FORM 10: IAA/IIA Request Form
NUMBER
HRP-220
DATE
12/16/2015
PAGE
1 of 2
Use for requesting that Tufts Health Sciences IRB assume or cede IRB oversight for research. Include in submission for
initial review, modification or continuing review. Complete the applicable sections in black depending on whether you are
requesting an IIA or an IAA. Refer to our Request to Cede/Assume IRB page for more information.
IRB Number:
or
Pending (no IRB # assigned)
Study Title:
Principal Investigator:
Study Coordinator:
Study’s Funding Source:
Research Team Members:
Name:
Institutional
Affiliation, or specify
if “none”:
If an IIA, choose type
Individual
Institutional
Investigator Investigator
Agreement: Agreement:
Study/Institutional Role: List all research
activities conducted by the personnel or
institution, i.e., recruitment, informed consent,
enrolling subjects, analysis of de-identified or
identifiable data, interaction with participants, etc.:
Individual/Institutional Investigator Agreement (IIA)
All must apply for Section A or B for this to be an IIA, otherwise complete for an IAA in sections below.
A. Independent Investigator Agreement (IIA)
A collaborating independent investigator is:
1. Not otherwise an employee or agent of Tufts Medical Center / Tufts University;
2. Conducting collaborative research activities outside the facilities of Tufts Medical Center / Tufts University; and
3. Not acting as an employee of any institution with respect to his or her involvement in the research being conducted by Tufts
Medical Center / Tufts University.
4. Any payment will be made directly to the collaborating independent investigator, if applicable.
Note: If 2 or more independent investigator agreements are required for investigators at a single institution, institutional
investigator agreements (IIAs) may be required.
B. Institutional Investigator Agreement (IIA)
A collaborating institutional investigator is:
1. Not otherwise an employee or agent of Tufts Medical Center / Tufts University;
2. Conducting collaborative research activities outside the facilities of Tufts Medical Center / Tufts University;
3. Acting as an employee or agent of an institution that does not have an FWA (with respect to his or her involvement in the
research being conducted by Tufts Medical Center / Tufts University); and
4. Employed by, or acting as an agent of, an institution that does not have an FWA and that does not routinely conduct human
subjects research.
5. Any payment will be made to the collaborating institution, if applicable.
Note: If the institution routinely conducts human subjects research, then an IIA is not appropriate and the institution must
obtain an FWA and execute an IAA for the study.
State rationale for Tufts Health Sciences IRB to assume oversight for the individual’s/institution’s activities on this study:
Confirm that each team member has adequate training and expertise and has completed mandatory education requirements.
Confirm that each team member has completed a COI form. If they have no conflicts to disclose, these forms can be retained
on file. Any form(s) from research team members with “YES” responses must be submitted to the IRB office.
FORM 10: IAA/IIA Request Form
NUMBER
HRP-220
DATE
12/16/2015
PAGE
2 of 2
IRB Authorization Agreement (IAA)
Complete section A. if you want Tufts to assume IRB oversight for another institution.
Complete section B. if you want Tufts to cede IRB 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:
Does IAA fall under the existing Harvard Catalyst Agreement?:
A. IRB Authorization Agreement (IAA) for Tufts Health Sciences to assume IRB oversight for another institution
(all must be checked and completed for Tufts Health Sciences IRB to consider taking on oversight of another institution)
1. Location (specify address, building, etc.) where research will be performed at this institution:
2. Provide a compelling rationale for the Tufts Health Sciences IRB to assume oversight for the institution’s activities on this
study:
3. Provide a brief summary of the research activity to be performed at the designated site:
4. State who will be Principal Investigator (PI) at the designated site and describe the PI’s oversight of the research activity at the
site:
5. Describe the PI’s relationship (appointments) with the designated site and Tufts Medical Center/Tufts University:
6. 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 site is amenable to ceding review to Tufts 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 Tufts IRB/Privacy 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.
B. IRB Authorization Agreement (IAA) for Tufts Health Sciences IRB to cede IRB oversight to another institution
(all must be checked and completed for Tufts Health Sciences IRB to consider giving up oversight to another institution’s IRB)
1. Provide a compelling rationale for Tufts Health Sciences IRB 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 Tufts for this study.
Proposed IAA from the institution assuming IRB oversight is being submitted with this form.
The Tufts IRB/Privacy 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.
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 Tufts Health Sciences 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 the proposed new study personnel.
For Harvard Catalyst, please refer to the Harvard Catalyst Reliance Agreement information on the Tufts IRB website.
Investigator Acknowledgement
I will conduct this protocol in accordance with the requirement of the IRB who has oversight of this study.
Principal Investigator (print name):
Principal Investigator signature:
Date: