NSF 118 Determinations for Short IRB Deadlines
The Council on Governmental Relations (COGR) had discussions with NSF administrators, and in late March 2016 announced that agreement had been reached on language that can be used to address the situation where NSF is asking for IRB review documentation but the project has not yet developed recruitment, data collection, and consent materials. As a result, NSF has approved the use of a “118 determination letter”. The notification letter indicates that the grant or protocol meets the requirements of 45 CFR 46.118 and stipulates that “one year from the date identified above, the Authorized Organizational Representative is required to either verify that the project continues to lack immediate plans for the involvement of human subjects, their data, or their specimens; or provide documentation to the cognizant NSF Program Officer to demonstrate that IRB approval has been obtained.” Universities that utilize this notification letter must track the expiration. These changes will be reflected in the next version of the NSF Proposal and Award Policies and Procedures Guide that is scheduled for release in October.
The OIRB has created such a notification letter and it can be obtained by following instructions on page 9 of the IRB Submission Checklist. Contact firstname.lastname@example.org with any questions.
FCOI Disclosures for IRB
IRB policy requires that all project team members on active human research studies complete a financial conflict of interest (FCOI) disclosure form annually and at the time of a material change (e.g. acquiring a new financial interest). This includes faculty, students, staff and external collaborators. The 2016-2017 disclosure forms are now available online at: http://researchcompliance.unm.edu/submit-fcoi-disclosure. Please contact email@example.com with any questions about the FCOI disclosure process.
OIRB Fall Workshop Series
The OIRB fall workshop series are ongoing through November. These workshops cover important information about IRB submission and review. Topics and remaining workshop dates are listed below.
IRB Regulations Oct. 24th 1-2pm
Applying federal regulations to your research
IRB Elements Sept. 19th 10-11am or Oct. 31st 1-2pm
Forms and documents needed for an IRB submission
IRB Protocol & Consent Oct. 3rd 10-11am or Nov. 7th 1-2pm
Writing the perfect protocol and consent form
IRBNet Sept. 26th 10-11am or Nov. 14th 1-2pm
Navigating the IRBNet submission website
Space is limited so reserve your space today by emailing us at IRBMainCampus@unm.edu and include which workshops you would like to attend!
OIRB Office Hours in the SUB
The OIRB has partnered with the Graduate and Professional Students Association (GPSA) to host walk-in office hours at the GPSA office in the 1st floor of the SUB. The office hours are held on the 1st and 3rd Thursday of each month from 10am -12pm. Please take this convenient opportunity to stop in and ask questions regarding your human research project!