Responsible Conduct of Research RCR Farida Lada University

Responsible Conduct of Research (RCR) Farida Lada University Director for Research Compliance March 22, 2016 http: //www. cuny. edu/research/compliance. html 1

Overview Rules • Federal regulations & State laws • Sponsor requirements • Institutional policies & procedures Ethics & Good Practice • International, national and institutional standards • Standards of relevant research community 2

Image borrowed from: http: //undsci. berkeley. edu/article/socialsideofscience_06 3

Research Misconduct Fabrication • Making up data or results, and recording or reporting them Falsification • 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 Plagiarism • Appropriation of another person’s ideas, processes, results or words without giving appropriate credit 4

Research Misconduct Example 1 2014: NSF Case # A 13050061 Plagiarism: NSF found that the PI knowingly plagiarized 153 lines & 42 embedded references into an NSF proposal Outcome: PI must: – Comply with requirements imposed by the PI’s University (extensive) – Complete comprehensive RCR training in interactive format – Submit certifications that any proposals or reports submitted by the PI to NSF do not contain plagiarized, falsified or fabricated materials for 3 years – Submit assurances by a responsible official of the employer that any proposals or reports submitted by the PI to NSF do not contain plagiarized, falsified or fabricated material for 3 years http: //www. nsf. gov/oig/search/A 13050061. pdf 5

Research Misconduct Example 2 2015: ORI Case – David Anderson, Graduate Student, University of Oregon, Eugene; research funded by NIH Falsification: Falsified data by removing outlier values or replacing outliers with mean values to produce results that conform to predictions. Outcome: voluntary agreement that, for 3 years, i) have a supervision plan approved by ORI in place prior to any involvement in any PHS funded research; ii) institution must certify to ORI that data provided by him are based on actual experiments or legitimately derived and data, procedures & methodology are accurately reported in any application, report, manuscript or abstract; iii) not serve in any advisory capacity to the PHS; iv) assist UOE in retracting or correcting papers involving above falsification. https: //ori. hhs. gov/content/case-summary-anderson-david 6

Research Misconduct Example 3 2010: ORI Case - Sezen, Bengu (former graduate student at Columbia University); research supported by NIH Falsification, fabrication & plagiarism: ORI made 21 findings of research misconduct including fabrication, falsification and plagiarism across 3 papers and doctoral thesis. Outcome: ORI took administrative action that for 5 years, i) Dr. Sezen is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government; ii) Dr. Sezen is barred from service in any advisory capacity to the PHS. http: //ori. hhs. gov/content/case-summary-sezen-bengu 7

Research Misconduct • CUNY policy for disposition of allegations of research misconduct • CUNY policy on training in responsible conduct of research • Research Integrity Officers http: //www. cuny. edu/research/compliance/Responsible-Conduct-of. Research. html 8

Research Misconduct Case Summaries • US Department of Health & Human Services Office of Research Integrity http: //ori. dhhs. gov/case_summary • National Science Foundation http: //www. nsf. gov/oig/closeouts. jsp 9

Scenario #1: Self-plagiarism Susan is writing her thesis after 6 grueling years of study in the laboratory of Professor Winter. Due to excellent mentoring, Susan has published three first author papers that she co-wrote with Professor Winter. As she begins writing the literature study of her thesis, she copies and pastes some of the introductory materials from the papers she wrote. As Professor Winter begins reading early drafts of thesis, she becomes suspicious. 10

Scenario #1: Self-plagiarism So, what’s the right thing to do? 11

Scenario #2: Making an Error Joanna is a student in Professor Perfect’s lab. 12

Scenario #2: Making an Error • What should they do? • How will it affect the professor’s reputation? • How will it affect the student’s reputation? 13

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Conflict of Interest • Financial Conflict of Interest • CUNY policy, procedures and disclosure forms at http: //www. cuny. edu/research/compliance/conflictofinte restpolicy. html • Conflict of Commitment • Relationships with individuals or entities • Use of resources / funds • Honor time commitments made • College Conflicts Officers • CUNY Conflicts Committee 15

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Protection of Human Subjects • HRPP / IRB review is required when: • Activity involves research (systematic investigation for generalizable knowledge); and • Activity involves human subjects (living individual about whom data is collected through intervention or interaction; or private identifiable information is collected); and • CUNY is engaged • CUNY Human Research Protection Program (HRPP) • HRPP Coordinators / IRB Administrators (Research Compliance Administrators) • University Integrated (UI) Institutional Review Boards (IRB) • http: //www. cuny. edu/research/compliance/human-subjectsresearch-1. html 17

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Animal Welfare • Humane treatment of animals used in research and educational activities • Institutional Animal Care and Use Committees (IACUC) • Veterinarians, animal facilities staff, & IACUC administrators 19

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Biosafety • Environmental Health, Safety & Risk Management • Policies and procedures regarding laboratory safety, hazardous materials, health safety & radiation safety http: //www. cuny. edu/about/administration/offices/ehsr m. html • Responsible for training, oversight and audits • College specific Institutional Biosafety Committees (IBC) • Recombinant DNA & gene therapy research • Risk group 2 or higher infectious agent use • Use of transgenic animals 21

Biosafety • Other biosafety categories to be aware of: • Select agents & toxins: biological agents and toxins that are identified as having the potential to pose a severe threat to public health and safety, animal health and safety, plant health and safety, or to the safety of animal or plant products • Dual use research of concern (DURC): life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel or national security. 22

Image borrowed from: http: //www. dhra. mil/perserec/osg/counterintelligence/espionage-indicators. htm 23

Export Control • Controls • State, Commerce & Treasury Controls • Hardware, software, materials, equipment, technology & technological data that have civilian and inherent military or defense application • Defense articles designed or modified for defense or military application without civil equivalent and defense services. • Restricted transactions; for example, those with Cuba, Iran, Syria or Sudan • CUNY policy, procedures, guidance & forms • http: //www. cuny. edu/research/compliance/Export. Control. html • Export Control Administrators 24

Export Control • Requirements • Prior authorization or license may be required • Screening of all parties involved • Exceptions for fundamental research activities • No publication or citizenship restrictions accepted 25

Scenario #3: Sensitive Data Collection • The Belfast Project, as it came to be known, recorded the stories of paramilitary members on both sides of the conflict in Northern Ireland known as the Troubles. The researchers promised interviewees complete secrecy until their deaths. That promise ran aground when the British police sought access to the interviews in a murder investigation. (The Chronicle of Higher Education, January 28, 2014) • US Department of Justice subpoenaed interviews for a criminal investigation involving kidnapping and murder in Ireland because US and Ireland have a treaty allowing for this. • Boston College defended the case citing promise of confidentiality – The College considered it a victory when they were able to agree to turn over only 11 out of 85 interviews 26

Scenario #3: Sensitive Data Collection • What safeguards are available to protect subjects’ confidentiality? • What are the obligations of researchers and their institutions if a subject reveals criminal activity during an interview? 27

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Mentor / Trainee Responsibilities • • • Proactively set expectations Clarify evaluation criteria Clear distribution of responsibilities Standard operating procedures Criteria for establishing authorship & ownership Awareness of and compliance with institutional requirements 29

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 30

Publication Practices & Responsible Authorship • Authors • Made significant contributions to the research • Assumed responsibility for data collection & analysis • Participated in drafting the publication • Approved the final publication • Improper practice • Honorary authorship • Duplicate publication 31

Data Management • Data Ownership • Funding agency – grants vs. contracts • Institutional policy • CUNY Intellectual Property Policy: http: //www. cuny. edu/about/administration/offices/la/intellectual_pr operty_9. 20. 11. pdf • Data Source • Data Collection • Methods are appropriate for type of research • Data recorded such that it can be validated • Appropriate authorization • Human subjects; animal subjects; hazardous material & biological agent use; proprietary data; copyrighted or patented materials 32

Data Management • Data Protection • Proper storage to avoid accidental damage, loss or theft • Confidentiality & privacy agreements honored • Data retention according to contract &/or institutional practice • CUNY use of computer resources policy: http: //www. cuny. edu/about/administration/offices/CIS/policies/Compute r. Use. Policy. pdf • Data Sharing • We may enter into various types of data sharing agreements (data use, data transfer, etc. ) http: //www. cuny. edu/research/compliance/Research-Agreements. html 33

Collaborative Research • Roles & Relationships • Define each collaborator’s role in the project in a written agreement • Ensure common understanding of the research goals • Be familiar with each institution’s intellectual property & ownership policies • Management Plan • Financial Management: ensure that all collaborators are in compliance with funding agency’s financial management rules • Training & Supervision: address training & supervision of all research team members & be familiar with institutional requirements • Compliance: address how compliance with regulatory & institutional requirements will be ensured 34

Collaborative Research • Formal Agreements • Contact research compliance staff prior to signing these • Ensure that your collaboration is documented in a formal Agreement • Examples include: Memorandum of Understanding; Memorandum of Agreement; Material Transfer Agreement; Data Transfer Agreement • Signatory authority defined by policy: http: //www. cuny. edu//research-policies/Signatory. Authority. html 35

Scenario #4: Competing Interests Angie Stuck, a graduate student, is looking forward to starting her thesis work in the lab of a well-known professor on campus, Prof. Koi. The research project she will be working on is supported partly by the university but mainly by Huge Enterprise, a company of which Prof. Koi is a co-owner. 36

Scenario #4: Competing Interests • Are there any concerns about Prof. Koi’s roles as company owner, Principal Investigator, and faculty advisor? • Does Angie have any rights to anything that may be commercialized from the research findings? • Who can Angie go to for help in addressing the problem she is having in terms of working on her own thesis? • How should Angie handle this conflict with Prof. Koi? 37