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Office of Research Integrity

HRPP 9.3 Transnational Studies Policy and Procedures

Policy Name:  Transnational Studies Policy and Procedures
Approved:
Effective Date: 08/01/2012Page 1 of 5Section: HRPP 9.3
Replaced Policy: 05/05/2012

I.  POLICY

A. Introduction

In reviewing research protocols that will be conducted at international or other non-MUSC University sites, the MUSC IRB must obtain sufficient knowledge of the local Research context in order to fulfill its responsibilities under its FWA and to comply with all applicable required standards.  In particular, the IRB must be sensitive to community attitudes and be able to ascertain the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. All policies and procedures that are applied to research conducted domestically will be applied to research conducted in other countries, as appropriate, including oversight of the following: initial review, continuing review, and review of modifications; post-approval monitoring; and handling of complaints, noncompliance, and UPIRSOs.

B. Regulations

1. In accordance with federal regulations, the MUSC IRB, in reviewing research protocols that will be conducted at a non-MUSC foreign site, must obtain sufficient knowledge about the local research context to ensure that adequate protections are in place for the conduct of the research in that geographic location. Federal Regulations require that IRBs be knowledgeable about the local research context as demonstrated by fulfillment of the following criteria:

a) The IRB's composition must be adequate in light of the scope of the institution's research activities, types of subject populations, appropriateness of proposed review procedures in light of probable risks, and the size and complexity of the institution. [45 CFR §46.103(d)]

b) The IRB's members must be sufficiently qualified through experience, expertise, diversity (including race, gender, cultural background), and sensitivity to such issues as community attitudes to promote respect for the IRB's advice and counsel. [45 CFR §46.107(a)]

c) The IRB must be able to evaluate research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. [45 CFR §46.107(a)]

d) The IRB must also be capable of ensuring that the selection of subjects is equitable, privacy and confidentiality of subjects is maintained, informed consent is sought in language understandable to the subject and in circumstances that minimize the possibility of coercion, and that there are appropriate safeguards protecting vulnerable subjects. [45 CFR §46.111(a)(3),(a)(4),(a)(7),(b) and 46.116]

2. For the purposes of research that may be subject to regulation by the FDA, the FDA Regulations contain essentially the same requirements as those set forth above. [21 CFR 561.07, 56.111(a)(3),(a)(7) and (b)]. Both HHS and FDA Regulations, as well as other Federal regulations, may apply to the same research protocol.

C. Guidance on Additional Requirements of Federal Funding Agencies

Please note that protocols conducted by MUSC and sponsored by any of the following federal agencies

* the Department of Defense (DOD),

* Department of Education,

* Department of Energy,

* Department of Justice (DOJ) / National Institute of Justice (NIJ) and Bureau of Prisons (BOP) or

* Environmental Protection Agency (EPA)

have additional operational and review requirements. In addition, protocols following the International Committee on Harmonisation - Good Clinical Practices (ICH-GHP) have additional requirements. Further information available on the MUSC IRB Resources & Guidance Webpage <http://research.musc.edu/ori/irb/resources.html> ).

II. Definitions

Definitions of the following terms used in this section may be found in HRPP Guide Section 1.3 - Definition of terms

A. Transnational Research (Research conducted outside of the United States of America. )

III. Procedures

A. Knowledge of the local research context is essential for the IRB reviewing and overseeing non-exempt research conducted at an external location/site or for determining that the research is exempt. Sufficient information to assess the local context may be obtained in various ways, depending on the distance and differences between the IRB and the research site, previous experience with the location/site, presence of local collaborators, etc. The information that should be obtained also depends on the nature and scope of the research to be conducted at the site.

B. For research conducted off-site, adequate knowledge of the local context may be obtained in various ways, including the following:

Personal knowledge of one or more IRB members or an appropriate consultant, obtained through direct experience with the site, its populations, and the surrounding community;

Written materials submitted by the investigator or local site contact;

Site visit or conversation with the local site contact or other individual identified by the investigator as being knowledgeable about the research site.

C. For collaborating external investigators engaged in research, documentation of appropriate credentials to perform the proposed research and completion of training in human subjects' protection will be obtained.

D. For research conducted outside of the United States, the following information should be described in the research protocol:

a. Scope and nature of the research activities to be performed at the external location/site;

b. Relevance of the research to the local population's needs and interests;

c. Community in which the research will take place, including any customs or practices (e.g. , cultural, political, or religious) unique to the location/population;

d. Characteristics of the site that may affect selection and/or privacy of participants;

e. Influence of local officials on the population;

f. Literacy rate and language(s) understood by potential participants;

g. Local legal rights of the population (including relevant sub-populations such as women in general, unmarried v. married women, children, etc. );

h. Appropriateness of proposed compensation (if any) at the external location;

i. Facilities/equipment at the external site relevant to research performance and protection of participants;

j. Methods for maintaining confidentiality of data stored and transferred between sites;

k. Communication and oversight plans between MUSC and the external site;

l. How complaints will be reported and to whom;

m. The possibility of including officials from the area in the monitoring of the research;

n. Local standards of care for relevant medical conditions;

o. Applicable laws, site policies, and requirements relevant to the research and how the research team will comply with such.

