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California State University, Long Beach
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Informed Consent Process

(rev. 7/1/00)

The essence of Informed Consent is that the researcher provides to the potential human subject sufficient information that the potential subject can weigh the risks against the benefits and make an "informed decision" about whether to participate or to continue participating in a project. Accordingly, providing information and accepting consent is a process which is begun at the beginning of subject recruitment and which concludes only when the research concludes. The primary informed consent document is essential, but circumstances may evolve in such a way that additional documentation be provided and requests for consent take place.

Informed consent must take into account the institution's commitment to the ethic of respect for the individual and his or her autonomy. Moreover, throughout the informed consent process the researcher will respect any reduction to the autonomous decision-making ability of the individual, whether this reduced autonomy is due to the immaturity, disease, disability, legal status, or simply the affability and goodwill of the research subject. In some cases it may not be sufficient to simply state the research problem or situation; it may be necessary to elicit a response from the subject that unambiguously indicates the subject's understanding of the research and its implications. For instance, in an experiment involving radioactive substances it may be necessary to ask subjects what kind of "protection" a radiation dosimeter provides to ascertain their level of comprehension of the risks to themselves. (Obviously, a dosimeter provides zero protection against radiation; it only provides an estimate of the dose received per unit time, which is valuable information after the fact.)

Inducements to participation are often necessary, but human subjects shall not be coerced into participation in research projects. More subtle forms of persuasion, such as declarations of the expected benefits of the research or descriptions of intrinsically interesting research experiences are permitted, but are reviewed carefully. It should be understood that there are various psychological inducements, including putative benefits of the research that the researcher may assert. A researcher must understand the relationship that builds from the moment of recruitment through the conduct of the research as a continuous opportunity for the expression of informal or psychological inducements and, accordingly, must take adequate measures to assure that the subject continuously enjoys normal decision-making autonomy based on a realistic risk-benefit estimate.

The subject makes an initial decision on participation, but may not be held to an agreement to participate, and must be told this right explicitly. The subject's decision to participate is instantly revocable at any time. If data is taken before revocation, then Informed Consent shall indicate what the disposition of incomplete data will be. For example, a text might read (in part): "... you may terminate participation at any time, you will be free to leave at that time, and relevant data taken will be ....(destroyed, etc.)." Researchers are cautioned that the need for debriefing may increase as participation progresses. In some cases a different kind of debriefing may be necessary for subjects who break off their participation before the conclusion of the experiment.

Persons who decline to participate shall not be put at a disadvantage of the use of their time. As appropriate, alternative activities for the non-participants, e.g., members of a classroom of students, must be afforded them.

The General Requirements for Informed Consent are covered in 45 CFR 46.116 . The documentation requirements for Informed Consent are at 45 CFR 46.117 . In addition, the Office for Human Research Protections (OHRP) (which is the governing body regarding Informed Consent nationally), provides a Checklist for Informed Consent and Tips on Informed Consent.

Consent forms have a common content requirement. Some forms of research require that the research add additional, special statements to the Informed Consent to provide information about certain special concerns that may arise out of the specific research, such as what will happen if someone is injured. (Obviously, injuries from filling out survey instruments are rare and even rarer the responsibility of the researcher. Accordingly, injury disposition statements are not useful on many Informed Consent forms.)

Incentive payments are another element of Informed Consent. With for-profit businesses now entering the area of surveys for scholarly research the expectation of an incentive to participate is becoming greater. Accordingly, it is important to state whether or not incentive payments will be offered and, if so, what and when.

Generic Consent Form Template

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