[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

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

[CITE: 45CFR63.32]



[Page 165]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 63_GRANT PROGRAMS ADMINISTERED BY THE OFFICE OF THE ASSISTANT 

SECRETARY FOR PLANNING AND EVALUATION--Table of Contents

 

                      Subpart C_Special Provisions

 

Sec.  63.32  Data collection instruments.



    (a) Definitions. For the purposes of this section ``Child'' means an 

individual who has not attained the legal age of consent to participate 

in research as determined under the applicable law of the jurisdiction 

in which such research is to be conducted.

    ``Data-collection instruments'' means tests, questionnaires, 

inventories, interview schedules or guides, rating scales, and survey 

plans or any other forms which are used to collect information on 

substantially identical items from 10 or more respondents.

    ``Respondents'' means individuals or organizations from whom 

information is collected.

    (b) Applicability. This section does not apply to instruments which 

deal solely with (1) functions of technical proficiency, such as 

scholastic aptitude or school achievement, or (2) routine demographic 

information.

    (c) Protection of privacy. (1) No project supported under this part 

may involve the use of data collection instruments which constitute 

invasion of personal privacy through inquiries regarding such matters as 

religion, sex, race, or politics.

    (2) A grantee which proposes to use a data collection instrument 

shall set forth in the grant application an explanation of the 

safeguards which will be used to restrict the use and disclosure of 

information so obtained to purposes directly connected with the project, 

including provisions for the destruction of such instruments where no 

longer needed for the purposes of the project.

    (d) Clearance of instruments. (1) Grantees will not be required to 

submit data-collection instruments to the Assistant Secretary or obtain 

the Assistant Secretary's approval for the use of these instruments, 

except where the notification of grant award specifically so provides.

    (2) If a grantee is required under paragraph (d)(1) of this section 

to submit data-collection instruments for the approval of the Assistant 

Secretary or if a grantee wishes the Assistant Secretary to review a 

data-collection instrument, the grantee shall submit seven copies of the 

document to the Assistant Secretary along with seven copies of the 

Office of Management and Budget's standard form No. 83 and seven copies 

of the Supporting Statement as required in the ``Instructions for 

Requesting OMB Approval under the Federal Reports Act'' (Standard form 

No. 83A).

    (e) Responsibility for collection of information. A grantee shall 

not in any way represent or imply (either in a letter of transmittal, in 

the data-gathering instruments themselves, or in any other manner) that 

the information is being collected by or for the Federal Government or 

any department, agency or instrumentality thereof. Basic responsibility 

for the study and the data-gathering instruments rests with the grantee.

    (f) Parental consent. In the case of any survey using data-

collection instruments in which children are involved as respondents, 

the grantee, in addition to observing the other requirements contained 

in this section, and in Part 46 of this subtitle as appropriate, shall 

provide assurances satisfactory to the Assistant Secretary that informed 

consent will be obtained from the parents of each such respondent prior 

to the use of such instruments, except that a waiver from the 

requirements of this paragraph for specific data-collection activities 

may be granted upon the written request by the grantee and a 

determination by the Assistant Secretary that a waiver is necessary in 

order to fully carry out the purposes of the grant.