[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.6]



[Page 29-30]

 

                         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.6  Issuance of Confidentiality Certificates; single project 

limitation.



    (a) In reviewing the information provided in the application for a 

Confidentiality Certificate, the Secretary will take into account:



[[Page 30]]



    (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 proj ect;

    (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 

Sec. 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 Sec. 2a.8.