(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.

(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.

(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.

(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.

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 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)).

(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.

(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.

(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 or 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 an 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.

(a) A Confidentiality Certificate authorizes the withholding of the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate while the Certificate is in effect. The authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of the research. Persons so authorized may not, at any time, be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify the research subjects encompassed by the Certificate, except in those circumstances specified in paragraph (b) of this section.

(b) A Confidentiality Certificate granted under this part does not authorize any person to refuse to reveal the name or other identifying characteristics of any research subject in the following circumstances:

(1) The subject (or, if he or she is legally incompetent, his or her guardian) consents, in writing, to the disclosure of such information,

(2) Authorized personnel of DHHS request such 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 45 CFR 5.71 for confidentiality standards imposed on such DHHS personnel), or

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

(c) Neither a Confidentiality Certificate nor the regulations of this part govern the voluntary disclosure of identifying characteristics of research subjects.

(a) A Confidentiality Certificate is in effect from the date of its issuance until the effective date of its termination. The effective date of termination shall be the earlier of:

(1) The expiration date set forth in the Confidentiality Certificate; or

(2) Ten days from the date of mailing a Notice of Cancellation to the applicant, pursuant to a determination by the Secretary that the research project has been completed or discontinued or that retention of the Confidentiality Certificate is otherwise no longer necessary or desirable.

(b) A Notice of Cancellation shall include: an identification of the Confidentiality Certificate to which it applies; the effective date of its termination; and the grounds for cancellation. Upon receipt of a Notice of Cancellation the applicant shall return the Confidentiality Certificate to the Secretary.

(c) Any termination of a Confidentiality Certificate pursuant to this section is operative only with respect to the names and other identifying characteristics of individuals who begin their participation as research subjects after the effective date of such termination. (See § 2a.4(k) requiring researchers to notify subjects who enter the project after the termination of the Confidentiality Certificate of termination of the Certificate). The protection afforded by a Confidentiality Certificate is permanent with respect to subjects who participated in research during any time the authorization was in effect.