of substantial value in connection with the investigation or prosecution.

(3) There is no other practicable way of obtaining the information or evidence.

(4) The actual or potential injury to the physician-patient relationship in the program affected and in other programs similarly situated, and the actual or potential harm to the ability of such programs to attract and retain patients, is outweighed by the public interest in authorizing the disclosure sought.

(d) Scope. Both disclosure and dissemination of any information from the records in question shall be limited under the terms of the order to assure that no information will be unnecessarily disclosed and that dissemination will be no wider than necessary. Under no circumstances may an order under this section authorize a program to turn over patient records in general, pursuant to a subpoena or otherwise, to a grand jury or a law enforcement, investigative, or prosecutorial agency.

(e) Counsel. Any application to which this section applies shall be denied unless the court makes an explicit finding to the effect that the program has been afforded the opportunity to be represented by counsel independent of counsel for the applicant, and in the case of any program operated by any department or agency of Federal, State, or local Government, is in fact so represented.

§ 2.65-1 Investigation and prosecution of patients-Basis and purpose.

(a) The need for objective criteria for the issuance of court orders in connection with investigation or prosecution of patients seems particularly pressing. In the absence of such criteria, the assurance of confidentiality otherwise provided for by the authorizing legislation may be felt to be of little value.

(b) It has not been found possible to frame entirely satisfactory rules for the scope of orders under § 2.65, but an illustration may be helpful. Where a witness to a crime is believed capable of identifying a suspect by appearance, and the criteria set forth in § 2.65(c) are met, and the program has

photographs of its patients, the witness alone may be permitted to view the photographs, with no names attached. If the witness failed to identify any photograph as being a picture of the suspect, that would end the matter. If there was such an identification, the program would be authorized to give any information in its possession as to the suspect's identity and whereabouts to appropriate authori

ties.

(c) It is not the purpose of this section to substitute a mechanical formula for judicial discretion, but rather to provide criteria which define the area within which discretion is to be exercised. The reason for including all crimes committed on program premises or against program personnel is not any special solicitude for programs as opposed to other victims of crime, but is rather the result of the special difficulties which the broad definition of "records" in § 2.11(0) creates for program personnel as complaining wit

nesses.

(d) In regard to § 2.65(e), experience has demonstrated that independent counsel may be of crucial importance. The leading case construing 21 U.S.C. 1175, People v. Newman, 32 N.Y.2d 379, 345 N.Y.S.2d 502, 298 N.E.2d 651 (1973); certiorari denied, 414 U.S. 1163, 94 S.Ct. 927, 39 L. Ed.2d 116 (1974), would never have been presented to the courts but for the fact that legal counsel for Dr. Newman was furnished on a pro bono publico basis by a private law firm. In an entirely different case, a United States District Court appears to have issued a wholly inappropriate order under 21 U.S.C. 1175 in a case in which the treatment program involved was operated by an agency of the United States Government, and either was unrepresented, or was represented by the same attorney who represented the agency seeking the order. It is possible, of course, that the order would have been issued in any event, but it seems clear that there was no adequate presentation to the court of arguments or testimony in opposition. It is difficult to see how the purposes of subsection (b)(2)(C) of the authorizing legislation can be carried out if there is inadequate presen

tation of the issues to the courts which must decide them.

§ 2.66 Investigation and prosecution of programs-Rules.

(a) Applicability. This section applies to any application by an administrative, regulatory, supervisory, investigative, law enforcement, or prosecutorial agency for an order to permit disclosure of patient records or the making of copies thereof (including patient identifying information) for the purpose of conducting an investigation or an administrative or judicial proceeding with respect to any program or any principal, agent, or employee thereof in his capacity as such.

(b) Notice. An application under this section may, in the discretion of the court, be granted without notice, but upon the implementation of any order so granted, the program shall be afforded an opportunity to seek the revocation or amendment of such order.

(c) Scope. Both disclosure and dissemination of any information from the records in question shall be limited under the terms of the order to assure that patient identities will be protected to the maximum practicable extent, and that names and other identifying characteristics of patients are expunged from any documents placed in any public record. No information obtained pursuant to an order under this section may be used to conduct any investigation or prosecution of a patient, or be used as the basis for an application for an order under § 2.65.

§ 2.66-1 Investigation and prosecution of programs-Basis and purpose.

The principal purpose of § 2.66 is to enable a regulatory agency whose inspection or other source of information has disclosed a need for follow-up, or which has been refused access to patient records, to obtain the necessary authorization for access and copying. There may also be rare instances, such as those involving financial fraud, tax evasion, or other offenses where access by other investigative agencies is necessary, subject to the requirements and protections of this part.

