Criteria for informed Consent and Assent
The following information must be communicated in writing to all research subjects or respondents before they agree to participate in a project that qualifies for IRB Clearance. The information must be incorporated into a cover letter or information sheet to be distributed with a questionnaire or other survey instrument. Researchers are required to develop a consent form to be signed by each research subject. Additional elements of informed consent may be required for some projects. Following are the minimum required elements of informed consent.
Additional information may be included at your discretion.
1. a statement identifying the researchers and their affiliations.
2. an invitation to participate in the study as part of a research project.
3. an explanation of the purpose of the research, the expected length of time of the subject’s involvement, a description of the procedures to be followed, and identification of any procedures which are experimental in nature.
4. a description of any benefits to the subject or others which may reasonably be expected from the research.
5. a description of compensation (if any) for participation (money, extra course credit, etc.).
6. a statement describing the subject’s anonymity or the extent to which confidentiality of records identifying the subject will be maintained.
7. the names, addresses, and phone numbers of the people to contact for answers to questions about the research, and the office to contact for questions about the rights of research subjects.
8. an assurance that participation is voluntary and that the subject may withdraw from participation at any time.
9. for subjects under 18 years of age (or custodial adult) parental consent is required for any research in the expedited or full review categories. The IRB may waive that requirement under special circumstances. Written consent of a school administrator is required for all research, whether exempt or not.
10. for subjects under 18 years of age, a statement of informed "Assent" is required. "Assent" refers to the willingness of the research subject to participate. Thus, if the research subject is a minor (under 18 years of age) both parental (custodial) consent and "Assent" are required.