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manner which meets the written con- order under this section, the person sent requirements of these regulations. holding the records must be given: The proceeding may include an exam- (1) Adequate notice (in a manner ination by the judge of the patient which will not disclose patient identirecords referred to in the application. fying information to third parties) of

(d) Criteria for entry of order. An order an application by a person performing under this section may be entered only a law enforcement function; if the court determines that good cause (2) An opportunity to appear and be exists. To make this determination the heard for the limited purpose of procourt must find that:

viding evidence on the statutory and (1) Other ways of obtaining the infor- regulatory criteria for the issuance of mation are not available or would not the court order; and be effective; and

(3) An opportunity to be represented (2) The public interest and need for by counsel independent of counsel for the disclosure outweigh the potential an applicant who is a person perinjury to the patient, the physician-pa- forming a law enforcement function. tient relationship and the treatment (c) Review of evidence: Conduct of services.

hearings. Any oral argument, review of (e) Content of order. An order author- evidence, or hearing on the application izing a disclosure must:

shall be held in the judge's chambers or (1) Limit disclosure to those parts of in some other manner which ensures the patient's record which are essential that patient identifying information is to fulfill the objective of the order; not disclosed to anyone other than a

(2) Limit disclosure to those persons party to the proceedings, the patient, whose need for information is the basis or the person holding the records. The for the order; and

proceeding may include an examina(3) Include such other measures as tion by the judge of the patient records are necessary to limit disclosure for referred to in the application. the protection of the patient, the phy

(d) Criteria. A court may authorize sician-patient relationship and the the disclosure and use of patient treatment services; for example, seal- records for the purpose of conducting a ing from public scrutiny the record of criminal investigation or prosecution any proceeding for which disclosure of of a patient only if the court finds that a patient's record has been ordered. all of the following criteria are met:

(1) The crime involved is extremely $ 2.65 Procedures and criteria for or- serious, such as one which causes or di

ders authorizing disclosure and use rectly threatens loss of life or serious of records to criminally investigate

bodily injury including homicide, rape, or prosecute patients.

kidnapping, armed robbery, assault (a) Application. An order authorizing with a deadly weapon, and child abuse the disclosure or use of patient records and neglect. to criminally investigate or prosecute (2) There is a reasonable likelihood a patient may be applied for by the per- that the records will disclose informason holding the records or by any per- tion of substantial value in the invesson conducting investigative or pros- tigation or prosecution. ecutorial activities with respect to the (3) Other ways of obtaining the inforenforcement of criminal laws. The ap- mation are not available or would not plication may be filed separately, as be effective. part of an application for a subpoena or (4) The potential injury to the paother compulsory process, or in a pend- tient, to the physician-patient relaing criminal action. An application tionship and to the ability of the promust use a fictitious name such as gram to provide services to other paJohn Doe, to refer to any patient and tients is outweighed by the public inmay not contain or otherwise disclose terest and the need for the disclosure. patient identifying information unless (5) If the applicant is a person perthe court has ordered the record of the forming a law enforcement function proceeding sealed from public scrutiny. that:

(b) Notice and hearing. Unless an (i) The person holding the records has order under $2.66 is sought with an been afforded the opportunity to be

represented by independent counsel; and

(ii) Any person holding the records which is an entity within Federal, State, or local government has in fact been represented by counsel inde

dent of the applicant. (e) Content of order. Any order authorizing a disclosure or use of patient records under this section must:

(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.

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 afforded an opportunity to seek revocation or amendment of that order, limited to the presentation of evidence on the statutory and regulatory criteria 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 (e) of 82.64 of these regulations.

(d) Limitations on disclosure and use of patient identifying information: (1) An order entered under this section must require the deletion of patient identifying 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.

(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

$ 2.67 Orders authorizing the use of

undercover agents and informants to criminally investigate employees

or agents of a program. (a) Application. A court order authorizing 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:

PART 20–PROTECTION OF IDENTITY-RESEARCH SUBJECTS

Sec. 2a.1 Applicability. 2a.2 Definitions. 2a.3 Application; coordination. 2a.4 Contents of application; in general. 2a.5 Contents of application; research

projects in which drugs will be adminis

tered. 2a.6 Issuance of Confidentiality Certifi

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

(1) The program director is involved in the criminal activities to be investigated 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.

(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 must find:

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

(2) Other ways of obtaining evidence of this criminal activity are not available 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 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 criminally investigate or prosecute employees or agents of the program; and

(4) Include any other measures which are appropriate to limit any potential disruption of the program by the placement and any potential for a real or apparent breach of patient confidentiality; for example, sealing from public scrutiny the record of any proceeding for which disclosure of a 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 long

term 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 characteristics of individuals who are the subject of such research.

(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 effect thought, mood, or behavior.

an

on

$2a.2 Definitions.

(a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.

(b) Person means any individual, corporation, government, or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

(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).

$ 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

a

in $2a.1(b) will be forwarded to the ap- tory facility to be utilized in connecpropriate agency for consideration and tion with the research. the person will be advised accordingly. (c) The names, addresses, and sum

(c) An application may accompany, maries of the scientific or other approprecede, or follow the sumission of a priate training and experience of all request for DHHS grant or contract as- personnel having major responsibilities sistance, though it is not necessary to in the research project and the training request DHHS grant or contract assist- and experience requirements for major ance in order to apply for a Confiden- positions not yet filled. tiality Certificate. If a person has pre- (d) An outline of the research proviously submitted any information re- tocol for the project including a clear quired in this part in connection with a and concise statement of the purpose DHHS grant or contract, he or she may and rationale of the research project substitute a copy of information thus and the general research methods to be submitted, if the information is cur

used. rent and accurate. If a person requests (e) The date on which research will a Confidentiality Certificate at the begin or has begun and the estimated same time he or she submits an appli- date for completion of the project. cation for DHHS grant or contract as

(f) A specific request, signed by the sistance, the application for a Con

individual primarily responsible for the fidentiality Certificate may refer to

conduct of the research, for authority the pertinent section(s) of the DHHS

to withhold the names and other idengrant or contract application which

tifying characteristics of the research provide(s) the information required to subjects and the reasons supporting be submitted under this part. (See such request. SS 2a.4 and 2a.5.)

(g) An assurance (1) From persons (d) A separate application is required

making application for a Confidenfor each research project for which an

tiality Certificate for research authorization of confidentiality is re

project for which DHHS grant or conquested.

tract support is received or sought that

they will comply with all the require§ 2a.4 Contents of application; in gen

ments of 45 CFR part 46, “Protection of eral.

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

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

of the research project by the Sec(b) The location of the research proj- retary or used to coerce individuals to ect and a description of the facilities participate in the research project. available for conducting the research, (i) An assurance that any person who including the name and address of any is authorized by the Secretary to prohospital, institution, or clinical labora- tect the privacy of research subjects

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