On January 10, 2019, the U.S. Department of Health & Human Services, Office for Human Research Protections (OHRP) released draft guidance with respect to the timeline for compliance with the revised Common Rule (otherwise referred to as the 2018 Requirements) and implications when institutions elect to transition studies currently subject to the pre-2018 Requirements to the 2018 Requirements. By way of background, the revised Common Rule was promulgated by the Department of Health and Human Services (HHS) and other federal departments and agencies on January 19, 2017 and was set to become effective one year following, but its compliance date was initially delayed until July 19, 2018, and the compliance date was delayed again until January 21, 2019. Under the most recent Final Rule issued by HHS on June 19, 2018, regulated entities are required to continue complying with the pre-2018 Requirements until January 21, 2019, except that they are permitted to implement the three burden-reducing provisions from the 2018 Requirements during the delay period (anytime between now through January 20, 2019) if otherwise electing to transition to compliance with the 2018 Requirements. Any study initiated after January 21, 2019 must comply with the 2018 Requirements. Among other things, in this draft guidance OHRP summarizes the implementation timeline for the 2018 Requirements set forth in the rulemaking referenced above, along with examples of impact on studies at various stages and key takeaways. In short: OHRP has also posted timelines on its website illustrating this information. In addition, OHRP’s draft guidance includes a question and answer section, along with examples, to address the regulatory implications of voluntarily transitioning a study to compliance with the 2018 Requirements and addressing clarifications sought by the Secretary’s Advisory Committee on Human Research Protections (SACHRP). This Q&A section addresses: Hooper, Lundy & Bookman’s Academic Medical Center/Teaching Hospital Working Group provides assistance to health care providers and IRBs in all aspects of research compliance. For assistance relating to transition issues, please contact Katrina Pagonis or Andrea Frey in San Francisco at 415.875.8500; Amy Joseph in Boston at 617.532.2700; Kelly Carroll in Washington, D.C. at 202.580.7700, or your regular Hooper, Lundy & Bookman contact.OHRP Provides Draft Guidance Regarding the Revised Common Rule Implementation Timeline and Transition of Existing Studies
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