Best Practices and Improprieties of Research

Meticulous record-keeping is a sound scientific practice providing an accurate contemporaneous account of observations that become a permanent reference for the researcher, who otherwise might not remember several weeks, months, or years later exactly what had been observed or what methods had been used. An accurate record also serves others who may want to replicate the observation or to apply the method to other situations. In addition, it is an aid in allowing the eventual sharing of information with others and as documentation that might be useful for disproving any subsequent allegations of fabrication or falsification of data.

In many fields of laboratory research, it is standard practice to record data in ink in an indexed, permanently bound laboratory notebook with consecutively numbered pages. Research methods, including statistical treatments, should be either described in the notebook or referenced by citation to some other primary or secondary source. Information on materials used, along with their sources, should be recorded. Entries should not be erased or whited out. If mistakes are to be corrected, a thin line should be drawn through the erroneous entry so as not to obscure it and an initialed, dated correction written separately, along with an explanatory note, near the original entry or in the margin. All entries, or at least all pages of a notebook, should be dated and initialed. Such records may also be important at a later date in establishing scientific priorities or intellectual property claims.

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Research data obtained in studies performed at the University of Pittsburgh and/or by employees of the University are not the property of the researcher who generated or observed them or even of the principal investigator of the research group. They belong to the University of Pittsburgh, which can be held accountable for the integrity of the data even if the researchers have left the University. Another reason for the University’s claim to ownership of research data is that the University, not the individual researcher, is the grantee of sponsored research awards. Reasonable access to data, however, should normally not be denied to any member of the research group responsible for collecting the data. If there is any possibility that a copyright or patent application might emerge from the group project, a written agreement within the group should specify the rights, if any, of each member of the group to the intellectual property. A researcher who has made a finding which may be patentable should file an Invention Disclosure with the University’s Innovation Institute.

Data must be shared with the public in accordance with funding agency requirements and data sharing plans included in a funded proposal. However, selective sharing of unpublished data with a particular entity is generally prohibited. For example, it is unethical and a violation of conflict of interest principles for an investigator to selectively share unpublished data whose collection was funded by the government with a commercial entity with which the investigator has a financial relationship.

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Data should typically be stored securely for at least seven (7) years after completion of the project, submission of the final report to a sponsoring agency, or publication of the research, whichever comes last. Some agencies that sponsor research may specify a longer period for which data must be retained, and extended storage of some types of data may be required by laws or regulations. For example, the U.S. Food and Drug Administration (FDA) requires that data associated with Phase I-III clinical trials be retained for a minimum of two (2) years following final approval of the respective drug or device, which is likely to be substantially longer than seven years after completion of the research project. Human subject research done on children must be retained until all subjects reach the age of 23.

In the absence of a specific agency regulation, a conservative rule is to retain data for as long as there is still scientific interest in the details of the research.

Some types of data are expected to be deposited in a national or international databank, especially when they are so extensive as to preclude publication in a journal of record. Some examples are X-ray crystallographic data on protein structures, human genomic and proteomic data, and DNA microarray data. National Institutes of Health (NIH) has a Data Sharing Policy, effective January 25, 2023, that varies by the type of data collected. The Inter-university Consortium for Political and Social Research has guidelines for preparing data in the social sciences for archiving. It is required by the FDA and expected by many journals that human subject research studies be reported on the ClinicalTrials.gov website. In addition, all NIH-funded recipients and investigators conducting clinical trials, funded in whole or in part by the NIH, must ensure that their clinical trials are registered at, and that summary results information is submitted to ClinicalTrials.gov for public posting. In some research fields, authors are encouraged to create their own Web sites on which they may store extensive data sets for general access.

Some data may fall within the definition of "Controlled Unclassified Information" and will, therefore, be subject to additional federal regulation. For more information please refer to: https://www.tradecompliance.pitt.edu/procedures/controlled-unclassified-information

Publication of research results is important as a means of communicating to the scholarly world so that readers may be informed of research results and other researchers may build on the reported findings. In fact, it is an ethical obligation for an investigator at the University to make research findings accessible, in a manner consistent with the relevant standards of publication. The reported data and methods should have sufficient detail to permit other researchers to replicate the results. Publication should be timely but should not be hastened unduly. Haste may increase the risk of not subjecting all results to adequate internal confirmation or of not considering adequately all possible interpretations.

Some data may be sensitive, and a governmental funding agency may require approval to publish particular findings, such as those funded through a proposal with Controlled Unclassified Information (CUI) classification. CUI restrictions are specified in Part 2002 of 32 Code of Federal Regulations. Investigators must abide by any publication restrictions stipulated by regulations pertinent to their work.

A commercial sponsor of a research project may not prevent publication of experimental outcomes, although a delay of publication for an agreed period, not to exceed 90 days, may be allowed in order to permit filing of a patent application (see Corporate Research Agreement Template at: https://www.osp.pitt.edu/osp-teams/clinical-corporate-contractservices/negotiations/corporate-funded-agreements-cras).

A group of journal editors, acknowledging the potential abuse of published information by perpetrators of bioterrorist acts, have suggested that, on occasion, the potential harm to society of publication outweighs the potential societal benefits of open publication of research results. Editors concerned about the risk of publication of a submitted manuscript for this reason might advise the authors to modify or withhold publication and communicate their findings to the interested scientific community by other means.

Publications must give appropriate credit to all authors for their roles in the research. If more than one person contributes, the decision of which names are to be listed as coauthors should reflect the relative contributions of various participants in the research. Many professional associations and research journals have specified criteria for authorship. One common standard appearing in many of these statements is that each author should have participated in formulating the research problem, interpreting the results, and writing the research paper, and should be prepared to defend the publication against criticisms.

Other statements require meeting two or three of the above criteria and, with respect to the last of these requirements, a more limited expectation is often prescribed—that each author should be prepared to defend against criticism those portions of the publication falling within his or her particular area of expertise. A person’s name should not be listed as author without his or her knowledge, permission, and review of the final version of the manuscript that includes the names of all coauthors.

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Customs regarding the order in which coauthors’ names appear vary with the discipline. Whatever the discipline, it is important that all coauthors understand the basis for assigning an order of names and agree in advance to the assignments. Each paper should have designated a corresponding or senior author (often the first or last of the listed names in a multi-authored manuscript) who will be responsible for communicating with the publisher or editor, for informing all coauthors of the status of review and publication, and for ensuring that all listed authors have approved the submitted version of the manuscript. Sometimes two persons are identified as corresponding authors. Any corresponding author has a greater responsibility than other coauthors to vouch for the integrity of the research report and to be prepared to defend every element of the reported research.

In citing one’s own unpublished work, an author must be careful not to imply an unwarranted status of a manuscript. A paper should not be listed as submitted in anticipation of expected submission. A paper should not be listed as accepted for publication or in press unless the author has received a galley proof or page proof or a communication from an editor or publisher stating that publication has been approved, subject perhaps only to copyediting.

Researchers should not publish the same article in two different places without legitimate reason and must include appropriate citation in the later publication to the earlier one. In such cases, the editor must be explicitly informed of the prior publication when the manuscript is submitted. The same rules apply to abstracts. If there is unexplained duplication of publications without citation, sometimes referred to as self-plagiarism, a reader may be deceived as to the amount of original research data produced by that investigator.

It is improper in most fields to allow the same manuscript to be under review by more than one journal at the same time. Very often journals specify that a submitted work should not have been published or submitted for publication elsewhere, and some journals require that a submitted manuscript be accompanied by a statement to that effect.

An author should not divide a research paper that is a self-contained integral whole into several smaller papers merely for the sake of expanding the number of items in the author’s bibliography.

