Informed consent is a process with the goal of respecting the research subject's dignity. The process does this by attending to the subject's right to deliberate and to make a knowing decision whether to cooperate with the investigator's research interest.
Davidson College requires that every researcher (whether student, faculty or staff) secure the informed consent of any human subject used in research before involving that subject in the research project. Every potential subject who is a physically and mentally able adult must provide consent to participate in the research prior to the initiation of the actual research. Federal regulations define an adult as anyone at least 18 years old. The ideas of mental and physical normalcy revolve around the ability of the subject to provide truly informed and voluntary consent. If a person varies from this norm due to age or disability, special safeguards, described later, are required.
Researchers must ensure that the circumstances under which consent is sought will provide the subjects (or their representatives) with sufficient opportunity to consider whether or not to participate in the proposed research. The circumstances must minimize the possibility that the subjects will experience coercion or undue influence. The situation of the subjects may, in certain cases, be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, age, associations with others, place of residence (prisons, mental hospitals) and mental or physical capacities. Subjects in these categories need not be excluded from research; rather, researchers must make a special effort to ensure that potential subjects are given every opportunity to exercise free choice in consenting to participate in a research project.
The informed consent document communicates to the prospective research subject the purpose, procedures, risks and benefits of the study; the subject's rights in participating in the research; and the freedom to decline to participate without penalty. The consent document also allows the subject to obtain further information and answers to questions related to the study. The consent form, therefore, serves as a written summary of the proposed research and provides a reference for both the subject and the researcher.
If the subject is a minor, a consent form must be signed by the parent or guardian. In addition, those subjects capable of reading and understanding a simplified version of the consent form must sign an assent form. More details on obtaining assent.
All research participants under the age of 18 or not enrolled in college must provide written parental (or guardian) consent in order to participate in college-sponsored research projects.
Besides children, numerous other types of subjects require special attention when obtaining informed consent. In all cases, the guiding principle is respect for the rights of the potential subject. Federal regulations consider prisoners, the mentally disabled, and pregnant women to be "special populations," and as such, are entitled to extra protection under the law.
Other groups, such as racial minorities, the elderly, substance abusers, the economically disadvantaged, the very sick and the institutionalized are described as "vulnerable populations" and are extended similar protection when used as research subjects.
Researchers wishing to use these populations as research subjects must contact the Institutional Review Board (IRB) chair prior to protocol submission in order to determine what, if any, additional restrictions may be imposed in order to assure the protection of subjects falling in the special/vulnerable populations category.
The IRB may waive part or all of the normal consent requirements if certain criteria are met. More details on waivers of written (not oral) informed consent.
If oral consent is necessary (e.g. due to limited literacy) the subject or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. The IRB might require that a witness must also be present for this presentation and sign both the short form and a written summary of the oral presentation. The subject or his/her legal representative must receive a copy of both signed documents.
Research that qualifies for "exempted from further review" status does not require the use of an informed consent document. All researchers must submit a protocol following the instructions for requesting exemption from further review in order for the IRB to determine whether or not such status will be granted.
If the project requires the use of written informed consent or a child's assent, the IRB suggests that researchers adapt, as appropriate, the following sample forms and letters. Please write in lay language suited to the age and educational level of the participants, use a font size large enough to enable the participants to read the form easily, and avoid the use of jargon and technical terms.
NOTE: items marked with an asterisk must be included regardless of format used (with the exception of the assent form for young children). Items without an asterisk should be included only if they are applicable to the proposed study.
Quotation marks are only markers for text and should be omitted on the consent form.
Importantly, you should adapt the form so that it confirms to your specific research project. You should also proofread the entire form for syntax and style, and you should use a consistent point-of-view throughout the document.