All 101 Courses                         Accreditation                              Help                         About Us                      Home        

 

Ethics and Conflict of Interest in Health

 Course Number  LWE880
 Objectives At the end of this course, you will  be equipped to make basic ethical recommendations in the conflict of interest area in health.
 Credit Hours and Fee  3.0 CE Credit Hours with a fee of $24.00
 Instructor  Rudolf Klimes, PhD (Indiana University), MPH (Johns Hopkins University); Adjunct Professor at Folsom Lake College, Folsom CA.

Welcome to this 3-contact-hour Continuing Education  course with instant online processing and certification 24/7.  Study the course below, take the 12-question multiple-choice test, register and pay $24 online. If you score 75% or above, you may print your CE certificate on your printer as soon as you finish. If you have difficulty printing your certificate, click here. You may retake the test once.

 

Source: http://ethics.od.nih.gov/topics/conflicts.htm

NIH POLICY MANUAL

                   2400-04 Managing Conflicts of Interests and the Introduction of Bias 
Issuing Office: NIH Ethics Office 301-402-6628
Release Date: 06/18/08


 

Online information: http://www1.od.nih.gov/oma/manualchapters/


 
Introduction: A "Conflict of Interest" arises when an employee is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her, i.e., the employee's 1) spouse, 2) minor children, 3) general partner, 4) an organization in which the employee serves as officer, director, trustee, partner, or employee, or 5) a person or organization with which the employee is negotiating for prospective or has an arrangement for prospective employment. Conflicts can be real or apparent.

A real conflict exists when an employee participates personally and substantially in particular matters that have a direct and predictable effect on a financial interest of the employee, or one of the five 'others' listed above. In this case, participation in the official matter is in violation of statute 18 U.S.C. 208. If the Deputy Ethics Counselor determines that the financial interest is not "so substantial as to be deemed likely to affect the integrity of the services with the Government may expect" from the employee, a waiver granting permission to participate in the official matter may be given.

An appearance of a conflict exists when an employee is involved in a particular matter involving specific outside parties (including individual, corporate entities, etc) and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the employee's impartiality in the matter. Such circumstances include the involvement of a relative, spousal employer, or former employer in the matter. In this case, the Deputy Ethics Counselor could determine that it is in the best interests of the Government for that employee to be involved in that particular matter, despite the appearance of a conflict, and authorize the employee to participate.

Employees who have financial interests (outside employment, stocks and other financial holdings) of their own, or financial interests of anyone listed in the first paragraph above which are imputed to them, must disclose any conflict and work with the Deputy Ethics Counselor or Ethics Coordinator to obtain a waiver or authorization, or be disqualified from participating in particular matters concerning the outside entity.

Source: http://ethics.od.nih.gov/topics/coi.htm

A. Purpose

The National Institutes of Health (NIH), in the US Department of Health and Human Services (HHS), supports employee participation in activities involving outside organizations.  However, some activities raise concerns about real or apparent conflicts of interests (COIs).  Government ethics rules prohibit employees from participating in any activities that conflict with, or appear to conflict with, their official duties.  Employees must refrain from participating in official decisions which affect their own financial interests, or the financial interests of certain other individuals, organizations, or entities.  There are two types of conflicts, real and apparent, and as to each there are policies and procedures to follow to resolve a conflict to enable an employee to continue activities in an appropriate manner whenever possible.
 
This chapter discusses appropriate use of waivers, authorizations, disqualification (also referred to as recusals), and other mechanisms to resolve conflicts of interests. It also provides guidance on how to manage the introduction of bias that may result from engaging in professional activities as part of your official duties.  Case studies of extramural situations are provided to give examples of the proper handling of such bias.  For employee coverage, authorities and references, records retention, and management controls, see NIH Manual 2400-01 Introduction to Government Ethics at the NIH.

B. Real Conflicts of Interests

  1. Description of a Real Conflict:  A real, or actual, conflict of interest arises when an employee  is assigned official responsibilities in a particular matter that will directly and predictably affect the employee’s personal financial interests or the interests of other specific persons.  The persons whose interests are attributed to the employee (these interests are also referred to as imputed interests) are detailed in a statute, 18 USC § 208, and include the following:

     
    • the employee’s spouse;

       
    • the employee’s minor child(ren);

       
    • the employee’s general partner in an outside business endeavor;

       
    • an organization the Federal employee serves as officer, director, trustee, general partner, or employee; and

       
    • any organization or person with whom the employee is negotiating for or has an arrangement concerning prospective employment.
       

    For purposes of the statute, the financial interests of these persons are treated as if they are the employee’s own financial interests. 
     
    When an employee has a real conflict of interest in an assigned matter, the employee may not participate in that matter as a federal employee without first resolving the conflict. Conflicts are resolved through waiver, disqualification (also called recusal), or divestiture.  (These mechanisms are fully discussed below.) The Deputy Ethics Counselor (DEC) or other Institute/Center (IC) Ethics Office staff will review the situation with the employee and determine which of the resolution mechanisms are available to resolve the conflict. Conflicts of interest must be resolved to the satisfaction of the DEC before an employee may participate in any official matter that will affect his or her personal or imputed financial interests.

