Research Protections Guidelines
RPG01 The Responsible Conduct Of Research
Policy Steward:Associate Vice President for Research, Director of the Office for Research Protections>
- Guiding Principles
- Data Management and Data Integrity
- Responsible Authorship
- Dissemination of Research
- Publication Practices
- Peer Review
- Collaborative Research
- Financial Conflict of Interest
- Conflict of Commitment
- Fiscal Responsibility
- Responsibilities of Research Supervisors
- Research With Human Participants
- Research With Animal Subjects
- Research Involving Hazardous Materials and Potential Safety Hazards
- Concluding Statement
- Further Information
- Cross References
The Pennsylvania State University is committed to fostering integrity in the conduct of research. All members of the research community, including faculty, research staff, students, fellows, adjunct faculty, and visiting researchers, are expected to adhere to the highest ethical and professional standards as they pursue research activities to further scientific understanding.
The goal of the Guidelines is to offer a set of values, principles, and standards to guide decision-making and conduct throughout the research process.It is not intended to provide a set of rules that prescribe how researchers should act in all situations. Rather, the Guidelines are intended to increase awareness of research integrity and outline the University's expectations for ethical behavior amongst all researchers.
The Guidelines discussed are not mutually exclusive. There are many circumstances when many of them apply to a single project or activity. The risks of non-adherence to the Guidelines can be both personally and institutionally great. Potential consequences of non-adherence are outlined in the University polices that form the foundation for these Guidelines.
The Code of Conduct prescribes standards of work performance and ethicalconduct expected of all persons engaged in research at The Pennsylvania State University based upon the following guiding principles:
- Research is the pursuit of truth in the advancement of knowledge
- Researchers should, in all aspects of research-
- Demonstrate integrity and professionalism;
- Observe fairness and equity;
- Disclose and appropriately manage all conflicts of interest;
- Ensure the rights, safety, and dignity of those associated with research; and
- Comply with all legal, regulatory, and ethical requirements established by the University, regulatory bodies, funding sources, and professional organizations.
- Research methods and results should be open to scrutiny and debate.
Data integrity depends on the proper and ethical collection,representation, and retention of data. Falsification or fabrication of one's own data and unacknowledged use of data generated by others are unacceptable behaviors and constitute misconduct. The University maintains ownership of all data collected from research conducted at the University, under the auspices of the University, or with University resources, subject to restrictions stipulated in University-approved agreements with sponsors and other third parties.
- Accept primary responsibility for data collection, proper attribution, recording, storage, retention, and disposal or transfer to University Archives, as appropriate.
- Scrupulously record data in a form that is easily accessible for analysis and review and, if the research is supported by external funding, readily identifiable with and traceable to the sponsored project.
- Maintain the privacy of data as required by confidentiality agreements and regulations.
- Make data immediately available to scientific supervisors and collaborators, as confidentiality agreements permit.
- Post-publication, share data with other interested researchers who seek to verify and/or complement existing research.
- Maintain research data intact, preferably in original form, in accordance with University or sponsor's retention requirements or for a sufficient amount of time to allow for analysis of published results by other researchers, optimally a minimum of five years after publication.
Authorship is the process by which the results of original research are translated to published form to facilitate the communication of new knowledge to the professional community. Thus, the integrity of the scholarly record is of paramount concern to the research community. See University Policy IP02, Co-Authorship of Scholarly Reports, Papers and Publications.
- Attest to the originality of work.
- Assign credit appropriately in publications by citing relevant work of others.
- Discuss and resolve issues of authorship before beginning a study or as they arise during a study.
- Assign appropriate credit in publications to all those who have contributed significantly to the research process, including research staff, students, and support staff. See University Policy IP02, Co-Authorship of Scholarly Reports, Papers and Publications for further clarification on coauthorship.
- Confirm that all coauthors willingly agree to be listed as coauthors of publications and to assume responsibility for the accuracy and integrity of their contributions.
- Actively involve all coauthors in reviewing and verifying any and all parts of the manuscript.
- Identify a primary author to be responsible for the validity of the entire manuscript and for assuring that all contributions are appropriately recognized.
- Avoid honorary authorship, which is the practice of subscribing authorship to an individual who has not made a substantial contribution to a manuscript. Instead, utilize alternative forms of acknowledgment as allowed by the publication venue.
- Include information in the publication on the sources of financial support for the research. Be cautious of financial sponsorship that prohibits the naming of the sponsor in publication.
The University strongly upholds principles of academic freedom, and as an institution serving the public, encourages every effort to ensure that research conducted under the auspices of the University can be freely pursued and disseminated. Researchers are urged to be aware of overtly commercialized research that attempts to place boundaries on academic freedom to pursue research for the good of society and to make research results available to the general public. However, the nature of some research, particularly industrial and defense-related research, does present some circumstances where it may be appropriate and necessary for restrictions to be placed on dissemination. Where such situations are warranted, researchers should practice caution and abide by the following guidelines.
- Conduct classified research only in the Applied Research Laboratory.
- Maintain the secrecy of classified research.
- Maintain the confidentiality of proprietary information that has been provided to enable research.
- Refrain from publishing or otherwise disseminating research related to inventions until appropriate disclosure filings are made to protect your intellectual property.
- Abide by export control regulations that can place legal restrictions on the ability to publish or present.
- Refrain from disseminating research that may result in future harm to the public.
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 have the responsibility to communicate research results to the scholarly community. Both the reputation and the growth of a profession depend upon three key values: 1) openness in communication, 2) honesty in reporting results and methods, and 3) fairness in apportioning credit. All investigators are obligated to uphold these values.
- Include sufficient information in publications to enable others to replicate the results or otherwise scientifically validate the research.
- Avoid simultaneous submission of the same abstract or manuscript to multiple journals.
- Avoid fragmentary publication or multiple publications of highly similar research findings based on the same data set.
- Acknowledge any sources of financial support for the research and disclose any conflicts of interest in publications.
Peer review is an essential part of the research process. Peer review helps ensure that research has been carried out in an effective manner and will make a significant, timely contribution to the field. Researchers of all fields may find themselves in the position to offer peer review, and the obligation should be thought of as an additional way to contribute to the profession. The review process must be conducted according to the highest professional standards to ensure continuing widespread confidence in the peer review system.
- Review only manuscripts and grant applications on a subject matter of personal expertise and return a thoughtful review.
- Disclose real or perceived conflicts of interest. Identification of a conflict of interest may require a decision to remove oneself from the review process.
- Base a review objectively within the context of published information. Offer positively constructive comments rather than confrontational remarks.
- Retain the confidentiality of all manuscript and grant application contents, as both contain privileged information.
Collaborative research affords many opportunities to significantly expand research in response to more detailed questions by sharing expertise and resources. Researchers are encouraged to partake in collaborative research within the institution as well as across institutions, keeping in mind that all of the guidelines for research put forth are applicable to collaborative projects. Noncompliance by any single individual contributing to collaborative research may have negative repercussions for the entire research team.
- Ensure all those involved confirm their compliance with applicable regulations and policies of all institutions and professional standards.
- Abide by export control regulations that can place legal restrictions on the ability to publish or present.
- Ensure collaborators adhere to all grant management regulations and contractual obligations.
- Discuss and agree to authorship guidelines for the project.
- Advise collaborators of institutional policies for intellectual property and requirements for protecting privileged work invented in the course of the collaboration.
- Disclose all real or perceived conflicts of interest with collaborators prior to embarking on collaboration.
Conflict of interest occurs when a researcher uses his/her position,relationships, and reputation for personal gain or for the profit of a family member. Real or perceived conflict of interest can be detrimental to the research process in that it may lead some researchers to inappropriately influence a research study or results. The existence of a financial relationship does not necessarily lead to inappropriate actions. Consequently,it is important for researchers to disclose all relevant financial relationships. See University Policies IP06, HR91, and RP06.
- Disclose all potential significant conflicts of interest to:
- the University Conflict of Interest Committee prior to the submission of proposals or initiation of sponsored projects or at least annually or as changes in status occur.
- funding agencies when submitting funding applications.
- journal editors when submitting manuscripts for publication or acting as a peer reviewer.
- meeting organizers prior to delivering a scholarly presentation.
- the Institutional Review Board, when applicable.
- Attempt to eliminate significant conflicts of interest and appropriately manage those that cannot be eliminated.
Conflict of commitment occurs when demands on time and/or effort made by non-institutional entities or persons interfere with primary professiona lresponsibilities to the University. Avoiding irresponsible conflicts of commitment is essential for supporting credibility and accountability,providing sound stewardship of University resources, increasing trust among members of the University community, protecting researchers and the University from litigation, and for maintaining mission focus and academic freedom. The University allows and encourages extra-university research activities as long as such activities support the mission of the University and do not compete with the University. To avoid the appearance of unethical conflicts of commitment, researchers should disclose all potential conflicts to academic supervisors. See University Policy IP06.
- Attempt to effectively manage time and effort commitments that may detract from University obligations.
- Disclose all potential conflicts of commitment that arise from activities such as consulting, external teaching, privately-funded research, and start-up companies.
