Research Protections Guidelines

RPG01 The Responsible Conduct of Research

Policy Status: 

Active

Subject Matter Expert: 

Debra Thurley, 814-865-1775, djd116@psu.edu

Policy Steward: 

Associate Vice President for Research, Director of the Office for Research Protections

Contents:

SCOPE:

This Guideline is applicable to all University research as defined below. 

DEFINITIONS:

Principal Investigator: The Principal Investigator (PI) is the individual responsible for the preparation, conduct, and administration of research and/or the oversight of delegated responsibilities regarding research.  Although the University is the actual recipient of a grant or contract, the PI is held accountable for the proper management and conduct of the project (see also, e.g., RA03, RP03, RA02).

Research: a systematic investigation, study, evaluation, demonstration, or experiment designed to develop or contribute to generalizable knowledge.  This applies to all fields of scholarly study, including but not limited to all fields of science, mathematics, engineering, arts, and the humanities.

Research Data: also referred to as “scientific data,” or, as used in this Guideline, “data;” any type of records or materials that document research efforts or results that embody the facts resulting from scholarly inquiry.  Research Data include any data needed to validate and replicate research findings and computer code used to generate, validate, or replicate findings.

Research Process: also referred to as “the research lifecycle,” is the process of conducting research, from the initial planning, funding, and designing of a project to the publishing and/or dissemination of the research and results.  For more information, see the Office of Sponsored Programs (OSP) (for research conducted at University Park and Commonwealth Campuses) or the Office of Research Affairs (ORA) (for research conducted at the College of Medicine).

Researcher: University-affiliated faculty, staff, students, and any other persons otherwise employed at or affiliated with the University involved in the design, conduct, or reporting of research regardless of the funding source, including academic appointees, postdoctoral scholars, fellows, research trainees or assistants, and medical center staff and clinicians engaging in research.

Scientific Integrity: Scientific integrity is the adherence to professional practices, ethical behavior, and the principles of honesty and objectivity when conducting, managing, using the results of, and communicating about science and scientific activities. Inclusivity, transparency, and protection from inappropriate influence are hallmarks of scientific integrity. For more information, see the White House Office of Science and Technology Policy (OSTP) Scientific Integrity Policy

University Research: research conducted at, or under the auspices of, the University or with University resources.

PURPOSE:

The University’s “Position Statement on Research” (RA01) emphasizes the importance of research at the University.  Research is a primary function of the University, and research with integrity is a primary goal of all University Research.  

The purpose of this Guideline is to provide instruction to enhance and promote a continuing culture of scientific integrity. This Guideline aims to ensure the integrity of all aspects of scientific activities including proposing, conducting, reviewing, managing, communicating about science and scientific activities, and using the results of science. 

A list of University Policies referenced may be found at the end of this Guideline and a list of University Policies providing more information on the ethical duties of various University-affiliated individuals is available from the Office of Ethics and Compliance;however, all University employees are expected to have read, understood, and be in compliance with all policies and procedures applicable to their role in the research process listed at policy.psu.edu.

PROMOTING A CULTURE OF SCIENTIFIC INTEGRITY:

It is the goal of the University to promote a culture of scientific integrity. This means both creating an empowering environment that is conducive to innovation and progress and also protecting scientists and the process of science. “Science, and public trust in science, thrives in an environment that shields scientific data and analyses and their use in policymaking from political interference or inappropriate influence.” Scientific findings and products should not be suppressed, delayed, or altered for political purposes and should not be subjected to inappropriate influence. (Adopted from the OSTP Scientific Integrity Policy.)

RESEARCH AND THE RESEARCH PROCESS:

While aspirational in nature, this guideline emphasizes some of the University’s core ethical principles and the expectations the University has of Researchers and should be used in addition to other relevant University policies and guidelines to inform the actions and decisions of Researchers (see AD88).

In addition to the statements in the University’s Position Statement on Research, AD88, and the “Penn State Values,” the following general guidelines apply to all research conducted at the University, regardless of type, subject, or funding source. Researchers should, in all aspects of the research process:

  1. Demonstrate integrity and professionalism (see e.g., AC47, AD88, RP02).
  2. Observe fairness and equity (see, e.g., AD91, AD85, AD29).
  3. Disclose and appropriately manage all conflicts of interest and commitment (see, e.g., AC80, AD83, IP06, HR91, and RP06).
  4. Treat with respect and compassion and ensure the rights, privacy, safety, and dignity of all those associated with and involved in the research process (see, e.g., RP03, RP04, RP07, AD29, AC47, AD88).
  5. Manage research data to monitor for access, ensure transparency of the research project, meet applicable sponsor or other requirements, and allow for validation and replication (see e.g., NIH, NSF, DOE).
  6. Ensure the accuracy of the scientific record, represent their contributions to scientific work fairly and accurately, and correct identified inaccuracies that pertain to any of their contributions to any scientific records (see, e.g., RP02, RA01, IP02, AD88, AC47).
  7. Obtain all required approvals prior to the commencement of research, including but not limited to, as applicable:
    1. Institutional Review Board (IRB) Review of Human Subject Research (see, e.g., RP03, RP05, RP13)
    2. Institutional Animal Care and Use Committee (IACUC) Review of Vertebrate Animal Research (see, e.g., RP04)
    3. Diving Control Board (DCB) Review of Scientific Diving Research (see, e.g., RP09)
    4. Institutional Review Entity (IRE) Review of Dual Use Research of Concern (see, e.g., RP10)
    5. Institutional Biosafety Committee (IBC) Review of Research using Regulated and Biohazardous Materials, (see, e.g., RP11)
    6. University Isotope Committee (UIC) Review of Research involving the use of radioactive materials, or radiation-producing instruments (see, e.g., SY14, SY15)
    7. Embryonic Stem Cell Research Oversight (ESCRO) Review of Human Embryonic (Pluripotent) Stem Cell Research (see, e.g., RP14)
    8. In certain limited circumstances, reviews related to crowdfunding of research (see, e.g., AD90).
  8. Comply with all legal, regulatory, and ethical requirements for research established by regulatory bodies, funding sources, and applicable professional organizations, and employ and participate in practices that ensure the quality of research and other scientific activities such as quality assurance systems (see, e.g., AD88, AC47, RP02RP05, RP06, RP13).
  9. Show appropriate diligence toward protecting and conserving University and sponsor-provided research resources, such as equipment and other property, and records of data and results that are entrusted to them (see University Policies FN03, FN04, FN05, FN11, FN14, FN17, FN18, FN27, BS07, BS14, BT02, RA02, RA10, RA22, and RA21. See also, University Guidance FNG02).
  10. Accurately manage research funds and conduct fiscally sound and ethically responsible research. Managing project budgets and effort responsibly contributes to the legitimacy of the overall research project (see University Policies FN03, FN04, FN05, FN11, FN14, FN17, FN18, FN27, BS07, BS14, BT02, RA02, RA10, RA22, and RA21. See also, University Guidance FNG02).
  11. Cooperate with all legal, regulatory, and ethical University-established processes for research-related reviews and investigatory processes as appropriate and/or requested, including but not limited to:
    1. Quality Assurance (QA) (University Park) or Research Quality Assurance (RQA) (College of Medicine) Review of Human Subjects Research (see, e.g., RP05, RP13)
    2. Research Misconduct proceedings (see, e.g., RP02)
    3. Investigations of potential retaliation (see, e.g., AD67)
    4. Inspections and monitoring of storage of Controlled Substances and related records (see, e.g., RP13)
    5. Conflict of Interest Committee (COIC) reviews (see, e.g., RP06).

Additionally, researchers should endeavor to follow best practices as outlined in the sections below.  

RESEARCH DATA INTEGRITY AND MANAGEMENT:

Data integrity depends on the proper and ethical collection, documentation, organization, storage, representation, dissemination, and retention of Research Data. To maintain the integrity of data, researchers should seek to: 

  1. Identify, collect, manage (including storing in a method/location appropriate for the type of data, see, e.g., AD95, RP07, and the University’s Data Categorization tool) and retain Research Data as custodian for the University (see the University’s General Records Retention Schedule).
  2. Ensure that sufficient records are kept to document the experimental methods and accuracy of data collection as well as the methods and accuracy of data interpretation and that these records are available to the University along with the relevant data, if necessary (see, e.g., RP02, AD88, AD47).
  3. Adopt an orderly and dated system of Research Data organization (see, e.g., AD47).
  4. Communicate the chosen system of data organization to all members of his/her research team, including appropriate administrative personnel.
  5. Comply with sponsor requirements regarding data access and retention.
  6. Comply with the University’s rules on the ownership of data associated with inventions or tangible research property that the University wishes to commercialize (see, e.g., IP01).

RESPONSIBLE AUTHORSHIP:

Credit should be given to individuals who make clear material contributions to activities which lead to scholarly reports, papers, and publications. Manuscripts should adhere to journal expectations for authorship and publication (see, e.g., COPE Guidance on Authorship and Contributorship). To be named as an author, contributors should have made a substantial intellectual contribution, written sections or provided editorial revisions that include critical intellectual content, approved the final version, and agreed to be accountable for all aspects of the work.  Researchers should neither accept nor assume unauthorized and/or unwarranted credit for another’s accomplishments. Work derived from a student’s dissertation or thesis should never be published without the student as a coauthor or otherwise appropriately credited (see, e.g., RP02, IP02, AC47, AD88. For more information, see the guidance on authorship and plagiarism provided by the Office for Research Protections.).

All individuals listed as authors on a work should review the work prior to submission, as it is the expectation of the University that an author takes responsibility for the integrity and content of the entire work on which they are an author unless otherwise explicitly noted.  At a minimum, an individual should never be listed as an author on a publication without their knowledge and consent. See, e.g., IP02 and AC47.

Finally, authors should always identify themselves and their University affiliation accurately and in a manner that avoids creating confusion or ambiguity. See, e.g., AC64, AD07.

DISSEMINATION OF RESEARCH:

Timely communication of research results is the primary method for the public dissemination of new knowledge, which is necessary for fostering growth in a professional field.  As such, Researchers are encouraged to engage in research or scholarship of their own undertaking and to publish the results. 

However, when publishing or otherwise disseminating research or scholarship, Researchers should be mindful to identify themselves and their University affiliation accurately and in a manner that avoids creating confusion, ambiguity, or the appearance of speaking on behalf of the University on matters of public interest.  See, e.g., AC64, AD07.

PUBLICATION RESTRICTIONS:

As an institution serving the public, the University strongly encourages the free pursuit and dissemination of research performed at the University.  Researchers should be aware of and avoid overtly commercialized research or research that otherwise attempts to place unreasonable boundaries on the academic freedom to pursue research for the good of society and to make research results available to the public.  See AC02AC64, AD96.

PUBLICATION PRACTICES:

Generally, in addition to the expectations noted above and those previously outlined regarding responsible authorship, when publishing an article or other scholarly work, Researchers should:

  1. Include sufficient information in publications to enable others to replicate the results or otherwise scientifically validate the research and should allow their research methods and results to be freely discussed (appropriate restrictions notwithstanding) and open to scrutiny and collegial debate as well as inspection by appropriate individuals when necessary (see, e.g., AC02, AC64, AC47, and AD88).
  2. Avoid simultaneous submissions of the same work to multiple places.
  3. Avoid fragmentary publication or multiple publications of highly similar research findings based on the same data set.
  4. Identify themselves and their affiliation with the University appropriately, acknowledge any sources of financial support for the research, and disclose any conflicts of interest in publications (see, e.g., AC80AD07, AD83HR91, RP06.
  5. Avoid overtly commercialized research and/or unreasonable restrictions on publication, except in situations where such restrictions are appropriate and/or necessary (see, e.g., AC02, AC64).
  6. Avoid publishers or journals who have employed deceptive or questionable processes to profit from publishing scholarly works, often referred to as “predatory” journals or publishers.

See also, University Policies IP02 and RP02.

PEER REVIEW:

Peer review helps ensure that research has been carried out in an effective manner and will make a significant, timely contribution to the field.  Individuals at the University who participate in peer review should familiarize themselves with and abide by current best practices in their discipline in addition to any specific instructions from the journal, conference or other entity that assigned the review.  Additionally, peer reviewers should follow federal agency expectations (see, e.g., NIH stance on use of AI during peer review).

Researchers engaging in peer review should:

  1. Review only material on subject matters of personal expertise/qualification and return appropriate reviews.  Reviews should be objectively based on the content of the submission’s information and should offer positively constructive comments rather than confrontational remarks or other unhelpful or uncollegial comments.
  2. Disclose all real or perceived conflicts of interest.  Identification of a conflict of interest may require a decision to remove oneself from the review process.
  3. Retain the confidentiality of the materials to be reviewed.  Peer review responsibilities should not be delegated unless appropriate (e.g., any necessary disclosures/prior approvals have been made/obtained), and if responsibilities are delegated, credit should be given where appropriate.

See, e.g., University Policies AC47, AD88, RP02, RP06.

COLLABORATIVE RESEARCH:

As noted above, the University recognizes research can potentially involve multiple and varied internal and external collaborators throughout the span of the research lifecycle.  Collaborative research affords many opportunities to significantly expand research by sharing expertise and resources, and Researchers are encouraged to partake in collaborations with other individuals at the University as well as those at other institutions. When collaborating, both internally and externally, Researchers should:

  1. Ensure that all collaborative research is compliant with any applicable laws, rules, and/or regulations for all locations where the collaborative research is taking place (see e.g., Research Security Program guidelines, AC01, AC80, AD89, AD95, ADG09RP06, TR01).
  2. Comply with the applicable policies, guidelines, and expectations of their collaborators’ institutions and ensure, to the extent possible, that their collaborators comply with applicable University policies and expectations, including those noted throughout this Guideline.
  3. Discuss and reach a consensus regarding the terms of the collaboration in advance, including, but not limited to, the following:
    1. The duration of the collaboration.
    2. Researcher and institutional roles and responsibilities with respect to the project, understanding that these may need to be reestablished from time to time as the research evolves.
    3. How data will be collected, shared, stored, managed, and retained, including any restrictions on storage, sharing, and/or dissemination (see, e.g., AD35, AD89, AD95.  See also, e.g., ADG09RAG40).
    4. Guidelines regarding authorship of publications related to the project (see, e.g., “Responsible Authorship” in this Guideline and AC47, IP02, and IPG01).
    5. Guidelines for future use of the data and other information resulting from the project once the collaboration has ended.
    6. Ownership of any intellectual property which may result from the collaboration, including any requirements related to privileged work invented in the course of the collaboration (see, e.g., AC47, AD88, IP01, IPG01.  A complete statement on the University's policies and procedures relative to technology transfer and entrepreneurial activities, including consulting, is also available from the Intellectual Property Office).
  4. Treat all collaborators, regardless of status, title, or station, with the respect and professional courtesy contemplated in these guidelines and in other University policies, guidelines, and other stated expectations, such as AC47, AD88, and/or the “Penn State Values.” as well as any discipline-specific professional standards, norms, or codes of conduct.
  5. Use appropriate channels to resolve conflicts as they arise and avoid retaliatory behavior if a collaborator makes a good faith report through these channels or otherwise participates in an investigation, inquiry, hearing, etc. (see, e.g., AD67, AC76, AD85, AD91, HR79).
  6. When collaborating with University Researchers who have retired, ensuring that RAG03 is followed.

RESPONSIBLE CONDUCT OF RESEARCH EDUCATION:

The responsible conduct of research (RCR) is essential to quality science; therefore, RCR training should occur throughout a researcher’s career.  In recognition of this fact, multiple federal agencies have set forth requirements that various amounts of training in the responsible conduct of research be completed by individuals receiving grants from those agencies, regardless of the individual’s title/institutional status or prior research experience (see, e.g., Notice NOT-OD-22-055,  2 CFR Part 422, and 42 U.S.C. 1862o-1).  As such, the University offers RCR training through the Scholarship and Research Integrity (SARI) program.  The SARI program is designed to create an awareness of ethical principles and established professional norms in the performance of all activities related to scholarship and research.  The University expects Researchers to be aware of and fulfill any University, college, funder, or other requirements regarding their participation in SARI or receipt of RCR training, as failure to complete required training may prevent an individual from conducting University and/or federally sponsored Research or other activities.

RESPONSIBILITIES OF RESEARCH MENTORS/SUPERVISORS:

Mentoring less-experienced researchers in the technical as well as ethical aspects of research is a significant responsibility (see, e.g., AC47, AC70, RA01). As such, Researchers who have research supervisory responsibilities, whether as an adviser, PI, lab manager, or other position in which their duties include the supervision or mentorship of others in the conduct of research, should:

  1. Be cognizant of and avoid ethical issues related to research supervision, particularly of students, post-doctoral scholars, and other “early career” or “trainee” researchers, such as: the potential for abuse of power over those who are dependent upon a research supervisor for financial, academic, citizenship/immigration, and/or other support; conflicts of commitment between the productivity of the supervisor's research and the supervisee’s academic progress; financial conflicts of interest created by assigning supervisee to projects in which the research supervisor stands to gain financially; and other scenarios in which the individual being supervised is at a significant disadvantage in some way compared to the individual who is supervising their research.
  2. Use appropriate channels to resolve conflicts and avoid retaliatory behavior if a supervisee makes a good faith report through these channels or otherwise participates in an investigation, inquiry, hearing, etc. (see, e.g., AC70AC76, AD67, AD85, AD91, HR79).
  3. Provide instruction, supervision, guidance, and examples to supervisees to further their academic, technical, and/or professional development and ensure that all individuals under their supervision have received the required and appropriate RCR and technical instruction pursuant to the expectations and requirements of the University and any funder or oversight agency.
  4. Provide appropriate oversight of experimental procedures including study design and data collection, validity, reporting, and data retention and ensure, to the best of their ability, that all supervisees abide by all relevant laws, rules, and/or regulations as well as any University or funder-specific policies or contractual requirements related to the research being conducted.
  5. Ensure the scientific integrity of all work stemming from the group they supervise and oversee the preparation and submission of accurate and timely reports, publications, and/or other deliverables.
  6. In cases where the individual with supervisory responsibilities is also the PI, ensure the proper fiscal management and conduct of the project.

University Policies and Guidelines relevant to these expectations include, but are not limited to: AC47, AC80, AD29, AD67, AD85, AD88, AD91, AD98, RA01, RA02, RP02, RP06.

CONCLUDING STATEMENT:

Research is a primary function of the University, and research with integrity is essential for promoting public trust in both the University and in science as a whole.  See, e.g. RA01.  As such, all aspects of the research process should be conducted in accordance with the importance placed on research at the University by the University’s “Position Statement on Research” (RA01) and guided by the “Penn State Values” of integrity, respect, responsibility, discovery, excellence, and community (see also, AC47).  

FURTHER INFORMATION:

For questions or additional detail, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.

