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Electronic Code of Federal Regulations
§2.31 Form of written consent.
(a) Required elements. A written consent to a disclosure under these regulations must include:
(1) The specific name or general designation of the program or person permitted to make the disclosure.
(2) The name or title of the individual or the name of the organization to which disclosure is to be made.
(3) The name of the patient.
(4) The purpose of the disclosure.
(5) How much and what kind of information is to be disclosed.
(6) The signature of the patient and, when required for a patient who is a minor, the signature of a person authorized to give consent under §2.14; or, when required for a patient who is incompetent or deceased, the signature of a person authorized to sign under §2.15 in lieu of the patient.
(7) The date on which the consent is signed.
(8) A statement that the consent is subject to revocation at any time except to the extent that the program or person which is to make the disclosure has already acted in reliance on it. Acting in reliance includes the provision of treatment services in reliance on a valid consent to disclose information to a third party payer.
(9) The date, event, or condition upon which the consent will expire if not revoked before. This date, event, or condition must insure that the consent will last no longer than reasonably necessary to serve the purpose for which it is given.
(b) Sample consent form. The following form complies with paragraph (a) of this section, but other elements may be added.
1. I (name of patient) □ Request □ Authorize:
2. (name or general designation of program which is to make the disclosure)
3. To disclose: (kind and amount of information to be disclosed)
4. To: (name or title of the person or organization to which disclosure is to be made)
5. For (purpose of the disclosure)
6. Date (on which this consent is signed)
7. Signature of patient
8. Signature of parent or guardian (where required)
9. Signature of person authorized to sign in lieu of the patient (where required)
10. This consent is subject to revocation at any time except to the extent that the program which is to make the disclosure has already taken action in reliance on it. If not previously revoked, this consent will terminate upon: (specific date, event, or condition)
(c) Expired, deficient, or false consent. A disclosure may not be made on the basis of a consent which:
(1) Has expired;
(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;
(3) Is known to have been revoked; or
(4) Is known, or through a reasonable effort could be known, by the person holding the records to be materially false.
(Approved by the Office of Management and Budget under control number 0930-0099)