ResponsibleConductofResearchcisb.mit.edu/wp-content/uploads/2014/08/2016MIT-RCR-by... · 2016-05-02 · SocialConsciousnessSculptureattheMuseumofArt inPhiladelphia,PennsylvaniabyJacob

Professor Barry R. Masters, BS, MS, PhD

Elected Fellow of AAAS (American Associa>on for the Advancement of Science),

OSA (Op>cal Society of America), and SPIE.

Formerly, Visi>ng Scien>st, Department of Biological Engineering, MIT, and

Visi>ng Scholar, Department of the History of Science, Harvard University, and

AAAS Congressional Science & Engineering Fellow, United States Congress

2016

B. R. Masters, Responsible Conduct of Research 1

Responsible Conduct of Research

Outline •  What is Science? •  What is Pseudoscience? •  Promo>on of Science

•  Mentoring •  Risk taking and innova>on

•  Protec>on of Science •  What damages Science?

•  Plagiarism •  Scien>fic Misconduct

•  Advancement of Science •  Scien>fic Communica>on

•  Authors, Reviewers, and Editors •  Good Research Prac>ces •  Human and Animal Research •  Intellectual Property

B. R. Masters, Responsible Conduct of

Research 2

Social Consciousness Sculpture at the Museum of Art in Philadelphia, Pennsylvania by Jacob Epstein


Scien>sts' goals:

The promo>on, protec>on, and the advancement of science • Mentoring students • Genera>ng knowledge • Communica>ng knowledge


• What is Science? • Why Responsible Conduct of Research MaXers? •  Fostering Curiosity, Risk taking, Innova>on • Mentorship: the paths to becoming an ethical, successful, independent scien>st

•  Sources of ethical behavior


•  Scien>fic Communica>on

• Authorship

• Plagiarism

• Peer Review

• Research Misconduct



• What is Science?

Science is a social process that is

built on trust and ethical conduct


Why mentoring the new generaAon of scienAsts is criAcal •  Science is a process to generate knowledge of the physical universe

•  The process of science can be taught to others and passed on from genera>on to genera>on

• Without the mentoring and training of a new genera>on of scien>sts science will end as the last scien>st dies


We strive to promote mentorship, foster

collabora>on, coopera>on, advance our

research and work in the context of social

responsibility


•  Protec>on of the process of Science •  Legal and ethical aspects of RCR •  Federal, state, and ins>tu>onal aspects of RCR


Why Responsible Conduct of Research (RCR) maDers?

Why Responsible Conduct of the Process of Science?

•  The social context of science: diversity •  Scien>sts receive public support and have social responsibili>es

•  Specific ac>vi>es can result in loss of public support for research and loss of trust in scien>sts

• Professional Codes of Conduct, University Regula>ons, City, State and Federal laws

•  Social, Ethical, Moral, and Religious Beliefs


Academic Integrity at MIT •  hXp://integrity.mit.edu/ •  Free course at MIT: Responsible Conduct of Research hXp://osp.mit.edu/compliance/rcr

•  hXp://integrity.mit.edu/handbook/wri>ng-‐original-‐work

•  hXp://cmsw.mit.edu/wri>ng-‐and-‐communica>on-‐center/resources/writers/

•  Purdue University OWL Online Wri>ng Lab hXp://owl.english.purdue.edu/owl/resource/589/01/


WPA Council of WriAng Program Administrators •  hXp://wpacouncil.org/posi>ons/WPAplagiarism.pdf •  Defini&on: In an instruc>onal se`ng, plagiarism occurs when a writer deliberately uses someone else’s language, ideas, or other original (not common-‐knowledge) material without acknowledg-‐ing its source.

•  This defini>on applies to texts published in print or on-‐line, to manuscripts, and to the work of other student writers.

•  Most current discussions of plagiarism fail to dis>nguish between:

•  Submi`ng someone else’s text as one’s own or aXemp>ng to blur the line between one’s own ideas or words and those borrowed from another source, and

•  Carelessly or inadequately ci>ng ideas and words borrowed from another source.


