[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2002]
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 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

[[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)).