Informed Consent
The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46. This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human participants research described in the Belmont Report. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. The Belmont Report states that an autonomous agent is “an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” Respect for persons requires that prospective research participants “be given the opportunity to choose what shall or shall not happen to them” and thus necessitates adequate standards for informed consent.
Required Elements Of Informed Consent
According to HHS regulations at 45 CFR 46.116(a), the following information must be conveyed to each participant:
- a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the participant’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- a description of any reasonably foreseeable risks or discomforts to the participant;
- a description of any benefits to the participant or to others which may reasonably be expected from the research;
- a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
- a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
- for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- an explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant; and
- a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
Consent Form Templates
To ensure that studies conducted at Benedictine College follow the requirements surrounding informed consent, the IRB has provided the templates below. Researchers should modify the templates to make them consistent with the details of their proposed study, remove italicized text, and then include the consent form as an appendix to their IRB application.
Studies That May Not Require Informed Consent
In rare circumstances, the requirement to obtain informed consent may be waived. Researchers requesting a waiver or alteration of the informed consent requirement must make the case in their application, demonstrating that all of the following criteria apply to their study:
- The research involves no more than minimal risk to the participants;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the participants; and
- Whenever appropriate, the participants or legally authorized representatives will be provided with additional pertinent information after participation.
