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(1) The program director is involved PART 20–PROTECTION OF in the criminal activities to be inves- IDENTITY-RESEARCH SUBJECTS tigated by the undercover agent or informant; or

Sec. (2) The program director will inten- 2a.1 Applicability. tionally or unintentionally disclose the 2a.2 Definitions. proposed placement of an undercover 2a.3 Application; coordination. agent or informant to the employees or

2a.4 Contents of application; in general.

2a.5 Contents of application; research agents who are suspected of criminal

projects in which drugs will be adminisactivities.

tered. (c) Criteria. An order under this sec- 2a.6 Issuance of Confidentiality Certifition may be entered only if the court cates; single project limitation. determines that good cause exists. To 2a.7 Effect of Confidentiality Certificate. make this determination the court

2a.8 Termination. must find:

AUTHORITY: Sec. 3(a), Pub. L. 91-513 as (1) There is reason to believe that an amended by sec. 122(b), Pub. L. 93–282; 84 employee or agent of the program is

Stat. 1241 (42 U.S.C. 242a(a)), as amended by

88 Stat. 132. engaged in criminal activity; (2) Other ways of obtaining evidence

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

otherwise noted. of this criminal activity are not available or would not be effective; and

$2a.1 Applicability. (3) The public interest and need for the placement of an undercover agent

(a) Section 303(a) of the Public or informant in the program outweigh

Health Service Act (42 U.S.C. 242a(a) the potential injury to patients of the

provides that "[t]he Secretary (of

Health and Human Services] may auprogram, physician-patient relationships and the treatment services.

thorize persons engaged in research on

mental health, including research on (d) Content of order. An order authorizing the placement of an undercover

the use and effect of alcohol and other

psychoactive drugs, to protect the priagent or informant in a program must:

vacy of individuals who are the subject (1) Specifically authorize the place

of such research by withholding from ment of an undercover agent or an in

all persons not connected with the conformant;

duct of such research the names or (2) Limit the total period of the

other identifying characteristics of placement to six months;

such individuals. Persons so authorized (3) Prohibit the undercover agent or

to protect the privacy of such individinformant from disclosing any patient

uals may not be compelled in any Fedidentifying information obtained from

eral, State, or local civil, criminal, adthe placement except as necessary to ministrative, legislative, or other procriminally investigate or prosecute ceedings to identify such individuals." employees or agents of the program; The regulations in this part establish and

procedures under which any person en(4) Include any other measures which gaged in research on mental health inare appropriate to limit any potential cluding research on the use and effect disruption of the program by the place- of alcohol and other psychoactive ment and any potential for a real or drugs (whether or not the research is apparent breach of patient confiden- federally funded) may, subject to the tiality; for example, sealing from pub- exceptions set forth in paragraph (b) of lic scrutiny the record of any pro- this section, apply for such an authorceeding for which disclosure of a pa- ization of confidentiality. tient's record has been ordered.

(b) These regulations do not apply to: (e) Limitation on use of information. No (1) Authorizations of confidentiality information obtained by an undercover for research requiring an Investigaagent or informant placed under this tional New Drug exemption under secsection may be used to criminally in- tion 505(i) of the Federal Food, Drug, vestigate or prosecute any patient or and Cosmetic Act (21 U.S.C. 355(i)) or to as the basis for an application for an approved new drugs, such as methaorder under 82.65 of these regulations. done, requiring continuation of long

term studies, records, and reports. Attention is called to 21 CFR 291.505(8) 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 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.

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$ 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 in g2a.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 autho tion of confidentiality is requested. $ 2a.4 Contents of application; in gen

eral. 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 labora

tory 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 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)).

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 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

$ 2a.5 Contents of application; re

search projects in which drugs will

be administered. (a) In addition to the information required by $2a.4 and any other pertinent information which the Secretary may require, each application for an authorization of confidentiality for a research project which involves the administering of a drug shall contain:

(1) Identification of the drugs to be administered in the research project 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 research project will be conducted.

(b) An application for an authorization 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 possession, 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.

§ 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:

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(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.

(b) After consideration and evaluation of an application for an authorization of confidentiality, the Secretary will either issue a Confidentiality Certificate or a letter denying a Confidentiality Certificate, which will set forth the reasons for such denial, or will request additional information from the person making application. The Confidentiality Certificate will include:

(1) The name and address of the person making application;

(2) The name and address of the individual primarily responsible for conducting the research, if such individual is not the person making application;

(3) The location of the research project;

(4) A brief description of the research project;

(5) A statement that the Certificate does not represent an endorsement of the research project by the Secretary;

(6) The Drug Enforcement Administration registration number for the project, if any; and

(7) The date or event upon which the Confidentiality Certificate becomes effective, which shall not be before the later of either the commencement of the research project or the date of issuance of the Certificate, and the date or event upon which the Certificate will expire.

(c) A Confidentiality Certificate is not transferable and is effective only with respect to the names and other identifying characteristics of those individuals who are the subjects of the single research project specified in the Confidentiality Certificate. The recipient of a Confidentiality Certificate

shall, within 15 days of any completion

discontinuance of the research project which occurs prior to the expiration date set forth in the Certificate, provide written notification to the Director of the Institute to which application was made. If the recipient determines that the research project will not be completed by the expiration date set forth in the Confidentiality Certificate he or she may submit a written request for an extension of the expiration date which shall include a justification for such extension and a revised estimate of the date for completion of the project. Upon approval of such a request, the Secretary will issue

amended Confidentiality Certificate.

(d) The protection afforded by a Confidentiality Certificate does not extend to significant changes in the research project as it is described in the application for such Certificate (e.g., changes in the personnel having major responsibilities in the research project, major changes in the scope or direction of the research protocol, or changes in the drugs to be administered and the persons who will administer them). The recipient of a Confidentiality Certificate shall notify the Director of the Institute to which application was made of any proposal for such a significant change by submitting an amended application for a Confidentiality Certificate in the same form and manner as an original application. On the basis of such application and other pertinent information the Secretary will either:

(1) Approve the amended application and issue an amended Confidentiality Certificate together with a Notice of Cancellation terminating original the Confidentiality Certificate in accordance with $2a.8; or

(2) Disapprove the amended application and notify the applicant in writing that adoption of the proposed significant changes will result in the issuance of a Notice of Cancellation terminating the original Confidentiality Certificate in accordance with $2a.8.

§ 2a.7 Effect of Confidentiality Certifi.

cate. (a) A Confidentiality Certificate authorizes the withholding of the names and other identifying characteristics of

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