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New Forms and Templates, Researcher Handbook, and Quality of Submissions

Friday, March 15, 2019

Newly Updated IRB Forms and Submission Templates

As a result of the revisions to the Common Rule, we have updated all relevant forms and templates.  When submitting to the IRB, please remember to always check the IRB Library for the newest forms and templates.  Using these documents will reduce the need for clarifications and changes during the review process.

UNM IRB Researcher Handbook

We have recently updated the Researcher Handbook to include revisions relevant to the revised regulations along with other general administrative updates. If you conduct human research, please take a moment to review the handbook and ensure you are up to date with the latest and greatest in human research protections! 

OHRP Guidance on Posting of Clinical Trial Consent Forms

The Office of Human Research Protections (OHRP) has issued an official guidance on new requirements related to the public posting of consent forms. The federal regulations now require that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision.  Detailed guidance can be found at the following link: https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html

New Policy and Guidance on FDA Regulated Human Research

The OIRB has published a new policy and research guidance on the review of FDA research.  These can be found in the IRB Library.  FDA regulations, which are more restrictive than the Common Rule, are invoked when conducting research using drugs and/or medical devices.  Examples of types of research that fall under FDA regulations include the administration of FDA approved drugs, brain stimulation studies, and some exercise studies using functional neuroimaging techniques.  We have also created a new Drug Information Form and revised the existing Device Information Form, which must be submitted when using drugs or devices. Please review these documents if this is applicable to your area of research and contact our office with any questions.

Quality of IRB Submissions

We have recently noticed a decline in the quality of submissions submitted to the UNM IRB.  Poor quality submissions require more back and forth between our staff and the project team and result in increased review and approval times.  The OIRB provides extensive submission guidance and tools in the IRB Library, the UNM IRB Researcher Handbook, and offers a variety of workshops the specifically address IRB submission requirements (see dates below).  We will be analyzing these submissions more closely to determine if certain departments or labs require additional targeted training.  If you are interested in having the OIRB come to your department/lab/class to provide training and answer questions about the submission process, please contact us at irbmaincampus@unm.edu.

Spring IRB Educational Workshops

The second round of Spring educational workshops has been scheduled from 10am – 11am on the dates listed below.  Be the first to register to attend by emailing irbmaincampus@unm.edu.  Seating at each workshop is limited to the first 12 attendees.

March 19, 2019 – IRB Regulations and Policies

March 26, 2019 – IRB Elements:  Navigating the IRB Review Process at UNM

April 2, 2019 – IRB Protocol and Consent:  Developing an IRB Protocol and Consent Form

April 9, 2019 – Common Mistakes

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.