  2. Examples of Real Conflicts: The following examples are not exhaustive, but can be used to help identify situations where a conflict of interest would exist.
     
    Example 1: The spouse of an extramural program official, e.g., Health Scientist Administrator (HSA), who manages a grant portfolio works at a local university.  Since the spouse’s income is imputed to the employee, that is, treated as if it were the employee’s own financial interest, the employee may not be involved in official particular matters which affect that local university’s ability or willingness to pay the spouse’s salary or benefits or that will otherwise affect the spouse’s financial interests unless the conflict is appropriately resolved (see mechanisms to manage, below).
     
    Example 2: An employee holds stock in a pharmaceutical company, valued above the amount defined in the regulation as being the amount below which a conflict cannot arise (the de minimis level).  Stock ownership constitutes a financial interest in the company.  An employee who owns stock in a company may not engage in any official particular matter that will affect the employee’s interest in that company unless the conflict is resolved.
     
    Example 3: An administrative officer (AO) has an approved outside job working in an office furniture store, and the AO is considered an employee of the furniture store (rather than an independent consultant).  The AO’s IC is planning to renovate and expects to submit a large furniture purchase.  The AO’s outside employer submits a bid.  The AO cannot officially participate in this particular procurement because it will affect the financial interests of his/her outside employer unless the conflict is appropriately managed.
     
    Example 4: An employee may not personally participate in official matters affecting an outside organization with which the employee is negotiating future employment, or already has an arrangement in place for future employment, unless that conflict is appropriately resolved.

C. Appearances of Conflicts of Interests

  1. Description of an Apparent Conflict:  As discussed above, interests of  parties identified in the statute (18 USC § 208) result in a real conflict if a matter to which an employee is assigned could affect those interests.   The appearance of a conflict of interest arises where an employee is assigned to participate in an official duty matter where an organization with which the employee has a covered relationship is or represents a party to that matter, or where the matter is likely to affect the interests of a household member, and there are circumstances that would cause a reasonable person with knowledge of the relevant facts to question the employee's impartiality in the official matter. The regulation (5 CFR § 2635.502) provides that employees have covered relationships with:

     
    • Members of their households and relatives with whom they are deemed to have close personal relationships;
    • Persons or organizations with whom they have or seek a business, contractual or other financial relationship other than a routine consumer transaction;
    • Persons or organizations for whom their spouses, parents or dependent children are, to their knowledge, serving or seeking to serve as an officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee;
    • Persons or organizations for whom they have, within the last year, served as an officer, director, trustee, general partner, agency, attorney, consultant, contractor or employee; or
    • An organization in which they are an active participant (e.g., serves as a committee chair, spokesperson, promotes the organization, coordinates fund-raising events).

    When an appearance of a conflict of interest arises under 5 CFR § 2635.502, the employee may not participate unless an authorization is issued to permit him or her to participate in the government matter even though the appearance of a conflict exists.  The IC DEC must find that, in light of all relevant circumstances, the Government’s interest in the employee's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations.

  2. Examples of Apparent Conflicts of Interest:  The following examples are not exhaustive but can be help identify situations where the appearance of a conflict of interest would exist.
     
    Example 1: An IC is planning a renovation, including new carpet and furniture.  The brother of the AO working on the procurement owns a carpet store and submits a bid.  The AO has an appearance of a conflict of interest because of the family relationship.  The AO may not continue working on the procurement unless the apparent conflict is resolved.
     
    Example 2: An employee ended an outside activity six months ago.  That employee may not participate in an official matter where the previous employer is a party during the one-year ‘cooling off’ period (recusal time) following the end of an outside activity unless the apparent conflict is resolved through authorization.

D. Managing the Introduction of Bias from Professional Activities with Outside Organizations

In addition, NIH management exercises inherent authority to assign work in a manner that protects the perceived integrity of NIH programs and operations.  NIH staff often engage in professional activities that involve outside entities or organizations and these activities are often part of the employee’s official duties.  Examples of professional activities are scientific collaborations, co-authorship of a paper, and certain editorial positions.  This section assumes that none of these official duty assignments create a real or apparent financial conflict of interest as discussed above, or if such a conflict did arise, it was resolved.

In ensuring the integrity of NIH programs, it is essential to ensure that employees are free from conflicts of interest and apparent conflicts, as discussed above, and that an employee’s official professional activities cannot be perceived as biasing NIH decisions or actions.  Perceptions of bias may arise when an employee stands to benefit professionally from a particular research outcome, collaboration, or service that results from an official duty.  It might occur when an employee has multiple assigned official duties that involve a particular outside organization or person, or when an employee has assigned official duties involving different entities or investigators who view themselves as competitors.  Note that most conflicts between two official duty assignments can be managed by the supervisor and employee as opposed to a personal (financial) conflict or apparent conflict which often requires the help of the IC ethics office to resolve.
 
