The Office of
The following notice was distributed via campuswide informational e-mail bulletin on 9/17/07.
It is sometimes difficult for students, faculty advisers and course instructors to distinguish activities that require IRB review from those that do not. We first issued guidance in this area in 2005, and this has now been updated to further clarify and simplify. Guidance like this can only provide generic examples, and you are encouraged to consult with your IRB about individual scenarios. Click here for updated guidance: <http://ohre.unc.edu/misc/student_research_irb_guidance.pdf>
The federal Office for Human Research Protections has clarified <http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf> that some secondary uses of information or specimens do not constitute human subjects research under the regulations, provided that certain conditions are met. Among them, researchers must not be able to ascertain the identity of individual research subjects; this requires that specimens or data be stripped of identifiers, or coded in such a way that investigators will never have access to individual identities. If this describes your proposed research, you may be able to submit for IRB review using this abbreviated application form: <http://ohre.unc.edu/forms/initial/not_human_subjects_research_determination.doc>
The revised policy described above has opened the door for studies that previously received IRB approval to be removed from ongoing oversight at the time of continuing review. If your project fits this scenario, the IRB will explore this possibility with you after they receive your annual progress report. Investigators should not assume that their studies no longer require approval, if the IRB has not confirmed this in writing.
There are circumstances where researchers are required to collect SSN from their subjects. Most often this relates to payments for participation that may trigger IRS income reporting obligations. In 2005, the General Assembly enacted the North Carolina Identity theft Protection Act, which imposes additional restrictions and requirements on the use of SSN and other personal identifiers. Please understand that these are legal obligations of the University, and are not "IRB policies." Nevertheless, the IRB has now been authorized to review and approve the collection of SSN when required in a research setting, so that investigators will no longer need to submit for additional review to a separate committee in the Office of University Counsel. Given the considerable complexity and confusion in this area, we have prepared guidance: <http://ohre.unc.edu/sop/ssnpolicy.pdf>
Updated templates for studies that access Protected Health Information (PHI), such as medical records, have been posted on the IRB website. Among other things, the header of this HIPAA form has been modified to display the same study-specific details (title, etc) as the consent form for that study; this is necessary to remain in compliance with HIPAA regulations. As always, research teams are encouraged to visit the OHRE website with each IRB submission and obtain the most recent versions of any form.
<http://ohre.unc.edu/forms/consent/hipaa_auth_14sep07.doc>
Research teams and their departments are reminded that they can access current status information about research projects via this web portal. The real-time data are pulled from multiple offices across campus, relating to grant applications, IRB and IACUC reviews, licenses and patents and more. Click here for more information and links: <http://ohre.unc.edu/yourirb.php>
As most are already aware, all IRBs on campus have now been integrated into a consolidated operation. All previously separate IRB offices are now located in Medical School Building 52 on Mason Farm Rd (CB 7097) and all IRB data have now been merged into a modernized information system. This common electronic platform sets the stage for enhancements to the ways in which investigators and IRBs communicate and share information, including ONLINE PREPARATION AND SUBMISSION OF IRB APPLICATIONS. Programming for this "paperless" application process is already underway, and we will share further details as work progresses.
As always, we welcome user feedback at