Policy Guidance for Reporting and Assessment of Conflicts of Interest for Public Health Service Projects
The Public Health Service (PHS) regulations, found at 42 C.F.R. § 50.601, et seq., outline specific requirements for reporting, identification, and management of conflicts of interest. RAND’s conflict of interest policies and procedures are designed to promote objectivity in research by ensuring that the design, conduct, and reporting of its research, including PHS- or Centers for Medicare & Medicaid Services (CMS)-funded research are free from bias or the appearance of bias resulting from conflicts of interest. This document outlines requirements applicable to Associates on projects sponsored by PHS or CMS.
Contents
Training and Reporting Requirements
All Associates are required to participate in conflict of interest training and to report interests as outlined in this procedure on at least an annual basis.
Training
RAND provides conflict of interest training to Associates via the online disclosure tool. Associates are required to review and certify completion of the training on at least an annual basis.
Reporting Requirements
All Associates are required to report their Outside Professional Activities. Associates should refer to the Outside Professional Activities procedure for further guidance on approval and reporting.
Associates in the following categories have additional reporting requirements as outlined below:
- All Research Professionals are also required to disclose all relationships and Financial Interests that: (a) are related to the individual's RAND research or research management responsibilities; (b) could directly and significantly affect the design, conduct, and reporting of research or otherwise call into question the objectivity of the research; or (c) could create the appearance of bias or favoritism in the selection of RAND subcontractors and vendors.
- Due to the nature of their roles, Key Staff Members are required to report all relationships and Financial Interests related to each of the subject matter areas in the conflict of interest disclosure form.
Interests Subject to Reporting
Associates are required to disclose personal Financial Interests and relationships, as well as Financial Interests of their spouse or domestic partner, dependent child, and any other member of their household.
Financial Interests
Financial Interests that must be disclosed include, but are not limited to:
- Receipt of any form of remuneration, including salary, wages, or other form of payment for services (including consulting fees, honoraria, or fees/royalties for authorship)
- Service in a management position with an Entity other than RAND, including as a management employee, officer, partner, or member of a governing body (e.g., director or trustee)
- Ownership of any equity interest, including stock, stock options, bonds, or any other ownership interest (but excluding investments in widely held diversified mutual funds and retirement accounts, such as 401(k), 403(b), or IRA accounts)
- Holdings in a sector-oriented mutual fund or retirement account
- Defined benefit pension plan benefits or other post-employment payments
- Reimbursed or sponsored travel
- Gifts of more than nominal value (more than $20) from clients or vendors (see RAND's policy on Acceptance of Gifts and Gratuities)
- Intellectual property rights or interests, for example, patents or copyrights, from which income is derived (for example, royalty payments)
- Any other circumstances, interests, or relationships that could be influenced by or benefit from the results of the employee's work at RAND or that could give rise to an appearance of bias.
Relationships
Close personal relationships that may create the appearance of a conflict of interest should be disclosed. Associates should disclose close personal relationships where the existence of the relationship could impact the formation of a business relationship with RAND or the design, conduct, and reporting of RAND research. Associates must disclose close personal relationships where any of the following circumstances apply:
- The Associate is in a position to request or approve a procurement or contractual relationship, and the Associate has a close personal relationship with an employee or representative of the entity doing business, or seeking to do business, with RAND.
- The RAND Research Professional or Key Staff Member, to the extent they are involved in the design, conduct, or reporting of research, has a close personal relationship with employees or representatives of the RAND client or Entities that could be affected by the results of RAND work.
Reporting Thresholds. Associates must report all qualifying interests of any value where required.
Reporting Process. RAND has developed an online screening and disclosure tool that Associates must use to disclose their relevant Financial Interests and report approved Outside Professional Activities. The information disclosed is maintained in a confidential, limited-access database. Associates must make disclosures on an annual basis via a process initiated by the Office of General Counsel.
Associates who charge to projects should disclose interests relevant to the subject matter areas on which they have worked or been included on a proposal in the preceding year, as well as in those areas they expect to work in the upcoming year.
Continuing Obligation. As noted above, Associates have continuing obligations to keep their disclosures up to date. Where an Associate will be included on a proposal, the Associate should ensure that appropriate disclosures are updated and submitted via the online screening and disclosure tool prior to the submission of the proposal.
Reporting Thresholds
Associates must report all qualifying interests of any value where required.
Reporting Process
RAND has developed an online screening and disclosure tool that Associates must use to disclose their relevant Financial Interests and report approved Outside Professional Activities. The information disclosed is maintained in a confidential, limited-access database. Associates must make disclosures on an annual basis via a process initiated by the Office of General Counsel.
