In accordance with 45 CFR 46.114, any institution covered by this policy that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The information provided on determining engagement is based on OHRP's detailed guidance. A determination of institutional or organizational engagement for cooperative research may indicate the necessity for establishing a Reliance Agreement.
Definition: The Revised Common Rule single IRB mandate defines cooperative research as projects located in the United States that involve more than one institution with the exception of those where more than single IRB review is required by law (tribal law, VA) or research not subject to the regulations (Exempt). To note, in order to be considered cooperative research, research activities need to be operating on the same overall study aims and hypothesis under a single protocol but do not need to be conducting the same specific research activities at each site.
There are three basic components for considering whether an institution is engaged
Will researchers be involved in participant interactions, such as screening for eligibility, consenting, conducting surveys or administering interventions?
Access to identifiable data
Will researchers have access to identifiable data? Important to remember here is that this includes biospecimens and that recordings are considered identifiable.
Is the institution/organization the prime awardee or is the affiliated Investigator named as an MPI on the grant? The prime awardee or MPI is considered to hold "parental rights" to all data collected for the project. Researchers may not be interacting with the participants or planning to view any of the identifiers associated with the research but as the “parent” you have intrinsic rights that would allow access.
There are certain situations where it may seem that an institution or organization is engaged but they actually are not.
Institutions or agencies that perform commercial or other services for investigators are not considered engaged provided that the services do not merit professional recognition or publication privileges, the services are typically performed for non-research purposes, and the institution or agency doesn’t administer any study interventions.
Submissions including a commercial entity will be reviewed by the IRB/HRPP to determine engagement. Determinations will be considered for each protocol on an individual basis. The following criteria must be met for a commercial entity to be considered NOT engaged in the research:
- The commercial entity must have established procedures for both staff training and confidentiality measures in human subjects research.
- The commercial entity does not retain research data. Any data collected on behalf of the research study will be destroyed upon transference to the investigator.
- The commercial entity must utilize research materials (i.e. informed consent documents, recruitment materials) approved by Brown's IRB for the associated protocol.
* Examples that meet this condition would include transcription services, survey firms or lab services (blood or urine analysis), MRI & X-Ray. The use of Brown’s fMRI facility alone does not engage Brown in the research.
Routine clinical services
Institutions or agencies that provide clinical trial-related medical services that would typically be performed as part of routine clinical monitoring or follow-up provided that the institution or agency doesn’t recruit or consent, the institution or agency doesn’t administer any study interventions, and the study investigator retains responsibility.
* These are generally health-related services that may be included in the research but are part of a participant’s routine care. Examples of this might also be blood work or a physical exam, X-Rays, CT scans.
Institutions or agencies that administer the study interventions limited to a one time or short term basis provided that it would be in the participant’s best interest, the institution or agency doesn’t recruit or consent, the study investigator retains responsibility, and the overseeing IRB is informed
* This scenario is designed to address emergency situations where a participant is suddenly called out of town or is unexpectedly hospitalized. It is intended for clinical trials in which the participant’s well-being is dependent on the study procedures being administered.
Site use / Recruitment
Institutions or agencies that permit the use of their facilities are not considered engaged. Institutions or agencies that inform prospective participants about the research are not considered engaged.
- Provide recruitment materials
- Provide consent forms
- Provide study contact information
- Obtain permission for the study team to contact them
- Conduct screening for eligibility
- Obtain informed consent
- Provide participant contact information without expressed permission for the study team to contact them
Institutions whose employees or agents obtain coded private information must not have the means to re-identify the data.
Institutions whose employees or agents release identifiable private information or identifiable biological specimens provided that the data was collected for purposes outside of the proposed research, the release of data conducted for a previous research study would not violate the informed consent, and the research results will not be linked back to the original source for use in their research projects.
* The institution that owns the data will decide what and how they want to share. They may require a Data Use Agreement (DUA).
All inquiries and requests for Data Use Agreements should be directed to Brown’s Research Data Management Team at [email protected]
Individuals on-site covered under overseeing IRB
This category pertains to people who are working at the institution, for a particular project, and not retaining any of the work or data for projects under the auspices of any other institution. They would only access research data and materials while on-site for the project. Examples here would be contracted work, research assistants, study physicians.
Student researchers, including medical students at the Warren Alpert Medical School, are engaged in the research under the auspices of Brown University if any of the following conditions are met:
The student researcher is receiving sponsored funding
The research is fulfilling an educational requirement
The student researcher is utilizing Brown University resources to carry out their research activities
- The student will utilize study data for research under the auspices of Brown University
Student researchers, including medical students at the Warren Alpert Medical School, who are hired as research staff outside of the above conditions are not engaged in the research under the auspices of Brown University provided that:
All proposed research activities would be conducted regardless of the involvement of the student researcher
The student researcher would not be retaining any of the data for use in Brown University research
- Brown University is not and will not be included in the approved protocol.
Clinical faculty generally submit their research to the IRB of their hospital affiliation. However, their research activities engage Brown University if any of the following conditions are met:
The investigator is receiving Sponsored funding under their Brown University affiliation
The investigator is utilizing Brown University resources to carry out their research activities
- Clinical Faculty may need to submit a PI Eligibility Form with the appropriate signatures to request approval to conduct research under the auspices of Brown University
Brown University employees or agents who receive a non-federal parent award and provide subawards to subrecipients, internal or external to Brown, may request a non-engagement determination from the OVPR Institutional Official for their involvement in the human subjects research conducted by the subrecipients. This determination may not be made by the Brown recipients, themselves.
Requests for non-engagement will be considered on a case-by-case basis, and guided by whether any participation by Brown researchers is so limited or marginal that considering them to be engaged would not meaningfully add to the protection of the human subjects in research.
Contact the HRPP at [email protected] for more information and a list of the required material needed for this process.