Appendix E: Guidelines for Informed Consent for Human Subjects in a Study

INTRODUCTION

One of the most important components of research involving human subjects is that of informed consent.

For the purpose of these guidelines, informed consent will be defined as: Consent freely given by a participant in a research project based upon full disclosure of the procedures that the individual will undergo.

GENERAL INFORMATION

The consent form should be written in terms comprehensible to the lay person and should include all information about the study that any reasonable person would need and want to know. It should, realistically and honestly, express what a participant may expect, and should avoid persuasion by raising false hopes.

Informed consent forms used for research programs are not legal documents, although there have been adverse legal decisions in cases where informed consent was felt to be sufficiently lacking.

Informed consent is to be obtained from every person who agrees to participate in any program falling under the jurisdiction of the Consent Committee. The consent form for each study is to be submitted to the Committee with the approved protocol before the beginning of any part of the investigation.

All efforts should be made so that the participant fully understands the information obtained in the informed consent, despite any complicating factors, such as mental incompetence, language difficulties, illiteracy, age, and so forth. If it appears that patients, parents, or guardians are incapable of comprehending this information, the executive officers should be notified and a member of the Consent Committee will be made available. In cases of a language barrier, the executive officer will obtain the assistance of a knowledgeable person in that language to translate the informed consent or interpret during the explanation. Should the participant have questions, and so forth, regarding the research once it has begun, the participant will again be provided with an interpreter.

A. WRITTEN INFORMED CONSENT

A standardized format has been devised in order to facilitate writing of informed consent.

Using the standardized format, the following elements should be included:

• Description and explanation of procedure

• Risks and discomforts

• Potential benefits

• Alternatives

• Consent

1. DESCRIPTION AND EXPLANATION OF PROCEDURE

The basic procedures of the research should be stated clearly and concisely in nontechnical terms. Special note must be made of any part of these procedures that are experimental. The purpose of the study should be described, and the reason this person is being asked to participate should be explained.

2. RISKS AND DISCOMFORTS

List in simple terms the most serious risks and those most likely to occur. For each risk or hazard, whenever applicable, answer such questions as:

• How much will it hurt?

• How long will it take?

• What danger will ...