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Introduction to HRP’s Series on Institutional Engagement

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October 28

For the next three weeks, the regulatory team at the HRP Group is tackling one of the most complicated and hotly debated Common Rule concepts: engagement.  In one article each week, we work through the gray areas in OHRP’s institutional engagement guidance and offer practical tips for handling them.  In this piece, we provide context about the term “engagement” what it encompasses, and what it does not.

The Common Rule (subpart A of 45 CFR part 46) mentions engagement four times (emphasis below mine):

  • 45 CFR 46.101(a): “Except as detailed in § 46.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. […] Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy.”
  • 45 CFR 46.101(l)(4): “Transitioning research. If, on or after July 19, 2018, an institution planning or engaged in research otherwise covered by paragraph (l)(3) of this section determines that such research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination.”
  • 45 CFR 46.103(a): “Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under § 46.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy.”
  • 45 CFR 46.114(b)(1): “Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.”

While the Common Rule tells us what obligations engaged institutions have, it does not define the term or explain which institutions are considered “engaged.”  Instead, OHRP (and OPRR before it) has attempted to clarify the meaning of this term through guidance. As we discussed in How to Read a Reg Roundup: A Short Guide to Rules, Notices, Guidance, and Dates, guidance is a tool that executive branch departments and agencies use to explain how they interpret their regulations; it generally does not bind the public or have the force of law.

This matters because, although OHRP’s engagement guidance reads as prescriptive and many institutions treat it as legally binding, institutions in fact have significant flexibility. 

Here is a comprehensive list of OHRP guidance that covers engagement.  The list ends with several OHRP-issued documents that include information relevant to an engagement analysis but that are not directly related to engagement:

Help shape the tool this series is building toward!

HRP is launching a free practical decision tool built to help IRB offices, HRPPs, and research administrators work through engagement analyses. If you would like early access to beta test that tool, sign up here.

Questions, Comments? Let us know!

We’d love to hear your feedback! How has your institution handled thorny engagement scenarios? Is there another engagement-related topic that you’d like for us to tackle? Provide your feedback here or add your thoughts in the comments on LinkedIn.