§ 2a.4 - Contents of application; in general.

§ 2a.4 Contents of application; in general.

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)).