Resources and References


CSE’s White Paper on Promoting Integrity in Scientific Journal Publications, 2009 update http://www.councilscienceeditors.org

Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (Updated October 2008) Publication Ethics: Sponsorship, Authorship, and Accountability, International Committee of Medical Journal Editors, http://www.icmje.org

Office of Research Integrity (ORI)


Free pdf of Introduction to RCR http://ori.hhs.gov/ori-intro

Case summaries of Scientific Misconduct by year http://ori.hhs.gov/case_summary Publication and Authorship http://ori.hhs.gov/publicationsauthorship

Books ¨  Shamoo, A.E., Resnik, D. B. Responsible Conduct of

Research, Second Edi>on, New York, Oxford University Press, 2009. ISBN 978-‐0-‐19-‐536824-‐6

¨  Emanuel E. J., Grady, C., Crouch, R. A., Lie, R.K., Miller, F. G.,

Wendler, D. (Eds.)The Oxford Textbook of Clinical Research Ethics, New York, Oxford University Press, 2009. ISBN 978-‐0-‐19-‐516865-‐5

¨  Beauchamp T. L., Childress, J. F. Principles of Biomedical Ethics, Fijh Edi>on, New York, Oxford University Press, 2001 ISBN 0-‐19-‐514332-‐9

¨  Steinbock, B. (Ed.) The Oxford Handbook of Bioethics, New

York, Oxford University Press, 2007. ISBN: 978-‐0-‐19-‐927335-‐5


Books ¨  Scien>fic Style and Format, The CSE Manual for Authors, Editors, and

Publishers. 7th ed. Council of Science Editors, Reston (VA): The Council and The Rockefeller Press, 2006

¨  Coghill, AM, Garson, LR, eds. The ACS Style Guide, Effec>ve Communica>on of Scien>fic Informa>on, 3rd ed. New York, Oxford University Press, 2006

Part 1. Scien>fic Communica>ons: Ethics in Scien>fic Communica>on, Peer Review, Copyright Basics

¨  AMA Manual of Style, A Guide for Authors and Editors, 10th ed. New

York, Oxford University Press , 2007

Ethical and Legal Considera>ons: Authorship Responsibility, Acknowledgements, Conflicts of Interest, Financial Disclosures, Duplicate Publica>on, Scien>fic Misconduct, Conflicts of Interest, Intellectual Property, Ownership, Access, Rights and Management, Confiden>ality. Protec>ng Research Par>cipants'’ and Pa>ents’ Rights in Scien>fic Publica>on


Books ¨  The Chicago Manual of Style, the Essen>al Guide for Writers, Editors,

and Publishers, 15th ed. Chicago, the University of Chicago Press, 2003 ¡  Chapter 4, Rights and Permissions: Copyright Law and the Licensing of Rights, Author’s

Responsibili>es, Publisher’s Responsibili>es

¨  Publica>on Manual of the American Psychological Associa>on, 5th ed. Washington, DC, American Psychological Associa>on, 2001 ¡  Chapter 2, Expressing Ideas and Reducing Bias in Language ¡  Appendix C: Ethical Standards for the Repor>ng and Publishing of Scien>fic Informa>on

¨  MLA Style Manual and Guide to Scholarly Publishing, 2nd ed. Gibaldi J, New York, The Modern Language Associa>on of America, 1998 ¨  Chapter 2, Legal Issues in Scholarly Publishing (A. F. Abelman): Copyright, Contracts,

Defama>on, Right of Privacy


Research 19

The CollaboraAve InsAtuAonal Training IniAaAve (CITI Program)

•  hXps://www.ci>program.org/index.cfm?pageID=265

•  Responsible Conduct of Research

•  CITI Program’s RCR series consists of a basic course, complemented with a set of addi>onal modules of interest, and a refresher course. Both courses contain modules that cover core norms, principles, regula>ons, and rules governing the prac>ce of research. Both the Na>onal Ins>tutes of Health (NIH) and the Na>onal Science Founda>on (NSF) have policies that require certain categories of researchers to receive RCR training. RCR is increasingly viewed as an essen>al component of training, regardless of a researcher’s source of funding


BOOKS

• Gene>cs: Ethics, Law and Policy, second edi>on, Andrews, LB, Mehlman, MJ, Rothstein, MA St. Paul, Thompson/West (2006) This book discusses gene>cs research, biobanks, research on human embryos, commercializa>on of gene>c research, and medical applica>ons of gene>cs, gene>c tes>ng, screening, counseling, gene therapy, pharmacogene>cs, and enhancement; forensics, privacy and confiden>ality


Books on how science works •  Out of the Shadows, Contribu>ons of Twen>eth-‐Century Women

to Physics. Nina Byers and Gary Williams, 2006, Cambridge

University Press 978-‐0-‐521-‐82197-‐1

•  Drive and Curiosity, What Fuels the Passion for Science. Istvan

HargiXai. 2011. Prometheus Books. 978-‐1-‐61614-‐468-‐5

•  Madness and Memory, The Discovery of Prions-‐A New Biological

Principle of Disease. Stanley B. Prusiner, M.D. 2014, Yale

University Press. 978-‐0-‐300-‐19114-‐1


Books on pseudo-‐science

• How to differen>ate science and

pseudoscience?

• The boundaries between science and

pseudoscience


Be SkepAcal! • What is knowledge and what is nonsense?

