1. Responsible Conduct of Research Office of Research Assurances 2016 1

2. Introduction 2 A portion of the material presented here is summarized from the “Introduction to the Responsible Conduct of Research,” which can be downloaded at: http://ori.hhs.gov/documents/rcrintro. pdf Additional information can be found at the U.S. Department of Health and Human Services (DHHS) and the Office of Research Integrity (ORI) website: http://ori.hhs.gov/http://ori.hhs.gov/

3. Introduction Research responsibilities are complex and must be discussed in order to be understood. Research responsibilities are found in many different sources: Professional codes; Government regulations; Institutional policies; and Personal convictions.

4. Why discuss Responsible Conduct of Research? To establish an environment that fosters open communication; Develop a common foundation; Promote best practices; Share ideas; Increase understanding; Establish a culture of concern; Seek to overcome the lack of a perceived need for guidance on the responsible conduct of research.

5. 1)Data Acquisition, Management, Sharing, and Ownership 2)Conflict of Interest and Commitment 3)Human Subjects 4)Animal Subjects 5)Research Misconduct 6)Publication Practices and Responsible Authorship 7)Mentor/Trainee Responsibilities 8)Peer Review 9)Collaborative Science 5 Introduction The Office of Research Assurances supports programs designed to promote education and training in the responsible conduct of research (RCR) that covers the following 9 instructional areas:

6. Introduction In addition to the 9 core areas covered within the responsible conduct of research education a successful researcher must possess some basic core values: Honesty – conveying information truthfully and honoring commitments; Accuracy – reporting findings precisely and taking care to avoid errors; Efficiency – using resources wisely and avoiding waste; Objectivity – letting the facts speak for themselves and avoiding improper bias.

7. 1. Data Collection, Management, Sharing, and Ownership Integral to the research process is data. Data management practices are complex (including ownership, collection, storage, and sharing) and should be discussed before the collection of data. The integrity of data is of paramount importance and requires attention to detail, from initial planning to final publication.

8. Data Collection Important considerations regarding data collection include: Appropriate methods Attention to detail Recording Prior Authorization o Human (IRB) & Animal (IACUC) subjects o Hazardous materials and Biological agents (IBC) o Radioactive materials (RSO/RSC) o Information posted on some Web sites o Copyrighted or patented processes or materials

9. Data Management (protection) Once collected, data must be protected for later use (confirmation, establish priority, or to be reanalyzed by others):  Data Storage: Lab notebooks in a safe place; computer files backed up; samples saved so as not to degrade.  Confidentiality: Some data may be subject to privacy restrictions such as (human subjects or confidential business information).  Retention: In general data must be retained for 3 years after the completion of the research.

10. Data Sharing Although there is general agreement that research data must be shared there are often difficult questions that must be addressed: Preliminary data: generally should not be released Confirmed or Validated data: keeping data confidential until publication is widely accepted Published data: Once published there is an expectation that all the information about that experiment (including final data) should be freely available

11. Data Ownership Grants: researchers perform research and submit reports, but control of the data remains with the institution that received the funds Contracts: require the researcher to deliver a product or service which is then owned or controlled by the government Support for research institutions is awarded to the research institution, not to individual researchers In general, WSU owns the data Who owns research data? In general for government funding (state or federal):

12. 2. Conflict of Interest / Conflict of Commitment 12 Conflicts of interest are to be expected in the complex world of research with many competing demands and interests. Conflicts of interest or commitment are not necessarily good or bad – What is important is how they are managed.

13. The COI Committee must: Increase accountability; Add transparency; Enhance regulatory compliance and effective administrative management of PIs’ financial conflicts of interest. We want to manage conflicts and potential conflicts in order to support entrepreneurship while protecting the reputation of WSU and the PI’s. 13 Conflict of Interest Committee

14. Conflict of Commitment Conflicts of commitment occur from the competing demands on a researcher’s time and loyalties: Working on more than one funded project; Preparing proposals for new projects; Teaching and advising students; Attending professional meetings; Serving as a peer reviewer; Serving on advisory boards; and Working as a paid consultant, officer, or employee in a private company. Concerns include allocation of time, relationships with students, use of resources, disclosure of affiliations, and representing outside entities.

