Consent Development: IRB Guidance for All Research Studies

Last revised: 

Documentation of informed consent: Federal and state regulations direct that informed consent be documented, in general, with a written consent form approved in advance by the IRB and incorporating the required elements of consent. The participant or his/her legally authorized representative reads, signs and dates the consent form. The person obtaining consent also signs and dates the consent form. A signed copy of the consent form is given to the participant or, when appropriate, to his/her legally authorized representative. 

Note: No changes may be made to the form without prior approval from the IRB

The IRB may ask for the inclusion of additional elements of consent that are recommended by the Common Rule, including:

  • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
  • Any additional costs to the subject that may result from participation in the research
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
  • A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
  • The approximate number of subjects involved in the study

Need assistance or have clinical study management questions?

Please email the IRB or call 415-476-1814.