Nonsense can cause great harm when it affects public policy

• crea>onism? • Lysenkoism? • parapsychology?


Does publicaAon and consensus validate the findings? Truth?

• Luminiferous aether, Wikipedia In the late 19th century, luminiferous aether, or ether, meaning light-‐bearing aether, was the postulated medium for the propaga>on of light. •  Cold Fusion: Control experiments are part of the scien>fic method to prove that the measured effects do not happen by chance, but are direct results of the experiment. One of the points of cri>cism of Fleischmann and Pons was the lack of control experiment

Fleischmann, Mar>n; Pons, Stanley (1989), "Electrochemically induced nuclear fusion of deuterium", Journal of Electroanaly>cal Chemistry 261 (2A): 301–308, doi:10.1016/0022-‐0728(89)80006-‐3


•  POLYWATER AND THE ROLE OF SKEPTICISM •  The following excerpt is from On Being a Scien>st: Responsible Conduct in Research, 2nd edi>on, a report by the CommiXee on Science, Engineering, and Public Policy, part of the Na>onal Research Council. Published by Na>onal Academy Press, Washington, D.C., in 1995.

•  The case of polywater demonstrates how the desire to believe in a new phenomenon can some>mes overpower the demand for solid, well-‐controlled evidence.

•  In 1966 the Soviet scien>st Boris Valdimirovich Derjaguin lectured in England on a new form of water that he claimed had been discovered by another Soviet scien>st, N. N. Fedyakin. Formed by hea>ng water and le`ng it condense in quartz capillaries, this "anomalous water," as it was originally called, had a density higher than normal water, a viscosity 15 >mes that of normal water, a boiling point higher than 100 degrees Cen>grade, and a freezing point lower than zero degrees. Over the next several years, hundreds of papers appeared in the scien>fic literature describing the proper>es of what soon came to be known as polywater.


Polywater In August, 1973, Derjaguin and N. V. Churaev published a leXer in the journal Nature in which they write that, "these [anomalous] proper>es should be aXributed to impuri>es rather than to the existence of polymeric water molecules.“ Franks, F., Polywater, MIT Press, 1981, ISBN: 0-‐262-‐06073-‐6


Trust Experts? Important theories that were resisted and ridiculed by experts

•  Gregor Mendel’s laws of inheritance

•  Barbara McLintock’s discovery of gene>c transposi>on 1983 Nobel Prize in Physiology or Medicine •  Peter Mitchell’s chemiosmo>c mechanism of ATP synthesis 1978 Nobel Prize in Chemistry

•  Alfred Wegener’s con>nental drij hypothesis


Books on how science works •  The Pseudo-‐Science Wars. Immanuel Velikovsky and the

birth of the modern fringe. Michael D. Gordin, 2012.

The University of Chicago Press. 978-‐0-‐226-‐30442-‐7

•  Voodoo Science: The Road from Foolishness to Fraud

Robert L. Park. 2000, Oxford University Press,

978-‐0195135152


Zernike on innovaAon… •  “… I am impressed by the great limita>ons of the human mind. How quick are we to learn, that is, to imitate what others have done or thought before. And how slow to understand, that is, to see the deeper connec>ons. Slowest of all, how-‐ever, are we in inven>ng new connec>ons or even in applying old ideas in a new field.” Fritz Zernike, Nobel Lecture, December 11, 1953



Einstein on Light (Risk taking) e-‐ico.org (Read it in Spanish, Latvian, Chinese, French, Greek, Armenian, Portuguese, Slovak, Hebrew, Italian and Hindi) “And God said, ‘Let there be light,’ and there was light.” Genesis 1:3

“For the rest of my life, I will reflect on what light is.” Albert Einstein, c. 1917

“All the fiCy years of conscious brooding have brought me no closer to the answer to the quesFon: What are light quanta? Of course today every rascal thinks he knows the answer, but he is deluding himself.” Albert Einstein, 1951



The Nobel Prize in Chemistry 2014 was awarded jointly to Eric Betzig, Stefan W. Hell and William E. Moerner "for the development of super-resolved fluorescence microscopy".

•  Eric Betzig on “risk taking in science.” The last 6 minutes of his Nobel Lecture

•  hXp://www.nobelprize.org/mediaplayer/index.php?id=2407

•  “I dedicate this talk to all the unknown people, in any walk of life, who gambled their fortunes, their careers, and their reputa>ons, to try to take risks and in the end failed. The struggle itself is its own reward and the sa>sfac>on that you knew that you gave everything you had to make the world a beXer place.” E. Betzig


Mentorship: the path to becoming an independent, ethical scienAst

• Why we need mentorship?

