1 / 26

EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS …or… What’s an “IRB” and why should you care?

EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS …or… What’s an “IRB” and why should you care?. Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel Hill.

yanka
Download Presentation

EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS …or… What’s an “IRB” and why should you care?

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS…or…What’s an “IRB” and why should you care? Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel Hill Presentation for IBD Patient Governance Committee February 4, 2014

  2. But research is a good thing… why do research subjects need “protection?” Concerns for protecting subjects grew out of a long history in which people were abused in the name of science

  3. “It is not cruel to inflict on a few criminals sufferings which may benefit multitudes of innocent people through all centuries.” Celsus, 1st century AD

  4. Informed consent “contract” used by Maj. Walter Reed for yellow fever transmission experiments in Cuba, signed 26 Nov 1900 (duplicate in Spanish) Courtesy of Col. Arthur Anderson, U.S. Army

  5. Nazi Medical Experiments During WWII

  6. Case No. 1 of the Nuremberg Military Tribunal U.S.A. vs. Karl Brandt et al.Dec 9, 1946 - Aug 20, 1947 15 of 23 guilty, 7 hanged, 5 life sentences

  7. NUREMBERG CODE1947 • Voluntary informed consent absolutely essential • Research should yield useful results • Base research on prior work • Avoid physical and mental suffering • No expectation of death or disabling injury • Risk must be outweighed by importance • Subjects must be protected from injury • Qualified scientists, adequate facilities • Subject free to stop at any time • Investigator must be ready to withdraw subject

  8. “Before IRBs, the only consent required was that of a researcher's department head. The Nuremberg Code was ignored in practice. As I look back on it, the interpretation of these codes was that they were necessary for barbarians, but not for fine upstanding people... In this prestigious unit we had a very strong obligation to behave in a civilized manner.” Dr. William Silverman, Columbia pediatrician, on the postwar mentality (ACHRE interviews)

  9. Willowbrook State School Staten Island, 1956-1963 • Institutionalized children • Deliberate infection with hepatitis A • Coercive recruitment through restricted admission • Rationalization Introducing Jerry Rivers, 1971

  10. “Tuskegee Syphilis Study” Conducted by US-PHS in Rural Alabama1932-1972

  11. Syphilis Expose

  12. Philadelphia Inquirer, 1972

  13. “Sometimes, with the best of intentions, scientists and public officials… working for the benefit of us all, forget that people are people. They concentrate so totally on plans and programs, experiments, statistics- on abstractions- that people become objects, symbols on paper, figures in a mathematical formula…” Atlanta Constitution, July 27, 1972

  14. US National Research ActJuly, 1974 • Established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978) • The Belmont Report (1979) • Code of Federal Regulations (1981) • Institutional Review Boards (IRBs) • Informed consent Public Law 93-348

  15. THE BELMONT REPORTEthical Principles and Guidelines for the Protection of Human Subjects of Research Respect for Persons Beneficence Justice National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979

  16. Translating Ethical Principles Into Regulations

  17. Translating Ethics into Regulations“The Twin Pillars of Protection” Rights and Welfare of Human Subjects Independent Review Informed Consent

  18. WHAT IS AN IRB?Institutional Review Board • Independent review of proposed research, to protect the rights and welfare of participants • At least 5 members, not all men, not all women (UNC IRBs have 10-25 members) • Not all members of one profession • Diversity • Expertise appropriate to the research • At least one scientist, one non-scientist • At least one member not otherwise affiliated with the institution

  19. WHAT IS AN “IRB?”Institutional Review Board • 5 IRB committees at UNC-Chapel Hill • Social and Behavioral Sciences • Biomedical Sciences (x4) • Members include 80 faculty, staff and community representatives • Oversee approx 4000 active research studies

  20. What does an IRB do when it reviews a research study? • Risks minimized • Balance of risks and benefits • Equitable selection of subjects • Informed consent • Monitoring plan for safety • Privacy and confidentiality • Additional safeguards for vulnerable populations

  21. Informed Consent

  22. INFORMED CONSENT • Obtaining consent is a PROCESS in which... • investigator discloses all relevant information • potential subject has opportunity to ask questions • investigator answers questions • subject signs a consent form • The consent form is a permanent record of... • information conveyed • subject’s willingness to participate

  23. What Questions Should You Ask Before Participating in a Research Study? • What is the study about? • Who put this study together? • Who is going to be in this study? • What will I get out of this study? • What are the possible risks? • How will I be protected from harm? • What do I have to do in this study? • What will happen after the study is over?

  24. Our National System for Protecting Research Subjects has Come Under Scrutiny

  25. Current Challenges and Opportunities • Continuing legacy of Tuskegee • Storing specimens and data for future unspecified research • Genetic testing • Return of results to participants • Research results? • Incidental findings? • Data sharing  data security • Waiver of consent • Community engagement • Study design issues • Multisite research • “Standard of Care” research • Cluster randomized trials

More Related