NIH single IRB policy - Update
The NIH single IRB (sIRB) policy, which requires all sites participating in human subjects research funded by NIH to utilize a centralized sIRB, will be effective January 2018. The policy requires that new grant applications to NIH submitted on or after this date include a plan for use of a sIRB, including identification of the sIRB, relying site agreement to utilize the sIRB, and a plan for communication between the sIRB and the relying sites. The HSO is continuing to assess the impact of the policy and to draft procedures and processes for local implementation of sIRB review, both for studies impacted by the NIH policy and studies for which sponsors and funding agencies other than NIH are requesting sIRB review. If you are planning for an NIH proposal which will be submitted after January 25, 2018 or have questions about potential reliance on an external IRB, please contact Amy Waltz at firstname.lastname@example.org.
HSO continues to receive questions about requesting the IU IRBs provide IRB review for external performance sites and serve as the central IRB for multi-site studies. It’s important to remember that the IU PI and study team would need to be responsible for collecting the required IRB information from external sites and investigators, compiling it for the IU IRB, making IRB submissions on behalf of sites and investigators, and communicating IRB decisions and approved documents back to the sites and investigators. Many study teams aren’t fully prepared to handle this level of coordination and communication, so HSO asks that you contact the HSO reliance team before offering to utilize the IU IRBs for multiple sites.
HSO update – Revised Common Rule
On January 19, 2017, the Department of Health and Human Services published revised regulations on the protection of human subjects in research, known as the Common Rule. Read the previous announcement, which includes an overview of the proposed changes and the HSO’s response. The revised regulations are effective January 19, 2018.
Over the past months, HSO has been taking positive steps to prepare for implementation of the revised Common Rule and has convened several working groups to obtain input from the research community during the process – see below. More specific information regarding implementation of the revised Common Rule will be available throughout the fall and winter of 2017.
The new Common Rule focuses largely on reducing administrative burdens, especially those that do not offer additional protection for human subjects, and tries to better align administrative requirements with the level of risk of the research. A few important changes to note:
- Several categories of research which previously required expedited IRB review will now be considered exempt from the regulations. Exempt research must be conducted in accordance with ethical guidelines but isn’t subject to the same, formal IRB review and informed consent requirements as expedited and full board research. Exempt research is submitted to HSO via a much shorter application and does not require ongoing review, with the exception of substantive changes to the research. The new Common Rule allows for exempt review of several areas of research which were previously subject to expedited IRB review, including: research with benign behavioral interventions which meet certain criteria; secondary research use of information/biospecimens protected by HIPAA, e.g. retrospective and prospective chart reviews; and use of identifiable information which meets certain criteria even when disclosure could place subjects at some additional risk.
- Annual or ongoing renewal will no longer be required for expedited research, or for research which is greater than minimal risk research but continuing only for long-term follow-up or data analysis. Investigators will still be required to request prospective IRB approval before making changes to expedited and full Board research; however, formal annual review will only be required for research which is FDA-regulated, greater than minimal risk and continuing to intervene with subjects, or expedited research which the IRB reviewer specifically requests renewal on a case-by-case basis. For research not requiring annual or ongoing renewal, IU investigators will receive an automatic annual notification for all research projects which are open with the IU IRB, reminding them of ongoing responsibilities to the IRB and requesting that the study be closed when completed.
- The informed consent process and template will include new requirements. Most importantly, informed consent must begin with a concise and focused presentation of key information which potential participants need in order to make a decision about whether to participate in the research. Generally, this information will include a statement that the project is research and that participation is voluntary, and a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment. This information will be outlined in a short summary of the research which will be added to the informed consent template and made available to researchers in late October. Informed consent documents which are already concise will not need to utilize the specific template and there will be no requirement to reconsent previously-enrolled subjects.
In addition to the concise and focused presentation, several new elements must be included in the informed consent template. Some of these elements are already commonly included in IU consent documents, and the revised informed consent template will include these new elements for consistency.