• Why we need metrics to measure outcomes?

•  How to measure success?


hDp://tyelab.org/philosophy/ •  The Tye Lab Mission

•  To make a las>ng impact on the field of behavioral neuroscience. To make a great impact on the field, we must achieve the following tasks:

•  Perform well-‐designed experiments that lead us to exci>ng and novel discoveries

•  Communicate these findings within and beyond the greater scien>fic community

•  Mentor trainees to become some of the best neuroscien>sts of their genera>on


Kay M. Tye, Ph.D. Assistant Professor Principal Investigator Whitehead Professorship Chair Picower Institute for Learning and Memory Dept. of Brain and Cognitive Sciences Massachusetts Institute of Technology

hDp://tyelab.org/philosophy/

•  Expecta>ons of Post-‐Docs

•  I expect you to realize your maximum poten>al…and I would not accept you into my lab as a post-‐doc if I did not believe that you had the poten>al to be one of the best neuroscien>sts in your genera>on.

•  I expect you to tell me what you need to realize your vision and I will do my best to ensure that you have it. My goal is to place all of my post-‐docs into career paths where they can make the maximum impact on the scien>fic community. My post-‐docs will have ample opportuni>es to develop the skills that will serve them as a principal inves>gator, including mentoring, wri>ng grants, giving talks, publishing papers and leading projects to frui>on. Most of all, I expect post-‐docs in my lab to tell me what I can do to be a beXer PI.


hDp://tyelab.org/philosophy/ Expecta&ons of Kay

•  You can expect me to help you to envision, implement and communicate/publish your stories, and cul>vate your career development, whatever your goals may be. You can expect me to make sure that the lab has funding and that you get whatever you need to test your hypothesis.

•  You can be sure I will work hard to help you prepare for all your personal milestones, be they job talks, qualifying exams, or grad school interviews. You can expect me to nominate you for awards and support your travel to conferences. You can expect me to meet success with celebra>on and failure with moral support, and always keep it real.

•  You can count on me to care about your happiness, your project, and your future.


Mentoring and CollaboraAon B. Alberts, Editor-‐in-‐Chief of Science ,13 November 2009 “On Becoming a Scien>st”

¨  The Importance of Mentoring ¡  Pick a Mentor with high scien>fic and ethical standards

¨  Teaching students how to do research

¡  How to iden>fy important scien>fic problems ¡  How to think cri>cally

¡  How to design effec>ve research strategies

¨  Cri>quing and suppor>ng student’s research –teaching ¨  Training students about research ethics ¨  Promo>ng their student’s careers ¨  Helping students in their personal lives


The Mentor-‐Student RelaAonship • One part is highly vulnerable • Doctor-‐pa>ent rela>onship •  Lawyer-‐client rela>onship

•  Fiduciary rela>onships: powerful party is entrusted with protec>ng the interests of the vulnerable party

• Du>es of powerful party: beneficence, nonmaleficence, confiden>ality, respect, and jus>ce


How mentors may abuse students Responsible Conduct of Research, Shamoo and Resnik, 2 ed.

• Giving students misinforma>on or poor advice. •  In>mida>ng and harassing students • Discrimina>ng against students •  Showing favori>sm to one or more students • Not recognizing when students are having psychological troubles that require counseling


To improve mentoring, NIH 2000

• Reward mentors for effec>ve mentoring • Provide mentors with enough mentoring >me •  Ensuring that student “whistle blowers” are protected

• Promote a psychologically safe and nondiscriminatory work environment

• Promote a diverse work force in research •  Ethical leadership


CollaboraAon: who can be held accountable? •  Robert Lee Hotz, The Wall Street Journal, November 30, 2009

•  Collabora>on at the Large Hadron Collider (LHC) •  2,900 authors listed in recent LHC status report •  38 countries collaborate in the research •  100,000 computers used to process the data •  150 universi>es are involved in the project •  15 million Gibabytes of informa>on produced annually


Research CollaboraAon •  Extent: >me, effort, money • Roles and responsibili>es •  Funding • Conflicts of interest • Resource sharing • Dissemina>on of results • Deadlines • Authorship • Ownership of data and data access



• Defini>ons, Concepts, Prac>ces and Case Studies • Mentoring and Collabora>on •  Scien>fic communica>on: to publish and disseminate results

• Authorship: Who? Why? Author’s Responsibility • Data Fidelity •  Scien>fic Misconduct • Plagiarism: what it is and how to prevent it



• Peer Review • Conflicts of interest (COIs) •  Intellectual Property: Copyright and Patents • Ownership and Control of Data, Open-‐Access Publica>ons

• Animal and Human Studies • Gene>cs, Cloning, and Stem Cell Research •  Interna>onal Research • University and Industry


