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
Ann M. Ferris and Grace S. Marquis2*
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
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 participa-
tion, 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 impli-
cations 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 ef-
fectiveness, 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 pharmaco-
logical clinical trials might be viewed with alternative delivery
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 Nutri-
tional Sciences, University of Connecticut, Storrs, CT, and Grace S. Marquis,
Department of Food Science and Human Nutrition, Iowa Sate University,
Ames, IA.
2
To whom correspondence should be addressed.
E-mail: gmarquis@iastate.edu.
0022-3166/05 $8.00 © 2005 American Society for Nutritional Sciences. J. Nutr. 135: 916 –917, 2005.
916
models and in cultures requiring family or community consent
for individual participation. Among the issues that the speak-
ers discussed are:
● The inclusion of differing societal approaches to decision
making and the implications that following or not fol-
Downloaded from jn.nutrition.org by on July 25, 2009
lowing 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 in-
cluded in a research protocol. In other situations and
societies, similar expectations exist for community ap-
proval before an individual can participate or for a hus-
band’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 “vulner-
able” 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 re-
search 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 pop-
ulations have over the decimation of data produced?
What tensions develop when the research is not exclu-
sively designed to benefit the population studies?
● The assurance of effective and inclusive study recruit-
ment and retention. Societies and subpopulations within
those societies have differing expectations for socializa-
tion. The researcher who does not understand the subtle
messages of those groups may discourage subject partici-
pation and inclusion of their data in the analyses and the
interpretation of outcomes. For example, some groups
expect social distance, whereas others expect the oppo-
site 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.
 BIOETHICS IN SCIENTIFIC RESEARCH
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, as-
sesses the state of current research, and offers recommenda-
tions 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 “Conduct-
ing research in developing countries: experiences of the in-
formed consent process from community studies in Peru,”
Creed-Kanashiro and colleagues (4) discuss the multiple issues
of justice in research, including participant access and obtain-
ing 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
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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 in-
fluence 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.
LITERATURE CITED
1. Kahn, J. P., Mastroianni, A. C. & Sugarman, J. (1998) Beyond Consent:
Seeking Justice in Research. Oxford University Press, New York, NY.
2. Kahn, J. (2005) Informed consent in the context of communities. J.
Nutr. 135: 918 –920.
3. Burke, G. S. (2005) Looking into the Institutional Review Board: ob-
servations from both sides of the table. J. Nutr. 135: 921–924.
4. Creed-Kanashiro, H., Oré, B., Scurrah, M., Gil, A. & Penny, M. (2005)
Conducting research in developing countries: experiences of the informed con-
sent process from community studies in Peru. J. Nutr. 135: 925–928.
5. Kiskaddon, S. H. (2005) Balancing access to participation in research
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and protection from risks: applying the principle of justice. J. Nutr. 135: 929 –932.
6. National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research. Department 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).
U.S. Government Printing Office, Washington, DC.