UNCW INSTITUTIONAL REVIEW BOARD Informed Consent Checklist INSTRUCTIONS: 1. Include all of the following elements in your consent form 2. Check each box to indicate you have included that element. 3. Submit this form with your protocol and informed consent document. 4. You do not have to use this checklist if you are using the Informed Consent Template. TIPS FOR A WELL-WRITTEN CONSENT FORM: 1. Write the consent form in ordinary language that is appropriate to your audience. 2. Consider using a larger size font for small children or the elderly. 3. DO NOT include language that waives or appears to waive any legal rights of the subject. 4. DO NOT include any kind of language that appears to provide a release of liability or negligence. INCLUDE: Research: A statement that you are asking/inviting the subject to be involved in your research. Purpose: An explanation of your purpose in obtaining information from the subject. Benefit to Researcher: A statement of any financial or other benefit that you stand to gain from the research (this does not mean a grant award). Activities and Duration: An explanation of any and all activities the subject will be involved in and how long each activity will take. Risks and Discomforts: A description of whether or not there are any reasonably foreseeable risks or discomforts to the subject. Keep in mind that risks and discomforts may not only be physical. They may include emotional, social, legal or other risks. Benefits: A description of whether or not there are any benefits to the subject or others that may come directly from the research (not rewards). Rewards: If you are offering subjects any monetary, course credit or other rewards for their participation, a description of the reward and what happens with the reward if the subject does not complete the full course of activities (partial payment/credit?). Identifiable Information: An explanation of whether you will or will not collect any information that will personally identify the subjects. If you will, state how you will protect this information, and with whom you will or will not share the information. Keep in mind that under certain circumstances (UNCW or federal audit) you may be required to show this information to others. This should be revealed to the subject. Voluntary: A statement that participation is voluntary and the subject may stop participation at any time without any penalty or loss in benefits due to the subject. Copy: A statement that the subject will receive a copy of the informed consent form (required unless specifically waived by the IRB). Contacts: Inform the subject that he or she may contact you with any questions about the research and provide your name and phone number. Rights: Inform the subject that he or she may contact the IRB Chair if they have any questions about their rights as a research participant and provide the IRB Chair’s name and phone number. You may be required by the IRB to include additional information IF: your research poses more than minimal risk to the subjects; you have obtained a certificate of confidentiality; other federal guidelines apply; or the IRB deems the additional information will better serve to protect the subject. Approved informed consent forms will be stamped, dated and initialed by the IRB Chair. Only copies of the stamped, approved document may be used in obtaining consent or assent/permission.