§ 2.67 Undercover agents and informants-Rules.

(a) Applicability. This section applies to any application by an administrative, regulatory, supervisory, investigative, or law enforcement agency for an order to permit such agency to have an undercover agent or informant in a program under circumstances which would otherwise be prohibited under § 2.19.

(b) Notice. An order under this section may be granted without notice where the criminal conduct for the investigation of which it is granted is believed to be carried on by the program director or by any employee or agent of the program with the knowledge of the program director or under such circumstances that in the exercise of reasonable care the program director should know of such conduct. Under any other circumstances, an order under this section may be granted only after the program director has been afforded notice and opportunity for hearing.

(c) Criteria. An order under this section may be granted only where there is reason to believe that a program or any principal, agent, or employee thereof is engaged in serious criminal misconduct, and that other means of securing evidence of such criminal misconduct are not available or would not be effective.

(d) Scope. An order granted pursuant to this section may authorize the use by the applicant of an undercover agent or informant, either as a patient or as an employee, of the program in question.

(e) Time periods. An order under this section may not authorize the use of an undercover agent for an initial period exceeding 60 days. At any time prior to the expiration of such 60-day period, the applicant may apply for an order extending such period for an additional period not to exceed 60 days, but in no event may the use of an undercover agent in any program be authorized for more than 180 days in any period of 12 consecutive months.

(f) Duty of agent. Except to the extent expressly authorized in an order under this section, which shall be limited to disclosure of information

directly related to the purpose for which the order is granted, an undercover agent or informant shall for the purposes of this part be deemed an agent of the program within which he is acting as such, and as such shall be subject to all of the prohibitions of this part applicable to disclosures of any information which he may acquire.

§ 2.67-1 Undercover agents and informants-Basis and purpose.

The legal rationale underlying this section has been set forth in § 2.19-1. It is expected that this section will find its principal and perhaps its exclusive application in the area of drug law enforcement. Experience has demonstrated that medical personnel, no matter how credentialed, can engage in the illicit sale of drugs on a large scale, and that the use of undercover agents and informants is normally the only effective means of securing evidence sufficient to support a successful prosecution.

of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals." The regulations in this part establish procedures under which any person engaged in research on mental health including research on the use and effect of alcohol and other psychoactive drugs (whether or not the research is federally funded) may, subject to the exceptions set forth in paragraph (b) of this section, apply for such an authorization of confidentiality.

to:

(b) These regulations do not apply

(1) Authorizations of confidentiality for research requiring an Investigational New Drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or to approved new drugs, such as methadone, requiring continuation of longterm studies, records, and reports. Attention is called to 21 CFR 291.505(g) relating to authorizations of confidentiality for patient records maintained by methadone treatment programs.

(2) Authorizations of confidentiality for research which are related to law enforcement activities or otherwise within the purview of the Attorney General's authority to issue authorizations of confidentiality pursuant to section 502(c) of the Controlled Substances Act (21 U.S.C. 872(c)) and 21 CFR 1316.21.

(c) The Secretary's regulations on confidentiality of alcohol and drug abuse patient records (42 CFR Part 2) and the regulations of this part may, in some instances, concurrently cover the same transaction. As explained in 42 CFR 2.24 and 2.24-1, 42 CFR Part 2 restricts voluntary disclosures of information from applicable patient records while a Confidentiality Certificate issued pursuant to the regulations of this part protects a person engaged in applicable research from being compelled to disclose identifying charac

(c) "Research" means systematic study directed toward new or fuller knowledge and understanding of the subject studied. The term includes, but is not limited to, behavioral science studies, surveys, evaluations, and clinical investigations.

(d) "Drug" has the meaning given that term by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).

(e) "Controlled drug" means a drug which is included in schedule I, II, III, IV, or V of Part B of the Controlled Substances Act (21 U.S.C. 811-812).

(f) "Administer" refers to the direct application of a drug to the body of a human research subject, whether such application be by injection, inhalation, ingestion, or any other means, by (1) a qualified person engaged in research (or, in his or her presence, by his or her authorized agent), or (2) a research subject in accordance with instructions of a qualified person engaged in research, whether or not in the presence of a qualified person engaged in research.

(g) "Identifying characteristics" refers to the name, address, any identifying number, fingerprints, voiceprints, photographs or any other item or combination of data about a research subject which could reasonably lead directly or indirectly by reference to other information to identification of that research subject.