Accurately managing research funds contributes to the fiscally sound and ethically responsible conduct of research. Managing project budgets and effort responsibly contributes to the legitimacy of the overall research project. See University Policies RA01,RA21, RA04, and RA06.
- Understand that grants, contracts, and gifts are awarded to the University, rather than to individuals employed by the University.
- Effectively manage research-appropriated funds to ensure all costs incurred on a project are reasonable, allowable, and allocable.
- Comply with all terms and conditions imposed by the financial sponsor.
- Initiate all required approvals for budgetary and programmatic changes that may be necessary during a project.
- Comply with University purchasing and travel policies as well as all sponsor regulations.
- Submit effort certifications for all projects annually, but review effort assignments monthly to avoid unallowed expenses for federally funded projects in particular.
Mentoring young researchers in the technical as well as ethical aspects of research is a significant responsibility. Research supervisors have the rewarding and unique opportunity to inform, instruct, and set an example for the responsible conduct of research. However, researchers should be cognizant of ethical issues related to the supervision of research trainees such as the potential abuse of power over those who are dependent for financial, academic,and emotional support; conflicts of commitment between the productivity of the supervisor's research and the trainee's academic progress; and financial conflicts of interest created by assigning research trainees to projects in which the supervisor stands to gain financially.
- Ensure the scientific integrity of all work stemming from one's research group.
- Provide supervision, guidance, and example to trainees to further their academic, technical, and professional development.
- Provide oversight of experimental procedures including study design and data collection, validity, reporting, and retention.
- Instruct graduate students, post doctoral fellows, and other research assistants on all relevant regulations, university policies, and university procedures for research with humans, animals, and/or hazardous materials.
- Ensure the proper fiscal management and conduct of the project.
- Oversee the preparation and submission of technical reports and any other required deliverables.
The conduct of research with human participants is highly regulated and is guided by ethical considerations. First and foremost, researchers should be cognizant of the fact that research with human participants is a privilege, nota right stemming from Academic Freedom. Researchers are obligated to conduct research with human participants in such a way as to minimize any risks or harm to participants. The Institutional Review Board (IRB) review and approval process is in place to ensure that all research with human participants adheres to this mandate. See University Policies RP03 and RA22.
- Minimize risk to participants and ensure that research is justified by maximizing potential benefits.
- Obtain informed consent of participants throughout the duration of the research as appropriate.
- Ensure the safety and privacy of all participants, as well as the confidentiality of all information.
- Employ additional safeguards when vulnerable populations are involved.
- Obtain written IRB approval for research prior to contact with human participants.
- Adhere to all relevant federal regulations.
Research involving animals must be humane and meet normative standards of conduct. Animal researchers are duty-bound to conduct their research ethically and humanely. Researchers should be cognizant of the fact that the use of animals in research is a privilege, not a right stemming from Academic Freedom. See University Policy RP04, Care and Use of Vertebrate Animals.
- Ensure all research associates working with animals are adequately evaluated according to the Animal Care and Use Occupational Health and Safety program, trained and supervised.
- Identify how the research will benefit animals or human kind.
- Minimize the number of animals involved in a research study to include only the number necessary to ensure the integrity of the research.
- Design protocols to avoid or minimize discomfort, distress, and pain, using appropriate pain medication where appropriate.
- Obtain written approval of research from the Institutional Animal Care and Use Committee (IACUC) prior to the commencement of any research or teaching with animals.
- Adhere to the IACUC-approved protocol throughout the study.
- Conduct all research activities in accordance with University policy, the Animal Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide for Care and Use of Laboratory Animals, and U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Teaching, Research, and Training.
Research involving biohazardous, radioactive and other hazardous materials, such as chemicals, if, improperly handled, has the potential to pose a threat to researchers, the Penn State community, and society at large.Additionally, other potential safety hazards may exist in the research environment and measures need to be in-place to prevent injury or negative impacts. It is essential that an organizational structure for safety be established and followed so that safe processes are integral with daily activities. See University Policy SY01, Environmental Health and Safety Policy.
All supervisors (department chairs, faculty, and other employees with direct oversight of University activities) have specific responsibilities to provide for the health and safety of those supervised.
- Be thoroughly informed of appropriate University and Departmental safety policies, rules and procedures and how they specifically apply to your responsibilities and authority.
- Ensure all employees and students understand and abide by relevant safety and health policies, rules, regulations, and procedures.
- Provide and maintain required safety equipment, devices and personal protective equipment and apparel. Ensure proper usage.
- Provide instruction and assistance in the proper operation of equipment or materials that may be potentially hazardous.
