COMMUNITY CONSULTATION: LESSONS LEARNED IN HIV COMMUNITY-BASED RESEARCH Ronald P. Strauss, D.M.D., Ph.D. University of North Carolina at Chapel Hill

The realms of biomedical research ethics have been a central societal concern during the past 70 years. 2 main historical events: 1. Nazi Medial Experimentation 2. Tuskegee Syphilis Study

Linking Communities and Scientists Project LinCS was launched to investigate the social and ethical issues in linking scientists and communities. Funded jointly by CDC and NIAID 3 Universities: UNC-CH U of Penn UCSF

Goal 1: To understand how communities perceive biomedical research and what can be done to improve community trust in science, scientific institutions and scientists.

Goal 2: To identify factors that facilitate collaboration between biomedical research establishments and the communities they seek to work with.

Focus: How Communities Can be Meaningfully Involved in HIV Clinical Efficacy Trials

Community Involvement:  Community-based research design in partnership with Community Advisory Boards (CAB)  Explicitly incorporate subjects of research into the design and conduct of the inquiry.

Larger Questions:  How do you construct university-community partnerships?  How do you define community?  Who speaks for the community?  What is the role of CABs?  Who controls the research? The methodology? The results?  How do you build trust?  What promises need to be made to assure ethical, sensitive research?

Major questions were raised in the process: 1. Is biomedical research always positive? 2. How should poor outcomes of research be managed? 3. Should biomedical research be controlled? How? Codes? 4. How can truly informed consent be achieved? 5. What values guide the ethical choices of scientists? Situational? Principles? Religious? 6. Do scientists utilize and respect community input?

Lessons Learned : Getting the Community Involved in Research.

Community Comes First Before the research begins, researchers must build trust and communication with the community. Scientists should think about community consultation before writing their grant.

 Conflicts of interest for investigators should be declared and made evident to the community and review boards  Health and other risk factor education must be part of all HIV-related research  Careful that participants don’t act risky because of a study  Careful about the therapeutic misconception

Concerns:  Perceptions of placebos in clinical trials  Informed consent, literacy, understanding, cultural competency, time to think  Marginalized and disenfranchised communities  Distrust of government and public health researchers  Control of the research/ role of the CAB

HIV Specific Issues:  Stigma and Fear  HIV transmission during research  HIV testing – Privacy

Community Advisors Can: facilitate informed consent advise researchers pretest forms/questionnaires guide recruitment monitor conduct of research analyze findings disseminate results

Community Advisor Issues: autonomy and authority window-dressing resources/time leadership organization  payment and incentives

Community Advisor Goals:  Clarify the similarity and difference between Doctor/Patient relationships and Investigator/Subject relationships.  Assure treatment for people who seroconvert during the research.  Determine future use of research products and community access to products after the research concludes.  Promise full-disclosure to participants

Community Advisor Goals (continued)  Clarify conflicts of Interest/funding – corporate, government, university  Improve the local standard of care and health care infrastructure.  Become educated about Randomized Clinical Trials – early efficacy, Data Safety Management, trial completion

PROJECT LINCS CAB Developed: WHAT QUESTIONS SHOULD YOU ASK ABOUT RESEARCH STUDIES? You could ask the following questions of anyone who wants you or members of your family or community to be part of a research study

“What is the study about?” 1. Why are you doing this study? 2. Why do you want to study me or people like me? Who else is being studied? 3. What do you want to get out of this study? What will you do with the results? 4. Have you or others done this type of study ever before? Around here? What did you learn?

“Who put this study together?” 1. Who is running or in charge of this study? 2. Whose idea was this study? 3. How were people like me part of putting it together? 4. Who are the researchers? Are they doctors or scientists? Who do they work for? 5. Have they done studies like this before? 6. Is the government part of this study? Who else is a part of this study? 7. Who is paying for this study? 8. Who will make money from the results of this study?

“How can people like me share their ideas as you do this study?” 1. How will the study be explained in my community? 2. Who of people like me will look at this study before it starts? 3. Who of people like me are you talking to as you do this study? A Community Advisory Board? 4. Who from the study can I go to with ideas, questions or complaints? 5. How will people like me find out about how the study is going?

“Who is going to be in this study?” 1. What kinds of people are you looking for? Why? 2. Are you trying to get minorities in this study? 3. Are you including people less than 18 years old? 4. How are you finding people for this study? 5. Is transportation and/or daycare provided for people in this study? 6. Do I need to sign to participate? 7. Will you answer all of my questions before I sign the consent form? 8. Can I quit the study after signing the consent form? If I quit the study, will anything happen to me?

“What will I get out of this study?” 1. What are the benefits? 2. Is payment involved? How will I be paid? 3. Will I get free health care or other services if I participate? For how long? 4. Will I get general health care and/or psychological care if I participate? For how long?

“How will I be protected from harm?” 1. How do I stand a chance of being harmed in this study? In the future? 2. Does the study protect me from all types of harm? 3. If I get harmed, who will take care of me? Who is responsible? 4. If I get harmed in any way will I get all needed treatment? Who pays for treatment?

“How will my privacy be protected?” 1. Who is going to see the information I give? 2. Will my name be used with the information? 3. What happens to the information I gave if I quit the study? 4. Is there a written guarantee of privacy?

“What do I have to do in this study?” 1. When did you start this study? How long will it last? 2. How much of this study have you already done? 3. Have there been any problems so far? 4. Will I get treated the same as everyone else? 5. What kinds of different treatments are offered in this study? Is there a real and a fake treatment?

“What will be left behind after the study is over?” 1. What will happen to the information people give? How will it be kept? 2. What are you going to do with the results of the study? 3. How will the public learn about the results? Will results be in places where the public can see them? 4. Are you going to send me a copy of the results? When? 5. What other studies are you planning to do here?

Questions