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(1) Limit disclosure and use to those parts of the patient's record which are essential to fulfill the objective of the order;

(2) Limit disclosure to those law enforcement and prosecutorial officials who are responsible for, or are conducting, the investigation or prosecution, and limit their use of the records to investigation and prosecution of extremely serious crime or suspected crime specified in the application; and

(3) Include such other measures as are necessary to limit disclosure and use to the fulfillment of only that public interest and need found by the court. (52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987)

82.66 Procedures and criteria for or

ders authorizing disclosure and use of records to investigate or prosecute a program or the person hold

ing the records. (a) Application. (1) An order authorizing the disclosure or use of patient records to criminally or administratively investigate or prosecute a program or the person holding the records (or employees or agents of that program or person) may be applied for by any administrative, regulatory, supervisory, investigative, law enforcement, or prosecutorial agency having jurisdiction over the program's or person's activities.

(2) The application may be filed separately or as part of a pending civil or criminal action against a program or the person holding the records (or agents or employees of the program or person) in which it appears that the patient records are needed to provide material evidence. The application must use a fictitious name, such as John Doe, to refer to any patient and may not contain or otherwise disclose any patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny or the patient has given a written consent (meeting the requirements of $2.31 of these regulations) to that disclosure.

(b) Notice not required. An application under this section may, in the discretion of the court, be granted without notice. Although no express notice is required to the program, to the person

holding the records, or to any patient whose records are to be disclosed, upon implementation of an order so granted any of the above persons must be af. forded an opportunity to seek revocation or amendment of that order, limited to the presentation of evidence on the statutory and regulatory criteris for the issuance of the court order.

(c) Requirements for order. An order under this section must be entered in accordance with, and comply with the requirements of, paragraphs (d) and (€ of $2.64 of these regulations.

(d) Limitations on disclosure and use of patient identifying information: (1) AD order entered under this section must require the deletion of patient identify. ing information from any documents made available to the public.

(2) No information obtained 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 of these regulations. 82.67 Orders authorizing the use of

undercover agents and informants to criminally investigate employees

or agents of a program. (a) Application. A court order author. izing the placement of an undercover agent or informant in a program as an employee or patient may be applied for by any law enforcement or prosecutorial agency which has reason to believe that employees or agents of the program are engaged in criminal misconduct.

(b) Notice. The program director must be given adequate notice of the application and an opportunity to appear and be heard (for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order), unless the application asserts a belief that:

(1) The program director is involved in the criminal activities to be investigat by the undercover agent or informant; or

(2) The program director will intentionally or unintentionally disclose the proposed placement of an undercover agent or informant to the employees or agents who are suspected of criminal activities.

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2a.6 Issuance of Confidentiality Certifi

cates; single project limitation. 2a.7 Effect of Confidentiality Certificate. 22.8 Termination.

AUTHORITY: Sec. 3(a), Pub. L. 91-513 as amended by sec. 122(b), Pub. L. 93-282; 84 Stat. 1241 (42 U.S.C. 242a(a)), as amended by 88 Stat. 132.

SOURCE: 44 FR 20384, Apr. 4, 1979, unless otherwise noted.

(c) Criteria. An order under this section may be entered only if the court 'determines that good cause exists. To make this determination the court ti must find:

(1) There is reason to believe that an employee or agent of the program is s engaged in criminal activity;

(2) Other ways of obtaining evidence of this criminal activity are not availsable or would not be effective; and

(3) The public interest and need for the placement of an undercover agent or informant in the program outweigh the potential injury to patients of the program, physician-patient relationships and the treatment services.

(d) Content of order. An order authorizing the placement of an undercover agent or informant in a program must:

(1) Specifically authorize the placement of an undercover agent or an informant;

(2) Limit the total period of the si placement to six months;

(3) Prohibit the undercover agent or informant from disclosing any patient identifying information obtained from

the placement except as necessary to fort

criminally investigate or prosecute employees or agents of the program; and

(4) Include any other measures which are appropriate to limit any potential ni disruption of the program by the place

ment and any potential for a real or ris apparent breach of patient confiden

tiality; for example, sealing from pub"lic scrutiny the record of any proceedjI ing for which disclosure of patient's record has been ordered.

(e) Limitation on use of information. No information obtained by an undercover agent or informant placed under this section may be used to criminally investigate or prosecute any patient or as the basis for an application for an order under $2.65 of these regulations.

$ 2a.1 Applicability.

