A summary of ORI Introduction to the Responsible Conduct of Research

Written by Nicholas H. Steneck

Table of Contents

• A summary of ORI Introduction to the Responsible Conduct of Research
  • Table of Contents
  • Chapter Summaries
    • Foreward
    • Preface
    • Part I
      • Chapter 1: Rules of the Road
      • Chapter 2: Research Misconduct
    • Part II
      • Chapter 3: The Protection of Human Subjects
      • Chapter 4: The Welfare of Laboratory Animals
      • Chapter 5: Conflicts of Interest
    • Part III
      • Chapter 6: Data Management Practices
      • Chapter 7: Mentor and Trainee Responsibilities
      • Chapter 8: Collaborative Research
    • Part IV
      • Chapter 9: Authorship and Publication
      • Chapter 10: Peer Review
    • Part V

Chapter Summaries

Chapter specific summaries

Foreward

This book is published by the Office of Research Integrity (ORI) as supplemental material to assist in the teaching of the responsible conduct of research. The ORI oversees and directs the Public Health Service (PHS) research integrety on behalf of the Secretary of Health and Human Services as well as the American public. This book stems from the ethics that were raised in biology related fields in 1989 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 does what “good citizenship” mean within each field. This book was 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 what is and isn’t responsible. Furthermore, a researcher’s personal judgement must also solve this ethical calculus. In order of importance of whose rules to listen too, it goes: 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, and once accepted, are incorporated into the Code of Federal Regulations and must be followed. Researchers are advised to seek help in understanding Federal rules.

Chapter 2: Research Misconduct

Research misconduct policies provide guidance on responsible conduct in these three areas:

1. Establish definitions for misconduct in research,
2. Outline procedures for reporting and investigating misconduct, and
3. 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’s (OSTP), a Federal agenct, definition of research misconduct is, “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results”. For an action to be considered research misconduct, it must meet the following criteria:

1. Represent a, "significant departure from accepted practices",
2. Have been, "committed intentionally, or knowingly, or recklessly"; and
3. Be, "proven by a prponderance of evidence".

The federal policy puts the responsibility of research misconduct reporting and investigation on both researchers and their research institutions. Research misconduct puts a researcher’s career on the line. Additionally, a whistleblower runs the risk of illegal retaliation. Furthermore, the accused researcher(s) only face punishment when proven guilty.

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 be classified as research misconduct. It is assumed that research misconduct is under reported. Regardless, this misconduct taints the public image of research, wastes donated or tax-funded dollars, and harms both the professional reputations of researchers and institutions.

Part II

Chapter 3: The Protection of Human Subjects

Human subjects are used in order to find improvements to the human experience. This could involve the creation of new medicines, surgeries, or experiments.

Researchers who use human subjects are subject to Federal regulations. Both the Nuremberg Code and the Declaration of Helsinki 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”, 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; or

- Taste and food quality evaluation and consumer acceptance studies.

Any institution that performs human research must have a Federally mandated Internal Review Board (IRB) consisting of at least 5 people, one of which is a scientist, one of which is a non-scientist, and one who is not affiliated with the institution. Furthermore, all researchers working with human subjects must undergo National Institutes of Health (NIH) training.

All human subjects must have to informed consent and the right to withdraw. Furthermore, there is an ethical concern in human subjects research that some experiments have risks without any benefits.

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 and the 1985 Health and Research Extension Act both act as Federal regulations that researcher’s experimenting on human subjects must abide by. The United States Department of Agriculture (USDA) 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), acting through the National Institutes of Health (NIH) and the Office of Laboratory Animal Welfare (OLAW), NIH. Furthermore, activists have put together guidelines through the Animal Care Panel (ACP) commonly reffered to as th Guide. The Guide is widely accepted both in public and private institutions as well as 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”. the definition of an animal from the Common Rule that implements the Animal Welfare Act 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”.

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. Prior to using animal subjects, researchers must defend the usage of animal subjects against the “three R’s”:

1. Replacement - using non-animal models such asmicroorganisms or cell culture
techniques, computer simulations, or species lower on the phulogenetic scale,

2. 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

3. Refinement - the elimination or reduction of unnecessary pain and distress
[in animal subjects].

Chapter 5: Conflicts of Interest

Researchers can experience three different types of conflicts of interest:

1. Financial gain,
2. Work commitments, and
3. 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. As an example (not mentioned in this book; purely my own thought probably taken from someone else) is a pro-life reseacher working on abortificants.

