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Research Question

  1. How can researchers working with human subjects obtain informed consent when potential subjects have cultural biases against signing consent forms, limited literacy, or other barriers to signing?

Ethical and legal considerations require that human research subjects who provide certain kinds of information be able to provide informed consent when doing so. Obtaining consent from older people and from people with low levels of literacy or limited language fluency can pose challenges. For field trials, researchers evaluating the impact of a pension program in Yucatan sought to develop an informed-consent procedure that was culturally sensitive and complied with Mexican norms and standards and with U.S. government and RAND Corporation ethical standards for conducting research with human subjects. This report documents the process the research team developed to obtain informed consent from those choosing to participate in the research; provides background on the development of norms and regulations for conducting research involving human subjects in the United States and Mexico; and reviews how the team developed and tested a culturally sensitive approach for collecting informed consent among the elderly in Yucatan, including testing of methods and subsequent adaptations. Finally, it reviews the implications of the findings for similar future research efforts.

Key Findings

Researchers Encountered Barriers in Obtaining Informed Consent from Potential Elderly Human Subjects in Yucatan

  • Many similar studies in Mexico rely on oral consent, which was not likely to be sufficient under U.S. regulations and RAND policies.
  • Subjects in Yucatan distrusted, did not understand, or could not read lengthy, complex written consent forms.

Researchers Found Creative Ways to Obtain Informed Consent While Complying with Legal Requirements and Population Norms

  • Researchers could sign forms as witnesses of the consent given, and subjects would not have to sign the forms themselves.

Recommendation

  • Obtaining informed consent should not overburden potential research participants or discourage them from participating in the research.

Table of Contents

  • Chapter One

    Introduction

  • Chapter Two

    Norms and Regulations for Human-Subject Research in Mexico and the United States

  • Chapter Three

    Developing and Testing Informed-Consent Methods Among the Elderly in Yucatan

  • Chapter Four

    Conclusion

The research described in this report was made possible with funding from the government of the state of Yucatan, the U.S. National Institute on Aging (NIA), RAND Center for the Study of Aging, RAND Labor and Population, and the Center for Latin American Social Policy (CLASP).

This report is part of the RAND Corporation technical report series. RAND technical reports may include research findings on a specific topic that is limited in scope or intended for a narrow audience; present discussions of the methodology employed in research; provide literature reviews, survey instruments, modeling exercises, guidelines for practitioners and research professionals, and supporting documentation; or deliver preliminary findings. All RAND reports undergo rigorous peer review to ensure that they meet high standards for research quality and objectivity.

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