- Encourage reporting of health and safety concerns. Take prompt, corrective action when unsafe conditions, practices or equipment are reported or observed.
- Conduct a thorough investigation in all work-related injuries, illnesses and accidents, submit appropriate recommendations on all accident reports, and follow through to ensure corrective measures have been implemented.
- Coordinate or conduct inspections to maintain safe and healthful conditions, and address any deficiencies that are identified.
- Provide for health and safety training.
Guidelines for Use Involving Biohazardous Materials:
The Institutional Biosafety Committee (IBC) and Environmental Health and Safety (EHS) exist to ensure compliance with regulations pertaining to the use of these materials. See University Policy SY24, Use of Regulated and Biohazardous Materials in Research and Instruction.
- Submit any research or teaching involving the use of genetically modified materials (recombinant DNA); infectious agents; human blood, tissues, or unpreserved body fluids; Select Agents, or USDA regulated agents to the Institutional Biosafety Committee for review and written approval prior to conducting the activities.
- Ensure all laboratory work areas have current and protocol appropriate inspections by Environmental Health and Safety.
- Ensure all research personnel are properly trained and supervised for handling biologic and chemical materials to which they may be exposed.
- Dispose of all biological hazards and chemical materials according to established regulations.
- Conduct all research activities in accordance with relevant University polices, federal regulations, and state laws.
Guidelines for Use of Radioactive Materials:
The University Isotope Committee (UIC) and Environmental Health and Safety (EHS) exist to ensure compliance with radiation rules and procedures.See University Policy SY14, Use of Radioactive Materials.
- Obtain written authorization from the University Isotope Committee prior to beginning research utilizing radioactive materials.
- Acquire all radioactive research materials through Environmental Health and Safety.
- Ensure the proper containment of radioactive materials being utilized in work areas.
- Ensure all research associates and technicians working with radioactive materials are properly trained by EHS.
- Immediately report radioactive material spills or exposure to the environment.
- Dispose of all radioactive materials according to established regulations.
- Conduct all research activities in accordance with all relevant University policies, federal regulations, and state laws.
Guidelines for Use of Radiation-Producing Equipment:
The use of radiation-producing equipment such as x-rays poses a potential serious hazard to those individuals exposed. It is also regulated by federal and state agencies. See University Policy SY15, Radiation-Producing Instruments.
- Consult with EHS as early as possible prior to ordering or installing any radiation-producing equipment.
- Arrange to have newly installed systems inspected by EHS for required labeling, safety devices, radiation levels, and evaluation of the system location to assure user and non-user safety.
- Prepare written operating procedures for the use of all radiation-producing instruments and review them with the user(s).
- Inform EHS prior to the transfer of the equipment or when a system is permanently removed from service and is to be either disposed of or used for parts.
- Contact EHS for guidance on proper disposal.
The responsible conduct of research is essential for promoting public trust in research and in the University. The University expects that all research and other scholarly activities be conducted according to the highest ethical standards and guidelines. The personal and institutional consequences associated with unethical conduct can be significant. The risks of non-adherence to the guidelines stated here can include fines, loss of privileges to conduct particular types of research, loss of funding or the inability to apply for certain types of funding in the future, damaged reputation, disbarment from a federal agency, and dismissal from the University. As is stated in Policy RP02, the University will take all necessary actions to ensure the integrity of research and scholarly work.
For questions, additional detail, or to request changes to this policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.
IP02 - Co-Authorship of Scholarly Reports, Papers and Publications (Formerly Policy RA13)
HR91 - Conflict of Interest
RA01 - Determining the Allowability, Allocability, and Reasonableness of Costs on Sponsored Projects
RA21 - Preparing Budgets (Cost Estimates) For Sponsored Projects
RA04 - Making Revisions to Budgets and Program Plans on Federally Sponsored Projects [not sure of link - no policy by this name]
RA06 - Cost Recovery for Sponsored Projects [?? RA06 title= Small Business Innovation Research...]
RA08 - Reimbursement Salary Caps and Plan Effort Confirmation (formerly Salary Rate Limitations and Effort Confirmation) [policy does not exist'
RA12 - Technology Transfer and Entrepreneurial Activities (Faculty Research)
RP03 - The Use of Human Participants in Research
RP04 - Care and Use of Vertebrate Animals
RP07 - HIPAA and Research at Penn State University (Formerly Policy RA22)
SY01 - Environmental Health and Safety Policy
SY15 - Radiation-Producing Instruments
SY24 - Use of Regulated and Biohazardous Materials in Research and Instruction
Most Recent Changes:
- 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.
Revision History (and effective dates):
- December 3, 2003 - New Guideline, entitled The Responsible Conduct of Research.