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Workshop on External Funding

Workshop on External Funding. David Danner – Contract Specialist Phyllis Danner – Senior Fiscal Officer Reginald Cannon – e-PRAS Manager Research and Sponsored Programs Tennessee State University February 24, 2011 . Topics to Discuss. Research Conduct / Law and Ethics Grants.gov

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Workshop on External Funding

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  1. Workshop on External Funding David Danner – Contract Specialist Phyllis Danner – Senior Fiscal Officer Reginald Cannon – e-PRAS Manager Research and Sponsored Programs Tennessee State University February 24, 2011

  2. Topics to Discuss • Research Conduct / Law and Ethics • Grants.gov • Direct Costs vs. Indirect Costs • University’s Indirect Costs Rates • Cost Sharing • Multi-year budgets • e-PRAS

  3. The Responsible Conduct of Research: A Comparative Synopsis of Law and Ethics David E. Danner (TSU Class of 1991) Grants and Contracts Specialist Division of Research and Sponsored Programs Tennessee State University

  4. What is Research? • Research, as used herein, includes all basic, applied, and demonstration research in all fields of science, engineering, and mathematics. This includes, but is not limited to, research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals. Federal Research Misconduct Policy of the Office of Research Integrity (ORI) of DHHS, 65 Federal Register 76260, December 6, 2000.

  5. What is Ethics? • Ethics is the study of the general nature of morals and of specific moral choices; moral philosophy. • Ethics refers to the rules or standards governing the conduct of a person or the members of a profession … • e.g. research ethics. The American Heritage College Dictionary, 480 (4th Ed. 2002).

  6. Law v. Ethics:A Comparative Conceptualization • Law is a set of rules of minimum and adequate conduct which are enforced by the government (i.e. law enforcement). • Ethics is a set of principles or rules of correct and conscientious conduct which are enforced by a profession or other non-government entity.

  7. What is the core of Ethics? Values • Morality – Values that guide our behavior, (right vs. wrong). • Sharing ethical values promotes social cooperation (i.e. “secular morality”). • Values set a higher standard. • Law – Rules of conduct instituted by state. • External motivator for compliance is state sanctions. • Law sets a minimum standard.

  8. The Ultimate Ethics Standard is … You! Individual Values – Self Examination 1. Have I thought if action is right or wrong? 2. Will I be proud to tell of my action? Questions to ask yourself to help explore ethical values before making decisions. 3. Am I willing for everyone to act like me? 4. Will my decision cause harm? 5. Will my actions violate the law?

  9. What is Research Ethics?Shared Values

  10. What is Research Misconduct?Fabrication, Falsification, and Plagiarism (“FFP”) • Fabrication is making up data or results and recording or reporting them. • Falsification is 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 is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Code of Federal Regulations (CFR): Volume 45 CFR [NSF Regs] Section 689.1(a)(1),(2),(3); Volume 42 [DHHS Regs] CFR 93.103(a),(b),(c).

  11. Sources of Law - Rules

  12. Sources of Ethics - Principles Legal Regulation Professional Codes of Ethics Sources of Values Organizational Codes of Ethics Individual Values

  13. The Scientific Method: A General Standard of Research Integrity • A gap in knowledge is identified and questions posed • Existing information studied and a hypothesis/educated guess is formed • Information is gathered, analyzed and interpreted to test the hypothesis • Results may support or refute a hypothesis, but the hypothesis cannot be proved; it can only be disproved

  14. What is the Law of Ethics? The legal authority of government to regulate professional and personal lives is founded in the constitutional principles of: Commerce Clause Police Powers Performed by administrative agencies (e.g. NSF, DHHS)

  15. What is the Law of Research Ethics? • An Intersection of Research Principles/Values and Government Rules and Regulations:

  16. Federal Research Misconduct Policy • Office of Research Integrity, Public Health Service (PHS), U.S. Department of Health and Human Services (DHHS) • Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. 42 CFR 93.103 (65 Federal Register 76260, December 6, 2000)

  17. Federal Research Misconduct Policy (continued) • Office of the Inspector General, National Science Foundation (NSF) • Misconduct means fabrication, falsification, or plagiarism in proposing or performing research funded by NSF, reviewing research proposals submitted to NSF, or in reporting research results funded by NSF. 45 CFR 689.1(a) (67 Federal Register 11937, March 11, 2002)

  18. Federal Research Misconduct Policy (continued) • U.S. Congress: Animal Welfare Act of 1966, National Research Act of 1974, Health Research Extension Act of 1985, Health Insurance Portability and Accountability Act of 1996

  19. Additional Areas of Research Responsibility • Authorship and Contribution, Section 820.10(1), TSU Principal Investigator’s Handbook • Confidentiality, 45 CFR 164, 42 CFR 93.108, passim. • Conflicts of Interest, 42 CFR 50.604, TBR Policy No. 1:02:03:10 • Data Collection, Ownership, and Retention, Section 800.00, TSU Principal Investigator’s Handbook • Invention Disclosure and Intellectual Property, Section 800.00, TSU Principal Investigator’s Handbook • Mentoring and the Mentor-Trainee Relationship

