VT Human Subjects Protection Tutorial
1. Welcome --- 2. Reason for Training --- 3. Importance of Compliance --- 4. History --- 5. Selection of Subjects --- 6. Recruitment --- 7. Consent --- 8. Paying Subjects --- 9. Confidentiality & Anonymity --- 10. Who Regulates Your Research? --- 11. VT IRB Submissions --- 12. Continued Compliance ---QUIZ
10 Who Regulates Your Research?
The Department of Health and Human Service’s (DHHS) Office for Human Research Protections (OHRP) is responsible for the implementation of the US Code of Federal Regulations and the requirement of the establishment or use of an IRB for projects receiving federal funds.
Per Virginia Tech’s policies all research at Virginia Tech that includes the use of human subjects and/or private information about humans must comply with all of the regulations in the Code of Federal Regulations (CFR) at 45 CFR 46.
OHRP ensures regulatory compliance in the protection of human subjects and requires that Virginia Tech, an institution receiving federal funding for research, provide written assurance documenting how it will comply with requirements for the protection of human subjects.
Virginia Tech Institutional Review Board (IRB) for the Protection of Human Subjects
Responsibilities:
- Provides local assurance of compliance
- Reviews and approves, disapproves or requires modifications of protocols
- Conducts annual re-evaluation of ongoing protocols
- Ensures that Principal Investigators and staff are appropriately trained
- Reports noncompliance to Institutional Official and OHRP
.......
Page 10 of 12