Sources of Ethical Behavior

• Norms • Principles • Guidelines • Policies

•  Legal considera>ons


Ethical Principles

¨ Autonomy ¨ Nonmaleficence ¨ Beneficence ¨ Jus>ce

¨ REF. Beauchamp and Childress, Principles of Biomedical Ethics, Fijh Ed. New York, Oxford University Press, 2001


Fraud, FabricaAon, and FalsificaAon • Honesty and Trust in Science

• Misconduct involves inten>onal decep>on

• An error may cons>tute negligence; not misconduct


DefiniAon of ScienAfic Misconduct, Research Misconduct

¨ Fabrica>on, Falsifica>on, or Plagiarism in proposing, performing, or reviewing research, or in repor>ng research: all are unethical and illegal in USA

¨ Fabrica>on: making up data or results and recording or repor>ng them

¨ Falsifica>on: Manipula>ng research materials, equipment, or processes, or changing or omi`ng data or results such that the research is not accurately represented in the research record


Research Misconduct

¨ Errors or difference of opinion is not research misconduct

¨ A Finding of Research Misconduct requires that:

¡  There exist a significant departure from accepted prac>ces of the research community

¡  The misconduct is commiXed inten>onally, or knowingly, or recklessly

¡  The allega>on be proven by a preponderance of evidence


MisrepresentaAon •  Fabrica>on

•  Falsifica>on

• Omission


MisappropriaAon

• Plagiarism

• Breaches of Confiden>ality


ManipulaAon of Digital Images

• Any change in the digital image that results in a change in how the image is interpreted or that selec>vely reports, omits, or obscures important data is considered scien>fic misconduct

• Authors should indicate any changes or enhancements made to digital images in the legend of each figure


Cases of Alleged Misconduct in Biomedical Research •  William Summerlin, 1974 Fabrica>on Admission of Guilt

•  John Darsee, 1981 Fabrica>on Fabrica>on found

•  Eric Poehlman, 1995-‐2005 Falsifica>on Admission of Guilt

In jail

•  Woo Suk Hwang, 2005 Fabrica>on Fabrica>on found

Convicted, two years

In jail, suspended sentence


How Science is harmed •  “The physicist Jan Hendrik Schön, who faked the discovery of a new superconductor at the world famous Bell Laboratories. Many of the world’s top scien>fic journals and experts, including Nobel Prize-‐Winners, supported Schön, only to learn that they were the vic>ms of the biggest fraud in science.” From the publisher.

•  Publisher: Palgrave Macmillan Trade; 1st edi>on

2010 ISBN-‐13: 978-‐0230623842

Jan Hendrik Schön, at Bell Labs, faked data in at least

17 publica>ons, he published a paper every 8 days, Published in Science, Nature, Physical Review LeQers


The Impact of ScienAfic Misconduct on the Progress of Science

• Other scien>sts may be mislead by publica>ons, wasted work

• Wasted funding

• Wasted >me of editors, peer-‐reviewers

•  Loss of trust by the Public in the process of Science


•  Scien>fic Communica>on

• Authorship

• Plagiarism

• Peer Review

• Research Misconduct


Authorship

¨ Concept of Contributors (Rennie, JAMA 1997)

¨ Authorship and Accountability

¨ Criteria for Authorship (all three criteria) ¡  Concep>on and design, or acquisi>on of data, or analysis and interpreta>on of the data

¡  Drajing the manuscript or revising it cri>cally for important intellectual content

¡  Have read and reviewed and approved the manuscript


Research 59

Authorship •  First author has contributed most to the work •  Order of Authorship; Author # and Author # contributed equally

•  Guest and Ghost Authors •  Devalues the meaning of authorship Acknowledging support, assistance, and non-‐authors; financial support, grant support, material support, wri>ng assistance, editorial assistance, sta>s>cal assistance, technical assistance…

Author’s Conflicts of Interests and Financial Disclosures


Authorship • Duplicate Publica>on

•  Duplicate , repe>>ve, redundant, related, parallel, fragmented publica>ons is not necessarily unethical

•  Failure to disclose the existence of duplicate ar>cles, manuscripts or other related materials to the editors and the readers (covert duplica>on) is unethical and may represent a viola>on of copyright law

• Duplicate Submission


Plagiarism

•  From the La>n work plagiarius, kidnapper • A moral and ethical offense • Plagiarism can become a legal issue when there is copyright infringement

• Copyright infringement is a legal offense •  Copyright infringement is a legal offense—even when the violator acknowledges the source!


