 Wednesday, September 15, 2004
| Topic: |
Ethical Challenges in Human Subjects Research |
| Presenters: |
Camille Nebeker
Barbara Bigby |
| Location: |
La Jolla Professional Office Buildings, Suite C203
8950 Villa La Jolla Drive, La Jolla |
| Discussion: |
Given the existing regulatory structure and focus on continuing education in ethical research practices, the likelihood of demonstrating responsible conduct in research should be greatly improved. In practice, numerous challenges occur when conducting research that may compromise the process. For this session of the Research Ethics Journal Club, we will highlight some of the challenges for human subjects research with a special emphasis on the informed consent process. Discussion will focus on the roles and responsibilities of stakeholders in the conduct of research (Research Participants, Recruiters, Principal Investigators, Institutional Review Board, Institution, and Regulatory Agencies), evaluate the purpose of informed consent from these perspectives, and discuss regulatory and ethical practices specific to enhancing the responsible conduct of human subjects research. Informed consent documents from both biomedical and social/behavioral sciences will be used to identify perceptions and assumptions that may compromise the consent process.
Objectives:
- Identify the roles and responsibilities of the IRB, Investigator, Participant and community in the research process.
- Recognize common misconceptions about research.
- Examine methods to enhance the likelihood of obtaining truly informed consent.
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| Readings: |
- The Belmont Report
- General requirements for informed consent, Department of Health and Human Services, NIH, Office for Protection from Research Risks, Part 46 Protection of Human Subjects: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116
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