Human Subjects Research
Institutional Review Board (IRB)
IMPORTANT INFORMATION:
- Before submitting your IRB Research Application Packet to the IRB Compliance Coordinator, your faculty advisor for the research project must review your application forms, approve and sign your Form E and/or Form A.
- All forms must be completely filled out with all required signatures PRIOR TO being submitted to the IRB Compliance Coordinator. If you do not have all required forms and answers completed and requested signatures, your proposal will be returned to you and your review will be delayed until all are received.
The expected turnaround times for the IRB committee to process applications are as follows**:
Exempt - 4-6 weeks
Expedited - 6-8 weeks
Full review - 8-10 weeks
**Assuming that the proposals are complete and that no major revisions are requested. Please allow enough time for review.
FORMS:
- For Shenandoah University students and faculty: "Institutional Review Board" organization page in Blackboard
All IRB forms were revised on 4/25/12
IRB Application Checklist & Process
IRB Decision Charts
Form A-Application for Human Subjects in Research
Form B-Application for Human Subjects in Research
Form E-Application for Exemption from IRB review
Informed Consent Long Form
Form C-Amendments/Modifications to Research Protocols
Consent for Photographic or Voice Recording
Electrical Equipment Safety Check Memorandum
Sponsored Research Form
Submit all completed electronic forms (with signatures) and all attachments to SUComply@su.edu.
Paper (hard) copy of requested items should be sent to:
SU Compliance Coordinator
c/o Office of Academic Affairs
1460 University Drive
Winchester, VA 22601
GUIDANCE AND REGULATIONS LINKS
Federal Regulations
U.S. Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP)
- 45 CFR 46 - Protection of Human Subjects
U.S. Food and Drug Administration (FDA)
Federal Guidelines
National Institutes of Health (NIH)
- Guidelines on the Inclusion of Women and Minorities in research
- Inclusion of Children in Research
- Research Involving Individuals with Questionable Capacity to Consent
Office for Civil Rights (OCR
- HIPAA-Health Information Privacy for Research
- Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
Ethical Codes
Organizations
- Public Responsibility in Medicine and Research (PRIM&R)
PRIM&R is committed to the advancement of strong research programs and to the consistent application of ethical precepts in both medicine and research.
Sites of Interest
- NIH Bioethics Resources on the Web
- NIH National Human Genome Research Institute (NHGRI)
- President's Council on Bioethics
Guidance in Research
- International Compilation of Human Research Protections: A comprehensive guide to laws, regulations, and guidelines that govern human subjects research in 101 countries.
- HHS: Expedited Review Categories: 9 Categories of Research that may be Reviewed by an IRB by Expedited Procedure