Plagiarism

• Plagiarism: The appropria>on of another person’s ideas, processes, results, or words without giving appropriate credit

Resnik, Chapter 72, The Oxford Textbook of Clinical Research Ethics, Eds. E. J. Emanuel, et al., New York, Oxford University Press (2009)


Plagiarism

• Plagiarism is wrongfully represen>ng someone else’s ideas, words, images, inven>ons, or other crea>ve works as one’s own

•  Self-‐Plagiarism •  “Cita>on Amnesia”

•  The impact of plagiarism on the process of science


ScienAfic CommunicaAon

•  Ethical Obliga>ons of Authors

•  Ethical Obliga>ons of Editors of Scien>fic Journals

•  Ethical Obliga>ons of Reviewers of Manuscripts


Ethical ObligaAons of Authors

•  To present accurate account of research and objec>ve account of its significance

• Contain sufficient detail to permit peers to repeat the work

• Cite closely related works; cite publica>on of earlier works

• Avoid fragmenta>on of research reports • Coauthors have made significant contribu>ons • Reveal poten>al conflicts of interest


Requirements of Authors

• Authors should disclose all relevant conflicts of interest in the work at the >me of manuscript submission

• Repor>ng Funding and other support • Repor>ng the Role of the Sponsor • Access to Data Requirement


Ethical ObligaAons of Editors of ScienAfic Journals

• Give unbiased considera>on to all manuscripts • Responsibility to accept or to reject rests with the editor

• Note conflicts of interest between authors and the editor


Ethical ObligaAons of Reviewers of Manuscripts •  Every scien>st has an obliga>on to review

• Beware of conflicts of interest • Manuscript is a confiden>al document • Reviewer should explain and support all judgments • Reviewer should note failure of authors to cite relevant works by other scien>sts

• A reviewer should act promptly • Personal cri>cism of author is not appropriate



• Peer Review • Conflicts of interest (COIs) •  Intellectual Property: Copyright and Patents • Ownership and Control of Data, Open-‐Access Publica>ons

• Animal and Human Studies • Gene>cs, Cloning, and Stem Cell Research •  Interna>onal Research • University and Industry


Peer Review

¨  Confiden>al informa>on

¨  Government contracts and Grants ¨  Journals ¨  Promo>on and Tenure

¨  Problems with Peer Review… ¡  Bias and Lack of Reliability, Conflicts of Interest ¡  Fairness ¡  Peer review fails to stop publica>on of many papers with fabricated, falsified, or erroneous data


Ethical DuAes in Peer Review

• Confiden>ality • Respect for Intellectual Property • Addressing Conflicts of Interest • Punctuality

•  “Reviewers should conduct, thorough, cri>cal, and responsible reviews of papers and proposals” Shamoo and Resnik, Responsible Conduct of Research, second edi>on, 2009


Peer Review QuesAons •  Are the methods clearly and adequately described and referenced? •  Can others reproduce the experimental sec>on? •  Are the conclusions supported by the data? •  Is there anything that is unclear, confusing or ambiguous? •  Do the figures and the tables illustrate the data? •  Is the organiza>on of the paper logical? •  Does the introduc>on cite prior works? •  Are the appropriate references cited and are they accurate? •  Are symbols in the equa>ons defined? •  Is the data analysis correct? •  Are the sta>s>cal methods appropriate? •  Are there conflicts of interest? •  How Can I Improve the Manuscript?


Conflicts of Interest (COI)

• A COI occurs when a person’s objec>vity is poten>ally compromised by a desire for prominence, professional advancement, financial gain, or a successful outcome

•  Journals require authors to disclose all relevant conflicts of interest


Financial Interests

•  Employment • Consultancies •  Stock ownership • Honoraria •  Expert tes>mony royal>es • Patents (filed, pending, or registered) • Grants • Material or financial support from industry, government or private agencies


Nonfinancial Interests

• Personal or professional rela>onships • Affilia>ons • Knowledge or beliefs that may affect objec>vity

•  Journals require disclosure of financial interest from everyone including authors, reviewers, editorial board members, and editors (example JAMA)


Requirements of Peer Reviewers

• Reviewers should disclose conflicts of interest in reviewing specific manuscripts

• Reviewers should disqualify themselves from a specific review if necessary

• Authors may provide a list of names that should not be included in the list of peer reviewers

•  Objec>ve reasons must be provided for the exclusion of specific poten>al peer reviewers


Intellectual Property • Copyrights • Patents •  Trademarks

•  Renewable indefinitely for 10-‐year periods •  Trade Secrets


Copyright ¨  Copyright (Title 17, U.S. Code) federal law, protects original works of

authorship, fixed in a tangible medium of expression, for a specific >me period (life>me of author plus 70 years)