15. 3. Human Subjects (IRB) Institutional Review Board 15 The IRB is responsible for the review and approval of all research activities involving human subjects. The IRB is charged with protecting the rights and welfare of human subjects to ensure that all are treated physically, psychologically and socially in such a way as to minimize embarrassment and stress, and to avoid harm or other negative effects in compliance with the federal, state and university regulations and the guiding principles from the Belmont Report such as: Respect for Persons Beneficence Justice

16. Institutional Review Board (IRB) Research involving humans has many benefits for society and is often a necessary component of research. Research involving human subjects has many specific requirements. IRB review and approval  Peer review committee, made up of faculty and administrators with expertise in a wide range of research.  Research Protocols are submitted, reviewed, and returned for corrections or approved.  Through this process: Risks to subjects are minimized; Quality Informed consent documents are generated; and Education/Training of researchers; http://www.irb.wsu.edu

17. 4. Animal Welfare Institutional Animal Care & Use Committee 17 Use of animals in teaching, or animal models in research and testing is a privilege that is provided to the Institution. WSU IACUC works very hard with various stakeholders to uphold the welfare of the animals when they are being used for research, teaching or testing.

18. 4. Animal Welfare Institutional Animal Care & Use Committee 18 The IACUC’s charge includes: Monitoring and approving…  Live vertebrate animal use  Animal use in teaching  Animal use in research  Animal use in testing  Animal housing  Animal care  Training to work with animals  Undertaking periodic program review

19. IACUC Review and Approval  Reviews animal use protocols  Reviews WSU’s animal care program  Inspects animal facilities  Submits reports to agencies when necessary http://www.iacuc.wsu.edu/

20. Animal Welfare (IACUC) The IACUC (and the OCV) are concerned with many principles, including:  The humane use of animals in research;  Justifying the use of live animals  Avoiding or minimizing pain and suffering  Reducing the number of animals used; and  The 3 R’s (replacement, reduction, & refinement). AAALAC Accreditation provides assurance to oversight agencies and funding agencies.

21. 5. Research Misconduct Researchers who act dishonestly:  Waste public funds;  Harm the research record;  Distort the research process;  Undermine public trust; and  May adversely impact public health and safety. 21 Research misconduct is serious and has received considerable public attention.

22. Research Misconduct Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting results.  Fabrication is making up data or results and recording or reporting them.  Falsification is manipulating research materials, equipment, processes, changing, or omitting data or results, such that the research is not accurately represented in the research record.  Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving them appropriate credit.

23. Research misconduct does not include: Honest errors; Differences of opinion; or Differences in interpretations of data.

24. Research Misconduct Possible research misconduct should be reported to the Vice President for Research. Laws and policies are meant to protect both the individuals that make complaints and the individual who is accused of misconduct. Inquiries and investigations are handled with extreme confidentiality. The WSU policy can be found at http://officeofresearch.wsu.edu/ faculty_resources/policies.html http://officeofresearch.wsu.edu/ faculty_resources/policies.html

25. 6. Publication Practices and Responsible Authorship Researchers typically share the results of their activities with colleagues and the public through publication. Results of publication in research should meet some minimum standards:  A full and fair description of the work;  An accurate report of the results;  An honest and open assessment of the findings. Elements of a responsible publication include: (Methods) what they did; (Results) what they discovered; (Discussion) what they make of their discovery; and Notes, bibliography, and acknowledgements.

26. Responsible Authorship The names on a paper let others know who conducted the research and who should get credit for the work. Contribution: Authorship is typically limited to individuals who make significant contributions to the work. The International Committee of Medical Journal Editors recommends limiting authorship to persons who contribute to the conception and design, data collection and interpretation, and assist in drafting and finalizing the manuscript. Importance: Authors are usually listed in order of importance. The designation first or last author usually carries special weight (most significant contribution). Corresponding or primary author: This is an important responsibility as these authors will act on behalf of their colleagues.

27. Responsible Authorship Practices that must be avoided: Honorary authorship; Premature public statements; and Practices that put quantity of research above quality. Dividing one significant piece of research into a number of small experiments to increase the number of publications; or Duplicate publications.

28. 7. Mentor/Trainee Relationship Successful, experienced, established, and/or senior researchers often assume the added role of mentor while conducting investigations. The mentor/trainee relationship is complex and may harbor potential conflicts. Who gets credit? Who owns the results? When does the trainee become independent?

29. Mentor/Trainee Responsibilities The mentor/trainee relationship begins when an experienced and an inexperienced research agree to work together. Each brings something to the arrangement and each expects to get something out of the arrangement. Basic Responsibilities:  Trainees need to know: How much time the mentor expects them to work on the research project; criteria to judge performance; how responsibilities are divided or shared; SOPs; and authorship.  Mentors need to know that a trainee will: do assigned work conscientiously; respect the authority of others in the research; follow SOPs; protocols; procedures; and live by authorship and ownership agreements.

