NEW CHANGES TO THE COMMON RULE
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.
Important Notes:
- The new regulations do not impact IRB studies approved prior to January 21, 2019.
- These changes required the Office of Research Compliance and Integrity (ORCI) to update the IRB application forms. Forms have been updated in OneAegis. If you started to complete the previous version of the submission form before that date, you may continue to use and submit it after January 21, 2019; researchers will NOT be required to transfer all of the application information to the new version of the form.
Major Regulatory Changes
- Continuing Review - Is no longer required for some studies which involve minimal risk. This includes studies in which the only remaining activity is the analysis of identifiable data/biospecimens or follow-up activities for clinical data.
- Exemptions - There are new categories and clarification of existing categories. “Limited IRB Review” is required for some categories; this review is a simplified version of the expedited review process.
- Informed Consent - There is a new section: “Key Elements”. Rearrangement of the content in the informed consent is designed to help subjects determine whether or not they wish to participate.
- Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (academic, commercial, or hospital-based) starting January 20, 2020.
Click on the hyperlinks above for further details.
University Policy and Procedural Changes
Expect to see the following for new studies on or after January 21, 2019:
- Minor changes in the IRB application form.
- A new version of the New Protocol Submission Form has been incorporated in OneAegis. 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.
- Changes to the informed consent template
- An updated informed consent guidance document will be available soon.
- IRB policy update
- 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.
Administrative Actions
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:
- Studies approved prior to January 21, 2019, must comply with the existing ("pre-2018 Common Rule") regulations; studies approved on or after January 21, 2019, must comply with the revised Common Rule regulations.
- The IRB may choose to transition non-exempt studies approved prior to January 21, 2019, to the revised Common Rule regulations in an effort to reduce administrative burden for the researchers. GVSU's decision whether or not to transition such eligible studies will be made at a later date, once additional guidance is released from the federal Office of Human Research Protections and the ramifications for transitioning studies can be fully understood.
- Exemptions: GVSU will not be implementing the optional self-determination of exempt review. Exempt determinations must still be made by ORCI/IRB.
- Broad Consent: GVSU will not be implementing the "Broad Consent" option of the informed consent process. Exemption categories 7 and 8, which rely upon Broad Consent, will also not be implemented.
- sIRB: ORCI/IRB will continue to assess whether GVSU will serve as the single IRB of record for collaborative studies or if GVSU will cede review to a collaborator's IRB.
Continuing Review Changes
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:
- The project is regulated by a sponsor that requires continuing review
- The project involves additional regulatory oversight, such as a conflict of interest management
- An amendment or adverse event report reveals new findings that require additional oversight
- The researcher(s) have had previous non-compliance incidents
Regardless of the Continuing Review requirement, expedited protocols will still be required to submit the following:
- An Amendment Request Form for any proposed change to the protocol
- A Reportable Event Form for protocol deviations, unanticipated problems, and/or serious adverse events
- A Closure Form at the end of the study
Exemption Changes
Effective January 21, 2019, the federally-defined exemption categories for human subjects research have been updated. Changes include the following:
- Modification to most existing exempt categories
- Expansion of scope to several existing categories
- Addition of new categories
- New "Limited IRB Review" category that will allow some studies that would previously have fallen under expedited review to now fall under exempt review. Limited IRB review is an additional level of review that is required for certain exempt studies to ensure privacy/confidentiality protections are adequately in place.
A complete description of exempt and expedited categories is available here.
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
Change: None
Exempt Categories 7 and 8: These new "Broad Consent" categories will not be utilized by GVSU.
Informed Consent Changes
Effective January 21, 2019, the requirements for informed consent have changed as follows:
- A "Key Information" section must be presented at the beginning of the consent form
- New consent form elements must be included, depending on the nature of the study
- Changes to waiver criteria and documentation
- A "Broad Consent" option for unspecified future use of identifiable data/biospecimens (Note: GVSU will not be implementing this optional feature of the revised regulations due to the burdensome tracking requirements required.)
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.
Key Information
The Key Information section should include the following, as applicable:
- A statement that the study involves research and participant is voluntary
- A summary of the research, including purpose, duration, and a list of procedures
- Reasonable foreseeable risks or discomforts
- Reasonable expected benefits
- Alternate procedures or course of treatment, if any
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
- For projects involving the collection of identifiable private information or identifiable biospecimens, the informed consent must include a statement indicating whether identifiers may be removed, and de-identified information or biospecimens may or may not be used or shared for future research.
- For projects involving the use of biospecimens, the informed consent must include a statement indicating whether biospecimens may be used for commercial profit, and the subject will share in that profit.
- For projects involving clinically relevant results, the informed consent must include a statement indicating whether the clinical results, including individual research results, will be returned to the subject, and if so, under what conditions.
- For projects involving whole genome sequencing, the informed consent must include a statement indicating that the research will or might include whole genome sequencing.
Consent Process Changes
- A waiver of informed consent for the secondary use of identifiable private information/biospecimens must justify why the use of identifiers is necessary to carry out the research.
- Informed consent is not required under certain circumstances where identifiable information/biospecimens is used to identify potential study participants (i.e,, screening for recruitment purposes). (HIPAA requirements still apply, however.)
- For federally-funded clinical trials, a copy of the consent form must be posted to a "publicly available, federal website" after recruitment and no later than 60 days after the last study visit by any participant. The website to be used for this process has not yet been announced.
Single IRB-of-Record (sIRB)
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 risk level of the study
- The primary awardee of the grant
- The number of sites involved
- The location(s) involved in recruitment
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.)