Research Compliance: Principles and Policies

1. Research Compliance:Principles and Policies Dusty Layton Director, Research Compliance and Assurance University of South Alabama

2. Research compliance is: • Understanding what compliance means and sharing this with others in your department • Being “aware” of the rules and regulations • Showing and telling others how to “do the right thing” How do you fit in? • Be aware of the concepts and components of Responsible Conduct of Research

3. Protections/Safeguards • Conduct of Research Ensure validity of results/ Maximize return on public investment Provide safety/welfare of subjects & environment Ensuring Research Protection: Principles & Responsibilities Geoff Grant, May 2005

4. What is Responsible Conduct of Research (RCR)? • Indiviudal character and behavior that impact research • Areas defined by funding agencies for RCR: • Data acquisition, management, sharing and ownership • Conflict of interest and commitment * • Human subjects * • Animal welfare * • Research misconduct * • Publication practices and responsible authorship • Mentor/trainee relationships • Peer review • Collaborative science * Government regulated

5. RCR – Why? • Promote awareness and best practices in research • Obligation to maintain public’s trust • Ensure proper stewardship of research funds • Protect human and animal subjects • Assure compliance with federal/state regulations Current Climate • TRANSPARENCY

6. Yin and Yang • Complementary relationship is essential to obtaining compliance • Promotes integrity and good science • Culture • Exemplify a commitment to “do the right thing” • Compliance is a shared responsibility • Communication • Accountability

7. Circle of Compliance Research Compliance Ensures the ethical review of research Source: University of Maryland

8. Research Compliance Programs Human Subjects Animal Care and Use Biosafety Responsible Conduct of Research Export Controls Conflict of Interest

9. RCR Mandates • NSF mandate: applies to all NSF research proposals after January 4, 2010 • Institutional Training Plan tailored to undergraduates, graduates and postdoctoral fellows conducting research • NIH mandate: applicable to designated grants This policy takes effect for all new (Type 1) and renewal (Type 2) applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011 • training grant, career development award (individual or institutional), research education grant, and dissertation research grants

10. 3rd edition (2009), http://www.nap.edu/catalog/12192.html

11. Human Subjects Research? Any activity intended to obtain and record information from or about individuals or use of identifiable information for research purposes. • All human research conducted at, by or under the auspices of USA, regardless of funding must be reviewed in advance of project initiation. • Mechanisms of review

12. IRB Review • Any research involving interaction with living individuals or the collection of personal identifiable information • Educational, social & behavioral and biomedical research whether funded or unfunded • Dissertations and thesis involving human subjects • Research that is published, presented, or contributes to the field as generalizable knowledge

13. Animal Research at USA Voluntary program Developed by animal scientists Voluntary certification organization The Gold Standard Over 850 accredited institutions worldwide Site visit every three years

14. IACUC Review? • Any work in labs or in the field involving live vertebrate animals in teaching, laboratory demonstrations, or research • Animals euthanized for research, teaching purposes, or tissues obtained from a live animal

15. IBC Review? • Recombinant DNA (rDNA) • Agents infectious to humans • Bacteria • Viruses • Fungi • Human blood, unfixed tissue • Human cell lines • Infectious animals • Select agents & toxins

16. Compliance Program Support • Assist with protocol submissions • Guidance on interpretation of regulations • Shepherd protocols through the review and approval process • Provides information to departments about processes • Education • Assist with reports of concern

17. IRBNet • Online portal for ALL submissions to the IRB, IACUC and IBC • User Profile-Required for: • Investigators • Faculty Advisors • Key Personnel • All DIGITAL - No Hardcopies • Forms, checklists, guidance, templates We’re streamling processes

18. IRBNet Access and Resources

19. Avoiding Being Penalized: Research Misconduct

20. Research Misconduct • The OSTP's definition states: “research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” • USA Policies and Procedures for Responding to Allegations of Research Misconduct Whistleblowing: Reporting Research Misconduct Government regulations require institutions to have policies and systems in place so that individuals are able to report misconduct confidentially and without fear of retaliation. • Report Misconduct Concerns: • - Whistleblower Hotline: 460-6393 • Email: Internalaudit@usouthal.edu • Whistleblower Submittal Form • Mail: Internal Audit • Fax: 461-1497

22. Export Controls Law • A comprehensive series of regulations enforced by the Federal government that regulate the distribution of certain exports to foreign nationals and foreign countries • Laws apply to all activities, not just sponsored research projects • “Control” involves obtaining a license from the federal government prior to exporting or by deemed export in the U.S.

23. Export Laws: Fundamental Research Exclusion • Vast majority of university research is not effected 734.8 (b) (1) –University Based Research. Information resulting from basic and applied research in science and engineering conducted at an accredited institution of higher education in the U.S. that is ordinarily published and broadly shared within the scientific community.

24. Conflict of Interest andConflict of Commitment A conflict of interest exists when an employee’s financial or personal considerations may compromise, or have the appearance of compromising, an employee’s personal judgment in administration, management, instruction, research, and other professional and academic activities. A conflict of commitment exists when professional service or research contracted outside the University interferes with the employee’s paramount obligations to students, colleagues, and the primary missions of the University.

25. How are Conflicts Identified? • Financial Conflict of Interest Annual Disclosure (Sept 30th) • USA policy seeks management at the most local level possible: • Department chair • Consultation with College Dean • University Committee, if needed • Update within 30 days of change or acquire new financial conflict • External professional activities of faculty • File an External Professional Activities for Pay form at department level • Technology transfer activities • Bayh-Dole Act of 1980 • Sponsored research activities • Federal Conflict of Interest Regulations • Public Health Service • National Science Foundation

26. Conflict Management Conflicts of interest related to federally-funded research must be identified and managed prior to expenditure of fundsor within 60 days (for any COIs that arise after the research project begins).

27. Research Compliance Staff • Dusty Layton, Director • Amy Delcambre, Assistant Director • SuzAnne Robbins, IRB Compliance Specialist • Danny Housley, IACUC Compliance Specialist Contact Information http://www.southalabama.edu/researchcompliance/contactus.html