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.

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. This means that data collection method is appropriate and reliable. If the method is garbage, the result will be garbage (garbage in, garbage out). 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, data 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.

In the case of sharing data with other researchers or the general public, data must be fully validated, not be preliminary data, and can be confidential until publication.

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 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 9: Authorship and Publication

All forms of publication should present:

- A full and fair description of the work done,
- An accurate report of the results,
- An honest and open assessment of the findings,
- The methods of the researcher,
- What the results are, and
- A discussion of the results to better understand their impact.

Authorship serves to let others know who conducted the research and should get credit for it. It is generally limited to those who were:

- Intimately involved in the conception and design of the research,
- Assumed responsibility for data collection and interpretation,
- Participated in the drafting of the publication, and
- Approved the final version of the publication.

There is disagreement as to whether a researcher needs to adhere to all of these rules in order to be consider an author. The International Committee of Medical Journal Editors (ICMJE) have created the Uniform Requirements for Manuscripts Submitted to Biomedical Journals which lists out the following criteria for authorship:

1. Substantial contributions to conception and design, or acquisition of data,
or analysis and interpretation of data,

2. Drafting the article or revising it critically for important intellectual
content, and

3. Final approval of the version to be published

Authors should meet conditions 1, 2, and 3.

The ICMJE guidelines are strict and are not followed by all disciplines.

The first and last author on a paper carry weight. What this weight means is dependent upon the field that it is published in.

The corresponding or primary author of the paper is the individual who can intimately describe the work and is the public relations individual of the work.

A manuscript should include:

- An abstract to summarize the content of the paper,
- A methods section to describe the research methods to create the results,
- A results section to talk about what was found,
- A discussion section to describe what the results mean, and
- A notes, bibliography, and acknowledgments section to acknowledge the work of
previous researchers or minor authors to the paper

The following authorship practices should be avoided:

- Honorary authorship,
- Salami publications (using the same data/ study in two seperate papers),
- Duplicate publications, and
- Premature public statments

Chapter 10: Peer Review

Peer reviewed is done by fellow researchers (typically within the same field) to asses:

• Grant reviews,
• Manuscript reviews,
• Personnel reviews, and
• Literature reviews and expert testimony

Peer reviews must be:

- Timely,
- Thorough,
- Constructive,
- Free from personal bias, and
- Respectful of the need for confidentiality

Peer reviews assess the quality of the work by:

- Assessing whether the research methods are appropriate,
- Checking calculations and/or confirming the logic of important arguments,
- Making sure the conclusions are supported by the evidence presented, and
- Confirming that the relevant literature has bee consulted and cited

Research quality can be comprimised if the peer reviewer(s) find:

- Careless mistakes made in reporting data and/or listing citations,
- The deliberate favrication and falsification of data,
- Plagarism
- Inaccurate reporting of conflicts of interest, contributors/ authors, and
- The failure to mention important prior work, either by others of by the
researcher submitting a paper for publication.

Peer reviews judge the importance of the work by answering the following questions:

- Assuming a researcher could carry out a proposed research project, is it
important to do so?

- Are these research results important enough to publish?
- Has a researcher made important contributions to a field of study?
- Is this evidence important enough to be used in setting policy?

By juding importance, a reviewers personal bias is involved. To mitigate this, reviewers should write transparent reviews in which they lay out their bias as well as any documents or citations that they found that supports their bias.

Confidentiality is important in protecting peers from attacks from one another. There exists a double-blind review in which both the reviewers and the authors are anonymous from one another. It is not appropriate to:

- Ask students or anyone else to conduct a review you were asked to do,
- Use an idea or information contained in a grant proposal or unpublished
manuscript before it becomes publicly available,

- Discuss grant proposals or manuscripts you are reviewing with colleagues in
your department or at a professional meeting,
- Retain a copy of the reviewed mateial, and
- Discuss personnel and hiring decisions with colleagues who are not 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.