PROMOTING INFORMED CHOICE
National Council on Ethics in Human Research
774, Promenade Echo Drive
FAX: (613) 730-8251
National Council on
Ethics in Human Research (NCEHR) / Conseil national d'éthique
en recherche chez l'humain (CNÉRH)
The views expressed in this
document are for discussion purposes only.
They do not necessarily reflect those of NCEHR.
Copyright © NCEHR
1996. NCEHR authorizes REBs to photocopy the material.
Selected Bibliography on Informed
The following articles or reports
have been selected to provide researchers and REBs with
basic references to literature that examines central consent
issues involved in ethics and research involving human
participants. Selections have been made based upon the
balanced discussion of issue(s) and provision of reference
lists, or the article's status as a leading contribution
or 'classic' in the field. For a more extensive bibliography,
see the "NCEHR Selected Bibliography: Bioethics of
Research with Human Subjects in the Health Sciences (1983-1993)",
NCEHR Communiqué (Special Supplement) 1995; 6:2.
Annas GJ, Grodin MA. The
Nazi Doctors and the Nuremberg Code. New York: Oxford
University Press, 1992.
This volume contains
a detailed collection of essays examining the origins
of the Nuremberg Code and the legal requirements of
informed consent to human research.
Beecher HK. Ethics and clinical
research. New England Journal of Medicine 1966;
This influential article
drew widespread attention to the ethics of human experimentation
in North America after World War II. Beecher presents
22 examples of unethical medical research and challenges
researchers to consider important issues of autonomy,
informed consent, and scientific integrity. The article
is considered to have made a significant contribution
to the development of research ethics standards in the
Bioethics Line (1-800-MED-ETHX)
Established by the Georgetown
University Kennedy Centre for Ethics, the bioethics
line is used to conduct bibliography searches.
Bok S. Shading the truth in
seeking informed consent for research purposes. Kennedy
Institute of Ethics Journal 1995; 5(1):1-17.
Bok documents a number of
cases in which researchers provided partial information
to gain human subject consent, which prevented these
subjects from weighing the risks of involvement in studies.
She contrasts the Canadian Code of Ethics for Psychologists
with the American Code with respect to deceptive research.
Bok applauds the Canadian Code for its cautionary stance
and argues for two-way truthfulness, toward others and
Council for International Organizations
of Medical Sciences, International Ethical Guidelines
for Biomedical Research Involving Human Subjects.
Council for International Organizations
of Medical Sciences, International Guidelines for Ethical
Review of Epidemiological Studies. Geneva, 1991.
Davis TC, Crouch MA, Wills
G, Miller S, Abdehou DM. The gap between patient reading
comprehension and the readability of patient education
materials. The Journal of Family Medicine 1990;
In a study involving 151
patients, over 60% of participants were found to be
reading at least three grade levels below the grade
last attended. A further 40% of participants were reading
below the 5th grade level, while the written materials
were found to require an average reading comprehension
grade level between the 11th and 14th grades. The authors
recommend that better ways of estimating literacy level
and of improving reading material be found.
Faden RR, Beauchamp T. A
History & Theory of Informed Consent, New York;
Oxford University Press, 1986.
Considered a 'classic', this
book details the historical background and the theoretical
underpinnings of consent to treatment and consent to
Journal of Clinical Epidemiology
1991; 44 Supplement (Entire Issue).
This issue of the Journal
contains a wealth of articles devoted to ethics and
ethical guidelines for epidemiology and epidemiological
research. Contributers include well known ethics experts
including Beauchamp, Capron, and others, as well as
epidemiologists. Topics include ethical theory and epidemiology,
ethical guidelines for epidemiologists, protection of
research subjects, and epidemiologists' responsibilities
to research participants.
Keyserlingk EW, Glass KC, Kogan
S, Gauthier S. Proposed guidelines for the participation
of persons with dementia as research subjects. Perspectives
in Biology and Medicine 1995; 38(2): 319-362.
Based upon a wide consultative
process, this article offers guidelines regarding persons
with dementia serving as research subjects. Due attention
is given to weighing risks and benefits, protecting
the incompetent, voluntariness in consent, and substitute
decision-making. Specific guidelines are offered for
various types and levels of dementia.
King's College, London. Manual
for Research Ethics Committees. London: 3d ed. 1994.
This work contains a useful
compendium of materials for research ethics committees,
principally in the British context.
Kopelman L. Consent and randomized
clinical trials: Are there moral or design problems? Journal
of Medical Philosophy 1986; 11:317-348.
The compatibility of current
consent requirements and randomized clinical trial (RCT)
schemes is considered, first by outlining the key issues
at stake, and then by examining seven RCT designs. The
author concludes that some RCTs are morally troubling
because they compromise physician duties and patients'
rights. This article is very helpful in clarifying moral
dilemmas of RCTs.
Levine RL. Ethics and Regulation
of Clinical Research. New Haven: Yale University Press,
Levine's text is considered
a classic in research ethics and covers a wide range
of topics including significant discussion of informed
consent, deception, privacy and confidentiality, and
specific issues arising from the use of several types
of vulnerable populations in research.
Medical Research Council of
Canada (MRC). Guidelines on Research Involving Human
These guidelines are currently
under review by a Tri-Council Working Group, appointed
by the Medical Research Council of Canada, Natural Sciences
and Engineering Research Council of Canada, and Social
Sciences and Humanities Research Council of Canada.
McCarthy CR. To be or not to
be: waiving informed consent in emergency research. Kennedy
Institute of Ethics Journal 1995; 5(2): 155-162.
McCarthy reviews the current
debate in the US regarding the definition of minimal
risk as a criterion for allowing waivers of informed
consent in emergency situations. He notes the potential
for excluding the economically deprived and minorities
from participation in clinical trials if informed consent
cannot be waived in some emergency situations.
National Council on Ethics
in Human Research (NCEHR). Reflections on Research
Involving Children. Ottawa: 1993.
An NCEHR report that discusses
leading ethical issues raised by research involving
children in Canada.
Parker LS, Lidz CW. Familial
coercion to participate in genetic family studies: Is
there cause for IRB intervention? IRB: A Review of
Human Subjects Research 1994; 16(1,2): 6-12.
Using genetic research as
case example, these authors provide an empirical review
of literature on coercion and families in research and
in treatment. They discuss the role of the IRB in cases
where potential for family coercion to participate exists,
and underscore the importance of trust in subject recruitment
Peterson BT, Clancy SJ, Champion
K, McLarty JW. Improving readability of consent forms:
What the computers may not tell you. IRB: A Review
of Human Subjects Research 1992; 14(6): 6-8.
The authors provide valuable
information about computer programs and their ability
to bridge the gap between subject reading comprehension
and readability of consent forms. As well, they demonstrate
how graphic presentations of the information improve
United States National Institutes
of Health, Office for Protection from Research Risks.
Institutional Review Board Guidebook. Washington,
DC: Government Printing Office, 1994.
A useful guidebook for research
ethics committees, from a US perspective. While its
focus is on US requirements in the ethics review process,
its discussion of the issues often proves helpful at
a generic level.