NIH POLICY MANUAL

1. Explanation of Material Transmitted: This chapter sets forth policy and procedures to avoid the occurrence of conflicts of interest or the appearance of such conflicts, among Special Government Employees (SGEs) and other Federal employees appointed as members of NIH advisory committees and subject to the Federal Advisory Committee Act.
   
   
2. Filing Instructions:

   Remove: NIH Manual 1810-1 dated 04/12/99
   Insert: NIH Manual 1810-1 dated 12/31/05

PLEASE NOTE: For information on:

• Content of this chapter, contact the issuing office listed above.

• NIH Manual System, contact the Office of Management Assessment, OMA, on 301-496-2832; online information is available at: http://www1.od.nih.gov/oma/manualchapters/.

A. Purpose: This chapter sets forth policy and procedures to avoid the occurrence of conflicts of interest or the appearance of such conflicts, among Special Government Employees (SGEs) appointed as members of NIH advisory committees subject to the Federal Advisory Committee Act. Since Federal employees may serve as regular appointed members or ex officio members of National Advisory Councils and Boards, Program Advisory Committees, and Boards of Scientific Counselors, reference to conflict of interest procedures relevant to these members are also noted in this issuance.

This issuance describes procedures to ensure: (1) the appropriate collection, review, and evaluation of financial disclosure report forms and supplemental disclosure forms for prospective and current SGE advisory committee members and Federal employees serving as ex officio or regular members on advisory committees; (2) standardized methods of review of financial disclosure reports among Institutes and Centers; (3) appropriate verification and update of the Confidential Financial Disclosure Report (OGE Form 450); (4) waivers and authorizations are executed, where appropriate; (5) appropriate collection, review, and evaluation of the Foreign Activities Questionnaire (HHS Form 697) for prospective and current SGE advisory committee members; (6) SGE advisory committee members receive annual ethics training; and (7) confidentiality of information from these forms is maintained.

See Appendix 1 for definitions of terms contained in this policy.

B. Background: The Standards of Ethical Conduct for Employees of the Executive Branch, 5 CFR Part 2635, became effective February 3, 1993, for all government employees, including SGE advisory committee members. Federal employees and SGE advisory committee members are also subject to the rules governing financial disclosure found in the Ethics in Government Act of 1978, as amended by the Ethics Reform Act of 1989, and Executive Order 12674, as modified by Executive Order 12731, and 5 CFR Part 2634. Additionally, Federal employees and SGE advisory committee members must comply with restrictions imposed by the Emoluments Clause of the U. S. Constitution (Article I, section 9, Clause 8) and the Foreign Gifts and Decorations Act (5 U.S.C. § 7342).

C. Policy: NIH’s policy is to avoid conflicts of interest, or the appearance of such conflicts, in the selection and use of SGEs and Federal employees serving as advisory committee members and in the operation of advisory committees; to maintain adequate records regarding financial and organizational interests of such committee members; and to safeguard the confidentiality of these records.

It is essential that the work of committees not be compromised by any significant conflict of interest. A conflict of interest, for this purpose, means any financial or other interest which conflicts with the service of the individual because it (1) could significantly impair the individual’s objectivity or (2) could create an unfair competitive advantage for any person or organization. A conflict of interest is more than individual bias. There must be an interest, usually financial, that could be directly affected by the work of the committee.

D. Coverage: This issuance covers SGEs who are serving as appointed members of NIH National Advisory Councils and Boards, Program Advisory Committees, and Boards of Scientific Counselors. SGEs, for this purpose, are appointed to perform temporary duties on an intermittent basis for a period not to exceed 130 days during any period of 365 days. This issuance also covers all Federal employees who are appointed as regular or ex officio members of these committees.

Since members of initial/integrated scientific and technical peer review groups are not appointed as SGEs, they are not covered by this issuance.

E. References:

1. Executive Order 12674 (April 12, 1989), as modified by Executive Order 12731 (October 17, 1990), "Principles of Ethical Conduct for Government Officers and Employees."

2. 18 U.S.C. § 208. 

3. 5 CFR Part 2635, "Standards of Ethical Conduct for Employees of the Executive Branch."

4. 5 CFR Part 2634, "Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture."  

5. Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services, 5 CFR Parts 5501 and 5502.

6. Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects, 42 CFR Part 52h.

7. NIH Manual 1130: Delegations of Authority, General Administration #9B, "Grant Conflict of Interest Waivers for IC Directors and Advisory Committee Members" (appointed by the Director, NIH, or Secretary, DHHS).

8. NIH Manual 1805: "Use of Advisors in Program & Project Review and Management."

9. NIH Manual 2300-735-1: "Avoiding Conflicts of Interest."

10. NIH Manual 1743: "Keeping and Destroying Records", Introductory Note and Parts 1100-G-6 and 1100-G-8-b.

11. Memorandum from Associate General Counsel for Ethics, "Issuance of Foreign Activities Questionnaire," dated May 10, 2002.

12. Emoluments Clause of the U. S. Constitution (Article I, Section 9, Clause 8).

13. Foreign Gifts and Decorations Act, 5 U.S.C. § 7342.

F. Responsibilities:

1. Institute and Center (IC) Deputy Ethics Counselors (DECs)

a. Ensure the avoidance of conflicts of interest, or the appearance of such conflicts, in the appointment of SGE advisory committee members.

b. Coordinate and manage IC financial disclosure reporting systems. Provide advice to IC staff and SGEs regarding the application of conflict of interest guidelines and completion of financial disclosure report forms.

c. Oversee, within their respective ICs, the implementation of policies and procedures set forth in this issuance and in accordance with other applicable laws, regulations, and policies.

d. Review and certify OGE 450 forms and other required documentation, i.e., waivers/addendums and authorizations for SGE members. (See Appendices 2 and 2a)

Approval and signature authorities delegated to the DECs may not be redelegated. Waivers/ addenda are effective upon signature of the DEC.

e. Review SF 278, Public Financial Disclosure Report, and OGE 450, Confidential Financial Disclosure Report, filed by Federal employees appointed as regular or ex officio members of NIH advisory committees, for any potential conflict of interest due to committee responsibilities. Inform employees of financial interests which could create a potential conflict in relation to committee responsibilities. Provide copies of any recusals and waivers to IC Committee Management Officers upon request.

f.  Review HHS 697, Foreign Activities Questionnaire, to ensure compliance of the Emoluments Clause.  (See Appendix 3).

2. Ethics Counsel, NIH, Office of the General Counsel, Ethics Division (OGC/ED)

a. Functions as the NIH liaison to the Office of Government Ethics (OGE).

b. Provides advice and guidance on conflicts of interest, financial disclosure, and foreign activities issues.  When appropriate, provides detailed guidance to CMOs on new and/or changing conflicts of interest policies and procedures.

c. Ensures that policies and procedures affecting confidential financial disclosure systems and foreign activities are in compliance with Departmental and government-wide policies and procedures, disseminates HHS policies and procedures, and OGC/ED, OGE, and Department of Justice interpretations of Government ethics requirements, and provides guidance to NIH DECs.

d. Reviews SF 278 financial disclosure forms filed by the Director, NIH, the Director, NCI, and other Institute Directors who serve as DECs and as regular or ex officio members of NIH advisory committees, for any potential conflict of interest due to committee responsibilities.

e. Reviews and transmits a copy of each signed waiver/addendum issued under the authority of 18 U.S.C. § 208 to the OGE (See Appendices 4, 4a, and 4b.)

3. Director, Office of Federal Advisory Committee Policy (OFACP), OD/NIH

a. Functions as the liaison between the Office of the Secretary; the Office of the General Counsel, Ethics Division; the Office of the General Counsel, Public Health Service Division; the Department Committee Management Office; and the Institutes and Centers of NIH concerning conflict of interest matters relating to NIH SGE advisory committee members.

b. Furnishes policy and guidance to NIH officials for collecting, reviewing, and handling conflict of interest information for NIH SGE advisory committee members.

c. Establishes necessary controls and procedures to ensure compliance with applicable laws, regulations and policies, and submission of required documents and reports.

d. Coordinates all NIH advisory committee activities designed to avoid the occurrence of conflicts of interest or the appearance of such conflicts, in the nomination and selection of SGE advisory committee members.

4. Executive Secretaries (Designated Federal Officials) of NIH Advisory Committees

a. Acquire a working knowledge of pertinent statutes, regulations, policies, and procedures regarding conflict of interest and financial disclosure. Attend training sessions periodically on evaluation of conflict of interest situations.

b. Together with IC CMO, ensure that SGEs are fully aware of conflict of interest and financial disclosure requirements and, where appropriate, resolve any conflicts before service.

c. Review all OGE 450 forms from prospective SGE advisory committee members prior to appointment, all Verification forms (see Appendices 5, 5a, and 5b) and Recusal Lists (see Appendix 6) for current SGE members prior to each meeting. Advise the IC Deputy Ethics Counselor of potential or apparent conflicts of interest by waiver/addendum, or in some cases, by authorization. (See Appendix 7)

d. Review HHS 697 forms (see Appendix 3) from prospective SGE advisory committee members prior to appointment, and then once yearly during their term of service.

e. Review grant and cooperative agreement applications to be considered individually at a Council or Board meeting. Determine that no member has a real or apparent conflict of interest which would preclude that member’s participation in committee discussions concerning program or project concept development or concept clearance. Report any such situations to IC Director or other appropriate official(s).

f. Ensure that all Conflict of Interest and Confidentiality Certification forms (Certification) of no conflict of interest, and confidentiality of information forms that members complete at the meeting, are made part of the official meeting files.

g. Ensure that the procedures used to avoid conflicts of interest during the meeting are consistent with this issuance and are noted in the minutes of the meeting.

5. IC Committee Management Officers (IC CMOs) (hereafter referred to as CMO.)

a. Ensure that prospective SGE advisory committee members receive letters of invitation stating that their appointment is contingent upon review and approval of their completed OGE 450 form (see Appendix 2) and HHS-697 form (see Appendix 3), and that they receive an Administrative Fact Sheet (see Appendix 8) which provides instructions for completing the form. Also ensure that prospective members receive appropriate personnel appointment forms, the Standards of Ethical Conduct website, and other specified ethics materials.

b. Review prospective SGE members’ OGE 450 forms to ensure that forms are completed properly. Ensure that current members receive a blank Verification form (see Appendix 5) along with a copy of their OGE 450 form and most recent Recusal List (see Appendix 6), for updating their financial interests and covered relationships prior to each meeting. Perform initial conflict of interest review of completed forms. Ensure that advisory committee members meet reporting deadlines.

c. Prepare Recusal List, identifying section 208 financial interests and section 2635.502 covered relationships. (See Appendices 6 and 9.) 

d. Review prospective members’ HHS-697 forms for foreign activities applicable to the Emoluments Clause of the U. S. Constitution. (See Section I.) Consult with the NIH Ethics Counsel when necessary.

e. Obtain signature of acknowledgment, prior to each meeting, from Federal employees who have filed an SF 278 form or OGE 450 form, that current recusals and waivers remain in effect and of their agreement to report any changes in financial interests that may affect matters before the committee. (See Appendix 10.)

f. Ensure that new ex officio committee members are informed of the Office of Government Ethics and NIH’s requirement that they and their alternates provide a copy of appropriate financial disclosure forms before attending a committee meeting. (See Appendix 11.) If an ex officio member or their alternate does not comply in a timely manner, CMO alerts the committee’s Executive Secretary to obtain at the meeting a one-time certification of no conflicts of interest. (See Appendix 12.)

g. Ensure that all SGEs receive required annual ethics training (see Appendix 13) and maintain documentation that training material was sent, or the website address for reviewing the electronic training material was provided, and/or that in-person training was held.

h. Alert the IC DEC, Executive Secretary, or other appropriate IC officials, of any potential conflict or appearance problems, and advise on the proper procedures to handle such conflicts.

i. In consultation with Executive Secretary, prepare waivers/addenda/ authorizations for SGE advisory committee members, when appropriate, and discuss remedies for conflict or appearance problems with IC DEC or employing agency ethics officials for Federal employee members.

j. Ensure confidentiality and security of OGE 450 and other verification forms, and any other information obtained or prepared in connection with the forms, in accordance with the applicable Privacy Act System of Records and NIH policy. (See NIH Manual 1743, "Keeping and Destroying Records," Introductory Note and Part 1100-G-6.)   

k. Provide copies of all waivers/addenda issued to SGE members to NIH Ethics Counsel, OGC/ED.

6. Program Staff, Review Staff, and Grants Management Staff

a. Provide guidance, in their respective areas of authority, as appropriate, to assist SGE advisory committee members in avoiding participation in real or apparent conflict of interest situations. 

b. In their respective areas of authority, remain alert to SGE advisory committee members' possible conflict of interest situations, and advise and assist CMO, Executive Secretary, and other officials with responsibilities for reviewing OGE 450 forms and Certifications about these concerns.

7. Program/Project Review and Management

All NIH advisors participating in the peer review of applications and/or discussions of program or project concept development or concept clearance are required to certify at the meeting their avoidance of real and apparent conflicts of interest. Refer to NIH Manual 1805, "Use of Advisors in Program and Project Review and Management" for additional guidance.

8. SGE Advisory Committee Members

a. Ensure timely appointment to advisory committee by promptly completing OGE 450 and HHS-697 forms upon receipt. Return completed forms to IC CMO, along with other required appointment documents.

b. Upon receipt, current members promptly review most recent Recusal List, and complete "Verification of Review of Financial Interests" form (see Appendix 5) prior to each meeting, identifying any changes in financial interests. Return completed Verification form to CMO.

c. Complete Certification at each meeting, acknowledging avoidance of real and apparent conflicts of interest by leaving the meeting room during the individual discussion with which they may have an actual or apparent conflict of interest.

G. Implementation:

1. Overview

The Office of Government Ethics, HHS, and NIH require that individuals who are appointed to serve as SGE advisory committee members disclose certain financial interests prior to their appointment or participation. They are also required to update this information prior to each meeting in accordance with established procedures described below, beginning with G.3.

All new SGE advisory committee members must file an OGE 450 form to determine actual or apparent conflicts between the members’ public responsibilities and private interests and activities. Supplemental instructions require members to report the source of any non-Federal support available for research endeavors through research or training grants, cooperative agreements, or contracts. Reporting should also be made for funds that are available to a spouse, minor child, or close professional associate for research activities. (See Appendices 2 and 2a.) In all cases, a member’s appointment is contingent upon approval of their completed OGE 450 form.

Authority to review and approve OGE 450 forms for SGE advisory committee members, and to issue waivers and authorizations, within their respective organizations has been delegated to IC Deputy Ethics Counselors (DECs). This authority may not be redelegated.

