第十四屆物理新進人員及研究推動研討會 (10/17/14)

What is “Responsible Conduct of Research (RCR)”? 什麼是「負責任的研究行為」？ Ye-Hwa Chen School of Mechanical Engineering Georgia Institute of Technology

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

Albert Einstein

“Setting an example is not the main means of influencing another; it is the only means.”

Albert Einstein

Historical Background and Government Policy

NSF and Research Misconduct* •

The Office of Inspector General… “has seen a dramatic increase in substantive allegations of plagiarism and data fabrication, especially with respect to junior faculty members and graduate students. Over the past 10 years, the number of allegations received by our office has more than tripled, as has the number of findings of research misconduct NSF has made based on OIG investigation reports.”

•

"Since 2003, our investigations have resulted in 120 findings of research misconduct, more than 80 percent of which found plagiarism.“

•

"Extrapolating the number of allegations OIG has received across the 45,000 proposals NSF receives annually, suggests 1300 proposals could contain plagiarism and 450-900 proposals could contain problematic data.“ * Source: Statement of Allison C. Lerner, Inspector General, National Science Foundation, Committee on Science, Space, and Technology Subcommittee on Investigations and Oversight United States House of Representatives "Top Challenges for Science Agencies: Reports from the Inspectors General - Part 1”, February 28, 2013, http://www.nsf.gov/oig/2-28_testimony.pdf (last visited March 18, 2013).

Retractions “In the early 2000s, only about 30 retraction notices appeared annually. This year, the Web of Science is on track to index more than 400…even though the total number of papers published has risen by only 44% over the past decade.”

Source: Richard Van Noorden, Science publishing: The trouble with retractions, Nature 478, 26-28, October 5, 2011, http://www.nature.com/news/2011/111005/full/478026a.html (last visited Dec. 6, 2013).

Definition Responsible Conduct of Research (RCR) is defined by NIH “...as the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.”

Characteristics of RCR • Based on professional norms (academic society, journal, funding agency, etc.) • Based on ethical principles (utilitarianism, deontology, virtual ethics, etc.) • RCR is not about law • RCR is not hard science

NSF RCR Policy (excerpt) “Effective January 4, 2010, NSF will require that, at the time of proposal submission to NSF, a proposing institution's Authorized Organizational Representative certify that the institution has a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research.”

Source: National Science Foundation, Responsible Conduct of Research, Federal Register, Volume 74, Number 160, August 20, 2009.

NIH RCR Policy (excerpt) “While on-line courses can be a valuable supplement to instruction in responsible conduct of research, online instruction is not considered adequate as the sole means of instruction. A plan that employs only online coursework for instruction in responsible conduct of research will not be considered acceptable...”

Source: National Institutes of Health, Update on the Requirement for Instruction in the Responsible Conduct of Research, November 24, 2009 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html (last visited August 5, 2013).

GT RCR Academic Policy • All doctoral students admitted Fall 2011 or later are required to complete RCR training. • Two components: – (1) an online CITI RCR course; students who need to complete the requirement for RCR online training can refer to: http://www.rcr.gatech.edu/online-training/ (be sure to use your GT email address and nine digit GTID number)

and – (2) in-person training through this class (PHIL 6000) or through an institutionapproved “in-house” approach

GT RCR Compliance Policy “…students who participate in Georgia Tech’s President’s Undergraduate Research Award Program (PURA) and students or trainees receiving research funds or who participate in research activities funded by certain types of NIH or the National Science Foundation (NSF) awards…shall engage in a program of study in the Responsible Conduct of Research.”

Source: GT Office of Research Integrity Assurance, Responsible Conduct of Research, http://www.osp.gatech.edu/forms/GT_RCR.pdf (last visited Nov. 8, 2013).

GT Ombuds Programs •

• •

• •

The Ombuds Program — a confidential, neutral, informal, and independent conflict resolution and management resource — is available to assist any member of the Georgia Institute of Technology community seeking assistance. The Office of the Provost is home to the ombuds serving faculty and graduate students; the Office of Human Resources manages the program for classified staff. This program's practices and procedures are guided by the Standards of Practice and Code of Ethics (pdf) established by the International Ombudsman Association (IOA). Prohibition of Retaliation Attempts to intimidate or retaliate against a person for utilizing the Georgia Tech Ombudsman Program is contrary to the program's purpose and is unacceptable. Persons who make such attempts will be subject to disciplinary action.

GT Ethics Point https://secure.ethicspoint.com/domain/media/en/gui/7508/index.html

• Georgia Tech partners with EthicsPoint, Inc. • Confidentially and anonymously report issues of concern to management. • Allows greater flexibility to set up anonymous communications and feedback. • Solicit questions, comments, and feedback.

