Consent Document Checklist

The checklist below details the “elements of informed consent” that, according to federal regulations and guidelines, should be part of every informed consent process. The regulations provide for waiver of various elements. If you wish to modify or omit one or more of these elements, you should explain why in the protocol.

Identify yourself and your connection to the University of Florida.

Identify your faculty supervisor (when you are a student or staff member).

Provide a statement that the study involves research.

State the scientific purpose of this research.

Explain exactly what the participant will be asked to do.

Note the amount of time the participant can expect to allow for participation (number of days, minutes — over what time period).

Indicate where and when will the procedure take place (if not where and when the consent if being obtained).

Disclose alternative procedures or treatment that may be advantageous to participants.

State who will administer the procedure.

Describe any anticipated risks or discomforts (if there are no risks, indicate this).

Describe potential benefits to participant or others (if there are no direct benefits, indicate this).

Explain how and to what extent the participant’s identity will be protected (if confidential, state how you will maintain the participant’s privacy and then insert Your identity will be kept confidential to the extent provided by law).

Indicate whether or not compensation will be awarded. Specify what will be offered as compensation, if applicable.

Make a statement that the participant has (when a minor is involved state that the parent and child have) the right to withdraw consent at any time without consequence.

State that the participant does not have to answer any question that s/he does not wish to answer, if applicable (e.g., survey, interview, questionnaire).

If audio or video recording are to be made; indicate who will have access to the tapes and what the disposition of the tapes will be.

Indicate with whom (if anyone) the results (group or individual) will be shared? May participant (parents of participating minor) request a copy? If so, make allowances for this in signature section of consent.

Offer to answer questions and provide a means of contacting the PI (and faculty supervisor, if applicable).

Explain how to contact the IRB02 office.

Include concluding statement (refer to samples).

Provide signature and date lines (refer to samples).

Where applicable, include additional elements, such as the insurance statement.

If participant is to be a minor, attach a child assent script.

When participants will be drawn from a classroom or special program:

Is the procedure part of the regular curriculum of a class or program?

Will the participant miss any regularly scheduled work/class? If so, will s/he be allowed to make up this work?

Note whether participation or non-participation will affect the participant’s grade or status in a program?

What will non-participants do while the experimental procedure is taking place?