1. 1 CReATE W. Ross Ellington, Ph.D. Responsible Conduct of Research (and Creative Activity), RCR W. Ross Ellington, Associate VP for Research and Professor of Biological Science

2. 2 from the FSU Faculty Handbook In fostering academic freedom, it is the policy of The Florida State University to uphold the highest standards of integrity in research and creative activity, and to protect the right of its employees to engage in research and creative activity. Researchers are expected to adhere to the standards of research in their area of endeavor, and to encourage adherence to those standards by their colleagues and by those under their supervision.

3. 3 from the FSU Faculty Handbook The Florida State University is committed to adhering to and enforcing applicable federal, state and local laws and to following procedures required by granting agencies from which grant funds are secured. Researchers are to be aware of any special provisions regarding standards of research and of procedures required by funding agencies for resolving allegations of misconduct in research.

4. 4 What do we mean by RCR? It is the practice of good citizenship & stewardship in the conduct of research and creative activities. It is multi-faceted, involving the actions of principal investigators and their research groups as well as support staff who manage/administer grants and contracts.

5. 5 Regulation of RCR  Common assumptions among professionals:  No need for specific rules, for self-regulation  Either peer review process or attempts at research replication prevents misconduct  Misconduct: Committed only by the unbalanced or morally reprobate  Lack of perceived need for rules poses problems when seeking guidance on RCR

6. 6 Regulation of RCR Impact of abuses has led to governmental regulation  1966 Animal Welfare Act (PL 89-544)  1974 National Research Act (PL 93-348)  1985 Health Research Extension Act (PL 99-158)

7. 7 Regulation of RCR  Office of Research Integrity (ORI) established 1992 ( http://ori.dhhs.gov/) http://ori.dhhs.gov/  To respond to misconduct allegations  To promote integrity and RCR training  If research institutions accept federal funds, must have RCR policies

8. 8 Required Institutional Policies  Committees to review human & animal research  Procedures for reporting and investigating  Research misconduct  Conflicts of interest  Approve & manage all research budgets  Establish practices for handling hazardous substances in research

9. 9 Institutions Must:  Designate persons authorized to receive & investigate allegations  Conduct initial inquiry to determine if allegations have merit  Provide formal investigation  Designate person with authority to impose administrative actions to redress the misconduct  Provide mechanism for reporting to Office of Research Integrity (ORI), if federally funded

10. 10 Outline of CReATE RCR Module  9 Core Areas of RCR  Violations of FSU Policy  Role of Administrators and RCR  Sources of Information  Credits

11. 11 Core Areas of RCR  Fabrication: Making up data or results & recording or reporting them  Falsification: Manipulating research materials, equipment, processes, or changing or omitting data or results so 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 1) Research/Scholarly Misconduct

12. 12 Core Areas of RCR 1) Research/Scholarly Misconduct cont FSU policy on research and creative activity is described in the Faculty Handbook ( http://facultyhandbook.fsu.edu/section6.html#s12) http://facultyhandbook.fsu.edu/section6.html#s12 Involves reporting, inquiry and investigation done at the level of the academic dean. Vice President for Research may be required to report certain instances and actions taken.

13. 13 Core Areas of RCR 2) Protection of Human Subjects  Protocols must be approved by the Institutional Review Board (Human Subjects Committee)  Risk to benefit ratio must be weighed very carefully  Informed consent is critical (we’ll hear more about this later)

14. 14 Core Areas of RCR 3) Welfare of Laboratory Animals  Protocols must be approved by the Institutional Animal Care and Use Committee (IACUC)  A variety of issues must be considered (e.g., why necessary? which species? level of distress? alternatives available?) (we’ll hear more about this later)

15. 15 Core Areas of RCR 4) Conflict of Interest Conflicts of Interest- A situation in which an individual has one or more significant financial interest that have the potential for tainting or have the potential to taint the conduct or reporting of the work conducted under a sponsored project (http://ori.dhhs.gov/education/products/rcradmin/glossary. shtml )http://ori.dhhs.gov/education/products/rcradmin/glossary. shtml (we’ll hear more about this later)

16. 16 Core Areas of RCR Others 5) Data Management 6) Mentor & Trainee Responsibilities 7) Collaborative Research 8) Authorship & Publication 9) Peer Review

17. 17 Violations of FSU Policy  Forgery or unauthorized alteration of documents or computer records  Falsification or misrepresentation of reports to management & external agencies, including time sheets, official travel claims for reimbursement or other expense reimbursement reports  Authorizing or receiving payment for time not worked;  Misappropriation of funds, securities, supplies or other assets;

18. 18 Violations of FSU Policy  Impropriety in handling or reporting of money or financial transactions;  Engaging in unauthorized activities that result in a conflict of interest;  Disclosing confidential or proprietary information to unauthorized individuals;  Removal of university property, records or other assets from the premises without supervisory approval

19. 19 Violations of FSU Policy  Unauthorized use or destruction of university property, records or other university assets; and  Taking information & using it or providing the information that would lead to identity theft. These sorts of violations are not uncommon in the context of a research university

20. 20 Role of Administrators and RCR Administrators are responsible for implementing controls: 1. Incompatible duties are properly separated; 2. Financial transactions are properly authorized & approved; 3. Reports of financial activity are periodically reviewed for completeness & accuracy

21. 21 Role of Administrators and RCR 4. Official personnel actions (e.g., appointments) & employee time & leave are properly authorized & approved; 5. Assets are physically secured; 6. Computer passwords are protected & not shared; 7. Confidential & sensitive information is protected from unauthorized access; & 8. Employees are effectively supervised.

22. 22 Role of Administrators and RCR 9. Identify potential or real conflicts of interest (COI) Administrators must be able to identify situations in which a conflict of interest has arisen, or as well as instances in which there is a potential for a conflict arising, or a good possibility that others will perceive the existence of a conflict of interest. It also means that administrators must be familiar with the institution's and sponsor's policies that are used to resolve or mitigate an actual or potential conflict. (http://ori.dhhs.gov/education/products/rcradmin/ind ex.html )http://ori.dhhs.gov/education/products/rcradmin/ind ex.html

23. 23 Role of Administrators and RCR COI continued….. FSU policy and procedures for disclosure of financial conflicts of interest- http://www.research.fsu.edu/contractsgrants/findisclpoli cy.html http://www.research.fsu.edu/contractsgrants/findisclpoli cy.html

24. 24 Heads Up! New PHS Financial Conflict of Interest (FCOI) mandate implemented 8/24/12  Requires training of all investigators (anyone that conceives, conducts or communicates research supported by NIH); includes subcontractors and unpaid collaborators  Requires reporting to an university FCOI officer  If university determines that a significant FCOI exists, a mitigation plan must be developed  Requires public disclosure of FCOIs and mitigation plans

25. 25 Heads Up!

26. 26 Useful Resources ORI introduction to RCR (http://ori.dhhs.gov/education/products/RCRintro/ )http://ori.dhhs.gov/education/products/RCRintro/ Tutorial from ORI on RCR and administrators (http://ori.dhhs.gov/education/products/rcradmin/index. html )http://ori.dhhs.gov/education/products/rcradmin/index. html Inventory of educational modules available from ORI (http://ori.dhhs.gov/education/products/ )http://ori.dhhs.gov/education/products/

27. 27 Acknowledgement This presentation was adapted from an RCR module prepared by Dr. Judith J. Devine Associate Dean, FSU Graduate School