The ability of an employee to participate in professional activities is dependent on the nature of the activity, whether the professional activity may introduce or appear to introduce bias towards other official duty assignments, and whether the resulting bias or perception of bias can be appropriately managed or mitigated.  This policy requires the NIH staff member to personally consider whether a conflict exists with respect to professional activities and other official duty activities.  The NIH employee is responsible for:  1) identifying any real or apparent source of bias that may arise from official duty interactions with organizations with which they have professional interests or relationships; 2) resolving the identified conflicts with the help of his/her supervisor (and the Deputy Ethics Counselor (DEC) if necessary); and 3) securing approval from the appropriate source, if required, prior to entering into such an activity.
 
The Official Duty Activity chart , available on the NIH Ethics Program web site, is to be used as guidance in managing professional activities and official duties.  The chart lists examples of many different official duty activities in which NIH staff might engage with an outside organization.  This chart allows NIH staff to identify professional activities, understand who should be approving such activities, what conflicts or biases may arise as a result of the activity, and how those should be managed.   Most of these activities only require supervisory approval.  Such approval may be given after any self-identified conflict that would arise from a personal outside interest or relationship has been resolved with the help of the supervisor (and IC DEC, if necessary).
 
In addition, case studies are available that illustrate scenarios where professional activities and official duties may conflict or lead to bias and how they can be resolved. See the Official Duty Activity topic page.

E. Mechanisms to Resolve Real and Apparent Conflicts of Interests
  1. Regulatory Exemptions: The regulations (5 CFR Part 2640) implementing the conflict of interest statute (18 USC § 208) describe several types of financial interests where particular interests are too remote or too inconsequential to affect the integrity of the services of our employees.  These regulatory exemptions exist to permit the affected employees to participate without any further actions.  Those employees required to file a Public or Confidential financial disclosure report must still report these holdings on their financial disclosure report, even if they think that one of the regulatory exemptions removes their conflict.  The DEC will make the final determination whether a regulatory exemption applies.  See details on the NIH Ethics Program web site, on the Topics/Financial Disclosure page. [Note: The regulatory exemptions have no effect on financial disclosure reporting and/or other approval requirements.]

     
  2. Recusal/Disqualification:  Employees are responsible for identifying any situation that could pose a real or apparent conflict and to discuss it with their supervisor and/or IC Ethics Office staff before taking any action or otherwise participating in any way in the matter. If the analysis and consideration demonstrates that a conflict of interest or impartiality problem exists and that recusal is required, the supervisor accepts responsibility for handling the official matters which could affect the employee’s conflicting interest. (For some employees (e.g., IC Directors), an NIH official other than the supervisor will accept responsibility for the matter. Regardless, the official must be at a higher organizational level than the employee.) The supervisor may reassign or keep that responsibility. The employee must inform those who need to know about the reassignment or conflict or are affected by the decision, including his or her supervisor, so the employee is not inappropriately involved in the official matter. The employee then is never to be consulted about the matter. Nor may the employee seek information about any matters from which s/he is or should be recused.
     
    When IC Ethics Offices become aware of circumstances that could pose a real or apparent conflict for employees, DECs will issue cautionary notes to the employees to inform them when disqualification is or may be necessary based on their duties, financial interests, and other known relationships.  Such cautionary notes must be updated annually, or sooner when appropriate, and are based on the ethics records (e.g., financial disclosure reports, and outside activity and award request forms) contained in the employee’s files.  Employees are required to review, correct and acknowledge receipt of such notes.  Employees who give no information to the IC Ethics Office, i.e., they are not required to file an ethics form, or the forms they do file contain no information suggesting that a conflict currently exists or may arise in the future, will not receive a cautionary note.  Regardless of whether a note is issues, IC Ethics Offices can be consulted at any time to discuss whether a recusal is needed for a particular situation.
  3. Waiver of the Conflict: A waiver may be used for resolving a real conflict of interest under the criminal statute (18 USC § 208).  The waiver may be issued to resolve conflicts that arise when an employee’s personal or imputed financial interest will be affected by the matter, when the interest is determined in consultation with IC ethics officials and the NIH Ethics Counsel not to be so substantial as to be deemed likely to affect the integrity of the employee’s service in conducting his or her official responsibilities.
     
    Waivers must be issued in writing and must address all issues prescribed by the Office of Government Ethics (OGE), as outlined in the template provided on the NIH Ethics Program web site, on the Forms page.  All waivers issued under the authority of 18 USC § 208(b)(1) (i.e. the authority generally used in relation to FTEs) must be reviewed and cleared by the NIH Ethics Counsel prior to issuance.
     
    A waiver of the provisions of 18 USC § 208 (the criminal conflict of interest statute) must be obtained from the employee’s appointing authority/official, who is the only person with legal authority to approve the waiver.  Generally the IC Director will be the employee's appointing authority, though the IC Director may redelegate the authority to the DEC, or some other official.   The delegation must be in writing and maintained in the ethics files.  The IC may determine the internal format for routing the waiver, i.e., whether the waiver memo is completed by the employee and sent through the supervisor to the appointing authority, or from the DEC to the appointing authority on behalf of the employee.  Waivers are approved on a case-by-case basis.  Waivers can be recommended by the Deputy Ethics Counselor (DEC) when the DEC and IC Director are not the same person.  If the DEC and appointing official are the same person, the waiver can be from the individual requesting the waiver or from a supervisor.  In either case, the format and content remain the same.