30. Mentor Responsibilities Research Environment: Mentors tend to establish the research environment. Some may emphasize competition and others may emphasize cooperation. No matter what their style mentors should:  Provide equal treatment;  Maintain a professional atmosphere; and  Train and educate in the responsible conduct of research. Supervision and review: Mentors assume responsibility to properly and appropriately train.  Assure proper instruction in research methods;  Foster intellectual development;  Impart an understanding of responsible research practices; and  Routinely check and “coach” to make sure the trainee develops into a responsible researcher.

31. Mentor/Trainee: Transition to Independent Researcher The ultimate goal of research training is to produce successful, independent researchers. The mentor’s final responsibility is to help the trainee become firmly established as independent researchers. History has repeatedly shown that experienced researchers often do not give over control to the next generation easily.

32. OMBUDSMAN “The ombudsman is designated by the university to function as an impartial and neutral resource to assist all members of the university community. The ombudsman provides information relating to university policies and procedures and facilitates the resolution of problems and grievances through informal investigation and mediation.” ombudsman.wsu.edu/

33. 8. Peer Review An essential component of research is peer review. Many important decisions depend on peers, including: Grant reviews; Manuscript reviews; Personnel reviews; Literature reviews and expert testimony. Regardless of the type of peer review it must: 1)Meet the deadline: Be timely. 2)Assess quality: Be thorough with respect to methods, calculations, conclusions, & relevant literature cited. 3)Judge importance: Is the research important? Does it contribute in a significant way?

34. Peer Review 4)Preserve confidentiality: Peer review occurs with the understanding that the information will not be used or shared with anyone else without permission. It is not permissible to do any of the following (without prior permission):  Ask a student or anyone else to do the review assigned to you;  Use an idea or information contained in a grant or unpublished manuscript;  Discuss a grant proposal or manuscript with colleagues  Retain a copy of the reviewed materials; or  Discuss personnel and hiring decisions with colleagues who are not part of the review process.

35. 9. Collaborative Science Researchers collaborate with colleagues who have expertise and/or resources to contribute to a project. Federal agencies and universities seek to foster interdisciplinary science. Any project with more than one person working on it requires collaboration – working together. Collaborations can offer many benefits and advantages, however there are added responsibilities: Increasingly complex roles and relationships; More complex management requirements; Common but not necessarily identical interests; and Cultural differences

36. Collaborative Science Roles and relationships: Effective collaboration begins with a clear understanding of roles and relationships, which should begin the day the collaboration is established. Goals and anticipated outcomes Roles of each partner Data collection, storage, and sharing Preconfigured strategy how to modify the research design Other Considerations: Who will draft publications Criteria to rank authors Authority to speak publicly Intellectual property rights and ownership How the collaboration can be changed When the collaboration will end

37. Collaborative Science Effective management plan must include: Financial management: Responsibility for ensuring that federal funds (project funds) are expended in accordance with federal rules (A-21 and A-110). Training and supervision: All research staff and project personnel should be properly trained and supervised. Formal agreements: Some aspects of collaboration must be worked out with formal agreements in advance (who owns materials, uses/restrictions on the materials, and acknowledgements of the source). Compliance: Collaborative projects must take into account the need for meeting compliance responsibilities throughout the project sites and not just at one institution.

38. Collaborative Science Research interests: Collaborative projects encourage researchers to pursue interdisciplinary research, however, most researchers have devoted their career to one field of research and spend their time talking to colleagues with similar interests. This may cause tension or competing goals in a collaborative project. Cultural difference: Not only geographic differences, but differences resulting from the research field. Researchers from different fields may bring different practices or expectations to a project. Such differences may include potential conflict of interest, ownership and intellectual property, collecting data, publishing results, etc. When in doubt, follow the more stringent course of action (the highest standard of conduct).

39. Additional Programs in the Office of Research Assurances Biosafety Radiation Safety Export Controls Hazardous Materials Shipping

40. Institutional Biosafety Committee(IBC) 40 http://www.bio-safety.wsu.edu/

41. Institutional Biosafety Committee (IBC) The IBC is a presidential committee charged to review, monitor, and ensure adequate containment of all infectious or potentially infectious agents (i.e. pathogens), toxins, or organisms with recombinant or synthetic nucleic acids (r/sNA). All research with these biological materials at WSU is reviewed to protect the research staff, investigators, the public, and the environment.

