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Revised Common Rule is here!

Wednesday, January 9, 2019

Good afternoon and Happy New Year!  Please see the following important announcements from the UNM OIRB:

Revised Common Rule

The Common Rule, which are the federal human research protections regulations, is being revised for the first time since being promulgated in 1991. The revisions are extensive, therefore I will only cover highlights via this email but if you are interested in reading it in its entirety, you can access it online at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf.  The implementation of the revised Common Rule was delayed for one year and now these new regulations will go in effect on January 21, 2019. Forms and templates have been revised to accommodate the revised Common Rule and will be posted in the IRB Library by 1/18/19.  It is important that you download the most current versions of IRB submission documents to prevent delays in the review process.   Please note that these changes are specific to federally funded research.

Some of the important elements of the revised rule include:

  • The requirement for consent forms to provide potential research participants “key information” so they can make a more fully informed decision about whether to participate.
  • The establishment of new exempt categories of research based on the level of risk posed to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rule.
  • Removal of the requirement to conduct continuing review of ongoing minimal risk research studies in instances where such review does little to protect participants.
  • New informed consent waiver criterion that requires the researcher to justify why access to identifiable data or biospecimens is necessary.
  • The requirement that consent forms for certain federally funded clinical trials be posted on a public website.
  • The requirement to use a single institutional review board (sIRB) for multi-site federally funded research.  This particular requirement has an implementation date of 2020 but has already been adopted by NIH and is now required for NIH funded multi-site studies.

Based on the revised Common Rule, the UNM IRB has made some important changes in our institutional policies and procedures, which are highlighted below:

  • There are now two tracks for review of human research:  federally funded projects (and projects expected to be submitted for federal funding) and non-federally funded projects.  It is important to keep the IRB informed of the funding status of your project to ensure it is reviewed under the appropriate policies.
  • Most minimal risk research (regardless of funding) no longer requires continuing review by the IRB unless recommended by the IRB reviewer.  Approval letters will indicate whether continuing review is required for your project.  NOTE that current IRB approval expiration dates are valid until the project is reviewed under the revised regulations.  Also amendments must still be submitted to the IRB for approval prior to implementation.
  • All human research will be subject to post approval monitoring (PAM) such as directed self-assessments, consent form reviews, and administrative check-in by OIRB staff in order for the University to ensure that research is being conducted in accordance with IRB approval and ethical standards.

Detailed information about UNM IRB’s transition to the new regulations is available here.  Please review this document and contact our office with any questions.  I strongly recommend that all human researchers review our updated policies and download new forms that will be posted on our website by the end of next week.  When submitting new packages to the IRB, always obtain forms and templates from the IRB Library to avoid delays in processing.  Again, note that if you have a currently approved project with an expiration date, that expiration date is still in effect until the IRB reviews the project under the new regulations

Spring IRB Educational Workshops

The first round of Spring educational workshops have 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.

January 28, 2019 – IRB Regulations and Policies

February 4, 2019 – IRB Elements:  Navigating the IRB Review Process at UNM

February 11, 2019 – IRB Protocol and Consent:  Developing an IRB Protocol and Consent Form

February 18, 2019 – Common Mistakes

February 25, 2019 - Working with IRBNet:  Submitting your Application Online

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.

New Graduate Student Member

The UNM IRB welcomes our new Graduate Student member, Camille Velarde. She is a PhD student in Health Communication from the Department of Communication and Journalism. Her research focuses on mental health and health campaigns that utilize digital media. Congratulations, Camille!

Customer Service Survey

The OIRB is very interested in improving our service to the UNM research community.  Please take a moment to complete our Customer Service Feedback survey! Your comments will be reviewed and incorporated into our 2019 quality improvement goals.  Thank you for valuable feedback!