Telephone Consent Guidance

[Printable Word Document]

Telephone Consent will be allowed under certain circumstances as outlined below:

PROCEDURES:

1. A verbal approval to participate in a research study does not satisfy federal regulations for the requirement for documented (signed copy of informed consent) informed consent. The IRB encourages that whenever possible the informed consent process be done in person and not over the telephone. In addition, the IRB has the authority to disapprove or require alterations in any recruitment strategy which includes obtaining telephone informed consent.
2. However, in some cases, it is acceptable to send by mail or facsimile a copy of the informed consent document to the legally authorized representative (LAR) and to conduct the consent interview by telephone when the legally authorized representative can read the consent as it is discussed.
3. It is acceptable, under some circumstances to also conduct the assent interview by telephone if the minor has a copy of the assent document in front of him/her and he/she can read the document as it is discussed.
4. If the LAR and/or the minor agrees to participate, s(he) can sign the consent document and return it to the investigator by mail or facsimile. No intervention can begin until the consent document is received by the investigator unless a waiver or alteration of the consent process is requested and approved by the IRB. For example, the investigator cannot request the subject withhold medication prior to the receipt of the informed consent document without IRB approval.
5. If telephone consent is to be used in a study, the investigator must state so in the IRB application and fully describe the process which will be used to obtain and document telephone informed consent.