    A special circumstance that causes a conflict of interest arises when an employee serves as an officer or member of a board of directors or similar position for an outside organization as part of his or her official duties.  As a matter of law, such service involves a fiduciary responsibility.  If such service is provided as part of one's official duties, there is a conflict between the employee's responsibilities to the Government and responsibilities to the outside organization.  This conflict can be resolved with a waiver if the employee’s service in that capacity further the agency mission. See the waiver template on the NIH Ethics Program web site, on the Forms page, for guidance on preparing the waiver memo for this situation.
  4. Authorization to Participate:  An authorization may be used to resolve the appearance of a conflict of interest under the regulation (5 CFR §2635.502).  The authorization permits (or authorizes) the employee to participate in the official matters with the particular outside organization, despite the appearance of a conflict of interest. The IC may determine the internal recommendation and approval process, i.e., completed by the employee and routed through the supervisor to the DEC, or prepared by the DEC to the employee.  Although no particular written or formal form is required, documentation reflecting the agency designee’s consideration of the regulatory considerations should be maintained in the employee’s ethics file.  A sample template is provided  on the NIH Ethics Program web site, on the Forms page.
  5. Resignation: Occasionally, it may be necessary for an employee to resign from an outside activity in order to resolve a conflict with his/her official responsibilities.  The employee must send a resignation letter to the outside entity with a copy to the DEC.  The one-year cooling off period following an outside activity remains in place so a decision is necessary whether the employee will remain disqualified from matters where the outside organization is a party for one year from the date of resignation, or grant an authorization to the employee to allow his or her participation despite the recent association with the outside entity.  It is also possible that an employee prefers to resign from the Federal Government and keep his/her outside interest, which then resolves the conflict of interest for that individual.
  6. Divestiture: Occasionally, it may be necessary for an employee to divest of a particular conflicting financial interest  (sell, gift, or otherwise permanently give up the conflicting interest).  When the DEC determines that divestiture is necessary and capital gains tax would be owed due to the resulting sale, the employee may request a Certificate of Divestiture (CD)  to defer the requirement to pay such tax when the interests are divested. The CD must be obtained prior to the sale.  Additional details about CDs are available on the NIH Ethics Program web site.
  7. Blind Trust: This mechanism to resolve a conflict is rarely used.  It is an expensive legal process handled by the Office of Government Ethics.  The DEC will contact the HHS Office of the General Counsel, Ethics Division, and the Office of Government Ethics if this option appears to be necessary.

F. NIH Policy

In addition to the policies stated in the descriptions of the mechanisms to resolve conflicts of interest above, the following specific policies will prevent conflicts for the employee and for the NIH.

  1. Outside Activities: Except in extenuating circumstances, an employee will not be granted a waiver or authorization to initiate an outside activity with an organization with which the employee has an official relationship.
  2. Sponsored Travel: ICs should not accept sponsored travel for employees where they have certain official relationships, e.g., the offering organization is in the grant portfolio of an extramural Health Scientist Administrator (HSA), supplies a drug for a clinical trial the employee conducts, or is a Cooperative Research and Development Agreement (CRADA) or Materials Transfer Agreement (MTA)-CRADA partner with the employee (unless the travel was explicitly negotiated as part of the CRADA contract).  In addition, sponsored travel may not be accepted by the NIH if the employee is traveling to explore potential collaborative activities with the organization, or if the employee has conducted an approved outside activity with the organization less than 12 months ago.  Although official travel is governed by the regulations from the General Services Administration and sponsored travel is a gift to the NIH not to the individual, it is important to consider the potential conflicts of interest for the employee and the NIH associated with accepting sponsored travel from an outside organization.
  3. Negotiating Employment: An employee who wishes to negotiate employment with an outside organization with which the employee also has an official relationship must disqualify him/herself from the matters that would affect the interests of the prospective employer.

 G. Availability of Forms

Sample waiver, authorization, and recusal memos are available from each IC’s Ethics Office and on the NIH Ethics Program web site.

H. Confidentiality of Documentation/Release of Information

Waivers, authorizations, recusals and other documents are maintained in a secure area with other ethics documents, in accordance with the instructions in NIH Manual 2400-01 Introduction to Government Ethics at the NIH.  The DEC is responsible for maintenance of the ethics files.  Waivers, recusals and authorizations may sometimes be released in response to a Freedom of Information Act (FOIA) request.  If a request is received, contact the FOIA officer and the NIH Ethics Office for assistance.

 I.  Additional Information

For additional information or answers to your questions, contact your IC’s Deputy Ethics Counselor or Ethics Coordinator, whose names are listed on the NIH Ethics Program web site, or review the topics on the web site.   

Additional information may also be obtained from the NIH Ethics Office (301-402-6628).

See the introductory chapter NIH Manual Chapter 2400-01, Introduction to Government Ethics at the NIH (6/18/08) for information regarding relevant Authorities and References (Section D), Records Retention and Disposal (Section H), and Management Controls (Section I).

