December 26, 2007 Feature

Ethical and Regulatory Considerations

As our professional and scientific linkages become more global, researchers and students can enrich their experiences and the quality of their science by participating in research outside the United States. This research may be done as an independent investigator at a foreign site, in collaboration with foreign colleagues, on a sub-contract basis—in which one entity provides a research-related service to another—or on a mentoring basis, such as when individuals participate in research at a host laboratory as trainees.

For an example of the types of opportunities available, consider that you, as a U.S. investigator, may engage in a multi-center project designed to explore the prevalence of craniofacial anomalies among various populations. Or, you may offer measurement and analysis services related to neural imaging data gathered in another country. In a third scenario, you spend a sabbatical year working in a laboratory and learning from a colleague in another country.

During the planning for any international research collaboration, a question emerges: which institution, country, regulatory agency, or government entity has oversight responsibilities for your research? Secondly, how might procedures familiar to investigators in the United States change to accommodate the needs of different settings and cultures?

Research Protections

In the most simple case, all research supported by the U.S. Department of Health and Human Services and 13 other federal agencies must include protections described in the so-called "common rule" (CFR Title 45, Part 46). This rule requires that research proposals be reviewed by the investigator's home institution to determine that:

  • Risks to participants are minimized
  • Risks are reasonable in relation to anticipated benefits
  • Selection of participants is equitable
  • Informed consent is sought from each prospective or legally authorized representative
  • Informed consent is appropriately documented
  • Data will be monitored for participant safety, when appropriate
  • Provisions will be made to protect the privacy of the participants and the confidentiality of the data

Federal Regulations

Many U.S. institutions have filed a Federalwide Agreement (FWA), which stipulates that all research conducted by the institution will comply with federal regulations. Any foreign research would be held to the same procedures and standards as federally funded research. In addition, many foreign entities have filed FWAs with the United States. This means that the protections and procedures followed by those entities are considered to meet the U.S. standards and that review procedures in those countries will be equivalent to those in the United States. If foreign colleagues are collaborating in research that receives federal funding at your home institution, then the foreign entity will be required to file an FWA with the United States.

If the foreign entity does not have an FWA and you are not funded by the federal government, your home institution has more latitude. When research covered by the common rule takes place in foreign countries, the usual procedures to protect human subjects may differ from those in the federal regulations. An example is a foreign institution that complies with guidelines consistent with the World Medical Assembly Declaration, known as the Declaration of Helsinki, amended 1989. If a review determines that the procedures prescribed by the institution provide protections that are at least equivalent to those in the federal policy, then the substitution of foreign procedures is permitted.

These guidelines make it easier to determine oversight responsibilities for research conducted outside of the United States. If the research is supported by federal funding, then the institution that receives the federal funds will be responsible for the oversight, no matter where the research is conducted. If the home institution has filed an FWA that stipulates all research will be reviewed in the same way, then your work in another country will be monitored by your Institutional Review Board (IRB) regardless of the source of support.

Adapting Research

In conducting research outside the United States, how might you meet the intention of federal regulations while adapting procedures to the local context? Guidance can be found in the ethical principles originally outlined in the Belmont Report (1979):

  • Respect for Persons—requires that persons should be treated as autonomous agents and that persons with diminished autonomy (e.g., children, elderly, prisoners) are entitled to protection
  • Beneficence—stipulates that persons are treated in an ethical manner by respecting their decisions and protecting them from harm
  • Justice—benefits of the research activity should be distributed to persons on some rational basis

In addition, the principle of respect dictates that the sovereignty of the foreign site be honored. The International Compilation of Human Subjects Research Protections [PDF], 2007 edition provides a country-by-country breakdown of responsible agencies.

Putting It Together

The following hypothetical cases demonstrate how these regulations apply to specific situations.

Case 1. You wish to travel to a remote location to study spoken language produced by children and adults. First, recognize the sovereignty of the location. Determine if a special visa is needed to conduct the research, and if permission is required at a national, regional, or local level. Regulations regarding informed consent should be interpreted in a local context. For example, a village leader may be the appropriate person to provide consent for all participants. Written documentation of consent may be waived if the participants typically do not sign documents, or if they are unable to read. If you want to obtain audio recording of utterances produced by the participants, your IRB will probably want to know if any participant's identity can be determined by listening to the tapes and when the tapes (not transcripts) would be destroyed.

Case 2. As part of a research project, international colleagues will send you MRI images for analysis. If the images have been de-identified and you do not obtain information directly from the participants, then you could take the position that your work does not involve human participants. However, if your contribution results in a published article that lists you as an author, be aware that the federal government may determine that you engaged in research without prior IRB review. It would be best to approach your IRB prior to the study; present a proposal that emphasizes that you will be examining de-identified records that were collected with appropriate institutional approval at the original site and that your research poses only minimal risk to participants. Stipulate what would happen if you were to discover a previously undetected pathology in your review of the images. Your IRB will probably give you a letter exempting your role in the project from oversight.

In spite of the proliferation of laws, regulations, guidelines, and oversight panels throughout the world, collaborative research can be undertaken globally with confidence that appropriate protections are in place if the investigators are mindful of the principles that drive the regulations. Information about virtually all research settings can be accessed easily on the Web. Interagency communication is improving and discrepancies created by geographic and political boundaries are lessening. These changes should facilitate collaborations within an international community of investigators who hold common interests in addressing research problems.

Theodore J Glattke, is a professor of speech, language, and hearing sciences at the University of Arizona. He is the founding (now emeritus) chair of the University of Arizona Social and Behavioral Sciences Institutional Review Board. Contact him at glattketj@comcast.net.

cite as: Glattke, T. J. (2007, December 26). Ethical and Regulatory Considerations. The ASHA Leader.

  

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