Human Research Protection Program

Consent Process Review Criteria

1. How will consent be obtained (written, verbal, electronic)?

2. Is a waiver or alteration of written informed consent being requested? If yes:

   • a. Does the research involve no more than minimal risk?

   • b. Is the waiver or alteration appropriate and justified?

     • i. Is the consent document the only record linking the subject and the research, and is the principal risk the loss of confidentiality?

     • ii. Would it be impractical for the research to be conducted without a waiver or alteration of signed consent?

   • c. Will an information sheet be used in lieu of a consent form

3. Are subjects capable of providing informed consent? If no:

   • a. Is the party being authorized to provide consent appropriate?

   • b. Will assent be obtained from subjects? If no:

     • i. Is lack of assent appropriate and justified?

4. Is the consent form and process comprehensible for the subject population or those authorized to provide consent?

5. Does the consent form/information sheet include all necessary elements (see Appendix F)?

6. Does the consent process provide for adequate discussion to ensure consent is truly informed?

7. Is the consent process devoid of any appearance of coercion or undue influence?