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Institutional Review Board (IRB) Overview for Medical, Behavioral and Educational Research. Jack Medendorp M.S., B.S.N., CIP. Office of Regulatory Research Compliance Drexel University. DISCUSSION POINTS. Regulatory Oversight What is Research? Levels of IRB Review
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Jack Medendorp M.S., B.S.N., CIP.
Office of Regulatory Research Compliance
All of the above force us to reexamine concepts of:
- Personal responsibility
- Ethical or legal culpability
Operate in accordance to all Federal, State, local regulations
HHS/NIH supported clinical and non-clinical research
Drug, Devices, Biologicals, Radiological
Protection of personal, identifiable health information
Encompass all areas of research
HHS regulations define research at 45 CFR 46.102(d)
DUCOM research oversight is registered with DHHS under the Assurance for Drexel University College of Medicine.
Four separate IRBs:
IRB #1- Adult Medical/Psychological Trials
IRB #3- Adult Behavioral/Educational/Social
IRB #4- Children Medical/Psychological Trials
Western IRB (WIRB)- Multicenter Sponsored Clinical Trials
DUCOM offers four (4) CITI training courses
All applicable CITI training courses require recertification every two (2) years.
1601 Cherry Street,
3 Parkway Bldg., Suite 10-444
Philadelphia, Pa 19102
A case study/case report application is the only application to the IRB in which the research may be done in advance of IRB application and approval
A case study/case report may not be discussed, shared or published until receipt of your IRB approval
NO RESEARCH ACTIVITIES MAY COMMENCE UNTIL:
(if any and however trivial they may be)
Human subject research being carried out without IRB review and approval by institution’s IRB. Serious noncompliance also includes substantive modifications to IRB-approved research without IRB approval.
This involves a principal investigator making the same mistake several times repeatedly, particularly after an IRB has informed him or her and his/her team member(s) of the problem. Continuous noncompliance includes; when the principal investigator has multiple problems with noncompliance over a long period of time or has a problem with multiple projects.
The IRB and the Signatory Official and the Humans Subject Protection Administrator have the authority to suspend or terminate approval of human subject research that is not being conducted in accordance with the IRB’s requirements
Contact the Office of Regulatory
Research Compliance at