Federal employees serving as regular or ex officio members of National Advisory Councils and Boards, Program Advisory Committees, and Boards of Scientific Counselors may already have a financial disclosure report (SF 278 form or OGE 450 form) on file with their IC or agency. Membership for Federal employees is contingent upon a review of the report by the respective IC DEC for potential conflicts of interest related to their committee responsibilities. If ex officio members have not filed any form, their agency ethics official must have them complete an SF 278 or OGE 450 form.

The HHS Office of the General Counsel, Ethics Division, also requires all SGE advisory committee members to complete an HHS 697 form. (See Appendix 3.) Information provided will help SGE members and committee staff determine if there is or could be a violation or potential violation of the restrictions of the Emolument Clause of the U. S. Constitution. Please see Section I. for procedures.

2. Procedures for Prospective SGE Advisory Committee Members 

a. Upon approval of nomination, CMO sends a Letter of Invitation and appropriate appointment forms, including the OGE 450 and HHS 697 forms, with additional instructions and guidance (see Appendices 5a, 5b, 5c, and 5d), to prospective SGE advisory committee member. An Administrative Fact Sheet (see Appendix 8) which provides instructions for completing the form, and Supplemental Instructions for Reporting Non-Federal Research/Training Support on the OGE 450 form are also provided. (See Appendices 2 and 2a)

b. Prospective SGE advisory committee member completes, signs, and returns OGE 450 form, along with other appointment documents.

c. CMO reviews OGE 450 form for completeness, returning incomplete form to prospective SGE or contacting prospective SGE to obtain additional required information.

d. ICMO reviews completed OGE 450 form and other disclosures, e.g., CV, Foreign Activities Questionnaire, to identify the SGE’s financial interests and covered relationships. For easy identification of section 208 financial interests versus section 2635.502 covered relationships (see Appendix 9), CMO records financial interests and covered relationships that could pose a conflict on a Recusal List (see Appendix 6), under the appropriate heading. (The member’s financial interests that do not fall into either category present no conflicts, so no action is required.)

e. CMO, in consultation with Executive Secretary, reviews the OGE 450 form and Recusal List and determines if an initial waiver (see Appendix 4), or in some cases, an authorization (see Appendix 7), is required. Prepare initial waiver where applicable, for signature of Executive Secretary, listing all financial interests, except primary employment and covered relationships noted on the Recusal List. (See Appendix 6.) If appropriate, CMO prepares an authorization to permit SGE to participate in a specific party matter involving an entity with which the SGE has a covered relationship.

f. CMO sends OGE 450 form, new waiver, and Recusal List to appropriate IC Deputy Ethics Counselor for review and signature.

g. CMO sends a copy of each signed waiver to the Ethics Counsel, NIH, and retains original waiver in the CMO office official files with (but not attached to) the SGE advisory committee member’s OGE 450 form.

h. CMO, in consultation with Executive Secretary, ensures that SGE advisory committee member is advised to recuse from matters that pose an actual or apparent conflict.

i.  CMO gives a copy of Recusal List to the SGE advisory committee member and Executive Secretary before the meeting begins to ensure compliance.

(1) Waivers and the Recusal List apply to all particular matters scheduled for discussion at open and closed sessions of advisory committee meetings. Particular matters may be general or specific, and involve deliberation, decision and/or action. Examples include: grants, contracts, licenses, patents, lawsuits, and policy-making.

(2) New SGE members will be formally appointed only after clearance of OGE 450 form and completion of other aspects of the appointment process.

(3) A new OGE 450 form is not required for members being reappointed to the same committee, e.g., reappointments to Chair; reappointments from a partial term to a full term, provided the total service does not exceed six years and there is no break in service. However, reappointed members are required to continue updating their form prior to each meeting.

3. Procedures for Current SGE Advisory Committee Members

a. CMO sends a blank Verification of Review of Financial Interests (see Appendix 5) to SGE advisory committee members prior to each advisory committee meeting, along with additional instructions and guidance (see Appendices 5a, 5b, 5c and 5d), a copy of their OGE 450 form and the most recent Recusal List. (See Appendix 6.) SGE members review their financial interests and update them on the Verification form to reflect any changes that have occurred up to 30 working days prior to the date of the meeting for those members serving on one advisory committee, or up to 45 working days for members serving on two advisory committees at the same time. If an advisory committee meets twice within 45 days, the Verification documentation may be used for both meetings.  SGE signs the Verification form, and returns it to CMO.

b. CMO, in consultation with Executive Secretary, reviews the Verification form and determines whether there are any new financial interests or covered relationships that pose potential conflicts of interest or appearance problems. For easy identification of section 208 financial interests versus section 2635.502 covered relationships, CMO records financial interests and covered relationships on a new Recusal List (even if there are no changes), under the appropriate heading. (See Appendices 6 and 9.)  When applicable, prepares new waiver or addendum (see Appendix 4b) for signature by the Executive Secretary, listing all financial interests, except the primary employment and covered relationships noted on the Recusal List. If appropriate, CMO prepares an authorization to permit SGE to participate in a specific party matter involving an entity with which the SGE has a covered relationship.

c. CMO completes tracking form, "Clearance Process to Identify and Resolve Potential Conflicts of Interest," for SGE Advisory Committee Members, attaching new waivers, addenda, and updated Recusal Lists. (See Appendix 14.)

d. CMO transmits tracking form and updated forms to Executive Secretary for review and signature, and then forwards to appropriate IC Deputy Ethics Counselor for review and signature.

e. CMO retains original waivers and addenda with (but not attached to) the SGE advisory committee member’s OGE 450 and Verification forms, and sends a copy of each newly signed waiver and addendum to the Ethics Counsel, NIH.

f. CMO, in consultation with Executive Secretary, ensures that SGE advisory committee member is advised to recuse from matters that pose an actual or apparent conflict.

g. CMO gives a copy of the most recent Recusal List to the SGE advisory committee member and Executive Secretary before the meeting begins to ensure compliance.

4. Procedures for NIH Employees Serving as Regular Members of NIH Advisory Committees

CMO notifies IC DEC of those NIH employees who serve as regular members of NIH advisory committees, and sends a copy of committee charter to IC DEC.

NOTE: IC DEC is the DEC from the advisory committee member’s home institute.

a. If member has a SF 278 form on file:

(1) IC DEC reviews form and any recusals/disqualifications or waivers for potential conflicts of interest due to committee responsibilities.

(2) IC DEC returns copy of SF 278 to employee, along with memo stating that recusals/disqualifications and waivers continue to apply in relation to committee responsibilities.

(3) IC DEC forwards copy of member’s current recusals/ disqualifications and waivers to CMO.

(4) IC DEC maintains SF 278 form and related documentation.

(5) CMO obtains member’s signature prior to each meeting, acknowledging that current recusals and waivers remain in effect regarding matters before the committee (see Appendix 10) and his or her obligation to recuse from matters involving or affecting his or her financial interests unless a waiver or authorization has been issued.

(6) CMO retains original acknowledgment.

(7) Ethics Counsel, NIH, reviews SF 278 forms filed by the Director, NIH, the Director, NCI, and other IC Directors who serve as DECs and as regular members of NIH advisory committees.

b. If member has an OGE 450 form on file:

(1) IC DEC transmits copy of form to CMO.

(2) CMO reviews, maintains, and updates according to prescribed procedures in section 3.a., EXCEPT Federal members do not receive a waiver/authorization (except in consultation with IC DEC).

(3) CMO obtains member’s signature prior to each meeting, acknowledging that current recusals and waivers remain in effect regarding matters before the committee (see Appendix 10) and their obligation to recuse from matters involving or affecting their financial interests unless a waiver or authorization has been issued.

(4) CMO retains original acknowledgment.

c. If member does not have a SF 278 or OGE 450 form on file:

(1) Member must complete OGE 450 form.

(2) CMO reviews, maintains, and updates according to prescribed procedures in section 3.a., EXCEPT Federal members do not receive a waiver/authorization (except in consultation with IC DEC).

(3) CMO obtains member’s signature prior to each meeting, acknowledging that current recusals and waivers remain in effect regarding matters before the committee (see Appendix 10) and his or her obligation to recuse from matters involving or affecting his or her financial interests unless a waiver or authorization has been issued.

(4) CMO retains original acknowledgment.

5. Procedures for non-NIH Federal Employees Serving as Regular Members of NIH Advisory Committees

CMO requests SF 278 or OGE 450 forms for non-NIH Federal employees serving as regular members on NIH advisory committees from their respective agencies.

NOTE: The Office of Government Ethics advises that SF 278 forms from other agencies must be marked "Confidential-Not for Public Release," and maintained like the OGE 450 forms. The SF 278 forms may be requested from the members’ home agency.

NOTE: IC DEC is the DEC for the advisory committee.

a. If member has a SF 278 form on file:

(1) CMO forwards form to IC DEC for review. 

(2) IC DEC returns SF 278 form to CMO for filing.

(3) CMO obtains member’s signature prior to each meeting, acknowledging that current recusals and waivers remain in effect regarding matters before the committee (see Appendix 10) and his or her obligation to recuse from matters involving or affecting his or her financial interests unless a waiver/authorization has been issued permitting participation in committee matters.

(4) CMO retains original acknowledgment.

b. If member has an OGE 450 form on file:

(1) CMO reviews, maintains, and updates prior to each meeting according to prescribed procedures in section 5.a.

(2) CMO obtains member’s signature prior to each meeting, acknowledging that current recusals and waivers remain in effect regarding matters before the committee (see Appendix 10) and his or her obligation to recuse from matters involving or affecting his or her financial interests unless a waiver/authorization has been issued permitting participation in committee matters.

(3) CMO retains original acknowledgment.

c. If member does not have a SF 278 or OGE 450 form on file:

(1) Member must complete OGE 450 form.

(2) CMO forwards form to IC DEC for review.

(3) IC DEC reviews OGE 450 form and returns original to CMO.

(4) CMO reviews prior to each meeting according to prescribed procedures in section 5.a.

(5) CMO obtains member’s signature prior to each meeting, acknowledging that current recusals and waivers remain in effect regarding matters before the committee (see Appendix 10) and his or her obligation to recuse from matters involving or affecting his or her financial interests unless a waiver/authorization has been issued permitting participation in committee matters.

(6) CMO retains original acknowledgment.

6. Procedures for Federal Non-NIH Ex Officio Members Serving on NIH National Advisory Councils (NACs) and Program Advisory Committees (PACs)

a. ICMO sends letter (see Appendix11) to new ex officio advisory committee member informing him or her that he or she must submit a copy of his or her financial disclosure form (SF 278 or OGE 450) that is on file with his or her home agency before serving on a Federal advisory committee. This requirement also applies to alternate ex officio members serving in the member’s absence.

NOTE: NIH does not have authority to request an ex officio from another agency to complete an OGE 450 form if he or she does not have one on file. In this instance, the CMO may contact the ex officio member’s home agency ethics official to request that the member complete an OGE 450 form.

b. CMO reviews ex officio member’s SF 278 or OGE 450 form in relation to committee responsibilities and meeting agenda. The home agency will not have ready access to this information and would nevertheless be less-equipped than NIH officials to identify potential conflicts of interest..

c. CMO requests ex officio member’s home agency ethics official to prepare waiver, when necessary. Only the home agency has authority to grant waivers to ex officio members. If a conflict is identified based upon review of the ex officio member’s SF 278 or OGE 450, the home agency must issue the waiver, or the ex officio member must recuse him or herself from participating in the particular matter(s) with which he or she has the conflict(s).

d. If ex officio members or their alternates do not submit their financial disclosure forms for review prior to the advisory committee meeting, they must certify at the meeting by signing the Conflict of Interest Certification (see Appendix 12) that they did not participate in any matters in which they may have been in conflict. These instances should be unique and infrequent.

In these isolated cases, the certification can be used only once by the ex officio member. It is used because the member’s expertise is absolutely required at the particular meeting.

In these instances, ex officio members or alternates must submit a copy of their financial disclosure form immediately following the meeting. CMOs retain these forms in their official files for OGE 450s or SF 278s. SF 278 forms from other agencies must be marked "Confidential-Not for Public Release," and maintained like the OGE 450 forms. The SF 278 forms may be requested from the members’ home agency.

7. Procedures for Review of OGE 450 and Verification Forms 

a. CMO reviews the OGE 450 and Verification forms for completeness, promptly returning incomplete forms to the submitter, or making annotations based on additional information from the submitter.

In sections for which there is no information, prospective or current advisory committee member must check "NONE" or the equivalent; blank spaces are not acceptable. The exception is Part V, which should be left blank because it is not applicable.

b. Executive Secretary reviews all new OGE 450 forms and Verification forms submitted by prospective or current SGE advisory committee members on their committees, giving particular attention to the members' committee responsibilities in relation to employment and financial interests, and other relationships.

c. CMO prepares Recusal List (see Appendix 6) and, in consultation with Executive Secretary, advises IC DEC of potential conflicts of financial interest and appearance concerns.

d. Executive Secretary in consultation with IC DEC advises prospective member of the various remedial actions available with respect to certain financial interests, when an actual or apparent conflict of interest has been identified, so that committee membership or continued membership may become possible. These remedial actions include, as appropriate:

(1) Issuance of a waiver under 18 U.S.C. § 208(b) (see section 8.a. below);

(2) Disqualification (recusal) from matters specifically involving or affecting those interests;

(3) Voluntary resignation, or transfer to another committee; or

(4) Issuance of an authorization (see Appendix 7) under 5 CFR section 2635.502 (See section 9 below for procedures.)

In addition, in rare instances, in order for a member to serve, remedial actions may include:

(5) Divestiture of a conflicting interest;

(6) Resignation from a position with a non-Federal business or other entity; or

(7) Establishment of a qualified blind or diversified trust

e. IC DEC signs the OGE 450 forms as approving official, after all potential conflicts of interest and appearance problems are resolved through one or more of the above remedial actions.

The OGE 450 form (see Appendix 2) includes two signature blocks for review and approval. Persons delegated the authority listed above must sign as the second-level reviewing official ("Agency's Final Reviewing Official"). The first-level (or intermediate) reviewing official may be the Executive Secretary or another designated official.

f. CMO ensures that the OGE 450 and HHS 697 forms are returned to any individual who is not officially appointed. The appropriate IC official documents for the record the reasons why the individual was not officially appointed.

8. Procedures for Issuance of Waivers

a. SGEs: Authority 18 U.S.C. § 208(b)(3)

(1) Criminal conflict of interest statutes preclude SGE advisory committee members from personally and substantially participating as Government employees in any particular matter in which, to their knowledge, they, their spouse, minor child, partner, or an organization with which they are seeking employment or that they serve as an officer, director, trustee, general partner, or employee has a financial interest.

