Federal Regulation 45 CFR 46 “Protection of Human Subjects”, referred to as the ‘Common Rule’, is an anchor regulatory text on which investigators and IRBs rely and must comply to protect human subjects in research.
The U.S. Department of Health and Human Services (HHS) has issued revisions to the Common Rule that will become effective on January 21, 2019.
The listing of “key changes” are outlined below. Please also see the “what to expect” section below.
Major Upcoming Regulation Changes (Effective January 21, 2019)
- Exemption Category #1:
- The following restriction has been added: “Not likely to adversely impact student’s opportunity to learn required education content, or assessment of educators who provide instruction.”
- Exemption Category #2:
- Expanded to allow identifiable information (even if sensitive) to be recorded, provided that an IRB member conducts a limited review.
- Exemption Category #3:
- New category for benign behavioral interventions.
- Must be brief in duration (no more than 3 hours in total), harmless, painless, not physically invasive, no significant adverse lasting impact, and nothing offensive or embarrassing.
- Allows for identifiable information (even if sensitive) to be recorded, provided that an IRB member conducts a limited review.
- This category does not include research w/ minors.
- Exemption Category #4:
- Expanded to include prospective data review (no longer limited to existing data only).
- Exemption Category #5:
- Restriction added indicating that the project must be published on a federal website.
- Learn more about Exempt Review.
- Expedited Protocols:
- Annual renewals will no longer be required for protocols that were approved under the Expedited Review process (with the exception of FDA regulated studies).
- Investigators will now be required to renew their Expedited protocols every 3 years.
- Expedited and Full Board Protocols:
- Continuing review will no longer be required for protocols that have progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care
- See more about Managing an FIU IRB Approved Project.
- The consent process will need to begin with a concise summary of essential study info that individuals would want to know in order to make an informed decision about participation.
- The consent form will need to disclose any plans to conduct future research using info and/or biospecimens collected during the research.
- When applicable, consent form will need to 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.
- Access the Revised Consent Form Templates.
- The clinical trial definition has been expanded: “Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes”. (This is the same definition used by NIH)
- For each federally funded clinical trial, one IRB-approved informed consent form used to enroll subjects must be posted to ClinicalTrials.gov or to a docket folder on Regulations.gov (docket ID: HHS-OPHS-2018-0021). The informed consent form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
- Learn more about the Clinical Trial Requirements.
Activities No Longer Considered Research
- Scholarly and journalistic activities that focus directly on specific individuals (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship) will not require IRB approval.
- Note: It is not the particular field that removes the activity from the definition of research, but rather that the purpose and design of the particular activity is to focus on specific individuals only.
- Learn more about Determining if IRB Approval is Needed.
Single IRB-of-Record (sIRB)
- As of January 25, 2018, all NIH-funded multi-site research must rely on a single IRB-of-Record (sIRB) for review.
- As of January 19, 2020 all multi-site research that is federally funded—not just NIH-funded—must rely on a single IRB-of Record for review.
- Learn more about Single IRB Review.
What to Expect
Freeze on New Submissions
The revisions to prepare for all of the new regulatory requirements will require considerable preparation from the Office of Research Integrity (ORI). To facilitate a smooth transition, there will be a freeze period from January 2, 2019 – January 20, 2019 on all new protocol submissions.
During this freeze period, the IRB Original Form, IRB Amendment Form, IRB Renewal Form, and IRB Event Form will be temporarily disabled in the TOPAZ system. We ask investigators to utilize this time period to work towards finalizing any pending submissions that are currently under review.
Requests to submit a new application during the freeze period will only be granted in rare cases relating to funding deadlines.
Unless you absolutely need to start your research right away, it would be best for you to wait and submit your protocol on or after January 20th, to avoid confusion during the review and to take advantage of new regulations and procedures that may mean less work for you. If you are concerned about the timing of a particular submission, please contact ORI staff and we’ll be happy to help you figure out the best way forward.
Investigators with protocols that are in draft form (i.e., have never been submitted to the IRB) will need to submit those applications on or before January 1, 2019. The Office of Research Integrity will not be accepting new submissions that utilize an older version of the IRB application form after this date.
Projects that have been submitted to the IRB, but have not received final approval are considered as “pending”. All pending submissions need IRB approval by January 16, 2019. If a pending submission does not receive IRB approval by January 16, 2019, then it will need to be withdrawn and resubmitted on the latest version of the IRB approval form (to comply with the new regulatory requirements).
Projects Due for Renewal in January/February 2019
Investigators with protocols expiring during the months of January or February 2019 will need to submit their IRB renewals early to help avoid any lapses in their IRB approvals.
Existing IRB Approved Projects
All active Expedited or Full Board projects that were previously approved (on or before 01/20/19) will be transitioned to the new Revised Common Rule regulatory requirements at the time of the project’s next renewal submission.
If the project is still actively enrolling participants at the time of renewal, the PI will be required to switch to the new Informed Consent Form Templates that comply with the Revised Common Rule changes.
Until this transition has occurred, existing active Expedited and Full Board studies will need to continue operating under the old regulatory requirements.
Existing IRB Exempt Projects
All active Exempt projects that were previously deemed as exempt (on or before 01/20/19) will not be transitioned to the new Revised Common Rule regulatory requirements. These projects will continue to operate under the old regulatory requirements for the life of the project.