The new year brings big changes to National Institutes of Health policies on human subjects research, including s ingle IRB policy requirements, c linical trial being newly defined, and c ertificates of confidentiality. Click here for an overview video. 

The National Institutes of Health (NIH) has issued a policy on the use of a single Institutional Review Board (IRB) for multi-site research with the expectation that a single IRB (sIRB) of record will be used for the ethical review of NIH funded, multi-site, non-exempt human subjects research protocols. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.

What this means:

• In the NIH application/proposal for research funding, the applicant (PI) is expected to submit a plan describing the use of a single IRB to serve as IRB of record for all study sites

• The PI will need to select the sIRB. This can be pre-determined by the study sponsor or grant, established by prior arrangement (e.g. network central IRB) by the IRB from the lead PI's institution, or selected based on expertise in the study area (e.g. type of procedures to be performed or subject population). It is important that the PI discuss this with Sponsored Programs and Research Integrity at the proposal development stage of the proposal application.

• The PI needs to budget the costs associated with the sIRB as applicable.

For more information on applying the sIRB policy to your next NIH proposal, click here.

SMART IRB is a Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform designed to harmonize and streamline the IRB review process for multisite studies, while also ensuring a high level of protection for research participants. SMART IRB is funded by the National Center for Advancing Translational Sciences and is intended to serve as a roadmap for institutions to implement the National Institutes of Health requirement for sIRB policy compliance.  To learn more, click here .

In an effort for the NIH to improve clinical trial data collection and establish a process for using this data effectively, clinical trial policy changes have been implemented to ensure rigor, transparency and effectiveness of the US federally-funded clinical trial enterprise. To learn more, click here.

The Division of Research has formalized the process regarding Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) congruency and a 1:1 ratio of grant proposal to approved protocol application on federally funded projects. Please refer here for more information.

The long awaited program description for the Animal Research Protections Program was submitted to the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) by the Dec. 1 deadline. The next step toward accreditation will be a site visit by AAALAC Council Members in February. Stay tuned for updates. 

Research Integrity will continue to offer many training opportunities throughout the spring semester for:

Please refer to the training calendars available on our website to sign up for these valuable workshops. 

To view the latest interactive training video released from the federal Office of Research Integrity on how to avoid research misconduct, click here.

Recognizing the outstanding commitment of our committee members, Vice President for Research Dr. Daniel Flynn hosted a reception to recognize all the faculty, staff and community members who participate in the research compliance committees and training programs facilitated by the Division of Research. Research Integrity extends a special thank you to our 54 faculty, staff and community members who volunteer across five compliance committees and four-part instructional training program: