Research Policies

Conduct of Research Policy

Responsible Unit: Office of Scholarly Activity   | Executive lead: Provost 

Created: 03/25/22 | Reviewed/Revised: N/A | Effective: 6/7/2022 

Compliance: N/A 

Approving Body: PAC | Classification: Institution-wide 

Policy:    

The purpose of this policy is to provide a framework for the fair and open conduct of research at Pacific Northwest University (PNWU), assure scientific freedom, and reflect PNWU’s institutional commitment to quality in the search for new knowledge. By its design and nature, this policy addresses broad aspects of research conduct. Additional sources of information regarding standards of research conduct are contained in relevant federal, state, and local regulations. 

A. Scope 

The PNWU Conduct of Research Policy applies to any person paid by, under the control of, or affiliated with PNWU, such as employed or volunteer faculty, preceptors, trainees, technicians, and other staff members, students, fellows, guest researchers, or collaborators at affiliated institutions. 

B. Research Ethics 

All those included in the scope of this policy are expected to conduct their scholarly research and publish the results of that research consistent with the highest standards of ethical conduct, integrity, and accuracy. Any instance of suspected academic fraud or research misconduct should be reported to the Provost, the Research Integrity Officer, or as otherwise provided in PNWU’s Research Misconduct Policy and Standard Operating Procedures, which describe PNWU’s process for conducting inquiries and investigations (See PNWU Policy Library). Faculty, staff, and students are required to cooperate fully in any inquiry or formal investigation of such allegations, e.g., by providing requested documents and information. Failure to comply may result in disciplinary action. 

C. Openness of Research 

Two of the University’s essential purposes are to impart knowledge and to enlarge humanity’s store of knowledge. Conducting research in an open manner supports these core purposes. Yet both are clearly inhibited when open publication, free discussion, or access to research are limited. As such, PNWU does not permit the conduct of secret or classified research. Agreements may, however, permit sponsors a brief period to review proposed publications and presentations to identify (1) proprietary information that may require patent or copyright protection, or (2) information confidential to the sponsor that must be removed. In general, sponsors are granted review periods of 30 to 45 days prior to submission for publication, but review and delay periods should total no more than 90 days.  

D. Research Involving Human Subjects 

In accordance with federal regulations and University policy, PNWU has negotiated a Federal Wide Assurance, filed with the U.S. Department of Health and Human Services, which requires that every PNWU investigator conducting human subjects research, whether or not funded by a federal sponsor, to submit a proposed research plan to the PNWU institutional review board (IRB) for review. In addition, investigators who participate in human subjects research must complete training in human subjects research, and otherwise must comply with IRB policies and procedures. Research activities may not begin until the IRB has fully approved the research plan and all related consent documents, and the required training has been completed (See the Human Research Protection Policy in the PNWU Policy Library). 

E. Investigator Eligibility and Responsibilities Related to Sponsored Programs 

As the recipient of sponsored programs awarded to support the activities of its faculty, PNWU is responsible for establishing, administering, and monitoring processes and procedures to meet its obligations to the sponsors and to comply with all applicable requirements. The type of research (or other supported activities), funding source, performance location, materials and methods, and other factors will determine the full range of requirements applicable to a sponsored program. To fulfill these obligations, PNWU has designated specific roles and responsibilities related to the oversight of sponsored programs. 

  • Investigators are individuals who play a significant role in the design, conduct, and/or reporting of research and share in the associated responsibilities such as adherence to research integrity principles, professional standards and norms, institutional policies, and compliance with applicable regulatory requirements (e.g., national/federal, state, indigenous/tribal, locality, and sponsor). 
  • The Principal Investigator (PI)/Project Director (PD) are investigators designated by PNWU to direct the activities supported by a sponsored program. The named PI/PD on a specific project is responsible for ensuring that PNWU meets its obligations to sponsors for the design, conduct and reporting of research and other sponsored activities. As such, the PI/PD bears primary responsibility for day-to-day performance and fiscal management of the project. All applications to and awards from extramural sponsors must follow PNWU policy. These applications and awards are also subject to policy and eligibility criteria from the sponsor. 

To ensure that sponsored research is conducted by those who have the requisite education, training and experience, as well as the appropriate affiliation to PNWU, the University will typically support submission of research proposals only when the PI or PD has a CV that demonstrates such requisite background through successful conduct of related projects and research products, such as publications. Also, PNWU requires PIs or PDs to hold a PNWU appointment equal to or greater than 0.5 FTE.  PI or PD status for those individuals whose appointments do not fall within the above-stated eligibility criteria may be granted special permission upon written approval from the provost. 

F. Publication Practices 

Publication of study findings is an integral and essential component of research. Other than presentation at scientific meetings or other considerations related to intellectual property matters, publication in a scientific journal should usually be the mechanism of first disclosure of new findings. Authors should be aware of and make significant efforts to avoid publishing in predatory publisher venues (See the Research Support page on PNWU Library’s website for more information). Lead or corresponding authors affiliated with PNWU should first consult with the Office of Scholarly Activity (OSA) about the journal in which a manuscript may be submitted to. OSA can answer questions about the quality of the targeted journal and assess the journal for predatory publishing risks. PNWU strongly discourages the publication of manuscripts in known predatory journals because of the risk to the author’s and the University’s reputation.  

Each publication should contain sufficient information for the reader to assess its validity and to replicate the study. In addition, each paper should acknowledge all sponsors of the research (including specific award numbers) and disclose any financial interests that the authors have in these sponsors. (See the Financial Conflicts of Interest Policy in the PNWU Policy Library). 

Faculty members and research staff of the University with an appointment of equal to or greater than 0.5 FTE should use the PNWU name to identify themselves (e.g., “Jane Doe, Professor, Pacific Northwest University of Health Sciences”) in publications. In using the PNWU name to identify themselves in connection with activities conducted with outside individuals and entities (e.g., presentations, publications in research or educational journals), faculty and staff members should use caution so that the PNWU name is used in a manner that does not imply PNWU endorsement or responsibility for the particular activity, product, or publication involved. 

G. Data Management 

Federal “Guidelines for the Conduct of Research” at the National Institutes of Health provides that, “research data, including detailed experimental protocols, primary data from laboratory instruments, and procedures of reduction and analysis of primary data, are the essential components of scientific progress. Scientific integrity is inseparable from meticulous attention to the acquisition and maintenance of these research data”. (See Responsible Science: Ensuring the Integrity of the Research Process: Volume II, Part B, Section 7 , National Academies Press, 1992). 

Research data should always be immediately available to scientific collaborators, supervisors, and institutional officials for review. In collaborative projects involving different units, all investigators should know the status of all contributing data and have direct access to them. PNWU requires that all documents related to federally sponsored projects, including primary research data, be available to federal auditors for the period specified by federal regulation¾in most cases, a period of three years from the filing of the final financial report. PNWU expects faculty members to retain all research data, whether resulting from federal sponsorship or not, in their laboratories or other bona fide research locations, and to provide access to the data when requested to do so by authorized institutional officials. Requests from sponsors for access to research data should be forwarded to the Office of Scholarly Activity. (For more details on research data management and retention at PNWU, see SOP 113.03). 

Definitions:  

Research: a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. 

Investigator: The Project Director (PD) or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or proposed research, which may include, for example, senior research staff, collaborators, or consultants. 

Principal Investigator (PI)/Project Director (PD): The PI or PD are the individual(s) designated by the applicant organization/recipient (i.e., PNWU) to have the appropriate level of authority and responsibility to direct the project or program to be supported by a research award. The applicant organization (i.e., PNWU) may designate multiple PIs/PDs or Co-PIs/PDs who share the authority and responsibility for leading and directing the project, intellectually and logistically. 

Research data: Recorded factual material commonly accepted in the scientific or scholarly community as necessary to validate research findings, excluding preliminary analyses, drafts of scholarly or scientific work, plans for future research, peer reviews, communications with colleagues and physical objects (e.g., laboratory samples). See OMB Uniform Guidance 2 CFR § 200.315. 

Sponsored Program: Any externally funded research, public service, or scholarly activity (including hosting or attending conferences) at the University that has a defined scope of work often including a set of specific programmatic objectives and/or deliverables, and line-item-based budget, providing the basis for sponsor expectations and awardee accountability (i.e., a reciprocal transfer of something of value). Sponsored programs are funded through agreements that usually include terms and conditions for the disposition of tangible properties and outcomes (e.g., equipment, records, specified technical reports), or intangible properties and outcomes (e.g., rights in data, copyrights, and inventions). Note: The terms sponsored program, sponsored project, and/or sponsored activity are often used interchangeably. 

Procedure: 

PNWU SOP 113.03 Data Management and Disposition 

Related Documents: 

Research Misconduct Policy 

Human Research Protection Policy 

Financial Conflicts of Interest in Funded Research Policy 

Institutional Surveys Policy

Responsible Unit: Office of Integrated Institutional Effectiveness | Executive lead: Provost  

Created: 02/22/2018 | Reviewed/Revised: 12/06/2022 | Effective: 12/06/2022  

Compliance: N/A 

Approving Body: PAC | Classification: Institution wide  

Policy:     

All institutional surveys intended for distribution to members or prospective members of the PNWU community (applicants, students, faculty, staff, board members, volunteers, and alumni) must be reviewed and approved by the Office of Integrated Institutional Effectiveness (OIIE) prior to dissemination, and includes surveys approved by the Institutional Review Board (IRB). 

Institutional surveys do not include: 

  • Evaluation of an event by participants (unless the participants are made primarily of PNWU community members) 
  • Feedback from individual clients at the point of service (e.g. feedback questionnaire offered on various web pages) 
  • Teaching and course evaluation forms 
  • Input on availability and/or agenda items for meetings 

Surveys may be administered using paper and pencil, phone, or electronic format. Regardless of the method used, all surveys must be approved by OIE before the survey can be administered except those specifically exempted by this policy. 

Failure to adhere to the policies and guidelines relating to the use of surveys will result in a written notification to the data collector as well as their direct supervisor and the chief officer who is responsible for their unit or department. Violators of this policy must then receive clearance from their respective chief officer to administer any future surveys for a period determined by the provost. 

Definitions  

Institutional survey: Survey that is intended to capture or extrapolate thoughts and/or opinions of the PWNU community or member group(s) of that community 

PNWU community: Applicants, students, faculty, staff, board members, volunteers, and alumni 

Procedure 

Institutional Survey Guidelines 

Survey Request Form 

Related Documents: 

Detailed Schedule/Timeline of Planned Institutional Assessment Activities 

PNWU Information and Data Protection Policy   

Financial Conflicts of Interest in Funded Research Policy

Responsible Unit: Office of Scholarly Activity | Executive lead: Provost  

Created: 08/21/2021 | Reviewed/Revised: 06/28/2022 | Effective: 06/28/2022  

Compliance: CFR Title 42, Chapter I, Subchapter D, Part 50, Subpart F AUTHORITY: 42 U.S.C. 216, 289b-1, 299c-4; Sec. 219, Tit. II, Div. D, Pub. L. 111-117, 123 Stat. 3034. SOURCE: 76 FR 53283, August 25, 2011, unless otherwise noted. NIH Financial Conflict of Interest, NWCCU 2.D.3 

Approving Body: PAC | Classification: Institution-wide  

Policy:   

1. POLICY PURPOSE   

The Purpose of this Policy is to promote integrity and objectivity in research at Pacific Northwest University (University) by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded by U.S. Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from any financial interest of an investigator, as defined and set forth below. This policy is specifically designed to meet the requirements of the U.S. Public Health Service (PHS) regulations regarding Financial Conflicts of Interest.   

2. POLICY SCOPE AND IMPLEMENTATION  

This policy applies to all University employees, collaborators, and subrecipients (subcontractors, subgrantees) who are responsible for the design, conduct, or reporting of research. These individuals must comply with this University policy to disclose financial interests, cooperate with the University processes, and abide by any management plan adopted to manage financial conflicts of interest (FCOI).   

The provost is primarily responsible for the implementation of this University policy.  

