The Regulatory Environment: Compliance Network

1. The Regulatory Environment:Compliance Network Guide to the Administration of Sponsored Projects December 17, 2009

2. Conscience is the inner voicewhich warns us thatsomeone may be looking. - H L Mencken

3. A133 Human Stem Cell Research Guidelines Compliance Universe Select Agents rDNA Biohazards ARRA Terms and Conditions Research Involving Animals Public Access Policy Authorship Standards Research Misconduct Time & Effort Reporting Conflict of Interest Human Subjects Research A110 Property Management A21 RCR Training Hazardous Materials Radiation Safety HIPAA Employment Issues Clinical Trial and Publication Registration Procurement Issues GLP OSHA Dept/School/UMB Requirements GAAP F & A Cost Accounting Data Sharing Facilities Issues Technology Transfer Requirements Sponsor/Project-Specific Requirements Employment Issues ITAR and EAR Export Controls

5. Regulated Areas • Use of Animals • Human Subjects • Environmental Health and Safety • Intellectual Property • Export Control • Finances & HR • Conflict of Interest • International Research • Research Misconduct • The Compliance Network

6. UMB FY 2009 Sources and Uses of Funds $909 Million Sources of Funds Uses of Funds

7. Research Compliance Roles Society/The Public Opinions/Votes The Media Information Information Govts/Legislators Scientific and Medical Communities President VPs/Central Administration/ORD Dean Dept Chair Data Research Administrator $$$ Research Personnel Research Research Research Research Research

8. Conflict of Interest

9. Conflict of Interest • A situation in which the integrity of a research activity, may be, or may be perceived to be, influenced by another interest of an investigator conducting the research or of the institution at which the research will be conducted.

10. Maryland State Public Ethics Law Public-Private Partnership Act

11. Why Are These Issues Important? • Maintain Academic Integrity • State Legislation • Federal Regulation

12. Applicable Policies and Procedures • USM Policy On Conflicts of Interest In Research or Development • UMB Procedures Implementing Board of Regents Policy on COI… http://www.umaryland.edu/research_integrity/COI/conflict_interest.html

13. www.umaryland.edu/research_integrity/COI/conflict_interest.htmlwww.umaryland.edu/research_integrity/COI/conflict_interest.html

14. Applicable Policies and Procedures(cont’d) • UMB IRB Policies and Procedures 6c: Investigator and Study Personnel Conflicts of Interest http://medschool.umaryland.edu/ORAGS/hrpo/docs/HRPP_Policies.pdf

15. NIH Objectivity In Science http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm (http://www.umaryland.edu/research_integrity/COI/conflict_interest.html)

16. Initial CoI Disclosureby Investigator Research Integrity Office CCT via Clinical Research Review Request ORD via Coeus IRB via Cicero Investigator

17. COI Disclosure / Exemption Management Process President issues exemption letter with provisions/conditions VPAA review & forward to President COI Advisory Committee review & recommendations Dean approval Dept Chair approval Written disclosure & exemption request Ongoing management of COI & annual review

18. Exemption Provisions/Conditions(examples)

19. Internal to UMB As required in provisions Annually Whenever a significant change occurs External to UMB Chancellor State Ethics Commission Public Record Research Sponsors, where applicable Reporting Requirements

20. COI ManagementSchool/Dept Roles • PI • Dean • Department Chair • Research Administrator

21. Suggested Approach • Analysis • Does any investigator have a financial interest in the sponsor of the research? • Does any investigator have any other financial interest in the outcome of the research? • Does the research involve human subjects? • Disclosures • ORD Coeus Application • UMB Form • CCT Service Request • IRB Cicero Protocol • IACUC Protocol • FDA Forms

22. Questions (And answers)

23. Research Misconduct

24. Responsible Research Research Misconduct Irresponsible Research

25. Scientists Behaving Badly • “Overall, 33% of the respondents said they had engaged in at least one of the top ten [misconduct] behaviours during the previous three years.” Martinson, et al in Nature, Vol 435, No 9:737-738, 2005.

