Title: Institutional Review Board for Human Research (IRB) Human Subject Protections
1Institutional Review Board for Human Research
(IRB)Human Subject Protections
- Susan Sonne, PharmD, BCPP
- Chair, MUSC IRB II
2Nuremberg Code
- first major control on research in any
nation - prescribed 1948 as part of trial of a Nazi
Physician - willfully harmful research on unwilling human
subjects
3Jewish Chronic Disease Hospital Study
- July 1963
- Injection of live cancer cells into 22
patients - No written consent
- Some verbally informed involved in
experiment - Never told being given live cancer cells
- Guilty of fraud, deceit, unprofessional
conduct
4The Declaration of Helsinki
- Produced 1961, adapted 1964
- Informed consent ethical research
- Basis for FDA policy
5Willowbrook State School
- Study began 1956
- Institution for mentally defective children
- Study designed to contribute to
understanding etiology of infectious
hepatitis and test effects of gamma globulin
in preventing disease. - First subjects fed extracts of infected
stool - Public attention 1971
6National Research Act of 1974
Created National commission for the protection of
Human Subjects of Biomedical and Behavioral
research. Charge was to Identify basic ethical
principles that should underlie conduct of
biomedical and behavioral research involving
human subjects
7More specifically, consider
Boundaries between research and practice Role of
assessment of risk-benefit Selection of
subjects Nature and definition of informed
consent Result was 1976 Belmont report
8Good Clinical Practice Why have this training?
9The Tuskegee Syphilis Study
- 1932 to 1972
- 399 African American Males were denied treatment
for syphilis - Study conducted by U.S. Public Health Service
10From President Clinton
- "Although these regulations Protection of Human
Subjects, Code of Federal Regulations, Title 45,
Part 46 provide the framework for protecting
human subjects in research, we must exercise
constant care and ensure that these regulations
are strictly enforced by departments and
agencies. Therefore, I direct each department and
agency of Government to review present practices
to assure compliance with the Federal Policy for
the Protection of Human Subjects and to cease
immediately sponsoring or conducting any
experiments involving humans that do not fully
comply with the Federal Policy." -Bill Clinton,
1994 - The people who ran the study at Tuskegee
diminished the stature of man by abandoning the
most basic ethical precepts. They forgot their
pledge to heal and repair. They had the power to
heal the survivors and all the others and they
did not. Today, all we can do is apologize.
Bill Clinton, 1997
11OHRP Suspensions
- During the last 6-7 years, OHRP has suspended all
human research at the following institutions - University of Illinois, Chicago Campus
- University of Colorado
- Duke University
- Johns Hopkins
- University of Pennsylvania
- And others
12General Rule for Human Subject Protection
Any element of research? ? Yes ? Undergo review
13IRB Purpose
- To protect the rights and welfare of human
research subjects - Authority to approve, require modification and
disapprove any research involving human subjects
14- Institutional Review Board
- responsible to verify
- Safety
- Integrity
- Human rights
- Public reassurance
- Scientific content
15The Belmont Report
- 3 Basic Principles for Protection of Human
Subjects - Respect
- voluntary informed consent
- privacy
- protections for vulnerable populations
- Beneficence
- Justice
16Beneficence
- Persons treated in an ethical manner
- Protecting them from harm
- Helping to secure their well being
17Justice
-
-
- Who ought to receive the benefits of
research and bear the burden of research? - Equals ought to be treated equally
- Fairness in distribution
- What is deserved
18Criteria for Approval
- Risks are minimized
- Reasonable riskbenefit ratio
- Equitable selection of subjects
- Informed consent obtained appropriately
- Informed consent adequately documented
- Monitor data to insure safety
- Protect confidentiality
- No coercion
19- Informed Consent
- Essential to ethical conduct of clinical
investigation - Potential subject chooses whether or not they
will participate - Obtained after full information is given and
understood - Explanation of study objective, potential
benefits, risks, inconveniences, subjects
rights and responsibilities
20- Informed Consent
- Introduction
- Purpose of the Study
- Procedures
- Potential Risks and Discomforts
- Anticipated Benefits to Subjects
- Anticipated Benefits to Society
- Alternative to Participation
- Emergency Care and Compensation for Injury
- Payment for Participation
- Financial Obligation
- Privacy and Confidentiality
- Participation and Withdrawal
- Rights of Research Subjects
- Signatures
21The Mountain of Responsibility
FDA
Sponsor
Investigator
- Protecting Participants
- Implementing Study
- Reporting Accurately
Research Team Coord, RA, etc
22- Investigator Obligations
- Conducts a clinical investigation
- Responsible for
- All procedures conducted
- All data collected
- May delegate work in conducting study but
they retain responsibility
23- Investigators and by delegation all study staff
responsibilities - To protect the rights of participants
- To obtain informed consent from each participant
- To keep specific records and issue specific
orders - To assure that the IRB is provided information
for initial and continuing review of the study
24Useful Regulatory/Policy Material
- MUSC IRB
- http//research.musc.edu/ori/irb/home
- Office for Human Research Protections
- http//www.hhs.gov/ohrp/
- Food Drug Administration
- http//www.fda.gov/oc/ohrt/irbs/default.htm