A blog provided by the CITI program
recently outlined some tips on how researchers can be prepared for the changes the Common Rule requirements will bring.
For those who still have the winter break blahs, as of January 20, 2020, the 2018 Common Rule requires most federally supported, non-exempt, human subjects research involving more than one institution to comply with the requirement for a sIRB to review the research. On November 12, 2019 OHRP clarified that the following research is exempt from the single IRB mandate:
- Cooperative research conducted or supported by HHS agencies other than the NIH, if an IRB approved the research before January 20, 2020; or
- Cooperative research conducted or supported by NIH if either the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020 or if the NIH exempted the research from its single IRB policy before January 20, 2020.
The hiccup, however, is that the the Office for Human Research Protections (OHRP) still has not formally clarified whether sIRB review will be required for human subjects involving more than one institution and for which an IRB conducted a limited IRB review for the research to qualify for exemption.
Key differences between exist between the NIH policy and the Common Rule. These are delineated in the table below:
|Applies only to human subjects research that the NIH either supports or conducts
||Applies to all research involving human subjects that is conducted, supported, or that is subject to the Common Rule
|Applies to multi-site studies where each site will conduct the same protocol
||Does not include a similar specification
So what tips can institutions and researchers look at to clear any confusion? The blog recommends the following:
All institutions regardless of role
- Ensure institutional policies reflect what is required in a reliance arrangement and how such arrangements will be documented.
- Identify who can make decisions on behalf of the institution to enter into reliance arrangements (either to cede IRB review or serve as a Reviewing IRB) and what information is required to make reliance decisions.
- Educate research teams on when sIRB is required, their roles and responsibilities related to reliance arrangements (including at the grant writing stage), and the process they need to follow to initiate reliance requests.
Institutions that serve as a Reviewing IRB
- Ensure policies address when the institution may serve as a Reviewing IRB for external institutions.
- Assess the capacity of the institution to serve as a Reviewing IRB and any limits on it (e.g., the type of study or number of sites involved).
- Identify the resources and processes required for the review of multi-site research, including what information is required for IRB review, how information relevant to IRB review will be collected from Relying Institutions and research teams, and how IRB determinations will be communicated to research teams and others.
- Ensure relevant policies and procedures are available to Relying Institutions and research teams (e.g., event-reporting requirements, expectations for submission of local vs. study-wide amendments, what local context information is required) and reflect that research teams may be external to the Reviewing IRB’s institution.
- Determine whether fees will be assessed for IRB review.
Institutions that may need to rely on an external IRB (i.e., Relying Institutions)
- Ensure policies address the potential that the institution may need to rely on an external IRB.
- Assess whether changes are required to processes and/or systems to collect information about studies that will be ceded to external IRBs, so that the institution can track its research portfolio.
- Identify point people to communicate with Reviewing IRBs on behalf of the institution (e.g., to provide local context information or regarding information or events that may affect the ceded review) and with research teams regarding the reliance arrangement.
- Ensure resources are in place to ensure compliance with the terms of a reliance agreement and IRB determinations, which could include personnel who can perform auditing functions.
- Identify and communicate to research teams any requirements beyond IRB approval that must be met before a study can begin (e.g., ancillary review committee approvals) and what information may need to be communicated to both the Reviewing IRB and to the local institution.
Investigators, researchers and staff can always contact the UTMB IRB office with questions and for guidance.