How are US institutions implementing the new key information requirement?

Jessica Mozersky, Matthew P. Wroblewski, Erin D. Solomon, James M. Dubois

Research output: Contribution to journalArticlepeer-review


Recent revisions to the Federal Policy for the Protections of Human Subjects require that informed consent documents begin with a concise and focused presentation of the key information a participant requires. Key information must be organized and presented in a way that facilitates comprehension. The regulations do not specify what information be included, nor how it must be presented to facilitate comprehension. It is unknown how institutions and Institutional Review Boards (IRBs) are interpreting the current regulations. We conducted a review of randomly sampled available key information templates at 46 US medical institutions to determine how they are implementing the new regulations.

Original languageEnglish
Pages (from-to)365-369
Number of pages5
JournalJournal of Clinical and Translational Science
Issue number4
StatePublished - 2020


  • implementation
  • informed consent
  • key information
  • regulatory guidance
  • research ethics
  • review
  • Revised Common Rule


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