(2) A waiver is a mechanism to resolve an actual conflict of interest. For SGE advisory committee members, a waiver may be granted by the SGE’s appointing authority based on the need for the individual’s services. Specifically, a waiver under 18 U.S.C. § 208(b)(3) can be granted only when the need for the members’ services outweighs the potential for a conflict of interest created by the financial interest involved. (See Appendix 4.)

(3) SGE advisory committee members who would otherwise be disqualified by 18 U.S.C. § 208(a) may be permitted to participate in certain particular matters only if they are granted an individual waiver issued under U.S.C. § 208(b)(3), prior to their participation.

NOTE: Final approval and signature on any required waivers or addenda has been delegated to DECs and may not be redelegated.

b. Federal Employees: Authority 18 U.S.C. § 208(b)(1)

All Federal employees who serve on advisory committees as either appointed members or ex officio members, who would otherwise be disqualified, may participate in certain particular matters only if they are granted an individual waiver issued under 18 U.S.C. § 208(b)(1), prior to the advisory committee member’s participation, if the employee’s appointing authority determines that the financial interest is not so substantial as to be deemed likely to affect the integrity of the services which the Government may expect from the employee. (See Appendix 4a.)

NOTE:  Federal employees having relevant waivers for general party matters and recusals in effect when appointed to an advisory committee will not require an additional 208(b)(1) waiver in order to participate in committee matters.

NOTE:  NIH does not have the authority to grant waivers to ex officio advisory committee members. If a conflict is identified, the home agency must issue the waiver, or the ex officio member must recuse their self from participating in matters with which they have the conflict(s).

9. Procedures for Granting an Authorization Under 5 CFR Section 2635.502 

a. An appearance of a conflict of interest arises where a member participates in a specific party matter (see Definitions in Appendix 1) involving outside parties (including individuals, corporate entities, etc.) with which the member is deemed, by law, to have a covered relationship, and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the SGE's impartiality in the matter.

Covered relationships include:

(1) A person of the member's household, e.g., domestic partner, or a relative with whom the member has a close personal relationship;

(2) A person with whom the member has or seeks a business, contractual, or other financial relationship that involves other than a routine consumer transaction;

(3) Any organization/person for whom the member's spouse, parent or dependent child is, to the member's knowledge, serving or seeking to serve as an officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee;

(4) Any organization/person for whom the member has, within the last year, served as an officer, director, trustee, general partner, agent, attorney, consultant, contractor, or employee, including any institution which paid an honorarium to the member; or

(5) Any organization in which the member is an active participant.

b. IC DEC determines whether the member should be authorized to participate in the matter. The IC DEC may determine that the member's impartiality is likely to be questioned and the member should not participate in the matter, or that the risk that any question of impartiality will arise is insignificant and an authorization should be given, allowing the SGE to participate in the specific party matter affecting the person/entity with which the member has a covered relationship. (See Appendix 7.)

c. IC DEC must determine that, in light of all relevant circumstances, the interest of the Government in the member's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations.

Factors that may be considered:

(1) The nature of the relationship involved;

(2) The effect that the resolution of the matter would have upon the financial interests of the person involved in the relationship;

(3) The nature and importance of the member's role in the matter, including the extent to which the individual is called upon to exercise discretion in the matter;

(4) The sensitivity of the matter;

(5) The difficulty of reassigning the matter; and

(6) Adjustments that can be made in the member's duties that would reduce or eliminate the likelihood that a reasonable person would question the member's impartiality.

d. The authorization shall be documented in writing.

10. Availability of "Confidential Financial Disclosure Report" (Forms OGE 450) and Related Documents

ICs may order supplies of OGE 450 forms through the General Service Administration's (GSA) Federal Supply Service, National Stock Number 7540-01-351-9173, or they may reproduce the form from the following web sites:

• http://www3.od.nih.gov/cmo/

• http://ethics.od.nih.gov/

ICs may also reproduce HHS-697 forms from the above web sites.

H. Multi-Campus Institutions:

1. Private Institutions and Affiliates

This section applies ONLY to private institutions and affiliates.

a. An SGE advisory committee member who is employed by a private institution may participate in the review of a grant application submitted by an affiliate of the private institution if the SGE:

(1) does not hold a joint appointment with that affiliate;

(2) does not have affiliate-wide responsibilities; and

(3) has a waiver to do so.

For example, a professor at Harvard may review a grant application from Beth Israel, a Harvard affiliate, if that professor does not hold a joint appointment with Beth Israel, does not have affiliate-wide responsibilities, and has a waiver which states the following:

Additionally, I recommend that you grant [name of individual] a waiver that would allow this individual to participate in specific matters that may affect any of the affiliates of [name of institution]. I believe that such a waiver is appropriate because [name of individual] does not hold any joint appointments with the affiliates and has no affiliate-wide responsibilities.

b. An SGE advisory committee member who holds a joint appointment at a private institution and at one of its affiliates may participate in a review of a grant application submitted by another affiliate if the SGE:

(1) does not hold an appointment with the affiliate that has submitted the grant application;

(2) does not have affiliate-wide responsibilities; and

(3) has a waiver to do so.

For example, a doctor at Harvard Medical School who also holds an appointment at Massachusetts General Hospital, a Harvard affiliate, may review a grant application submitted by Beth Israel if the doctor does not hold an appointment with Beth Israel, does not have affiliate-wide responsibilities, and has a wavier which states the following:

Additionally, I recommend that you grant [name of individual] a waiver  that would allow this individual to participate in specific matters that may affect any other of the affiliates of [name of institution]. I believe that such a waiver is appropriate because [name of individual] does not hold any joint appointments with any other affiliate and has no affiliate-wide responsibilities.

At meetings when applications are reviewed in groups without discussion, i.e., "en bloc" concurrences, the vote of an individual member does not apply to applications from private institutions and any affiliate in which the member holds an appointment or is otherwise in conflict.

2. State Multi-Campus Institutions

This section applies ONLY to State multi-campus institutions.

An SGE advisory committee member who is employed at one university of a State multi-university system may participate in any particular matter affecting another university of the same system, provided the member has no multi-campus responsibilities.

Example 1: An SGE member of an NIH advisory council is from California (Cal) State Fullerton. The SGE may participate in formulating the committee’s recommendation to award a grant to a researcher at another university of the California State University system, so long as the SGE’s employment at Cal State Fullerton entails no multi-campus responsibilities.

Therefore, with this recent OGE guidance and contrary to previous regulations, the separate universities of the California State system are now considered separate entities in the same way as the separate universities of the University of California system had been, under 45 CFR Part 73, Subpart J. However, the separate campuses within, for example, Cal State Fullerton, are not considered separate entities for purposes of this policy.

Example 2: A member of the Board of Regents at a State university is asked to serve on an advisory committee established by the National Institutes of Health to consider applications for grants for human genome research projects. An application from another university that is part of the same State system will be reviewed by the committee. Unless he receives an individual waiver under section 208(b)(1) [for Federal employees] or (b)(3) [for SGEs], the advisory committee member may not participate in matters affecting the second university that is part of the State system because as a member of the Board of Regents, he has duties and responsibilities that affect the entire State educational system.

I. Emoluments Clause of the U.S. Constitution:  

Without consent of Congress, the Emoluments Clause of the U.S. Constitution (Article I, Section 9, Clause 8) prohibits Government employees (interpreted to include SGE advisory committee members) from receiving any present, emolument, office, or title of any kind whatsoever from a foreign state. Also, SGEs cannot accept concurrent outside employment with a foreign government or a political subdivision of a foreign government, including certain public universities or commercial enterprises owned or operated by a foreign government. An emolument includes without limitation any gift, salary, honoraria, transportation, per diem allowances, household goods shipment costs, and housing allowances. The Emoluments Clause applies at all times during the SGE’s advisory committee appointment.