3. Applicable regulatory PROVISIONS   

Before applying for or using funding from a PHS funding component, the University must fully satisfy the provisions of thePHS COI regulations. PHS funding components include, among others, the National Institutes of Health, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention.1  

4. MANAGEMENT OF FCOI  

  1. Disclosure of SIGNIFICANT Financial INTERESTS
    • When applying for or using PHS funding, an investigator must disclose any Significant Financial Interest (SFI) which reasonably appears to be related to the investigator’s PNWU responsibilities. The University must receive all disclosures before a funding proposal is submitted to PHS.  
    • When applying for or using PHS funding, an investigator must disclose the following financial interests of the investigator or the investigator’s family that reasonably appear to be related to the investigator’s institutional responsibilities:
      • The value of remuneration received by an investigator or their family from a publicly-traded entity in the 12 months preceding the disclosure.    
      • The value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.  For purposes of this policy, equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.  
      • The value of remuneration received from a non-publicly-traded entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator and/or the investigator’s family holds any equity interest in a non-publicly-traded entity.  
      • The values above should include any intellectual property rights and interests (e.g., patents, copyrights), held by the investigator and/or the investigator’s family upon receipt of income related to those rights and interests.  
      • Any travel reimbursed or sponsored (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to the investigator’s PNWU responsibilities; except travel that is reimbursed or sponsored by a nonconflicting institution as defined above.  
      • All gifts received from an entity other than a nonconflicting institution during the 12 months preceding the disclosure if the aggregate value of the gifts exceeds $50.   
    • Note:Do not include salary, royalties, or other remuneration paid by the University if the investigator is currently employed or appointed by the University; income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a nonconflicting institution; or income from service on advisory committees or review panels for a nonconflicting institution or a research institute that is affiliated with an institution of higher education. As noted above, the term “nonconflicting institution” does NOT include foreign institutions or foreign government entities.  
    • Each investigator who is participating in the PHS-funded research must submit an updated disclosure of significant financial interests at least annually during the period of the award. Such disclosure shall include any information that was not disclosed initially to the Institution, or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).  
    • Each investigator who is participating in the PHS-funded research mush submit an updated disclosure of significant financial interest within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.  
    • Investigators shall submit all disclosures required by this policy to the PNWY Office of Scholarly Activities (OSA) using such forms or though such means as OSA may require.  
  2. FINANCIAL CONFLICT OF INTEREST REVIEW of Disclosure Form Process
    • The provost and/or the provost’s designees shall review all pertinent documentation, disclosures of significant financial interests, and FCOI resolution plans for potential or actual FCOI cases, based on applicable law and University policy. The provost and/or the provost’s designees have the responsibility and authority to (1) assess whether an actual or potential FCOI exists, (2) assess the extent of the FCOI, and (3) develop a plan to manage, reduce or eliminate the actual or potential FCOI before approving the research, or at any later date when an actual or potential FCOI is disclosed or discovered.  
    • The investigator or research employee, in collaboration with the provost and/or the provost’s designees, must develop a suitable management strategy for an identified FCOI, subject to the provost’s approval. If the investigator or research employee disagrees with the decisions of a provostial designee, they may ask the provost to review the decision.  
    • The management plan may include monitoring of the plan until the completion of the research project and/or a retrospective review and a mitigation report pursuant to PHS regulations.   
    • The provost may establish additional procedures related to the FCOI review and the FCOI management process, as appropriate, consistent with applicable law.   
  3. CONFLICT OF INTEREST MANAGEMENT PLAN PROVISIONS  
    The provisions of a conflict management plan may include, but are not limited to: Public disclosure of the FCOI;
    • For human subjects research, disclosure of FCOIs directly to participants;  
    • Independent monitoring to protect the research against potential bias;  
    • Modification of the research plan;  
    • Change of personnel or responsibilities, or disqualification of personnel from participation in all or a portion of the research;  
    • Reduction or elimination of the conflicting financial interest (e.g., sale of an equity interest); and/or  
    • Severance of relationships that create FCOI.  
  4. CONFLICTS THAT MUST BE ELIMINATED
    • Some FCOI are not allowable in a management plan. In sections 2 and 3 below, the term “participate” means the actions of approving, disapproving, making decisions regarding, or making recommendations of contract terms.  
    • Honorariums are not permitted when:
      • The person offering the honorarium is seeking or is reasonably expected to seek a contract or subcontract with the University and the University employee who is offered the honorarium is in a position to participate in the terms of that contract or subcontract. An investigator is presumed to participate in a contract or subcontract related to their research, as is anyone negotiating, managing, or substantially performing the agreement, contract, or subcontract.  
      • The person offering the honorarium is regulated by the University and the University employee is in a position to participate in that regulation.  
      • The person offering the honorarium is seeking or opposing or is reasonably likely to seek or oppose enactment of administrative rules or actions or policy changes by the University and the University employee may participate in that process.  
    • FCOIs may not be managed if the investigator or research employee participates on the University side of a contract or subcontract and also participates for the other party. A principal investigator is presumed to participate in a contract or subcontract related to their research, as is anyone negotiating, managing, or substantially performing the contract or subcontract.  
    • FCOI which violate federal or state law or professional ethical standards may not be managed unless the violation of law can be entirely eliminated.  

5. FAILURE TO COMPLY BY INVESTIGATORS  

Failure to comply fully with this policy and any management plan adopted under this policy may result in action under federal and/or University policy against the investigator or research employee, including disciplinary action pursuant to PNWU policy, up to and including termination.   

6. RETROSPECTIVE REVIEW PROCESS  

  1. If during an ongoing PHS-funded research project, the University finds that a SFI has not been disclosed timely or was not previously reviewed by the COIC, the University’s designated official(s) are to, within sixty days, determine whether the SFI is related to PHS-funded research and/or determine whether a FCOI exists, and, if so:
    • Implement a management plan to manage the COI going forward;  
    • Determine if the untimely disclosure was due to investigator noncompliance, and if so:  
    • Complete a retrospective review within 120 days, including a determination whether the COI biased the PHS-funded research project.  
    • Create a review report is to include, at minimum:
      • PNWU/PHS Project numbers;  
      • Project title;  
      • PD/PI or contact PD/PI if a multiple PD/PI model is used;  
      • Name of the investigator with the COI;  
      • Name of the entity with which the investigator has a financial conflict of interest;  
      • Reason(s) for the retrospective review;  
      • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);  
      • Findings of the review; and  
      • Conclusions of the review.  
    • If appropriate, the University amends any previously submitted COI report and specifies the actions that are to be taken to manage the COI.  
    • If bias is found, the University must notify the PHS awarding component promptly and submit a mitigation report that includes the review report, a description of the impact of the bias on the research project, and the plan of action to eliminate or mitigate the effect of the bias.  
    • The University may impose reasonable interim measures to the investigator’s participation in the PHS-funded research project between the time the University discovers there is undisclosed SFI or COI and the completion of the retrospective review, as the University deems necessary.  
    • Whenever the University implements a management plan based on noncompliance that requires a retrospective review, the University monitors compliance with the management plan until the completion of the PHS-funded research project.  

7. REQUIRED Notification to PHS  

  1. If the failure of an investigator to comply with the disclosures required by this policy or with a management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the University promptly notifies the PHS awarding component of the corrective action taken or to be taken.  
  2. The PHS may ask for records created under this policy at any time, regardless of whether or not a disclosure resulted in the University’s determination of a financial conflict of interest. The University is required to submit, or permit on site review of, all records pertinent to compliance with this part. The PHS awarding component has the authority to issue a stop work order via the contracting officer or take other enforcement action based on its review of those records.  
  3. In any case in which the Department of Health and Human Services (HHS) determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an investigator with a financial conflict of interest that was not managed or reported by the University as required by this part, the University is to require the investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.  

8. REQUIRED REPORT TO PHS FUNDING COMPONENT  

  • Reporting of FCOI: Before spending any funds under a PHS-funded research project, the University must provide to the PHS awarding component a FCOI report on any investigator’s SFI that the University determines to be a FCOI and ensure PHS that a management plan for that COI has been implemented. If the FCOI has been eliminated prior to the expenditure of PHS-awarded funds, the University is not required to submit a COI report to PHS.  
  • The report must include sufficient information to enable PHS to understand the nature and extent of the financial conflict, and to assess the appropriateness of the University’s management plan. The report is to include, at minimum:
    • Project/contract number;  
    • PD/PI or contact PD/PI if a multiple PD/PI model is used;  
    • Name of the investigator with the financial conflict of interest;  
    • Name of the entity with which the investigator has a financial conflict of interest;  
    • Nature of the financial interest (e.g.,equity, consulting fee, travel reimbursement, honorarium);  
    • Value of the financial interest in dollar ranges: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the interest’s value cannot be readily determined through reasonable measures of fair market value;  
    • A description of how the financial interest relates to the PHS-funded research and the basis for the University’s determination that the financial interest conflicts with such research; and  
    • A description of the key elements of the management plan, including:
      • Role and principal duties of the conflicted investigator in the research project;  
      • Conditions of the management plan;  
      • How the management plan is designed to safeguard objectivity in the research project;  
      • Confirmation that the investigator agrees to comply with the management plan;  
      • Monitoring of the management plan to ensure investigator compliance; and  
      • Other information as needed.  
    • For any COI previously reported regarding an ongoing PHS-funded research project, the University must provide an annual COI report that addresses the status of the financial conflict of interest and any changes to the management plan.  
  • If HHS determines that a PHS-funded project to evaluate a drug, medical device, or treatment was conducted by an investigator with a COI that was not disclosed or managed, HHS may require the investigator to disclose the conflict in each public presentation of the results of the research.  

9. UNIVERSITY RESPONSIBILITIES  

  • PNWU MUST HAVE AND ENFORCE AN FCOI POLICY
    • The University must make this policy available via a publicly-accessible website;  
    • The University must inform each investigator of this policy, the investigator’s responsibilities under this policy, and of the PHS regulations; and  
    • The University must require each investigator to complete training regarding the same before participating in PHS-funded research and at least every four years, and immediately when:
      • The University revises its policy or procedures in any manner that affects the investigator’s responsibilities under this policy:  
      • An investigator is new to the University; or  
      • The University finds that an investigator violates this policy or management plan  
  • SUBRECIPIENTS
    • A subrecipient must abide by this policy or a comparable policy of the subrecipient’s own, and take reasonable steps to ensure that any subrecipient investigator complies with FCOI policy.  
    • A subrecipient must be familiar with and comply with the University’s policy to disclose financial interests, cooperate with the University FCOI processes, and abide by any management plan adopted by the University to manage FCOIs.  
    • The subcontract must include terms requiring a subrecipient to comply with this policy or have a policy that is effective in practice and that satisfies PHS FCOI regulations and the regulations of any other federal sponsor.  
    • A subrecipient applying its own policy must certify in the subcontract that its policy complies with FCOI regulations.  
    • If a subrecipient’s investigators must comply with this policy, the subcontract must specify time(s) for the subrecipient to submit disclosures of SFIs to the University.  
    • The University provides FCOI reports to the PHS awarding component regarding all financial FCOIs of all subrecipient investigators prior to the expenditure of funds and/or within 60 days of any subsequently identified FCOI.  
  • CERTIFY TO THE PHS AWARDING COMPONENT
    • The University has a written and enforced process to identify and manage, reduce, or eliminate conflicting interests;  
    • Before spending any funds under the award, the University reports to the PHS awarding component the existence of FCOI and assures that the FCOI are managed, reduced, or eliminated, as provided in this policy; and  
    • Upon request, the University makes information available to HHS regarding all conflicting interests and how those interests have been managed, reduced, or eliminated.  
    • The Provost or the Provost’s designees review to determine the existence of FCOI and take actions to ensure that the FCOI are managed, reduced, or eliminated;  
    • The University provides for retention of FCOIC review records for at least three years from the date of submission of the research project’s final expenditures report or other dates as specified in45 CFR 74.53(b) and 45 CFR 75.361.   
    • The University establishes adequate enforcement mechanisms and sanctions where appropriate; and  
    • The University’s written policy includes “A Review of Disclosure Forms” section that provides:
      • Guidelines for the designated official(s) to identify FCOI and take actions to ensure that they are managed, reduced, or eliminated; and   
      • Examples of conditions or restrictions that might be imposed to manage FCOI.  
  • FCOI REPORTS TO PHS
    • Prior to spending any funds under a PHS-funded research project, University sends the PHS awarding component an FCOI report that includes any investigator’s FCOI and assurance that a management plan has been implemented. No report is required if any FCOI was eliminated prior to the expenditure of PHS funds.  
    • Any FCOI identified after the University’s initial FCOI report and during an ongoing PHS-funded research project (e.g., upon the participation of an investigator who is new to the research project), must be reported (along with a management plan) within 60 days to the PHS awarding component. If the COI report involves a SFI that was not disclosed timely by an investigator or, for whatever reason, was not previously reviewed or managed by University (e.g., was not timely reviewed or reported by a subrecipient), the University must complete a retrospective review and, if appropriate a mitigation plan.  
    • Any COI report must include sufficient information to enable PHS to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan. The report must include, but is not limited to:
      • Project number;  
      • PD/PI or contact PD/PI if a multiple PD/PI model is used;  
      • Name of the investigator with the FCOI;  
      • Name of the entity with which the investigator has a FCOI;  
      • Nature of the financial interest;  
      • Value of the financial interest in dollar ranges: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the interest is one whose value cannot be readily determined through reference to reasonable measures of fair market value;  
      • A description of how the financial interest relates to the PHS-funded research and the basis for University’s determination that the financial interest conflicts with such research; and  
      • The key elements of the management plan, including:
        • Role and principal duties of the conflicted investigator in the research project;  
        • Conditions of the management plan;  
        • How the management plan is designed to safeguard objectivity in the research project;  
        • Confirmation that the investigator has agreed to the management plan;  
        • The nature of monitoring to ensure investigator compliance with the management plan; and  
        • Other information as needed.  
    • University must provide an annual FCOI report to PHS that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual report must specify whether the financial conflict is still being managed or explain why it no longer exists.  
  • TRANSPARENCY AND PUBLIC ACCESIBILITY
    • Prior to spending PHS funding, University ensures public accessibility, by written response to any requestor within five business days of a request, of information concerning any SFI disclosed to University that:  
    • The investigator previously disclosed and still holds;  
    • The University determined was related to the PHS-funded research; and  
    • The University determined is a FCOI.
      • The University provides information to the requester within five business days of a request. The information includes the investigator’s name, title, role on the research project; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000); or a statement that the interest is one whose value cannot be readily determined using reasonable measures of fair market value.  
      • Information concerning the SFIs remain available for responses to written requests for at least three years from the date that the information was most recently updated.  

Definitions: 

Clinical Trialmeans any research that assigns human subjects to intervention and comparison groups to study the relationship between a medical intervention and a health outcome.  

Financial Conflict of Interest (COI)means a significant financial interest held by an investigator or research employee and/or specified members of their family which could affect the design, conduct, or reporting of research and scholarship activities.  

Disclosure of Significant Financial Interestsmeans disclosure of significant financial interests to PNWU.   

Equity Interestmeans stocks, stock options, ownership, partnership or limited liability company, or other ownership interests. Equity interest does not include interest in a mutual fund or other stock management vehicle not under the individual’s control, but does include interest held in a deferred compensation plan that is under the individual’s control.  

Familymeans the investigator’s or research employee’s spouse/domestic partner, dependent children, and other dependent relatives living in their household (investigator’s/research employee’s financial interest includes the aggregate financial interest of the family).  

Financial Conflict of Interest (FCOI)means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.  

Financial Interestmeans anything of monetary value, whether or not the value is readily ascertainable.  

Giftmeans anything of received of economic value without giving adequate consideration. A gift of greater than $50 from an outside entity is a significant financial interest and must be disclosed if it is from an entity that may be affected by the recipient’s research. (The law provides exceptions for gifts from persons such as family members.)  

Honorariummeans money or thing of value offered for a speech, appearance, article, or similar item or activity in connection with a state employee’s official role.  

Investigatormeans the project director (PD) or principal investigator (PI), the co-principal investigators (Co-PI), and any other person, regardless of title or position, including the PD/PI and senior/key personnel as defined in this policy, who is responsible for the design, conduct, or reporting of a research project, funding, or proposal.  

Investigator’s PWNU Responsibilitiesmeans an investigator’s professional responsibilities on behalf of the University, which may include, for example, activities such as research, research consultation, teaching, professional practice, and institutional committee memberships.  

Managemeans taking action to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research is free from bias.  

Nonconflicting Institutionmeans the University, a federal, state, or local government agency, an institution of higher education as defined at20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. Note well: Pursuant to NIH notice NOT-OD-18-160, Financial Conflicts of Interest: Investigator Disclosures of Foreign Financial Interests, 20 USC 1001(a) refers only to U.S. Institution of higher education or a federal, state, or local government agency within the U.S. investigators and subrecipients must disclose all financial interests received from a foreign institution of higher education or the government of another country or its governmental subdivisions.    

PD/PImeans a project director or principal investigator of a research project; the term “investigator” in this policy includes a PD/PI.  

PHSmeans the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS, including the National Institutes of Health (NIH).  

PHS Awarding Componentis a division of the Public Health Service (PHS), such as NIH, that funds the research.  

Remunerationmeans salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reasonable measures of fair market value.  

Researchmeans a systematic scientific investigation designed to develop or contribute to generalizable knowledge including basic and applied research as well as associated instruction, scholarly, creative, public service, product development, and extension activities. When PHS funding is applied for or used, “research” includes any activity for which research funding is available from a PHS awarding component.  

Research Employee: The following may qualify as research employees:  

  • University employees who are responsible for the design, conduct, or reporting of research, including research scientists, postdoctoral research associates, professional staff and graduate students.  
  • Appointees without formal employment status who are obligated to follow University policies and procedures. This may include visiting scientists, scholars and faculty whose responsibilities include contributions via scholarly research.  

Senior/Key Personnelmeans the PD/PI and any other person identified as senior/key personnel in the grant application, progress report, or any other report submitted to the PHS. The term “investigator” in this policy includes senior/key personnel.  

Significant Financial Interest (SFI) means a financial interest of an investigator (and those of the investigator’s family) that reasonably appears to be related to the investigator’s institutional responsibilities.  

Sponsormeans the entity which has or will provide financial support for the research, which may include corporate sponsors, state agencies, the University, or agencies of the federal government, including the Public Health Service (PHS).  

Travel Disclosureincludes the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  

Procedure:   

Specific directions for section 4, part B (Financial Conflict of Interest Review of Disclosure form Process) are found in the Financial Conflict of Interest Disclosure Form   

Related Documents:  

National Institutes of Health Central Resource for Grants and Funding, Policy Compliance, Financial Conflict of Interest (https://grants.nih.gov/grants/policy/coi/index.htm)   

Electronic Code of Federal Regulations, Title 42, Chapter I, Subchapter D, Part 50, Subpart F—Promoting Objectivity in Research ( https://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=992817854207767214895b1fa023755d&rgn=div5&view=text&node=42:1.0.1.4.23&idno=42#sp42.1.50.f)  

Financial Conflict of Interest Disclosure Form

Human Research Protection Policy

Responsible Unit: Office of Scholarly Activity | Executive lead: Provost  

Created: 03/01/2017 | Reviewed/Revised: 1/17/2019, 1/19/2023 | Effective:  4/22/2023 

Compliance:  COCA 8.2, NWCCU 2.D.2, 45 CFR 46, 21 CFR 46  

Approving Body: BOT | Classification: Institution-wide  

Purpose:  

To describe the human research protections program at Pacific Northwest University of Health Sciences (PNWU).  

Scope:  

This policy applies to all agents, offices, departments, and affiliate sites of PNWU.  

Policy:   

3.1 PNWU fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of PNWU. In the review and conduct of research, actions by PNWU will be guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report).  The actions of PNWU will also conform to all applicable federal, state, and local laws and regulations.  

3.2 In order to fulfill this mission, PNWU has established a human research protections program (HRPP). The mission of the HRPP is to:  

  • Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;   
  • Provide guidance and support to the research community in the conduct of research with human subjects;  
  • Assist the research community in ensuring compliance with relevant regulations;  
  • To provide timely and high- quality education, review and monitoring of human research projects; and   
  • To facilitate excellence in human subjects research.  

3.3 PNWU will designate an Institutional Official (IO) who has overall responsibility for PNWU’s HRPP. The IO is appointed by the PNWU President. The duties of the Institutional Official are as follows:  

  • Fostering, supporting and maintaining an organizational culture that supports the ethical conduct of all research involving human subjects and the adherence to regulations and organizational policies;  
  • Oversight of the Institutional Review Board (IRB);  
  • Ensuring that the IRB functions independently by, among other mechanisms, being directly accessible to the IRB Chair(s) and members if they experience undue influence or if they have concerns about the function of the IRB;  
  • Oversight of the Institutional Review Board (IRB);  
  • Oversight over the conduct of research conducted by all PNWU investigators;  
  • Ensuring the IRB members are appropriately knowledgeable to review research in accordance with ethical standards and applicable regulations;  
  • Ensuring that all investigators are appropriately knowledgeable to conduct research in accordance with ethical standards and applicable regulations;   
  • Oversight of the development and implementation of an educational plan for IRB members, staff and investigators;  
  • Ensuring compliance with institutional policies and all applicable regulations for the protection of human subjects;  
  • Serving as the signatory authority and ensuring compliance with the terms of the Federalwide Assurance to the Office of Human Research Protections; and   
  • Providing support to the human research protections program, by ensuring that the HRPP has the sufficient staff and resources to fulfill its mission and obligations.  

In the performance of these duties, the Institutional Official has the authority to delegate such activities as may be necessary in order to fulfill these duties.  

3.4 To conduct its responsibility effectively, PNWU maintains an Institutional Review Board (IRB) to review research protocols involving human subjects.  The IRB is an autonomous administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of PNWU. The IRB has the following authority:  

  • To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted under the auspices of PNWU, regardless of location of the research activities;   
  • To require that informed consent be obtained and documented in accordance with regulatory requirements unless the criteria for the waiver or alteration of such requirements has been satisfied and approved by the IRB.  The IRB may require that information, in addition to that specifically mentioned in the regulations, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects;  
  • To conduct continuing review of research at intervals appropriate to the degree of risk of the research;  
  • To suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects;   
  • To observe, or have a third party observe, the consent process;   
  • To observe, or have a third party observe, the conduct of the research; and   
  • To determine whether data or information gathered without IRB approval or in association with serious noncompliance may be published or used for research purposes.  

3.5 All IRB-approved non-exempt research studies are subject to ongoing review, which must be conducted at least once annually by the IRB.  If approval by the IRB lapses, all research activity must stop unless it is determined to be in the best interest of already enrolled subjects to continue participating in the research. The investigator can petition the IRB to continue an individual subject’s research intervention/interaction during a period of lapsed IRB approval if the investigator believes there is a safety concern or ethical issue such that it is in the best interests of the individual participant to do so.  

3.6 The IRB has jurisdiction over all human subject research conducted under the auspices of PNWU, regardless of funding source or performance site. Research under the auspices of the institution includes research:  

  • Conducted at this organization;   
  • Conducted by or under the direction of any employee or agent of this organization (including students) in connection with his or her organization responsibilities;   
  • Conducted by or under the direction of any employee or agent (including students) of this organization using any property or facility of this organization; or   
  • Involving the use of this organization’s non-public information to identify, contact, or study human subjects.  

3.7 No non-exempt research involving human subjects may be conducted without IRB approval and no research may commence until all required Institutional approvals (including IRB) are obtained. 

3.8 Exempt research is subject to review for determination of exemption status. At PNWU exempt studies are reviewed and granted by appropriately qualified members of the Institutional Review Board. Exempt research undergoes an annual check-in procedure that assists the IRB in determining if the exempt research is ongoing or if changes have been made to the research since the initial submission. Exempt study reviews are assigned to members on a rotating basis.   

3.9 PNWU may review any human subjects research protocol and has the right to disapprove or terminate approval of a research protocol that has been approved by the IRB.  However, no one at PNWU shall approve the implementation of human subjects research that has not been approved by the IRB nor may anyone override a decision of the IRB.    

3.10 All institutional and non-institutional performance sites for PNWU, domestic or foreign, will be obligated by this policy to conform to ethical principles which are at least equivalent to those of this institution or as may be determined by the Department of Health and Human Services (DHHS) Secretary.  

3.11 The Institutional Official and the IRB shall adopt operating procedures to implement this policy.  These procedures shall serve as the governing procedures for the conduct and review of all human research conducted under the auspices of PNWU   

Related documents:  

Code of Federal Regulations, Title 45, Public Welfare, Department oOf Health aAnd Human Services Part 46, Protection of Human Subjects, Revised Common Rule, Effective January 21, 2019  https://www.hhs.gov/ohrp/regulations-and-policy/index.html  

PNWU Standard Operating Procedure 124 Review and Approval of Studies  

OSA External Funding/Sponsored Project Proposal Submission Policy

Responsible Unit: Office of Scholarly Activity | Executive lead: Provost  

Created: 3/27/2023 | Reviewed/Revised: N/A | Effective: 4/11/2023  

Compliance: NWCCU 2.E.3   

Approving Body: PAC | Classification: Institution-wide  

Policy:   

Every proposal submission for external/sponsored project funding; to a federal, state, or local government agency or an external award recipient disbursing pass-through funds to PNWU from a government agency must be vetted through the Office of Scholarly Activity (OSA) and must receive administrative approval (e.g., Provost, Chief Financial Officer, Department Chair, College Dean, Program Director, OSA Director, etc.) prior to submission. There are no exceptions to this rule. External/sponsored project proposal submissions may only occur as follows:  

Proposal Development: Individuals interested in and/or planning to submit an external funding/sponsored project proposal must notify OSA immediately prior to beginning the proposal development process. This is to validate that PNWU is eligible to apply and to verify that the funding opportunity is a good fit for the institution and for the individual.   

Submission Approval: OSA determines the process and documents necessary for administrative approval to submit external funding/sponsored project applications. Project directors and principal investigators (PD/PI) must follow the proposal submission procedures established by OSA. 

Proposal Submission: Only OSA’s designee (e.g., Grants and Contracts Administrator), on behalf of the Provost, may submit external funding/sponsored project applications to government agencies either as a prime applicant or sub-applicant with another institution. Faculty, staff, and students are not authorized to submit a proposal as they are not authorized officials that can legally bind the institution. PNWU’s Provost is the Authorized Official/Signing Authority for all governmental proposal submissions.   

Award Acceptance: Only the Chief Financial Officer, Provost, or OSA’s designee (e.g., Grants and Contracts Administrator) can accept external funding/sponsored project awards on behalf of PNWU from federal, state, and local government awarding agencies. In addition, all awards for research, including research funds from donors, corporations, foundations, etc., will be reviewed and accepted by OSA even if the original proposal was submitted by or funds were initially processed through the Office of Development (OD). 

Failure to comply with the above policy will result in a review of the individual’s actions by the representative deans and program directors. In the event of an award of a non-compliant proposal submission, a review by the representative deans and program directors will also be conducted, and all awarded funds are subject to being rejected, and funds returned to the funding agency.  

Exception: Proposal submissions to individual donors, corporations, foundations, funds, associations, insurance companies, etc., will be vetted and managed through the OD (except for research funds which are managed by OSA). Contact OD for more information about submitting to these entity types.   

Definitions:   

N/A  

Procedure:   

External Funding Development, Submission, and Award Management Procedure (available in OSA’s MyPNWU) 

Related Documents:  

Guidelines for Determining Management of External Funding – Office of Development or Office of Scholarly Activity (available in OSA’s MyPNWU) 

Research Misconduct Policy

Responsible Unit: Office of Scholarly Activity| Executive lead: Provost  

Created: 10/10/2021 | Reviewed/Revised: N/A | Effective: 10/10/2021  

Compliance: U.S. Department of Health and Human Services 42 CFR Part 93, NWCCU 2.D.2, 2.F.1 

Approving Body: PAC | Classification: Institution wide  

Policy:   

Maintaining high ethical standards in the conduct of research is an important University responsibility imposed by public trust and is essential to the discovery of new knowledge and the reputation of research and teaching institutions.  

Research misconduct is prohibited in any form as it violates the trust of agencies, foundations, and other entities that sponsor research at the University as well as the public and subjects who might participate in the research. This policy and its associated standard operating procedures aim to promote timely, effective and fair responses to allegations of research misconduct and address such problems as: fabrication, falsification, or plagiarism (as defined below) in proposing, performing, or reviewing research, or in reporting research results.  

The administrative procedures to be followed by the University pursuant to this Policy are, in all cases, subject to the requirements of law. The University will comply with all applicable federal and state laws, regulations and policies with respect to research misconduct.  

This Policy is based on the Federal Policy on Research Misconduct of the Office of Science and Technology Policy (the “OSTP Policy”), Public Health Service (PHS) 42 CFR Part 93.  

All federal agencies that conduct or support research have been directed to implement the OSTP Policy. To the extent that any research that is subject to allegations of research misconduct was supported by, or is proposed to be supported by, any federal agency that has not implemented the OSTP Policy, or the terms of this Policy are inconsistent with such agency’s policy, the terms of such agency’s policy shall apply to the administrative processes described. Should a case arise in the future at the University involving an allegation of research misconduct where a different federal sponsoring agency’s funds have been requested or received, any conflict between the PHS Regulations and that agency shall, as required, be governed by said agency’s regulations.  

This policy applies to all persons affiliated with PNWU including, but not limited to, faculty, affiliate faculty, students, and staff. All persons affiliated with PWNU are required to report observed, suspected, or apparent research misconduct. This policy applies regardless of funding source.  

In dealing with allegations of research misconduct, employees are urged to keep in mind the following basic principles:  

  1. That research, teaching, and patient care should conform to the highest standards;  
  2. That members of the academic community have a responsibility to report what they believe to be research misconduct and to cooperate in investigations of research misconduct; this duty of cooperation includes the obligation to provide all documentation reasonably requested by those charged with investigatory responsibilities herein;  
  3. That allegations of research misconduct are to be investigated promptly, thoroughly, objectively and fairly; and  
  4. That the rights and reputation of all parties involved in allegations of research misconduct, including those suspected of research misconduct and those who report research misconduct in good faith, are to be protected from retaliation.  

Upon receipt of an allegation of research misconduct, PNWU will secure the relevant research record and review the allegation in a prompt and fair manner. Retaliation against complainants or witnesses is prohibited. A finding of research misconduct requires that there be significant departure from accepted practices of the relevant research community, that the misconduct be committed intentionally, knowlingly, or recklessly and that the allegation is demonstrated by a preponderance of the evidence (42 CFR 93.103).  

Individuals who are found to have committed research misconduct are subject to disciplinary action, up to and including discharge or expulsion. In addition, where appropriate, the findings will be reported to external entities and/or authorities and the external entity or authority may take additional action. All disciplinary actions will follow University policies and procedures.  

Definitions:   

Fabrication: Making up data or results and recording them or reporting them.  

Falsification: Manipulating research materials, equipment, processes, or changing or omitting data or results such that the research is not accurately represented in the research record.  

Misuse of Data: Reporting of incomplete results where the reporting of all results would influence conclusions that might be drawn.  

Plagiarism: An act or instance of using or closely imitating the language and thoughts of another author without authorization and the representation of that author’s work as one’s own, as by not crediting the original author.  

Research misconduct: Fabrication, falsification, plagiarism in proposing, performing, or reviewing research, or in reporting research results. (42 CFR 93.103)  Note: Research misconduct does not include honest error and differences of interpretation, authorship disputes that do not involve plagiarism, and violations of other University policies (e.g., sexual harassment policy).  

Research Record: The record of data or results that embody the facts resulting from scientific inquiry, and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.  

Procedures:   

SOP 153 – Recognizing, Assessing and Responding to Possible Research Misconduct or Noncompliance  

SOP 129 – Required Reporting: Protocol violations, deviations and noncompliance  

Related Documents:  

Public Health Service Policies on Research Misconduct – 42 CFR Part 93  

PNWU Whistleblower Protection Policy  

Sponsored Programs Data Management and Sharing Policy

Responsible Unit: OSA | Executive Lead: Provost  

Created: 1/6/2023 | Reviewed/Revised: N/A | Effective: 2/14/2023  

Compliance: Final NIH Policy for Data Management and Sharing, NOT-OD-21-013 (effective January 25, 2023; Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing NOT-OD-21-015  

Approving Body: PAC | Classification: Institution-wide  

Policy:   

Federal Agencies, including the National Institutes of Health (NIH) have had a longstanding commitment to making the results and outputs of NIH-funded research available to the public through effective and efficient data management and data sharing practices. Data sharing enables researchers to rigorously test the validity of research findings, strengthen analyses through combined datasets, reuse hard-to-generate data, and explore new frontiers of discovery. In addition, NIH emphasizes the importance of good data management practices, which provide the foundation for effective data sharing and improve the reproducibility and reliability of research findings.   

