National Council on Ethics in Human Research                        Conseil national d'éthique en recherche chez l'humain
 
 

S U P P L E M E N T   

Volume 7 Number 2
NCEHR Communiqué CNERH
December 1996

S U P P L E M E N T

FACILITATING ETHICAL RESEARCH:
PROMOTING INFORMED CHOICE

Discussion Document


National Council on Ethics in Human Research
(NCEHR)


774, Promenade Echo Drive
Ottawa, Canada

TEL: (613) 730-6225
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.
ISSN 1181-8778

Table of Contents

Introduction

Section 1

Consent as an Ethical Imperative: Key Elements of Informed Choice

Section 2.

Competence and Informed Choice

Section 3.

Disclosure and Informed Choice

Section 4.

Voluntariness and Informed Choice

Section 5.

Sample Consent Forms and Checklist

Section 6.

Selected Bibliography on Informed Choice

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Section 6:

Selected Bibliography on Informed Choice

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; 274(24):1354-1360.

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 US.

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 oneself.

Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, 1993.

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; 31(5): 533-538.

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 research.

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, 1986.

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 Subjects 1987.

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 for research.

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 readability.

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.