Scientific Integrity

Temidayo O OgundiranMBBS (Ibadan), MHSc (Toronto), FACS, FRCS (Edinburgh),

FWACS

Division of Oncology, Department of Surgery, University of Ibadan and University College Hospital, Ibadan

West African Bioethics Programme, University of Ibadan

Research

activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge

(Belmont Report)

Research...

a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

(45 CFR 46.102)

Research...

The acquisition of knowledge is the mission of research, the transmission of knowledge is the mission of teaching and the application of knowledge is the mission of public service

(JA Perkins, 2004)

Acquisition of knowledge

Transmission of knowledge Application of

knowledge

teaching public service

research

Albert Einstein

“Most people say that it is the intellect that makes a great scientist. They are wrong; it is character”

Scientific Integrity

Individual• Individual’s commitment to intellectual honesty

and personal responsibility• An aspect of moral character and experienceInstitution• Commitment to creating an environment that

promotes responsible conduct by embracing standards of excellence, trustworthiness and lawfulness

Shared Values Among Scientists

• Honesty- conveying information truthfully and honouring commitments

• Accuracy-reporting findings precisely and taking care to avoid errors

• Efficiency-using resources wisely and avoiding waste

• Objectivity-letting the facts speak for themselves and avoiding improper bias

Integrity in Scientific Research

Important to• the public- public good is advanced by

science conducted in the interest of humanity• research institutions• scientists• the scientific enterprise

Elements of Integrity in Research

Individual• intellectual honesty in proposing, performing and reporting research• accuracy in representing contributions to research proposals and reports• fairness in peer review• collegiality in scientific interactions, communication and sharing of

resources• transparency in (potential) conflicts of interest• protection of human subjects in the conduct of research• humane care of animals in the conduct of research• adherence to mutual responsibilities between investigators and their

research teams

Elements of Integrity in Research

Institution: provides• leadership in support of responsible conduct of research• respect for everyone involved in the research enterprise• productive mentor-trainee interactions• adherence to rules on all aspects of conduct of research• management individual/institutional conflicts of interests• management of allegations of scientific misconducts• educational opportunities on research integrity• environment that supports integrity in conduct of research

Fostering Integrity in Research Environment and Institution

Integrity in Research Environment and Institution

• the support of the public for science, scientists and scientific institutions is based on trust and honesty

• scientists and scientific institutions are accountable to the public

• fostering an environment that promotes integrity in the conduct of research is part of that accountability

Institutional Requirements

• Policies- that cover various aspects of institutions research programmes

• Review committees- for human and animal research• Financial policy-approval and management of all research

budgets• Biosafety regulations• Research misconduct procedures- reports, investigations,

adjucating, sanctions, etc• Training for researchers on responsible conduct of research• Research office/officer-manages all research responsibilities

Institutional Commitment to Integrity

• development and implementation of a programme to promote integrity in research

• creating a climate and promoting a culture of responsible conduct of research

• supportive leadership• effective educational programmes• evaluation of institutional commitment

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SCIENTIFIC WRITINGS

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Scientific Writings

• Papers-original articles, review articles, case reports, proceedings, abstracts, letters to editors, commentaries/opinions

• Reports, monograms• Books/chapters in a book• Grants proposals, research manuscripts• Dissertations/thesis• etc

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Competence of the Researcher

• Academic and professional competence

• Scientific validity and competence

• Ethical issues- participants’ protection issues, scientific rigour and thoroughness, etc

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Data Management is Essential to Quality Scientific Research

• Maintain objectivity in the collection of research data

• Avoid bias and conflicts of interests• The principal investigator has roles in ensuring

data quality, accuracy, and custody• Institutions should have policies on data

management

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Quality of Data

• The use of accepted norms in statistical analysis and inclusion (retention) of data

• Data sharing policies for published work

• Respecting confidentiality with certain types of data e.g. genetics

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Recording Data

• Maintenance of records on methods used in the laboratory or research field

• Maintenance of research data (hard vs. soft copies)

• Laboratory information management systems• Electronic laboratory notebooks

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Retaining Data

• All primary/original data must be retained for required time

• Storing data under conditions that will maintain its quality

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Qualities of Research to be Published

• Complete piece of scholarship with adequate replications

• Not published before, redundant, or duplicating of other work

• No fabrication, falsification or plagiarism• No trimming, smoothing, salami slicing

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Criteria for Authorship

• Each author should meet criteria for what constitutes a significant contribution

• Acceptance of responsibilities for all or specified parts of work

• International Committee of Medical Journal Editors guidelines

• Need for institutional or laboratory authorship policy with defined roles

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Publication

• Writing a scientific manuscript (including final approval of all authors)

• The concepts and procedures for peer review of manuscripts

• The roles of reviewers of manuscripts• The roles of editors in manuscript review• Sharing research information after publication

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Peer Review

• Peer review is a procedural safeguard in the scientific method that provides institutionalized self-criticism and quality control

• Peer review is the scrutiny of research by others with the objectivity and expertise to evaluate the quality of the work fairly

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Peer Review 2

• Public release of research findings should come only after peer review

• Peer reviewers are usually journal board members or are selected ad hoc by the editor

• Peer reviewers’ qualifications include appropriate scientific expertise, no conflict of interest, and adequate time to review

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Peer Reviewers’ Responsibilities

• Peer review helps the editor decide whether to publish the manuscript and helps the author present the work effectively

• The written review should provide an overview and specific recommendations for improving the work

• Reviewers must respect the author’s intellectual property

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RESEARCH MISCONDUCTS

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Scientific/Research Misconduct

Fabrication, falsification, plagiarism, and other practices that seriously deviate from those normally accepted within the scholarly and scientific community for proposing, conducting or reporting research

(42 CFR Part 93)

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Scientific/Research Misconduct

Does not include honest errors or differences in interpretations or judgments of data or of opinion

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• Misconduct versus Honest Errors

• Should honest errors in science be punished?

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• Misconduct versus Honest Errors

• In both: “someone is led to disbelieve something that is actually true or to believe something that is actually false”

(Michael D. Mann)

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"The only ethical principle which has made science possible is that the truth shall be told all the time.

If we do not penalise false statements made in error, we open up the way..... for false statements by intention.

And of course a false statement of fact made deliberately, is the most serious crime a scientist can commit” (Snow, 1959)

“Scientists have an obligation to check all their data thoroughly and to draw only valid conclusions from them” (Mann)

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Fabrication

making up data or other relevant information at any stage of the typical scientific process from research development and application for funding up to the submission of findings for publication

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Plagiarism…1

• the appropriation of another person’s ideas, processes, results or words without giving appropriate credit

• a matter of false attribution• failing to reveal or credit an existing source

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Plagiarism...2

Self plagiarism• using one’s own previously published work (or

parts of it) without citing any source

• repeatedly publishing copies of one's own research findings or papers in different scientific journals

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Plagiarism…3

Unpublished plagiarism• unattributed use of material to which one has

acquired confidential access in a review process, in grant proposals or manuscripts

• difficult to prove when the original work is unpublished and also secured under the provisions of confidentiality

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Giving Due Credit

• Authorship

• Acknowledgement

• Citation/References

• Prior contacts

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Other Deviant Behaviours• Faulty data gathering procedures

-using data from participants who are not meeting the requirements of the research

-malfunctioning equipment-inappropriate treatment of participants-recording data incorrectly

• deviation from proposed protocol without permission• falsification of credentials• deception in research proposals and execution of proposals• piracy of materials• failure of informed consent; breaches of confidentiality• any deviation from accepted ethical standards

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Danger to Science

• violates moral precepts• undermines the most fundamental

tenet of science- trust• undermines the normal progression of

science• loss of self esteem

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Cases of Research Misconducts

History repeats itself; that’s one of the things that’s wrong with history

Clarence Darrow

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WERNER BEZWODA

• WR Bezwoda, L Seymour and RD Dansey. High dose chemotherapy with hemopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial. JOC 1995;13:2483-2489

• Retracted JOC 2001;19:2973• RB Weiss et al Lancet 2000;355:999-103• P. Cleaton-Jones Lancet 2000;355:1011-1012

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Woo Suk Hwang

• The South Korean stem-cell researcher Woo Suk Hwang has been at the centre of one of the largest investigations of scientific fraud in living memory.

