Tips for Writing an Informed Consent

Obtaining informed consent is a process, not just a document, and is central to the ethical involvement of human subjects in research. Investigators should be forthright and realistic in describing the benefits and drawbacks of participating in human subjects research and in answering all questions posed by the subjects.

The information must be presented to enable persons to decide voluntarily whether to participate as a research subject. The consent process begins with the recruitment of participants, and continues with a full description of the research purpose and personnel, procedures, risks and benefits, and the reiteration that research is voluntary. If the risks change during the course of the project, it is necessary to re-consent the participants to ensure they are fully informed and still agree to participate.

45 CFR part 46.116 declares that an informed consent must contain the following information:

• that the study is research
• that participation is voluntary
• that there is no penalty for refusing to participate · that the participant can stop at any time
• what the risks of participation are · how any risks will be minimized by the researchers
• what the benefits of participation are
• what the participant will be asked to do · when, where and how long the research will be
• what the costs are for participation, if any
• what the payment for participation is, if any
• whom the participant may contact with any questions or concerns

Before you begin

The Informed Consent contains the same elements or categories as the Protocol Statement, except the Subject Population section, and should be written in the second person, addressed to the participant (use the pronoun "you.") The informed consent must mirror the protocol, in that you must make sure that the purpose of the research, the procedures, risks, benefits, costs and payment if any, are the same in the consent as in the protocol. For instance, if the protocol states that an interview will be audiotaped, the consent must also state that the interview will be audiotaped.

The prospective participants want to know what will happen to them if they agree to participate. Your job is to tell them, clearly and concisely. Therefore, the informed consent document must be readable, to the IRB as well as to the prospective participants. Use a 12-point font, and write at a 6th -8th grade level so that the widest pool of prospects will be able to read it. Use everyday language, for the same reason. Give them some white space. Save esoteric bits of theory for the thesis, where presumably your advisor will know what you mean.

The entire document is the informed consent. The participants will get a copy of the entire form, signed by the researcher. The subjects will then sign the document, and should get a copy of the signed form. The subjects should have the complete document as a record of the procedures and risks/benefits they have agreed to, and for the researcher’s contact information. The subjects must be given a copy of the entire document to keep, and the researcher is required to keep copies of all consent forms, signed by the participants, for at least three years. If conditions of the research change, the changes must be approved by the IRB before being implemented. If the risk to the subjects increases or new procedures is introduced, the researcher must obtain consent from the participants again to agree to the new conditions.

Sections of the Informed Consent:

A. Purpose and background:
Be sure this is understandable to the prospective subjects and correctly represents the purpose of the research. The purpose of the research should be boiled down to one sentence. The next sentence should state why these particular people have been invited to participate, and it should be the most basic reason: because they are in an undergraduate Psychology class, because they are high school students who plan to go to college, because they are between 18 and 34 and have a cell phone, etc. Do not say “because I believe your insight into this problem will greatly improve my thesis.”

B. Procedures:
State exactly what will happen to the subjects, how long it will take, where the research will take place, how often they will be asked to perform the research tasks. Use a bullet format to make this very clear. Briefly state what the survey or interview will be about, that is, what types of questions and demographic information the participants will be asked, for instance, “you will be asked questions about your cell phone usage, and your age and zip code.” If a procedure is experimental, this must be emphasized.

The length of their time commitment is an important consideration for most people, so give them a breakdown of each task, and give them a total amount of time they can expect to be contributing to your project. Do not include any of your time, such as analzying statistics, or coding for themes. Only include the length of time you will be interacting with the participants. This is usually no more than two hours at the most. Interviews should not last longer than one hour. That is about the amount of time people are willing to volunteer for a master’s research project. The researcher should be able to collect enough data in this time.

For a Parental Permission for a Minor to Participate in Research, include in this section the type of information parents might need to make the decision to allow their child to participate: will the research be carried out during class time? If so, how will the students make up the class work they will miss? What alternatives are set up for those students who cannot or will not participate? If this will be after school, how long will it take? Will it affect their arrangements for getting their children home after school?

C. Risks:
State each risk, and then state how the researcher will reduce that risk. Take each risk one at a time, followed immediately by the statement of how the researcher will try to reduce that risk. Risks and mitigations listed in the consent form must be the same as those listed in the protocol. Be sure to discuss how you will maintain the confidentiality of the material, as well as protecting the subject’s privacy. (Privacy refers to the person, confidentiality to the data.)

D. Benefits:
As in the protocol, the standard wording here is: There are no direct benefits to you for participation in this study. Direct benefits are major or universal benefits, such as getting a specific experimental drug therapy, or curing a disease. If you anticipate indirect benefits, use the conditional tense, as in: Benefits may include a greater understanding of the motivation to exercise.

E. Alternatives:
Alternative therapies, treatment, class work, extra credit arrangements, etc. must be revealed. If none of these applies, the alternative is not to participate in the research study.

