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June Listserv Announcement

Monday, June 12, 2017

OIRB Website makeover is almost complete!

We are very pleased to announce that the OIRB website has had a much needed makeover.  The site has been redesigned in response to our customer service survey to make it more interactive and make information more accessible to better serve the research community.  Thank you for everyone who completed the survey.  In order to migrate the site, our website will be inaccessible today from 4-6pm.  The new site will be live by tomorrow so please check it out at irb.unm.edu.  Special kudos to Brooke Cholka, Sr. IRB Analyst, for her hard work in designing and creating our new website!

New NIH Requirement for Single IRB

Effective 9/25/2017, NIH policy requires the use of a single IRB (sIRB) for multi-site research.  This policy applies to domestic awardees and participating domestic sites.  Foreign sites participating in NIH-funded, multi-site studies (including tribal nations) will not be expected to follow this policy.  Please note that In the application/proposal for research funding, the applicant is expected to submit a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites.  The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled.  If, in delayed-onset research, an sIRB has not yet been identified, applications/proposals should include a statement that awardees will follow this Policy and communicate plans to use a registered IRB of record to the funding NIH Institute/Center prior to initiating a multi-site study.  The applicant may request direct cost funding for the additional costs associated with the establishment and review of the multi-site study by the sIRB, with appropriate justification; all such costs must be reasonable and consistent with cost principles, as described in the NIH Grants Policy Statement and the Federal Acquisition Regulation (FAR) 31.302 (Direct Costs) and FAR 31.203 (Indirect Costs).  Please contact me (petreel@unm.edu) promptly prior to negotiating the sIRB as it requires written agreements between participating institutions.  It is expected that, in most cases, the UNM IRB would serve as the sIRB if UNM is the prime awardee.

New NIH Requirement for SBER Good Clinical Practice (GCP) Training

Effective 1/1/2017, NIH implemented a policy with regard to GCP training for NIH-funded clinical trials (including SBER clinical trials).  On main campus, this will mostly pertain to research being submitted by CASAA and Psychology:  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html.  This policy establishes the expectation that all NIH-funded investigators and staff involved in clinical trials be trained in GCP.  The OIRB is recommending that all UNM NIH-funded researchers that submit proposals for clinical trials complete the NIH SBER GCP training.  This training is now available through Learning Central and is entitled “NIH GOOD CLINICAL PRACTICE FOR SOCIAL AND BEHAVIORAL RESEARCH – ELEARNING COURSE”.

OIRB Summer Office Hours

The OIRB is open for regular office hours during the summer (M-F 8am – 5pm).  The summer is a great time to schedule a consultation with one of our expert staff.  To schedule a consultation, please submit a request using our online form.

Thank you and have a wonderful and safe summer!