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The Department of Health and Human Services (DHHS) has incorporated changes to the Federal Policy for the Protection of Human Subjects (a.k.a. the “Revised Common Rule”), effective January 21, 2019, that will affect Institutional Review Board (IRB) protocols.
Click on the hyperlinks above for further details.
Expect to see the following for new studies on or after January 21, 2019:
1. Minor changes in the IRB application form.
A new version of the New Protocol Submission Form has been incorporated in IRBManager. If researchers are currently working on the old version of the form when the changes go into effect, the old version of the form may still be submitted; researchers will not need be required to transfer responses to a new version of the form.
2. Changes to the informed consent template
An updated informed consent guidance document will be available soon.
3. IRB policy updates
4. For collaborative studies, ORCI consultation with collaborating IRB(s) prior to protocol review in order to determine which institution will serve as the lead IRB.
Please contact the ORCI prior to filling out an application form when conducting collaborative human subjects research studies with external institutions.
The Office of Research Compliance and Integrity has worked with the Institutional Review Board Policy and Procedures Committee (IRBPPC) and university leadership to interpret the new Common Rule elements and update the University's policies, business processes, and protocol submission systems to accommodate the changes while continuing to protect its subjects.
Decisions made to date:
Effective for studies approved on or after January 21, 2019, Continuing Review will no longer be required for most studies that are approved under expedited review. Studies must be of no more than minimal risk and meet one of the Office of Human Research Protections Expedited Review Categories to be approved under expedited review. Removal of this requirement reduces administrative burden for the researchers and ORCI/IRB without impacting the human subject participants.
The IRB still retains the option of enforcing a continuing review requirement for expedited studies when warranted. Some reasons for choosing to enforce the requirement include, but are not limited to, the following:
Regardless of the Continuing Review requirement, expedited protocols will still be required to submit the following:
Effective January 21, 2019, the federally-defined exemption categories for human subjects research have been updated. Changes include the following:
A brief summary of the revised categories is provided below.
Exempt Category 1: Educational Exemption
Change: Studies involving possible "adverse effects" on student learning of the required educational content and/or the assessment of educators will no longer be allowed under the exemption.
Exempt Category 2: Surveys, Interviews, Educational Tests, and Observation of Public Behavior
Change: The scope is expanded to include collection of sensitive and identifiable data, including visual and auditory recordings. This exemption still does not allow for the following: interventions, collection of biospecimens, linking to additional personally-identifiable data, and research with minors (except for educational tests or some public observation). Limited IRB review is required for certain Category 2 studies.
Exempt Category 3: Benign Behavioral Intervention [New Category]
Change: This category permits data collection via a benign interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement. "Benign intervention" is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting impact. This exemption cannot be used for the following: research with minors, deception (unless prior agreement is obtained), physiological data collection methods (e.g., EEGs, wearable devices, blood pressure monitors), or linking to additional personally-identifiable data. Limited IRB review is required for certain Category 3 studies.
Exempt Category 4: Secondary Research (Identifiable Private Information/Biospecimens)
Change: The scope is expanded to include the following: prospective data review; maintenance of identifiers, if all study data is protected health information (PHI); and research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities.
Exempt Category 5: Public Benefit/Service Program Research (Federal Demonstration Projects)
Change: In order for this exemption to be applied, the project must be published on a federal website.
Exempt Category 6: Taste/Food Quality Evaluation & Consumer Acceptance
Exempt Categories 7 and 8: These new "Broad Consent" categories will not be utilized by GVSU.
Effective January 21, 2019, the requirements for informed consent have changed as follows:
These changes are intended to facilitate the participants' understanding of the proposed research and ensure they understand how their data and biospecimens may be used.
Any studies approved on or after January 21, 2019, must incorporate these informed consent changes, even if the protocol was under review (but not yet approved) prior to January 21, 2019.
The Key Information section should include the following, as applicable:
The level of detail required for the "Key Information" section will depend on the complexity of the project. Note that many social/behavioral science projects already implement this information, so including a "key information" section may be redundant. Further federal guidance is expected at a later date.
New Consent Elements
Consent Process Changes
Effective January 25, 2018, NIH-funded multi-site studies involving non-exempt human subjects research are required to employ a single IRB-of-Record (sIRB). This change was designed to avoid duplicate review by multiple IRBs. The NIH policy applies to domestic research only, where the same protocol is used at multiple sites within the study. The sIRB will handle IRB review functions only; local review processes (such as conflict of interest monitoring, training requirements, etc.) will continue to be under the oversight of the individual participating institutions. This policy applies to NIH grant applications (new, renewal, revision, resubmission) received on or after 1/25/18 and NIH contract solicitations issued on or after 1/25/18.
The decision to determine which institution will serve as the lead IRB will be made by ORCi in conjunction with the IRBs of the other site(s) involved in the study. Decisions are made on a case-by-case basis and must be designated in the NIH grant application. Therefore, GVSU PIs involved in multi-site NIH-funded studies need to contact ORCI during grant preparation. Factors influencing the decision include:
The sIRB requirement of the Revised Common Rule goes into effect on January 20, 2020. This will apply to all non-exempt collaborative human subjects research sponsored by other federal agencies following the Common Rule. (Prior to January 20, 2020, only the NIH is imposing the sIRB requirement.)
Check this website periodically for new information. We will continue to add information as it becomes available.