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The Roles of IRB & Investigators in Clinical Research. Definitions. IRB : A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
IRB: A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
RESEARCH: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
HUMAN SUBJECTS: A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information.
Permissible Medical Experiments” Trials of War Criminals before
the Nuermberg Military Tribunals under Control Council Law No.
World Medical Association General Assembly, Edinburgh,
Scotland, October 2000
Report of the National Commission for the Protection of Human
Subjects ot Biomedical and Behavioral Research, DHEW, April
The federal regulations are intended to implement the basic ethical principles governing the conduct of human research. These ethical principles are set forth in the Belmont Report. No one should be involved in human research at any level without being familiar with these ethical principles.
21 CFR 50 FDA - Protection of Human Subjects, Informed Consent
21 CFR 56 FDA - Institutional Review Boards
45 CFR 46, Subpart A DHHS - Basic Policy for Protection of Human Research Subjects (Common Rule)
45 CFR 46, Subpart B DHHS - Research Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization
45 CFR 46, Subpart C DHHS - Additional Protection for Children Involved as Subjects in Research
45 CFR 46, Subpart D DHHS - Additional Protections Pertaining to Research Involving Prisoners as Subjects
CODE OF FEDERAL REGULATIONS
TITLE 45PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICESNATIONAL INSTITUTES OF HEALTHOFFICE FOR PROTECTION FROM RESEARCH RISKS
PART 46PROTECTION OF HUMAN SUBJECTS
* * *
Revised June 18, 1991Effective August 19, 1991
In order to fulfill the requirements of this policy each IRB shall:
(a) Follow written procedures in the same detail as described in 46.103 (b)(4) and to the extent required by 46.103 (b)(5).
(b) Except when an expedited review procedure is used review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting
often than annually
significant or non-significant risk
The process of protocol review and approval not only improves the protection of research participants, it improves the research itself.
The IRB is a speed bump on my road to progress.
The progress report is just one more opportunity for the IRB to obstruct my research.
Continuing review of every protocol is an important component of human subject protections.
Give me a break! What does the IRB know about adverse events?
An IRB must be made aware of adverse events - this is the only way to provide continuing assessment of the risks and potential benefits of the study.
Have a nice trip! See you next time!!
Here’s a phone card, call to check in. Call immediately if something bad happens. If we don’t hear from you, your trip is cancelled!
And remember… plan to get together a few times during your trip.
1. Source Documentation
2. Lab Documentation
3. Investigator Brochure
4. NIH Progress Report/DSMB
5. Curriculum Vitae (CVs)
6. Study Logs
7. Eligibility Criteria Checklist
8. Consent Form Issues
9. Protocol deviations, violations
10. Record Keeping