Currently in this society, the only method to document the consent process is use of a written consent form.
Consent is a topic that periodically undergoes close public scrutiny.
Therefore, the IRB spends considerable time evaluating the text of the proposed consent form to determine that it provides relevant information to prospective subjects in a format and in language that is easily understandable. This form contains preprinted regulatory information about the research subject's rights on the reverse side. This language has been approved by the Institutions' legal counsel offices. Justification for any proposed deviations from the use of Form C or changes to the standard language on the reverse side must be provided to the IRB in the RPN application. A copy of the guidelines and a sample consent form are available as Appendix U in this guidelines.