The Common Rule revision published January 19, 2017 announced January 19, 2018 effectiveness and general compliance, with a separate January 20, 2020 compliance date for section __.114(b). This January 20 account examines the previous day's publication. The later date concerns a particular cooperative-research provision, not every responsibility of institutions working together on a study. [2017-01058]

Cooperative research means covered projects involving more than one institution. Section __.114(b) requires a U.S.-located institution to rely on approval by one institutional review board, or IRB, for the portion conducted in the United States. Exceptions cover research for which law, including qualifying tribal law, requires more than one board, and cases where a supporting or conducting federal agency documents that a single board is inappropriate. [2017-01058][2015-21756]

The September 2015 proposal supplies the policy rationale: oversight should be proportionate to risk, avoiding burdens that do not provide corresponding participant protection. That rationale helps explain the final effort to reduce duplication, but it is not proof that review became cheaper or faster. Each institution remains responsible for safeguarding participants' rights and welfare under the final cooperative-research section. [2017-01058][2015-21756]

Consent is a separate element of the revision. The final requires an understandable discussion and, except for broad consent, a focused opening presenting key information. The proposal had sought to keep important material from being buried in long forms. These records trace one rulemaking, not independent evaluations. Reading their chronology accurately means reporting the announced schedule without treating proposed ideas or future compliance as completed results. [2017-01058][2015-21756]

Source documents

  1. Federal Policy for the Protection of Human Subjectshttps://www.govinfo.gov/content/pkg/FR-2017-01-19/html/2017-01058.htm
  2. Federal Policy for the Protection of Human Subjectshttps://www.govinfo.gov/content/pkg/FR-2015-09-08/html/2015-21756.htm