Regulations governing human subjects research are changing. The federal Office for Human Research Protections (OHRP) has announced changes to federal regulations that protect the rights and welfare of human research participants. These regulatory changes to 45 CFR 46, referred to as the “Revised Common Rule,” have been delayed twice and are scheduled to be implemented on January 21, 2019. The Common Rule changes seek to modernize, strengthen and make more effective the federal policies for the protection of human research participants.
What this means to WMU researchers:
All research projects that involve human subject must be submitted to the WMU IRB for review and receive approval prior to implementation (e.g., recruitment, data collection, etc. cannot proceed without IRB approval). The IRB will make the determination on the category of review, continuing review, and post approval changes.
The WMU IRB and Research Compliance have been updating and revising policies and procedures in preparation for the Revised Common Rule.
This guidance will take you through an overview of significant changes made to each section the Common Rule. New guidance will be posted to the website as it becomes available.
Revised Common Rule Impact on Studies with Pending Approval on January 21, 2019
The most notable changes are to the consent process and form, what qualifies for exempt review, and when continuing review is required. Due to the effective date and the implementation date of the Revised Common Rule being the same, some studies awaiting approval may need to be updated and resubmitted for review. Your study approval date or pending approval will determine whether you must comply with the Revised Common Rule changes or will continue to follow the Pre-2018 Common Rule.
|Approved Before January 21, 2019
|If your study was approved before January 21, 2019, the Pre-2018 Common Rule regulations will continue to apply to your study.
|Approved On or After January 21, 2019
|Approval Date on or after January 21, 2019, you must adhere to the New Revised Common Rule.
- Exempt or Expedited studies which are approved with modifications (revisions required), must satisfy all conditions before January 21, 2019 or must comply with the Revised Common Rule.
- A Full-Board Study which is approved with conditions (revisions required), will have an approval date based on the date of the Full-Board Meeting when it was originally approved.
- Important Note:
The Pre 2018 Common Rule will still apply to studies sponsored by federal agencies that have not yet signed on to the Revised Common Rule (e.g., The Department of Justice (DOJ)).
Revised Common Rule Impact on Existing Studies
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. The Office of Research and Innovation continues to work with the WMU IRB on this process. Guidance on existing studies will be posted in the future.
Studies that must comply with the Revised Common Rule
“New” protocols (e.g., exempt, expedited, etc.) that are approved after the Revised Common Rule goes into effect on January 21, 2019 must comply with the New Revised Common Rule. Some change will reduce researchers’ burden and other requirements will increase research responsibilities.
Consent Form—Informational Element
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.
Exempt Categories Updated
New revised exempt categories and updated categories.
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.
Continuing Review Requirement Changes
Continuing IRB review may no longer be required for many minimal risks studies. To assist researchers approval letters will indicate what type of continuing review is required. The IRB will continue to send notification at 60 and 30 days for the continuing review or progress report.
The IRB is still required to conduct post approval monitoring and an annual Progress Report and Final Report will be required.
Post Approval Changes/Amendments/Modification
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.
Post-approval monitoring will continue 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 (e.g., Department of Justice, Department of Veterans Affairs, etc.)
- 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 Human Subject Protection Program or WMU IRB that may involve the following:
o Student-led research;
o Research involving non-WMU investigators;
o Research conducted internationally;
o Research including particularly vulnerable populations;
o Research involving additional regulatory oversight, such as a conflict of interest (COI) management plan;
o Research amendment or incident report revealing new findings that require additional oversight;
o Investigator that has had previous protocol deviations.
o Investigator that has had previous serious non-compliance or a pattern of non-serious non-compliance;