You must use one of three types of consents:
Waiver of Consent: In order for the IRB to approve a waiver of consent, the IRB must be satisfied that the following criteria are met:
•The research involves no more than minimal risk to the subjects.
•The waiver or alteration will not adversely affect the rights and welfare of the subjects.
•The research could not practicably be carried out without the waiver or alteration.
•Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
The waiver of consent is the most frequently requested type of consent for both retrospective and prospective chart reviews.
Waiver of Documentation of Consent: Under a waiver of documentation of consent, an investigator must still obtain consent from the subject. This type of consent is not usually requested for a chart review. However, the investigator does not need to obtain a signed consent form from subjects if the IRB agrees that the following criteria are met:
•The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject is asked whether the subject wants documentation linking the subject to the research, and the subject's wishes will govern.
•The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
Written Consent: In certain instances, the IRB may determine that written consent is required if the investigator is unable to justify why it is impracticable to conduct the research without a waiver. This is more often the case for prospective chart review studies, but sometimes occurs in retrospective chart review studies. For example, an investigator wants to review the charts of all his patients who he refers for a colonoscopy to collect outcome measures. The IRB may determine that the investigator should obtain written consent since he or she will have the chance to obtain consent from the patients during their clinic visit with him or her.