Associates who charge to projects should disclose interests relevant to the subject matter areas on which they have worked or been included on a proposal in the preceding year, as well as in those areas they expect to work in the upcoming year.
Continuing Obligation
As noted above, Associates have continuing obligations to keep their disclosures up to date. Where an Associate will be included on a proposal, the Associate should ensure that appropriate disclosures are updated and submitted via the online screening and disclosure tool prior to the submission of the proposal.
Screening and Mitigation of Conflicts of Interest
Screening
The Office of the General Counsel reviews disclosures of Key Staff Members to determine whether there are any potential conflict of interest concerns. For all other Associates, screening is conducted on a project- or proposal-based system where Administrators from each research division evaluate each research project or task to determine whether it could give rise to a personal or organizational conflict of interest.
If a project could give rise to conflicts of interest related to Associates’ Financial Interests, the research division will conduct project-specific conflict of interest screening using a subset of the data available in the online screening and disclosure tool. If the project-specific screening indicates the presence of a potential personal conflict of interest, the research division will work with the Associate and the Office of the General Counsel to address the conflict.
Identifying Conflicts
Identifying Conflicts. The disclosure of an interest, whether a Financial Interest or relational interest, does not, by itself, create an impermissible conflict of interest. The Office of General Counsel is responsible for determining when an actual or potential conflict of interest exists in a given situation, and a variety of criteria may be considered in determining whether a particular interest creates a conflict of interest.
Typically, a conflict exists where a Significant Financial Interest could directly and significantly affect the design, conducting, or reporting of the research. The Office of General Counsel also bears responsibility for developing and implementing a management plan (see Mitigation Section below). This responsibility is exercised in cooperation with the relevant research division or corporate manager and with full participation by the Associate.
Mitigation
RAND will take appropriate steps to address circumstances that give rise to actual, apparent, or potential personal or organizational conflicts of interest, including Financial COI, to ensure that RAND’s business activities and the design, conduct, and reporting of RAND’s research are free from bias or the appearance of bias. RAND will develop appropriate mitigation plans to address these concerns. Research division management or the appropriate corporate manager, the Office of the General Counsel, and affected Associates participate in the development of a mitigation plan, which will be documented by the Office of the General Counsel. For mitigation of conflicts related to research activities, the plan will be reported, as required, to clients.
Depending on the facts of the specific situation, a conflict of interest may be mitigated in a number of ways, including the application of one or more of the following:
- For Associates involved in research, disclosure to the client for the purpose of obtaining permission to involve the Associate subject to appropriate restrictions;
- If shared responsibilities create a conflict of interest, creation of a firewall between lines of business and management or critical staff from work on the project or task;
- Public disclosure of a significant Financial Interest of Associates working on a project or of a key staff member who would be involved in the performance of the project;
- Disclosure of a significant Financial Interest to participants in research projects involving human subjects;
- Monitoring of projects by reviewers who do not have a significant Financial Interest and who are capable of implementing measures to protect the design, conduct, or reporting of the research against bias arising from identified financial conflicts of interest;
- Modification of the research plan, including, for example, change of personnel or personnel responsibilities with respect to particular tasks;
- Disqualification of personnel from participation in all or a portion of a research project;
- Reduction or elimination of a Financial Interest held by Associates working on a project or of a manager who would be involved in the performance of the research project (e.g., sale of stock); or
- Severance of a relationship that gives rise to actual or potential conflicts (e.g., consulting activities or other outside professional activities) of Associates working on a project or of a manager who would be involved in the performance of the research project.
Public Health Service (PHS) and Centers for Medicare and Medicaid Services (CMS) Requirements
PHS regulations require that all individuals who participate in the design, conduct, or reporting of research funded by PHS agencies complete training on financial conflicts and disclose personal financial interests that could give rise to a conflict, or the appearance thereof. These regulations also apply to research funded by CMS.
Applicability
The rules in this section apply to any research activity funded by PHS or CMS. As defined by applicable regulations, research means a systematic investigation, study, or experiment designed to develop or contribute to the generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development research (e.g., a diagnostic test or drug).
Training and Disclosure
All Research Professionals are required to complete training, submit a financial conflict of interest screening form, and disclose relevant Financial Interests if they worked on a PHS or CMS-funded project in the preceding year, if they expect to work on a PHS or CMS-funded project in the upcoming year, or at any time they are named in a proposal for a PHS or CMS-funded project. Key members of management and certain administrative and support department staff are also required to complete the training and the screening form and provide relevant disclosures, if they are responsible for the design, conduct, or reporting of research provided by the PHS or CMS.