CROSS REFERENCES:

AC01 – Visiting Scholars

AC02 – Open Access to Scholarly Articles

AC64 – Academic Freedom 

AC80 – Outside Business Activities and Private Consulting

ACG02 – Open Availability and Open Licensing of Instructional and Other Materials

AD35 – University Archives and Record Management

AD77 – Engaging in Outside Professional Activities (Conflict of Commitment) (Under Review)

AD83 – Institutional Conflicts of Interest

AD89 – University Export Compliance Policy

AD90 – Crowdfunding Solicitation Policy

AD91 – Discrimination and Harassment and Related Inappropriate Conduct

AD95 – Information Assurance and IT Security

ADG06 – Appropriate Use of Student Data

ADG09 – Export Compliance Definitions, Procedures and Implementation Guidelines

BS07 – Authority and Procurement

BS14 – Penn State Purchasing Card

BT02 – General Budget Regulations

FN03 – Substantiation, Disclosure, and Accountability for the Receipt of Contributions from Non-Governmental Sources

FN04 – Petty Cash and Change Funds

FN05 – Operating Cash Funds

FN11 – Contracts and Leases

FN14 – Use of University Tangible Non-Capital Property, Capital Property, Supplies and University Services

FN17 – Required Use of Approved University Forms Appearing in the General University Reference Utility

FN18 – University Approval Authorization Policy

FN20 – Student Group Travel Policy

FN22 – Policy on Institutional and Employee Relationships With Educational Lenders

FN27 – Establishing and Billing Service Center User Rates

FNG02 – Limited Delegation of Contract Approvals

HR91 – Conflict of Interest

IPG01 – Faculty Guidance On Student Intellectual Property Rights 

IP01 – Ownership and Management of Intellectual Property

IP02 – Co-Authorship of Scholarly Reports, Papers and Publications 

IP06 – Technology Transfer and Entrepreneurial Activity (Faculty Research) 

RA02 – Stewardship of Sponsored Programs

RA06 – Small Business Innovation Research (SBIR) Collaboration

RA07 – Small Business Technology Transfer (STTR) Collaboration 

RA10 – Costing Principles for Sponsored Programs

RA21 – Development of Proposal Budget

RA22 – Participant Support Costs

RA40 – Compliance with Federal Export Regulations for Sponsored Research Efforts

RAG40 – Guidelines for Ensuring Compliance with Export Control Policy RA40

RP03 – The Use of Human Participants in Research

RP04 – Care and Use of Vertebrate Animals

RP06 – Disclosure and Management of Significant Financial Interests

RP07 – HIPAA and Research at Penn State University 

RP11 – Use of Regulated and Biohazardous Materials in Research and Instruction

SY01 – Environmental Health and Safety Policy

SY14 – Use of Radioactive Materials 

SY15 – Radiation-Producing Instruments

SY24 – Use of Regulated and Biohazardous Materials in Research and Instruction

TR01 – International Travel Requirements

Most Recent Changes:

  • December 13, 2023 - Removed reference to BT05 – Budget Regulations for Allocation Funds (Retired)

Revision History (and effective dates):

  • September 29, 2023 - Substantive revisions throughout to better align with White House Office of Science and Technology Policy (OSTP) Scientific Integrity Policy and federal sponsor guidelines and recommendations. Compliance areas with existing policies condensed into new "Research and The Research Process."  "Publication Practices" moved to "Dissemination of Research." New sections added: "Definitions," "Promoting a Culutre of Scientific Integrity," and "Responsible Conduct of Research Education." "Updated Responsibilities of Research Supervisors" to "Responsibilities of Research Mentors/Supervisors."
  • November 19, 2018 - Updated cross-reference links.
  • June 8, 2015 - This policy was previously a Research Administration policy, RAG16. It has been moved from the Research Administration section to the Research Protections section to reflect the reorganization, and links/cross references have been edited as appropriate.
  • December 3, 2003 - New Guideline, entitled The Responsible Conduct of Research.