Under the statutory provision of the Foreign Gifts and Decorations Act (FGDA), Federal employees, including advisory committee members, may accept items from a foreign government that do not exceed "minimal value" (currently $305). This figure is adjusted periodically for inflation. Minimal value gifts under the FGDA are gifts to which Congress consented, thus acceptance of such gifts would not violate the Emoluments Clause.  The Act authorizes acceptance of items over minimal value when the items consist of an educational scholarship, medical treatment, or expenses for travel taking place entirely outside the United States, thus permitting hotel and meal reimbursements in the foreign country, but not airfare for flights originating or terminating in the United States. If an SGE member participates in an activity with a foreign government on behalf of their university, the foreign government may reimburse the university directly for the individual’s expenses, including travel originating and terminating in the United States.

The FGDA’s limitation on gifts extends to family members of Federal employees, including advisory committee members. However, family members may accept titles, offices, or positions from foreign government entities, and may accept employment compensation and benefits.

To help SGE members and committee staff determine if there is or could be a violation or potential violation of the restrictions of the Emoluments Clause, the HHS Office of the General Counsel, Ethics Division, issued a mandatory HHS-697 form, that must be completed by all SGE advisory committee members. (See Appendix 3.)

1. Procedures for Prospective SGE Advisory Committee Members

a. CMO includes HHS-697 form, with appointment package, as described in the Administrative Fact Sheet for Special Government Employees (see Appendix 8), and additional instructions and guidance. (See Appendices 5b and 5d.)

b. CMO reviews and, when necessary, advises Executive Secretary and IC DEC of violation or potential violation of Emoluments Clause restrictions.

c. CMO consults with NIH Ethics Counsel if unable to determine, after careful analysis, if violation or potential violation exists.

d. CMO, after consultation with IC DEC or NIH Ethics Counsel, informs Executive Secretary if a violation is identified and advises that 1) the member must terminate their foreign activity(s), or 2) they must decline appointment to serve on the advisory committee.

2. Procedures for Current SGE Advisory Committee Members

a. CMO sends HHS-697 form to members, with additional instructions and guidance (see Appendices 5b and 5d.), prior to the first committee meeting of each calendar year. The form should be forwarded with the OGE 450 update/verification of financial interests.

b. CMO reviews and, when necessary, advises Executive Secretary and IC DEC of violation or potential violation of Emoluments Clause restrictions

c. CMO consults with NIH Ethics Counsel if unable to determine, after careful analysis, if violation or potential violation exists.

d. CMO, after consultation with IC DEC or NIH Ethics Counsel, informs Executive Secretary if a violation is identified and advises that 1) the member must terminate their foreign activity(s), or 2) they must terminate their service on the advisory committee.

J. Annual Ethics Training Requirement: Office of Government Ethics regulations (5 C.F.R. Part 2638 Subpart G, dated April 7, 1992; amended in 1997 and published in the Federal Register on March 12, 1997) require that all Federal employees, including SGEs, who are required to file confidential financial disclosure reports (OGE 450 and SF 278) receive annual ethics training.

Office of the General Counsel, Ethics Division, HHS (OGC/ED/HHS) is responsible for approving the content of annual training programs and providing training information and guidance to DECs for use in developing internal training programs.

SGE advisory committee members may meet the annual training requirement by reading written materials such as the Ethics Rules for SGEs, provided by the OGC/ED/HHS. (See Appendix 13.) The format and type of training, e.g., videotapes, computer-based training, for NIH employees who are filers with advisory committee responsibilities is determined by the IC DEC that employs the individual.

Additionally, each year as a part of the annual ethics training, committee members receive a copy of a notice informing committee members associated with law, public relations, lobbying, or accounting firms that they are prohibited from receiving compensation as a result of their firm representing a specific client on a particular matter which is the subject of a committee’s meetings. (See Appendix 13a.)

CMOs are required to maintain documentation that training material was sent, the website address for reviewing electronic training materials was provided, or that in-person training was held for the SGE advisory committee members.

K. Confidentiality: Information provided on the OGE 450 form is maintained under Privacy Act System Notice OGE/GOVT-2, "Confidential Statements of Employment and Financial Interest." The Privacy Act of 1974 (5 U.S.C. § 552a) gives the subject individual right of access upon request and limits disclosure to the public except by court order or by request of the U.S. Congress, by the General Accounting Office as part of a Federal agency audit, or as otherwise provided under the Privacy Act.

1. Office Responsible for Reviewing Management Controls Relative to this Chapter:

The Office of Federal Advisory Committee Policy (OFACP), IC Deputy Ethics Counselors (DECs), and Ethics Counsel, NIH.

Through this manual issuance, the OFACP in the Office of the Director, NIH, is accountable for ensuring that CMOs have implemented appropriate management controls.

2. Frequency of Review:

OFACP staff conduct ongoing as well as biennial reviews, as described below, of CMO files. Annual ethics training is also provided to the CMOs.. In addition, the Office of Government Ethics, at their discretion and in their time frame, may audit any or all of the ICs within NIH. An ongoing review schedule from 1-3 years will be established for the NIH Office of Management Assessment to do an internal review to determine IC compliance with the policy.

3. Method of Review:

The procedures implemented in this chapter receive an ongoing review by the Office of Federal Advisory Committee Policy during monthly meetings with IC CMOs, and through continuous individual discussions between OFACP staff and IC CMOs. The OFACP staff also maintain appropriate oversight through biennial reviews of CMO procedures and files. Evaluation of the compliance with the policy is conducted using a sample of members to ensure that all ethics requirements are being adhered to by the CMOs. Problem issues identified by the reviewers are brought to the attention of the Director, OFACP, and are again reviewed for compliance within a reasonable time. Additional training is provided, as necessary, and issuance of interim policies and procedures, as required.

Additionally, the Director, OFACP and senior staff maintain open communications with NIH ethics staff and colleagues of other Federal agencies for best practices.  Recommendations for program improvements are made when appropriate.

4. Review Reports:

Reviewers send their reports to the Director, OFACP, and when appropriate, the IC DECs and Ethics Counsel, NIH, indicating that controls are in place and working well, or include any management control issues that should be brought to the attention of the report recipients.

APPENDICES

APPENDIX 1: Definitions

1. Actual Conflict of Interest

Members of National Advisory Councils and Boards, Program Advisory Committees, Boards of Scientific Counselors, including Federal employees and other individuals who serve as SGEs, are prohibited by criminal statute, 18 U.S.C. § 208(a), from participating personally and substantially in an official capacity in any particular matter in which, to their knowledge, they or any person whose interests are imputed to them has a financial interest, if the particular matter will have a direct and predictable effect on that interest. The financial interests of the following persons (and organizations) are considered imputed: the member's spouse; minor child; general partner; an organization or entity for which the member serves as officer, director, trustee, general partner or employee; and a person (organization) with whom the member is negotiating for or has an arrangement concerning prospective employment.

2. Appearance of a Conflict of Interest

An appearance of a conflict of interest arises where an advisory committee member is involved in a particular matter involving specific outside parties (including individuals, corporate entities, etc.) and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the advisory committee member's impartiality in the matter because the member is deemed by law to have a covered relationship with a party to the matter.

