Responsible Conduct of Research (RCR)

Farida LadaUniversity Director for Research ComplianceMarch 24, 2015http://www.cuny.edu/research/compliance.html

Overview

Rules• Federal regulations & State laws• Sponsor requirements• Institutional policies & procedures

Ethics & Good Practice• International, national and institutional standards• Standards of relevant research community

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

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

Research Misconduct Example 1

2014: NSF Case # A13050061

Plagiarism: NSF found that the PI knowingly plagiarized 153 lines & 42 embedded references into an NSF proposalOutcome: 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/A13050061.pdf

Research Misconduct Example 2

2010: ORI Case – Mungekar, Sagar S. (former MD/PhD student at NYU School of Medicine); research funded by NIH

Falsification: Dr. Mungekar increased statistical significance by discarding some experimental data in his PhD thesis; falsified 5 tables & 5 figures

Fabrication: calculations and conclusion based on falsified data were determined fabricatedOutcome: voluntary agreement that, for 3 yearsi) any institution requesting PHS support for research involving Dr. Mungekar must include a plan for supervision of his duties; ii) institution must certify that data provided by him are based on actual experiments or legitimately derived; iii) not serve in any advisory capacity to the PHS.

http://ori.hhs.gov/content/case-summary-mungekar-sagar-s

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

Research Misconduct

• CUNY policies & procedures for disposition of allegations of research misconduct; and CUNY policy on training in responsible conduct of research: http://www.cuny.edu/research/compliance/Responsible-Conduct-of-Research.html

• Research Integrity Officers

Research Misconduct Case Summaries

• US Department of Health & Human Services Office of Research Integrity http://ori.dhhs.gov/case_summary

• National Science Foundationhttp://www.nsf.gov/oig/closeouts.jsp

Scenario #1: Self-Plagiarism

David is writing his thesis after 6 grueling years of study in the laboratory of Professor Windbag. Due to excellent mentoring, David has published three first author papers that he co-wrote with Professor Windbag. As he begins writing the literature study of his thesis, he copies and pastes some of the introductory materials from the papers he wrote. As Professor Windbag begins reading early drafts of the thesis he becomes suspicious.

Scenario #1: Self-Plagiarism

So, what’s the right thing to do?

1. Is it OK for David to copy and paste the introduction from her papers into her thesis?

2. What are the implications of David having co-written the introduction of her papers with her mentor?

3. Should David have completely re-written the thesis introduction?

Scenario #2: Making an Error

John has published a paper in the Journal of Cellular Physiology with his mentor, Professor Perfect. After the paper is published and downloaded 74,000 times from the journal website, both student and professor are congratulating themselves on their fantastic accomplishment. However, after going over some of his notes, John realizes he has made an error in the paper, and used the wrong dataset in Figure 3. The error does not affect the main conclusions of the paper but could waste the time of someone who might want to reproduce the work.

Scenario #2: Making an Error

What is the right thing to do?A. Forget about it and hope no one notices.B. Call the journal and issue a correction.C. Write a new paper showing how there are different ways of

interpreting the data in figure 3.

How does a correction affect the reputation of John, Professor Perfect and the lab?

Conflict of Interest

• Financial Conflict of Interest• CUNY policy, procedures and disclosure forms at

http://www.cuny.edu/research/compliance/conflictofinterestpolicy.html

• Conflict of Commitment• Relationships with individuals or entities• Use of resources• Honor time commitments made

• College Conflicts Officers• CUNY Conflicts Committee

Protection of Human Subjects

• CUNY Human Research Protection Program (HRPP)• http://www.cuny.edu/research/compliance/human-subjects-resear

ch-1.html

• HRPP Coordinators / IRB Administrators (Research Compliance Administrators)

• University Integrated (UI) Institutional Review Boards (IRB)

• 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

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

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/ehsrm.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

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

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 our purposes, those with Cuba, Iran, Syria or Sudan

• CUNY policy, procedures, guidance & forms• http://www.cuny.edu/research/compliance/Export-Control.

html

• Export Control Administrators

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

Scenario #3: Export Control

Doctoral student Sue Jones has just started working with Professor BrightIdeas on a research project designing high speed recording cameras for a sponsor company in Buenos Aires, Argentina. Sue has a lot of ideas about how to improve the design and function of these cameras and is looking forward to publishing her work in her thesis. She has a lunch meeting today with Professor Overseas to discuss the project.

Scenario #3: Export Control

1. Who can you discuss an export controlled project with?

2. What are some of the possible implications for publications if a project is subject to export control regulations?

3. Who can you go to at your campus for export control guidance?

Scenario #4: 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

Scenario #4: Sensitive Data Collection

1. What safeguards are available to protect research subjects’ confidentiality?

2. What are the obligations of researchers and their institutions if a subject reveals criminal activity during an interview?

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

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

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

Data Management

• Data Ownership• Funding agency – grants vs. contracts• Institutional policy

• CUNY Intellectual Property Policy: http://www.cuny.edu/about/administration/offices/la/intellectual_property_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

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/ComputerUsePolicy.pdf

• Data Sharing• Data transfer from CUNY outside of a research

collaboration requires a data transfer agreement

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

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/research-policies/Signatory-Authority.html

Scenario #5: 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, Professor Koi. The research project she will be working on is supported partly by the university, but mainly by Huge Enterprise, a company in which Professor Koi has ownership.

Scenario #5: Competing Interests

1. What are the conflicts in terms of Professor Koi’s roles as company owner, Principal Investigator and faculty advisor?

2. Does Angie have any rights to anything that may be commercialized from the research findings?

3. Who else can Angie go to for help in addressing the problem she is having in terms of working on her own thesis?

4. How should Angie handle this conflict with Professor Koi?

Scenario #6: Collaborating with Industry

Professor John Cheralot is attending a research conference and is meeting a former colleague, Aymen Business, for a few beers after a long day of seminars. Aymen now works for a technology start-up and is looking for potential academic collaborators to help grow his business.

Scenario #6: Collaborating with Industry

3 hours and 4 rounds of beers later

Scenario #6: Collaborating with Industry

5 years later

John’s idea was brilliant and Aymen’s company produced a product based on John’s academic work. That company went on to make significant profits and help many people around the world. Unfortunately, John wasn’t one of them. Government funding was harder to come by due to budget cuts and therefore John needed to scale back his research efforts.

Scenario #6: Collaborating with Industry

1. Did the company do anything wrong?

2. How could John have approached this relationship differently?

3. What resources are available to John to assist him in working with industry?