ORI Introduction to the Responsible Conduct of Research#
Book Summary Research
by Nicholas H. Steneck, David Zinn, and Tommy G. Thompson [5]
Foreward#
This book is published by the Office of Research Integrity (ORI) 1https://ori.hhs.gov/ as supplemental material to assist in the teaching of the responsible conduct of research. The ORI oversees and directs the Public Health Service (PHS) 2https://health.gov/ research integrety on behalf of the Secretary of Health and Human Services 3https://www.hhs.gov/ and the American public.
This book stems from the ethical concerns that were raised in biology related fields in 1989 [6] and has sinced expanded to become more general and applicable to other disciplines.
Preface#
As the importance of science and technology increases, so too has the public’s demand for the responsible conduct of research. Simply put, this means that good citizenship is applied to a researcher’s professional life. However, as each field is different, so too is the definition of “good citizenship”.
This book is written to briefly introduce researchers to what is generally accepted as responsible conduct regardless of their working field.
Part I#
Chapter 1: Rules of the Road#
There aren’t clear rules laid out to for researcher’s to easily understand what is and isn’t responsible research conduct. Rather, there are many organizing bodies, both official and non-official, that govern this 4IEEE and ACM come to mind for software engineering. Furthermore, a researcher’s personal judgement contributes to this ethical calculus.
Some of the ethical and legal guidelines researchers have to adhere to include:
Professional Codes,
federal,
State,
institutional policies, and
personal judgement.
Not all professions have Professional Codes. federal regulations have to first be made available for public comment in the federal Register 5https://www.federalregister.gov/, and once accepted, are incorporated into the Code of federal Regulations 6https://www.ecfr.gov/ and must be followed. Researchers are advised to seek help in understanding federal rules.
Chapter 2: Research Misconduct#
It is assumed that research misconduct is under reported. Regardless, misconduct taints the public image of research, wastes donated or tax-funded dollars, and harms both the professional reputations of researchers and institutions.
Research misconduct policies provide guidance on responsible conduct in these three areas:
Establish definitions for misconduct in research,
Outline procedures for reporting and investigating misconduct, and
Provide protection for whistleblowers and person accused of misconduct.
federal regulations for research misconduct technically only apply at the federal level, but many institutions incorporate and expand it within their own policies. The Office of Science and Technology Policy 7https://www.whitehouse.gov/ostp/ (OSTP) — a federal agency — defines research misconduct as:
“fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results,” [7] .
For an action to be considered research misconduct, it must meet the following criteria:
Represent a, “significant departure from accepted practices”,
Have been, “committed intentionally, or knowingly, or recklessly”, and
Be, “proven by a preponderance of evidence”.
The violation of
federal rules,
abuse of confidentiality,
authorship and publication violations,
failure to report misconduct,
obstruction of misconduct investigations, and
other institutional level policies
can also be classified as research misconduct.
Research misconduct puts a researcher’s career on the line. However, researchers accused of research misconduct only face punishment when proven guilty.
OSTP puts the responsibility of research misconduct reporting and investigation on both researchers and their research institutions. Research misconduct whistleblowers run the risk of illegal retaliation when reporting to governing bodies.
Part II#
Chapter 3: The Protection of Human Subjects#
All human subjects must have to informed consent and the right to withdraw from experiments conducted on them.
Human subjects are used in order to find improvements to the human experience. This could involve the creation of new medicines, surgeries, or experiments [9]_. There is an ethical concern in human subjects research that some experiments have risks without any benefits.
Researchers who use human subjects are subject to federal regulations. Both the Nuremberg Code [8] and the Declaration of Helsinki [9] are guidelines that are to be followed when testing on human subjects.
Additionally, the federal regulation 45 CFR 46 Subparts A - D, known as the “Common Rule” [1] , are expected to be followed as well. Exempt research from the “Common Rule” include:
Research conducted in established or commonly accepted educational settings,
Research involving the use of educational tests,
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if unidentifiable or publicly availible,
Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and
Taste and food quality evaluation and consumer acceptance studies.
Furthermore, all researchers working with human subjects must undergo National Institutes of Health (NIH) 10https://www.usda.gov/ training.
Any institution that performs human research must have a federally mandated Internal Review Board (IRB). It must consist of at least 5 people including one member who is a scientist, one is not a scientist, and one who is not affiliated with the institution.
