oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

(Approved by the Office of Management and Budget under control number 9999-0020)

$1028.118 Applications and proposals

lacking definite plans for involvement of human subjects.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of com

pounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under §1028.101 (b) or (i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency.

§1028.119 Research undertaken without the intention of involving human subjects.

In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted, by the institution, to the department or agency, and final approval given to the proposed change by the department or agency.

§1028.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.

(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the department or agency through such officers and employees of the department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

(b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.

§ 1028.121 [Reserved]

§ 1028.122 Use of Federal funds.

Federal funds administered by a department or agency may not be expended for research involving human

subjects unless the requirements of this policy have been satisfied.

§1028.123 Early termination of research support: Evaluation of applications and proposals.

(a) The department or agency head may require that department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy.

(b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragarph (a) of this section and whether the applicant or the person or persons who would direct or has have directed the scientific and technical aspects of an activity has have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).

§1028.124 Conditions.

With respect to any research project or any class of research projects the department or agency head may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects.

PART 1030-EMPLOYEE STANDARDS OF CONDUCT

Subparts A-C (Reserved)
Subpart D-Outside Employment and
Other Activities

1030.402 Outside employment.

1030.404 Outside professional or consultative work.

1030.405 Outside writing and editing. 1030.406 Teaching and lecturing activities.

1030.408 Membership in organizations and professional societies.

Subparts E-L (Reserved)

Subpart M-Disclosure of Information about an Individual

1030.1301 Applicability.

AUTHORITY: 5 U.S.C. app. (Ethics in Government Act); E.O. 12674, 54 FR 15159, 3 CFR 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306; 5 CFR part 2635.

SOURCE: 41 FR 8018, Feb. 23, 1976, unless otherwise noted.

Subparts A-C (Reserved)

Subpart D-Outside Employment and Other Activities

§ 1030.402 Outside employment.

(a) Employees considering engaging in outside employment shall be guided by the limitations of § 1030.401.

(b) An employee shall give advance notice of any outside employment to the Office, Bureau, or Area Office Director. Notice shall be given on CPSC Form 241. The Office, Bureau or Area Office Director shall complete the form with appropriate recommendation and forward it to the Ethics Counselor for approval.

[41 FR 8018, Feb. 23, 1976; 41 FR 25890, June 23, 1976]

§ 1030.404 Outside professional or consultative work.

(a) Employees may engage in outside professional or consultative work only after meeting the following conditions:

(1) The work is not to be rendered to organizations, institutions, or state or local governments with which the official duties of the employee are directly related, and/or the work creates a conflict or apparent conflict of interest.

(2) The work is not to be rendered for compensation to help organizations, institutions, or state or local governments in the preparation of offers to develop standards, grant applications, contract proposals, program reports, or other materials which are intended to become the subject of dealings with the Commission.

(b) All requests to perform consultative services, either compensated or

uncompensated, for organizations, institutions, or government units which have or will be awarded contracts or grants in the near future from the Commission must be carefully appraised to avoid any conflict or apparent conflict of interest.

(c) Employees shall give advance no@tice of all outside professional or consultative work to the Office, Bureau or Area Office Director. Notice shall be given on CPSC Form 241. The Office Bureau, or Area Office Director shall complete the form with appropriate recommendation and forward it to the Ethics Counselor for approval.

(d) For the purpose of this section, "professional and consultative work” is work performed in such occupations as those listed in chapter 300, appendix A of the Federal Personnel Manual.

[41 FR 8018, Feb. 23, 1976; 41 FR 25890, June 23, 1976]

1030.405 Outside writing and editing. Employees are encouraged to engage in outside writing and editing, whether or not done for compensation. Such outside writing and editing may be on a subject related or unrelated to an employee's official duties. Certain conEditions must be met in either case, as set forth below:

(a) The following conditions shall apply to all outside writing and editing whether related or unrelated to the employee's official duties:

(1) Government-financed time or supplies shall not be used by an employee in connection with the activity;

(2) Commission support must not be expressed or implied in the material itself or in advertising or promotional material, including book jackets and covers; and

(3) The activity must not involve approval or disapproval of advertising matter.