¨  U. S. Copyright Office, hXp://www.copyright.gov/

¨  Work must be “fixed,” in “tangible” form, not transitory

¨  Registra>on is not prerequisite to legal protec>on; work is protected even with out formal copyright no>ce

¨  Copyright protects the expression; the work must not have been copied, consciously or unconsciously from other sources

¨  Moral right against mu>la>on and misaXribu>on

¨  Published work can have trademark protec>on of >tle ¨  Work created ajer 1977-‐”Life plus seventy”

¨  Copyright does not protect: ideas, thoughts, not wriXen down, >tles (trademarks), methods and devices (patents) or works in the public domain; data, facts news


Copyright

•  Fair Use—limita>ons on rights granted to copyright holder

•  Scholarship of research-‐private researchers and nonprofit employees can make one copy of work for their own research purposes only

• Cri>cism or comment; news repor>ng •  Teaching only if spontaneous situa>on (but permission must be obtained if one knows in advance the copyrighted material will be used in class)


Copyright

¨  Fair use is only a defense; do not assume a use is a fair use; seek permission

¨  Publishers require transfer of copyright ownership as part of agreement between publisher and authors

¨  Informa>on on the Internet ¡  Someone owns the copyright to material on the Web site

¡  It is necessary to obtain permission to reuse it ¡  Lack of a copyright no>ce does not mean work is not protected


Infringement of Copyright

¨ Unauthorized use of copyrighted materials; it is illegal with either civil remedies or criminal prosecu>ons and court ac>on (fines and/or imprisonment)

¨ Photocopying too much of a book or ar>cle ¨ Selling copy ¨ Making copies for sale or rent ¨ Exhibi>ng a work in public ¨  Impor>ng illegal copies of a book for sale or rent


Patents

¨ Patent from L. patere, “to lay open” ¨ A State grants exclusive rights to an inventor for

a limited >me period in exchange for a public disclosure of an inven>on

¨ A limited property right ¨ Enforcement, ac>on of patent infringement in a

U.S. Federal Court ¨ Failure to disclose prior art ¨ Cases, IntermiXent windshield wiper, gas laser,

Polaroid versus Kodak, BioRad versus Zeiss


Patents

¨  Product of human ingenuity ¡  Diamond v Chakrabarty (1980) U.S. Supreme Court ruling the human inven>on is “anything under the sun made by man”

¡  Laws of nature, naturally occurring species are products of nature and cannot be patented

¨  Novelty ¡  Inven>on must be new or innova>ve, not previously patented or disclosed in prior art

¨  U>lity, in US law. Europe: does not consider u>lity, but patent must have industrial applicability

¨  Inven>on and Non-‐obviousness


Patents

¨ Nonobviousness ¡  Not obvious to a person trained in the field

¨ Usefulness ¡  DNA sequence is not useful, must give specific uses of data in drug development, diagnos>cs, bioengineering

¨ Enabling descrip>on ¡  Reduce inven>on to prac>ce, supply enough detail that a person trained in the field can make and use the inven>on


Patents

¨ United States Patent and Trademark Office ¡  hXp://www.uspto.gov/ ¡  A patent for an inven>on is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office. Generally, the term of a new patent is 20 years from the date on which the applica>on for the patent was filed in the United States or, in special cases, from the date an earlier related applica>on was filed, subject to the payment of maintenance fees. U.S. patent grants are effec>ve only within the United States, U.S. territories, and U.S. possessions. Under certain circumstances, patent term extensions or adjustments may be available.


Patents

¨  As with copyrights there is no interna>onal patent law or protec>on

¨  Individual countries issue patents and protec>ons; different laws and conven>ons

¨  Requirements for a patent applica>on ¨  Controversies: patents on biological materials, living cells,

gene>c sequences, stem cells, computer programs, business models and methods


Ownership and Control of Data, Open-‐Access PublicaAons • Methods to assure quality, objec>vity, integrity of research data

•  Good research prac>ces •  Standard opera>ng procedures •  Peer Review •  Data audit •  Literature Search

• Recording of laboratory data •  Bound, laboratory data notebook, pages numbered


Good Research PracAces

•  Fidelity in data recording, laboratory notebook • A paper trail exists documen>ng the origin of the data

•  The published procedures are sufficiently clear and give sufficient details so others can reproduce the data following the published procedures

•  The conclusions in the published research are consistent with the data


DisseminaAon and Sharing of Data

• Openness is a fundamental part of research and scholarship

• NIH encourage or require funded researchers to share reagents and model organisms

• Plans to share data are part of grant proposals •  Some journals, i.e. Science, require before publica>on that large data sets be sent to journal Web sites for data and suppor>ng materials.


