Guide to Writing Consent Forms and Oral Consent Scripts

Introduction to the Guide

The guide covers the information that must be provided to subjects and provides sample language that you may adapt. The samples are designed to prompt your thinking. Don't use them uncritically because they may not be right for your study.
When you write your scripts for oral presentation or write a consent form remember that you are engaging in a conversation with your potential subjects. Refer to yourself as "I" and to the subjects as "you."
Use lay language at the appropriate reading or comprehension level. Avoid academic jargon.
Ensure that your consent process is culturally appropriate. You may need to check with sources from the country where you will conduct your research.
Be aware that there may be multiple steps involved in securing informed consent. For example, you may send an introductory email message or letter describing your study and asking interested people to respond so that you can set up a time to meet or talk on the phone. When you meet or talk, you will need to have an informed consent form, or in the case of a telephone interview, a script. The form or script would restate, and perhaps expand upon, the information in the introductory letter.

In another scenario, you may recruit subjects orally and if they indicate interest, you would provide additional information, again orally, to allow them to make a final decision about whether to participate. At the completion of an oral process that involves two steps, potential participants must have all the information they need to make an informed decision about whether to participate.
Be aware that you may need to secure consent at multiple levels. For example, you many need to secure consent from community leaders as well as from individual participants.

To access sample consent forms and scripts, use your Duke NetID to login.

Outline of a consent form or script (click the arrow to read the full text):

1. Introduce yourself and invite people to participate in your

research. (Be sure to use the word "research.") Describe the

purpose of your research.

I am an undergraduate student at Duke University in the United States, studying the rise of the female monastic movement in contemporary Japan. I am writing to ask if you would be willing to participate in my research.
Hello, my name is Brian Daniel Flores and I am an undergraduate here at Duke. With the help of Dr. Francis Keefe, a professor of psychology here at Duke, I am conducting a survey research study to understand how college students cope with daily pain.
I am conducting research to write a paper for my college in America. I want to know how individuals who live in Jisha feel about Chinese and foreign tourists coming to the village. I am Aleksandra Chmielewski and I am working with Li Bo.
Ndo. Nkonyee nye Venis Wilder, and I am a fourth-year university student at Duke University in the United States. I hope to learn what girls, ages 11 to 14, feel about being black or African women. I am gathering information in Ghana while I am here for the next few weeks.

4. Describe risks and benefits, if any.

If there are neither foreseeable risks nor anticipated benefits, it isn’t necessary to say so, although you may choose to make statements similar to the following:

We do not anticipate any risks to study participants.
There will be no benefits for people participating in this study but we hope to learn more about XYZ.

Risks of disclosure of identifiable information:

The greatest risk to research subjects in research is the social and behavioral sciences is an inadvertent disclosure of private identifiable information that could cause harm to a research subject, such as the loss of a job or a damaged reputation. If your study poses such a risk, the confidentiality procedures you designed should minimize that risk.

Other risks:

Other risks include invasions of privacy and the possibility that subjects might find the subject matter distressing. The way to mitigate the possibility that subjects might be distressed, it is important to tell them what kinds of questions you plan to ask, and to make it clear that they can choose not to answer questions.

I will ask questions about your experiences as a refugee from the violence in the Congo. It is up to you to decide which questions you want to answer. You may provide brief answers or go into detail as you choose. It is entirely up to you.

5. Emphasize that is the potential participants' choice about

whether to be in the study.

It is completely up to you whether to participate. You may withdraw at any time and you may skip questions you would prefer not to answer.
Some of the questions are sensitive so please feel free to skip questions you would prefer not to answer.
You will be asked to answer some questions about your everyday thoughts and feelings and also about how you feel living apart from your parents. Some of the questions may be difficult to answer. Some of the questions may make you feel uncomfortable or sad. Of you want to skip a question just tell me and we will go on. You could say "next question' to let me know you want to skip to the next question.
Even if you do not want to be videotaped I would still like to have the opportunity to interview you.
If at any time you don't want to answer one of my questions or continuing talking about something, please tell me and we will move on and not go back to it. We can also stop at any time if you wish.
If at any point you are uncomfortable with my note-taking or questioning, please let me know as soon as possible so I can change what I'm doing.

8. Provide contact information.

Research subjects have the right to ask questions about the research before, during, and after participation. They should be able to contact the researchers and people who are not connected with the study who can address their rights as research subjects and respond to concerns subjects may not wish to discuss with the research team. Therefore, contact information should be provided:

a. For you: phone number, email, your dwelling at the research site - whatever is most appropriate

b. For your advisor in the US

c. For your in-country contact

d. For the IRB in the US if the research requires written consent

If you are using an oral consent script, you may want to provide subjects with a card listing the contact information.

If your subjects do not have the resources to make a contact outside the US, you may rely on an in-country contact to respond to questions about your research. This could be someone in your hosting organization if you are an intern, or a public service or research organization familiar with your study population and your topic. If review by an ethics committee in the country where the research is taking place is required, that committee should be the contact for questions about subjects' rights.

Here is a way to present the Duke IRB or in-country ethics committee contact to people who may not be familiar with the research review process.

All research with human volunteers in reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject, you may contact the committee, anonymously if you wish, at (Duke or local ethics review committee contact information.)

Here is a sample contact information script for subjects who have access to a telephone and to the Internet:

My advisor, Dr. Thavolia Glymph of the African and African American Studies Department of Duke University can also be reached as a reference for my research at +919-668-1625 or thavolis@duke.edu. If you have questions about the rights of participants in research, please contact the Chair of the Human Subjects Committee at +919- 684-3030 or at ors-info@duke.edu.

Guide to Writing Consent Forms and Oral Consent Scripts

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