Code of Federal Regulations, title 45, part 46, section 46.116 (General requirements for informed consent) should be reviewed and understood prior to the submission of a research request. A copy of the consent form to be completed by research subjects should be provided alongside other required documentation for IRB review.
Informed consent must be collected by the investigator(s) from all subjects. The following information should be included on the consent form provided to each subject:- An overview of the research, including but not limited to:
- The purposes of the research
- The anticipated duration of the subject's participation,
- A description of procedures to be carried out, including an indication of any procedures considered to be experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- Potential benefits to the subject or to others which may reasonably be expected from the research
- A statement of confidentiality, describing how identifiable information will be retained, maintained or destroyed
- A statement indicating that participation is voluntary
- A statement indicating the right to withdraw or discontinue participation at any time
- Contact information for those directly involved in conducting the research those supervising the research and a Kalamazoo Valley IRB point of contact
- A signature line for verifying legal consent to participate