Institutional Review Board: PI Request Form for Collaborative Studies
(outside individual investigator agreements or institutional agreements with another IRB)
This form is meant to provide information to the investigator who plans collaborative studies with individuals not affiliated with Rosalind Franklin University. Complete the applicable sections for either the outsideinvestigator agreement (IIA: Section I) or aninstitutional IRB Authorization Agreement (IAA: Section II).
Note that this is not the actual formal agreement form for signatures (those are available for download on the IRB website). The PI can initiate processing of investigator agreements (IIA). However, the IRB, not the PI, will process
institutional IRB agreements (IAA) with another University or institution and the information below will be needed.
IRB Number:
Study Title:
Principal Investigator:
Funding Source:
Research Team Members:
Name: / Institutional Affiliation, or specify if “none”: / Check type of Investigator
(defined in Section I) / Role in Study: summarize type of research activities planned for the individual (e.g. recruitment, informed consent, analysis of de-identified or identifiable data, interaction with participants, etc.)
Independent / Institutional
SECTION I: Institutional/Independent Investigator Agreement (IIA)
This is an agreement between RFU and one or more non-RFUInvestigator/s
All statements below (either A or B)must be accurate for in order to qualify.
(otherwise complete the information in Section II for an IRB Authorization Agreement).
A. Definitions:
A collaborating independent investigator is:
1.Not otherwise an employee or agent of RFU;
2.Conducting collaborative research activities outside the facilities of RFU; and
3.Not acting as an employee of any institution with respect to his or her involvement in the research being conducted by RFU.
Note: If 2 or more investigator agreements are required for investigators at a single institution, an institutional IRB agreement(IAA) might be more appropriate
A collaborating institutional investigator is:
  1. Not otherwise an employee or agent of RFU;
  2. Conducting collaborative research activities outside the facilities of RFU;
  3. Employed by, or acting as an agent of, an institution that does not have an FWA or that does not routinely conduct human subjects research.
Note: If the institution routinely conducts human subjects research, then an IIA is usually not appropriate and the IRB may elect to execute an IRB Authorization Agreement (IAA) instead.
B. Rationale Please state why you feel that theRFUIRB should to assume oversight by an IIA for the individual(s) activities on this study:
C. Training and conflict of interest (Check if accurate):
PI will confirm that each team member has adequate training and expertise and has completed mandatory education requirements.
PI will confirm that each team member has no conflicts of interest to disclose.
SECTION II. IRB Authorization Agreements (IAA)
Complete Part A: If you are requesting RFU to assume IRB review and oversight for another institution.
Complete B: If you are requesting RFU to cede IRB review and oversight to another institution.
Name of the Institution: / Institution’s FWA #:
Institution’s Signatory: / Signatory’s Contact Information:
IRB Name: / IRB Registration Number:
Study’s Funding Source:
  1. IRB Authorization Agreement (IAA) for RFU to assumeIRBoversight for another institution
(NOTE: All must be checked and completed for RFU’s IRB to consider taking on oversight for another institution)
Location (specify address, building, etc.) where research will be performed:
Provide a compelling rationale for the RFUIRB to assume oversight for the other institution’s activities on this study:
Provide a brief summary of the research activity to be performed at the designated site:
State who will be Principal Investigator (PI) at the designated siteand describe the PI’s oversight of the research activity at the site:
Describe the PI’s relationship with RFU:

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SECTION II. IRB Authorization Agreement (IAA)
CompletePart A: If you are requestingRFUto assume IRB review and oversight for another institution.
Complete B: If you are requestingRFU to cede IRB review and oversight to another institution.
Name of the Institution: / Institution’s FWA #:
Institution’s Signatory: / Signatory’s Contact Information:
IRB Name: / IRB Registration Number:
Study’s Funding Source:
  1. IRB Authorization Agreement (IAA) for RFUto assumeIRBoversight for another institution
(NOTE: All must be checkedand completed for RFU’sIRB to consider taking on oversight of another institution)
  1. Location (specify address, building, etc.) where research will be performed at RFU:

  1. Provide a compelling rationale for the RFUIRB to assume oversight for the institution’s activities on this study:

  1. Provide a brief summary of the research activity to be performed at the designated site:

  1. State who will be Principal Investigator (PI) at the designated siteand describe the PI’s oversight of the research activity at the site:

  1. Describe the PI’s relationship (appointments) with RFU:

  1. State who will be responsible for the regulatory oversight of the study, i.e. which coordinator or administrative staff person will coordinate IRB continuing review and other IRB / regulatory matters:

The designated siteis amenable to ceding review to RFU IRB for this study.
Each research team member at this institution will have supervision, training, and expertise to conduct the research activity.
The PI and each research team member at the designated site has completed mandatory education requirements.
Confirm each research team member has completed a COI form. If they have no conflicts to disclose, these forms can be retained on file. Any forms from research team members with a “YES” response must be submitted to the IRB office.
The RFUPrivacy Board will make HIPAA determinations for this study, if HIPAA applies.
The designated site’s Privacy Board will make HIPAA determinations for the Institution for this study.
  1. IRB Authorization Agreement (IAA)for RFU to cede IRB review and oversightto another institution
(NOTE: All must be checkedand completed for RFU’sIRB to consider ceding oversight of the protocol to another institution’s IRB)
  1. Provide a compelling rationale for RFU’sIRB to cede oversight for the institution’s activities on this study:

Confirm each research team member has completed a COI form. If they have no conflicts to disclose, these forms can be retained on file. Any forms from research team members with a “YES” response must be submitted to the IRB office.Submit the PI’s COI form to the IRB whether or not a conflict is indicated.
The institution is amenable to assuming IRB review for RFU for this study.
Proposed IAA from the institution assuming IRB oversight is being submitted with this form.
The RFUPrivacy Board will make HIPAA determinations for this study, if HIPAA applies.
The Privacy Board at the institution assuming IRB oversight will make HIPAA determinations for study.

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Additional Documentation that is being submitted with this form:
A copy of the study protocol.
A copy of the informed consent form(s) (ICF) for the study.
If this IIA/IAA is for an active study that has already been reviewed and approved by the RFU IRB, submit revised ICFs (modifying the HIPAA and Confidentiality sections, as applicable), protocol, and any other study documents that require revisions to reflect the addition of this site and/or study personnel. Specify in the protocol (or Site-Specific Appendix) the research activity that will occur at this proposed new site or by theproposed new study personnel.

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