 

A "Conflict of Interest" arises when an employee is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her, i.e., the employee's 1) spouse, 2) minor children, 3) general partner, 4) an organization in which the employee serves as officer, director, trustee, partner, or employee, or 5) a person or organization with which the employee is negotiating for prospective or has an arrangement for prospective employment. Conflicts can be real or apparent.

A real conflict exists when an employee participates personally and substantially in particular matters that have a direct and predictable effect on a financial interest of the employee, or one of the five 'others' listed above. In this case, participation in the official matter is in violation of statute 18 U.S.C. 208. If the Deputy Ethics Counselor determines that the financial interest is not "so substantial as to be deemed likely to affect the integrity of the services with the Government may expect" from the employee, a waiver granting permission to participate in the official matter may be given.

An appearance of a conflict exists when an employee is involved in a particular matter involving specific outside parties (including individual, corporate entities, etc) and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the employee's impartiality in the matter. Such circumstances include the involvement of a relative, spousal employer, or former employer in the matter. In this case, the Deputy Ethics Counselor could determine that it is in the best interests of the Government for that employee to be involved in that particular matter, despite the appearance of a conflict, and authorize the employee to participate.

Employees who have financial interests (outside employment, stocks and other financial holdings) of their own, or financial interests of anyone listed in the first paragraph above which are imputed to them, must disclose any conflict and work with the Deputy Ethics Counselor or Ethics Coordinator to obtain a waiver or authorization, or be disqualified from participating in particular matters concerning the outside entity.

http://ethics.od.nih.gov/topics/coi.htm

Definitions

Many terms used in the ethics statutes and regulations and in this manual are legal terms.  Therefore, they are very specific and important in determining the nature and appropriateness of activities governed by the applicable statutes and regulations.

  1. Actual Conflict of Interest:  An actual conflict of interest arises when an employee has (or would have) official responsibilities that will directly and predictably affect an employee’s personal or imputed interest in or with an outside organization, as defined by the statute at 18 United States Code (USC) Section 208. Imputed interests for purposes of this statute include those of the: spouse; dependent children; an entity by which the Federal employee is also employed; an entity which the employee serves as an office, trustee, or member of the board of directors. The employee who personally and substantially participates in a matter involving or affecting his/her own interest or those of any of these other persons or entities outlined in the statute likely violates that criminal statute (18 USC 208).  See “Financial Interest” (#9) below.

     
  2. Appearance of a Conflict of Interest:  An appearance of a conflict of interest arises when an employee is involved in a particular matter involving specific outside parties (including individuals or corporate entities) and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the employee's impartiality in the matter.  This may occur when the matter is likely to have a direct and predictable effect on a member of the employee’s household or involves the people or entities as outlined in 5 CFR § 2635.502 of the Standards of Ethical Conduct for Employees of the Executive Branch.  Under the regulation, an employee has a covered relationship with, among others, the following:  a person or organization with whom s/he seeks a business or financial relationship; a close relative; an entity that employs the employee’s spouse, parent, or dependent child; an organization in which the employee’s spouse serves as an officer, director, or other position; or an organization where the employee is an active participant.  In order to participate in an official decision or action affecting any of these individuals or entities, the employee must have an authorization prior to any participation.

     
  3. Authorization: An authorization is a written mechanism used to resolve an appearance of a conflict of interest under 5 C.F.R. §2635.502.  An authorization reflects the agency’s consideration of the circumstances and determination to permit the employee to participate in a particular official duty activity concerning an outside organization despite the appearance of a conflict of interest with that outside organization or person (see Appearance of a Conflict of Interest, above).  In making this determination, the agency designee concludes that the need for the employee’s official participation outweighs the concern that a reasonable person with knowledge of the relevant facts might question the employee’s impartiality or the integrity of the agency’s programs and operations.

     
  4. Cooling-Off Period:  The ‘cooling-off period’ is the time during which an employee must sometimes be disqualified from conducting any official activity which involves or affects an outside entity in order to comply with ethics regulations.  (See #7, Recusal, below.)

       
    1. Outside Activities:  For one year following the end of the outside activity, employees may not officially interact with the outside entity absent an authorization.  The cooling off period also applies to interactions with former employers (5 CFR § 2635.502).

       
    2. Extraordinary Severance Pay: In some cases, when a former employer decides to give an extraordinary severance payment (greater than $10,000) to an employee after learning that the employee may accept or has accepted a Government position, there is a two-year cooling-off period beginning the date the payment was received (5 CFR § 2635.503).  This provision may not apply if the severance pay was part of an established program of compensation or benefits, or if there is a history of similar payments being made to others not entering into Federal service.  In addition, under certain circumstances, this cooling-off period may be waived by the Secretary, HHS.  Discuss specific situations with your DEC or EC.

       
    3. Official Duty Activities:  There is no cooling-off period following the termination of an official duty activity with an outside organization. The employee and the DEC must, however, carefully review the circumstances and the appearance of using public office for private gain if an employee ends an official duty activity with an outside organization and immediately requests permission to initiate an outside activity with that same organization.

       
    4. Awards: When an employee is offered an award which requires advance approval via the request for approval of an award form, the employee is recused from all official matters which affect the donor organization immediately, until one year following receipt of the award.