• In January 2006, Hwang's home research institution, Seoul National University, delivered a damning report about Hwang's work on cloned human embryos, concluding it was all based on fraudulent data. The revelation has destroyed the best evidence so far that stem cells can be extracted from a clone matched to a specific patient. With Hwang discredited, both the field of therapeutic cloning and the public's trust in science have suffered a serious setback.

(Nature news 11 January 2006)

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Notice of Retraction

• The article published in the January 2001 issue of the Archives titled “Prophylaxis With Oral Granisetron for the Prevention of Nausea and Vomiting After Laparoscopic Cholecystectomy” by Fujii et al is hereby retracted. Allegations have been raised about the scientific integrity and ethical oversight of the research conducted by Dr Fujii.

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Notice of Retraction…2

Our investigation revealed that Dr Fujii and coauthors had not applied to the ethical committee for institutional review board approval regarding this study, and therefore we are retracting this article. Julie Ann Freischlag, MD, Editor; Howard Bauchner, MD, Editor in Chief. (Arc Sur Published Online June 18, 2012 www.archsurg.com)

Original article was published: Arch Surg. 2001;136[1]:101-104)

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Are there cases of scientific misconducts locally?

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Preventing/Detecting Fraud

1. Peer reviewshould -be standardized-accreditable

- include assessing performance of peer reviewers with blinded reviews of specially prepared articles

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Preventing/Detecting Fraud...2

2. Replication of studies

3. Designated corporate officers in charge of research integrity

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Preventing/Detecting Fraud...3

4. IRB/REC Process-Review of Protocols -Monitoring of research-Data and safety monitoring

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Preventing/Detecting Fraud...4

5. Internal depositories for all data-document to contain processes, analytic

procedures and research methodologies researchers use

-all of the resulting material should be audited by external bodies

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Preventing/Detecting Fraud...5

6.International systems to detect scientificplagiarism

using a template of the automated system used by colleges and universities to detect plagiarism in student assignments

(“Plagiarism Detection Services”)

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Preventing/Detecting Fraud...6

7. Collaboration, multiple authorship and mentoring

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Preventing/Detecting Fraud...7

8. Formal education in ethics• Through education and discussion, ethics

should impact on moral attitudes and behaviour.

• Critical thinking skills and analytical techniques from the humanities would help clinicians and researchers understand the implications and context of their actions

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Improving Integrity in Science

• attention to the issues of integrity in research

• promoting and evaluating research integrity• education in the responsible conduct of

research• promulgation of and adherence to policies

on research integrity• institutional self assessment • funding of research on scientific integrity

Resources

• Schneider B and Schuklenk U. Scientific misconduct. Developing World Bioethics 2005; 5(1);92-108

• Institute of Medicine-National Research Council, 2002:Integrity in scientific research-creating an environment that promotes responsible conduct

• ORI Introduction to the responsible conduct of research• Francis L Macrine. Scientific integrity, 2005: 3rd edition• IF Adewole. Research Integrity. West African Bioethics Program,

2005• Anderson MS, Steneck NH. The problem of plagiarism. Urologic

Oncology: Seminars and Original Investigations 29 (2011) 90–94

Resources• Michael D. Mann, The ethics of collecting and processing data and

publishing results of scientific research. Available athttp://www.unmc.edu/ethics/data/data_int.htm

• Online research ethics course. Available athttp://ori.dhhs.gov/education/products/montana_round1/issues.html

• James A. Perkins. President, Cornell. Quoted in New York Times, 3 November 1966

• Sara Rockwell. Ethics of Peer Review: A Guide for Manuscript Reviewers • Elizabeth Heitman, Ruth E. Bulger. Assessing the educational literature

in the responsible conduct of research for core content. Accountability in Research, 12:207–224, DOI: 10.1080/08989620500217420

THANK YOU

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