Responsible Conduct of Research (RCR) Farida Lada October 16,

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

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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 CUNY policies & procedures for disposition of allegations of research misconduct at Conduct-of-Research.html Conduct-of-Research.html Research Integrity Officers

Research Misconduct Case Summaries US Department of Health & Human Services Office of Research Integrity National Science Foundation

Conflict of Interest Financial Conflict of Interest CUNY policy, procedures and disclosure forms at estpolicy.html estpolicy.html College Conflicts Officers CUNY Conflicts Committee Conflict of Commitment Relationships with individuals or entities Use of resources Honor time commitments made

Protection of Human Subjects CUNY Human Research Protection Program (HRPP) subjects-research-1.html 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

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 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

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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 Control.html Control.html Export Control Administrators

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

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: _property_ pdf _property_ 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 Data Sharing Data transfer from CUNY 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 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

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