The subjects must be informed of alternatives for earning extra credit for classes, or alternative classroom assignments if they will not participate in the research. The usual wording is either " You have been informed of the alternative therapies/methods of earning extra credit/class assignments," or "The alternative is not to participate in the research study.”

F. Costs:
Include them if there are any. This section must mirror the protocol cost section. If you state that the participants will have to pay for transportation and parking in the protocol, state the same in the consent.

G. Remuneration:
Include if relevant. Payment can be cash, gift certificates, goodie bags, stickers or anything else you might give the participants as thanks for taking part in the study.

H. Questions:
The subject should be able to contact one or more of the researchers as well as someone not involved in the research, such as the researcher’s advisor or the IRB, in case they have any concerns about the research that they may not want to tell the researcher. The researcher's name and email address should go in this section, along with the research advisor's contact information. We recommend using email or a college or department telephone number, rather than home numbers. Include the contact information for the Committee for the Protection of Human Subjects (at the end of this page.)

I. Consent:
It is important that the researcher stress the voluntary nature of the research, the ability to stop at any time, and the lack of any penalty for non-participation at this point in the consent form. Use the "penalty paragraph" in the informed consent template.

Formatting Tips:

Consider your audience. The subjects may not understand acronyms or jargon peculiar to the researcher’s own discipline. Do not use them, or if it is unavoidable for some reason, explain what they mean.

The protocol and all consent forms, questionnaires, permission letters, etc. are separate documents. Number all pages "1 of _" in that section. For instance, the informed consent should be numbered “1 of 2.”

The research title and the researcher's name must be at the top of each page as a header.

Signatures cannot stand alone on the second (or last) page. They must directly follow the information to which the subject is consenting. Signatures should fit on page 2 of 2. If they cannot, the researcher should tighten up the writing or the spacing, unless the consent is very complicated and contains many procedures.

Individuals who do not speak English will need a translation into their own language. However, wait until the IRB approves the informed consent in English before translating the document. Some individuals may need an advocate to help them comprehend the study and the consent form; in these cases, the advocate should sign as a witness

Special Consents

Parental Permission for a Minor to Participate in Research
If the subjects are under 18, they will need their parents’ permission is to participate in research. This document should be formatted exactly as the informed consent document, referring to "you" or "your child". For instance, under Procedures, a researcher would write:

"If you agree to let your child participate in this study, you can expect the following to happen: Your child will be asked to complete a survey on fiction the class has read this semester. This survey will take approximately 15 minutes to complete and will take place after school in the school cafeteria."

Include the type of information that parents might need to make the decision whether or not to let their child participate. Will the research be carried out during class time? If so, how will the students make up the class work they will miss? What alternatives are set up for those students who cannot or will not participate? If this will be after school, how long will it take? Will it affect their arrangements for getting their children home?)

Minor's Assent to Participate in Research
Because children under 18 are not adults, they do not have the legal ability to consent to research participation. However, they can give or deny their "assent," and if the research includes children between the ages of 8 and 18, assent is required in addition to the parental consent. See Guidelines for Obtaining Minor Assent for information on obtaining verbal assent from very young children under the age of 8, and brief written assent from older children aged 9 through 13. High school students should be able to read at the level of the parental consent, if it is written at an 8th grade level.

The child should have the opportunity to decline to participate, even if parents have agreed to let them participate. Do not include signature lines for the parents on the child assent form, or vice versa. The two documents must remain separate, with separate signatures, so the child has the option to decline without undue parental influence to participate.

Consent for Anonymous Surveys
This is also known as "implied consent,” and eliminates the need to get signed consent forms from a large number of respondents on very low-risk surveys.

If any of the survey questions are sensitive in nature, a sentence should be added to the consent stating that: "You might feel some discomfort in answering these questions." The mitigation of this risk is: “You do not have to answer individual questions and you can stop answering questions at any time." A sample is under Forms and Templates.

Verbal Consent
Verbal consent is allowed where written consent is impossible (as when the subjects were part of an adult literacy program and did not know how to read or write.). It is also granted in situations where the consent itself is the only record linking the subject and research, where the principal risk would be potential harm resulting from a breach of confidentiality.

In these cases, the research must also present no more than minimal risk to the subjects, and involve no procedures for which written consent is normally required outside the research context, or the research could not practicably be carried out without the waiver or alteration. In these cases, the IRB may require the investigator to provide subjects with a written statement regarding the research. (In our example, the statement was read to the participants in the presence of a witness who signed a form indicating that the subjects understood and agreed to the research conditions.)

Focus Group Consent
Group discussions, or focus groups, contain an added risk of loss of privacy, because the nature of the discussion process is such that the researcher cannot guarantee that participants will not talk about what took place in the group once the group has dispersed. The "extra privacy protection for focus groups" is that the researcher will discuss the need for keeping the proceedings confidential with the group at the beginning, throughout the process and again at the end. A paragraph stating this should be included in protocols and consents for focus group subjects. Some researchers ask the participants to sign a brief statement that they will not discuss what happened in the group outside of the group.