  20. Ownership of Data and Intellectual Property • Funding agencies, via their grant award provisions, establish rules of invention disclosure and ownership of intellectual property within the standards of the Bayh-Dole Act of 1980 [The University and Small Business Patent Procedures Act], 35 U.S.C. 200; 37 CFR 401. • Tennessee State University, via its intellectual property (IP) policy, describes the rules of invention disclosure and profit-sharing between the University and its researchers: www.tnstate.edu/research/RSP.htm

  21. Scientific Record Keeping • I. Reasons for data collection and proper record keeping: • Authenticity • Accountability • Application • II.Keeping useful scientific records • Useful databooks explain: • Why you did it • How you did it • Where materials are • What happened (and what didn’t happen) • Your interpretation • What’s next • Good databooks: • Are legible • Are well organized • Allow repetition of your experiments • Are the ultimate record of your scientific contributions

  22. Mentoring • Characteristics of the Mentor-Trainee Relationship: • Mentors demonstrate and teach style and methodology in doing scientific research • Mentors evaluate and critique scientific research • Mentors foster the socialization of trainees • Mentors promote career development • Mentors perform different duties at different times • Trainees depend on mentors • The mentor-trainee relationship is an exclusive one • The mentor-trainee relationship requires trust

  23. Selection of a Mentor • Active publication record in high-quality, peer-reviewed journals • Extramural financial support base: competitiveness and continuity of support • National recognition: meeting and seminar invitations, invited presentations, consultant ships • Rank, tenure status, and proximity to retirement age • Prior training record: time it takes trainees to complete a degree, number of trainees, and enthusiasm for previous trainees’ accomplishments • Current positions of recent graduates • Recognition for student accomplishments (co-authorship practices) • Organizational structure of the laboratory and direct observation of the laboratory in operation

  24. Law Forum: Federal And MostState Court Systems Supreme Courts Appellate Courts Trial Courts

  25. Ethics Forum: TSU Research Integrity Committee (RIC)Section 520.00, TSU Principal Investigator’s Handbook • To ensure that research at Tennessee State University is conducted effectively, objectively and without improper influence or the appearance of improper influence, the Research Integrity Committee (RIC) was established. • The Committee has oversight of all inquiries and investigations associated with allegations of scientific or research misconduct.

  26. Ethics Forum: TSU Research Integrity Committee (RIC)Section 520.00, TSU Principal Investigator’s Handbook (continued) • Many queries involve questions of "honest differences” in interpretation or judgments of data which are specifically excluded under the PHS definition. These inquiries and investigations on scientific misconduct include the following: • Research Fraud • Falsification • Plagiarism • Fabrication • Other Serious Deviations

  27. Legal Sanctions • Encourage and force compliance • Punish and prevent crime • Benefit society and citizens

  28. Ethics Sanctions: The Nature and Severity of Disciplinary Action • Removal from the project • Letter of reprimand and special monitoring of future work • Probation • Salary reduction • Suspension • Rank reduction • Barred from University sponsored leaves • Termination of Employment • Ineligible for University Awards • Termination of Research/ Training Incentive Pay • Travel Restrictions • Barred from Conducting Future Research Projects at TSU • Possible criminal prosecution for certain egregious conduct that constitutes a statutory criminal violation.

  29. Regulatory Research Compliance:TSU Standing Committees • Institutional Review Board (IRB)/Human Subjects Committee, 45 CFR 46.101 • Institutional Animal Care and Use Committee(IACUC), 9 CFR 2.31 • Biosafety Committee, 42 CFR 73.1 • Radiation Safety Subcommittee, 21 CFR 361.1 • Research Integrity Committee, 42 CFR 93.100

  30. Regulatory Compliance Example: Human Subjects Research -TSU Institutional Review Board (IRB)

  31. Legal Procedure, Part 1: Lawsuit and Pre-Trial Pleadings Appeal Pretrial Motions PosttrialMotions Discovery Trial PretrialConference

  32. Legal Procedure, Part 2: Trial JurySelection–Voir Dire Jury Verdict Instruction to Jury Opening Statement – Overview of Essential Facts ClosingArguments PresentationofEvidence DirectedVerdict

  33. TSU Ethics Procedure, Part 1:RIC Procedure42 CFR 93.310-11; Section 520.10, TSU Principal Investigator’s Handbook Upon receipt of the inquiry findings that an investigation is warranted, the Committee will initiate the investigation promptly while notifying both the complainant and the respondent of such investigation. All involved parties are obligated to cooperate with the proceedings in providing information relating to the case. All necessary information should be provided to the respondent in a timely manner to facilitate the preparation of a response. The respondent should have the opportunity to address the charges and the evidence in detail. The University’s policies and procedures will address the role of legal counsel in the investigation. The University’s policy requires that an investigation be conducted as expeditiously as possible. The Committee must complete the entire investigation of the case within 120 days to be in compliance with the PHS guidelines and NSF regulations. If the deadline of 120 days of investigation cannot be met, the Committee may request an extension from the Vice President, Division of Research and Sponsored Programs, through the compliance coordinator.

