Informed Consent

This guide provides:

General guidance on preparing the informed consent process
A description and explanation of the basic components of informed consent
Four sample consent processes

You could also refer to the full list of the required Elements of Informed Consent.

General Guidance

Write scripts as if you were engaging in a conversation with potential participants. Refer to yourself as "I" or “we” and to the participant as "you."
Use lay language at the appropriate reading or comprehension level. Do not use jargon or academic language.
Ensure that your consent processes are culturally appropriate.
Prepare scripts and documents for all steps involved in securing informed consent. This may include recruitment messages, scripts, and flyers as well as the informed consent scripts or forms.
If you have multiple participant populations, clearly mark the consent materials for each population.
If appropriate, create scripts and documents to secure permission to conduct research from other parties such as community leaders, school principals, and others who serve as gatekeepers to the research site.
If you will share data, either with other researchers or as a requirement of publication or funding, participants must be informed.
Include the Protocol ID# on each consent process to help participants identify the study in case they need to reach you or contact the IRB with any questions.

The collection of biospecimens, such as saliva samples, includes additional components not listed in this guidance document. Contact IRB staff if you are collecting biospecimens.

Basic Components of Consent

When preparing consent documents, you should:

1. Introduce yourself and invite people to participate in your research.

Inform participants that you are a researcher from Duke University. A “statement of research” is a required component of informed consent. There are several ways to do this. For example, you can use words like "research” or “study” or statements like “I am looking into” or “I am interested in learning more about." It is important to convey to your participants that you are doing an investigation.

Include a subheading titled “Key Information” early in the consent form. If you will use an oral consent process, you can introduce the consent form with something like, “Here’s what you need to know.”

2. Describe the purpose of your research.

You do not have to reveal your hypothesis, but your participants should have a general idea of what the study is about. A simple, straightforward purpose statement will suffice. If including a purpose statement in the consent may invalidate the science, the requirement to include a purpose statement can be waived. However, the description of procedures (see #3 below) should be detailed and comprehensive.

When the study uses deception, consent processes cannot include false statements. A detailed description of procedures (see #3 below) should be provided.

3. Explain what participants will be asked to do and how long each task or activity will take.

Describe all the research activities participants will be asked to do. If you will ask participants to complete surveys or respond to an interview, describe the nature and scope of the questions.

If your study includes many tasks or is completed over multiple sessions, bulleted lists may be useful.

Always inform participants of the expected duration of participation.

4. Describe any foreseeable risks.

It is important for participants to know if there are any risks in the study. If there are no foreseeable risks, it is not necessary to say so. If you prefer to make a statement, you could say, “There are no anticipated risks of harm as a result of participating in the study,” or “There are no foreseeable risks of harm in this study.”

Risks related to research procedure or the research topic need to be described, such as nausea from perceptual tasks or distress from personal questions or questions about illegal behavior. An explanation about how you will manage the risks also needs to be provided.

5. Describe anticipated benefits to the participants, if any.

Individual participants seldom benefit directly from participation. If there are no direct benefits, it is not necessary to say so. If you prefer to make a statement, you can tell participants what you hope to learn through your research. (Please Note: Compensation is not a benefit. For compensation, see #8 below.)

6. Describe confidentiality procedures, if needed.

Participants should know how their information will be used in your research.

If you are collecting and retaining individually identifiable information that, if inadvertently disclosed, could pose risk of harm to participants, the informed consent process must include the measures you are taking to protect information they have shared with you. Simply informing participants that their “participation is confidential” or that their “information will be protection” is not sufficient. Refer to the Confidentiality Guide.

A simple explanation of how you will store and report data would be sufficient if 1) you are not collecting individually identifiable information about participants, or 2) if the individually identifiable data you collect would not pose risk of harm to participants if inadvertently disclosed

It can be confusing to describe elaborate data protection procedures for data that pose no risk of harm.

If participants are willing to be identified and/or have quotes attributed to them, explain how the process will work.

You also need to inform participants whether their data, in identified or de-identified form, will be made public, shared with other researchers as a requirement of publication or funding, or used for future research purposes.

