The Institutional Review Board is committed to protecting the people who participate in human subjects’ research whether the work is conducted domestically or internationally. Under the Federal Wide Agreement (FWA) the University has with the federal Office of Human Research Protections (OHRP), it is obligated to follow all of the rules and regulations promulgated by OHRP.  Both ethically and legally it is the responsibility of researchers to afford individuals who serve as international human subjects the same protections as they would for people in the United States. Additionally, individual countries or regions have their own regulations which researchers must familiarize themselves with and follow. Experienced researchers recognize that each country has their own customs and mores which will impact on how they conduct research so their participants are never put at unnecessary risk. Graduate or undergraduate students conducting international research should be provided with additional mentoring.
The Rutgers IRB applies review of international work to full/ expedited research as well as exempt research. It is necessary for the IRB to request relevant information from investigators in order to verify whether or not a study qualifies for exemption within the local research context.
 
This document provides guidance for researchers in assessing their international research plan and for addressing specific questions relating to the IRB review of protocols involving study sites outside of the U.S.A. Included are links to the revised applications and the companion appendices related to international research. 

I. Regulatory Authority
 The Office of Human Research Protections states that the all Institutional Review Boards must have the proper information to assess the local research context of work that is being done internationally.  Therefore, according to regulations:

Ensuring that the IRB possesses sufficient knowledge of the local research context for international studies may be accomplished in several ways:

II. Research that Involves Greater than Minimal Risk to Subjects

1. The various mechanisms for greater than minimal risk suggested in the OHRP Guidance Document, IRB Knowledge of Local Research Context, should be utilized on a case-by-case basis.
   
   
2. If the protocol is approved by an IRB designated under an approved foreign Federal Wide Assurance (FWA) in the country where the work will be done, then no other review is needed other than that of the Rutgers IRB.(Note: In some cases, such as in France, the FWA is tied to a region and not to an institution.) The IRB will require a notice of approval and a copy of the protocol which was reviewed.  A translation will be required.
   
   
3. For research where it is not possible to have the work reviewed under a foreign FWA, the IRB may demonstrate that it has obtained necessary information about the local research context through written materials (optional supplemental information), and one or more of the following at the discretion of the IRB: personal knowledge of the local research context on the part of one or more IRB members, discussions with appropriate consultants, review of the study by a local ethics committee or tribal council. In discussion with the investigator, the IRB will determine which method of collecting information is the most appropriate given the nature of the research and the context in which it will be conducted.

1. Written materials may include, for instance, peer-reviewed research publications that provide relevant information about the local research context that would assist the IRB in making its determinations under Section I.A. Written materials alone are not sufficient for a greater than minimal risk study, but may be submitted as supporting information.
   
   
2. Personal knowledge of the local research context on the part of one or more IRB members, such knowledge having been obtained through extended, direct experience with the subject population and their environment.
   
   
3. Appropriate consultant refers to individuals with personal knowledge of the study site, such knowledge having been obtained through extended, direct experience with the subject population and their environment, who are, in the estimation of the IRB qualified to provide an informed and independent review. Finding an appropriate reviewer, however, may take creative thinking depending on the circumstances.  For instance, individuals to contact may include a scholar, the author of a book, article (etc.), or someone who has traveled or lived within the country and whom the IRB deems has appropriate knowledge about the country, etc.
   
   
   1. The consultant(s) will be provided a summary of the study with sufficient information to make a determination under Section I.A. The summary of the protocol may either be provided by the study investigator or drafted by the IRB administration.
      
      
   2. The consultant will review the summary, and the review is to remain confidential. While maintaining final discretion to determine what information is necessary for it to review a protocol, the IRB will take under advisement any concerns the investigator may have about confidential, proprietary or other sensitive issues relating to his/her research.
      
      
   3. Based on the summary, the consultant will be asked to verify that, in his or her judgment, under the study design and for the social/political/cultural conditions of the study site that (as applicable): (1) selection of subjects is equitable; (2) privacy of subjects is protected and confidentiality of data is maintained; (3) informed consent is sought in a language understandable to the subject(s) and under conditions that minimize the possibility of coercion or undue influence; and (4) appropriate safeguards protect the rights and welfare of vulnerable subjects.
   4.  A consultant is just that, a person that the IRB may consult.  Final determination of whether to approve or not approve a protocol remains with the IRB regardless of what a consultant may advise.
4. The investigator can provide the IRB with the name of an appropriate local ethics committee or a tribal council within the country for the study site(s) in question. The protocol can be reviewed by the committee/council, and the information so provided used to assist the IRB in its review.  Language barriers may need to be addressed.

