Guide :: Informed Consent :: Consent Procedure
How do I develop a consent procedure?
The consent process is a conversation between the researcher and the participant, so in order to develop a good consent procedure, you need to understand the needs of your participants. For example, what is the anticipated reading level of your participants? Do all of the participants speak English? Are your participants capable of consenting (i.e. minors, adults with diminished capacity)? Will the participants’ data be used in areas beyond the research project (i.e. in classrooms or archived in libraries)? Will the participants be deceived as a part of your study? The answers to these questions will help determine what approach you need to take in developing an instructive consent procedure.
Notice that the title of this section is not “how do I develop a consent form?” The consent form is the minimum requirement for consent. It is the easiest way to document that a participant has received the information about the study as required by Code of Federal Regulations Title 45, Part 46, which outlines exactly what topics need to be addressed in a consent form (these topics are included as headers on our consent templates, please see the General Consent Template section). Remember, informed consent is an ongoing process, not just a form.
There may be other methods of informing a participant about a study that could be appropriate. Simply signing a form does not mean that the participant has necessarily been “informed.” Do not feel constrained by the form; for example, using a video presentation or a PowerPoint slideshow may help a participant better understand the information in the form. Simply sitting down with the participant and going over the study while using the form as a guide can vastly improve a participant’s comprehension of a study’s intent. The IRB will require documentation of consent via a signed consent form (except in specific cases, please see Consent Not Required, Oral Consent, Waiver of Documentation of Consent). Any additional effort to see that participants are informed about a study, however, will be rewarded by having participants ready to make an informed decision to participate, especially where the study is complicated and/or potentially risky for the participants.
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Guide :: Informed Consent :: Consent Procedure |