If you have to collect identifiable information in order to compensate participants, you cannot tell them that you will not collect their names.

7. Describe voluntariness.

Inform participants that the decision to take part in your research is completely up to them. Consent is an ongoing process so people can choose not to answer questions, not take part in activities, and they can withdraw from the study for any reason. Participants should be informed if there are tasks that must be completed so they can decide beforehand if they want to be in the study.

8. Describe compensation you will provide, if any.

Compensation can include monetary (cash, gift cards) and/or non-monetary (gifts, course credit) payments.

Explain under what conditions participants will receive partial or no payment. (If you plan to give participants a small token or gift, it is not necessary to tell them during the consent process.)

It is unnecessary to inform participants that they will not be compensated for being in the study, unless you think participants would expect to receive something.

Compensation is not a requirement; you are not obligated to compensate your participants. (Note: Compensation is not a direct benefit for study participation.)

Some department or unit accounting processes require researchers to collect additional information about their participants, for example, email addresses for electronic Amazon gift cards, mailing addresses, and/or social security numbers. The informed consent process should explain these conditions for compensation. Please check with your department or unit.

9. Give potential participants an opportunity to ask questions about your research.

Research participants have the right to ask questions about the research before, during, and after participation.

10. Provide contact information.

Provide participants with contact information for you and other individuals who can answer questions about the study. If you are using an oral consent script, you may want to provide participants with a card listing the contact information.

If appropriate, also include contact information for people who can address questions about participants’ rights or concerns. This is usually, but not always, the Campus IRB office.

If your participants do not have the resources to make contact outside the US or if there are language barriers, it is unreasonable to provide an IRB contact. In some instances, you may rely on an in-country contact to respond to questions about participants’ rights. This could be someone in your hosting organization or an on-site collaborator.

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 participants' rights.

Include the Campus IRB protocol ID number, and ask participants identify the study by the Protocol ID# in any communication with the researchers, Campus IRB, or in-country contact.

Below we have provided examples of how four different researchers incorporated the components of informed consent into their consent processes. Note that each researcher carried out a different type of study.

These are only samples and not intended to be duplicated for all consent processes.

Sample A. An undergraduate student asking other undergraduate students to complete an in-person survey.

	Key Information
Introduction	Hi. My name is Lee. I’m a student at Duke doing research for my Sr. Honors Thesis.
Purpose	I am studying the perceptions, beliefs and outlooks of female college students.
Procedures	If you agree to participate, I will ask you to read three short texts, then answer some questions about yourself, including demographic questions, questions about your political orientation, and questions about your perceptions and beliefs. Your participation will take about 15-25 minutes.
Risks	N/A. The researcher did not include a description of potential risk of harm because there were no anticipated risks to the participants.
Benefits	There is no benefit for people participating in this study, but your participation might help us to learn more about the beliefs and perceptions of female college students.
Confidentiality	I will collect your demographic information (including gender, year in school, major, and race/ethnicity). However, I will not use any of your individual information in my report. No individuals will be identified and all findings will be reported in aggregate.
Voluntariness	It is completely up to you whether to participate. You may skip questions or withdraw at any time for any reason.
Compensation	You will receive $3 at the completion of this study.
Questions	If you have any questions about this research, please ask me now. If you have questions at a later time, you can contact me. You can also contact my faculty advisor, Kelly Amos, Ph.D. For questions about your rights, contact the Duke University Institutional Review Board at 919-684-3030 or campusirb@duke.edu. To facilitate a response, let us know that you participated in the study for Protocol ID# 2020-1111.

Sample B. A graduate student conducting in-person interviews with community members.

