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Updated HSR Regulations

Wednesday, January 10, 2018

It is the start of a new year and we have important updates to share.  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 and affect much of what people are used to when it comes to submitting and complying with the regulations. Since the revisions are extensive, I will only cover highlights via this email but if you are interested in reading all 126 pages, you can access it online at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdfThese changes will go in effect on January 19, 2018. Forms and templates will be revised to fit the revised Common Rule and it is important that you download the most current versions of IRB submission documents to prevent delays in the review process.
 
Some of the important elements of the revised rule include:

  • The requirement for consent forms to provide potential research participants with a better understanding of a project’s scope, including its risks and benefits, 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 rules.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect participants.
  • 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:

  • IMPORTANT: There will be 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.
  • The non-federally funded review track allows for additional study procedures that the UNM IRB determines to be minimal risk (such as tDCS using standard dosing procedures).
  • Most minor amendments to non-federally funded minimal risk research will now be reviewed by qualified OIRB staff.
  • Most minimal risk research (regardless of funding) will no longer require 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 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.
  • Approved consent forms will no longer be given an “approval stamp” unless specifically requested by the PI.
  • Project team changes will no longer be reviewed by the IRB (with the exception of change of PI); PIs will be responsible for continual tracking of project team training expiration dates and annual Conflict of Interest disclosure and decision.
  • IRB approved projects can now be closed after all interactions with participants and data collection are complete (formerly required IRB oversight during analysis of identifiable data).

I strongly recommend that all human researchers review our updated policies and download new forms that will be posted on our website next week.  When submitting new packages to the IRB, always obtain forms and templates from the IRB Library to avoid delays in processing.  Also 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.
 
If you have any questions about these changes, please contact our office at (505) 277-2644 or irbmaincampus@unm.edu.