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Symposium: Bioethics in Scientific Research: Conflicts between Subject's Equitable Access to Participate in Research and Current Regulations

Bioethics in Scientific Research: Conflicts between Subject’s Equitable Access to Participate in Research and Current Regulations¹

Center for Public Health and Health Policy and the Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06268-4017 and ^* Department of Food Science and Human Nutrition, Iowa State University, Ames, IA 50011-1061

²To whom correspondence should be addressed. E-mail: gmarquis{at}iastate.edu.

Recent discussion on the ethics of human research has expanded from a focus on protecting subjects from harm to include a consideration of equal access as it affects participation, research agendas, and funding (1). Scientists working with human subjects have experience with regulations that protect subjects, primarily through the use of the informed consent process that stipulates for the individual participant, the associated risks and benefits, and the right not to participate or to withdraw. However, many scientists have not participated in discussions of the ethics of access to research and the implications that the issues of access have for the health and the well-being of population groups as well as the direction of future research. In addition, the institutionalization of informed consent procedures has occurred without scientific evidence of their effectiveness, especially among marginalized groups.

The articles included in this symposium are not tutorials on institutional review board (IRB) and human subject’s consent regulations. Instead, the authors were charged with developing a discussion on whether the regulations themselves or the application of the regulations prevents individuals or groups from participating in the research and thus, potentially biasing the outcomes. The authors also examined how regulations that were developed primarily for medical, surgical, and pharmacological clinical trials might be viewed with alternative delivery models and in cultures requiring family or community consent for individual participation. Among the issues that the speakers discussed are:

The inclusion of differing societal approaches to decision making and the implications that following or not following such approaches can have on the success of a research protocol. It is generally accepted that parental permission must be granted before a minor can be included in a research protocol. In other situations and societies, similar expectations exist for community approval before an individual can participate or for a husband’s approval before a wife can join a study. What are the moral, ethical, and research implications of seeking such approval and how do these approval processes affect individual consent? Similar questions arise when adults with more limited resources are designated as a "vulnerable" population by the majority society and thus, are due more protection.

The promotion of community involvement in the setting of research priorities, the design of studies, the analysis and evaluation of data, and the decimation of data. To what extent and under what circumstances should research priorities be set by the population studied? How does this priority setting interface with the consent and review process? What rights and controls do study populations have over the decimation of data produced? What tensions develop when the research is not exclusively designed to benefit the population studies?

The assurance of effective and inclusive study recruitment and retention. Societies and subpopulations within those societies have differing expectations for socialization. The researcher who does not understand the subtle messages of those groups may discourage subject participation and inclusion of their data in the analyses and the interpretation of outcomes. For example, some groups expect social distance, whereas others expect the opposite if they are to participate and to continue in the study. Others with minimal or low literacy may be intimidated by extensive consent forms and chose not to investigate participation. How and if these issues need to be part of the review process needs to be addressed.

The above list provides examples of issues that arise when researchers and IRBs seek to imbed "the concept of justice at all levels" (1) in the review and consent process.

In the first article, "Informed consent in the context of communities," Kahn (2) provides an historical overview of the process and the issues relevant to this symposia. The second article, by Burke (3), summarizes the important studies of IRB operations that have influenced policies and procedures, assesses the state of current research, and offers recommendations for research that is needed to inform and perhaps, reform the next generation of human subjects protection in the United States. Because U.S. perspectives and the concept of individual rights underlie the concept of human subjects’ consent, the next article focuses more on applications and issues for the developing world. In the third article "Conducting research in developing countries: experiences of the informed consent process from community studies in Peru," Creed-Kanashiro and colleagues (4) discuss the multiple issues of justice in research, including participant access and obtaining true informed consent from the international perspective. Specific issues that they address are the scope of consent beyond the individual, the appropriateness of verbal rather than written consent, and designing the consent process so that it is easily understandable. In the final article, "Balancing access to participation in research and protection from risks: applying the principle of justice," Kiskaddon (5) discusses the need for continued application of the Belmont principles (6) and the need for the IRB to look beyond meeting the letter of the regulation and to consider the benefit to the participant in the research.

Together, these 4 articles help set an agenda for further consideration of how the multifaceted issues in bioethics influence the process of science and, ultimately, the well-being of the world’s population. Each of the authors makes several suggestions on what is needed for continued dialogue and empirical studies that are needed to ensure the intent of the IRB process for human participation in research meets the intent of the process. The future direction of our societies should be to develop appropriate studies and future symposia that develop this agenda and continue the discussion among members.

	FOOTNOTES

 
¹ Presented as part of the symposium "Bioethics in Scientific Research: Conflicts between Subject’s Equitable Access to Participate in Research and Current Regulations" given at the 2004 Experimental Biology meeting on April 19, 2004, Washington, DC. The symposium was sponsored by the American Society for Nutritional Sciences and the Community and Public Health Nutrition and Nutrition Education Research Interest Sections, and supported in part by an unrestricted grant from the Dannon Institute. The proceedings are published as a supplement to The Journal of Nutrition. This supplement is the responsibility of the Guest Editors to whom the Editor of The Journal of Nutrition has delegated supervision of both technical conformity to the published regulations of The Journal of Nutrition and general oversight of the scientific merit of each article. The opinions expressed in this publication are those of the authors and are not attributable to the sponsors or the publisher, editor, or editorial board of The Journal of Nutrition. The Guest Editors for the symposium publication are Ann M. Ferris, Center for Public Health and Health Policy and the Department of Nutritional Sciences, University of Connecticut, Storrs, CT, and Grace S. Marquis, Department of Food Science and Human Nutrition, Iowa Sate University, Ames, IA.

	LITERATURE CITED

TOP LITERATURE CITED

 

1. Kahn, J. P., Mastroianni, A. C. & Sugarman, J. (1998) Beyond Consent: Seeking Justice in Research 1998 Oxford University Press New York, NY.

2. Kahn, J. (2005) Informed consent in the context of communities. J. Nutr. 135:918-920.[Abstract/Free Full Text]

3. Burke, G. S. (2005) Looking into the Institutional Review Board: observations from both sides of the table. J. Nutr. 135:921-924.[Abstract/Free Full Text]

4. Creed-Kanashiro, H., Oré, B., Scurrah, M., Gil, A. & Penny, M. (2005) Conducting research in developing countries: experiences of the informed consent process from community studies in Peru. J. Nutr. 135:925-928.[Abstract/Free Full Text]

5. Kiskaddon, S. H. (2005) Balancing access to participation in research and protection from risks: applying the principle of justice. J. Nutr. 135:929-932.[Abstract/Free Full Text]

6. National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchDepartment of Health, Education, and Welfare (1978) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research: Appendix (SuDoc Y 3.H 88:2 B 41/APP./V. 1–2) 1978 U.S. Government Printing Office Washington, DC.

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