New Common Rule (IRB Regulations)
The Federal Policy for Protection of Human Research Subjects (also known as “The Common Rule”) codifies the processes for IRB review and approval of research with human subjects. Changes to the Common Rule will take effect on studies starting on or after January 21, 2019.
Expedited IRB Review
- There will be no continuing review of expedited research unless the IRB has a reason to require it and can justify that reason
- There will be no continuing review for projects conducting data analysis only
- Expedited categories of IRB review will be annually evaluated by the HHS Office for Human Research Protections
IRB Exempt Review Categories
New Informed Consent Elements
- New required element of consent required for collection of identifiable info or identifiable specimens. Whether or not identities are removed, the consent must state:
unspecified future research may occur without additional consent; or that the information or biospecimens will not be used for future research
- New required section of consent:
“key information” must be presented first with sufficient detail for subjects understanding of reasons to participate – a revised UTMB consent template will be provided
- For clinical trials, one IRB-approved consent form used to enroll participants for that specific trial must be posted on publicly available website. This must be a clean, unsigned consent form.
- Waiver of documentation of consent — new additional exception for subjects for whom signing documents is not the cultural norm
Consent Process Changes:
- A waiver of informed consent for the secondary use of identifiable private information/biospecimens (not covered by Broad Consent) must justify why the use of identifiers is necessary to carry out the research.
- Use of identifiable information/biospecimens to identify potential subjects (i.e., screening for recruitment purposes) is allowed without informed consent under certain circumstances. A waiver of consent will no longer be needed for these screening activities. Note: HIPAA requirements still apply.
- For federally-sponsored clinical trials, a clean, unsigned copy of the consent form must be posted to a "publicly available, federal website" (TBD) post-recruitment and no later than 60 days after the last study visit by any subject.
- The revised Common Rule includes an option that would allow institutions to obtain broad consent for the storage, maintenance, and secondary research use of identifiable private information and biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, UTMB is not pursuing broad consent at this time. Investigators can continue to use biospecimens that are coded or to seek waiver of consent for use of biospecimens with identifiers retained consistent with current practices.
Single IRB Review
- Single IRB review will be required for all federally funded cooperative research studies effective January 2020 (NIH will require single IRB review beginning Sept 2017)
- Reviewing IRB must be identified by funding department or agency or proposed by the lead institution
- See UTMB guidance on single IRB reviews for multi-site studies.
Continuing Review Changes
- Continuing Review no longer required* for:
- Research approved by expedited review
- Exempt research requiring limited IRB review
- Research interventions completed and only involving:
- Data analysis, including identifiable private information or identifiable biospecimens.
- Accessing follow-up clinical data from clinical care procedures
* IRB can override this default and conduct continuing review, but must justify and document the reason
Research Terms: New/Revised
- Activities deemed not to be research:
- Scholarly and journalistic activities
- Government functions with separately mandated protections
- Benign behavioral intervention: interactions that are brief harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing
- Clinical trial: research study in which human subjects are prospectively assigned to interventions to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
- Human subject: a living individual about whom an investigator conducting research obtains
- information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
- Interaction: communication or interpersonal contact
- Intervention: physical procedures/environmental manipulations by which information or biospecimen are gathered
- Legally Authorized Representative: individual/judicial/body authorized under applicable law to consent on behalf of prospective subject
- Vulnerable Subjects: vulnerable to coercion/undue influence