Collaborative Research refers to research where your research team consists of App State affiliated investigators, and investigators not affiliated with App State. These external investigators can be affiliated with an institution that has an FWA (like another University), or they may be unaffiliated. There may be additional collaborative research considerations for research in collaboration with tribes, or done internationally. This web page walks you through several different types of collaborative research, the process of IRB review and approval of collaborative research, and provides you with the documents and guidance necessary to get the ball rolling on your collaborative research submission! More information can be found in our Cooperative Research and sIRB SOP located here.
Please note that external investigators are only considered “engaged” with human subjects research if they are: interacting or intervening with subjects, obtaining informed consent (including being listed as a contact person on the consent form), or accessing identifiable information about participants. If your external investigator(s) are not doing any of those three things, they are not considered engaged in human subjects research and do not require a cooperative research request form, reliance agreement, or individual investigator agreement (IIA) to assist with the non-human subjects aspects of your research.
Reliance Agreements
A reliance agreement, also called an institutional authorization agreement (IAA), is a document that describes the responsibilities of the reviewing and relying IRBs involved in the agreement, and documents key study information linking the reliance agreement to the proposed research for record keeping.
Institutions enter into reliance agreements when one institution agrees to review the collaborative research application according to the federal regulations [45 CFR 46], and collaborating IRB(s) agree to rely on that review. You may need a reliance agreement if you plan to conduct non-exempt human subjects research with faculty from another institution with an FWA and that both you and the external investigator will be interacting or intervening with subjects, obtaining informed consent (including being listed as a contact person on the consent form), or accessing identifiable information about participants.
When an IRB agrees to review the proposed research on behalf of collaborating institutions, they are referred to as the IRB of record.
The reliance agreement is considered executed when it has been signed by the designated signatory officials at both the reviewing and relying institutions, and all required documentation has been received by the IRB staff at the reviewing institution (this might include CITI training certificates for all personnel involved in the study, a PDF of the approved protocol, and/or any study documents included in the initial application).
The first step in submitting a request for a reliance agreement to the App State IRB is to submit an application in Cayuse. Guidance on how to submit an initial application in Cayuse can be found here. If you are requesting for App State to rely on the review of another IRB, you are still required to submit an application in Cayuse Human Ethics.
After indicating that you will be engaged in collaborative non-exempt research in your Cayuse application, you can submit a Cooperative Research Request Form to the IRB Office via email at irb@appstate.edu. Please note that this form needs to be filled out completely and accurately in order for IRB staff to determine what kind of collaborative research agreement is appropriate for your proposed research. If you need any assistance filling out this form, or have any questions regarding initiating the process for the review of your collaborative research please email the IRB staff at irb@appstate.edu.
Our Cooperative Research Request Form is a required piece of documentation that will initiate one of several potential collaborative research agreements. The Cooperative Research Request Form can be accessed here. The purpose of this form is to describe the roles of both the App State PI and the external investigator in detail. This helps us determine if App State can serve as the IRB of record (or reviewing IRB) in a reliance agreement, if it is appropriate for App State to rely on an external IRB’s review in a reliance agreement, if you will need an IIA for an external investigator (see below for additional information about the IIA process), or if any additional considerations need to be made in the context of tribal or international research.
All researchers involved in collaborative research must have up-to-date CITI training completion certificates. You will upload these certificates directly to your Cayuse application where prompted.
IRB office staff will send you a pre-filled reliance agreement form when it is determined to be appropriate based on the information provided to us in your Cayuse application and Cooperative Research Request Form. If you think a reliance agreement will be necessary for your research, you can also pre-fill your own reliance agreement by downloading the templates here (Reviewing Template/Relying Template) .Please do not submit signed reliance agreements, as the IRB office staff must be the ones to obtain required signatures to execute the reliance agreement. IRB office staff will upload the executed reliance agreement to your Cayuse application when received.
The App State IRB does not currently participate in SMART IRB.
