Delays are becoming commonplace when it comes to the Common Rule.
The U.S. Department of Health and Human Services (HHS) just announced it is delaying, again, rollout of the revised Common Rule on the protection of human subjects in clinical trials for six months—until January 21, 2019. HHS is also granting an exception from the existing federal policy for three burden-reducing provisions during the delay period.
Industry has been down this road before. The new federal policy was originally scheduled to go into effect on January 19, 2018, but was delayed for six months through a controversial January 17 interim final rule.
HHS can argue that it listened to industry, based on input received during a public comment period on the interim final rule in early 2018. Comments were next solicited on a Notice of Proposed Rulemaking (NPRM) to delay the full implementation of the 2018 requirements while permitting the use of three burden-reducing provisions in those requirements.
HHS received 62 public comments on the interim final rule. Of these, 36 comments were related to the Common Rule and the remaining 26 comments were not related to the Common Rule in any way. HHS received 73 comments on the NPRM, only five of which were not related to the Common Rule.
Several common themes emerged from the public comments on the interim final rule and the NPRM, HHS reported. These included:
- The need for the regulated community to have as much advance notice as possible about any delay in implementing the 2018 requirements.
- The need for guidance to be issued promptly.
- General support for a delay of the general compliance date, with more limited support for a delay beyond January 2019. “This support, however, was generally tied to concern with whether Common Rule departments and agencies will be able to issue guidance in a timely fashion prior to the new general compliance date of January 21, 2019,” HHS said in a guidance published today (June 19).
Both sets of comments tended to endorse some type of delay beyond July 19, 2018 in the general compliance date for the 2018 requirements. Comments on the interim final rule often suggested that institutions be permitted to voluntarily implement the 2018 requirements in their entirety at any time after July 19, 2018, while comments on the NPRM indicated broad support for the narrower approach of permitting the voluntary use of three burden-reducing provisions during the delay period.
Author: Michael Causey