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International Research Ethics: Issues in Prevention Trials. Steve Morin, Ph.D. AIDS Policy Research Center AIDS Research Institute University of California, San Francisco NIH Funding for International AIDS Research, FY 1996-2004.

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international research ethics issues in prevention trials

International Research Ethics: Issues in Prevention Trials

Steve Morin, Ph.D.

AIDS Policy Research Center

AIDS Research Institute

University of California, San Francisco

the community based vct prevention trial
The Community-Based VCT Prevention Trial
  • HPTN 043: A Phase IIB Randomized Trial to Evaluate the Efficacy of Community-Based HIV Voluntary Counseling and Testing to Reduce HIV Seroincidence (funded by NIMH).
  • 32 communities in Africa (Tanzania, Zimbabwe, and South Africa) and 14 communities in Thailand will be randomized to either a community-based HIV voluntary counseling and testing (CBVCT) intervention or clinic-based standard VCT (SVCT).
  • Most HIV infections are in sub-Saharan Africa, yet only a small fraction of Africans know their HIV status.
  • Voluntary HIV Counseling and Testing (VCT) is an effective method of promoting behavior change, but utilization of VCT is still low in African communities with a high prevalence of HIV.



~25% of sexually active Zimbabwean adults are infected with HIV, yet a small percentage know their HIV status

community based vct
Community-Based VCT
  • Intervention has three major strategies:
    • to make VCT more available in community settings
    • to engage the community through outreach; and
    • to provide post-test support.
  • These three strategies are designed to change community norms and reduce risk for HIV infection among all community members, irrespective of whether they participated directly in the intervention.
mobile vct pilot study
Mobile VCT Pilot Study
  • Offered free, anonymous VCT from a mobile caravan
  • Rotated once a week to 6 sites in Epworth
  • Rapid tests were performed (15 minutes)
  • Testers were offered the option to wait for results outside the caravan or return on another day
what s different about international research
What’s different about international research?
  • Vast disparities in wealth between sponsor and host countries
  • Limited resources in host country
  • History of exploitation
what are the ethical issues
What are the ethical issues?
  • Research questions and priorities
  • Interventions for control group
  • Post-trial access to interventions
  • Informed consent
  • IRB review
research questions and priorities
Research questions and priorities
  • Helsinki
    • “a reasonable likelihood that [study populations] stand to benefit from the results”
  • NBAC
    • “limited to those studies that are responsive to the health needs of the host country”
  • The CBVCT question emerged from prior research in Tanzania and Kenya.
  • Issue is considered important to key stakeholders in revising the National AIDS Control Plan.
  • It addresses both an important behavioral science question and a need of the host country.
interventions for control group
Interventions for control group
  • Helsinki
    • “Best current prophylactic, diagnostic, and therapeutic methods”
    • Rejected “highest attainable and sustainable” standard
  • NBAC
    • Effective treatment preferred, but current (no) care may be justified to meet host country health needs
  • The standard of care (SOC) for VCT as a prevention intervention was established in the Tanzania and Kenya trial.
  • In the control arm of this trial, we establish the same clinic-based VCT as SOC.
  • SOC was chosen over “available care” for scientific as well as ethical reasons.
post trial access to interventions
Post-trial access to interventions
  • Helsinki
    • Subjects “should be assured of access to the best proven prophylactic, diagnostic, and therapeutic methods identified by the study
  • NBAC
    • “Reasonable, good faith efforts” to provide access to participants
    • Address access issues in planning
    • Negotiate agreements in advance
  • Representative from the Zimbabwe Ministry of Health National AIDS Control Program serves as an investigator.
  • USAID involved in planning and primary VCT contractor serves as technical advisor.
  • CDC involved in planning and developing laboratory measures for assessing primary endpoint.
informed consent
Informed Consent
  • Communicate information
    • on multiple levels (community, family, individual)
    • in multiple formats (oral, written)
    • over time
  • Assess participant’s understanding
  • Involved local researchers in developing the informed consent documents.
  • Developed Community Advisory Board that reviewed consent documents and process.
  • Modified US approaches to be reduce miscommunication.
  • Integrated concepts of informed consent into pre-test counseling.
coverage of antiretroviral therapy in developing countries 2002 adults by region
Coverage of Antiretroviral Therapy in Developing Countries, 2002(Adults by Region)