Under the NIH Data Management and Sharing Policy (DMS), effective J, NIH requires researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing Plan (Plan). Upon NIH approval of a Plan, NIH expects researchers and institutions to implement data management and sharing practices as described. NIH recognizes that making data accessible and reusable for other researchers may incur costs. For that reason, investigators may request funds from the NIH toward data management and sharing in the budget and budget justification sections of their applications.  

This PNWU Sponsored Programs Data Management and Sharing Policy is designed to ensure PNWU’s compliance with NIH DMS Policy and other applicable federal data sharing requirements. This policy applies to NIH grant and cooperative agreement applications submitted on or after January 25, 2023 (see NOT-OD-21-013).  

Definitions:  

N/A  

Procedures:  

PROCEDURES FOR IMPLEMENTATION  

a. General Guidelines and Definitions  

1. Definitions:  

Scientific Data:The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens.  

Data Management:The process of validating, organizing, protecting, maintaining, and processing scientific data to ensure the accessibility, reliability, and quality of the scientific data for its users.  

Data Sharing:The act of making scientific data available for use by others (e.g., the larger research community, institutions, the broader public), for example, via an established repository.  

Metadata:Data that provide additional information intended to make scientific data interpretable and reusable (e.g., date, independent sample and variable construction and description, methodology, data provenance, data transformations, any intermediate or descriptive observational variables).  

Data Management and Sharing Plan (Plan):A plan describing the data management, preservation, and sharing of scientific data and accompanying metadata.  

2. Scope  

This Policy applies to all research, funded or conducted in whole or in part by NIH that results in the generation of scientific data. This includes research funded or conducted by extramural grants, contracts, Intramural Research Projects, or other funding agreements regardless of NIH funding level or funding mechanism. This Policy does not apply to research and other activities that do not generate scientific data, including training, infrastructure development, and non-research activities.  

3. Requirements  

All applications for NIH research funding must include the submission of a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations. Compliance with the awardee’s plan as approved by the NIH will be required.  

Costs associated with data management and data sharing may be requested from the NIH as part of the project budget. See Section 6 below regarding Budgeting and Allowable Costs for Data Management and Sharing.  

4. Data Management and Sharing Plans  

Researchers planning to generate scientific data are required to submit a Plan to the NIH as part of the Budget Justification section of the application for extramural awards, as part of the technical evaluation for contracts, as determined by the Intramural Research Program for Intramural Research Projects consistent with the objectives of this Policy, or prior to release of funds for other funding agreements. Plans should explain how scientific data generated by research projects will be managed and which of these scientific data and accompanying metadata will be shared. If Plan revisions are necessary (e.g., new scientific direction, a different data repository, or a timeline revision), Plans should be updated by researchers and reviewed by the NIH during regular reporting intervals or sooner. Plans from NIH-funded or conducted research may be made publicly available and should not include proprietary or private information.   

5. Managing and Sharing Scientific Data  

In drafting Plans, researchers should maximize the appropriate sharing of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical) that may affect the extent to which scientific data are preserved and shared. Any potential limitations on subsequent data use should be communicated to individuals or entities (e.g., data repository managers) that will preserve and share the scientific data.   

  • Considerations for Scientific Data Derived from Human Participants: NIH prioritizes the responsible management and sharing of scientific data derived from human participants. Applicable federal, Tribal, state, and local laws, regulations, statutes, guidance, and institutional policies govern research involving human participants and the sharing and use of scientific data derived from human participants. NIH also respects Tribal sovereignty in the absence of written Tribal laws or polices. This DMS Policy is consistent with federal regulations for the protection of human research participants and other NIH expectations for the use and sharing of scientific data derived from human participants, including theNIH’s 2014 Genomic Data Sharing (GDS) Policy,2015 Intramural Research Program Human Data Sharing Policy, and45 CFR 46. Researchers proposing to generate scientific data derived from human participants should outline in their Plans how privacy, rights, and confidentiality of human research participants will be protected (i.e., through de-identification,Certificates of Confidentiality, and other protective measures).  

NIH strongly encourages researchers to plan for how data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared. Researchers should consider whether access to scientific data derived from humans, even if de-identified and lacking explicit limitations on subsequent use, should be controlled.  

  • Data Repository Selection: NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data.   
  • Data Preservation and Sharing Timelines:Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first. Researchers are encouraged to consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidance for the minimum time frame that scientific data should be made available, which researchers may extend.  

6. Budgeting and Allowable Costs for Data Management and Sharing  

NIH recognizes that making data accessible and reusable for other researchers may incur costs. For that reason, investigators may request funds from the NIH as part of their project budget toward data management and sharing in the budget and budget justification sections of their applications.  

All allowable costs submitted in budget requests must be incurred (e.g., curation fees, data repository fees) during the performance period, even for scientific data and metadata preserved and shared beyond the award period. Consistent with 45 CFR 75.403 and the NIH Grants Policy Statement Section 7.4, budget requests must not include infrastructure costs that are included in institutional overhead (e.g., Facilities and Administrative costs) or costs associated with the routine conduct of research. Costs associated with collecting or otherwise gaining access to research data (e.g., data access fees) are considered costs of doing research and should not be included in scientific data management and sharing budgets. Costs may not be double charged or inconsistently charged as both direct and indirect costs.  

Reasonable, allowable costs may be included in NIH budget requests when associated with:  

  • Curating data and developing supporting documentation,including formatting data according to accepted community standards; de-identifying data; preparing metadata to foster discoverability, interpretation, and reuse; and formatting data for transmission to and storage at a selected repository for long-term preservation and access.  
  • Local data management considerations,such as unique and specialized information infrastructure necessary to provide local management and preservation (e.g., before deposit into an established repository).  
  • Preserving and sharing data through established repositories,such as data deposit fees necessary for making data available and accessible. For example, if a Data Management and Sharing Plan proposes preserving and sharing scientific data for 10 years in an established repository with a deposition fee, the cost for the entire 10-year period must be paid prior to the end of the period of performance. If the Plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.