A member has an apparent conflict of interest if the matter involves:

(1) a person or organization, other than a prospective employer, with whom the SGE member has or seeks a business, contractual, or other financial relationship that involves other than a routine financial transaction (e.g., person or organization which gives or awards to members or their non-Federal employing institutions a research or training grant or award);

(2) a person who is a member of the advisory committee member's household other than spouse or minor child, e.g. domestic partner, or who is a relative with whom the advisory committee member has a close personal relationship;

(3) a person or organization for whom the member's spouse, parent, or dependent child is, to the member's knowledge, serving or seeking to serve as an officer, director, trustee, general partner, agent, attorney, consultant, contractor, or employee;

(4) any person or organization for whom the member has, within the last year, served as an officer, director, trustee, general partner, agent, attorney, consultant, contractor, employee (including advisor, researcher, trainee), expert, or speaker

(5) any organization, other than a political party, in which the member is an active participant; and/or

(6) any person or organization where the member is concerned that circumstances would raise a question about the member's impartiality in the performance of Government activities.

3. Authorization

An authorization is a mechanism used to resolve an appearance of a conflict of interest. An advisory committee member must obtain an authorization under 5 CFR 2635.502 where the "employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his or her household, or knows that a person with whom he or she has a covered relationship is or represents a party to such a matter, and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his or her impartiality in the matter, the employee should not participate in the matter until he or she has informed the agency designee of the appearance problem and received authorization from the agency designee..." (5 CFR 2635.502(a)) (See Appendix 7.)

4. Covered Relationship

A term used to describe relationships that do not constitute financial interests, but which may cause a reasonable person to question an employee’s impartiality. A covered relationship may be any entity with which an advisory committee member has or seeks a financial, business, or other contractual relationship, such as research funding sources and award sources; any entity the member has served within the last year as officer, director, trustee, general partner, agent, attorney, consultant, contractor, or speaker such as one-time speaking engagements, sources of honoraria from speeches, or consulting as an "independent contractor." A covered relationship also exists with a former employer for one year after leaving. (See Appendix 9.)

5. Direct and Predictable Effect

The term "direct and predictable effect" refers to the impact an advisory committee member's official duties may have on an outside financial interest. A particular matter will have a direct effect on a financial interest if there is a close causal link between any decision or action to be taken in the matter and any expected effect of the matter on the financial interest. An effect may be direct even though it does not occur immediately. A particular matter will not have a direct effect on a financial interest, however, if the chain of causation is attenuated or is contingent upon the occurrence of events that are speculative or that are independent of, and unrelated to, the matter. A particular matter will have a predictable effect if there is a real, as opposed to a speculative, possibility that the matter will affect the financial interest. It is not necessary, however, that the magnitude of the gain or loss be known, and the dollar amount of the gain or loss is immaterial.

6. Emolument

An emolument includes without limitation any gift, salary, honoraria, transportation, per diem allowances, household goods shipment costs, and housing allowances. The Emoluments Clause of the United States Constitution prohibits U.S. Government employees, including SGEs, from receiving any present, emolument, office, or title of any kind from a foreign state. (See Section I.)

7. Employment

Employment includes but is not limited to employment by foreign governments or other entities, summer and part-time employment, membership on boards of organizations, service as an officer, director, or trustee, and consultant appointments, even if unremunerated.

8. Federal Advisory Committee

Any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof, which is established by statute, or established or utilized by the President or any agency official for the purpose of obtaining advice or recommendations on issues, policies, or other matters which are within the scope of his or her responsibilities and are related to the programs, responsibilities or activities of the Department. Excluded from this definition is any committee composed entirely of full-time officers or employees of the Federal Government.

9. Financial Interest

A financial interest, broadly defined, is any potential for gain or loss to the advisory committee member or anyone whose interests are imputed to the member (See Definition 1 above). Such financial interests include, without limitation, stock, options, bank accounts, mutual funds, sector funds, consulting relationships, leaves of absence agreements, royalty or licensing agreements, employment agreements, retirement assets, trust holdings, and bonds.

10. Particular Matter

There are two types of particular matters:

• Matters involving specific parties (also known as specific party matters) - those matters that are focused on the interests of the United States and one or more identified parties. A grant application is a specific party matter;
• Matters of general applicability (also known as general matters) - those matters that will not have a special or unique effect on any particular entity, but will instead have the same effect on all members of a class or group of entities. Consideration of new grant application requirements is an example of a general matter.

11. Personal and Substantial Participation

To participate personally means to participate directly. To participate substantially means that the advisory committee member's involvement is of significance to the matter, even if not decisive.

12. Special Government Employee (SGE)

As defined by 18 U.S.C. § 202(a), an SGE can be an officer or employee of the Executive Branch who is retained, designated, appointed, or employed to perform temporary duties, with or without compensation, for a period not to exceed 130 days during any period of 365 days, either on a full-time or intermittent basis. Members of NIH Advisory Councils and Boards, Program Advisory Committees, and Boards of Scientific Counselors who are not otherwise employed by the Federal Government are appointed as SGEs.

13. Waiver

A waiver is a mechanism used to resolve an actual conflict of interest. An SGE advisory committee member may obtain a waiver under 18 U.S.C. § 208(b)(3) when "the need for the individual’s services outweighs the potential for a conflict of interest created by the [otherwise disqualifying] financial interest." (See Appendix 4) Federal employees who are appointed as regular advisory committee members, regardless of whether they file a financial disclosure report OGE 450 or SF 278, may obtain a waiver under 18 U.S.C. § 208(b)(1) when "the employee’s financial interest in the particular matter or matters is not so substantial as to be deemed likely to affect the integrity of the services which the Government may expect from the employee." (See Appendix 4a.)

APPENDIX 2: OGE Form 450, "Confidential Financial Disclosure Report"  

APPENDIX 2a: Supplemental Instructions for Reporting Non-Federal Research/Training Support on OGE Form 450

In Part I - Assets and Income

Report the source of any (even if below the $1,000 asset threshold and the $200 income threshold indicated on the OGE 450 form) non-federal support (e.g., funds or resources) available for direct support of your research endeavors through research or training grants, cooperative agreements, or contracts. Reporting should also be made for funds that are available to a spouse, minor child, or close professional associate for research endeavors.

You should report the source of any such support that (1) you have received in the past twelve months, (2) you are currently receiving, and (3) you may have pending for review or award.

Report the identity of the organization (including the city and state) of the non-federal research/training support, the type of organization, the identity of the principle investigator, and the dates of the projected support. Note that the amount of the non-federal support need not be reported.

This information will be used by appropriate staff to determine whether this support might be perceived to constitute a real or apparent conflict of interest in the exercise of your duties as a member of an NIH advisory committee.

OFACP
06/17/98 No Change as of 12/31/05

APPENDIX 3: HHS Form 697, "Foreign Activities Questionnaire"

APPENDIX 4: Sample Conflict of Interest Waiver Format for SGE Advisory Committee Members

DATE:

TO:              [Name of Employee’s Deputy Ethics Counselor or Designee]
                    [Title]

FROM:        [Name of Recommending Official]
                    [Title]

SUBJECT:    Conflict of Interest Waiver for [Name of Individual]

I am writing to request a waiver for [name of individual], a member of the [name of advisory committee], from the conflict of interest prohibitions of 18 U.S.C. §208(a). Waivers under Section 208(b)(3) may be granted by the appointing official where "the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved" and where the individual has made a disclosure of the financial interests at issue. The Office of the General Counsel has determined that you are the appointing official for purposes of Section 208 in accordance with Executive Order 12731 Section 401. Therefore, you have the authority to grant [name of individual] a waiver under Section 208(b)(3).