	Key Information
Introduction	Thank you for your interest in talking with me about healthcare. As you know, my name is Carl and I am graduate student from Duke University doing research at the Alliance Medical Ministry.
Purpose	I am interested in learning how people experience health and healthcare clinics in the community.
Procedures	If you agree to be in my study, I will ask you to talk with me about your experiences in the community and with this clinic. I will ask you different kinds of questions about health, what it’s like to live in this community, and your experiences as a patient in healthcare settings. We can talk for as long as you like, but I expect our conversation will take about an hour. I would also like your permission to let me audio-record our conversation so that I can focus on our conversation rather than taking notes.
Risks	If you find that a question I ask is too private or personal, please let me know if you would like to skip the question.
Benefits	You may not personally benefit from our conversation, but I hope my findings will help improve our knowledge and understanding of community-based healthcare clinics and the communities they serve.
Confidentiality	Although I will have your name in my research notes, I will never use your name in any report I write. Instead, I will use a fake name or report my results in groups and averages so no one can be recognized. Although collected data may be made public or used for future research purposes, your identity will always remain confidential.
Voluntariness	You can skip any question that you do not want to answer. You can also stop our interview at any time, for any reason. If you do not want to be recorded, that is okay. Whatever you decide to do is fine. Your decision will in no way affect any of the services or healthcare you and your family receive now or in the future.
Compensation	In appreciation for your time, I will pay you $25. I will ask you to sign a receipt confirming you were paid. I will then turn this receipt over to the Accounting Office for record-keeping purposes only.
Questions	Please let me know if you have any questions for me at this time. For questions about this study, please contact me or my advisor, Dr. Doctorate. For questions about your rights, please contact the Duke University Campus Institutional Review Board at 919-684-3030 or campusirb@duke.edu. It will be helpful if you include Protocol ID# 2020-2222 in your communication.

Sample C. A graduate student doing an online study on MTurk.

	Key Information
Introduction	This study is being conducted by Kelsey, a doctoral student researcher, and her advisor, Dr. Fitzgerald, a faculty researcher at Duke University.
Purpose	This research examines people’s clothing styles and their goals.
Procedures	You will be asked to discuss your current goals and describe what you plan to wear today. The survey should take 5-10 minutes.
Risks	N/A. The researcher did not include a description of potential risk of harm because there were no anticipated risks to the participants.
Benefits	N/A. The researcher did not include a benefit statement because there were no anticipated benefits to the participants.
Confidentiality	We do not ask for your name or any other information that might identify you. Although collected data may be made public or used for future research purposes, your identity will always remain confidential.
Voluntariness	Your participation in this research study is voluntary. You may withdraw at any time and you may choose not to answer any question, but you must proceed to the final screen of the study in order to receive your completion code, which you must submit in order to be paid.
Compensation	After completing the survey, you will be paid $0.15 cents for your participation. In accordance with Mechanical Turk policies, we may reject your work if the HIT was not completed correctly or the instructions were not followed.
Questions	If you have any questions about this study, please contact Kelsey or Dr. Fitzgerald. For questions about your rights as a participant contact the Duke Campus Institutional Review Board at campusirb@duke.edu. Please reference Protocol ID# 2020-3333 in your email.

Sample D. A faculty member doing an informal interview as part of an ethnography.

	Key Information
Introduction	Hi, I’m a friend of Nancy and she said you might be interested in talking to me about my study. You may remember my name is Judy.
Purpose	As you may know, my project focuses on issues of gender in Bahrain.
Procedures	I would like to discuss your thoughts about the roles of men and women in Bahrain. The interview will last for about 45 minutes, but it is up to you.
Risks	Some of the things we talk about may be controversial so I will jot down notes without your name or any other information that could identify you to ensure no one else will ever know how you answered my questions. This information may be made public or used for future research purposes.
Benefits	N/A. The researcher did not include a benefit statement because there were no anticipated benefits to the participants.
Confidentiality	The risk statement above addresses confidentiality: “I will jot down notes without your name or any other information that could identify you to ensure no one else will ever know how you answered my questions. This information may be made public or used for future research purposes.”
Voluntariness	You can skip any questions you do not want to answer or stop the interview at any time, for any reason.
Compensation	N/A. The researcher did not include a compensation statement because she was not offering compensation.
Questions	Do you have any questions for me before we begin? Please use my business card and contact me at any point if you have questions or concerns about the research. If you need to get in touch with us, you can refer to this study as #2020-4444.