Informed Consent, Part 3

by National Cancer Institute

(Page 3 of 5)

P1979 - The Belmont Report

After four years of work, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report sets forth three principles underlying the ethical conduct of research:

1. respect for persons: recognizing the autonomy and dignity of individuals, and the need to protect those with diminished autonomy (i.e., impaired decision-making skills), such as children, the aged, and the disabled;
2. beneficence: an obligation to protect persons from harm by maximizing benefits and minimizing risks;
3. justice: fair distribution of the benefits and burdens of research.

The Belmont Report explains how these apply to research practices; for example, it identifies informed consent as a process that is essential to the principle of respect. In response to the report, both the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration revised their regulations on research studies that involve people.

P1991 - Federal Policy for the Protection of Human Subjects

This policy was adopted to ensure a uniform system of protections in all federal agencies and departments that conduct research.

What to Expect

What Should I Expect During the Informed Consent Process?

According to The Belmont Report, the informed consent process relies on three principles:

• adequate information is provided (generally, what a "reasonable person" would want to know to make a decision);
• participants comprehend the information; and
• consent is given voluntarily.

While this process varies among different research institutions and clinical centers, you generally should expect the following:

An initial meeting during which a member (or members) of the research team provides you with the informed consent document and explains its content to you. This discussion may also include your oncologist (cancer specialist) and primary care doctor, as well as a nurse, social worker, patient representative, and/or staff psychologist. You may wish to bring along a family member or friend for support, and to help you keep track of the information presented. This information should be given logically and at a comfortable pace, with plenty of time allowed for you to consider it and ask questions. You may be given a video, audiotape, or even an interactive computer program to help you better understand the information in the consent document.

If your child (under age 18) is the one who will participate in the clinical trial, you will go through this process on his or her behalf. More and more frequently, children over the age of 6 are being asked to give their "assent" to participation as well. If this is the case, you will be asked to give permission for your child to take part in the assent process. During this process, a child or teenager is provided with a form that explains, in concrete and age-appropriate terms, the purpose of the research, what they will be asked to do, and what procedures they will undergo. Usually, a nurse or other heath professional also explains the information and gives the child a chance to ask questions. Then they are asked to indicate their assent either by signing the form or making a mark in a specific place.

The following example gives you an idea of what a child participant assent form might look like:

CHILD PARTICIPANT ASSENT FORM (approximate ages 7-12) [TITLE OF STUDY] [SAMPLE WORDING OF A DRUG STUDY ASSENT] Dr. __________ is doing a research study to find out how a new medicine works in kids who have (name of condition in common term). You are being asked if you want to be in this research study because you have (name of condition). If you decide that you want to be in this research study, this is what will happen to you: 1. Dr. ______ will give you some medicine to take for the next 5 days. It might be the new medicine or it might be the medicine that you would get if you weren't in this research study. You won't know which one you get and Dr. ______ won't know what you get either. 2. You will have to have a needle stick today (like a shot) to take some blood out of your arm. Dr. _______ has to take some more blood out of your arm in 5 days to find out if the medicine you are taking is making you better. And even if you don't want to do the research study, you are still going to get a needle stick today because you're sick. 3. If you still are not getting better after 5 days, Dr. ____________ will (tell them what to expect such as being given another medicine or other treatment). Sometimes kids don't feel good after they take the medicine. They might feel these things: an upset stomach very sleepy a headache get a rash on their skin If you feel any of these things, be sure to tell your mom or dad. You don't have to be in this research study if you don't want to. Nobody will be mad at you if you say no. Even if you say yes now and change your mind after you start doing this study, you can stop and no one will be mad. Be sure to ask Dr. ______ to tell you more about anything that you don't understand. Yes, I will be in this research study. No, I don't want to do this. _____________________________________________ Write your name on this line ____________________ Date

Time to digest the information. It can be very difficult to absorb this information in one sitting, especially at a time of emotional distress. You should be given a copy of the document so that that you can take it home, review it as many times as you need, and discuss it with family, friends, social workers, clergy, a patient representative, or other trusted advisors.

Assessment of your understanding. The research team should take some steps to ensure that you comprehend the information, either by having you fill out a questionnaire, asking you questions orally, or having you explain certain aspects of the trial in your own words. You also should alert team members to anything you do not understand. If you find that the document is written in words that are too difficult for you, don't hesitate to let them know that.

Opportunities to ask questions. Both during the initial meeting and in follow-up discussion(s), you should be given the chance to ask questions and raise concerns. Keep asking questions until you have all the information you need to make your decision.

Continuing updates on new information. As the trial proceeds, the research team may discover new information that could affect your health, welfare, or willingness to remain in the study. They will share this with you and may ask you to sign a new informed consent document. Of course, you are free to leave the study if this information leads you to have doubts about continuing to participate.

About the Author

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