Section 208(a) prohibits Federal Executive Branch employees, including Special Government Employees, from participating personally and substantially in particular matters in which any of the following individuals or organizations has a financial interest: (1) the employee; (2) the employee's spouse; (3) the employee's minor child; (4) an organization in which the employee serves as an officer, director, trustee, partner, or employee; or (5) a person or organization with which the employee is negotiating for prospective employment or has an arrangement for prospective employment. Since [name of individual] is a Special Government Employee, this individual is under a statutory obligation to refrain from participating in any deliberations that involve a particular matter having a direct and predictable effect on a financial interest attributable to this individual.

The member's financial interest subject to waiver are:

Organization    Kind of Organization    Nature of Interest

The functions of the Committee, as stated in its charter, are to [add description of committee functions and any specific functions that are pertinent]. As a member of the [name of advisory committee], [name of individual] potentially could become involved in particular matters that affect reported financial interests. Under Section 208, [name of individual] is prohibited from participating in particular matters. However, as noted above, you have the authority under 18 U.S.C. § 208(b)(3) to grant a waiver permitting [name of individual] to participate in particular matters as you deem appropriate.

DECISION:

__________ Waiver granted based on my determination, made in accordance with Section 208(b)(3), that the need
                      for the individual's services outweighs the potential for a conflict of interest created by the financial interest
                      attributable to the individual.

__________ Waiver denied.

______________________________________________
[Name of Employee’s Deputy Ethics Counselor or Designee]

                              _______________
                              Date

cc: NIH Ethics Counsel, OGC/ Ethics Division

APPENDIX 4a: Sample Conflict of Interest Waiver Format for Federal Employees Appointed as Regular Advisory Committee Members

DATE:

TO:              [Name of Employee’s Deputy Ethics Counselor or Designee]
                    [Title]

FROM:        [Name of Recommending Official]
                    [Title]

SUBJECT:    Conflict of Interest Waiver for [Name of Individual]

The purpose of this memorandum is to request that you grant a waiver from the conflict of interest prohibitions of 18 U.S.C. §208(a) for [name of individual], a member of the [name of advisory committee]. Waivers under section 208 (b)(1) may be granted by the appointing official when it is determined that "the (disqualifying financial) interest is not so substantial as to be deemed likely to affect the integrity of the services which the Government may expect" from the employee and where the individual has made a disclosure of the financial interests at issue. We have determined that you are the appointing official for purposes of section 208. Therefore, you have the authority to grant [name of individual] a waiver under section 208 (b)(1).

[Name of individual] serves as [individual’s title]. Section 208(a) prohibits Federal Executive Branch employees from participating personally and substantially in particular matters that will have a direct and predictable effect on a financial interest of the employee, [his/her] spouse, minor child, general partner, or any organization of which the individual is an employee, general partner, officer, director, or trustee.

[Name of individual] has disclosed [his/her] potentially conflicting personal and imputed financial interests as follows:

[Describe the types of financial interests of the individual and the identity of the person whose financial interest is involved, if other than the employee, that may present a conflict of interest. This includes, but is not limited to, interests in real or personal property, stocks, stock options, bonds, job offer, and partnership interests. In addition, describe any entities for which the individual is an officer, director, trustee, general partner, or employee. 

For the following reasons, I believe that it would be appropriate for you to grant a waiver to [name of individual] that would allow [him/her] to participate in matters that will affect the above [financial interests, companies/organizations, etc.] to the same extent as they would affect all similarly situated entities.

[Describe the reasons for granting the waiver, focusing on the test, i.e., that the interest is not so substantial as to be deemed likely to affect the integrity of the services that the Government may expect from the individual. Describe the amount of the interest and why it is not substantial.]

In addition, the nature of the duties that [name of individual] performs are such that the integrity of [his/her] services are not likely to be compromised. The duties involve [describe]. Since [name of individual] is recused from participating in any deliberations that involve any particular matters that uniquely and distinctly, as well as directly and predictably, affect any of the financial interests described above, the only matters in which [he/she] will participate that will affect [his/her] financial interests will be those matters that affect the interests of all entities similarly situated to the same extent. While this participation is technically covered by the current interpretation of section 208, it poses far less risk of bias or conflict of interest than participation in matters that relate specifically to a particular entity.

Accordingly, I recommend that you grant [name of individual] a waiver that would allow this individual to participate as [individual’s title] in all matters that may affect entities in which this individual has a personal or imputed interest only to the same extent as they affect all similarly situated entities. I believe that such a waiver is appropriate because in this case, the interest is not so substantial as to be deemed likely to affect the integrity of the services which the Government may expect from [name of individual].

                      _______________________________
                               [Name of Signee]

DECISION:

_________     Waiver granted based on my determination, made in accordance with section 208 (b)(1), that the interest
                        is not so substantial as to be deemed likely to affect the integrity of the services which the Government
                        may expect  from such employee.

_________    Waiver denied.

                                        ___________________________________________________
                                        [Name of Employee’s Deputy Ethics Counselor or Designee]

APPENDIX 4b: Sample Addendum to Conflict of Interest Waivers

ADDENDUM TO CONFLICT OF INTEREST WAIVER

NAME OF MEMBER:                      [Name of Individual]

ADVISORY COMMITTEE:             [Name of Advisory Committee]

DATE OF ORIGINAL WAIVER:     [Date of Waiver]

Organization        Kind of Organization         Nature of Interest

All new items:

[Name of Company  [e.g., Drug Company     [e.g., Stock (new) or
       /Institution]           or University]                Professor, (new or left)]

[Describe how the new financial interests identified above may be affected by the work of the committee.]

________________________              ___________
[Name of Recommending                     Date
Official & Signature]

DECISION: I have read the original waiver issued to this member. Based upon the description therein of the matters handled by this committee and the new financial interest(s) identified above, this:

_______          Addendum to waiver is granted based on my determination, made in accordance with Section 208(b)(1) or 208(b)(3), that the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest attributable to this individual.

_______        Addendum to Waiver denied.

_____________________________         ___________
[Name of IC Deputy Ethics                      Date
Counselor & Signature]

cc: NIH Ethics Counsel, OGC/ED

APPENDIX 5: Sample Verification Review of Financial Interests Form  

VERIFICATION OF REVIEW OF FINANCIAL INTERESTS
PRIOR TO THE MEETING OF THE

[Name of Committee]
[Date of Meeting]

I have reviewed my 1) OGE 450, Confidential Financial Disclosure Report and 2) most recent Recusal List.  I find that:

ORGANIZATION_____ KIND OF ORGANIZATION_____ NATURE OF INTEREST (& DATE, if applicable)_____  ADD/DELETE
________________________________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

(PLEASE INCLUDE UPDATED NON-FEDERAL RESEARCH/TRAINING SUPPORT.)

__________________________          ______________
Signature                                             Date

(Refer to Privacy Act Statement on page 3 of OGE 450 form.)

APPENDIX 5a: Transmittal Memorandum for Verification of Review of Financial Interests[insert date]

APPENDIX 5b: Transmittal Memorandum for Verification of Review of Financial Interests and Foreign Activities

[insert date]

The U. S. Office of Government Ethics (OGE) requires all Special Government Employees (SGEs) serving on NIH advisory committees to complete an OGE 450 form, Executive Branch Confidential Financial Disclosure Report, upon accepting office.  SGE must also review and update their financial information within 30 working days before each committee meeting until the completion of their term.

Also, HHS requires SGE advisory committee members to complete the HHS-697 form, AForeign Activities Questionnaire@