IRB Consent Form preparation
Federal regulations require that, except as explained below, an informed consent document include at least eight basic elements:
- An explanation of the purposes of the research;
- A description of foreseeable risks or discomforts;
- A description of the reasonable expected benefits of the research;
- A disclosure of any appropriate alternative procedures;
- A statement describing the extent to which confidentiality of records will be maintained;
- An explanation of any compensation and available medical treatments if injury occurs;
- The name of the contact person for the research; and
- A voluntary participation statement.
Two sample consent forms that you may edit for your own application can be viewed. See Sample Consent Forms in instructions #11.
Detailed Instructions for the Eight Elements of Informed Consent Forms
Stationery for consent form. All consent forms should appear on appropriate letterhead (University/Institutional or other Agency affiliation).
1. Purpose of research.
A statement of purpose for the research project must be included in the introductory paragraph of the consent form. NOTE: If deception is necessary for successful conduct of the research project, the following statement may be used: “Because the outcome of the study could be affected if the purpose of the study is fully divulged prior to my participation, I understand that the purpose of the study cannot be revealed at this time. Further, I understand that I will have an opportunity to receive a complete explanation of the purpose of the study following my participation.” NOTE: This statement may be omitted if the IRB determines that its inclusion will harm a research project otherwise acceptable to the Board.
2. Description of any risks to subject. A description of any risks and/or inconveniences that might reasonably be anticipated to occur for the subjects must be provided. For a definition of risk, see Definitions. Wherever appropriate, a statement should appear that the given procedure(s) may involve unforeseeable risks.
3. Benefits, if any, for subject. The benefits that the subject can reasonably be expected to receive must be indicated.
4. Alternative Procedures or Situations where standard treatment has been withheld. If any standard treatment has been withheld, this information must be disclosed. In addition, if other appropriate alternative procedures that might be more advantageous to the subject are available, the subject must be so informed.
5. Confidentiality of data. The issue of confidentiality must be addressed if the data are to be available to anyone other than the subject, the investigator(s), or the investigator’s (s’) staff. The person(s) or agencies to whom the information will be furnished must be indicated along with the purpose of the disclosure and the type of information to be provided. If data are to be in the form of tape recordings, photographs, movies, or videotapes, these procedures should be described. Furthermore, the intended use of such data for other purposes must be disclosed and permission obtained by using a special portion of the standard consent form. Also, the final deposition of any tape recordings, photographs, movies, or videotapes should be specified. Confidentiality, asherein used, means that the investigator(s) will not make unauthorized disclosure of identifying information and/or data that have been obtained from a respondent.
6. Protocol for treatment of physical injury resulting from research project. It is essential that all subjects be informed that in the event of physical or psychological injury resulting from participation in a research project, financial compensation is not available and that neither medical nor psychological treatment is provided free of charge by the University. Further, subjects must be informed as to the appropriate person to contact in the event of physical or psychological injury in research involving more than minimal risk. NOTE: This section may be omitted if no medical, physical, or psychological risks exist.
7. Protocol to answer questions.
- The name, address, and telephone number of the investigator(s) must appear so as to provide a contact person(s) for any questions about the nature or procedures of the research project.
- Protocol to address concerns about treatment of human subjects. If a signed, written consent form is being utilized, said form must include the name, address, and telephone number of the Chair of the Institutional Review Board for the Protection of Human Subjects, to whom complaints may be addressed:
Dr. Don Bredle, Chair
Institutional Review Board for Protection of Human Subjects
University of Wisconsin?Eau Claire
Eau Claire, Wisconsin 54702
8. Voluntary nature of participation.
- State that the participation in the research project is voluntary and:
- Not a part of any job or instructional requirements;
- Not a condition for being the recipient of benefits or services from the agency, institution, or organization to which the subject is otherwise entitled; and
- Decline of or discontinuance of participation. The subject must understand that she/he is free to decide not to participate or to later withdraw consent and discontinue participation in the research project without prejudice. It is not permissible to utilize any exculpatory language (e.g., before you withdraw, you must inform the investigator). If appropriate, the conditions under which the investigator would terminate a subject’s participation in the research project also must be described. In addition, if withdrawal from participation could lead to any undesirable consequences for the subject, the subject must be informed. Further, all subjects must be provided with information concerning any significant new findings developed during the course of the research project which may affect their willingness to continue participation.
- Question of compensation and costs. If subjects are to receive payment for participation, the amount must be stated.
- Consideration of time allocation. The approximate length of time required for participation, including the number of sessions if applicable, should be clearly stated.
Additional Informed Consent Details
9. Subject to be given copy of consent form. If a signed, written consent form is being utilized in the research project, the investigator must give each subject or her/his representative a copy of the consent form. The reasons for this procedure are these:
- The subject receives assistance in maintaining a continuing understanding of her/his involvement in the research project and can help avoid problems should the subject ever forget that she/he has been previously informed of a risk or discomfort;
- By giving the subject a copy of the consent form, the subject will be able to recognize differences between her/his actual experience and what was expected; and
- The procedure helps to preserve a good relationship between the investigator(s) and the subject.
- The signature of the investigator also should be utilized so that it can be established who discussed the nature of the research project with the subject. Furthermore, whenever appropriate (i.e., language barrier, functional illiteracy, etc.), there should be space available for the signature of a witness.
10. Agreement to participate in research project. The key elements of agreement to participate in a research project are these:
- The signature indicates that, having read the information provided above, the subject decided to participate and understands that she/he has the right to withdraw from participation at any time without prejudice.
- If someone other than the subject is giving her/his consent, such as the parent or guardian if subject is a minor, the signature of only one parent is ordinarily required. (Example: “Your signature indicates that you have read the above information, and you have decided to permit SUBJECT’S NAME to participate.”)
- Children who are capable of some understanding should be given an opportunity to refuse to participate in a research project. Therefore, informed consent of children includes:
- Nursery, Kindergarten, and Elementary School—parental consent and child’s assent.
- Middle School/Junior High—parentalconsent and child’s assent, or consent as appropriate.
- High School—parental consent (for minors) and child’s assent or consent, as appropriate.
- If a subject has diminished capacity, the guardian’s consent and subject’s assent is required.
- In the case of pregnant women, the mother and father must give informed consent and only after having been fully informed regarding the possible impact on the fetus, except that the father’s informed consent is not required if:
- The purpose of the research activity is to meet the health needs of the mother;
- The father’s identity or whereabouts cannot reasonably be ascertained;
- The father is not reasonably available; or
- The pregnancy resulted from rape.
11. Format. Please see suggested Sample Consent Forms