Responsible Conduct of Research: what it is, what it isn’t, and the consequences of misconduct Development of Professional Skills for Scientists and Engineers August 29, 2012 Catherine Paquet, Director, Office of Research Ethics and Integrity Tim Stanley, Vice-Dean, Faculty of Graduate and Postdoctoral Studies 1

What does Responsible Conduct of Research (RCR) include? The collection, the use, the retention, and the sharing of data. 2

Ethics and Method 1. Ethics often an afterthought 2. All research balances cost and benefit 3. Ethics is a question of method 3

What this means Integrity is the central principle of academic life. Honest report findings Honest sharing of credit Acknowledging the contributions of others 4

Why is RCR important? Without it there can be harms to: ◦ Participants ◦ The research community ◦ Research itself / development of knowledge Risk of losing the confidence of both the lay and professional communities Researchers’ responsibility to use public funds appropriately 5

What is RCR? Using a high level of rigour in proposing and performing research; in recording, analyzing, and interpreting data; and in reporting and publishing data and findings. Keeping complete and accurate records of data, methodologies and findings, including graphs and images, in accordance with the applicable funding agreement, institutional policies and/or laws, regulations, and professional or disciplinary standards in a manner that will allow verification or replication of the work by others. Referencing and, where applicable, obtaining permission for the use of all published and unpublished work, including data, source material, methodologies, findings, graphs and images. From Tri-Agency Framework (2011) 6

What is RCR? (cont’d) Including as authors, with their consent, all those and only those who have materially or conceptually contributed to, and share responsibility for, the contents of the publication or document, in a manner consistent with their respective contributions, and authorship policies of relevant publications. Acknowledging, in addition to authors, all contributors and contributions to research, including writers, funders and sponsors. Appropriately managing any real, potential or perceived conflict of interest, in accordance with the institution's policy on conflict of interest in research. From Tri-Agency Framework (2011) 7

Conflict of Interest (COI) A situation where a person or organization has several interests which could compete against each other and where these could possibly affect their actions or professional judgment in regards to one of these interests. It can include ◦ Financial, professional or personal considerations or commitments; ◦ Being in a position to influence, either directly or indirectly, business, research, or other; ◦ A situation in which an existing relationship with a party might prejudice decisions with respect to a certain activity. COIs may be: ◦ potential, ◦ actual, or ◦ apparent or perceived The presence of a conflict of interest in itself does not automatically mean that and individual or organization has done something wrong. It may be possible to manage them but they MUST be disclosed. 8

What RCR isn’t (and what constitutes misconduct) TermDefinition Fabrication:Making up data, source material, methodologies or findings, incl. graphs &images. Falsification:Manipulating, changing, or omitting data, source material, methodologies or findings, [...], without acknowledgement and which results in inaccurate findings or conclusions. Destruction of research records: The destruction of one's own or another's research data or records to specifically avoid the detection of wrongdoing or in contravention of [...] laws, regulations and professional or disciplinary standards. Plagiarism:Presenting and using another's published or unpublished work, including theories, concepts, data, source material, methodologies or findings, including graphs and images, as one's own, without appropriate referencing and, if required, without permission. From Tri-Agency Framework (2011) 9

What it isn’t (cont’d) TermDefinition Redundant publications: The re-publication of one's own previously published work or part there of, or data, in the same or another language, without adequate acknowledgment of the source, or justification. Invalid authorship:Inaccurate attribution of authorship, including attribution of authorship to persons other than those who have contributed sufficiently to take responsibility for the intellectual content, or agreeing to be listed as author to a publication for which one made little or no material contribution. Inadequate acknowledgement: Failure to appropriately recognize contributions of others in a manner consistent with their respective contributions and authorship policies of relevant publications. Mismanagement of Conflict of Interest: Failure to appropriately manage any real, potential or perceived conflict of interest, in accordance with the Institution's policy on conflict of interest in research. IS NOThonest error or differences of opinion 10

The Nature of the Academic Contract 1. Public 2. Results/Findings Reproducible 3. Full Disclosure of All Relevant Information 4. Peer Review 11

Examples of Misconduct 12

Case 1: 1953 – James Watson & Francis Crick Discovered the structure of DNA, for which they eventually would share the Nobel Prize in Secretly obtained key x-ray diffraction data from Rosalind Franklin without her permission. “Many voices have argued that the Nobel Prize should also have been awarded to Rosalind Franklin, since her experimental data provided a very important piece of evidence leading to the solving of the DNA structure. The case Plagiarism Inadequate aknowledgment The issues Watson & Crick were awarded the Nobel prize but R. Franklyn was not awarded one because she died in 1953 and the prize is not awarded posthumously. The consequences Nobelprize.org. 15 Aug

Case 2: 1974 – William Summerlin Used a black felt-tip pen to darken patches of fur on a white mouse—to serve as proof of his astonishing claim that he could transplant skin grafts between unrelated individuals without immune rejection. Summerlin’s claims dissolved when a dab of rubbing alcohol washed the so-called transplants away. Summerlin quickly confessed and blamed the “pressure cooker” atmosphere at the Memorial Sloan-Kettering Cancer Center. The case Falsification The issues An institute committee attributed Summerlin’s actions to a “serious emotional disturbance” and put him on sick leave with a year of pay. Summerlin never returned to the center, but reportedly moved to rural Louisiana to work in obscurity as a doctor. “This was so bizarre because [misconduct] cases are usually so much more complicated,” says colleague John Leavitt, now a biotech consultant. “But this was simply a guy with a Magic Marker.” The consequences: NATURE MEDICINE VOLUME 12 | NUMBER 5 | MAY

