Common Rule Revisions

The Federal Policy for the Protection of Human Subjects announced 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.

This compliance date for this rule is effective on January 20, 2019.

Read more below.

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 20, 2019 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.

What Are Some of the Major Changes?

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

Revised Common Rule Education

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