4. Identifying appropriate consultants, local ethics committee or tribal councils

1. The protocol investigators can recommend local ethics committee or tribal councils, or individuals who have personal local knowledge about the site where the foreign work would be conducted. These individuals must be qualified to provide an informed and independent review.
2. The protocol investigators may indicate circumstances where it is not appropriate for local ethics committees, tribal councils, or specific individuals to review the research in question, either to protect human subjects, or to preserve the integrity of the research. The IRB will take under advisement any concerns the investigator may have about confidential, proprietary or other sensitive issues relating to his/her research.
3. The protocol investigators or the IRB administration may use the following means to identify appropriate consultants, local ethics committee or tribal councils if needed:

1. Reviewing the International Compilation of Human Subjects Research Protections http://www.hhs.gov/ohrp/international/HSPCompilation.pdf  is an extremely valuable reference found on the OHRP website that all researchers doing international researcher should be familiar with and adhere to all related requirements. This document contains information from 72 different countries. Language barriers may need to be addressed.
2. Consulting an organization or department within Rutgers or another academic or research institution.
   
   
5. It is not acceptable for the consultant to be one of the following:

1. A friend of the investigator(s)
2. A collaborator on protocols or grants of the investigator(s)
3. Anyone who has personal/professional ties with the protocol investigator(s) that precludes him or her (in the opinion of the IRB) from speaking independently and objectively about the research project
4. Anyone who in the estimation of the IRB is not qualified to conduct the review.

III. For research that involves no greater than minimal risk to subjects

A.  At the discretion of the IRB on a case-by-case basis, written materials alone may suffice for a given minimal risk study (except where foreign institutional approval is also needed. See Section II. B).

1. Written materials may include, for instance, peer-reviewed research publications that provide relevant information about the local research context that would assist the IRB to make its determinations under Section I.A.

2. Written materials may include, at the IRB’s discretion, investigators’ previously published peer-reviewed papers or dissertations that are judged by the IRB to be applicable to the local context for the protocol being reviewed.

3. Non-published, written materials provided by the investigator(s) (e.g., the protocol application itself) may not be the sole source of written material for the evaluation of the protocol by the IRB.

B. Protocol approval by a foreign IRB (or equivalent) may be applicable for a given study when formal collaboration with a foreign institute is involved. Such approval would preclude the need for investigators to provide written materials.

C. For minimal risk research where the protocol has not been approved by a foreign IRB (or equivalent), or the IRB has determined that written materials may not solely suffice for making its determinations under I.a., then the IRB will follow the procedure outlined in Section II for greater than minimal risk research (e.g., if the IRB finds it necessary to seek additional information regarding the risks involved, then independent verification will be needed of the local research context, say, for instance by an individual with personal knowledge of the study site).

IV. Exemptions

A.  In order for the IRB to determine if work qualifies for exemption, information is needed regarding the international work. Therefore, Rutgers applies the regulatory requirements noted above to this type of research.

B.   Since all exempt work must be no greater than minimal risk, please refer to Section III. A. 1. 2. 3. B. C., for guidance regarding the exemption form.
 

V. IRB Applications and Appendices
Protocol applications forms marked as version 3.08 and going forth, include asking whether or not international work will be conducted. Companion appendices are also referenced.

To facilitate the review process for both researchers and IRB reviewers, the following has been done:

A.  The Full/Expedited Application Form to Request Review of a Research Protocol Involving Human Subjects – Version 3.08 found at <http://orsp.rutgers.edu/Humans/downloads/Protocol/hsProtocolForm.doc has been modified to expand question 6. Sites to Domestic/International Sites to include a reference to completing Appendix C Full/Expedited Studies Involving International Research found at http://orsp.rutgers.edu/Humans/downloads/appendix_c.doc which asks specific questions regarding the international research. This valuable document also includes sample responses for each of the questions to provide the researcher with additional guidance.

B.  The Application for Request for Exemption from Full Review- Version 3.08 found at
http://orsp.rutgers.edu/Humans/downloads/Exemption/exemption.doc
has also been modified by adding Question 15 regarding international research and directing researchers who answer in the affirmative to Appendix D Exempt Studies Involving International Research found at http:// orsp.rutgers.edu humans/downloads/appendix_d.doc whichalso asks specific questions about the proposed international research and provides sample responses.
 
C.  The Request for Continuing Review Form version 3.08 found at
http://orsp.rutgers.edu/Humans/downloads/continuing.doc
has also been modified to include brief questions regarding international research and request researchers to complete Appendix C, as sited above, if international work has not been previously reviewed.  

D.  Amendments
If researchers are planning on expanding their approved international work to different countries an amendment must be submitted to the IRB for review and approval prior to the start of new work. In addition, Appendix C cited above in V.B. must be completed.

VII. Contacts

Karen Janes, Associate Director of Research Integrity and Compliance
janes@orsp.rutgers.edu or 732-932-0150 ext. 2105

Michelle Gibel, IRB Administrator,
gibel@orsp.rutgers.edu or 732-932-0150 ext. 2104

Erica Graser, IRB/IACUC Administrator
graser@orsp.rutgers.edu of 732-932-0150 ext. 2113

Lauren Zizza Compliance Administrator
zizza@orsp.rutgers.edu or 732-932-0150 ext.2109

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