Case 3: 1998 – Andrew Wakefield Research on Autism Had financial interest in proving vaccine was responsible for Autism Very selective choice of participants (almost all had previous issues) The case Mismanagement of Conflict of Interest Falsification The issues Barred from practicing medicine in the UK Various journals retracted his articles Less people getting their children vaccinated has lead to rise in cases of measles The consequences 15

Case 4: – Woo-Suk Huang Research on somatic cell nuclear transfer (stem cell research) Coerced female lab members into donating eggs for his research Multiplied the number of stem cells by manipulating his data (2 vs. 11), manipulated photos of cells The case Fabrication Falsification Unprofessional conduct Issues He was fired from Seoul National University Eventually indicted on fraud and embezzlement charges (2006) Consequences East Asian Science, Technology and Society: an International Journal (2008) 2:1–7 DOI /s x 16

Regulations 17

University of Ottawa Regulations FGPS Guidelines for the Ethical conduct of Research and Procedures for Investigating Misconduct ◦ Section 3: Guidelines for the Ethical Conduct of Research ◦ Section 4: Procedure for Investigating Reports of Misconduct in Research ◦ APUO collective agreement ◦ Section10: Professional ethics ◦ Section 13: Grievances and arbitration APTPUO Collective Agreement ◦ Article 2.6 Ethical Behaviour ◦ Section 4: Complaints, grievance and arbitration procedure ◦ Section 6: Discipline and Discharge 18

Canadian federal regulations Tri-Agency Framework: Responsible Conduct Of Research (2011) ◦ Joint policy of CIHR, NSERC & SSHRC ◦ Sets out the responsibilities and corresponding policies for researchers, Institutions, and the Agencies re RCR, including how to handle allegations of a breach of policy. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2 nd edition (2010) ◦ Joint policy Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC) & Social Sciences and Humanities Research Council of Canada (SSHRC) ◦ Core principles: respect for persons, concern for welfare, justice Secretariat on Responsible Conduct of Research provides support for ◦ Federal research granting Agencies (CIHR, NSERC and SSHRC) ◦ Panel on Responsible Conduct of Research (PRCR) – for the Framework ◦ Panel on Research Ethics (PRE) – for the TCPS2 All institutions receiving funds from the Agencies must abide by the policies set out in the Framework andTCPS2 Professional associations usually have their own regulations as well. 19

Canadian federal regulations (cont’d) PanelDocumentMandate (edited) Panel on Research Ethics (PRE) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2) (2008 & 2010) promote high ethical standards of conduct in research involving humans; TCPS 2 interpretations; identify educational activities and mandate the Secretariat to implement and promote them; recognize the diversity of approaches used in research involving humans; Panel on Responsible Conduct of Research (PRCR) Tri-Agency Framework: Responsible Conduct of Research (the Framework) (2011) consider allegations of breaches of Tri- Agency policies by reviewing institutional investigation reports; recommend recourse, if appropriate; provide advice to the Agencies on matters related to the responsible conduct of research & on revisions to the Framework; and 20

U.S. Office of Research Integrity (ORI) – the Lab Description In "The Lab: Avoiding Research Misconduct," you become the lead characters in an interactive movie and make decisions about integrity in research that can have long-term consequences. The simulation addresses Responsible Conduct of Research topics such as avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices. 21

What should you do if you suspect misconduct has taken place? Make sure your understanding of the event is accurate – an accusation can seriously hurt someone’s reputation even if it isn’t true. Consult others to see if they agree. Don’t make any accusation without proof. Know the University’s and your field’s rules. If you can, get someone with experience to back you up. Report to someone who isn’t / shouldn’t be in a conflict of interest (Dean, FGPS, VPR). FYI: The University does not investigate anonymous allegations. 22

Resources and references 23

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Resources and links Panel on Responsible Conduct of Research ◦ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2 nd ed. 2010) ◦ politique/initiatives/tcps2-eptc2/Default/ politique/initiatives/tcps2-eptc2/Default/ Tri-Agency Framework: Responsible Conduct Of Research ◦ politique/framework-cadre/ politique/framework-cadre/ 25

Refs SRA 2011 presentation by Debra Schaller-Demers, Director, Research Outreach and Compliance, Memorial Sloan-Kettering Cancer Center "The Discovery of the Molecular Structure of DNA - The Double Helix". Nobelprize.org. 15 Aug uble_helix/readmore.html Nature Medicine, Volume 12, Number 5, May

BÉIR / OREI Personnel 27 Directrice / Director Catherine Paquet Germain Zongo ext Kim Thompson ext Riana Marcotte ext 1783 Questions générales / General Inquiries Mélanie Rioux, Research Ethics Coordinator / Responsables d’éthique en recherche / Protocol Officers for Ethics in Research

Faculty of Graduate and Postdoctoral Studies Tim Stanley Vice-Dean, FGPS Séraphin Marion St. (Hagen Hall) Tel: (613) Fax: (613)