1. Susan Sonne, PharmD, BCPP Chair, MUSC IRB II
Institutional Review Board for Human Research (IRB) Human Subject Protections
Susan Sonne, PharmD, BCPP
Chair, MUSC IRB II

2. Nuremberg Code prescribed 1948 as part of trial of a Nazi Physician
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

3. Jewish 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

4. The Declaration of Helsinki
Produced 1961, adapted 1964
Informed consent = ethical research
Basis for FDA policy

5. Willowbrook 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

6. National 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

7. More 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

8. Good Clinical Practice
Why have this training?

9. The Tuskegee Syphilis Study
1932 to 1972
399 African American Males were denied treatment for syphilis
Study conducted by U.S. Public Health Service

10. From 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

11. OHRP 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

12. General Rule for Human Subject Protection
Any element of research? 
Yes
Undergo review

13. IRB 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

15. The Belmont Report
3 Basic Principles for Protection of Human Subjects:
Respect
voluntary informed consent
privacy
protections for vulnerable populations
Beneficence
Justice

16. Beneficence Protecting them from harm
Persons treated in an ethical manner
Protecting them from harm
Helping to secure their well being

17. Justice Equals ought to be treated equally Fairness in distribution
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

18. Criteria for Approval Risks are minimized
Reasonable risk:benefit 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, subject’s 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

21. The 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

24. Useful Regulatory/Policy Material
MUSC IRB
Office for Human Research Protections
Food & Drug Administration