Collaborative, Multi-site Research, Reliance and Single IRB Agreements
The Virginia Tech Human Subjects Research Protection Program (HRPP) and the Institutional Review Board (IRB) are committed to ensuring the safety and protecting the rights of human subjects participating in research conducted by faculty, staff, students, and affiliates of the University.
To streamline the facilitate timely review of human subjects research protocols and to implement the new requirements for single IRB review of multisite projects, Virginia Tech has a few options to facilitate reviews.
What is collaborative research?
Collaborative research is when two or more institutions coordinate, with each institution completing a portion of the research activities outlined in the research protocol.
What is multi-site research?
Multi-site research is when two or more institutions coordinate or collaborate, with each institution completing all research activities outlined in the research protocol.
What are reliance and Single IRB (sIRB) agreements?
These agreements allow an institution to rely (sometimes referred to as “cede”) on another IRB for review and approval of research. These agreements help streamline the review process and allow institutions to comply with the revised Common Rule cooperative research provision and the NIH Single IRB policy which mandate sIRB review of cooperative or multi-site research.
Notes
- These agreements only apply to nonexempt human subjects research. Virginia Tech does not enter into reliance or sIRB agreements for research that has been determined to be exempt.
- Virginia Tech has special agreements in place with Carilion Clinic and Edward Via College of Osteopathic Medicine. If you are collaborating with one of these institutions please send an inquiry to irb@vt.edu to get instructions on how to proceed.
How to request a Reliance or sIRB agreement?
If Virginia Tech is not the lead institution on the research or if it has been determined that another IRB will serve as the reviewing IRB, Virginia Tech may agree to rely on another IRB. Researchers should complete HRP-1814, Request to Rely on an External IRB and submit the completed form along with any supporting documents (see form for details) and submit to irb@vt.edu
If Virginia Tech is the lead institution on the research or if it has been determined that the Virginia Tech IRB will serve as the reviewing IRB, the researcher should advise the collaborating institution(s) to complete HRP-1812, Local Context - Virginia Tech IRB of Record. The completed form should be uploaded in the supporting documents section of protocol management.
Virginia Tech is a participating institution. SMART IRB is a platform that was designed to streamline the requirements of initiating multi-site research. It is a master reliance agreement that facilitates the authorization agreement process between participating institutions. A list of participating institutions can be found on the SMART IRB website.
If the collaborating institution is part of SMART IRB please make sure the institution's SMART IRB point of contact’s information (name, email, and phone number) is included in the HRP-1812 or HRP-1814. Do not use the SMART IRB Online Reliance System to submit the request.
The completed form should be emailed to irb@vt.edu or submitted in protocol management.
If a researcher is collaborating with an independent investigator, who is not employed by an institution that has a Federalwide Assurance (FWA) or who is employed by an institution that has an FWA but is not acting as an employee of the institution with respect to their involvement in the search, the researcher may request an individual investigator agreement by completing HRP-1855, Request for Individual Investigator Agreement, and submitting in protocol
Virginia Tech has a contract with a commercial IRB. The commercial IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The requirements for use of the commercial IRB have changed. To determine if your research should be reviewed by the commercial IRB please send an inquiry to irb@vt.edu before submitting a request in protocol management.
More information can be obtained by contacting the HRPP office.