Screening and Disclosure Form
The RAND online conflict of interest screening and disclosure tool is available on the RAND Intranet. All Investigators must fully and accurately complete the disclosure within the time allotted, depending on the circumstances giving rise to the need for disclosure.
Proposals and Projects
Investigators named in a proposal for a project funded by PHS or CMS must complete the training and the online disclosure before the proposal is submitted. Investigators who were not named in a proposal and who participate in the design, conduct, or reporting of PHS- or CMS-funded work must complete the training and the online disclosure before beginning any work on a project funded by PHS or CMS.
Subrecipients
Where research activities on a project funded by PHS or CMS are conducted by subrecipients, the agreement must indicate whether the subrecipient’s Investigators are to comply with this SOP or the subrecipient’s conflict of interest policy. Where the subrecipient is unable to certify that its conflict of interest policy complies with the applicable PHS regulations, the subrecipient’s investigators are required to comply with RAND’s conflict of interest policy and SOP.
Retrospective Review
Where it is discovered that an investigator failed to timely disclose a significant financial interest, the investigator should immediately notify the PI and division management so that it can be determined whether a conflict of interest exists. Where a conflict of interest is determined to exist, the division and RAND Office of the General Counsel will work together to implement a management plan and conduct a retrospective review within 120 days of the determination of noncompliance to determine whether the PHS-funded research was biased in design, conduct, or reporting as a result of the non-compliance. In conducting the retrospective review, RAND is responsible for:
- Documenting the retrospective review and capturing key elements, including methodology for conducting the review, findings, and conclusions; and
- Reporting the key elements and mitigation plan to the relevant PHS awarding component.
Financial Interests
A conflict of interest includes a situation where the investigator’s significant financial interest could be affected by PHS-funded research or is in an entity whose financial interests could be affected by the research.
A conflict of interest includes a situation where the investigator’s significant financial interest could be affected by PHS-funded research or is in an entity whose financial interests could be affected by the research.
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For PHS and CMS-funded projects a significant financial interest includes the Financial Interest of an Investigator (including the spouse or domestic partner, dependent child, or other member of the Investigator’s household) in any Healthcare-Related Entity if:
- The Financial Interest reasonably appears to be related to the Investigator’s Institutional Responsibilities at RAND, and
- The aggregate value of all interests held in a particular Healthcare-Related Entity exceeds $5,000.
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The Financial Interests to be reported include those identified in the Interests Subject to Reporting section above in addition to reporting reimbursed or sponsored travel related to an Investigator’s Institutional Responsibilities.
- Sponsored travel means travel expenses paid on behalf of an Investigator (or household member) rather than paid by reimbursement.
- Travel reimbursed or sponsored by the following entities is excluded: federal, state, or local government agencies; institutions of higher education; academic teaching hospitals; medical centers; and research institutes affiliated with institutions of higher education.
- Investigators will be required to provide the following information with respect to any reimbursed or sponsored travel: name of entity that sponsored or reimbursed any expenses associated with the trip; purpose of the trip; destination; date and duration of the trip; and amount of reimbursement received.
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For the purposes of determining whether a conflict of interest exists, the following Financial Interests do not give rise to a significant financial interest:
- Salary, wages, and remuneration paid by RAND.
- Travel expenses paid or reimbursed by RAND.
- Income from mutual funds and retirement accounts (other than healthcare sector-oriented funds), as long as the Investigator does not directly control the investment decisions made by the funds.
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency; an institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education.
- Service on advisory committees or review panels for a federal, state, or local government agency; an institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education.
Exceptions and Sanctions
Appeals
An appeal from a finding of conflict of interest should be submitted to the Vice President and General Counsel for review and final determination.
Exceptions
Exceptions to this policy are strongly discouraged. Any request for exception must be approved by the Vice President and General Counsel or their designee.
Sanctions
Failure to adhere to this policy may lead to sanctions and consequences based upon the severity of the conduct or failure to comply, up to and including termination of employment or association with RAND.
Definitions
- Applied Research
- means effort which (1) normally follows basic research, but may not be severable from the related basic research, (2) attempts to determine and exploit the potential of scientific discoveries or improvements in technology, materials, processes, methods, devices, or techniques, and (3) attempts to advance the state of the art. Applied research does not include efforts whose principal aim is design, development, or test of specific items or services to be considered for sale; these efforts are within the definition of the term "development," defined below.
- Associate
- means all Regular and Term Employees, Adjunct or Affiliated Adjunct Staff, Sponsored Fellows, and RAND School of Public Policy students.
- Basic Research
- means research directed toward increasing knowledge in science. The primary aim of basic research is a fuller knowledge or understanding of the subject under study, rather than any practical application of that knowledge.
