Human Subjects Review Committee

1. Human Subjects Review Committee Trinity Christian College Chairperson: Rose Malinowski

2. Historical Examples of Research Gone Bad • The Tuskegee Syphilis Experiment (1932-1972) “The United States government did something that was wrong—deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all citizens.” President Clinton’s apology for the Tuskegee Syphilis Experiment to the 8 remaining survivors, May 16, 1997

3. Tuskegee Syphilis Experiment • For 40 years between 1932 and 1972, the U.S. Public Health Service conducted an experiment on 399 black men in the late stages of syphilis. These men, for the most part illiterate sharecroppers from one of the poorest countries in Alabama, were never told what disease they were suffering from or its seriousness.

4. Tuskegee Cont… • Informed that they were being treated for “bad blood,” their doctors had no intention of curing then of syphilis at all. That data for the experiment was to be collected from autopsies of the men, and they were thus deliberately left to degenerate under the ravages of syphilis – which can include tumors, heart disease, paralysis, blindness, insanity, and death. • “As I see it,” one of the doctors involved explained, “we have no further interest in these patients until they die.”

5. What has been done to stop bad research? • The U.S. and other governments have taken several actions to reduce research harm.

6. Chronology of Significant Events Involving the Protection of Human Subjects • Nuremberg Code (1946) • Code developed in response to Nazi physician experiments • Helinski Declaration (1964) • World Medical Organization develops broader guidelines to govern biomedical research

7. Chronology Cont… • Family Educational Rights and Privacy Act (1974) • Regulations to protect students’ educational records • National Research Act, 45 CFR 46 (1974) • Guidelines governing Federally funded research • Provided for review by Institutional Review Boards (HSRC)

8. National Commission for the Protection of Human Subjects(1974-1979) • Issues the Belmont Report

9. Belmont Report • 3 Principles basic to the protection of human subjects: • Respect for persons • Beneficence • Justice

10. What has TCC done to comply with these rules?

11. TCC’s Human Subjects Review Committee Purpose • Trinity Christian College affirms that all persons are created in the image of God and therefore have inherent dignity and worth. Consistent with this underlying principle the purpose of the HSRC is to promote ethical research practices by students, faculty, staff, and administrators both on campus and in the broader community

12. HSRC Composition • Specific Minimal Requirements • At least 5 Members – 46.107(a) • Both Sexes – 46.107(b) • Varied Professions – 46.107(b) • Member(s) whose primary concerns are in scientific and nonscientific areas – 46.107(c) • Member(s) not otherwise affiliated with the institution – 46.107(d) • Sensitive to needs and concerns of the community • Sensitive to special issues concerning vulnerable populations e.g. children, prisoners, etc. • May invite people with special competence to provide advice

13. HSRC Authorized to… • Approve, Modify, Disapprove Research • Observe Research and Consent Process • Obtain Verification that there is no change in research • Suspend or Terminate research for noncompliance or serious harm

14. Research A systematic investigation including research development, testing, and evaluation; designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities

15. Minimal Risks • means that the probability and potential magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

16. Human Subject • means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information or records

17. Types of Research Proposal Submissions • Exempt • Expedited • Full

18. HSRC Approval Criteria • Minimize Risks • Use sound research design • Use accepted standards • Risks reasonable in relation to benefits • Risks & benefits resulting from the reaserch

19. HSRC Approval Criteria • Equitable selection of subjects • Informed consent • Consent documentation • Data monitoring for safety • Privacy & confidentiality of data • Additional safeguards as needed

20. Informed Consent • Information • Voluntariness • Comprehension

21. Approval Period • At the time of HSRC approval, the continuing review interval is also determined. The approval period is appropriate to risk as determined by the HSRC – at least yearly.

22. Continuing Review • At least yearly – approval period appropriate to level of risk • Reminders sent by HSRC, but it is the investigator’s responsibility to insure Continuing Review application is submitted to allow sufficient for HSRC review prior to a lapse in HSRC approval • There is no grace period!!!

23. Amendments • Changes or amendments to any aspect of the research (recruitment, consent process, intervention, interaction, etc…) must be submitted for review and approval prior to initiation • Only exception to eliminate immediate hazards to subjects – still must be submitted to the HSRC for review

24. Informed Consent a.) Include a statement that the study involves research, and explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and the identification of any procedures that are explained b.) Describe any reasonably foreseeable risks or discomforts to the subjects c.) Disclose appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

25. Informed Consent cont… d.) Describe any benefits to the subject or to others which may reasonably be expected from the research e.) Describe the extent, if any, to which confidentiality of records identifying the subject will be maintained (a separate form may be used to obtain authorization under the Health Insurance Portability and Accountability Act, where applicable). f.) For research involving more than minimal risk, explain whether any compensation and whether any medical treatment is available if injury occurs, and if so, what they consist of, or where further information may be obtained.

26. Informed Consent cont… g.) Inform participants to contact the chair for answers to questions about the research, about their rights as subjects and about any research-related stress or injuries h.) State that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that he subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

27. Informed Consent cont… i.) State that the particular treatment or procedure may involve risks to the subject (or embryo or fetus, is the subject may become pregnant) which are currently unforeseeable. j.) Include anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent k.) Identify any additional costs to the subject that may result from participation in the research

28. Informed Consent cont… l.) State the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject m.) State that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject n.) Include the approximate number of subjects involved in the study

29. HSRC Committee Members • Dr. Brad Breems • Dr. Dick Cole • Professor Charlie Emmerich • Dr. Derrick Hassert • Dr. Rose Malinowski (chair) • Dr. Robin Pals-Rylaarsdam • Dr. Rick Snoeyink