Collaborative Research

The U.S. Department of Health and Human Services (DHHS) has issued revisions to the Common Rule (45 CFR 46), which went into effect, January 21, 2019. Information presented on this page will be updated to reflect those changes in the coming days.

Fundamental Principles

  1. Duke University must approve research conducted by Duke faculty, students, and staff, no matter where the research is conducted, before the research can begin.
  2. Duke cannot approve research conducted by researchers affiliated with other institutions.
  3. In limited circumstances, assurance-holding institutions may provide alternative review processes, for example, one institution may review the research conducted by affiliates of another. 

Assurances

Assurances describe how research subjects will be protected. Assurances registered with the Office of Human Research Protections (OHRP) incorporate regulations for protecting research subjects, most often 45 CFR 46. This means that institutions can have some degree of confidence that subjects at other institutions will be protected, for example, the elements of consent provided in the regulations will be used and risk will be appropriately managed. Therefore, institutions may be willing to allow another assurance-holding institutions to provide the review for a study.  This is done using formal inter-institutional agreements.

The inter-institutional agreement is called and IRB Authorization Agreement (IAA). The IAA designates one IRB as the IRB that will review the research conducted at both institutions. (One institution may be the responsible IRB for multiple institutions engaged in the same research.) The reviewing IRB also reviews requests to amend and renew the protocol as well as reports of unanticipated problems. Usually, the institution that agrees to be the reviewing IRB is the institution where the research will take place.

IRB Authorization Agreements may only be used between institutions that have OHRP-registered assurances. Almost all universities in the US have these assurances as do many universities and research institutions abroad.

Assurances describe how research subjects will be protected. Assurances registered with the Office of Human Research Protections (OHRP) incorporate regulations for protecting research subjects, most often 45 CFR 46. This means that institutions can have some degree of confidence that subjects at other institutions will be protected, for example, the elements of consent provided in the regulations will be used and risk will be appropriately managed. Therefore, institutions may be willing to allow another assurance-holding institutions to provide the review for a study.  This is done using formal inter-institutional agreements.

The inter-institutional agreement is called and IRB Authorization Agreement (IAA). The IAA designates one IRB as the IRB that will review the research conducted at both institutions. (One institution may be the responsible IRB for multiple institutions engaged in the same research.) The reviewing IRB also reviews requests to amend and renew the protocol as well as reports of unanticipated problems. Usually, the institution that agrees to be the reviewing IRB is the institution where the research will take place.

IRB Authorization Agreements may only be used between institutions that have OHRP-registered assurances. Almost all universities in the US have these assurances as do many universities and research institutions abroad.

If the IAA FAQ’s do not address your concerns, please contact the IRB staff.

Engagement in Research

It is possible that collaborating institutions’ contributions to a study do not need IRB review. The concept of engagement, as defined by OHRP provide guidance for making the determination by:

  1. Defining activities that must be reviewed, either by the institution whose employees are conducting the activities (or through an IAA).

For example, the employees of the other institution secure consent from subjects and gather information from them through interviews or surveys

  1. Describing ways that collaborators may assist researchers from other institutions in ways that do not require review

For example, the employees of the collaborating institution may provide prospective subjects information about an available study or provide space for conducting the study. 

Engagement in Research includes more examples of activities that constitute engagement and those that do not.

When collaborators are partners in a study, although perhaps performing different tasks, there are two options:

  1. Each institution reviews the research conducted by its faculty, students, and staff.

Protocol Tips:

If you are collaborating with researchers who are getting IRB review at their home institutions, clearly differentiate what you will do and what your collaborators will do so the IRB knows what it is being asked to review. 

Don’t list your collaborators on the cover sheet of the Duke protocol, instead talk about their contributions to the study in the text of the protocol.

  1. If each institution is conducting the same research activities, in order to avoid duplicative review, the institutions’ IRB Administrators can discuss whether an IRB Authorization Agreement is appropriate. An IAA designates one IRB that will review the research conducted at both institutions.

In order to enter into IRB Authorization Agreements, institutions must have Assurances with the Office of Human Research Protections that describe how research subject will be protected.  Almost all universities in the US have these assurances as do many universities and research institutions abroad.

Note: Some universities will not enter into IAAs because of the liability posed by either ceding review to another institution or assuming responsibility for the behavior of researchers they do not know. Duke has some restrictions on the use of IAAs. See the IAA FAQs.

Note: The NIH recently released a final policy stating that all domestic sites of multi-site, NIH-funded studies must use a single Institutional Review Board (sIRB) of record for non-exempt human subject research. This policy applies to all competing grant applications (new, renewal, revision or resubmission) with receipt dates on or after September, 2017.

Securing an IRB Authorization Agreement

IRBs are inter-institutional agreements prepared by institutional staff using information provided by researchers. 

Researchers who wish to secure IAAs study should contact the Director of the Campus IRB.  

If Duke is issuing a subcontract to another university to conduct a portion of the research, the terms of the subcontract will require that the recipient secure IRB approval. (The converse is also true.) The protocol prepared by the Duke researchers must identify the recipients of the subcontracts but only needs to describe what the role subcontractors as necessary to explain the overall project.

Protocol Tips:

Do not list the principal investigators receiving the subcontracts on the cover sheet of the Duke protocol. 

Do not include research materials that will be used solely by the subcontractor in the protocol.

Limit the description of the subcontractor’s role to what is necessary to explain the overall project.

Consultants

When consultants are hired, the transfer of sensitive identifiable data needs to be addressed. Generally, because consultants provide a service for a fee, they do not own any data they collect on behalf of the researcher. However, if you propose and alternate agreement regarding the data, it must be addressed in the protocol.

Students

When hiring students, their enrollment status determines what kind of agreements need to be put in place. If they are participating in the research as part of their studies, the agreement for their services must be with their institutions. And because the institution is engaged in the research, the institution needs to secure IRB approval for their students’ activities.  If the students are not enrolled, for example, during the summer, agreements will be made with them as individuals.  Because the students are directly employed by the researcher, their activities can be described in the Duke protocol.

Protocol Tips: The protocol needs to describe how the students will be trained and supervised

The fundamental principles for collaborations among US institutions apply to research conducted abroad. 

Assurances

Assurances describe how research subjects will be protected. OHRP-registered assurances usually incorporate the federal regulations for protecting research subjects (45 CFR 46). This means that institutions can have some degree of confidence that subjects will be protected, for example, that the elements of consent provided in the regulations will be used, risk will be appropriately managed, and so on. Therefore, institutions may be willing to allow another assurance-holding institutions to provide the review for a study.

More and more foreign institutions have International Assurances registered with the US Office of Human Research Protections (OHRP) to facilitate research with US collaborators. However, if they do not and they are engaged in the research, an alternate assurance may need to be put in place. Alternate assurances must include protections that are comparable to the US protections, such as the need to secure informed consent.

In Country Approvals

Many countries require that research be approval by a designated national body. In addition, various levels of local review may be required.

The European Union, representing countries with strict privacy policies, will be issuing guidance about the protection of and access to research data.  

Export Controls

If your proposed research will be physically conducted outside the U.S. or you plan to collaborate with a foreign entity please contact the Duke University Office of Export Controls for approval.