Institutional Review Board (IRB)
Office of Regulatory Research Compliance LCSB 28
(Phone) 442-9050 (Fax) 442-9997 (E-mail)
Version 09.01.11.
supplemental form #15
research involving a collaborating External Organization
[Includes Collaborating External Investigator and Collaborating External Organization Agreement Templates]
(do not leave any questions blank, indicate n/a when necessary)
The Office of Human Research Protection (OHRP) supports the idea of IRBs from collaborating institutions also collaborating – in essence, permitting one institution’s IRB to defer review of a human subjects research application to another IRB. This collaboration eliminates redundancies in the review of a study, and may provide a more efficient process. In order for the University at Albany to consider such an arrangement, the following must be true:
1. The activity proposed must be a collaborative research project with a UAlbany Investigator (the external institution is not merely a research site) and;
2. The collaborating external institution must have a Federal-Wide Assurance from the OHRP (see below re: When the external Institution does not yet have an Assurance.)
An IRB is considered the “IRB of record” when it assumes IRB responsibilities for another institution. In limited circumstances, the University will consider becoming the IRB-of-Record for the engagement in research conducted in collaboration with an outside entity or ceding authority for review and oversight of University research, in whole or in part, to an outside IRB. IRBs have a central role in determining whether proposed arrangements preserve and promote protections for human participants in research for which they have responsibility, and, thus, are acceptable.
Such a review-sharing arrangement requires a formal agreement between the institutions approved by the Institutional Official(s) or their designee(s). Thus, this option is available only upon mutual agreement of the UAlbany Institutional Official and the Institutional Official of the external collaborating Institution. The University at Albany's Institutional Official for the Protections of Human Participants is the Assistant Vice President for Research/Director of the Office of Regulatory Research Compliance.
1. Provide a list of the collaborating Individual External Investigator(s) who will be involved in your project by completing the following table. Describe how the individuals will participate in or facilitate the research:
Note: A copy of the CITI Human Subject Training Report must be attached for PI/Co-PI and all Key Personnel.
NAME / ROLE IN PROTOCOLExample: Developed protocol,
collecting data, analyzing
data, writing report / CITI TRAINING COMPLETION DATE / ORRC Date /
BY:
* Mandatory Human Subjects Research Training must be completed by all individuals who interact with human participants, are engaged in research involving human research participants, or work with identifiable participant data.
If training was completed at another institution, a copy of the certification must be submitted.
2. Study personnel who are not affiliated with the University at Albany must complete an Collaborating External Investigator Agreement which allows the University to extend its Federalwide Assurance to cover a External (not affiliated with UAlbany) Investigator who is collaborating with a UAlbany Investigator. The Agreement is below.
A Collaborating External Investigator Agreement for each unaffiliated investigator must be on file with the Office of Regulatory Research Compliance before final IRB approval will be granted.
Collaborating External Institutions
The IRB/ORRC staff will assist the investigator in determining if an institution is merely a performance site or if it is "engaged in research covered by 45 CFR 46" and must therefore operate under a valid Federalwide Assurance. In making this determination, the IRB staff will follow the OHRP Guidance that institutions are so engaged when their employees or agents (1) intervene or interact with living individuals for research purposes or (2) obtain individually identifiable private information for federally supported research purposes. Institutions receiving federal awards are automatically considered to be engaged in covered research regardless of where the research activities are carried out.
2. Provide a list of the collaborating external organizations that will be involved in your project:
Research Site/Organization Name / Role in Research / Federalwide Assurance # / External Institution’s IRB Office or Institutional Official Contact Information (Name, phone, etc.)
The UAlbany IRB may enter into a collaborative agreement with an institution that holds a Federalwide Assurance
A fully executed Institutional Review Board (IRB) Authorization Agreement must be in place for each collaborating Institution that designates either UAlbany or the external organization (Institution B) as the IRB of record. FORM IS BELOW. (NOTE: When Institution B will serve as IRB of Record, Institution B may elect to use its own institutional version of the agreement template.) By this agreement, either the UAlbany IRB or the external Institution’s IRB assumes responsibility for the review and continuing oversight of the research.
The agreement may be limited to a specific research project(s) or may be broader in scope. The IRB Authorization Agreement will specify the scope of the agreement.
When the external Institution does not yet have an Assurance
UAlbany may only extend the terms of its Federalwide Assurance to an external institution that has an Assurance of its own. When the external collaborating institution does not yet have an Assurance (typically, this is owing to the fact that the other institution does not routinely conduct human subjects research) the other institution will be required to:
1. apply for a Federalwide Assurance, complying with all of the requirements, and
2. designate the UAlbany IRB as the IRB of record for the research on that Assurance.
Again, the designation is documented in an executed Institutional Review Board (IRB) Authorization Agreement signed by the signatory officials designated in UAlbany’s and Institution B’s Federalwide Assurances. A fully executed IRB Authorization Agreement must be in place for each collaborating Institution that designates either UAlbany or the external organization (Institution B) as the IRB of record. FORM IS BELOW.
When this occurs the UAlbany IRB assumes responsibility for the review and continuing oversight of the specified research on behalf of Institution B.
