About This Series
Publication Date: January 2010
Contents
Who Approves Affected Activities?
Forms and Written Statements
Appendixes
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About This GuideResources

Forms and Written Statements

Consent Forms and Written Statements

Federal regulations require that certain information be provided to ensure that prospective human subjects understand the nature of the research activities and can knowledgeably and voluntarily decide whether to participate in a study. Ensuring that human subjects make a free and informed choice whether or not to participate in research activities protects not only the human subjects but also the program conducting the research.

Obtaining informed consent from human subjects is a process; it is not just having them complete a form. You should consider the type of information to be communicated and the situation under which the consent process will take place (e.g., approach, timing, personnel involved). The onus is on the program to ensure that prospective human subjects fully understand the research activities they will participate in.

Some important issues to keep in mind include the following:

Obtain consent either in writing or through verbal communication.
Keep in mind that you may obtain informed consent from subjects either in writing or through verbal communication. For example, you may have the subject sign a document, generally called a consent form, or have the subject read a written statement that you’ve prepared and then have the subject verbally consent.

Written consent may be an issue for victims who have serious security concerns. In this event, the IRB may still require that you give subjects a written statement regarding the research. These statements should provide the same information as consent forms but not include a signature line. Instead of a signature, you will be required to obtain verbal consent.

Use laymen’s language.
Consent forms should be written in laymen’s language. Consider the age, reading level, and comprehension skills of potential human subjects. These considerations are especially important for victims who may have very limited English speaking skills and little education in their native country. Therefore, use simple and succinct language in consent forms and translate forms into the victims’ native language when appropriate. It also is a good idea to include copies of translated documents in your IRB application. Sample consent forms are included in appendix B (PDF 101 KB).

Do not use exculpatory language.
Consent forms should not contain any exculpatory language. In other words, you cannot ask participants to waive their legal rights or release the program from liability or negligence (e.g., “I waive any possibility of compensation for injuries that I may receive as a result of participation in this research”). Federal regulations further require that consent forms include the information listed in exhibit 1 and found in 28 CFR 46.116(a).

Exhibit 1
Informed Consent Checklist
check mark icon Statement asserting that the study involves research.
check mark icon Brief explanation of the purposes of the research.
check mark icon Expected duration of the subjects’ participation.
check mark icon A clear explanation of the procedures to be followed.
check mark icon Identification of any experimental procedures.
check mark icon Description of any foreseeable risks or discomforts to the subject.
check mark icon Description of any benefits that may be reasonably expected, including a statement as to whether subjects will be compensated for participation.
check mark icon For research involving more than minimal risk, an explanation as to whether any compensation is available as well as a discussion of alternative procedures or courses of treatment.
check mark icon Statement outlining the extent to which confidentiality of records identifying the subject will be maintained.
check mark icon Explanation of whom to contact with questions about the research and the research subjects’ rights or to report any study-related problems.
check mark icon Statement regarding subjects rights.
check mark icon Statement asserting that participation is voluntary; refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled; and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Consider carefully what your research entails.
Consider carefully what your research activities will entail and include in the consent form any additional information that subjects or the IRB may need. Relevant additional information could include the following:

  • Approximate number of human subjects involved in the study.
  • A statement asserting that any significant new findings developed during the research activities that may affect the human subject’s willingness to continue participation will be provided to the human subject.
  • Any additional costs to the human subject that may result from participating in the research activities.

Consider modifying existing language to suit your needs.
Here is a list of some suggested language that you may want to use in consent forms and written statements:

  • “Because this is a group meeting, it is important that each of you agree to respect and protect each other’s privacy, just as we are obligated to respect and protect your privacy. By verbally consenting to participate in this group, you agree to protect the confidentiality of all other group participants and to keep any information you hear or learn today in the strictest of confidence, including the names of others in this group. This means you will not disclose or discuss anything you hear or learn today with anyone outside of this group. Please be aware that we cannot guarantee that other participants will uphold this pledge of confidentiality, and that your participation is voluntary.”
  • “If you understand all of the information that we have provided to you about the project and would like to participate in the group discussion, please raise your hand.”
  • “You have given permission for the discussion to be audiotaped and further understand that the transcripts will be used only for research or statistical purposes and that your name will not be associated with your transcript or audiotape.”
  • “Your participation is completely voluntary. You do not have to answer any questions that you do not want to answer. Your participation, or any decision not to participate, will not affect your immigration status or any other services to which you are entitled.”

You may modify this language as appropriate for your needs. In addition, you may decide to use some of this language in informational materials you use to recruit potential human subjects, and in introductory scripts and text for data collection protocols (e.g., interview guides, focus group guides, and surveys).