RCR Core Topic Areas* • • • • • • • • • • •

Animal Subjects Research Authorship and Publication Collaborative Research Conflicts of Interest and Commitment Data Collection, Management, Ownership, and Sharing Human Subjects Research Laboratory Safety Peer Review Research Misconduct Responsibilities of Mentors and Trainees Science and Engineering in Society *Derived from NIH (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html).

Other Important Topics • “Dual Use” • Export Control

Research Misconduct

Major Forms of Research Misconduct 1. Plagiarism 2. Fabrication 3. Falsification

Major Forms of Research Misconduct 1. Plagiarism… “Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.”

Source: Office of Science and Technology Policy, Federal Policy on Research Misconduct, http://ori.hhs.gov/federal-researchmisconduct-policy (last visited August 5, 2013).

From IEEE • IEEE has policies and procedures for addressing the issue when plagiarism appears in its journals. • Delineates five main levels of plagiarism. • http://www.ieee.org/publications_standards/publications/rights/plagiaris m_FAQ.html (last visited August 5, 2013)

The Five Levels of Plagiarism • •

•

•

• •

1. Uncredited verbatim copying of a full paper. Results in a violation notice in the later article’s bibliographic record and a suspension of the offender’s IEEE publication privileges for up to five years. 2. Uncredited verbatim copying of a large portion (up to half) of a paper. Results in a violation notice in the later article’s bibliographic record and a suspension of publication privileges for up to five years. 3. Uncredited verbatim copying of individual elements such as sentences, paragraphs, or illustrations. May result in a violation notice in the later article’s bibliographic record. In addition, a written apology must be submitted to the original creator to avoid suspension of publication privileges for up to three years. 4. Uncredited improper paraphrasing of pages or paragraphs (by changing a few words or phrases or rearranging the original sentence order). Calls for a written apology to avoid suspension of publication privileges and a possible violation notice in the later article’s bibliographic record. 5. Credited verbatim copying of a major portion of a paper without clear delineation of who did or wrote what. Requires a written apology, and to avoid suspension, the document must be corrected. The guidelines also make recommendations for dealing with repeated offenses.

Major Forms of Research Misconduct 2. Fabrication… “Fabrication is making up data or results and recording or reporting them.”

Source: Office of Science and Technology Policy, Federal Policy on Research Misconduct, http://ori.hhs.gov/federal-researchmisconduct-policy (last visited August 5, 2013).

Major Forms of Research Misconduct 3. Falsification… “Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.” Source: Office of Science and Technology Policy, Federal Policy on Research Misconduct, http://ori.hhs.gov/federal-researchmisconduct-policy (last visited August 5, 2013).

What Research Misconduct Is Not • Example 1: Simply illegal, improper or unacceptable behavior • Example 2: Honest error • Example 3: Disagreement based on honest differences of opinion • Example 4: Simply authorship disputes • Example 5: Arguably unethical behavior • Example 6: Sloppy science

Questionable Research Practices* • For example… – Altering digital images (http://www.uab.edu/researchintegrityandimages /default.html) – Insufficient supervision – Refusing to share information – Sloppy recordkeeping – Stopping research prematurely (not collecting enough data points) * The term is from National Research Council. (1992). Responsible Science, Volume I: Ensuring the Integrity of the Research Process. Washington, DC: The National Academies Press, http://www.nap.edu/catalog.php?record_id=1864 (last visited Dec. 2, 2013).

Why Do Researchers Commit Misconduct?

Some theories… • • • • •

Career pressure First to publish Concern about losing a grant Desire to graduate Did not understand professional norms and ethical guidelines • Believe that they are not being treated fairly • Self-deception • Others?

Case Studies (yes, these are true stories)

Yoshitaka Fujii (藤井善隆), PhD • Associate professor in anesthesiology, Toho University, Japan • Fabricated data in 172 papers, all retracted • Committee report: "It is as if someone sat at a desk and wrote a novel about a research idea." • Dismissed from faculty post (Feb. 2012) • Also see Nature article “Retraction record rocks community” (9/19/12)

Hwang Woo-suk (黃禹錫), PhD • Professor of theriogenology and biotechnology, Seoul National University • Fabricated data in 2004 and 2005 papers • Dismissed from faculty post (March 2006) • Convicted of embezzlement, bioethical violations • 18 months suspended prison sentence • Also see NY Times article “Disgraced Cloning Expert Convicted in South Korea” (10/27/09)