- Close Personal Relationship
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includes the following:
- Family relationships including those related by marriage, domestic or civil union partnership, which includes spouse, domestic partner, sibling, parent (biological, adoptive or foster parent, stepparent, legal guardian or the parent of a spouse/domestic partner), child (biological, adopted or foster child, stepchild, legal ward, or child that you have accepted the duties and responsibilities raising; children of domestic partners are included), grandparent, grandchild, or person whose relationship with the employee is equivalent of a family relationship;
- Business/commercial/financial relationship;
- Sexual/intimate relationships; and
- Close friendship or any other close personal, non-work related relationship such as one involving emotional and/or social closeness and interdependence outside of the relationships defined above.
- Development (research methods and tools)
- means the systematic use, under whatever name, of scientific and technical knowledge in the design, development, test, or evaluation of a potential research method or research tool (or of an improvement in an existing product or service) for the purpose of meeting specific objectives. Development includes the functions of design, prototyping, and testing a research method or to establish the viability and value of a research tool.
- Entity
- means a corporation, partnership, limited liability company, joint venture, non-profit organization, trust, government agency, regulatory body, political organization, or business with a legally identifiable existence.
- Financial Conflict of Interest
- means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.
- Financial Interest
- means anything of monetary value, whether or not the value is readily ascertainable.
- Healthcare-Related Entities
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include any organization or entity (including both publicly traded and private companies) that provides healthcare-related products or services, including but not limited to:
- Healthcare providers, including hospitals and clinics
- Healthcare insurance companies
- Healthcare research or service organizations
- Health information technology companies
- Medical device and equipment manufacturers and distributors
- Medical technology companies
- Pharmaceutical companies
- Other organizations that could be impacted by healthcare-related research, including alcohol, tobacco, or food products companies
- Any other entity, publicly-traded or private, that could be materially affected by the conduct or results of PHS or CMS-funded Research.
- Institutional Responsibilities
- means an Investigator’s professional responsibilities relating to seeking (by submission of proposals for the award of contracts or grants) or conducting CMS or PHS-funded Research, including but not limited to: research; peer review; editing, publication, and dissemination of research; service on the RAND Human Subjects Protection Committee; and relevant work performed in administrative or support functions including the Office of the General Counsel, the Office of External Affairs, the Office of the Chief Financial Officer, and the Office of Research Services and Operations.
- Investigator
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means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research. For purposes of this procedure, the following individuals at RAND are considered Investigators when they are included on a research proposal or are otherwise responsible for the design, conduct, or reporting of research:
- Research Professionals
- Survey Research Group
- Peer reviewers
- Human Subjects Protection Committee members
- Key Staff Members
- Key Staff Members
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include all Senior Executives and Associates serving in the following positions:
- Contract and Grant Services department staff
- Procurement Services department staff
- Proposal Development Services staff
- Communications & External Affairs exempt (salaried) staff and any non-exempt staff whose job duties include editing, publication, or dissemination of RAND research
- Office of the General Counsel attorneys
- Office of the Chief Financial Officer management staff
- President, RAND Europe
- Director, RAND Australia
- Managing Director, Research & Analysis Operations
- Research Financial Operations staff
- Director, Office of Research Quality Assurance and division Quality Assurance Managers
- All directors in Global Research Talent
- Outside Professional Activities
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are activities not within the scope of an Associate’s employment with RAND:
- for which payment is received by an Associate, such as employment or consulting, or
- are unpaid but require the application of professional skill, talent, or expertise, such as service on government or professional advisory boards, speaking engagements, or authoring articles or book chapters, or
- impose a fiduciary duty on an Associate, such as service on a charitable organization’s board of directors.
- PHS
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means the Public Health Service of the United States Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health. The PHS includes the agencies listed below:
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Preparedness & Response (ASPR)
- Office of Global Affairs (OGA)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Research Professional
- means any person that performs professional-level technical work in a role that is included in calculating Staff Years of Technical Effort (“STE”). Associates who are Research Professionals should be designated in Workday as “Included in STE.” A complete list of Research Professional (aka STE-Eligible) roles is available on the Corporate Planning and Analysis intranet site.
- Senior Executives
- means: all (i) corporate officers, (ii) Vice Presidents (including Senior Vice Presidents), (iii) persons holding Executive Director positions; and (iv) all other persons holding leadership positions that report directly to the President and CEO.
- Significant Financial Interest
- means a Financial Interest likely to have a material effect on the research.
Questions regarding this policy guidance and the Health and Human Services regulations should be directed to Robert Case, Vice President, General Counsel and Corporate Secretary.
Effective: August 21, 2025.