Revision raises complex challenges for research institutions.
On January 17, 2018, just two days before the newly revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule) was scheduled to go into effect, the Department of Health and Human Services’ Office for Human Research Protections announced an Interim Final Rule that delayed the effective and general compliance date of the new rule by six months, making it effective on July 19, 2018.
The delay is an acknowledgement of the complexity of the new rule, the yet-to-be-drafted federal guidance on numerous new requirements (e.g., determining research that is exempt, standards for protecting privacy of participants and confidentiality of data) and the onerous task of redesigning institutional policies, procedures, and electronic systems for institutional review boards (IRBs).
However, the delay also affords the federal departments and agencies that are signatories to the Common Rule the time to develop another notice of proposed rulemaking for public comment on further delaying implementation of the revised rule until January 21, 2019.
So, what does this mean for the research community? It maintains status quo, with the original Common Rule in effect until either July 19, 2018 or January 21, 2019.
Perhaps even indefinitely, if the recommendations of a Congressionally-mandated report by The Academies were to be adopted. That 2016 report called for Congress to establish a national commission to take a fresh look at the “ethical, legal, and institutional frameworks governing human subjects research.”