26. UMB Definition(academic misconduct;misconduct in scholarly work) • Means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research or other scholarly work; also includes any form of behavior, including the making of allegations that involve frivolous, mischievous or malicious misrepresentation, whereby one’s work or the work of others is seriously misrepresented; does not include honest error or honest differences in interpretations or judgments of data.

27. Categories of Research Misconduct • Fabrication: making up experiments, data • Falsification: changing results, data without statistical justification • Plagiarism: appropriating the words or ideas of another and presenting them as one’s own

28. What Research MisconductIs Not • Example 1: Simply illegal, improper or unacceptable behavior • Example 2: Honest error • Example 3: Disagreement based on honest differences of opinion • Example 4: Simply authorship disputes • Example 5: Arguably unethical behavior • Example 6: Sloppy science

29. Some Definitions • Allegations • Complainant (whistleblower) • Respondent • Senior Academic Official • Responsible Official

30. Applicable Policies • USM Policy On Misconduct In Scholarly Work • UMB Policy and Procedures Concerning Misconduct In Scholarly Work • NIH Policy 42CFR93 (PHS Policies On Research Misconduct) http://www.umaryland.edu/research_integrity/misconduct/index.html

31. http://www.umaryland.edu/research_integrity/misconduct/index.htmlhttp://www.umaryland.edu/research_integrity/misconduct/index.html

32. Process • Inquiry • Investigation • Consequences

33. Research Misconduct ManagementSchool/Dept Roles • Research Personnel • Dean • Department Chair • Research Administrator

34. Suggested Approach • Analysis • Do the allegations involve fabrication, falsification or plagiarism? • Do the allegations involve other improper activity requiring notification? • Consultation / Notification • Appropriate UMB official(s) • Research Integrity Office • Maintain strict confidentiality

35. Questions (And answers)

36. Protecting OurResearch Mission

37. The Compliance “Network”

38. Support Investigators Protect Department School University Identify, Learn and Apply Policies Regulations Guidelines Standards Assure and Verify Compliance Remediate Non-Compliance Role(s) of theResearch AdministratorIn Research Compliance

39. Case Study

40. Rebecca Quinn, PhD, a postdoctoral fellow in your department wants to submit a proposal for an NIH R01 with Angela Sands, a faculty member in another department. Drs Quinn and Sands think they have discovered a new technique for detecting anthrax on the skin and in the hair and they wish to test the technique. What further information would be helpful at this point and how would you get it?

41. Angela Sands has a PhD. • The technique they wish to test involves the use of radioactive antibodies to anthrax. • They will test it first on dogs, then on humans.

42. Dr Quinn’s husband runs a company that has a number of federal bio-defense contracts. The plan is to purchase the anthrax antibodies from his company and then radiolabel them here on campus.

43. The grant is awarded!

44. Dr Quinn is appointed as an Assistant Professor. • Drs Quinn and Sands wish to put a new postdoc, from Iran, on the grant to do the radiolabeling of the antibodies.

45. 9 months later, Dr Quinn comes to you and says she thinks the postdoc has been making up the specifications on the radiolabeled antibodies he was to have produced. Some of them have already been used on human participants.

46. Questions (And answers)

47. UMB CONTACT LIST

48. ACCOUNTING (RESTRICTED FUNDS) CHERYL WILLIAMS-SMITH MANAGER FINANCIAL SERVICES SARATOGA STREET GARAGE ROOM 02-128 410 706-0487 cwsmith@af.umaryland.edu

49. ANIMALS IN RESEARCH(IACUC) ANGELA PEISER DIRECTOR, ACUO/IACUC SOM ANIMAL CARE AND USE OFFICE HEALTH SCIENCES FACILITY ROOM 210 410 706-4365 apeiser@som.umaryland.edu

50. CONFLICT OF INTEREST & RESEARCH MISCONDUCT JOE GIFFELS Research Integrity Office 410 706-1853 jgiff001@umaryland.edu ALISON WATKINS Research Integrity Office 410 706-1266 athom001@umaryland.edu ACADEMIC AFFAIRS 5th Floor 620 W Lexington