       
    5. Honorary Degrees: When an employee is offered an honorary degree, that employee is immediately recused from all official matters involving the degree granting institution, until receipt of the honorary degree.  No further cooling off period following receipt is required.

       
  5. “Dependent” vs. “Minor” Child:  The terms “minor child” and “dependent child” are used in various sections of law and regulation and, accordingly, throughout this chapter.  For these purposes, a “dependent child” is any person claimed as such for income tax purposes.  Whether a child is a “minor child” is a question of state law.

     
  6. Direct and Predictable Effect:  The term "direct and predictable effect" refers to the impact a government matter may have on a financial interest.  A direct effect may exist if there is a close causal link between any decision or action to be taken in the particular matter and any expected affect the matter may have on the financial interest. An effect may be direct even though it does not occur immediately.  A particular matter will have a predictable effect if there is a real possibility that the matter will affect the financial interest. It is not necessary to know the magnitude of the gain or loss as the dollar amount is irrelevant.   A particular matter will not have a direct effect on a financial interest, however, if the chain of events expected to affect the matter is contingent upon the occurrence of other events that are speculative or that are independent of and unrelated to the matter.

     
  7. Disqualification or Recusal: To disqualify (also called recuse) is to remove oneself from official participation in a matter which could affect one’s personal or imputed financial interest or where an appearance of conflict would arise.

     
  8. Fiduciary Duty:  A fiduciary duty or responsibility is a legal obligation to act in the best interests of another party.  For example, a board member of a corporation has a fiduciary duty to the shareholders, an attorney has a fiduciary duty to a client, a trustee has a fiduciary responsibility to the trust, or a business owner has a fiduciary responsibility to him/herself and the business.  A fiduciary obligation exists whenever special trust and confidence is placed, by law, in a person who is relied upon to exercise his/her discretion or expertise in acting for the client, company, etc.  Fiduciary duties typically involve the internal business, management, or personnel activities of the organization and are not limited to financial matters.

     
  9. Financial Interest:  A financial interest is any potential for gain or loss.   A financial interest may arise from service as an officer, employee, trustee, or general partner (such as from an outside activity).  Such interests include, but are not limited to, stock interests, bank accounts, mutual funds, sector funds, consulting relationships, sources of salaries, and leave of absence agreements.  The monetary interest may be present or future (future royalties and patent rights, return to a position with former employer).  A financial interest may also arise from service on the Board of Directors of an outside organization or from financial interests of a general partner or organization in which the employee has a financial interest, such as an interest in an organization with which the employee is seeking employment.

     
  10. Health Care Provider and Insurer [5 CFR § 5501.109(b)(8)] means:

       
    • a hospital, clinic, skilled nursing facility, rehabilitation facility, durable medical equipment supplier, home health agency, hospice program, or other provider of health care items and services; or

       
    • a health maintenance organization, managed care organization, or other entity licensed as a risk-bearing entity eligible to offer health insurance or benefits coverage.

       
  11. Negotiation:  Negotiation is a means of discussion or communication with another person, or that person's agent or intermediary, mutually conducted with a view toward reaching an agreement, such as negotiating for employment.  The term is not limited to discussions of specific terms and conditions, but may involve generalities.

     
  12. Official Duty Activities: In this Manual, “official duty activities” refers to approved activities with an outside organization carried out by an employee as part of his/her official Government duties and responsibilities because the activities relate to his/her official responsibilities. An activity is considered related to official duties if:

       
    • the employee was invited to perform the activity primarily because of the employee’s official position;

       
    • it deals with any matter to which the employee is presently assigned, or was assigned to in the past, even if it was publicly disclosed;

       
    • it deals with any ongoing or announced policy, program or operation of the NIH or HHS;

       
    • the invitation or offer of compensation is extended by a source who has interests that could substantially be affected by the performance or non-performance of the employee’s official duties; and/or

       
    • the activity advances the agency mission.

    Employees already receive a salary for completing their official responsibilities so they cannot accept additional compensation from the outside organization.  Travel expenses may be paid by NIH or accepted by the NIH via the HHS-348 sponsored travel mechanism.  Some examples of official duty activities may include serving as a peer reviewer of manuscripts submitted to scientific journals or serving as a Federal liaison to an outside organization.

  13. Outside Activities:  Outside activities are outside work, separate from official responsibilities.  An outside activity involves engaging in providing a service to or a function for an outside organization, with or without pay or other compensation. Outside activities may not conflict with an employee’s official duties or work schedule.
     
