Human Subjects Research
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Committee for Human Subjects Research
Guidelines for Informed Consent & Debriefing
Please be sure that the information in the informed consent documents matches the information in the research proposal exactly. In particular, all risks mentioned in the research proposal should be stated in the informed consent documents, along with the procedures that will be used to minimize those risks.
The purpose of the consent form is to give participants enough information to allow them to make an informed decision about whether or not they would like to participate. The language used should be completely clear and non-technical, and there should be no grammatical or spelling errors.
Basic Elements of Informed Consent
Every consent form must include the following basic elements (see 45 CFR 46.116):
- A statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject'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 subject;
- A description of any benefits to the subject or to others that 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 subject;
- A statement describing the extent to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation or 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 subjects' rights, and whom to contact in the event of a research-related injury to the subject;
- 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.
In particular, the following information concerning the participants' rights must be stated prominently and in plain language on every consent form:
- Their participation is voluntary.
- They may withdraw from the study at any time during the data collection session or immediately afterward. Withdrawal from the study will not affect any compensation to which they would otherwise be entitled. Potential participants expecting "extra credit" from their instructor for their participation must be informed that the instructor is required to offer a reasonable, comparable option so as not to coerce the students into being subjects or unduly influence them.
- All information is confidential and will be used for research purposes only.
Mail Survey Research and Informed Consent
If a survey is to be conducted via mail, the requirement that an informed consent form be signed and returned by the subject may be waived. In such cases, the cover letter accompanying the survey will serve as the informed consent document, and consent by the subject will be implied if the subject chooses to return the survey. Cover letters accompanying such surveys must include all relevant elements of the informed consent form.
Groups Requiring Special Safeguarding Procedures
If infants, juveniles, individuals with impairments, or detained individuals are to be included in the research, special procedures for obtaining informed consent are required, as explained below.
- Infants. Consent must be obtained from parents or from those serving in loco parentis (e.g., legal guardians).
- Juveniles (children under 18 years of age). Consent must be obtained from both parents/legal guardians and the juvenile.
- Individuals with impairments. In situations where individuals may not be able to fully understand the study or communicate their decision to participate, researchers should consider employing a comprehension tool and/or having an advocate who is capable of understanding the individual's reaction and decision (e.g., close family member, therapist) present during the informed consent process.
- Detained individuals (e.g., prisoners). Particular care should be taken over informed consent, paying attention to the special circumstances that may affect the person's ability to give free informed consent, such as mechanical restraint or isolation.
Not all research projects require a debriefing. The aim of a debriefing is to inform the participants of the purposes of the study and to minimize any negative effects of the study. Debriefing can be accomplished via written and/or oral means. As in the informed consent document, the language should be clear and non-technical, and the debriefer should allow the subjects to ask questions. Debriefings are particularly important if deception is involved or if the study involves sensitive topics. It is the researcher's responsibility to minimize any negative feelings that a subject may have as a result of participating in the study.
Informed Consent Form Template
The Committee has developed a template for informed consent forms and strongly encourages its use.