Informed consent

Informed Consent for Participation in the Discussion Groups

ICF Macro is conducting discussion groups for the Food and Drug Administration’s Center for Drug Evaluation and Research, to better understand consumers’ perceptions of warning information on OTC and Prescription labels. We have invited you to participate in a 90-minute discussion with other consumers or purchasers of medications to share your knowledge and thoughts about these warnings.

If you consent to participate in the discussion, here are some things you should know:

• Your participation is totally voluntary.

• Your name will not be used in any reports about this discussion group. We will be taking notes during the discussion about what was said, but we will not record who made the comments.

• The discussion will be video- and audio-taped so that when we write our report we can make sure we understand everything that was said.

• There will be observers from the Food and Drug Administration and ICF Macro in another room taking notes during this discussion.

• Anything discussed during the group will be confidential

• You will receive $75 for participating in the group.

• You may discontinue participation at any time, either by leaving the discussion group or not answering a question, without penalty or loss of benefits.

• The discussion group will last approximately 90 minutes.

• Any questions you have about the discussion groups will be answered before we begin our discussion. Contact information is provided below for any questions that arise after the discussion.

• You will be provided with a copy of this form to take with you.

Contact information: If you have any concerns about your participation in this discussion group or have any further questions about the project, contact _________at ICF Macro, telephone number ________.

Your signature below indicates that you understand the above and agree to participate in this group.

Print your name: _________________________ Date: __________________

Signature: _________________________ Witness: ________________­__