Collaborative Research and IRB Reliance

Collaborative research has become more prevalent and researchers are increasingly working across multiple sites and institutions to support complex research projects. When conducting collaborative or multi-site research involving human subjects, it is the investigator’s responsibility to contact their institution’s institutional review board (IRB) office to determine which IRB will have oversight of their research.

This means that as an employee or agent of Texas A&M University, you are required to contact the TAMU HRPP prior to initiating or engaging in any human subjects research activities, regardless of where the research is taking place.

Importantly, even if your collaborative partner has already received IRB approval from their institution, you are still required to contact the TAMU HRPP office prior to initiating or engaging in any human subjects research activities.

1) Why do I need to contact the TAMU IRB office if the research is being conducted at another institution?

Texas A&M is still responsible for research conducted by its employees and agents, including faculty, staff, and students. These obligations include, but are not limited to, ensuring that the Texas A&M’s employees and agents are qualified to conduct the research activities as delegated, maintain compliance with research protocols, and meet sponsor and federal reporting requirements, including the need for reliance agreements.

This is true even if the research is being conducted at another institution. In order for Texas A&M to meet these obligations, it is imperative that all TAMU employees and agents contact the TAMU HRPP office before initiating or engaging in human subjects research, regardless of where the research is taking place, and obtain documentation that the TAMU HRPP has evaluated and acknowledged the research activities taking place at an external institution.

2) Do I still need to contact the TAMU IRB if my collaborator has already received IRB approval?

Yes. Texas A&M is still responsible for its investigators and reserves the right to determine on an individual study basis whether or not to cede IRB review to another qualified institution. This determination is solely made by the institution and is not under the discretion of the investigator.

If you are conducting collaborative, non-exempt (i.e., Expedited or Full Board) research involving human subjects with an institution that has a federalwide assurance (FWA), it maybe possible to establish a reliance agreement allowing one institution to rely on IRB review conducted by the other institution.

3) What if I am credentialed or have privileges including adjunct status at another institution, do I still need to contact the TAMU HRPP?

Yes. If you are conducting research on behalf of or as an agent (faculty, staff or student) of TAMU, then you are required to contact the TAMU HRPP office before engaging in research at another institution. If you are employed at both TAMU and another institution where you are performing research, it is important to know which institution(s) you are engaging.

4) What is a reliance agreement?

A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in human subjects research to delegate review to another qualified IRB. This helps avoid duplicative review and streamlines the review process across research sites. The reliance agreement delineates the responsibilities of both the relying and reviewing institutions, as it pertains to the review, reporting, and oversight of the research. Reliance agreements are subject to federal review upon request.

Every institution engaged in the research reserves the right to enter or decline participation into a reliance agreement on a case-by-case basis. For this reason, it is imperative that you work with your collaborator to see if they have obtained permission from their institution to enter into a reliance agreement and identify what additional steps, if any, are required.

5) How do I request a reliance agreement?

The first step in the reliance agreement process is to contact your IRB Coordinator. Your IRB coordinator will help you identify if a reliance agreement is appropriate for your collaborative or multi-site project. Please understand that not all reliance requests can be granted, and failure to contact your IRB coordinator early in the planning stages may lead to major and costly delays.

In assessing whether the TAMU IRB is willing to cede review to an external IRB, your IRB coordinator will gather information and/or send forms to the external IRB to determine if the external IRB meets the requirements for reliance such as but not limited to registration with the Office for Human Research Protections (OHRP) and maintaining an approved OHRP Federal Wide Assurance (FWA).

Research determined to be Exempt, not involving human subjects research, or TAMU is found to not be engaged in the research will not be considered for a reliance agreement, unless the sponsor requires it or there are special conditions that necessitate it. Additional considerations for relying on an external IRB may be found here.

6) Is there a preferred method of establishing IRB reliance agreements?

Yes. The TAMU HRPP prefers to use the SMART IRB national reliance platform to manage IRB reliance agreements. SMART IRB is a free online reliance system available to all domestic institutions that maintain an OHRP approved FWA. Currently, there are over 1100 institutions that use the SMART IRB Master Common Reciprocal IRB Agreement process. Collaborators are encouraged to complete the joinder agreements necessary for participation. Go to SMART IRB | National IRB Reliance Initiative to see if your collaborators belong to SMART IRB. You can also locate a useful walkthrough video that gives an overview of the decision making process and how to submit a request for a reliance in SMART IRB.  

7) What if I want TAMU to be the reviewing IRB for a collaborative or multi-site project?

The TAMU IRB may provide reviewing oversight for federally funded, non-exempt research where TAMU is listed as the prime awardee of the grant, but some conditions may apply. Regardless of the funding type, the researcher is encouraged to contact their IRB Coordinator before submitting a new IRB application, preparing a grant submission, or entering into a contract that proposes TAMU as the IRB of record for a multi-site or collaborative project.  In such situations, the TAMU HRPP will evaluate on a case-by-case basis if the TAMU IRB can adequately support or oversee the research based on the complexity of the protocol, the number of active research sites, and the availability of institutional resources. In some cases, the TAMU HRPP may suggest the use of a commercial IRB which will affect the study budget.

8) What if I already have TAMU IRB approval, and I want to add additional sites or institutions?

You may submit a request to have the TAMU IRB serve as the IRB of record for a multi-site or collaborate project. Your request must be submitted as a modification to your existing and approved research protocol. Your request must include the scope of work for each participating site and/or institution. Based on the information you provide, TAMU IRB will determine if there exists adequate resources and justification for the agreement to be carried out.

Please be aware that collaborating institutions often require that the local research team submit to their IRB a request to enter into a reliance agreement with an external IRB (in this case, TAMU). In order to avoid costly delays, it is important that you and your collaborators reach out to all IRBs involved in the proposed research early in the planning stages to identify what submission requirements must be satisfied in order to establish a reliance agreement.

9) How long does it take for a reliance agreement to be approved?

Every case is different and there are many factors that influence how long it takes for institutions to reach a reliance agreement. To help ensure that your project does not encounter major roadblocks that may significantly delay your approval, it is important that you contact your IRB Coordinator early in the planning stages. Your IRB coordinator will advise you on the feasibility of establishing a reliance agreement for your project and the steps necessary for initiating the reliance agreement process.

Investigators should understand that each institution involved in the reliance process will have their own requirements to follow. The TAMU IRB has no control over another institution’s reliance process

10) What if my research is Exempt?

TAMU IRB typically restricts reliance agreements to non-exempt human subjects research. If you are joining research that has already been deemed exempt elsewhere, you are encouraged to contact your IRB Coordinator to inquire about ways to streamline the IRB application process.

11) Is establishing an IRB reliance agreement for external IRB review faster than going through the TAMU IRB?

No, not in all cases. There may be times when establishing a reliance agreement with an external IRB is faster, especially if the study is already approved but in many cases it may take longer to because of the complexity of working with two IRB administrations instead of one. Although, only one of the IRBs will perform the ethical review portion of the approval process, both institutions must ensure their requirements are met by sending the research through an administrative review process.