Source: Fauci, NIAID, 2003

total federal hiv aids spending by category fy 2002
Total Federal HIV/AIDS Spending by CategoryFY 2002

Source: Kaiser Family Foundation, 2003

total federal hiv aids spending by department of agency fy 2002
Total Federal HIV/AIDS Spending by Department of AgencyFY 2002

Source: Kaiser Family Foundation, 2003

president s emergency plan for aids relief funding breakdown
President’s Emergency Plan for AIDS Relief: Funding Breakdown

Source: Fauci, NIAID, 2003

nih mission
NIH Mission

1) Foster fundamental creative discoveries, innovative research strategies, and their applications as a basis to advance significantly the Nation’s capacity to protect and improve health;

2) Develop, maintain, and renew scientific human and physical resources that will assure the Nation’s capability to prevent disease;

3) Expand the knowledge base in medical and associated sciences in order to enhance the Nation’s economic well-being and ensure a continued high return on the public investment in research; and

4) Exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

community advisory boards
Community Advisory Boards
  • Represent community -- bridge, link, go-between, liaison -- make suggestions about protocols
  • Safeguard/protect the community -- clearinghouse for ethical issues -- promote respect for participants
  • Legitimize research in communities -- respond to misinformation, provide access

Community leaders play an important role, as they facilitate access to the local community, as well as understanding and acceptance of research.

“That is why you saw us coming to look in, when the caravan came … people could see that I was also involved in this project and that they should not try anything because I am here and we are the ones who have brought this project.

We were giving ourselves thought you had the accolades but we were the ones who had them!

We want to tell you … we were telling people we brought the project so that they could embrace it, there was no problem my children (referring to staff).”

Barbara Mangwende, Chair of the Epworth CAB

  • Challenge: Many participants coming for pilot study were weak from hunger. Nurse raised issue of whether we can feed them bread?
  • Should the research study feed them?
  • Extensive discussion in counseling supervision session and consultation with other projects.
  • Determined that offering food would be coercive under the circumstances; referral to food programs would be more appropriate.
  • Providing food (incentive) would also change the study -- would no longer be testing whether changing community norms leads to increased awareness of status and decreased new infections.
antiretroviral therapy
Antiretroviral Therapy
  • Challenge: HIV drugs are not generally available. Referral options are limited. Treatment advocates, some developing country researchers, and some at NIH have suggested it is “unethical” to conduct HIV testing if the researchers do not provide treatment.
  • What should the researchers do?
  • Conducted focused discussion of the issue with local CAB.
  • Consensus was that VCT was of benefit to participants and community even in absence of treatment.
  • Providing treatment would also change the study -- would no longer be testing whether changing community norms leads to increased awareness of status and decreased new infections.
hptn guidance
HPTN Guidance
  • Prevention trials should make “practically achievable” effective prevention methods “reasonably available” to all people screened or enrolled -- VCT & condom availability.
  • In conducting research in settings where standards of HIV care are poor, consider opportunities to contribute to the local infrastructure.
what should investigators do
What should investigators do?
  • Raise and address issues
    • Expect close scrutiny and harsh criticism
    • Justify design proactively
    • Plan for potential criticisms
  • Make good-faith, reasonable efforts
    • Involve host country scientists, community leaders, political leaders
  • Seek US and host country review and consider community consultation
  • National Institute of Mental Health (NIMH) and Office of AIDS Research (OAR)
  • Leslie Wolf, JD & Bernard Lo, MD, UCSF Program in Medical Ethics and CAPS Policy & Ethics Core
  • Epworth Community Advisory Board and Epworth Local Board
  • Community Working Group & Ethics Working Group, HIV Prevention Trials Network
  • Zimbabwe Investigators: Gertrude Khumalo-Sakutukwa, Katherine Fritz, Tinofa Mutevedzi, Taurai Vaki and Owen Mapfumo