When is a protocol eligible for a 10-year approval?
While the revised federal regulations governing human subjects research (the 2018 Requirements), effective 1/21/2019, don’t require expiration dates for minimal risk, non-FDA-regulated research, CPHS has implemented a 10-year approval period for applicable studies in order to administratively track active vs non-active protocols.
Studies that are eligible for a 10-year approval period include those that:
- involve no more than minimal risk to participants (as defined by 45 CFR 46.102);
- are not supported by industry sponsors;
- are not subject to FDA oversight; or
- are not required to have more frequent review by CPHS, the *funding agency, or sponsor.
*The Principal Investigator is responsible for determining whether the funding agency (e.g. foundation) or sponsor requires a shorter approval period. This information should be included within the protocol to facilitate review.
When is a protocol not eligible for a 10-year approval?
The following DO NOT qualify for a 10-year approval period:
- research projects that CPHS determines are “greater than minimal risk” studies;
- research involving procedures, devices, or drugs subject to FDA oversight;
- any industry-sponsored research or studies with other individuals, or entities; or
- CPHS determines a shorter approval period is necessary, with justification documented.
What if my protocol is given a 10-year approval and later becomes ineligible?
If there is a change (e.g., addition of procedures, devices, or drugs subject to FDA regulations) to a protocol that causes it to become ineligible during the course of the 10-year approval, the PI must immediately submit a Continuing Review Application with an amendment to add the new procedures, devices, or drugs subject to FDA regulations or other relevant addition(s) that increase the level of risk. The CPHS will then review and issue a new approval letter with a shortened approval period, as appropriate.
What are other expectations?
Amendments: Investigators are still expected to modify and/or update their protocols through an amendment (or through the continuing review process if the protocol becomes ineligible for 10-year approval). This must be done in advance of implementing any change planned to the protocol (e.g., in procedures, design, personnel, subjects, sites, funding, recruitment or data collection materials, consent materials, etc.). It is the investigator’s responsibility to ensure that the protocol at all times accurately reflects the research study.
Reporting requirements: If there is an unanticipated problem involving risks to subjects or others, or a serious adverse event, it must be reported as usual. Likewise, any deviation from the approved protocol must also be reported.
Monitoring: CPHS/OPHS reserves the right at any time to monitor research processes and/or audit research records (e.g., consent forms) to ensure compliance with the 10-year approval period conditions.Other limitations: For collaborative studies that meet the 10-year approval criteria (mentioned above), and for which another institution relies on UCB for review, OPHS will notify the relying IRB of UCB’s 10-year approval policy. However, if this policy is deemed unacceptable by the relying IRB, then the collaborating institution or investigator may not rely on UCB for review of the study.