42. Radiation Safety Office/Radiation Safety Committee (RSO/RSC) 42 http://www.rso.wsu.edu/

43. With the oversight and direction of the Radiation Safety Committee (RSC), the WSU Radiation Safety Office supports the University's teaching, research and outreach mission by administering a program that ensures the secure and safe use, transport and disposal of radioactive materials and radiation machines on the Pullman campus and other University sites around the state. 43 RSO/RSC

44. ExportControls 44 http://www.ora.wsu.edu/ExportControls /

45. Export Controls exist to protect the national security and foreign policy interest of the United States. The U.S. export control laws & associated regulations govern: The release of technology, technical data, software, & information to foreign nationals with in or outside the U.S.; The furnishing of defense services to foreign persons whether in the U.S. or abroad; The shipment or other transmission of items or defense articles outside the U.S.; and The ability to transact with certain individuals, countries, & entities. It is the responsibility of University faculty, staff, and administration to be aware of the export control requirements under the regulations. 45 Export Controls

46. Key Issues for Universities: 46 National Security vs. Academic Freedom Exemptions & Exclusions Fundamental Research Non-Fundamental Research Concerns Employment Exemption Employment Exclusion Education Exclusion Public Domain Exclusion Troublesome Clauses Applications to Research Shipping, Travel, Equipment Use, & Software University/PI Responsibilities

47. Hazardous Materials Shipping (HMS) 47 http://www.ora.wsu.edu/Shipping/

48. Who Is Subject to the Hazardous Material Regulations? 48 Each person who: Offers a hazardous materials for transportation in commerce; or Performs or is responsible for performing any of the pre- transportation functions:  Determining the hazard class of a hazardous material;  Selecting a hazardous material packaging;  Filling and or Securing a closure on a filled or partially filled hazardous material package;  Marking a package to indicate that it is a hazardous material;  Labeling a package to indicate the it contains a hazardous material; or  Preparing a shipping paper. Source: PHMSA, USDOT, July 2015

49. Hazardous Materials Shipping Is my shipment (potentially) hazardous? Dry Ice Laboratory Chemicals (including preservatives) Pathogen or virus Animal or Human specimens Compressed gas cylinders Batteries Computers/laptops/scientific devices Radioactive materials* If your material is hazardous or you are not sure, please call: ORA Hazmat Shipping 509-432-3869 *Radiation Safety 335-8916 49

50. Penalties for Violating HMR Violations of the HMR may result in: Civil penalties up to $175,000  Minimum $495 for training related violation  Each day of a continuing violation is a separate offense Criminal penalties of up to  $250,000 (individuals)  $500,000 (corporations)  Plus up to ten years in prison 50 Source: PHMSA, USDOT, July 2015

51. IBC DHHS/OHRP WSU Policy & Procedure NIH IACUC WSU RSO WSU EHS USDA/APHIS IRB FDA DOT/FAA DHHS/ORI WSU Biosafety Researcher Collaborative obligations Responsible conduct of research Conclusion!!

52. Office of Research Assurances Director Mike Kluzik 335-9553 mkluzik@wsu.edu IACUC Coordinator Rani Muthukrishnan 335-7951 rani_m@wsu.edu IRB Coordinator Malathi Jandhyala 335-3668 mjandhyala@wsu.edu IRB & IBC Program Coordinator Patrick Conner 335-7183 patrick_conner@wsu.edu Biosafety and Hazmat Shipping (HMS) Industrial Hygienist Ryan Schwager 335-4462 rschwager@wsu.edu Export Controls, RCR, & HMS Doug Cuellar 335-0039 dcuellar@wsu.edu dcuellar@wsu.edu Biological Safety Officer (BSO) Levi O’Loughlin 335-1585 levi.oloughlin@wsu.edu

53. Radiation Safety Office Assistant RSO Rey McGehee 335-6763 rmcgehee@wsu.edu Radiation Safety Technician III Scott Finch 335-4221 sfinch@wsu.edu Radiation Safety Officer Jean Cloran 335-7057 jcloran@wsu.edu Health Physicist Kreta Johnson 335-7058 kretaj@wsu.edu Radiation Safety Technician III Sonja Fenimore 335-8175 katmere@wsu.edu

54. Responsible Conduct of Research