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General Information
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For Research Participants and the Public
What's New on the OHRE Web Site
- Investigators are reminded that when the IRB approval for a study lapses, all study related activities must cease. In cases where halting study related procedures would jeopardize the welfare of subjects, PIs must request in writing that currently enrolled subjects continue to receive study treatment or intervention(s).
- IRB SOPs updated, effective July 1, 2009. See Regulatory Documents
- Consent Forms for Storing Biological Specimens updated June 24, 2009. Both Forms clarify specimen ownership. The Consent Form for Storing Specimens With Identifying Information also provides definitions of GWAS and GINA.
- Beginning June 1, 2009, Unanticipated Problems/Adverse Events must be submitted online. Click here for complete instructions, training, and access to the web portal.
- The following forms were updated, May 22, 2009: Initial IRB Application; Determination; Renewal; Modification; Social Behavioral and Biomedical Adult Consent, Parental Permission, and Adolescent Assent; Minor Assent; and Short Consent.
- HIPAA Authorization revised Martch 18, 2009 under section # 2, to remove the requirement that subjects provide separate initials for certain types of sensitive records to be obtained (e.g., mental health, HIV).
- HIPAA Authorization revised February 17, 2009. In accordance with NC law, instructions related to the collection of sensitive information were added so that the person signing the form will need to initial (as relevant) the collection of data related to mental health, drug or alcohol abuse, HIV/AIDS or other communicable diseases, or genetic testing.
- Application for IRB Approval updated February 13, 2009. New general instruction added, advising users not to delete or alter sections. New Conflict of Interest question added at A.3.1(c). New question added at C.1, asking whether investigator using secondary data was involved in the original study.