Clinical research compliance alert: Common Rule update

Update from January 22, 2019:

The new requirements for informed consent in clinical research went into effect on January 21, 2019. 

Update from June 20, 2018:

On June 19, 2018, HHS finalized the proposed updates to the Common Rule, adopting the proposals set forth in the NPRM without change.

Original post from May 15, 2018: 

The Department of Health and Human Services (HHS) and 16 other federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) proposing to delay the compliance date for updates to the Common Rule for an additional 6 months.

The Common Rule updates make significant changes to informed consent that entities involved in government-funded clinical research involving human subjects must heed. The updates implement new steps to better protect human subjects, while aiding valuable research and reducing burden, delay and ambiguity for research institutions. As we noted in our prior publication, which discusses the substance of the Common Rule updates, the initial compliance date has already been delayed once. If the NPRM is finalized as proposed, the updates that were to go into effect on July 19, 2018, will be further delayed until January 21, 2019. The purpose of the additional delay is to give regulated entities additional time to prepare for the new requirements.

Although the effective date for compliance with the Common Rule updates would be delayed until January 21, 2019, the NPRM proposes giving entities the option to implement three provisions of the updated Common Rule early. Those provisions are intended to reduce burdens on regulated entities:

1. The amended definition of “research,” which excludes four categories of activities from the definition;

2. The allowance for no annual continuing review of certain types of research; and

3. The abolition of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

Regulated entities would be required to comply with all pre-2018 requirements during the period of delay, unless the institution chooses to implement the three burden-reducing provisions for qualifying studies early.

The comment period for the NPRM ends on May 21, 2018.