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February Listserv Announcement

Monday, February 13, 2017

Conflict of Interest Review

New procedures have been implemented which allow for increased communication between the IRB and the Conflict of Interest (COI) committee.  Federal regulations and institutional policy require that all individuals involved in the design, conduct and/or reporting of human research report disclosable interests with regard to conflict of interest and conflict of commitment.  On UNM Main Campus, this is primarily done through mandatory annual reporting (additional reporting requirements apply if the researcher has a material change or grant submission to a federal entity).  Effective January 1, 2017, the IRB will only review studies for which all project team COI disclosures have been reviewed by the COI office or committee, as applicable.  Please submit online disclosures promptly to ensure there will not be delays in the IRB review of new projects and project team member additions.  In addition, any COI management plan or decision memo with stipulations must be provided to the IRB as part of the submission process.  If you have questions about this, please reference IRB SOP 504 in the IRB Library or contact our office.

Expedited Review Process

The UNM IRB is pleased to announce changes to its “expedited review” process.  Approximately 2/3 of all studies submitted to the UNM IRB are eligible for expedited review (review by one IRB member on behalf of the entire IRB).  In order to increase accuracy and reduce review turnaround times, we have formed three expedited review committees, which will meet weekly to conduct expedited initial and continuing reviews.  Thank you to all of our IRB members who were willing to adjust their schedules to accommodate these meetings.

Reliance on External IRBs

In some cases, it is appropriate to defer IRB oversight for research that involves multiple organizations.  In addition, NIH has recently issued a policy that mandates the use of a single IRB for multi-site research.   When IRB oversight is deferred to an external institution, the UNM Human Research Protections Program maintains responsibility for ensuring that the research is conducted in compliance with federal regulations, the IRB’s determinations and UNM’s institutional policies, which includes COI review.  According, we have recently issued a revised policy (SOP 207.2) that requires annual reporting of certain information to the OIRB.  The “Deferred Projects Annual Report” form is now available in the IRB Library.

Project Demographics Form in IRBNet - FYI

The OIRB has implemented a new smart form to track study demographics and assist with reporting.  The “Project Demographics Form” tracks important information about a study, including funding, special determinations, waivers, etc.  This form will be visible in IRBNet under “Board Documents”.  No action is required from the research team with regard to this form.  It is being used for internal OIRB purposes only.

Educational Workshops

The OIRB spring educational workshop series are underway.  These workshops cover different topics that relate to IRB submission and review.  All workshops are held in the OIRB Conference Room at 1805 Sigma Chi Rd.

IRB Elements    April 10th 2-3pm    Forms and documents needed for an IRB submission

IRBNet   Feb. 20th 10-11am and April 17th 2-3pm   Navigating the IRBNet submission website

IRB Protocol & Consent   Feb. 27th 10-11am and April 24th 2-3pm    Writing the perfect protocol and consent form

IRB Regulations     April 3rd 2-3pm  Applying federal regulations to your research

Space is limited so reserve your space today by emailing us at IRBMainCampus@unm.edu!

Faculty – remember to invite us to present at your department meetings, methods classes, etc.!!!  Presentations can be tailored to meet the needs of your faculty and/or students.