[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR2a.4]



[Page 28-29]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 2a_PROTECTION OF IDENTITY_RESEARCH SUBJECTS--Table of Contents

 

Sec. 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 proj ect 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



[[Page 29]]



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 Sec. 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 Sec. 2a.8(c)).