Chapter 4: The Welfare of Laboratory Animals#
Research on animal subjects is done to benefit humans without experimenting on humans. The 1966 Animal Welfare Act [2] and the 1985 Health and Research Extension Act [10] both act as federal regulations that researcher’s experimenting on human subjects must abide by.
The United States Department of Agriculture (USDA) 11https://olaw.nih.gov/ is responsible for the transportation, care, and use of animals. The usage of animals for biomedical and behavioral research is subject to the Secretary of Health and Human Services (HHS) [3], acting through the National Institutes of Health (NIH) and the Office of Laboratory Animal Welfare (OLAW) 12For example, Globus, Zenodo, and figshare.. Furthermore, activists have put together guidelines through the Animal Care Panel (ACP), commonly reffered to as the Guide [4]. The Guide is widely accepted both in public and private institutions and federal laboratories.
The definition of an animal from the PHS Policy is:
“any live, vertebrate animals used or inteded for use in research, research training, experimentation, or biological testing or for related purposes.” [3]
The definition of an animal from the Common Rule that includes warm blooded animals (mammals) but excludes:
“Birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research purposes and other farm animals”.
Prior to using animal subjects, researchers must defend the usage of animal subjects against the “three R’s”:
Replacement - using non-animal models such asmicroorganisms or cell culture techniques, computer simulations, or species lower on the phulogenetic scale,
Reduction - using methods aimed at reducing the numbers of animals such as minimization of variability, appropriate selection of animal model, minimization of animal loss, and careful experimental design, and
Refinement - the elimination or reduction of unnecessary pain and distress in animal subjects.
Institutions testing on animals must create an Institutional Animal Care and Use Committee (IACUC) which acts similarly to an IRB but for animals. These, along with the OLAW, USDA, and accrediation programs, are responsible for the proper care and respect of animal subjects.
Chapter 5: Conflicts of Interest#
Researchers can experience three different types of conflicts of interest:
Financial gain,
Work commitments, and
Intellectual and personal matters.
Financial gains involve reciving money from an institute that the researcher has a vested in. This could involve having stock in the company, or being a member of the company.
Work commitments involve colluding multiple working positions into one in order to serve a singular purpose. In other words, if a position at work is being used to further a research objective or vice versa, it is a conflict of interest.
Intellectual and personal matter conflicts of interest occur when the idealogy, beliefs, or viewpoint of a researcher could interfere with their research objectives.
Part III#
Chapter 6: Data Management Practices#
Research is not possible without data. Because of this, there are responsibilities that researchers have to the proper ownership, collection, storage, and sharing of data 13Garbage in, garbage out. When sharing data with others, it must be fully validated, be finalized, and can be confidential until publication.
Data can be owned by one or many sources. This includes:
the funders of the research,
the institution where the research was conducted, and
the original source of the data.
Typically, government funded research allows the data to be shared for the public good, privately funded research retain the right to disseminate the data, and philinthropic funding sources retain or give away their data ownership rights depending on their motive.
Data must be collected responsibly through appropriate and reliable methods If these methods are unreliable, the the resulting data will also be unreliable 14https://www.nationalpostdoc.org/. The data collected must be detailed enough to support the results. It must also be authorized for collection, and when recorded, proper metadata must be captured to include the date, time, source, and other important facts about the source of the data.
After collecting the data, it must be stored properly so as to prevent the theivery or loss of data. This includes securing lab notebooks and regularly backing up data files. Additionally, any data that includes personal identifying information or is otherwise confidential, must go through a process of anonymizing the data so as to respect the source’s privacy. Furthermore, some data may be subject to a period of retention and if not, data should otherwise be retained indefinetly.
Finally, future considerations about the data must be taken into account. For example, the generated data of an experiment can be larger than the amount of usable computer storage. Furthermore, there is now a concern that released data can contribute to the terrorism or foreign entities that wish to do harm to the American public. Ethical concerns about the release of such data must be taken into consideration prior to releasing said data.
Chapter 7: Mentor and Trainee Responsibilities#
Trainee refers to anyone learning to be a researcher learning from a senior researcher. To establish the basic understandings of the relationship, trainees must know from their mentors:
How much time they are expected to put into research,
How performance is judged,
How responsibilities are shared or divided,
Standard operating procedures, and
How credit and authorship are assigned.
