Common Rule Revisions

IMPORTANCE ANNOUCEMENT

Six Month Delay in the Revised Common Rule

Within two days of the effective date the U.S. Department of Health and Human Services have announced a six month delay to the effective date of the Revised Common Rule.  This pushes the effective date back to July 19, 2018.

 

From OHRP January 17, 2018:

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the ?Federal Policy for the Protection of Human Subjects? (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).  Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. 

 The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

 The IFR has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf . This means that before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule. An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at __.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.

An example of a revised provision that conflicts with the pre-2018 rule, and thus could not be implemented prior to July 19, 2018, is the provision eliminating the requirement for continuing review in certain circumstances (as described in the revised rule at __.109(f)). Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance.

The IFR does not delay the compliance date for the cooperative research provision of the revised Common Rule (found at __114(b)), which remains January 20, 2020.

Federal departments and agencies listed in the IFR are also in the process of developing a notice of proposed rulemaking (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019).  If such an NPRM is published, after consideration of the public comments, the federal departments and agencies will determine whether a final rule to further delay the revised Common Rule will be issued.

Common Rule Revisions

The Federal Policy for the Protection of Human Subjects announced on January 19, 2017 revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.

WILL THIS AFFECT ME AS A RESEARCHER?

It is likely the Common Rule revisions will affect you in some way. The IRB Office is working to identify policies, procedures, applications as well as our standard operating procedures to see what needs to be modified and how to make these changes in accordance with the January 2018 deadline.

Here is a summary of the things we are working on and how they may affect your interactions with the IRB office.

In the meantime it would be good for you to familiarize yourself with the Revised Common Rule here.

IMPORTANT DATES

This compliance date for this rule is effective on January 19, 2018.

What are some of the major changes?

Category

Topic

Details

 

IRB operations

Single IRBs for multisite research ("cooperative  research?" (46.114)

Single IRBs generally required; however, some flexibility is provided in determining and documenting when a single IRB is not appropriate

External IRBs (46.103)

Reliance arrangement with non-institutional IRB must be documented

Checking the box (46.101)

Option for FWA holders to check the box has been eliminated

Continuing review (46.109 & 46.115)

Continuing review of research is no longer required under various circumstances

 

Informed consent

New language/clarity (46.116)

Consent forms must be clearer and more focused; many changes added to emphasize that information provided must facilitate a potential subjects? understanding of why one would participate or not

Basic and additional elements of informed consent (46.116)

New basic element on collection of identifiable private information or identifiable biospecimens; three new additional elements on commercial profit, return of clinically relevant research results and whole genome sequencing

Broad consent  (46.111 & 46.116)

Broad consent is an option for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens

Recruitment/screening  waivers  (46.116)

Allows waiver of informed consent for subject recruitment or screening, under certain conditions

Clinical trials consent forms (46.116)

Some clinical trials must post consent form online

Electronic consent (46.117)

Electronic consent is ok; must provide written copy

Legally authorized representatives (46.102)

If no law, institution can designate a representative

 

Scope

Definition: Research (46.102)

Defines what's NOT research: certain journalistic, public health surveillance, and criminal justice or intelligence activities

Definition: Human subjects (46.102)

Includes "information or biospecimens" obtained from through intervention and interaction OR ?identifiable private information or identifiable biospecimens?

Definition: Clinical trial (46.102)

Clinical trials are now specifically defined

Definition: Identifiable biospecimen/identifiable private information (46.102)

Will be re-examined within one year and every four years after

Definition: Vulnerable populations (46.111)

Pregnant women and "handicapped" removed; replaces "mentally disabled"  with "individuals with impaired decision-making capacity"

Tribal law (46.101, 46.114, 446.116)

Tribal law applies where applicable; added throughout

 

New guidelines for exemptions

Additional exemptions for low-risk studies (46.104- see also 46.103, 46.109, 46.110, 46.111)

Exemptions added for secondary research on identifiable private information and identifiable biospecimens under various circumstances and regulatory requirements, such as limited IRB review and broad consent, may apply

Compliance dates

1 year (1/19/18), 3 years for multisite (1/20/20)  (46.101)

Previous Rule applies to research approved prior to 1/19/18; new rule to approvals 1/19/18 or later