  34. TSU Ethics Procedure, Part 2:Allegation and Investigation 42 CFR 93.310 -13; Section 520.10 TSU Principal Investigator’s Handbook • Action Step I: File allegations with the Vice President of the Division of Research and Sponsored Programs and/or the Research Integrity Officer and an inquiry is initiated • The RIC gathers information concerning the allegations and notifies the respondent of the charges. • The respondent provides written response to the allegations to the RIC along with documentation of evidence supporting the response. • The RIC reviews the response and evidence and submits an Inquiry Report to the Vice President of the Division of Research and Sponsored Programs indicating whether an investigation is warranted. • Action Step II: Investigation of Research Misconduct • The purpose is to explore further the allegations and determine whether fraud or other misconduct has been committed. • Individuals involved in the research in question are notified and requested to respond to the allegations, data are analyzed for accuracy, and the primary respondent is interviewed.

  35. TSU Ethics Procedure, Part 3:Report of Findings 42 CFR 93.310-13 ; Section 520.10 TSU Principal Investigator’s Handbook • a finding of fraud, • a finding of serious scientific misconduct short of fraud, • a finding that no culpable conduct was committed, but serious errors were discovered • finding that no fraud, misconduct, or serious scientific error was committed.

  36. TSU Ethics Procedure, Part 3 cont.: Findings of Research Misconduct - Federal Standards A finding of research misconduct requires that: • There be a significant departure from accepted practices of the relevant research community; and, • The misconduct be committed intentionally, or knowingly, or recklessly; and, • The allegation be proven by a preponderance of evidence. 42 CFR 93.104, 45 CFR 689.2(c); Section 520.10, TSU Principal Investigator’s Handbook.

  37. TSU Ethics Procedure, Part 4: Appeal/Final Review 42 CFR 93.314; Section 520.10 TSU Principal Investigator’s Handbook • The decision of the Committee can be appealed through a written appeal of the Committee’s decision. • The appeal must be restricted to the body of evidence already presented. • Appeals involving new evidence may warrant a new investigation. • The decision of the review made by the President of the University is final.

  38. Sites for Federal and University Policies • Office of Research Integrity, Department of Health and Human Services (DHHS): www.ori.hhs.gov • Division of Research and Sponsored Programs, Tennessee State University: www.tnstate.edu/research/RSP

  39. Questions? • Email: ddanner@tnstate.edu • Tel.: 615.963.2934

  40. Sources • Terrance L. Johnson, Ph.D., TSU Research Integrity Officer, Professor and Chair: Biological Sciences, Director: TSU MBRS-SCORE Program, Director: Title III Activity IV Program • Lee Reed, Peter Shedd, Marisa Pagnattaro, and Jere Morehead, The Legal and Regulatory Environment of Business, McGraw-Hill Irwin, Inc. (15th ed. 2009) • Nicholas H. Steneck, Office of Research Integrity (ORI), U.S. Department of Health and Human Services (DHHS), Introduction to the Responsible Conduct of Research (2007)

  41. Grants .gov • Demonstration of Grants.gov

  42. Planning your budget • Where to start • Budgets will contain both direct & facilities & administrative costs (F & A), or indirect costs, unless not allowed by the awarding agency. • The budget can be as simple as a one page justification or as complex as a spreadsheet & pages of budget justifications • Your budget will be the best estimation of the entire project costs and should be prepared with consideration & care.

  43. Planning your budget -2 • It is required that your budget be spent as proposed. • Budgets need to be whole dollar amounts, no cents if possible. • Use escalating figures for salaries, travel, & tuition if the project is intended to be more than one year, which will cover the costs of inflation. Use 3% of salary increase & 5% for tuition • If any, be sure to clearly identify all in-kind and matching funds that are committed to the project.

  44. Direct costs Direct costs are the cost of all resources that must be committed to implement a project.

  45. Direct costs • Salaries and Wages • Fringe Benefits • Consultants • Equipment • Supplies (Lab) • Travel • Subcontracts • Training Costs

  46. Other Direct Costs • Books, Reprints, Scientific Journals, Memberships • Consultants Services • Equipment Maintenance and Repair Costs • Materials and Supplies • Sub Awards • Printing, Duplication, Copying (relevant to project) • Publication • Telephone and Telegraph (long distance call only) • Tuition Support (Student)

  47. Allowable Costs Advertising (for personnel) Books Equipment-usually must be budgeted or approved in advance Meals-for subjects and participants or employees during travel Unallowable Costs Alcoholic Beverages Construction –unless authorized by agency Entertainment Goods and Services for Personal Use Allowable vs. Unallowable Costs

  48. Indirect Costs Costs incurred for the common or joint objectives and therefore cannot be identified readily and specifically with a particular sponsored project, instructional activity, or any other institutional activity.

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