UW Oshkosh IRB Revised Common Rule
The Department of Health and Human Services announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight. Implementation of the Revised Common Rule has been delayed for an additional 6 months. The new effective date is January 21st, 2019.
Changes to Exempt Research
Classroom research cannot adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.
New Use of identifiable information may be exempt if IRB conducts a Limited IRB review to determine that the research includes appropriate provisions for protecting privacy and confidentiality. Research involving benign behavioral interventions on adults; will likely result in the majority of currently-expedited social-behavioral-eduacational research being exempt. Secondary research use of information protected by HIPAA; will allow exempt review of retrospective and prospective chart reviews. No continuing review for exempt or expedited research (unless justified by IRB for limited IRB/expedited review) or full board research limited to long-term follow-up only or data analysis only New Exempt Categories may be viewed on IRB Forms page.
Exempt studies will still be reviewed by IRB members and trained IRB staff to make the IRB exempt determination. Some activities previously reviewed under expedited categories have been moved to exempt status; e.g., EXEMPT CATEGORY 3, which includes research involving benign behavioral intervention in conjunction with the collection of data from an adult (not minor) through verbal or written responses or audio-recoding; + may include deception if prospectively authorized by the participant
- There are no changes to the current expedited categories. Expedited Categories may be found on the IRB Forms page.
Removal of Continuing Review
Revisions of 2018 were created to reduce the administrative burden on investigators and IRBs where the burden does not provide additional protection of human subjects. Under the 2018 requirements: No continuing review will be required for: 1) Exempt or expedited research (unless requested & justified by IRB during Limited IRB/Expedited Review) OR 2) Full board research limited to long-term clinical care follow-up only or data analysis only (including identifiable data)
- Researchers will receive an annual check-in email outlining their ongoing responsibilities to the IRB but no formal IRB review will be required for research meeting the above criteria.
- Any changes to the study will require an IRB Modification Request Form and approval from IRB before implementation.
- Existing protocols approved prior to July 19, 2018, will be grandfathered into the old rules until the time of annual continuing review. At the time of continuing review, the IRB will transition the protocol to the new requirements, unless applying the 2018 Requirements will not provide benefit to investigators or subjects. Transitioning will be done a case-by-case basis.
Informed Consent Changes
New Key Information at Beginning of Consent
- Consent must begin with a concise and focused presentation of key information (e.g. statement that the project is research and that participation is voluntary, a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment).
- Should be written at an appropriate comprehension level to assist the participant in making a decision on why one may or may not choose to participate in the research.
New required elements of consent
Notice about possible future research use of information or biospecimens stripped of identifiers:
Notifying prospective subject that subjects’ information or biospecimens may be used for future research without additional consent; or will not be used for future research.
- Consent is not needed for data screening/prescreening.
- Must provide participants an opportunity to obtain a copy of the consent form, even for online studies.
- Post online the consent form for clinical trials supported by federal funding
Additional elements of consent (when applicable):
- Potential for commercial profit and sharing of profits with subjects.
- Whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions.
- For research involving biospecimens, whether the research will involve whole genome or exome sequencing.
- Secondary research use of identifiable private information for which consent is not needed (See Exempt Category 4).
The key information section and new elements of informed consent are included in the new UWO Informed Consent Template on the IRB Forms page.
Revised Clinical Trial Definition
Clinical Trial: “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.”
NIH funded studies meeting the definition of a clinical trial will have additional requirements, including posting the consent document and training in good clinical practices.
Cooperative Research & Single IRB
Requirement for Single IRB Review: All U.S. institutions engaged in federally funded collaborative research for the portion of the research conducted in the U.S. Implementation Date: January 20, 2020; NIH funded research has a single IRB effective date of January 25, 2018
- When more than a single IRB review is required by law.
- Whenever any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
CITI Program Training Updates
CITI Program will be updating all human research training modules effective on the implementation date (January 21, 2019).
- Current CITI training will be valid until it expires (3 years from date completed).
- When CITI refresher training is due, the revised human subjects course will automatically be assigned to researchers.
- Names of the courses will not be changing at this time.
- A specific course titled: Revised Common Rule Course is available to all faculty, staff, or students interested in learning more on the revisions to the human research regulations.
CITI Final Rule Overview Resources: https://about.citiprogram.org/en/final-rule-resources/
Resources on Common Rule Changes
External resources on Common Rule changes:
- HRP Consulting Group: Appendix A: Applicability of the Common Rule, Changes to FWA.
- HRP Consulting Group: Appendix C: Management of pre-existing studies
- SACHIRP Attachment A: Recommendations on Compliance Dates and Transition Provisions
- SACHIRP Attachment C: Recommendations for Broad Consent Guidance
- HRP Consulting Group: Appendix B: Broad Consent.
- CITI Final Rule Overview Resources: https://about.citiprogram.org/en/final-rule-resources/
- A list of helpful Q&A’s is available on OHRP’s website: www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html