(h) "Psychoactive drug" means, in addition to alcohol, any drug which has as its principal action an effect on thought, mood, or behavior.

§ 2a.3 Application; coordination.

(a) Any person engaged in (or who intends to engage in) the research to which this part applies, who desires authorization to withhold the names and other identifying characteristics of individuals who are the subject of such research from any person or authority not connected with the conduct of such research may apply to the Office of the Director, National Institute on Drug Abuse, the Office of the Director, National Institute of Mental Health, or the Office of the Director, National Institute on Alcohol Abuse and Alcoholism, 5600 Fishers Lane, Rockville, Maryland 20857 for an authorization of confidentiality.

(b) If there is uncertainty with regard to which Institute is appropriate or if the research project falls within the purview of more than one Institute, an application need be submitted only to one Institute. Persons who are uncertain with regard to the applicability of these regulations to a particular type of research may apply for an authorization of confidentiality under the regulations of this part to one of the Institutes. Requests which are within the scope of the authorities described in § 2a.1(b) will be forwarded to the appropriate agency for consideration and the person will be advised accordingly.

(c) An application may accompany, precede, or follow the sumission of a request for DHHS grant or contract assistance, though it is not necessary to request DHHS grant or contract assistance in order to apply for a Confidentiality Certificate. If a person has previously submitted any information required in this part in connection with a DHHS grant or contract, he or she may substitute a copy of information thus submitted, if the information is current and accurate. If a person requests a Confidentiality Certificate at the same time he or she submits an application for DHHS grant or contract assistance, the application for a Confidentiality Certificate may refer to the pertinent section(s) of the DHHS grant or contract application which provide(s) the information required to be submitted under this part. (See §§ 2a.4 and 2a.5.)

(d) A separate application is required for each research project for which an authorization of confidentiality is requested.

§ 2a.4 Contents of application; in general.

In addition to any other pertinent information which the Secretary may require, each application for an authorization of confidentiality for a research project shall contain:

(a) The name and address of the individual primarily responsible for the conduct of the research and the sponsor or institution with which he or she is affiliated, if any. Any application from a person affiliated with an institution will be considered only if it contains or is accompanied by documentation of institutional approval. This documentation may consist of a written statement signed by a responsible official of the institution or of a copy of or reference to a valid certification submitted in accordance with 45 CFR Part 46.

(b) The location of the research project and a description of the facilities available for conducting the research, including the name and address of any hospital, institution, or clinical laboratory facility to be utilized in connection with the research.

(c) The names, addresses, and summaries of the scientific or other appropriate training and experience of all personnel having major responsibilities in the research project and the training and experience requirements for major positions not yet filled.

(d) An outline of the research protocol for the project including a clear and concise statement of the purpose and rationale of the research project and the general research methods to be used.

(e) The date on which research will begin or has begun and the estimated date for completion of the project.

(f) A specific request, signed by the individual primarily responsible for the conduct of the research, for authority to withhold the names and other identifying characteristics of the research subjects and the reasons supporting such request.

(g) An assurance (1) From persons making application for a Confidentiality Certificate for a research project

for which DHHS grant or contract support is received or sought that they will comply with all the requirements of 45 CFR Part 46, "Protection of Human Subjects," or

(2) From all other persons making application that they will comply with the informed consent requirements of 45 CFR 46.103(c) and document legally effective informed consent in a manner consistent with the principles stated in 45 CFR 46.110, if it is determined by the Secretary, on the basis of information submitted by the person making application, that subjects will be placed at risk. If a modification of paragraphs (a) or (b) of 45 CFR 46.110 is to be used, as permitted under paragraph (c) of that section, the applicant will describe the proposed modification and submit it for approval by the Secretary.

(h) An assurance that if an authorization of confidentiality is given it will not be represented as an endorsement of the research project by the Secretary or used to coerce individuals to participate in the research project.

(i) An assurance that any person who is authorized by the Secretary to protect the privacy of research subjects will use that authority to refuse to disclose identifying characteristics of research subjects in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to compel disclosure of the identifying characteristics of research subjects.

(j) An assurance that all research subjects who participate in the project during the period the Confidentiality Certificate is in effect will be informed that:

(1) A Confidentiality Certificate has been issued;

(2) The persons authorized by the Confidentiality Certificate to protect the identity of research subjects may not be compelled to identify research subjects in any civil, criminal, administrative, legislative, or other proceedings whether Federal, State, or local;

(3) If any of the following conditions exist the Confidentiality Certificate does not authorize any person to which it applies to refuse to reveal identifying information concerning research subjects: (i) The subject con