Tutorial Chapter 16: What are researchersí obligations when doing research in foreign countries?

Case Study:

An American student in the Department of Sociology at NYU who is fluent in Croatian proposes a study for her doctoral dissertation in which she will explore the aftereffects of the civil war during a six month stay in that country.

She believes that participants may not involve themselves to the fullest extent if they realize she is attached to an American university since anti-American feelings run high in the community in which she intends to live.

Since her work is being conducted outside of the US, the researcher feels that she does not have to follow strictly the guidelines established by the UCAIHS.

In fact, she has already started the study by enlisting peers in Croatia to begin conducting interviews on her behalf. The information obtained in these interviews will be used as a basis for the second round of interviews that she will conduct herself when she arrives in Croatia.

Should the investigator continue with her research as planned?

  • A: The researcher is correct in her thinking and can continue with her study since she is working in a foreign country.
  • B: After sharing information with a colleague, the researcher realizes that she may have violated several key requirements for human subjects research and needs to rectify her approach before she continues with any further work.

Foreign governments vary in their approach to research ethics. The Council of Europe, for example, developed guidelines in 1985 which were further reinforced by those published by the European Union in 1990. In addition, recent collaborative efforts between the World Health Organization and the Council for International Organizations of Medical Sciences have resulted in proposed international guidelines for human subjects research that could be used in many areas of the world.

These guidelines mainly reflect those principles expressed in the Declaration of Helsinki.

Common to all the guidelines are:

  • Prior approval by an independent review board
  • Obtaining informed consent from prospective subjects
  • Favorable risk to benefit ratio
  • Equitable selection of subjects
  • Protection of data confidentiality
  • Privacy of subjects.

Recent issuances from world organizations also emphasize the special consideration which is needed when research is conducted by investigators from more developed countries on human subjects in less developed countries and that informed consent needs to be obtained in a way that is sensitive to the particular culture and to the potential for exploiting the subjects.

When the Federal government funds international research, it requires that the procedures prescribed by the study offer protections that are at least equivalent to those provided in the US.

Chapter Review

Question 1

There is a completely consistent approach to research ethics by foreign governments.

Question 2

Research by NYU investigators in foreign countries may be conducted using (select all that apply):

  • the country's own ethical standards
  • Helsinki Code of Ethics
  • the researcher's own personal code of conduct
  • UCAIHS requirements

Question 3

Special consideration should be given by researchers to ensure that subjects in less developed countries are protected from potential exploitation.

Question 4

When the Federal government funds international research it requires that the protections afforded to human subjects are at least equivalent to those afforded in the US.

Next Chapter: What types of decisions can the UCAIHS make?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Glossary
  • References