    Examples of outside activities requiring advance approval include:  serving as an officer of an outside organization; consulting; writing an article for publication in a professional/scientific journal; working as a physician or other health care professional.  Activities which do not require advance approval include retail clerk or similar activities, as outlined in the HHS Supplemental Standards of Ethical Conduct (5 CFR § 5501.106 ).
  14. Particular  Matter:  A particular matter is a government matter that involves deliberation, decision, or action that is focused upon the interests of specific persons, or upon a discrete and identifiable class of persons.  A particular matter does not need to involve formal parties and may include governmental action such as legislation or policy-making that is narrowly focused on the interests of a discrete and identifiable person or class of persons, e.g., one specific university system.  It does not include general policy or other discussions that affect a large class of persons or entities, e.g., all universities as a whole.
  15. Personal and Substantial Participation:  Personal participation means the employee is directly involved in the matter or actively supervises someone actively involved in the matter.  Substantial participation means that the employee's involvement is of significance to the matter.  Participation may be substantial even though it does not determine the outcome of a particular matter.  For example, an employee involved in multiple discussions and planning sessions for a particular program initiative may be personally and substantially involved, even if the final decision is not made during the employee’s actual participation.  Clerical functions such as typing, though possibly time-consuming, are not considered personal and substantial participation.
  16. Prohibited Source:  Employees are subject to restrictions on  accepting gifts from entities that are considered prohibited sources.  Prohibited source means any person or entity who:
    • is seeking official action by the employee's agency; or
    • does business or seeks to do business with the employee's agency; or
    • conducts activities regulated by the  employee's agency; or
    • has interests that may be substantially  affected by performance or nonperformance of the employee's official duties; or
    • is an organization, a majority of whose members meet any of the above criteria.
  17. Substantially Affected Organization (SAO):   [5 CFR § 5501.109(b)(10)] means any of the following entities:
    • biotech, device, and pharmaceutical companies, and others significantly involved (directly or indirectly through subsidiaries) in the research, development or manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, treatments, or products;
    • any organization a majority of whose members are such entities; and
    • other entities identified as substantially affected by the work of the NIH by the HHS Designated Agency Ethics Official (DAEO) or by the NIH in consultation with the DAEO.
  18. Supported Research Institution (SRI) [5 CFR 5501.109(b)(11)] means any educational institution or non-profit independent research institute which:
    • is, or within the last year was, an applicant, recipient, or partner on an NIH grant, cooperative agreement, or Research and Development contract; or
    • is, or within the last year, proposed or was a partner on a Cooperative Research and Development Agreement (CRADA) with the NIH; or
    • is any organization a majority of whose members are such entities.
  19. Waiver:  A waiver is a written determination used to resolve a real conflict of interest under the statute (18 USC § 208).  The employee’s appointing authority or delegate may, in consultation with NIH Ethics Counsel, issue a waiver to permit an employee’s official participation in a matter that would affect a personal or imputed financial interest, but where that interest is not so substantial as to be deemed likely to affect the integrity of the employee’s service to the Government.

 G.  Violations

If it appears that an employee has engaged in an activity in violation of the criminal statutes or regulations, it is the responsibility of the supervisor, management, and/or ethics staff to report the alleged violation.  Because this action may result in future investigations and prosecution, DECs and ECs are encouraged to consult with staff in the NIH Ethics Office or NIH Ethics Counsel in connection with reporting alleged violations.  For details, see NIH Manual Chapter 2400-08 Referring Employees Non-Compliant With Government Ethics Requirements. See also NIH Manual 1754, Reporting Allegations of Criminal Offenses, Misuse of NIH Grant & Contract Funds, or Improper Conduct by an NIH Employee.   

 

Records Retention and Disposal

All records (e-mail and non-e-mail) pertaining to this Manual must be retained and disposed of under the authority of NIH Manual Chapter 1743, “Keeping and Destroying Records,” and Government-wide General Records Schedule 25 covering ethics program records.  Note that some records may need to be held longer than the time frame indicated if they are still current, e.g., policies.  In addition, if files are stored electronically, originally submitted forms, reports and requests must continue to be held for the full required time period, though can be stored off site as long as they are immediately available electronically (e.g., scanned).

  1. Six-year retention cycle:  DECs must retain the ethics forms and records noted below for a minimum of six years after the termination of the activity except that documents needed in an on‑going investigation will be retained past the 6-year time frame until no longer needed in the investigation. To determine which reports should be destroyed, subtract six from the current year.  Everything filed prior to that resulting year number is destroyed.  For example, 2008 minus 6 = 2002.  Therefore, everything filed prior to 2002 is destroyed, including financial disclosure reports filed in 2002 or earlier, outside activities which ended in 2002 or earlier, and other activities which ended in 2002 or earlier.
     
    Disposition:  Destroy (burn or shred) when 6 years old.
     
    Documents covered by the 6-year retention cycle: Maintain the following records for six (6) years:
    1. Financial disclosure, both public (SF 278) and confidential (OGE 450, 450A).
    2. Records relating to the Standards of Ethical Conduct, the Supplemental Standards. the criminal conflict of interest statutes, or executive orders, e.g., Outside Activity forms, Official Duty Activity requests, honorary degrees, awards, recusals, waivers, authorizations, advice, training certificates.
    3. Ethics agreements.
    4. Referrals and notifications to the Inspector General, Department of Justice, or the Office of Government Ethics (OGE).
    5. Ethics program procedure files, e.g., policies and procedures, hold longer than 6 years if not superseded (i.e., hold 6 years or until superseded or obsolete, which ever is later)
    6. Ethics program review files, e.g., the report from the OGE following their review of the NIH/IC Ethics Programs (see #3 below).
  2. Three-year retention cycle:  Records relating to routine application of settled legal standards, as noted below, are destroyed after three (3) years.  Subtract three from the current year and destroy forms for activities in all years prior to the remainder.  For example, 2008 ‑ 3 = 2005; destroy WAG forms for activities prior to 2005, unless needed for an ongoing investigation.
     
