Working with Other Institutions

If you have questions about the Single IRB Process, contact Misty White: misty.white@colorado.edu. Before beginning this process, we strongly encourage investigators to contact us and discuss the steps necessary for Single IRB oversight to occur.

Why single IRB? Types of collaborations Reviewing IRB / Relying IRB Information for Principal Investigators (PI) Information for outside IRBs

Why single IRB?

Single IRB Review is an arrangement in which one institution's IRB provides review, approval and oversight for the Human Research activities of investigators engaged in research at multiple institutions. This is intended to streamline the IRB review process, preventing duplication of effort required if each institution’s investigators were required to submit research for review separately.

The Revised Common Rule includes a (Single IRB) requirement for all . This requirement applies to federally funded or supported non-exempt human subjects research that involves multiple institutions.

The for Single IRB applies to NIH funded non-exempt human research involving multiple US sites conducting the same protocol. It applies to all competing grant applications for due dates on or after January 25, 2018. The NIH policy differs from the Common Rule requirement in that there are NIH requirements that must be addressed in the grant or contract applications that do not apply to studies under the broader Common Rule requirement.

To reduce administrative burden, the ��񱦵� IRB has extended the Single IRB option to any non-exempt human subjects research, provided the cooperation of the outside relying/reviewing institution.

��񱦵� does not enter into reliance agreements for . When collaborating with other institutions engaged in research that meets the definition of Exempt research, each collaborating site must obtain an exempt determination from its own IRB.

Types of collaborations

Cooperative/collaborative

This type of research involves two or more US research sites where each site is conducting a different part of a research protocol under the supervision of a lead Principal Investigator.

Example: A ��񱦵� investigator enrolls participants and collects data at ��񱦵� and sends data to a collaborator at another institution for analysis (or vice versa).

Multi-site

This type of research involves the same research procedures being conducted at two or more institutions overseen by a Principal Investigator at each site. Multi-site studies usually have a lead site/lead PI that oversees the administrative functions of the project in addition to conducting the same research procedures as the other participating sites.

Example: ��񱦵� is one of several sites that recruit, enroll, and collect data from participants using the same protocol.

Reviewing IRB / Relying IRB

The Reviewing IRB, or IRB of Record, is the IRB that assumes regulatory oversight responsibilities for the research.

This includes:

Initial review and approval
Amendments
Continuing reviews
Reportable events

The Relying IRB cedes review to, or relies on, the IRB of Record. The Relying IRB is responsible for local issues such as investigator training, conflicts of interest, etc.

Information for Principal Investigators (PI)

Principal Investigator Responsibilities

When ��񱦵� is the Reviewing IRB, the ��񱦵� PI is the primary person of contact for the study for the IRB and the relying site PIs. All communication from the ��񱦵� IRB will be disseminated to the relying site PIs by the ��񱦵� PI. The ��񱦵� PI responsibilities include (but are not limited to):

Communicating with relying site PIs regarding any site-specific language that must be included in study documents
Preparing and submitting the Initial Application, Continuing Review/Check-ins, study-wide Amendments, Reportable Event, and Final Report to the ��񱦵� IRB
Providing documentation of IRB determinations to relying site PIs
Providing IRB-approved study documents to relying site PIs

When ��񱦵� is the Relying IRB, the ��񱦵� PI responsibilities include (but are not limited to):

Submitting the ��񱦵� Initial Application (required documents listed below)
Submitting documentation of study-wide Amendment determinations made by the Reviewing IRB
Submitting any ��񱦵�-specific Amendments (e.g., updating ��񱦵� staff, CITI training records, COI information, etc.)

When ��񱦵� is the Relying IRB, IRB staff will assist with the following:

Obtaining signatures for IRB Authorization Agreements
Providing local context to the Reviewing IRB regarding state laws and institutional requirements, investigator training/qualifications, and any conflicts of interest information pertinent to the study
Incorporating site-specific language for consent forms. This document can be downloaded and used to assess the consent form as well: Non-��񱦵� Consent Information (link to new document)

If ��񱦵� is the Reviewing IRB ...

Use this list to gather information the IRB needs to review the research.

Determine engagement for other institutions

IRB review and approval is required when an institution is engaged in non-exempt human subjects research. In general, an institution is considered to be engaged if its agents or employees are involved in research that includes any of the following:

Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e., awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another institution.
Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures.
Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment.
Institutions whose employees or agents interact for research purposes with any human subject of the research.
Institutions whose employees or agents obtain the informed consent of human subjects for the research.
Institutions whose employees or agents obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research. It is important to note that, in general, institutions whose employees or agents obtain identifiable private information or identifiable specimens for non-exempt human subjects research are considered engaged in the research, even if the institution’s employees or agents do not directly interact or intervene with human subjects. In general, obtaining identifiable private information or identifiable specimens includes, but is not limited to:
1. observing or recording private behavior;
2. using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution; and
3. using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators.

The Office for Human Research Protections guidance document provides examples of engagement, exceptions to engagement, and activities for which an institution would not be considered engaged. If an institution is not engaged in the research, IRB oversight is not required.

Gather necessary documents

Determine the type of collaboration using the descriptions on the second tab of this webpage.

For cooperative/collaborative research, gather:

for each engaged institution
��񱦵� Protocol with other institution’s activities clearly described per the instructions in the
Any other supporting documents necessary for the conduct of the research at each site

For multi-site research, gather:

for each engaged institution
��񱦵� Protocol with each institution’s activities clearly described per the instructions in the
Consent Form(s) and any other supporting documents with site-specific language included as necessary for outside institutions

Create an Initial Application or Amendment (as appropriate) in eRA and submit for review

More information about creating submissions for the IRB can be found on the IRB website:

If ��񱦵� is the Relying IRB ...

Use this list to gather information the IRB needs to review the research.

Determine engagement for ��񱦵�

Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another institution.
Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures.
Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment.
Institutions whose employees or agents interact for research purposes with any human subject of the research.
Institutions whose employees or agents obtain the informed consent of human subjects for the research.
Institutions whose employees or agents obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research. It is important to note that, in general, institutions whose employees or agents obtain identifiable private information or identifiable specimens for non-exempt human subjects research are considered engaged in the research, even if the institution’s employees or agents do not directly interact or intervene with human subjects. In general, obtaining identifiable private information or identifiable specimens includes, but is not limited to:
1. observing or recording private behavior;
2. using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution; and
3. using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators.

Gather necessary documents

Determine the type of collaboration using the descriptions on the second tab of this webpage.

For cooperative/collaborative research, gather:

IRB Authorization Agreement
Protocol document approved by the Reviewing IRB with ��񱦵� activities clearly described
Reviewing IRB Approval letter

For multi-site research, gather:

IRB Authorization Agreement
Protocol document approved by the Reviewing IRB with ��񱦵� activities clearly described
with ��񱦵� specific language included

NOTE: If an Approved Protocol document or IRB Approval letter are not available, please contact the Single IRB Coordinator, Misty White: misty.white@colorado.edu.

Create an Initial Application or Amendment (as appropriate) in eRA and submit for review

More information about creating submissions for the IRB can be found on the IRB website:

Information for outside IRBs

Single IRB Coordinator: Misty White misty.white@colorado.edu

��񱦵� is a SMART IRB affiliated institution

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