Informed Consent Form
The central requirement for any human subjects research is that individuals participate voluntarily. Informed consent means ensuring that the subjects genuinely understand the purpose, risks, and benefits of participating in the research study. Thus, information must be comprehensible, expressed in terms and language appropriate for the study population. The consent form formalizes this agreement and should be designed to document the process. But because subjects always retain the right to withdraw from a study, the informed consent process continues until the subject’s participation is complete.
Written consent forms are required for all research with two exceptions:
In accordance with Federal regulations [45 CFR 46.116(a)&(b)], every consent form must include:
We encourage you to use the SU Sample Informed Consent forms, but you may submit an alternate form or edit the template, according to the needs of your study.
Sample Informed Consent Form
Researchers must obtain parental permission for studies involving children under the age of majority (18 years old in Washington State). If the research involves greater than minimal risk, signatures from both parents are required unless: only one parent has legal responsibility for the care and custody of the child, or if one parent is deceased, unknown, or incompetent. On some occasions, the IRB can grant a “waiver of parental permission” (see Waiver or Alteration of Consent below), if the research involves minimal risk, if it will yield significant benefits to the population being studied or a public program, and/or if obtaining parental consent would pose a considerable risk to the potential subjects. Additionally, for some research, the requirement for parental permission may be inappropriate. For example, research involving older adolescents who, under applicable law, may consent on their own behalf for selected treatments (e.g., treatment for venereal disease, drug abuse, or emotional disorders). In other research (e.g., research on child abuse or neglect), the parents' interests may not adequately reflect the child's interests. In these cases, primary investigators must ensure alternative procedures for protecting the rights and interests of the children asked to participate, including, perhaps, the court appointment of special guardians.
Parental permission is documented similarly to an adult subject consent form, in which “your child” is substituted for “you.” Once the researcher has obtained written parental permission, the agreement of the child is required. (In therapeutic settings, parental permission overrules a child’s decision not to participate.)
A child’s agreement is documented with an “assent form,” a child-friendly document that outlines the essential information about the research. Most children 8 years old and above have the cognitive and emotional maturity to understand a research project and should be given the opportunity to assent to participation. Some children under the age of 8 may also be capable of granting and withholding assent, and the IRB asks researchers to be sensitive to the needs of these children on an individual basis.
In addition, a researcher must complete and submit Appendix B for Research Involving Minors.
For research involving non-English speaking subjects, a protocol submission must include both English-language and translated consent forms. An explanation of the translations and the expertise of the translator should be provided for IRB review. (The IRB may consult with language experts or require a “back-translation” into English.) The researcher should also include a confidentiality agreement to be signed by the translator.
As an alternative to translated consent forms, an oral presentation of informed consent information together with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally can be approved by the IRB. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary. If this situation applies to a proposed study, researchers must submit Appendix A -- Waiver or Alteration of Informed Consent Form when submitting the initial protocol.
When this procedure is used with subjects who do not speak English:
At the time of consent, the following signatures should be obtained:
The IRB must receive all foreign language versions of the short form document as a condition of approval (46.117(b)(2)). Expedited review of these versions is acceptable when: the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.
Sometimes a subject understands English but does not read or write English. An impartial witness should document that the subject understands the study and the consent process and consented to participate.
In some cases, a researcher may wish to employ deception (deliberately withholding information from subject participants) for the purpose of securing subject participation and/or to prevent potentially biased reporting of data or information by the subject. Before approving protocols involving deception, the IRB must verify that the following conditions will be met:
The procedures for deception must meet the guidelines established by the discipline of the investigator through its professional code of ethics. In addition, a researcher must complete and submit Appendix F for Research involving Deception.
On some occasions, Federal regulations for human subjects research permit a waiver of the requirement for informed consent, or an alteration of consent, including waiving parental permission. For example, a study may investigate certain aspects of public benefit or service programs but may not be practicably carried out without waiver or alteration of the consent process (see 45 CFR 46.116[c]). Only the IRB may approve waivers or modifications of the consent process, after having determined:
If this situation applies to a proposed study, researchers must submit Appendix A – Waiver or Alteration of Informed Consent Process when submitting the initial protocol.