    Disposition:  Destroy (burn or shred) when 3 years old.
     
    Documents covered by the 3-year retention cycle: Maintain the following records for three (3) years:
    1.  Widely Attended Gathering (WAG) approval forms.

       
    2.  Annual agency ethics program questionnaire submitted to HHS for submission to the OGE (see #3 below)

       
    3.  Sponsored travel requests and related files (HHS 348) (see #3 below)

       
  3. One-year retention cycle: The following files may be destroyed after one year.

       
    1. Background information used to prepare the annual agency ethics questionnaire, and agency responses and follow-up letters following receipt of the OGE report (see 2b above).

       
    2. Semiannual Expense Report on sponsored travel which is submitted to OGE (see 2c above).

       
  4. No retention time frame, destroy when superseded or obsolete: Policy chapters are retained until superseded, though for future investigations, it is useful to maintain copies of the previous policies. Training materials, such as handouts, may be retained until superseded or obsolete. Training certificates are covered by the 6-year retention cycle, above.

     
  5. Electronic Files: Electronic records such as word processing files and electronic mail are covered by other items in the General Record Schedule, and may be deleted 180 days after the official record keeping copy is made, e.g., after the file is finalized and printed.

     
  6. NIH e-mail messages:  NIH e-mail messages (messages, including attachments, that are created on NIH computer systems or transmitted over NIH networks) that are evidence of the activities of the agency or have informational value are considered Federal records. These records must be maintained in accordance with current NIH Records Management guidelines.  If necessary, back-up file capability should be created for this purpose.  Contact your IC Records Officer for additional information.
     
    All e-mail messages are considered Government property, and, if requested for a legitimate Government purpose, must be provided to the requester.  Employees’ supervisors, NIH staff conducting official reviews or investigations, and the Office of Inspector General may request access to or copies of the e-mail messages.  E-mail messages must also be provided to members of Congress or Congressional committees if requested and are subject to Freedom of Information Act requests.  Since most e-mail systems have back-up files that are sometimes retained for significant periods of time, e-mail messages and attachments may be retrievable from a back-up file after they have been deleted from an individual’s computer.  The back-up files are subject to the same requests as the original messages.

 I.  Management Controls

The purpose of the NIH Ethics Manual is to assure that all employees are aware of and abide by the conflict of interest statutes, the applicable regulations, and HHS and NIH policy regarding conflicts of interests.

  1. Office Responsible for Reviewing Management Controls Relative to this Chapter: NIH Ethics Office
     
    Through this issuance, the NIH Ethics Office, Office of the Director, NIH is accountable for the method used to ensure that management controls are implemented and working.
  2. Frequency of Review:  On-going review.
  3. Method of Review:  The NIH Ethics Office will initiate and lead reviews as deemed necessary.
  4. Other Reviews:  The HHS Office of the General Counsel, Ethics Division (OGC/ED) at NIH will be consulted as needed to determine the legal correctness of actions taken under the Standards of Ethical Conduct for Employees of the Executive Branch issued by the Office of Government Ethics and the criminal conflict of interest statutes.  These reviews will be performed on a case by case basis, as needed.
  5. The Office of Government Ethics (OGE) conducts periodic audits of the NIH ethics program including the legal correctness and propriety of outside work and other activities with outside organizations, financial disclosure, and other related topics.
  6. Finally, each IC has a DEC who is responsible for reviewing and approving or disapproving all ethics activity requests of the employees of their respective organizations.  Input from one or more of these sources often leads to the formulation of agency wide policy and/or training efforts to improve the NIH Ethics Program as well as the adequacy and propriety of outside activities engaged in by NIH personnel.
  7. Review Reports are sent to the NIH Deputy Director, the NIH Deputy Ethics Counselor, the Deputy Director for Management, OGC/E, and the Deputy Ethics Counselor in the audited IC(s). Reports should indicate that controls are in place and working well or indicate any internal management control issues that should be brought to attention of the report recipient(s).

 J.  Additional Information

Since the operating procedures and practices of employees participating in activities with outside organization differs from one IC to another, employees should direct their questions to their IC DEC or EC.  The names and phone numbers of ethics staff can be obtained by calling the Executive Office of your IC or by checking the NIH Ethics Program web site:
http://ethics.od.nih.gov/
 

TEST: http://www.nurseslearning.com/courses/make_test.cfm?courseKey=4148

Study this web-site for 3 hours for an approved (RN-CEP 11430, MFT- PCE 39) 3-hours Continuing Education Certificate (0.3 CEUs).  Click above link for test & online payment, and 2) receive your certificate immediately online. All is online, nothing by post-mail. 

 

 

Consider taking another LearnWell course.

© 1994-2010, Updated June 09, 2010
 Privacy  email us  login  
Google

Search WWW Search www.learnwell.org