Whereas mentors expect from their trainees that they:
Do work in a conscientious way,
Respect the authority of others,
Follow research regulations and protocols, and
Live by agreements established for authorship and ownership
To make sure these expectations are clear, the mentor should lay them out initally. Furthermore, mentors have are expected to supervise the work of a trainee. This results in the monitoring, support, and review of a trainees work, as well as imparting the ethos of being a researcher onto them.
The research environment that they mentor creates and the trainee learns in should be one of:
Equal treatment free from discrimination,
Professional, and
Follow the responsible conduct of research
Postdoctoral researchers have a rough time in the lab as they have the skills to be an independent researcher, but since they are no longer students nor faculty, they have little rights. Additionally, since they are working under someone else’s funding, they have little freedom to pursue their own research. The National Postdoctoral Association 15https://www.icmje.org/ has been created to ensure that postdocs have the rights that they deserve with respect to transitioning to independent researchers.
Chapter 8: Collaborative Research#
Collaborative research involves any time when two or more researchers collaborate on the same project. This could involve researchers from the same institution or different insititutions. This work is led by a primary investigator (PI) who heads the project and is responsible for the compliance of rules and responsible research conduct, financials, and training.
Collaborative research projects need to initially solve many problems with respect to:
The goals of the project and anticipated outcomes,
Everyone’s role,
How data will be collected, stored, and shared,
How changes in the research design will be made,
Who is responsible for drafting publications,
The criteria to identify and rank authorship,
Who is responsible for submitting reports and meeting other requirements,
Who is responsible for publicly speaking about the work,
How intellectural property rights and ownership issues will be resolved, and
How collaboration can be changed and when it comes ot an end.
With respect to compliance, it is best practice to work under the compliance guidelines of the institution or state that has the strictest policies to ensure that all researchers are following proper protocol.
Part IV#
Chapter 10: Peer Review#
Peer review is an essential component of the research process, carried out by fellow researchers—typically within the same field—who evaluate the quality, rigor, and significance of scholarly work. This evaluative process is used in a variety of contexts, including grant applications, manuscript submissions, personnel decisions, and the preparation of literature reviews or expert testimony.
Effective peer review adheres to several key principles. Reviews must be completed in a timely manner and should be thorough in their assessment of the material. They must also be constructive, offering feedback that can help strengthen the work, and they should be free from personal bias. Additionally, reviewers are expected to respect the confidentiality of the materials they assess.
The primary purpose of peer review is to determine the quality of the work under consideration. Reviewers examine whether the research methods used are appropriate, verify calculations and the logic behind important arguments, ensure that the conclusions are supported by the evidence provided, and confirm that all relevant literature has been properly consulted and cited. When reviewers identify issues—such as careless errors in data reporting or citations, deliberate fabrication or falsification of results, plagiarism, inaccurate disclosures of conflicts of interest or authorship, or the omission of key prior work—the integrity of the research is called into question.
In addition to evaluating quality, peer reviewers also judge the importance of the work. They may ask whether a proposed research project is worth pursuing, whether specific results merit publication, whether a researcher has made meaningful contributions to their field, or whether the evidence presented is substantial enough to inform policy decisions. Because these judgments inherently involve subjective interpretation, some degree of personal bias is unavoidable. To mitigate the influence of such bias, reviewers are encouraged to write transparent reviews that openly acknowledge their own perspectives and reference any sources or prior work that shaped their assessments.
Confidentiality is a cornerstone of the peer-review process, protecting both authors and reviewers and encouraging frank, honest evaluations without fear of personal or professional repercussions. Many venues employ double-blind review systems in which neither the authors nor the reviewers know one another’s identities. To maintain the integrity of this system, reviewers must follow strict ethical guidelines. It is inappropriate to delegate a review to students or colleagues, to use ideas or information from a confidential proposal or manuscript before it becomes public, or to discuss submissions under review with others — whether in one’s department or at professional meetings. Reviewers must not retain copies of reviewed materials once the process is complete, nor should they discuss personnel or hiring evaluations with individuals who are not formally part of the review process.
Part V#
It is well understood that many people early in their career have irresponsible research conduct. Additionally, what might be considered responsible conduct in one field may not apply to all fields. None the less, there is no justification for comprimising the core tennants of research: honesty, accuracy, efficiency, and objectivity. Upholding these is the responsibility of all researchers.
Bibliography#
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