Elements of Consent

Elements Necessary for Obtaining Informed Consent

(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.

The basic information necessary in seeking informed consent includes:

1.  An explanation of the purposes of the project, the expected duration of the subject’s participation, and procedures to be followed. Participants should understand what they will be asked to do during the study.

There should be a clear statement that the project involves research. Words such as “research,” “investigation,” “experiment,” “clinical trial” or “investigation” should be included.

Procedures that are experimental should be identified.

2.  A description of any foreseeable harm, discomfort, and risk

3.  A description of any benefits to the subject or others to be derived from the research (Neither payment nor course credit is a benefit)

4.  In the case of treatments, a disclosure of any appropriate alternative procedures that might be advantageous for the subject

5.  A statement describing the extent to which confidentiality of records identifying the subject are to be maintained

6.  A statement of whom to contact for answers to questions about the research. This must be the PI

7.  A statement that the person is free to discontinue participation at any time without penalty or prejudice.

Federal law requires that the actual procedure utilized in obtaining “legally effective informed consent” be fully documented. A written consent document embodying all of the basic elements of information given above must be read by or to the subject. In either case, the consent form must contain the required elements and must be signed by the subject or a legally authorized representative.