Guidance for Graduate Students Planning to Conduct Research in International Settings
University of Michigan, School of Nursing
Office of International Affairs
GUIDANCE ON CONDUCTING HUMAN SUBJECT RESEARCH IN INTERNATIONAL SETTINGS
IRB Health Science and IRB Behavioral Sciences
The School of Nursing and its faculty are responsible for ensuring that student research in international settings is conducted according to ethical guidelines, and follow University of Michigan policies and procedures. Faculty assist students in preparing material for the University of Michigan Institutional Review Board [IRB], and monitor students' compliance with approved protocol for the duration of the research project.
Students who plan to conduct research in international settings need to prepare and plan the timing of activities with care so that they may complete their work while meeting policy requirements of the University of Michigan.
A crucial starting point is for students to develop their research proposals and to obtain the approval of their faculty committees. No further steps can be taken without faculty committee approval that assures scientific merit.
The following information was provided by the offices of the Institutional Review Boards (IRBs) for Health Science and Behavioral Sciences. This information, while not specific to students in nursing, provides a brief overview of the issues that students planning to conduct research in an international setting should consider. More information can be found at the links within this document.
Undertaking human subjects research outside of the United States may create complex situations for the Institutional Review Board (IRB) responsible for review and oversight of the research and for principal investigators performing the research.
Research conducted internationally may present challenges for investigators that are not often encountered in domestic research studies: political instability, unfamiliar cultures and languages, insufficient electronic communication capabilities, and unfamiliar international regulations. Additionally, the research may pose unique or uncertain risks to the subjects as compared to risks that are well-understood in the United States.
This document is intended to provide a roadmap to issues that principal investigators should consider when undertaking international research. It is not exhaustive in its consideration of the issues; investigators should consult with their IRBs for additional information and guidance throughout their IRB application process and during the conduct of the study. Additional resources are also located on the Office of Human Research Protection (OHRP) website at: www.hhs.gov/ohrp/policy/index.html
Issues to Consider:
Funding Sources
Federal Funding (HHS)
Department of Health and Human Services (HHS) regulations require that each institution engaged in human subjects research must have an OHRP-approved Federalwide Assurance (FWA) and registered IRB. An institution is considered engaged when it receives a direct HHS award to support the research or when its employees or agents (i) intervene or interact with living individuals for research purposes, or (ii) obtain individually identifiable private information for research purposes. The University of Michigan already has its own FWA and registered IRBs according to these terms.
If a U-M investigator (student or faculty) is using an HHS award to conduct human subjects research at an engaged site, the site must also have an international FWA and registered IRB.
For further guidance on these topics and for information about international FWA’s (including lists of international institutions which already hold FWAs) see the OHRP website at: www.hhs.gov/ohrp/assurances/assurances_index.html
Federal Funding (non-HHS)
If sites are engaged, but the research is conducted with non-HHS federal funds, the U-M IRB may seek a written determination from the federal agency that an international FWA is not required. If no FWA is required by the agency, the U-M IRB will consider whether alternative mechanisms such as an ethics board review in the host country (or other similar review mechanism) are necessary to provide additional protections to the human subjects.
Non-Federal Funding
If sites are engaged, but the research is conducted without any federal support, an international FWA and IRB are not required. The U-M IRB will consider whether alternative mechanisms such as an ethics board review in the host country (or other similar review mechanism) are necessary to provide additional protections to the human subjects.
Any Funding Source – Not Engaged
International sites which are not engaged in the research, regardless of funding source, do not require an international FWA and IRB. The U-M IRB will consider whether alternative mechanisms such as an ethics board review in the host country (or other similar review mechanism) are necessary to provide additional protections to the human subjects.
Risks to Subjects
Like research conducted domestically, principal investigators conducting international research must design the study to minimize the risks to human subjects. Carefully consider the following:
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Is the research topic stigmatizing? Is the nature of the risk well understood and minimized in the study design? Is the stigmatization different than in the US?
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Is the compensation appropriate for the culture? Does it unnecessarily identify the subject with the study (a U-M mug as a token gift for a study about sexually transmitted diseases)?
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Will the study unintentionally identify a subject that is engaged in illegal behaviors?
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What is the age of consent in the country?
International Regulations
University of Michigan investigators are responsible for following all appropriate regulations and laws of the country in which they conduct their research. OHRP lists many of the relevant regulations at the following website:
www.hhs.gov/ohrp/international/HSPCompilation.pdf
Students as Principal Investigators
The University of Michigan allows students (undergraduate and graduate) to assume the role of principal investigator on research studies. Along with their faculty mentor (required for students), they accept full responsibility for the ethical conduct of the research study and compliance with laws and regulations. Conducting international research requires additional planning as many students travel without faculty accompaniment. Students should consider the following in developing their international research study:
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Select a U-M faculty mentor with an active interest in students and experience with the research topic. Faculty should be available to advise and problem-solve in spite of communication challenges due to time zone differences and remote locations.
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Develop solid international connections and resources to facilitate navigating challenging political, cultural or social situations.
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Design a project which is manageable in its scope. Carefully consider what can be accomplished according to academic timeframes. Projects which are too ambitious create challenges for the investigator and the IRB and may lead to non-compliance with the research protocol. Consider a project design that allows the IRB to approve a range of research procedures in order to reduce the number of amendments that must be submitted to the IRB if a change in study design is necessary.
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Personal safety as well as the safety of the research data should be carefully considered and managed. Sensitive data that is lost or stolen could have very serious consequences for the research subjects and/or the investigator.
Resources
Office of Human Research Protections: www.hhs.gov/ohrp
University of Michigan Operations Manual: www.hrpp.umich.edu/om
IRB Health Science & IRB Behavioral Sciences: irbhsbs@umich.edu or 734-936-0933.
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University of Michigan School of Nursing
Office of International Affairs
SNB, Room 3216
400 North Ingalls
Ann Arbor, MI 48109-5482
Contact: Shaké
Ketefian, EdD, RN, FAAN,
Professor and Director of OIA
Tel: 734-763-6669
Fax: 734-615-3798
Email: ketefian@umich.edu
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