Transnational StudiesTransnational Studies

IRB’s evaluation of a researcher’s plan for IRB’s evaluation of a researcher’s plan for complying with local laws and customs when complying with local laws and customs when

conducting transnational researchconducting transnational research

AAHRRP Element I.3AAHRRP Element I.3

The Organization’s transnational The Organization’s transnational research activities are consistent with research activities are consistent with the ethical principals set forth in its the ethical principals set forth in its Human Research Protection Program Human Research Protection Program and meet equivalent levels of and meet equivalent levels of participant protection as research participant protection as research conducted in the Organization’s conducted in the Organization’s principal location while complying principal location while complying with local laws and taking into with local laws and taking into account cultural context.account cultural context.

HRPP 9.3HRPP 9.3 Transnational Studies Policy and Transnational Studies Policy and

ProceduresProcedures

When reviewing research protocols that will When reviewing research protocols that will be conducted at a non-MUSC foreign site, be conducted at a non-MUSC foreign site, the MUSC IRB must obtain the MUSC IRB must obtain sufficient knowledge about the sufficient knowledge about the local research context local research context (local laws, (local laws, customs and requirements)customs and requirements) to ensure to ensure that adequate protections are in that adequate protections are in place for the conduct of the place for the conduct of the research in that geographic research in that geographic location.location.

Ways To Obtain Knowledge Of Ways To Obtain Knowledge Of Local ContextLocal Context

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

Written materials submitted by the investigator or Written materials submitted by the investigator or local site contactlocal site contact

Researchers may retain local lawyer to receive information Researchers may retain local lawyer to receive information on local laws and submit information to IRBon local laws and submit information to IRB

Researchers may rely on a strong collaborator to stay Researchers may rely on a strong collaborator to stay abreast of local details. This collaborator would be someone abreast of local details. This collaborator would be someone who has done research in the past in country or a local who has done research in the past in country or a local collaborator.collaborator.

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

Research ProtocolResearch Protocol

-Scope and nature of the research activities to be performed at the -Scope and nature of the research activities to be performed at the externalexternal

location/site;location/site;

-Relevance of the research to the local population’s needs and-Relevance of the research to the local population’s needs and interests; interests;

-Community in which the research will take place, including any -Community in which the research will take place, including any customs orcustoms or

practices (e.g., cultural, political, or religious) unique to the practices (e.g., cultural, political, or religious) unique to the location/population;location/population;

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

-Influence of local officials on the population; -Influence of local officials on the population;

Protocol Should Include (Cont.)Protocol Should Include (Cont.)

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

-Local legal rights of the population (including relevant sub-populations -Local legal rights of the population (including relevant sub-populations such assuch as

women in general, unmarried v. married women, children, etc.); women in general, unmarried v. married women, children, etc.);

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

-Facilities/equipment at the external site relevant to research performance -Facilities/equipment at the external site relevant to research performance andand

protection of participants; protection of participants;

-Methods for maintaining confidentiality of data stored and transferred -Methods for maintaining confidentiality of data stored and transferred betweenbetween

sites;sites;

Protocol Should Include (Cont.)Protocol Should Include (Cont.)

-Communication and oversight plans between MUSC and the external site;-Communication and oversight plans between MUSC and the external site;

-How complaints will be reported and to whom; -How complaints will be reported and to whom;

-The possibility of including officials from the area in the monitoring of the-The possibility of including officials from the area in the monitoring of the

research; research;

-Local standards of care for relevant medical conditions; -Local standards of care for relevant medical conditions;

-Applicable laws, site policies, and requirements relevant -Applicable laws, site policies, and requirements relevant toto

the research and how the research team will comply withthe research and how the research team will comply with

such.such.

HIPAA ConsiderationsHIPAA Considerations

The extent to which HIPAA applies to The extent to which HIPAA applies to international research is currently a matter of international research is currently a matter of discussion; however, once individually discussion; however, once individually identifiable health information is received by identifiable health information is received by MUSC (a covered entity), that information MUSC (a covered entity), that information becomes protected health information (PHI).becomes protected health information (PHI).

When a researcher sends individually When a researcher sends individually identifiable health information collected identifiable health information collected internationally across a MUSC network or internationally across a MUSC network or stores such information on a MUSC computer stores such information on a MUSC computer or server, the information becomes PHI.or server, the information becomes PHI.

Helpful Tips for IRB Helpful Tips for IRB ReviewersReviewers

Look for “key personnel” on the study who are Look for “key personnel” on the study who are local or and who have done research there local or and who have done research there before.before. Red flag – no local personnel on a study, or no local Red flag – no local personnel on a study, or no local

Co-I who is trained in research.Co-I who is trained in research. Did the researcher consult with Non-Did the researcher consult with Non-

Governmental Organizations? These Governmental Organizations? These organizations are often helpful to researchers organizations are often helpful to researchers as they have great links to communities.as they have great links to communities.

Its important to get a sense of how much time Its important to get a sense of how much time the US Investigator has spent in country and the US Investigator has spent in country and how much homework has taken place on the how much homework has taken place on the US Investigator’s part?US Investigator’s part?

Helpful Tips for IRB Helpful Tips for IRB Reviewers (Cont.)Reviewers (Cont.)

Issues of participant safety are Issues of participant safety are difficult to assess from afar. Routine difficult to assess from afar. Routine procedures might be quite risky in procedures might be quite risky in some settings.some settings. Find out if study procedures are new in Find out if study procedures are new in

a setting. If so, some basic write up on a setting. If so, some basic write up on local safetylocal safety would be useful. would be useful.

COMMUNICATIONCOMMUNICATION

When necessary, the MUSC IRB will When necessary, the MUSC IRB will communicatecommunicate

with the host country’s IRB or EC.with the host country’s IRB or EC.

Questions?Questions?

Stacey Goretzka Stacey Goretzka

IRB Program Manager IRB Program Manager goretzka@musc.edu

843-792-6527843-792-6527