(b) In addition to observing the conditions described in paragraph (a) of this section, an employee should omit use of his or her official title or affiliation with the Commission with respect to any writing and editing activities unrelated to the employee's official duties or, alternatively, use his or her official title and affiliation with a disclaimer, as described in paragraph (c) of this section.

(c) A disclaimer shall be used in all publications in which an employee uses his or her official title or affiliation with the Commission unless the Executive Director, upon request, determines that the nature of the publication is such that a disclaimer is not necessary. The disclaimer shall read as follows: "This (article, book, etc.) was (written, edited) by (employee's name) in his/her private capacity. It is not intended nor should it be inferred that opinions expressed herein represent the official position of the Consumer Product Safety Commission."

(d) An employee shall not use Commission information which is exempt from disclosure by the terms of the Freedom of Information Act in outside writing activities unless, upon written request, the Secretary determines that the exemption will be waived and the information may be publicly disclosed.

(e) Employees shall give advance notice of all outside writing and editing to the appropriate Office, Bureau or Area Office Director. Notice shall be given on CPSC Form 241. The Office, Bureau or Area Office Director shall complete the form with appropriate recommendations and forward it to the Ethics Counselor for approval.

[41 FR 8018, Feb. 23, 1976, as amended at 41 FR 25890, June 23, 1976]

§ 1030.406 Teaching and lecturing activities.

(a) Employees are encouraged to engage in teaching and lecturing activities which are not part of their official duties under the following conditions:

(1) Government-financed time and materials shall not be used in connection with such activity;

(2) Government travel or per diem funds shall not be used for these purposes;

(3) Such teaching or lecturing is not dependent on specific information which would not otherwise be available to the public under the Freedom of Information Act, unless upon written request, the Secretary determines that the information may be publicly disclosed;

(4) Teaching or lecturing may not be for the purpose of the special preparation of a person or class of persons for an examination of the Civil Service

Commission that depends on information obtained as a result of Government employment, except when that information has been made available to the general public or will be made available on request.

(b) Employees shall give advance notice of all outside teaching and lecturing activities to the appropriate Office, Bureau or Area Office Director. Notice shall be given on CPSC Form 241. The Office, Bureau or Area Office Director shall complete the form with appropriate recommendation and forward it to the Ethics Counselor for approval.

[41 FR 8018, Feb. 23, 1976, as amended at 41 FR 25890, June 23, 1976]

1030.408 Membership

in organizations and professional societies. (a) Employees may be members of professional, educational, public service, consumer, civic, or similar organizations and be elected or appointed to office in such an organization.

(b) Employees shall avoid any real or apparent conflict of interest in connection with such membership. For example, they must not:

(1) Directly or indirectly commit the Commission on any matter;

(2) Permit their name(s) to be attached to documents, the distribution of which would be likely to embarrass the Commission;

(3) Serve as representatives of such organizations in dealing with the Government;

(4) Bring any claim or proceeding before a federal agency or against the Federal Government in a court of law on behalf of the organization;

(5) Offer their views as the official views of the Commission unless the Commission has officially stated its views on a particular matter through an official Commission vote.

(c) In undertaking any office or function beyond ordinary membership in a professional association, a Commission employee must obtain advance approval from the Ethics Counselor in any situation in which the responsibilities as an officer would create a real or apparent conflict of interest with the responsibilities as a Commission employee.

Subparts E-L (Reserved)

Subpart M-Disclosure of Information about an Individual

§1030.1301 Applicability.

(a) Every officer and employee who is involved in the design, development, operation, or maintenance of a system of records or who has access to a system of records shall familiarize himself with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a) and the CPSC regulations issued thereunder and apply these requirements to all systems of records.