Acceptance of External Exemption Determinations
App State no longer enters into reliance agreements for exempt research. However, we are willing to accept an external institution’s exemption determination. If you are seeking to assist with a research project that has been determined to be exempt by an external institution, please follow these steps for requesting an exemption acceptance letter:
Submit an initial application Cayuse Human Ethics product that requests for App State to accept an external exemption determination.
When submitting this request, please answer “Yes” to the question that asks “Is this a multi-institutional study?” and indicate “No, another IRB Office has determined this project to be exempt, and I am asking Appalachian State to accept this exemption determination.” when asked if you are requesting for App State to serve as the IRB of Record.
Provide the exemption determination letter from the external institution where requested in the Cayuse application.
Provide a complete and accurate list in your Cayuse application of all App State personnel who will be conducting research procedures with human subjects. (Please note that anyone conducting research with human subjects must complete the required CITI Training).
Ensure that the reviewing institution (i.e. the institution who provided the exemption determination) is aware of the proposed involvement of App State personnel in the research.
IMPORTANT: You are not permitted to begin conducting exempt research procedures with human subjects until you have either (1) received an official exemption determination from App State or (2) received an official Letter of Acceptance of an Exemption Determination from App State. Conducting exempt research procedures in the absence of either of these determinations from App State constitutes noncompliance.
Individual Investigator Agreements
An Individual Investigator Agreement (IIA) is used when your research involves an external investigator that is not affiliated with an institution that has an FWA (like a University). Examples of this kind of external investigator could be a retired faculty member, a medical doctor, or a community member that you wish to involve in your research. Keep in mind, this external investigator will only need an IIA if they are: interacting or intervening with subjects, obtaining informed consent (including being listed as a contact person on the consent form), or accessing identifiable information about participants.
In order to initiate an IIA, you will indicate in your Cayuse application that you will be engaged in collaborative research with an individual(s) that is not affiliated with an institution that has an FWA. You will then upload a completed copy of the IIA form, including a signature from your external investigator to your Cayuse application. When filling out the IIA form, you must list the study number of the associated application(s) in Cayuse on the form (e.g. “HS-25-00”) or we will require you to submit a new IIA form with the required information included.
The IIA is considered executed when it has been signed by the external investigator, and all required documentation has been received by the App State IRB staff (this might include CITI training certificates for all external personnel involved in the study.)
Tribal Research
Additional steps and protections are often needed when conducting research in collaboration with American Indian or Alaska Native (AI/AN) communities and populations. This includes, but is not limited to, conducting research that targets members of these communities as participants or conducting any research procedures on tribal land, even if no one from the community will be engaged in human subjects research as an investigator. The Common Rule affirms that each tribe may have its own definition of research and its own set of research protections and laws that may have more restrictions than the Common Rule. Researchers must receive appropriate review and approvals from the tribe for their research.
At App State, Tribal IRB reviews supersede our review in instances where members of a tribe are participating in research and it will be up to them whether or not we need to be involved, enter into a reliance agreement, or perform the IRB review of this study. It is the study PI’s responsibility to obtain Tribal IRB approval prior to submitting an application in Cayuse for review by the App State IRB.
International Research
If you are conducting international research and there is no local IRB that will be reviewing the study, you may be required to include a Cultural Context Review as part of your IRB application.
A Cultural Context Review is the process of review of your study by an individual with knowledge of local community/ethical concerns and laws, subject population, institutional policies and values, along with the country's laws regarding human subjects research. It is the PI’s responsibility to furnish the IRB office with the name and contact information of an appropriate cultural context reviewer. It is also the PI’s responsibility to ensure timely execution of the cultural context review, which may mean following up with the cultural context reviewer, or furnishing contract information to the IRB office for an alternate cultural context reviewer if necessary. Please note that the cultural context reviewer for your research must be someone that does not have any affiliation with the research project you are planning to conduct.
Once the cultural context reviewer agrees to conduct a review of your study, you will send them a Cultural Context Review form, a PDF of your Cayuse application, and all study documents uploaded to your Cayuse Application.
The cultural context review is considered complete when the cultural context reviewer has completed their review of the study documents, the study PI sends the IRB office a completed cultural context review form, and all cultural context concerns are addressed by the PI in their Cayuse application.