David Baltimore, PhD • Professor of MIT, Nobel Prize in Physiology and Medicine (1975) • Imanishi-Kari case (1986-1996) • 19 counts of research misconduct but exonerated • Cell paper retracted; resigned as president of Rockefeller University • Publicly apologized for not taking a whistle-blower's charge seriously • Also see book “The Baltimore Case” (Daniel Kevles, 1998)

Jan Hendrik Schön, PhD • Researcher in condensed matter physics, nanotechnology, Bell Laboratory • 16 counts of research misconduct (1998-2014) • At least 28 papers retracted (Science, Nature, Applied Physics Letters, Physical Review) • Termination from Bell Lab, doctoral degree revoked • “…biggest fraud in physics in the last 50 years“, "credibility of science had been brought into disrepute". • Also see NY Times article “Phony Science” (10/13/02)

Victor Ninov, PhD • Researcher in nuclear chemistry at Lawrence Berkeley National Laboratory • Elements 116 and 118 • Research misconduct, paper in Physical Review Letters retracted • Termination from LBNL • Also see NY Times article “At Lawrence Berkeley, Physicists Say a Colleague Took Them for a Ride” (10/15/02)

Elizabeth Goodwin, PhD • Associate professor of genetics and medical genetics, University of Wisconsin, Madison • Falsified data in federally funded research grant proposals and in published papers. • Resigned from faculty post (Feb. 2006) • Two years in probation; $100,500.00 fine and restitution.

Elizabeth Goodwin, PhD • After making the difficult decision to turn in their advisor for scientific misconduct, a group of graduate students is trying to recover from the resulting damage to their careers. • The university handled the case by the book. • Three of the students, who had invested a combined 16 years in obtaining their PhD’s, have quit school. Two others are starting over, one moving to a lab at the University of Colorado. • The five graduate students who spoke with Science also described discouraging encounters with other faculty members, whom they say sided with Goodwin before all the facts became available. •sciencemag.org/cgi/content/full/313/5791/1222 (last visited: 9/28/14)

Authorship

Breaking of Symmetry

The Importance of Authorship • Credit • Accountability

Some Considerations for Determining Whether Authorship is Warranted • Did the person have a key role in defining the research problem? • Did the person assist with determining the procedure or method used for the project? • Was the person involved in multiple parts of the project (recruiting subjects, analyzing data, drafting the manuscript, etc.) ? • In short, did the person offer a significant intellectual contribution (something that is not easily replaced and the project would likely have been different without that person) ?

Guidance from IEEE “The IEEE affirms that authorship credit must be reserved for individuals who have met each of the following conditions: a. Made a significant intellectual contribution to the theoretical development, system or experimental design, prototype development, and/or the analysis and interpretation of data associated with the work contained in the manuscript; b. Contributed to drafting the article or reviewing and/or revising it for intellectual content; and c. Approved the final version of the manuscript as accepted for publication, including references.” Source: IEEE PSPB Operations Manual, 2013, http://www.ieee.org/documents/ops_manual.pdf (last visited August 5, 2013).

No Basis for Authorship • • • •

Acquisition of funding Routine collection of data General supervision of research group Providing technical advice, samples, or patient data • Commenting on the draft

Acknowledgements • Contributors who do not meet criteria for authorship should be listed in acknowledgements section (if permitted) – Person providing technical help – Person providing writing assistance – Department Chair who provided only general support

• Readers may infer endorsement of the data and conclusions – all persons should give written permission to be acknowledged

References Brain: A Journal of Neurology • Original paper: limited to 30 refs. • Limited to essential literature • “In preparation” or “submitted” not acceptable • “In press”: the name of the journal or book must be given • Should not include “personal communications” or other inaccessible information

Author Category • First author •

Performs bulk of the technical work .

• Senior author •

• •

Takes responsibility for the scientific accuracy, valid methodology, analysis, and conclusions. Able to explain all of the results. Directs, oversees, and guarantees the authenticity of the work.

• Corresponding author • • •

Typically assumed by the first or senior author. Able to explain all of the results. Communicates with editors and readers. Ensures that all authors are aware of and approve the submission of the manuscript, its content, authorship, and order of authorship.

• Middle/contributing author • •

Contributions do not rise to those of first or senior author. Order of these authors should reflect their relative contributions.

Guidance from AIP “The author who submits the paper for publication should ensure that all appropriate coauthors and no inappropriate coauthors are included on the paper, and that all coauthors have seen the final version of the paper and have agreed to its submission for publication…Any individual unwilling or unable to accept appropriate responsibility for a paper should not be a coauthor.”

Source: American Institute of Physics, Statement of ethics and responsibilities of authors submitting to AIP Journals, June 2012, http://www.aip.org/pubservs/ethics.html (last visited August 5, 2013).

