Revised Common Rule (Human Subject Regulations)

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This webpage will be updated as new information becomes available.

Revised Common Rule Highlights

The human subjects regulations are changing. The federal Office for Human Research Protections (OHRP) has scheduled the regulatory changes to be implemented on January 21, 2019. These changes have been referred to as the “Revised Common Rule.” Although these regulations were delayed twice in the past, the regulations appear to now be ready for implementation in January.  
 
What this means to you: Changes have been underway to the eIRB system, institutional policies, and templates in preparation for the Revised Common Rule. Some of the key proposed revisions to the Common Rule are listed below. 

Revised Common Rule Impact On Studies With Pending Approval on January 21, 2019

The Common Rule, a key federal regulation that regulates human research, has been revised. The revisions—most notably to: the consent process and form, what qualifies for exempt review, and when continuing review is required—become effective January 21, 2019. Because the effective date and the implementation date of the Revised Common Rule are the same, some studies in the queue may need to be updated while awaiting approval. The date when your study was or will be approved, determines whether you must comply with the Revised Common Rule changes or can continue to follow the Pre-2018 Common Rule, as outlined below:

Approved Before January 21, 2019

Approved January 21, 2019 or Afterwards

If your study was approved before January 21, 2019, the Pre-2018 Common Rule regulations will continue to apply to your study. Approval Date on or after January 21, 2019, you must adhere to the New Revised Common Rule.

(1) Studies which are Approved With Stipulations are considered Approved. 

(2) An Exempt or Expedited Study which is Approved With Conditions, must satisfy all conditions before January 21, 2019 or else it must comply with the New Revised Common Rule.

(3) A Full-Board Study which is Approved With Conditions, will have an approval date based on the date of the Full-Board Meeting when it was originally approved.         

Special Circumstances

For Department of Justice (DOJ) Sponsored Studies: The Department of Justice (DOJ), a previous signatory to the Common Rule, has not yet signed on to the Revised Common Rule, so the Pre 2018 Common Rule will still apply to DOJ-sponsored research.

For FDA Regulated Studies: The U.S. Food and Drug Administration (FDA) is not a signatory, nor are its regulations harmonized yet with the new Final Rule. FDA-regulated research must comply with the FDA regulations which differ in some respects from the Common Rule regulations.

Converting Existing Studies to Follow Revised Common Rule

There may be some circumstances under which studies that must comply with the Pre 2018 Common Rule may switch to comply with the Revised Common Rule. Guidance on which circumstances allow such a conversion will be posted in the future.

Questions?

Do you have a question about the Revised Common Rule? 

You can now email one of our HSPP Professionals for guidance: rCommon E-Mail.

 

Changes

The changes will only impact new protocols: meaning those approved after the Revised Common Rule goes into effect on January 21, 2019.  There are changes that will reduce the burden on researchers, and other requirements that will increase researcher responsibilities. New protocols include all types of new submissions (e.g. NHS, exempt, expedited, etc.). 
 

New Requirements for Consent Form Informational Elements
 
NEW REQUIREMENT! The consent form must begin with a concise summary of essential study information that individuals would want to know in order to make an informed decision about participation. 
 
NEW REQUIREMENT! Consent form must disclose any plans to conduct future research using info and/or biospecimens collected during the research. 
 
NEW REQUIREMENT! If applicable, consent form must disclose whether: (a) subjects will share in commercial profit; (b) clinically relevant research results will be returned; and (c) research will or might include whole genome sequencing. 
 
UPDATED CONSENT FORMS
The consent form templates have been updated to include necessary new elements (Forms and Templates).
New Revised Exempt Category List
 
NEW OPTION! With safeguards in place, studies using benign behavioral interventions may qualify for Exempt Review.
 
NEW OPTION! With a "Limited IRB Review" of a protocol plan to safeguard subjects’ privacy and confidentiality, more studies will qualify for exempt review.
 
UPDATED EXEMPT CATEGORIES
For details about the new Exempt Categories see:
Continuing Review Requirements
 
CHANGE! Continuing IRB Review may no longer be required for many studies that are approved as minimal risk (see details below). 
 
UPDATED ANNUAL REVIEW PROCEDURES
Although your study may qualify under this provision, you will still need to provide an annual Status Report through eIRB.
***(Please note that the FDA and DOJ have not yet signed onto these revisions, therefore, if your study falls under their jurisdiction you will not be able to implement these revisions (CRs). However, you will still need to include the new required Consent Form Elements as found in our revised consent forms (Forms and Templates).
Research Protocol Templates
 
CHANGE! Protocol Templates were revised  to ensure they were compliant with the new Revised Common Rule.
 
UPDATED RESEARCH PROTOCOL TEMPLATES
The Interventional and Non–Interventional Protocol templates have been updated to include additional sections required for the IRB to make revised Common Rule determinations (Forms and Templates).

 

Continuing Review under the Revised Common Rule And Status Reports

Rutgers will no longer require comprehensive continuing review for select minimal risk studies approved on or after the implementation date of January 21, 2019.  Instead, researchers will complete an annual Status Report through the eIRB system.  The IRB approval letter will indicate which type of submission will be required of the study.  Researchers will receive a 90, 60, and 30 day notice prior to the reporting date.
 
Amendments and modifications will still need to be submitted, reviewed, and approved by the IRB prior to their implementation.  In addition, unanticipated problems, protocol deviations, and other Reportable Events will still need to be submitted to the IRB.
 
HSPP will also increase post-approval monitoring to ensure that study activities are carrying on as described in the protocol.
 
The following studies will still need to undergo continuing review:
  • Research which requires annual review by a fully convened Board
  • Research which is subject to the US Food and Drug Administration (FDA) oversight or by another sponsor that requires continuing review
  • Research involving the Department of Veterans Affairs (VA)
  • Research that was approved prior to the implementation date of January 21, 2019 and has not transitioned to the revised Common Rule
  • Research subject to the discretion of the HSPP or an IRB that may involve the following:
    • Student-led research;
    • Research involving non-Rutgers investigators;
    • Research conducted internationally;
    • Research including particularly vulnerable populations;
    • Research involving additional regulatory oversight, such as a conflict of interest (COI) management plan;
    • Research amendment or incident report revealing new findings that require additional oversight;
    • Investigator has had previous serious non-compliance or a pattern of non-serious non-compliance;

 

Learn More

Training, Workshops, & Roadshows

The following are links to the All Campus Roadshow Training presentations held on November 27, 2018 (Newark Campus), 28 (Camden Campus) and 29 (New Brunswick & Piscataway Campuses):

Videos (NetID Required):

PowerPoint Presentations (NetID Required):
Need Help Accessing Our Presentation Materials? Email Us

 

Help

Do you have a question about the Revised Common Rule? 

You can now email one of our HSPP Professionals for guidance: rCommon E-Mail.