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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 i determines that good cause exists. To

make this determination the court * must find:

(1) There is reason to believe that an 2 employee or agent of the program is T! engaged in criminal activity;

(2) Other ways of obtaining evidence of this criminal activity are not avail9 able or would not be effective; and

(3) The public interest and need for in 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 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 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 authoriza tions of confidentiality pursuant

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Sec. 22.1 Applicability. 20.2 Definitions. 22.3 Application; coordination. 21.4 Contents of application; in general. 2.5 Contents of application; research

projects in which drugs will be administered.

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.

(8) Identifying characteristics refers to the name, address, any identifying number, fingerprints, voiceprints, pha tographs 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.

8 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).

(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.

§ 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 g2a.1(b) will be forwarded to the ap propriate 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

1 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 SS 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 sup authorization 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 § 2a.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 (i) An assurance that any person who

available for conducting the research, is authorized by the Secretary to proha

including 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. 11

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 AM 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 to be administered in the research projeci and a description of the methods for such administration, which shall include a statement of the dosages to be administered to the research subjects:

(2) Evidence that individuals who administer drugs are authorized to do so under applicable Federal and State law; and

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

(b) An application for an authoriza. tion of confidentiality with respect to a research project which involves the administering of a controlled drug may include a request for exemption of persons engaged in the research from State or Federal prosecution for pos session, distribution, and dispensing of controlled drugs as authorized under section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and 21 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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(b) After consideration and evalua- an amended Confidentiality Certifition of an application for an authoriza- cate. tion of confidentiality, the Secretary (d) The protection afforded by a Conwill either issue a Confidentiality Cer- fidentiality Certificate does not extend tificate or a letter denying a Confiden- to significant changes in the research tiality Certificate, which will set forth project as it is described in the applicathe reasons for such denial, or will re- tion for such Certificate (e.g., changes quest additional information from the in the personnel having major responperson making application. The Con- sibilities in the research project, major fidentiality Certificate will include: changes in the scope or direction of the

(1) The name and address of the per- research protocol, or changes in the son making application;

drugs to be administered and the per(2) The name and address of the indi- sons who will administer them). The vidual primarily responsible for con- recipient of a Confidentiality Certifiducting the research, if such individual cate shall notify the Director of the Inis not the person making application; stitute to which application was made

(3) The location of the research proj- of any proposal for such a significant ect;

change by submitting an amended ap(4) A brief description of the research plication for a Confidentiality Certifiproject;

cate in the same form and manner as (5) A statement that the Certificate an original application. On the basis of does not represent an endorsement of such application and other pertinent the research project by the Secretary; information the Secretary will either:

(6) The Drug Enforcement Adminis- (1) Approve the amended application tration registration number for the and issue an amended Confidentiality project, if any; and

Certificate together with a Notice of (7) The date or event upon which the Cancellation terminating original the Confidentiality Certificate becomes ef- Confidentiality Certificate in accordfective, which shall not be before the ance with $2a.8; or later of either the commencement of (2) Disapprove the amended applicathe research project or the date of issu- tion and notify the applicant in writing ance of the Certificate, and the date or that adoption of the proposed signifievent upon which the Certificate will cant changes will result in the issuance expire.

of a Notice of Cancellation terminating (c) A Confidentiality Certificate is the original Confidentiality Certificate not transferable and is effective only in accordance with $2a.8. with respect to the names and other identifying characteristics of those in- 8 2a.7 Effect of Confidentiality Certifidividuals who are the subjects of the single research project specified in the (a) A Confidentiality Certificate auConfidentiality Certificate. The recipi- thorizes the withholding of the names ent of a Confidentiality Certificate and other identifying characteristics of shall, within 15 days of any completion individuals who participate as subjects

discontinuance of the research in the research project specified in the project which occurs prior to the expi- Certificate while the Certificate is in ration date set forth in the Certificate, effect. The authorization applies to all provide written notification to the Di- persons who, in the performance of rector of the Institute to which appli- their duties in connection with the recation was made. If the recipient deter- search project, have access to informamines that the research project will tion which would identify the subjects not be completed by the expiration of the research. Persons so authorized date set forth in the Confidentiality may not, at any time, be compelled in Certificate he or she may submit a any Federal, State, or local civil, written request for an extension of the criminal, administrative, legislative, expiration date which shall include a or other proceedings to identify the rejustification for such extension and a search subjects encompassed by the revised estimate of the date for com- Certificate, except in cirpletion of the project. Upon approval of cumstancescified in paeh (b) such a request, the Secretary will issue of this seot

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