Templates and Guidance

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.

EXEMPT CONSENT GUIDANCE

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:

  1. The identity/affiliation and contact information of the Principal Investigator (PI) and Faculty Advisor for the project (if this is a student’s project).
  2. A statement that indicates that the activity is research.
  3. A brief statement of the purpose of the study.
  4. A brief but complete description of the study procedures.
  5. Anticipated duration of participation
  6. A statement that describes that participation is voluntary.
  7. A statement that subjects can refuse to participate or withdraw their participation at any time.
  8. A description of any anticipated risks or discomforts to study participants. If none, the Investigators should indicate so.
  9. A description of any benefits to participants or society.
  10. Name and contact information of individual to contact for answers to pertinent questions about the research. [This is usually the PI and/or the Faculty Advisor (if this is a student’s project).]
  11. Contact information for IRB, to respond to questions or concerns about subject rights.
  12. The following additional information, only if applicable:

    i. A statement that individually identifiable results will be disclosed outside the research team (such as, use of direct quotes that will be attributed to an individual in presentations/publications; data will be shared with the classroom teacher or the school administrators).

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.

Exempt Consent Templates

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