Do I Need to Obtain Informed Consent for Exempt Research?
Yes, for exempt research that involves interaction with subjects, there usually should be a process to ask subjects to participate and confirm their agreement. However, signed consent is not required for most exempt research, and the consent process and documents can be much simpler than those required for non-exempt research.
Verbal or implied consent may be sufficient for exempt research that involves interaction with subjects. For some purely observational research, consent may not be necessary.
You will need to ask for a waiver of documentation of consent in your IRB application.
The consent process should provide sufficient opportunity for subjects to consider whether to participate. Any information that will be disclosed to subjects to make a decision is presented in easy to understand language and should include the following:
ii. Adequate provisions to maintain the privacy interests of participants.
iii. A statement that refusal to participate or withdrawal from the study at any time will not affect their grades or class standing (if subjects are students in a class), or their employment or employment evaluations (if subjects are employees at a workplace).
iv. A description of any incentives, compensation, or reimbursement for research participation.
v. For funded studies, the name of the sponsor funding the research.