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Resources :: Guide :: Consent :: Informing participants

Informing Participants and Obtaining Consent

The federal regulations detail the necessary topics that need to be covered when a researcher asks a participant to participate in his or her study and asks permission to use the participant’s data. The General Consent Template provides all of the required topics as headers; it is important that this information is adequately explained in the consent form and that the participant understands these items before granting their consent to participate.

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. However, obtaining consent should continue throughout the study. Even after the initial consent conversation takes place, you should continue to check in with your participants to make sure that they are okay with the study. 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. Some participants may be illiterate or part of a culture where using a form is not appropriate. For those participants, particularly in Ethnographic studies, an Oral Consent Card is provided. Like the General Consent Template, this card provides all of the bullet points that need to be covered in an informed consent conversation. Using an Oral Consent Card doesn't waive the requirement for documenting consent; see Documenting Consent for more information. Regardless of a population’s special needs, any additional effort to see that participants are informed about a study 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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