E. The MUSC IRB must also assure that adequate provisions are made for data and safety monitoring, and take into consideration that some foreign IRBs or Ethics Committees may not require Continuing Review of approved research.

F. The informed consent documents must be in a language understandable to the proposed participants. The IRB encourages investigators to obtain back translations of the foreign language informed consent document(s) to verify translation accuracy. The translator's credentials should be provided in the IRB application. In some circumstances it may be inappropriate to document consent by using the standard written and signed informed consent document. The IRB must take also into account that there may be different laws regarding determination of who may serve as a Legally Authorized Representative (LAR).

G. Documentation Required from PI: The MUSC IRB also requires that the PI provide the following documentation before research that takes place at an international site is approved: an OHRP-approved FWA for the international site, if federally funded; a letter of cooperation showing that the appropriate institutional or oversight officials are permitting the research to be conducted at the site; an OHRP-registered local IRB (Ethics Committee) approval letter for the proposed research if an IRB (or Ethics Committee) exists, or documentation that the IRB (Ethics Committee) has determined that approval is not necessary.

H. The investigator is responsible for completing the amendments, continuing reviews, and reportable events, and for following all IRB policies and procedures. The investigator is responsible for notifying the MUSC IRB promptly if a change in research activities alters the international site's engagement in the research (e.g., an international site previously determined to be "not engaged" begins consenting research participants). The IRB is responsible for monitoring the research as with all other human subjects research under its purview.

I. The Investigator is responsible for providing to the MUSC IRB any reports of correspondence with the foreign institution or site and appropriate documentation of data and safety measures throughout the course of the study, including serious and unexpected adverse events and unanticipated problems to participants or others (e.g. , a breach of participant confidentiality resulting in local ramifications). �Any problems encountered with the research should be reported to the study sponsor, relevant regulatory bodies, and all reviewing IRBs or ECs as appropriate.

J. When necessary, the MUSC IRB will communicate with the host country's IRB or EC, should any of these exist.

K. MUSC General Council is available for consultation regarding questions about the laws of other countries where the research is conducted, particularly biomedical research.

IV. HIPAA Considerations

A. The extent to which HIPAA applies to international research is currently a matter of discussion; however, once individually identifiable health information is received by MUSC (a covered entity), that information becomes protected health information (PHI) (with a narrow exception for overseas foreign nationals receiving health care from US agencies). This means that when a researcher sends individually identifiable health information collected internationally across a MUSC network or stores such information on a MUSC computer or server, the information becomes PHI.

B. Because HIPAA concepts can be difficult to translate in international studies, researchers may request a "Waiver or Alteration of HIPAA Authorization", to ask the IRB to approve altered language or a simplified form of the required authorization language, and/or to approve an oral authorization process. Another option, where cultural barriers are significant, is for the IRB to waive the requirement of HIPAA Authorization entirely. To grant any of these requests, the IRB must determine that the request meets all of the waiver criteria in the HIPAA Privacy Rule. Or the investigator can avoid HIPAA considerations altogether by not bringing PHI to MUSC, and instead bringing only coded de-identified health information, or by bringing only a limited data set with an established data use agreement in place.

V. MEMORANDUM OF UNDERSTANDING

In aspects where the MUSC IRB is being utilized by the Ralph H. Johnson VA Medical Center, both parties will abide by the agreements set forth in the current "Memorandum of Understanding Between The Ralph H. Johnson VA Medical Center And The Medical University of South Carolina Concerning Utilization of the Medical University of South Carolina's Institutional Review Boards".

Transnational human subjects research conducted at the VA requires that the following requirements be met:

1. Permission must be obtained from the chief research and development officer, or designee, prior to initiating any VA-approved international research.

2. The VA facility director must approve any request for permission to conduct international research prior to forwarding it to the chief research and development officer.

3. The researcher must conduct the research in accordance with VA requirements and all other applicable federal requirements for protecting human subjects, tissue banking, use of databases, federal criminal laws, and the standards of ethical conduct for employees of the executive branch.

VI. REFERENCES

A. DHHS Title 45 Part 46

1. 45 CFR §§ 46.103(d);

2. 46.107(a);

3. 46.111(a)(3), (a)(4), (a)(7), (b)

4. 46.116

B. FDA Title 21 Part 56

1. 21 CFR §56.111(a)(3),(a)(7) and (b)

C. OHRP Guidance Document: Knowledge of Local Research Context, July 21, 2000