ORRC USE ONLY
Collaborating External Investigator Agreement(s) completed for all Unaffiliated Investigators? Y/N
IRB Authorization Agreement(s) fully executed for each collaborating Institution? Y/N
Collaborating External Investigator Agreement
The University at Albany
Institutional Review Board
FWA 00001970
External Investigator’s Name (not affiliated with UAlbany):
Principal Investigator’s Name (University at Albany Investigator responsible for the project):
Research Covered by this Agreement:
Protocol Number: #
Project Title:
1. The above-named External Investigator has reviewed: 1) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (or other internationally recognized equivalent; see section B.1. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions); 2) the U.S. Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46 (or other procedural standards; see section B.3. of the Terms of the FWA for International (Non-U.S.) Institutions); 3) the FWA and applicable Terms of the FWA for the institution referenced above; and 4) the relevant institutional policies and procedures for the protection of human subjects.
2. The External Investigator understands and hereby accepts the responsibility to comply with the standards and requirements stipulated in the above documents and to protect the rights and welfare of human subjects involved in research conducted under this Agreement.
3. The External Investigator will comply with all other applicable federal, international, state, and local laws, regulations, and policies that may provide additional protection for human subjects participating in research conducted under this agreement.
4. The External Investigator will abide by all determinations of the University at Albany Institutional Review Board (IRB) designated under the above FWA and will accept the final authority and decisions of the IRB, including but not limited to directives to terminate participation in designated research activities.
5. The External Investigator will complete all educational training required by the Institution and/or the IRB prior to initiating research covered under this Agreement.
6. The Investigator will report promptly to the IRB any proposed changes in the research conducted under this Agreement. The investigator will not initiate changes in the research without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.
7. The Investigator will report immediately to the IRB any unanticipated problems involving risks to subjects or others in research covered under this Agreement.
8. The Investigator, when responsible for enrolling subjects, will obtain, document, and maintain records of informed consent for each such subject or each subject’s legally authorized representative as required under HHS regulations at 45 CFR part 46 (or any other international or national procedural standards selected on the FWA for the institution referenced above) and stipulated by the IRB.
9. The External Investigator acknowledges and agrees to cooperate in the IRB’s responsibility for initial and continuing review, record keeping, reporting, and certification for the research referenced above. The External Investigator will provide all information requested by the IRB in a timely fashion.
10. The External Investigator will not enroll subjects in research under this Agreement prior to its review and approval by the IRB.
11. Emergency medical care may be delivered without IRB review and approval to the extent permitted under applicable federal regulations and state law.
12. This Agreement does not preclude the External Investigator from taking part in research not covered by this Agreement.
13. The External Investigator acknowledges that he/she is responsible for safeguarding the rights and welfare of each research subject, and that the subject’s rights and welfare must take precedence over the goals and requirements of the research.
External Investigator Signature: ______Date ______
Print Full Name:
Institutional Title: Degree(s):
Institution Name:
Address:
Phone:
Fax:
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
UAlbany Principal Investigator Assurance
I assure that I will ensure that that External Investigator: 1) is qualified by training and experience and licensure to perform study-related tasks that have been delegated to him/her; 2) has an adequate understanding of the research; and 3) will follow the IRB-approved protocol, including the recruitment and consent procedures described in the protocol.
Principal Investigator Signature ______ Date ______
Print Full Name:
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
FWA Institutional Official (or Designee): ______Date _______
Print Full Name: Adrienne D. Bonilla, Esq.
Institutional Title: Assistant Vice President for Research
Address: University at Albany
Office of Regulatory Research Compliance, LCSB 28
1400 Washington Ave Albany, NY 12222
Phone: 518-442-9050
Fax: 518-442-9997
Institutional Review Board (IRB)
Authorization Agreement
Name of Institution / FederalwideAssurance No. / IRB Registration No.
Institution Providing IRB Review (Institution A)
Institution Relying on Institution A’s IRB Review (Institution B)
The Officials signing below agree that Name of Institution B may rely on the designated IRB for review and continuing oversight of its human subjects research described below: (check one)
This agreement applies to all human subjects research covered by Institution B’s FWA.
This agreement is limited to the following specific protocol(s):
Title of Research Protocol:
Name of PI (Institution A):
Name of Investigator (Institution B):
Sponsor or Funding Agency: Award Number, if any:
Other (describe):
The review and continuing oversight performed by the Institution A’s IRB will meet the human subject’s protection requirements of Institution B’s OHRP-approved FWA. Both institutions agree to the following conditions:
1. Institution A will provide Institution B with copies of its findings and actions associated with the project(s) listed above. Institution A will provide Institution B with copies of minutes associated with the project(s) listed above upon request.
2. Institution A’s IRB will notify Institution B if the study is suspended or terminated and will provide a summary of the reasons for the suspension or termination.
3. Institution A’s IRB will notify Institution B of any unanticipated problems involving risks to human participants or others.
4. Institution A’s IRB will notify Institution B of audits/investigations by oversight agencies, the sponsor or funding agencies and will provide a summary of the findings.
5. If Institution A fails to notify Institution B as stated above, Institution B shall have the right to terminate this agreement immediately, and request any study related documents associated with Institution B’s investigator’s role in the study.
6. This document must be kept on file by both parties and provided to OHRP upon request.
NOTE: Once executed, Institution B must list Institution A’s IRB on its OHRP approved FWA.
Signature of Institutional Officials:
Institution A Official Institution B Official
Print NameTitle
Signature
Date