Authorship Order • By order of significance of contributions • Senior author last, the rest by order of significance of contributions • Alphabetical order

How to Avoid Authorship Disputes • Discuss expectations early on in the project • Accept an individual’s request not to be an author • Refer to professional society’s ethical code • Check specific journal requirements

Practices to Avoid • • • • • • •

Coercion authorship Denial of authorship Duplication authorship Gift or guest authorship Ghost authorship Mutual support authorship “Salami” publication (aka the “least publishable unit”)

From Nature “If part of a contribution that an author wishes to submit to a Nature journal has appeared or will appear elsewhere, the author must specify the details in the covering letter accompanying the Nature submission... If an author of a submission is re-using a figure or figures published elsewhere, or that is copyrighted, the author must provide documentation that the previous publisher or copyright holder has given permission for the figure to be re-published.” Source: Nature Publishing Group, Nature journals' policy on duplicate publication, http://www.nature.com/authors/policies/duplicate.html (last visited August 5, 2013).

From Science “We will not consider any paper or component of a paper that has been published or is under consideration for publication elsewhere. Distribution on the Internet may be considered prior publication and may compromise the originality of the paper or submission.”

Source: AAAS, For Authors: General Policies, http://www.sciencemag.org/site/help/authors/policies.xhtml (last visited August 5, 2013).

Other Important RCR Topics

Data Management • • • •

Data acquisition Data storage and protection Data analyses and interpretation Data ownership (funding agencies, research institutions/ data sources) • Data sharing • Granting agency policy on data

Mentoring and Collaborative Research • • • • 1. 2. 3. 4. 5.

Responsibilities of advisors and mentors Responsibilities of trainees Managing conflicts or disagreements Associated issues with collaborations Increasing number of individuals involved Differing goals Authorship priority Ownership of IP Different terminology and expertise

Peer Review • Responsibility • Assess project for quality • Make judgment regarding importance of research being proposed • Responsible conduct • Timely review • Constructive feedback • Free from personal bias • Maintain confidentiality

Conflict of Interest • Financial conflict of interest • GT conflict of interest policy http://www.policylibrary.gatech.edu/5.6-conflict-interest-and-outside-professional-activity-policy

• Sponsor reporting requirements • Government policy • NIH: $5,000 or more • NSF: $10,000 or more • Conflict of commitment • Relationships with individuals or entities • Use of resources • Honor time commitments that are made

Human Subjects Research • Is it HSR: • Could your work pose risks to the humans involved? • Could the work reveal personal information? • Are you gathering information about the participants’ personal opinions or behaviors? • Ethical principle: Respect for Persons / Autonomy, Beneficence, Justice, Non-maleficence

• Valid (informed) consent form

Animal Subjects Research • Benefit/pain calculus • How will the animals be housed? • Are the animals being euthanized in the most humane manner possible? • Have similar studies been performed before? If so, is this particular type of research necessary? • Replacement: is there an alternative way in which to gather the data? Is a computer simulation possible? • Refinement: is the least developed organism possible being used? • Reduction: are the fewest number of animals needed being used?

Export Control • Controls • Commerce Department’s dual use controls • Hardware, software, materials, equipment, technology & technological data that have civilian AND inherent military or defense application • State Department’s defense-based controls • Defense articles and activities specifically designed or modified for defense or military application without a civil equivalent • Treasury Department’s economic embargo controls • Restrict transactions with certain countries • Cuba, Iran, Syria & Sudan restricted for our purposes • Requirements • Prior authorization or license may be required • Exceptions for fundamental research activities • No publication or citizenship restrictions accepted by any sponsor

Dual Use • Good science can be put to bad uses: “…the same technologies can be used legitimately for human betterment and misused for bioterrorism.” (Report of the National Research Council of the National Academies, 2004)

• Roles and responsibilities of researchers: 1. Most critical element in oversight system 2. Be aware of DUR issues and assess work for DURC potential on ongoing basis 3. Consider implications of their work 4. Understand local and federal policies for DUR oversight 5. Ensure training of self and research staff 6. Communicate DURC in a responsible manner 7. Annually attest to assessing their work for DURC potential

Science and Engineering in Society • • • • • • •

Distribution of scarce resources and justice “Dual Use” Environmental impacts Privacy considerations Public safety Risk communication Workplace exposure

In Retrospect • Obligations go beyond recording data accurately and citing sources completely • Maintained throughout one’s career (Baltimore’s case) • Many pressures face researchers regularly but RCR should be maintained • It takes a village to maintain RCR mind and practices (authors, peer reviewers, mentors, advisors, administrators, university, society, government, etc.)

scholar

Thank you!