Publication of two papers representing different interpretations of the same data by different participants in the research is confusing to readers. The participants with differing interpretations of the same data should attempt to reconcile their differences in a single publication or present their alternative interpretations in the same paper.

"Self-plagiarism" also known as text recycling (https://textrecycling.org/) occurs when an author re-uses previously published text in later publications or manuscripts submitted for publication. Such re-use of one’s own words does not fall within the definition of research misconduct and, therefore, would not be investigated under research integrity policy. Generally, duplications of text describing experimental methods are not considered self-plagiarism. In the background, introduction, research description, results, and discussion sections, however, self-plagiarism is ethically dubious and may constitute a failure to meet the standards of professionalism in some disciplines. Self-plagiarism may also violate copyright law and therefore be subject to legal penalties.

The University expects scholars to follow the guidelines published by the Office of Research Integrity of the Department of Health and Human Services:

“Guideline 10: Authors who submit a manuscript for publication containing previously disseminated data, reviews, conclusions, etc., must clearly indicate to the editors and readers the nature of the previous dissemination. The provenance of data must never be in doubt.”

Further guidelines and examples relevant to the topic of self-plagiarism may be found at this site: https://ori.hhs.gov/why-duplication-and-other-forms-redundancy-must-be-avoided.

Most research funding agencies have proposed that all publications supported by federal funds be posted within a reasonable time in an electronically accessible form. For example, to advance science and improve human health, NIH makes the peer-reviewed articles it funds publicly available on PubMed Central. The NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central immediately upon acceptance for publication. The NSF requires that either the version of record or the final accepted manuscript in peer-reviewed scholarly journals and juried conference papers be deposited in a designated public access compliant repository and be available for download, reading and analysis free of charge no later than 12 months after initial publication. It is the investigator’s responsibility to be familiar with the accessibility of publication requirements from each of their funding agencies.

It is unethical to release to the media scientific information contained in an accepted manuscript prior to its publication or a presentation prior to its occurrence. This does not apply to sharing preliminary versions of research papers before peer-review by posting to online preprint servers. Exceptions to the prohibition against advance release may be made if a public health issue is involved and the editor or meeting organizers agree to an advance release.

Intentional removal of, interference with, damage, or miscalibration of any research-related property, instruments, and other equipment, is improper and could be classified as research misconduct.

If an error in data presented is found after publication, whether the error is intentional or inadvertent, or plagiarism should be discovered subsequent to publication, the investigator has an obligation to submit a correction or retraction in a form specified by the editor or publisher and, in the case of research misconduct, in a form agreed to by the University and a sponsoring federal agency.

A biographical sketch incorporated into a grant proposal, or a curriculum vitae used in an application for a fellowship, or any other position must follow the same standards of accuracy as a research publication. Inflated or otherwise inaccurate listings of educational background or academic status with an intent to deceive, including degrees, employment history, and professional accomplishments, are just as reprehensible as irresponsible entries in a list of publications. Allegations of such acts will be investigated and censured if warranted.

In listing publications, it is recommended that clearly labeled, separate sections be used for referenced research publications, chapters for books summarizing or reviewing a field, books or monographs, and abstracts. A separate additional listing of public presentations may be another appropriate category. No item should be listed more than once in the same category. Some schools of the University have established standard formats for curricula vitae.

Grant applications often include sections related to curricula vitae – the Biographical Sketch (Biosketch) and Current and Pending Support sections. Each contributing investigator is responsible for the integrity and completeness of their Biosketch and Other Support sections. Beginning January 25, 2022, NIH requires new formats for both the biosketch and the Other Support documents. For more details about the changes to the NIH biosketch and Other Support, see NIH Notice NOT-OD-21-073, Notice NOT-OD-21-110, Other Support FAQs, and Biosketch FAQs. Effective October 4, 2021, the NSF is requiring the use of new biographical sketch and current and pending support formats, which were updated to incorporate revisions in the Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 22-1). Any error of omission in Other Support information must be reported to the relevant agency office as soon as it becomes known.