(a) Section 303(a) of the Public Health Service Act (42 U.S.C. 242a(a)) provides that "[t]he Secretary (of Health and Human Services) may authorize persons engaged in research on mental health, including research on the use and effect of alcohol and other psychoactive drugs, to protect the privacy of individuals who are the subject 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.

(b) These regulations do not apply to:

(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 authoritions of confidentiality pursuant

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section 502(c) of the Controlled Sub- (8) Identifying characteristics refers stances Act (21 U.S.C. 872(c)) and 21 the name, address, any identifyi CFR 1316.21.

number, fingerprints, voiceprints, pi (c) The Secretary's regulations on tographs or any other item or combin confidentiality of alcohol and drug tion of data about a research subjet abuse patient records (42 CFR part 2) which could reasonably lead directly and the regulations of this part may, in indirectly by reference to other info some instances, concurrently cover the mation to identification of that ri same transaction. As explained in 42 search subject. CFR 2.24 and 2.24-1, 42 CFR part 2 re- (h) Psychoactive drug means, in addi stricts voluntary disclosures of infor- tion to alcohol, any drug which has a mation from applicable patient records its principal action an effect while a Confidentiality Certificate is- thought, mood, or behavior. sued pursuant to the regulations of this part protects a person engaged in

§ 2a.3 Application; coordination. applicable research from being com- (a) Any person engaged in (or who is pelled to disclose identifying charac- tends to engage in) the research to teristics of individuals who are the sub- which this part applies, who desires auject of such research.

thorization to withhold the names and

other identifying characteristics of in § 2a.2 Definitions.

dividuals who are the subject of such (a) Secretary means the Secretary of research from any person or authority Health and Human Services and any not connected with the conduct of such other officer or employee of the De- research may apply to the Office of the partment of Health and Human Serv- Director, National Institute on Drug ices to whom the authority involved Abuse, the Office of the Director, Nahas been delegated.

tional Institute of Mental Health, or (b) Person means any individual, cor- the Office of the Director, National Inporation, government, or governmental stitute on Alcohol Abuse and Alcoholsubdivision or agency, business trust, ism, 5600 Fishers Lane, Rockville, partnership, association, or other legal Maryland 20857 for an authorization of entity.

confidentiality. (c) Research means systematic study (b) If there is uncertainty with redirected toward new or fuller knowl- gard to which Institute is appropriate edge and understanding of the subject or if the research project falls within studied. The term includes, but is not the purview of more than one Institute, limited to, behavioral science studies, an application need be submitted only surveys, evaluations, and clinical in- to one Institute. Persons who are unvestigations.

certain with regard to the applicability (d) Drug has the meaning given that of these regulations to a particular term by section 201(g)(1) of the Federal type of research may apply for an auFood, Drug, and Cosmetic Act (21 thorization of confidentiality under the U.S.C. 321(g)(1)).

regulations of this part to one of the (e) Controlled drug means a drug Institutes. Requests which are within which is included in schedule I, II, III, the scope of the authorities described IV, or V of part B of the Controlled in § 2a.1(b) will be forwarded to the apSubstances Act (21 U.S.C. 811-812).

propriate agency for consideration and (f) Administer refers to the direct ap the person will be advised accordingly. plication of a drug to the body of a (c) An application may accompany, human research subject, whether such precede, or follow the sumission of a application be by injection, inhalation, request for DHHS grant or contract asingestion, or any other means, by (1) a sistance, though it is not necessary to qualified person engaged in research request DHHS grant or contract assist(or, in his or her presence, by his or her ance in order to apply for a Confidenauthorized agent), or (2) a research sub- tiality Certificate. If a person has preject in accordance with instructions of viously submitted any information rea qualified person engaged in research, quired in this part in connection with a whether or not in the presence of a DHHS grant or contract, he or she may qualified person engaged in research. substitute a copy of information thus

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submitted, if the information is cur- (e) The date on which research will rent and accurate. If a person requests begin or has begun and the estimated a Confidentiality Certificate at the date for completion of the project. same time he or she submits an appli- (1) A specific request, signed by the cation for DHHS grant or contract as- individual primarily responsible for the sistance, the application for a Con- conduct of the research, for authority fidentiality Certificate may refer to to withhold the names and other identhe pertinent section(s) of the DHHS tifying characteristics of the research grant or contract application which subjects and the reasons supporting

provide(s) the information required to such request. be submitted under this part. (See (8) An assurance (1) From persons S$ 2a.4 and 22.5.)

making application for a Confidential(d) A separate application is required ity Certificate for a research project for each research project for which an for which DHHS grant or contract supauthorization of confidentiality is re- port is received or sought that they - quested.

will comply with all the requirements

of 45 CFR part 46, “Protection of 82a.4 Contents of application; in gen- Human Subjects," or eral.