Refuse to Share Data

• Protec>on of intellectual property claims • Ajer publica>on; an obliga>on to share • Protec>on of confiden>al informa>on on human subjects


Animal Studies

•  In U.S. all animal research covered by the 1966 animal welfare Act (AWA) revised 1970, 1976, 1985, 1996

•  In U.S. vertebrate animal research funded by PHS is covered by U.S. Public Health Service Policy on the Humane Care and Use of Laboratory Animals.

• Professional Socie>es and Research Ins>tu>ons have guidelines for humane care and use of animals in research


Research 92

ProtecAon of Human Subjects in Research • What is wrong here?

•  The Nazi Medical Experiments •  The Imperial Japanese Experiments in China •  The Hepa>>s Experiments at the Willowbrook State School

•  The Tuskegee Syphilis Experiment •  USPHS Physicians inducing Syphilis in Guatemala, 1946-‐1848

•  The Gelsinger Case (University of Pennsylvania)


•  The The Tuskegee Syphilis Experiment Experiment

Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (The John Hope Franklin Series in African American History and Culture) by Susan M. Reverby (2009), 978-‐0807833100 •  Susan M. Reverby is the Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley


How United States Public Health Service Physicians experimented on prisoners in a naAonal penitenAary, inmates in a mental hospital, children in the naAonal orphanage, and soldiers in a barracks in the capital.

•  "Normal Exposure" and Inocula>on Syphilis: A PHS "Tuskegee" Doctor in Guatemala, 1946-‐1948

•  Susan M. Riverby •  Journal of Policy History Volume 23, Number 1, 2011 pp. 6-‐28


Informed Consent

• Consent should be informed, voluntary, comprehending, and jus>fied

• WriXen informed consent • AMA Code of Ethics, 1980 revision-‐physician’s obliga>on to respect pa>ents’ rights

• Confiden>ality


Elements of Informed Consent

• Consent must be informed, voluntary, and given by a competent person-‐no

• Competent-‐capaci>es for understand and communica>on

• Pa>ent can choose to leave the study at any >me


DecepAon in Clinical Research

• Decep>on occurs when communica>on is expected to results in par>cipants developing false beliefs

• Decep>on occurs when inves>gators provide false informa>on to par>cipants

• Decep>on occurs when per>nent informa>on is withheld from par>cipants

• Decep>on conflicts with ethical norms of clinical research

•  “Ethical Principles of Psychologists” APA


ParAcipant SelecAon and Special PopulaAons • Woman •  Ethnic and Minority Popula>ons •  Economically Disadvantaged Popula>ons • Children • Cap>ves: Prisoners, Students, and Soldiers


InsAtuAonal Review Boards

• Government Agencies-‐accepted Common Rule for IRB

• Na>onal Ins>tutes of Health-‐14 IRBs • Academic Ins>tu>ons-‐IRBs • Protec>on of Research Par>cipants

•  Informed Consent •  Risks and Poten>al Benefits •  Selec>on of Research Par>cipants •  Regulatory Compliance •  Problems with IRBs


Codes, DeclaraAons, other Ethical Guidance •  The Nuremberg Code •  The Declara>on of Helsinki •  The Belmont Report •  The Common Rule •  The Council of Europe • Na>onal Bioethics Commissions


GeneAcs, Cloning, and Stem Cell Research ¨  Respect for ethics, values, morals of individual

researchers ¨  Federal laws ¨  Federally funded grants ¨  Privately funded grants ¨  Different laws in different countries

¨  Andrews, LB, Mehlman, MJ, Rothstein, MA Gene>cs: Ethics, Law and Policy, second edi>on, St.

Paul, Thompson/West (2006)


MulAnaAonal Research • Benefits to Host Countries •  Standards of Care in Mul>na>onal Research • Responsiveness to Host Community Health Care Needs


University and Industry • Bayh-‐Dole Act of 1980 (35 USC 200), amended by the Technology Transfer Act of 1986 (Public Law 99-‐502)

•  Individuals and companies can commercialize research that was developed with government funds.

• University technology transfer office


University-‐Industrial RelaAons

Goals of the University should not be compromised

•  Research and the genera>on of knowledge •  Teaching and Mentoring Students •  Social Responsibility Analysis of Risks and Benefits


Documents

Responsible*Conduct*of*Researchcisb.mit.edu/wp-content/uploads/2014/08/2016MIT-RCR-by... · 2016-05-02 · SocialConsciousnessSculpture*at*the*Museumof*Art* inPhiladelphia,PennsylvaniabyJacob

ResponsibleConductofResearchcisb.mit.edu/wp-content/uploads/2014/08/2016MIT-RCR-by... · 2016-05-02 · SocialConsciousnessSculptureattheMuseumofArt inPhiladelphia,PennsylvaniabyJacob