The Federal Policy for Protection of Human Research Subjects, also known as “The Common Rule”, defines the processes for IRB review and approval of research with human subjects.
The New Common Rule applies to studies starting on or after January 21, 2019.
USC Implementation of the New Common Rule
- Studies under IRB review or and studies in the iStar queue on Jan 21, 2019 must be approved according to the New Rule
- Submissions on or after Jan 21 must comply with the New Rule (iStar will reflect the New Rule requirements)
- At Continuing Review the IRB reviewer will have an option to apply the New Rule so that Continuing Review would no longer be required
- FDA-regulated studies (research involving investigational drugs, devices, or biologics) must undergo Continuing Review as required by FDA even though it is not required by the Common Rule.
CHANGES TO IRB REQUIREMENTS
*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
The 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 USC 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 (sIRB) Review
- Under the New Common Rule, Single IRB review means one IRB reviews for all participating sites in U.S.
- FDA no longer requires local IRB review of device trials
- sIRB Review is required for multisite research funded by:
- NIH -effective January 25, 2018
- HHS -effective January 2020
- The reviewing IRB must be identified by funding department or agency or proposed by the lead institution
Continuing Review no longer required* for:
- Research approved by expedited review
- Research that is not FDA regulated, interventions have concluded, and the study is only:
- Analyzing data, 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
Changes to Research with Biospecimens
- The federal definition of “Human subject” has been revised to include “an individual from whom an identifiable biospecimen was obtained”. The term “biospecimens” has been added in several places where the regulations previously refered to “information/data”.
- Consents must ainform subjects whether:
- their biospecimens/data will be used for future research
- the research will include whole genome sequencing
- Research with identifiable biospecimens may be approved if:
- consent is waived or;
- researcher uses data for which broad consent was obtained
- Research with nonidentifiable biospecimens may be approved as:
- Exempt 4 (specimens were obtained for some other primary purpose)
- Expedited 2 (venipuncture), 3 (noninvasive biospecimen collection), or Full Board
Research Terms: New/Revised
Several frequently used terms have been newly codified or revised:
- Human subject: a living individual about whom an investigator conducting research obtains
(1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
(2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
- Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- Activities deemed not to be research:
- Scholarly and journalistic activities
- Government functions with separately mandated protections
- 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.
- Legally Authorized Representative: individual/judicial/body authorized under applicable law to consent on behalf of prospective subject
- 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
- Interaction: communication or interpersonal contact
- Intervention: physical procedures/environmental manipulations by which information or biospecimen are gathered
- Private information: information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Identifiable private information: private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- identifiable biospecimen: a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
- Vulnerable Subjects: vulnerable to coercion/undue influence
Resources for IRB Review: New Common Rule
- Exempt Review Decision Tree | University of Michigan
- New Rule Exempt – Review Checklist | USC
- New Rule Exempt – Review Checklist | WIRB
- Waiver of Consent – Reviewer Checklist | WIRB
- Waiver of Documentation of Consent – Reviewer Checklist | WIRB
- Unexpected Incarceration – Reviewer Checklist | WIRB
- Pregnant Women in Research – Reviewer Checklist | WIRB
- Tip Sheet: Exempt 1 – Education Research | University of Michigan
- Tip Sheet: Exempt 2 – Surveys, interviews, educational tests, and observations of public behavior exemption | University of Michigan
- Tip Sheet: Exempt 3 – Benign behavioral intervention| University of Michigan
- HIPAA Exemption – Interpretation and Application | HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP)