V. Informed consent guidelines
Informed consent is more than just a form; it is the basis of a dialogue between the researcher and research subject(s). Except under special conditions specified below (Waiving the informed consent requirements), researchers are required to obtain written informed consent from all adult participants. Researchers are required to provide prospective adult participants with sufficient information and opportunity to consider that information. Every consent form should obtain a statement of the participants’ rights. Basic elements of consent forms are summarized below.
When the participants are under 18 years of age, parental (or guardian) consent must be obtained. Parents and guardians may sign a consent form giving permission for their child(ren) to participate in a series of projects conducted over a period of an academic year. It is understood that although parental consent is obtained, child participants are free to decline invitations to participate without any penalty. Parent consent letters should provide information about the purpose of the research as well as information about the procedure itself from the child’s point of view. As with research involving adult participants, this letter should indicate how confidentiality would be maintained.
Child participants should be given an age-appropriate explanation about the procedures used and what to expect by way of participation. Children should be asked if they want to participate. Mere failure to object on the child participant’s part should not, in the absence of an affirmative response, be interpreted as assent. In the proposal, the researcher should indicate how assent would be obtained and documented. The researcher should also indicate how parental consent would be obtained including an example of the letter of consent (if relevant).
Eight basic elements of informed consent for adults
1. A statement that the study involves research, a readily understood explanation of the purpose(s) of the research, the expected duration of the subject’s participation, a brief description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject. These may include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience.
3. A description of any benefits to the subject or to others that may reasonably be expected from the research (if no direct benefit, this should be stated).
4. A statement concerning costs or compensation to the subject, if any.
5. An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research related injury to the subject. Possible contacts include: the Primary Researcher, the Departmental Coordinator of Human Subjects Research, or the IRB Chairperson. Student researchers must include contact information for their faculty sponsor. Phone numbers and emails should be provided.
6. Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained.
7. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
8. Signature of subject indicating agreement to participate and date of signature.
Waiving the informed consent requirements
Federal guidelines allow that there are some situations where a written consent form may not be required or where the above elements may be modified: (1) if the principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research; (2) if the consent document is the only record linking the subject with the research; (3) if the research involves no more than minimal risk to the subjects and involves procedures that do not require written consent when they are performed outside of a research setting; or (4) the research could not be carried out in any other practical way.
If there is no written consent form, an oral presentation of the research should be provided to the subjects by the researcher, with documentation that such a presentation was made to the subjects. In this instance, researchers should maintain a written summary of the oral presentation and some record that consent was provided by the participant.
For more information on informed consent, see Tips on Informed Consent, prepared by the Office for Protection from Research Risks (as well as Appendix E). Researchers who believe their proposal may qualify for a waiver of informed consent should refer to CFR 45 Part 46.116 C and D and then consult with the IRB Chairperson or their Departmental Coordinator.