Guidelines and Required Elements of Informed Consent

Taken from: http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm
45 CFR 116 & 117

1. General guidelines for obtaining informed consent or assent, as applicable.
a. Since informed consent is a PROCESS, a form is used to provide evidence of this important process, which protects all research subjects under the Belmont Report, to ensure that the ethical principles of “Respect for Persons, Beneficence and Justice” are met.
b. In rare circumstances research may be exempt from use of an informed consent form.  However, the circumstances resulting in greater risk than benefit from the use of the form must be rigorously justified, including but not limited to potential loss of anonymity or confidentiality (See 45 CFR 46.117c).
c. The consent form should be written in everyday language, not in scientific jargon, and should be fully understandable by any specific populations.
d. Two copies of the consent form should be provided for each research subject: one for the researcher’s files and another for the subject to keep for future reference.
e. The consent form itself is preferably written in second person; first person should be avoided, except for the phrase, “I have read and understood this form, and consent to the research it describes to me (or similar appropriate phrase to indicate the subject’s consent).”
f. For research involving individuals for whom the informed consent must be signed by a parent or a legal guardian (e.g., children, mentally disabled persons), assent, including an assent form must be included, which mirrors the consent process and form in its spirit but must be written in more appropriate language.
g. The researcher should consult http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm for additional guidance.

2. The consent form itself must include the following items, reflecting that the explanation or description of each of these elements to the individual subject has taken place prior to participation:
a. A statement that the subject is, in fact, participating in a research study, including a statement of the purpose of the research, potential uses of assessment instruments, a complete description of any tasks the subject might need to perform, any audio or videotaping that might occur, and the estimated duration of the subject’s participation.
b. A description of any foreseeable risks or discomforts.
c. A description of any benefits which might be expected to be derived from participation in the research, both direct and indirect.
d. A disclosure of appropriate alternative procedures or courses of treatment, if any.
e. A statement regarding the confidentiality and/or anonymity of records and the safeguards that will be taken to assure these for a minimum of 5 years.
f. A statement that although results might be made public, all individual data will remain anonymous and confidential.
g. For research involving greater than minimal risk, an explanation of whether or not any potential compensation will be available, and, if so, how and where such compensation may be obtained.
h. A statement that participation is voluntary, refusal to participate in the research will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may withdraw from the research at any time with no penalty.
i. An explanation of whom to contact with future questions about the research or the subject’s rights, or in the event of a research-related injury. Ideally, two contact persons should be made available to the subject. The subject should understand that he or she is to retain one copy of the consent form for his or her records.
j. A signature line for the Subject, date of signature, printed name of subject, signature of PI and date of signature should be included; a witness’ signature may be desired if the study task is being performed over long-distance (e.g., use of questionnaires and follow-up phone call)