Institutional Review Board

Transcription

1 Institutional Review Board Overview & Minimal Risk Research Jon Mark Hirshon, MD, MPH Vice-Chairman University of Maryland Institutional Review Board May 18, 2006 Jon Mark Hirshon, MD, MPH 1

2 Presentation Outline What is an Institutional Review Board (IRB) and why have one? What are the Belmont Principals? What is minimal risk research? What is exempt research? May 18, 2006 Jon Mark Hirshon, MD, MPH 2

3 What is an IRB? The group or committee that is given the responsibility by an institution to review research projects involving human subjects. Its primary purpose is to assure the protection of the safety, rights and welfare of the human subjects. By federal law, the group contains both scientific and non-scientific (community) members May 18, 2006 Jon Mark Hirshon, MD, MPH 3

4 What is Research? Systematic collection of data designed to produce knowledge that can be generalized. All research involving human subjects that is done Federal Wide Assurance (FWA) needs to be reviewed by an IRB. May 18, 2006 Jon Mark Hirshon, MD, MPH 4

5 What is a Human Subject? A human subject is a living individual about whom an investigator (whether professional or a student) conducting research obtains: Data through intervention or interaction with the individual or Identifiable private information From: 45 Code of Federal Regulations (CFR) May 18, 2006 Jon Mark Hirshon, MD, MPH 5

6 What Aspects Are Important for an IRB Review? Subjects adequately protected Potential Benefits > Risk Study design/scientific integrity of research Equitable Subject Selection (No Coercion) Appropriate Informed Consent Privacy & Confidentiality Protection Data & Safety Monitoring May 18, 2006 Jon Mark Hirshon, MD, MPH 6

7 Why have an IRB? Historical Perspective Federal legislation Recent laws and events May 18, 2006 Jon Mark Hirshon, MD, MPH 7

8 Historical Abuses Japanese WWII experiments Nazi experiments/nuremberg trial (1946) Tuskegee Study of Untreated Syphilis in the Negro Male (1932 to 1972) Human radiation experiments (conducted between 1946 and 1974), revealed in 1993 Milgram experiment of obedience (1963) May 18, 2006 Jon Mark Hirshon, MD, MPH 8

9 Nuremberg Code (1947) Informed consent of volunteers must be obtained without coercion Human experiments should be based upon prior animal experiments Anticipated scientific results should justify the experiment May 18, 2006 Jon Mark Hirshon, MD, MPH 9

10 Nuremberg Code (cont.) Only qualified scientists should conduct the medical research Physical and mental suffering should be avoided There should be no expectation of death or disabling injury from the experiment May 18, 2006 Jon Mark Hirshon, MD, MPH 10

11 Declaration of Helsinki (1964) Defined rules for therapeutic and nontherapeutic research Reiterated the Nuremberg code for requiring consent for non-therapeutic research, but allowed enrollment in therapeutic research without consent Declaration has been updated several times May 18, 2006 Jon Mark Hirshon, MD, MPH 11

12 Tuskegee Study of Untreated Syphilis U.S. Public Health Service conducted an experiment on poor, black, male sharecroppers in Alabama Supposedly to study the natural history of syphilis among African Americans Denied treatment to individuals Misled individuals to entice compliance with the research activities Lead to Congressional investigations and the Belmont Report May 18, 2006 Jon Mark Hirshon, MD, MPH 12

13 Belmont Report (1979) National Research Act of 1974 created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Regulations established IRB This commission in 1979 produced the Belmont report May 18, 2006 Jon Mark Hirshon, MD, MPH 13

14 Three principles (Belmont Respect for persons Report) Respect individual autonomy Protect individuals with reduced autonomy Beneficence Maximize benefits and minimize harm Justice Equitable distribution of research burdens and benefits May 18, 2006 Jon Mark Hirshon, MD, MPH 14

15 Oversight Agencies Office of Human Research Protections 45 CFR 46 Subparts A, B, C, D Food and Drug Administration 21 CFR 50, 56 Office of Good Clinical Practice Office of Research Oversight (VA) Department of Health and Human Services Agencies May 18, 2006 Jon Mark Hirshon, MD, MPH 15

16 Recent problems Death of research volunteers University of Pennsylvania (Jesse Gelsinger) Johns Hopkins University (Ellen Roche) Research at institutions temporarily suspended due to serious non-compliance University of Oklahoma, West LA Sepulvida VAMC, Duke, University of Chicago, etc. Kennedy Krieger Lead paint study in children lawsuits May 18, 2006 Jon Mark Hirshon, MD, MPH 16

17 Levels of Research Risk By federal rules there are essential two levels of research: Minimal Greater than minimal May 18, 2006 Jon Mark Hirshon, MD, MPH 17

18 Minimal Risk Research The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.* *[From: 45 CFR i.] May 18, 2006 Jon Mark Hirshon, MD, MPH 18

19 Examples of Minimal Risk Research Chart review Survey Physical exam Drawing blood Review of previously collected specimens Collection of stool or sputum specimens May 18, 2006 Jon Mark Hirshon, MD, MPH 19

20 What is Informed Consent? Informed Consent means the knowledgeable consent of an individual, or his/her legally authorized representative, who is able to exercise free power of choice without undue inducement or any form of force, fraud, deceit, duress or other form of constraint or coercion. May 18, 2006 Jon Mark Hirshon, MD, MPH 20

21 How is Consent Informed? To be informed, prospective participants must fully understand the risks involved, any benefit to the individual or society, exactly what will be expected of them during their participation, and their rights as a participant. May 18, 2006 Jon Mark Hirshon, MD, MPH 21

22 Informed Consent is Ongoing Informed consent is an ongoing process, not a one time event for documentation purposes. May 18, 2006 Jon Mark Hirshon, MD, MPH 22

23 Waiver of Consent Waiver in minimal risk studies Waiver in emergency situations Used for life-threatening situations were consent would delay possible beneficial treatment Requires community notification and involvement for consent May 18, 2006 Jon Mark Hirshon, MD, MPH 23

24 Waiver of Consent: Minimal Risk Studies The research involves no more than minimal risk to the subjects The waiver or alteration will not adversely affect the rights and welfare of the subjects The research could not practicably be carried out without the waiver or alteration May 18, 2006 Jon Mark Hirshon, MD, MPH 24

25 Waiver of Consent: Minimal Risk Studies (cont.) Whenever appropriate, the subjects will be provided with additional pertinent information after participation. Not all minimal risk research is eligible for waiver of consent May 18, 2006 Jon Mark Hirshon, MD, MPH 25

26 Exempt Research Certain minimal risk research activities are exempt (45 CFR b) The IRB, not the investigator, determines whether the research is exempt Six exempt categories Category #4 is the primary reason for exemption for research conducted at the University of Maryland May 18, 2006 Jon Mark Hirshon, MD, MPH 26

27 Questions? May 18, 2006 Jon Mark Hirshon, MD, MPH 27