Proposed Model Ethical Protocol for Collecting DNA Samples

Proposed Model Ethical Protocol for Collecting DNA Samples, Prepared by the North American Regional Committee of the Human Genome Diversity Project (1998)

TABLE OF CONTENTS

Introduction -- How to Use This Document 1

I. An Overview of the Ethical Issues and the Collecting Process 2

II. Before Contacting the Population 4

III. Making Contact with the Population 6

IV. Informed Consent 7

A. From Whom Should Consent Be Sought? 7

1. Individual Consent 7
2. Group Consent 8

B. When Should Consent Be Sought? 11
C. What Information Should be Provided and How? 12
D. What Form Should Consent Take? 14

V. Providing Benefits to Participating Populations 15

A. Honesty 16
B. Legality 16
C. Appropriateness 17

1. Appropriate in Nature 17
2. Appropriate in Scale 17
3. Appropriate in Distribution 18

VI. Medical Services 18

A. Medical Treatment 19
B. Medical Capabilities 20
C. Medical Screening 20

1. On-Site Screening 20
2. Screening of Samples 21

VII. Privacy and Confidentiality 22

A. Privacy in the Field 23
B. Individual Confidentiality 23
C. Group Confidentiality 24
D. Control of Confidentiality 25

VIII. Education and Racism 25

IX. Questions of Ownership and Control 26

A. Patenting and Commercial Use 26
B. Other Issues 28

X. Partnerships with Participating Populations 28

A. Involvement of the Population in Planning the Research 29
B. Involvement of the Population in Conducting the Research 30
C. Involvement of the Population in the Results of the Research 31

Conclusion 32



Introduction

How to Use This Document

This document is a Model Ethical Protocol for collecting DNA samples for the Human Genome Diversity Project (HGD Project). The HGD Project is an international effort to collect, preserve, analyze, and make available genetic and ethnographic information from people all around the world. The Project expects that its work will lead to advances in understanding the biological development and the history of our species and, ultimately, in understanding and treating many diseases with genetic components. The Project will collect DNA samples and ethnographic information from communities throughout the world, thus correcting the current bias in research in human genetics toward people of European descent. The Project expects that the samples will be preserved in repositories where they will be available to all qualified researchers. The samples will be analyzed, and the results of these analyses will be widely available through computerized databases. The Project is currently in its early stages and is still largely being planned.{1}

The Project is organized into different regional committees, coordinated by an international executive committee. This Model Protocol has been produced under the auspices of the North American Regional Committee of the Project and is intended to guide HGD Project sampling done in the North American region or sponsored by institutions within that region. That Committee hopes that the Protocol will also be helpful to HGD Project researchers and institutions in other parts of the world and even to researchers not involved in the HGD Project.

This document is intended as a guide to the ethical issues that will be encountered in collecting samples for the Project. The issues that the Protocol discusses are numerous and complex, but they are not new. They necessarily have been confronted in various contexts in anthropology, medicine, genetics, and many other fields.

In preparing this document, the North American Regional Committee has relied heavily on the work of others who have examined these issues. The Council for International Organizations of Medical Sciences has prepared two documents that were particularly useful: INTERNATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (1993) and INTERNATIONAL GUIDELINES FOR ETHICAL REVIEW OF EPIDEMIOLOGICAL STUDIES (1991). The Committee has also taken into consideration the 1982 Proposed International Guidelines for the Conduct of Biomedical Research by the CIOMS; the fourth edition of the Declaration of Helsinki of the World Medical Association; the Nuremberg Code; and United States regulations for the Protection of Human Subjects, among other sources.{2} We intend the Model Protocol to be consistent with those authorities.

At the same time, none of those authorities provides a direct discussion for the unique combination of ethical issues faced by the Project. This Model Protocol is intended to fill that gap, by applying the ethical principles set forth in those documents to the HGD Project's concrete challenges. We expect it to be useful to at least four different constituencies.

First, the Model Protocol is intended to provide detailed and specific advice to researchers involved in the HGD Project. We want it to state important principles and rules, to show researchers non-obvious issues that may arise, and to discuss usefully the complexities that may confront them in the field.

Second, the Model Protocol should be useful to populations that are participating or considering participating in the HGD Project, or other similar research projects. It may help them understand better some of the possible implications of participating in the Project and may serve as a way to test the good faith and sophistication of the researchers that approach them. Populations may learn of the Model Protocol directly or through the assistance of non-governmental or governmental organizations.

Third, the Model Protocol should be useful to Institutional Review Boards or other groups that review human subjects research. We have written the Model Protocol with those kinds of organizations in mind. We hope that they will use the Model Protocol to judge whether proposed research projects have given sufficient consideration to the ethical issues their work may raise and whether their plans for informed consent are appropriate. Similarly, sources for research funding, public or private, should find the Model Protocol useful in assessing applications for financial support.

Finally, the Model Protocol will guide the work of the North American Regional Committee of the HGD Project. Activities within North America or sponsored by North American institutions will not be accepted as part of the HGD Project unless they comply with these guidelines. The North American Regional Committee will provide no endorsement or support, including funding support it that becomes available, to researchers who violate the Protocol's principles. The Project may refuse to accept into its repositories any samples collected in violation of this Protocol or refuse to include in its databases any analyses of samples so collected. (The North American Regional Committee may apply similar penalties to failure to comply with other HGD Project protocols, such as those on the collection of ethnographic information.) We expect this Protocol to be the main guide for the North American Regional Committee in ensuring that its part of the Project is carried out in an ethical manner.

Notes
{1} More-detailed information about the Project is available from its North American Regional Committee, c/o Morrison Institute for Population and Resource Studies, Stanford University, Stanford, CA 94305-5020; by electronic mail to morrison@forsythe.stanford.edu.
{2} A particularly good discussion of many of the issue involved can be found in a symposium issue of Law, Medicine, and Health Care devoted to the CIOMS epidemiological guidelines. The articles by Barnard M. Dickens, A. M. Capron, Larry Gostin, Robert J. Levine, Nicholas A.