(b) No officer or employee shall disclose any record which is contained in a system of records by any means of communication to any person or to another agency, except pursuant to a written request by, or with the prior written consent of the individual to whom the record pertains, unless the disclosure is to a recipient specified in paragraph (c) of this section. The term record means any item, collection, or grouping of information about an individual that is maintained by an agency, including but not limited to his or her education, financial transactions, medical history, and criminal or employment history and that contains his or her name or the identifying number, symbol, or other identifying particular assigned to the individual, such as a fingerprint, voiceprint, or photograph. The term system of records means a group of any records under the control of CPSC from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The term routine use means, with respect to the disclosure of a record, the use of that record for a purpose which is compatible with the purpose for which it was collected. The term individual means a citizen of the United States or an alien lawfully admitted for permanent residence. The term agency is defined in 5 U.S.C. 552(e).

(c) An employee may disclose any record which is contained in a system of records without a written request by and without the prior written consent of the individual to whom the record pertains if the disclosure is:

(1) To those officers and employees of the agency which maintains the record who have a need for the record in the performance of their duties;

(2) Pursuant to section 552 of title 5 U.S.C.;

(3) For a routine use as defined in section (a)(7) of the Privacy Act of 1974 (described in paragraph (b) of this section);

(4) To the Bureau of the Census for purposes of planning or carrying out a census of survey or related activity pursuant to the provisions of title 13, United States Code;

(5) To a recipient who has provided the agency with advance adequate written assurance that the record will be used solely as a statistical research or reporting record and that the record is to be transferred in a form that is not individually identifiable;

(6) To the National Archives of the United States as a record which has sufficient historical or other value to warrant its continued preservation by the United States Government, or for evaluation by the Administrator of General Services or his or her designee to determine whether the record has such value;

(7) To another agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States for a civil or criminal law enforcement activity if the activity is authorized by law and if the head of the agency or instrumentality has made a written request to the agency which maintains the record specifying the particular portion desired and the law enforcement activity for which the record is sought;

(8) to a person pursuant to a showing of compelling circumstances affecting the health or safety of an individual if upon such disclosure notification is transmitted to the last known address of the individual;

(9) To either House of Congress, or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, any joint committee of Congress, or a subcommittee of any such joint committee;

(10) To the Comptroller General or any of his authorized representatives, in the course of the performance of the

duties of the General Accounting Office; or

(11) Pursuant to the order of a court of competent jurisdiction.

(d) No officer or employee shall maintain a record describing how any individual exercises rights guaranteed by the First Amendment unless expressly authorized by statute or by the individual about whom the record is maintained or unless pertinent to and within the scope of an authorized law enforcement activity.

(e) No officer or employee shall sell or rent an individual's name and address unless such action is specifically authorized by law.

(f) An officer or employee:

(1) Who by virtue of his or her employment or official position has possession of or access to agency records which contain individually identifiable information the disclosure of which is prohibited by paragraph (a) of this section or by any other rules or regulations established under the Privacy Act of 1974, and who

(i) Knowing that disclosure of the specific material is so prohibited, willfully discloses the material in any manner to any person or agency not entitled to receive it, or

(ii) Willfully maintains a system of records without meeting the notice requirements of the Privacy Act of 1974,

or

(iii) Knowingly and willfully requests or obtains any record concerning an individual from an agency under false pretenses, is subject to criminal penalties and administrative sanctions; or (2) Who:

(i) Makes a determination not to amend an individual's record in accordance with the Privacy Act of 1974; or

(ii) Refuses to comply with an individual's request to gain access to review and to obtain a copy of any information pertaining to him or her; or

(iii) Fails to maintain any record concerning any individual with such accuracy, relevance, timeliness, and completeness as is necessary to ensure fairness in any determination relating to the qualifications, character, rights, or opportunes of or benefits to the individual that may be made on the basis of such record, and consequently