The new regulations also revise the criteria to be met before the IRB can approve a waiver of the entire informed consent process. Many of the studies which currently require a waiver of consent will be considered exempt under the new regulations, so this change is unlikely to have a significant impact on the conduct of research.
- “Broad consent” is allowable under the new Rule but will be implemented at a later date. The revised Common Rule includes a new provision for obtaining informed consent for certain research. This provision, called broad consent, allows subjects to consent to the storage, maintenance, and use of their information and biospecimens for future research purposes on a shorter, more specific informed consent template. While the term “broad consent” implies a consent to future unspecified use, the regulations require that subjects be given a description of the research which would help them reasonably understand how their information and biospecimens will be used. Practically, this requirement means that the new consent provision is really consent to future, specific use. Declining broad consent has consequences for future use of subjects’ information and biospecimens for other research purposes. As such, use of this provision requires significant implementation and tracking mechanisms which are still being defined. The IU Human Research Protection Program will continue to address these challenges and implement the broad consent provisions sometime after the initial effective date, after IU and its affiliates have had a chance to consider the implications comprehensively. Consent to future use will continue to be allowable via the traditional informed consent mechanism.
The revised regulations are effective January 19, 2018. Any research approved after that date will be subject to the new regulations and requirements. HSO is still defining what impact, if any, the new regulations will have on previously-approved research and whether the investigators conducting those research studies will be able to take advantage of the reduced administrative requirements. More specific details will be available shortly.
What to Expect
HSO staff has spent the past few months analyzing the new rule and its impacts and making decisions about how to implement the changes, with feedback from the IRB Executive Committee, HRPP Advisory Committee, and consent working group. More specific information about the transition, including how the changes will affect previously-approved research and changes to KC IRB will be communicated beginning in November 2017. Training sessions on the revised Common Rule will be available throughout January and February 2018. Please feel free to contact the HSO at email@example.com to schedule a department-specific training for your group today.
Changes to NIH Policy on Certificates of Confidentiality
The NIH recently issued a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality. A Certificate of Confidentiality (CoC) helps researchers protect the confidentiality of human subjects enrolled in research by limiting disclosure of identifying information through otherwise-compulsory legal demands, such as court orders and subpoenas. Under the previous policy, investigators conducting potentially sensitive research could request a CoC from the NIH. Effective October 1, 2017, CoCs will automatically be issued for all applicable NIH-funded research.
Under the revised policy, CoCs will automatically be granted to all NIH-funded biomedical, behavioral, clinical or other research commenced on or after December 13, 2016, in which identifiable, sensitive information is being used or collected. This includes:
- Human subjects research unless information is recorded in a way that subjects cannot be identified; or
- Research involving the collection or use of identifiable information or biospecimens, or information or biospecimens for which there is a small risk that some combination of the biospecimens, a request for the biospecimens, and other identifiable data sources could be used to determine the identity of an individual; or
- Research involving the generation of individual level, human genomic data.
For investigators who are conducting non-federally funded research and wish to obtain a CoC, the NIH will continue to consider requests for specific projects in accordance with the current policy.
When Can Information Be Disclosed?
The new Policy allows disclosures when:
- Required by federal, state, or local laws (e.g., state laws requiring the reporting of communicable diseases to state and local health departments), EXCEPT instances of disclosure in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding; or
- Made with the individual’s consent;
- Necessary for the individual’s medical treatment;
- Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.
What Does This Mean for Study Teams?
It’s important for researchers subject to the new policy to carefully protect subjects’ identifiable information in accordance with the automatically-granted CoCs. In addition, the NIH policy requires that research subjects participating in studies protected by CoCs be provided with information about those protections. Research studies with previously-granted CoCs should already have the required language included in current consent forms. If you are conducting NIH-funded research which may be granted a CoC under the policy (e.g. almost all NIH-funded research begun after December 13, 2016), please contact HSO to determine appropriate steps for updating your IRB-approved documents.
More information on CoCs is available on the NIH CoC FAQs webpage. Specific information regarding CoCs for IU research is coming soon to the HSO website.