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New Common Rule Updates
Federal Regulations: WVU Implementation
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 research projects approved on or after January 21, 2019.
Exempt IRB Review
To qualify for review at the exempt level, the research must not be greater than minimal risk* and must fall into one or more of the exemption categories.
*Minimal risk is defined by the federal regulations ( 45 CFR 46) as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Expedited IRB Review
Expedited review categories remain unchanged however, the requirements of expedited research have been updated:
- No continuing review of expedited research unless the IRB has a reason to require it and can justify that reason
- 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
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;
- that the information or biospecimens will not be used for future research
- unspecified future research may occur without additional consent;
- New required section of consent:
- “Key information” must be presented first with sufficient detail for subjects understanding of reasons to participate – a revised WVU consent template will be provided.
- For clinical trials supported by federal funding, one IRB‐approved consent form used to enroll participants must be posted on publicly available website.
- Waiver of documentation of consent — new additional exception for subjects for whom signing documents is not the cultural norm.
Single IRB Review
- Single IRB review will be required for all federally funded, cooperative research studies effective January 2020 (NIH already requires single IRB review)
- Reviewing IRB must be identified by funding department or agency or proposed by the lead institution
Continuing Review no longer required* under federal mandate 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.
Expedited reviews for WVU studies will be every two (2) years.
Exempt reviews will be every five (5) years.
Several frequently used terms have been newly codified or 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
information or biospecimens through intervention or interaction with the individual,
and uses, studies, or analyzes the information or biospecimens;
- uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or 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:
- now those vulnerable to coercion/undue influence, and
- “individuals with impaired decision-making ability” replaces “mentally disabled persons”
Special thanks to the University of Southern California Office for the Protection of Research Subjects for sharing their content.