Conflicts of interest (COI) exist whenever a University member has personal, professional, commercial, or financial interests or activities outside the University that have the potential to interfere or be perceived to interfere with their University duties or objectivity.

The University Conflict of Interest Policy for Research (Policy RI 01) requires that full-time faculty and University investigators complete an Annual Disclosure Certification in "MyDisclosures" to disclose any outside interests, activities, or relationships that could create an actual or perceived COI in University research. The disclosures are reviewed by the discloser’s supervisor for both conflict of commitment (COC) and COI and, in some instances, are reviewed by the Conflict of Interest Division (COID) or the Conflict of Interest Committee (COIC).

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An investigator who leads a research group has leadership and supervisory responsibilities with respect to the research performed by members of the group. A principal investigator must not only put together the research group but also arrange for the assembly of an adequate financial and administrative structure to support the research. A supervisor not only provides guidance and advice to individual members of the group in the responsible conduct of the research but also has ultimate responsibility for the scientific integrity of the whole research project. They should thus take all reasonable steps to check the details of experimental procedures and the validity of the data or observations reported by members of the group, including routine reviews of primary data in addition to summary tables, graphs, and oral reports prepared by members of the group.

Written policies and procedures for collecting, maintaining, and communicating experimental data within the research group are highly recommended. Close oversight is particularly important during the first few months of participation in the group of a student, junior researcher, or new member of the research group.

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Investigators must read and follow all agency policies relevant to the award or grant supporting their research. For example, the National Institutes of Health Grants Policy Statement (NIHGPS) is an essential resource for NIH award recipients. NSF prepares a Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 22-1). Other agencies prepare similar policy documents.

Investigators must submit progress and final research reports to sponsors at times specified in the awards. They must authorize expenditures in a manner consistent with the approved budget and should review financial reports carefully.

Investigators who enter into agreements with commercial sponsors of research, as negotiated by the Office of Sponsored Programs, should familiarize themselves with the special terms of those agreements, such as those concerning reporting of results, disclosure of inventions, and confidentiality. Failure to comply with the provisions might sometimes constitute a breach of contract or might compromise the University’s claims to intellectual property.

Research protocols involving human subjects must be approved in advance by the University Institutional Review Board (IRB), the reviewing body for Human Research Protections (HRP), which determines whether risks posed to subjects are acceptable and whether information describing risks and benefits of subject participation is conveyed to subjects in an accurate and intelligible manner. IRB review also ensures that all relevant University, federal and state regulations, and policies are being followed.

The requirement for IRB review applies not only to biomedical and dental research, but also to research projects in the social and behavioral sciences. Furthermore, regardless of where the research is being conducted, if the principal investigator or co-investigator is a University of Pittsburgh faculty member, student, or staff, that research project must be submitted to the University of Pittsburgh IRB, even if it has been reviewed by another IRB.

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Investigators who use laboratory animals are obliged to follow humane procedures so as to minimize animal pain, suffering, and distress and to use no more animals than necessary to generate reliable and reproducible results. Wherever possible, alternatives not requiring the use of animals must be considered, and if practicable, adopted. Approval must be obtained from the Institutional Animal Care and Use Committee by submitting a protocol through the Animal Research Online system (ARO, https://www.aro.pitt.edu/) prior to the initiation of any research or teaching that requires the use of animals. The director and attending veterinarian of the Division of Laboratory Animal Resources (dlar@pitt.edu) are available for consultation about appropriate procedures with respect to working with animals. The same requirements for disclosure of research sponsorship and conflicts of interest in the use of human subjects in research apply for vertebrate animal research, except that the disclosures in the latter case are made to the IACUC.

All proposals for work involving gene therapy or recombinant DNA, whether in basic science or pre-clinical research, or in clinical trials, must be submitted for prior approval by the Institutional Biosafety Committee (IBC). The IBC website contains information about compliance with NIH guidelines for investigators, and assessment and determination of required biosafety measures.