(2) From all other persons making In addition to any other pertinent in- application that they will comply with formation which the Secretary may re- the informed consent requirements of quire, each application for an author- 45 CFR 46.103(c) and document legally ization of confidentiality for a research effective informed consent in a manner project shall contain:

consistent with the principles stated in (a) The name and address of the indi- 45 CFR 46.110, if it is determined by the vidual primarily responsible for the Secretary, on the basis of information conduct of the research and the spon- submitted by the person making applisor or institution with which he or she cation, that subjects will be placed at is affiliated, if any. Any application risk. If a modification of paragraphs (a) from a person affiliated with an insti- or (b) of 45 CFR 46.110 is to be used, as tution will be considered only if it con- permitted under paragraph (c) of that tains or is accompanied by documenta- section, the applicant will describe the tion of institutional approval. This proposed modification and submit it documentation may consist of a writ- for approval by the Secretary. ten statement signed by a responsible (h) An assurance that if an authorizaofficial of the institution or of a copy tion of confidentiality is given it will of or reference to a valid certification not be represented as an endorsement submitted in accordance with 45 CFR of the research project by the Secpart 46.

retary or used to coerce individuals to (b) The location of the research proj- participate in the research project. ect and a description of the facilities (1) An assurance that any person who available for conducting the research, is authorized by the Secretary to proincluding the name and address of any tect the privacy of research subjects hospital, institution, or clinical labora- will use that authority to refuse to distory facility to be utilized in connec- close identifying characteristics of retion with the research.

search subjects in any Federal, State, (c) The names, addresses, and sum- or local civil, criminal, administrative, maries of the scientific or other appro- legislative, or other proceedings to priate training and experience of all compel disclosure of the identifying personnel having major responsibilities characteristics of research subjects. in the research project and the training (j) An assurance that all research and experience requirements for major subjects who participate in the project positions not yet filled.

during the period the Confidentiality (d) An outline of the research proto- Certificate is in effect will be informed col for the project including a clear and that: concise statement of the purpose and (1) A Confidentiality Certificate has rationale of the research project and been issued; the general research methods to be (2) The persons authorized by the used.

Confidentiality Certificate to protect

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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 consents in writing to disclosure of identifying information,

(ii) Release is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of Federal Regulations), or

(iii) Authorized personnel of DHHS request identifying information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors and their employees or agents carrying out such a project. (See $2a.7(b));

(4) The Confidentiality Certificate does not govern the voluntary disclosure of identifying characteristics of research subjects;

(5) The Confidentiality Certificate does not represent an endorsement of the research project by the Secretary.

(k) An assurance that all research subjects who enter the project after the termination of the Confidentiality Certificate will be informed that the authorization of confidentiality has ended and that the persons authorized to protect the identity of research subjects by the Confidentiality Certificate may not rely on the Certificate to refuse to disclose identifying characteristics of research subjects who were not participants in the project during the period the Certificate was in effect. (See $2a.8(c)).

(1) Identification of the drugs tos administered in the research projec and a description of the methods such administration, which shall include a statement of the dosages to b administered to the research subjects

(2) Evidence that individuals who a minister drugs are authorized to do s under applicable Federal and Star law; and

(3) In the case of a controlled drug, a copy of the Drug Enforcement Admir istration Certificate of Registratic (BND Form 223) under which the search project will be conducted.

(b) An application for an authoriza tion of confidentiality with respect të a research project which involves the administering of a controlled drug met include a request for exemption of per sons engaged in the research from State or Federal prosecution for pos session, distribution, and dispensing a controlled drugs as authorized unde section 502(d) of the Controlled Sub stances Act (21 U.S.C. 872(d)) and 2 CFR 1316.22. If the request is in such form, and is supported by such information, as is required by 21 CFR 1316.22, the Secretary will forward it. together with his or her recommendation that such request be approved or disapproved, for the consideration of the Administrator of the Drug Enforcement Administration.

8 2a.6 Issuance of Confidentiality Cer

tificates; single project limitation. (a) In reviewing the information provided in the application for a Confidentiality Certificate, the Secretary will take into account:

(1) The scientific or other appropriate training and experience of all personnel having major responsibilities in the research project;

(2) Whether the project constitutes bona fide “research” which is within the scope of the regulations of this part; and

(3) Such other factors as he or she may consider necessary and appropriate. All applications for Confidentiality Certificates shall be evaluated by the Secretary through such officers and employees of the Department and such experts or consultants engaged for this purpose as he or she determines to be appropriate.

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