Ethical Obtainment of Informed Consent in Clinical Trials in Developing Countries.

Country of Interest:

South Africa - In planning for this project, the location where I will be conducting the research has been a consideration second to and dependent on the subject matter on which the project will focus. I am currently working with the HIV Trials Prevention Network to determine which of their sites would be most conducive for me to conduct my research. South Africa is the most promising thus far, so I have written my proposal as if I will work there. However, I am also still exploring opportunities in Uganda, Zambia, Zimbabwe, Peru and Mali through HPTN or similar organizations.

Proposed Dates for project:

May 21st-July 21st 2007

Describe why you are seeking this global health experience, including ties to personal goals, professional goals and your academic career at UVa. :

For my interdisciplinary distinguished major in Political and Social Thought, my core areas of focus are ethics, epidemiology, and medical anthropology. The research which I am proposing to conduct with a CGH grant will allow me to apply my foundational academic knowledge of these subjects to a real-world case study, better contextualizing my understanding. It will also ground me in the more tangibly human aspect of the medical research which I have been involved with on the scientific side. The data and results of the research will form a core component of my PST thesis and help me to better focus the topic. Following graduation, I intend to pursue a medical degree and graduate study in epidemiology. The experience gained from conducting this research would be a strong asset in cultivating this interest. My own beliefs in the value of human dignity and the obligation of individuals to invest themselves in its protection and promotion more deeply underlie these potentially de-contextualized and abstracted academic interests.

Host Organization name and supervisor name:

HIV Prevention Trials Network; I am currently working with Jeff Stanton to finalize placement, although my host country supervisor will be somebody else.

Host organization purpose / mission:

"The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV. Established in 1999 by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HPTN carries out its mission through a strong network of expert scientists and investigators from more than two dozen international sites partnered with a leadership group comprised of three U.S.-based institutions."

Your job description:

I will work with the HIV Prevention Trials Network (HPTN), an organization within the National Institutes of Health which develops and tests HIV prevention methods in both domestic and international trials. HPTN uses Community Advisory Boards (CABs) as formal hubs for channeling the input from communities in each of its 20 research sites about each clinical trial conducted there through HPTN. I will spend two months observing the meetings and proceedings of one site's CAB, interview its members, observe their approaches to soliciting input from the community itself, and interview other community and non-community members who are not directly involved in the CAB but have invested interests in the community or clinical trial (this includes the researchers themselves). I will follow the progress of one or more study protocols which are either in the pre-trial stage or currently in implementation. I will work with the HPTN site coordinators on evaluating their process of community consultation, and will also volunteer at R.K. Kahn Hospital (the institution through which HPTN trials in Chatsworth, South Africa are conducted), as to better immerse myself in the culture of the community and the institution and gain a better understanding of the general health situation of the area.

Description of the target population:

Stakeholders in HIV research in Chatsworth, South Africa.

What are the targeted learning objectives associated with your project?:

The specific questions I hope to better understand through this project are: 1) How is the idea of an "ethical study design" (specifically in terms of the informed consent process) conceptualized and understood by CAB members, community members and researchers, and how does the process of community consultation incorporate and reconcile these conceptions into trial design and implementation? 2) How is input from the community solicited and presented to researchers by community representatives and how does this affect the design and implementation of clinical trials? 3) What are the most prominent difficulties in community consultation and what approaches are pursued in trying to overcome these difficulties?

Background or rationale for your learning objective(s):

Obtaining meaningful informed consent is a critical component in ensuring that clinical trials conducted in developing countries are ethical rather than exploitative endeavors. Social, cultural, and linguistic differences between researchers and participants complicate the consenting process, and have made the issue a serious challenge to be confronted by the research community. Many ethicists argue that collaborative partnerships with the local community promote the development of ethical and culturally appropriate recruitment procedures, disclosure of information and consenting procedures¹. While community consultation is becomingly more frequently incorporated into study designs, little research exists regarding its general effectiveness or considering the best approach to collaboration. 1.Emanuel, EJ, Wendler D, Killen J, Grady C. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. JID 2004 189:930-937

Your hypothesis or question, associated with your objective(s):

What value does community consultation add to the design of ethical clinical trials in developing countries, specifically with reference to the design and impementation of processes for obtaining informed consent?

Methodology for data collection / analysis:

I will use empirical research methods (primarily qualitative interviews and observation and analysis of existing records) to better understand the value of community consultation. The focus will more specifically be on the development and implementation of the consenting procedure. I will observe community advisory board meetings, interview the board members, researchers, community stakeholders, and other members of the community, and shadow and observe the approach of community representatives in soliciting inputs from the community at large. Analysis will be done primarily by comparison of the final study protocol with protocols for similar studies in the region and similar studies in other regions. I will critically evaluate the protocol in terms of how it coincides with and diverges from international ethical standards for clinical research (as stated in such documents as the CIOMS ethical guidelines and the Belmont Report), considering the rationale and justifications for divergences in terms of the specific regional cultural context.

Benefits: What benefits can reasonably be expected from your project (Benefits may be to the participants, to the knowledge base of the area:

With the specter of colonialism still lingering heavily over the relationship between Africa and the Western world, the haphazard use of African communities as laboratories for medical research by Western (and Western-funded) researchers remains a well-grounded fear. Researchers and institutions who develop novel approaches to promoting ethical conduct of medical research move towards assuaging this fear and encouraging research and development of beneficial medical technologies in a manner which justly treats trial participants and host countries. HPTN has been committed to promoting ethical trials through community consultation, so an evaluation of their approaches and the formulation of constructive feedback offers to benefit not only the body of knowledge of research ethics, but also the people living in developing countries affected by Western researchers.

Risks: What risks can reasonably be expected from your project? Are there any possible physical, psychological, professional or personal risks and/or hazards for the participants? (Please be sensitive regarding potential risks for participants, partic:

In evaluating the community consultation process by interviewing all of its participants, there is a possibility for provoking a degree of antagonism between participants if questions were to be thoughtlessly worded.

What will be done with what you've learning during your project? How will this information be shared with the people in the location where you conduct your project? Do you expect to present, publish or disseminate your findings in a public forum (othe:

I will incorporate my research from this project into my thesis for my distinguished major program in Political and Social Thought. I will also go through the process of obtaining IRB approval from both UVA and my host institution as to allow me to potentially publish the results of my research. If at all possible, I will also try to present my research at one of the global related symposiums at UVA and formulate any noteworthy findings into feedback to my host institution.

If hazardous substances are involved, then (online training and following questions):

 

If animals are involved, then (online training and following questions):

 

Itinerary including in-country travel, data collection, analysis and other project activities.:

Spring 2007: Finalize research site, begin establishing network of contacts, continue reading existing literature on subject, draft initial outline of interview questions and specific topical foci, begin scheduling interviews and meetings with CAB members. May 21st-July 21st 2007: Travel to South Africa, observe CAB meetings, interview CAB members, community members and researchers, shadow CAB members in their interactions with community members, volunteer in assosciated hospital. July 21st - Fall 2007: Analyze results and write initial report. Spring 2008: Incorporate report into PST major thesis.

Estimated Budget including vaccines, health insurance, evacuation insurance, requisite visas, international airfare, meals and lodging, project supplies and the total that you are requesting from CGH.

VISA fees - $120.00 Yellow Fever Vaccine - $50.00 Malaria Medication - $100.00 Airfare to/from South Africa - $2,000.00 Travel expenses while in South Africa - $130.00 Housing/living expenses for May, June, July - $600.00
Total - $3,000.00