1. Responsible Conduct of Research (RCR) Farida Lada October 16, 2013 http://www.cuny.edu/research/compliance.html

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

3. Image borrowed from: http://undsci.berkeley.edu/article/socialsideofscience_06http://undsci.berkeley.edu/article/socialsideofscience_06

4. 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

5. Research Misconduct CUNY policies & procedures for disposition of allegations of research misconduct at http://www.cuny.edu/research/compliance/Responsible- Conduct-of-Research.html http://www.cuny.edu/research/compliance/Responsible- Conduct-of-Research.html Research Integrity Officers

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

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

10. Protection of Human Subjects CUNY Human Research Protection Program (HRPP) http://www.cuny.edu/research/compliance/human- subjects-research-1.html http://www.cuny.edu/research/compliance/human- subjects-research-1.html HRPP Coordinators / IRB 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

12. 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

14. 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 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

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

16. 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 and activities designed or modified for defense or military application without civil equivalent 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 http://www.cuny.edu/research/compliance/Export- Control.html Export Control Administrators

17. Export Control Requirements Prior authorization or license may be required Exceptions for fundamental research activities No publication or citizenship restrictions accepted

19. 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

20. 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

21. 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

22. 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 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

23. 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 Data Sharing Data transfer from CUNY requires a data transfer agreement

24. 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 Have a management plan Financial Management Ensure that all collaborators are in compliance with funding agency’s financial management rules Training & Supervision Management plan should address training & supervision of all research team members Be familiar with institutional requirements

25. 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 Compliance Management plan should address how compliance with regulatory & institutional requirements will be ensured