Upcoming Changes Stemming from Revised Human Subjects Protections Regulations

Upcoming Changes Stemming from Revised Human Subjects Protections Regulations

Dec 04, 2017
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The federal Department of Health & Human Services (DHHS) regulations addressing the protection of human subjects in research were revised in January 2017.  The effective compliance date for the new regulations (Final Rule) is January 19, 2018, although this date is under review by the Trump administration, with a proposed one-year delay for many of the provisions.

The UNH Institutional Review Board for the Protection of Human Subjects in Research and staff in Research Integrity Services (RIS), which administers UNH’s human subjects protection program, have been working on revisions to the IRB’s procedures to comply with the revised regulations.  The anticipated major changes that will impact researchers are as follows:

  • Studies approved at the Expedited level on or after January 19, 2018 will no longer automatically have an annual continuing review requirement (studies approved at the Expedited level before January 19, 2018 will still have to request approval annually).
  • The scope of studies that the IRB can review at the Exempt level will change to comply with revisions to the descriptions of Exempt level categories, and the number of Exempt level review categories will change from six to eight.  Examples include:
    • The Exempt level category involving research conducted in established or commonly accepted educational settings involving normal educational practices has a new qualifier, that the normal educational practices are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.
    • There is a new Exempt level category for research involving benign behavioral interventions in conjunction with the collection of information from adult participants through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection, and certain criteria are met.
  • The IRB will revise its informed consent document template to present “key” information up front, and to include new required information when collecting identifiable, private information. (Individuals who do not use the IRB’s informed consent template will be required to revise informed consent information to ensure that what the IRB considers “key” information is presented up front.)
  • The IRB will no longer require researchers to obtain informed consent from prospective subjects if they are collecting information solely for screening, recruitment, or determining eligibility for a study, when certain conditions are met.
  • The definition of a clinical trial has been expanded to include behavioral studies where one or more participants are prospectively assigned to one or more interventions (including control) to evaluate the effects of the interventions on health-related outcomes.  Further, if a clinical trial is sponsored by a Federal department or agency, the IRB-approved consent document used to enroll participants must be posted on a publically-available Federal website (to be determined) after the trial is closed to recruitment, and no later than 60 days after the last study visit by a participant.

As the IRB and RIS staff work to revise the requisite procedures to comply with the Final Rule, they invite UNH researchers to provide input to them, including what type of guidance would be useful.  Senior Vice Provost for Research, Jan Nisbet, sent an invitation to the campus community earlier in the semester.  They plan, at a minimum, to post information about the revisions (once finalized) on the IRB’s website, and to incorporate it into the IRB’s online training.

Please send your input directly to Julie Simpson or Melissa McGee by December 8, 2017.

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