1. 1 The Responsible Conduct of Research Daniel R. Vasgird, PhD, CIP Research Compliance Services Office of Research Responsibility University of Nebraska, Lincoln (402) 472-1837 dvasgird2@unl.edu http://research.unl.edu/orr

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3. 3 "For a scientist, integrity embodies above all the individual's commitment to intellectual honesty and personal responsibility … For an institution, [integrity] is a commitment to creating an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness…" -Integrity in Scientific Research, The National Academy of Sciences

4. 4 The Fundamental Proposition Rules are just a small part of the picture. The alpha and the omega has to be integrity from which all else will follow, including compliance.

5. 5 “Ethics primarily concerns the effects of our actions on others.” Randy Cohen

6. 6 “The first step in the evolution of ethics is a sense of solidarity with other human beings.” Albert Schweitzer

7. 7 ORCS Core Areas (Red = Federal Regulations) 1)Human research protections (IRB) 2)Animal research protections (IACUC) 3)Data acquisition, management, sharing, and ownership 4)Mentor/trainee relationships 5)Publication practices and responsible authorship 6)Peer review 7)Collaborative science 8)Research misconduct 9)Conflict of interest and commitment 10)Environmental health and safety liaison (IBC & RSC) 11)Export Controls

8. 8 ORCS Mission: Foster a culture of integrity and compliance within the University directed at ensuring that participants in the University of Nebraska, Lincoln research enterprise internalize and pursue the goal of self-directed responsible conduct of research.

9. 9 FSGO Compliance Elements (HHS & NSF) Implementing written policies and procedures; Designating a compliance officer and compliance committee; Conducting effective training and education; Developing effective lines of communication; Conducting internal monitoring and auditing; Enforcing standards through well-publicized disciplinary guidelines; and Responding promptly to detected problems.

10. 10 Organization & Governance of Research at UNL Academic and research activity is conducted through the faculties and departments, under the direction of the appropriate dean and the Vice Chancellor for Research For cases of research misconduct, graduate students involved in research are subject to the same disciplinary procedures as faculty or staff

11. 11 Robert K. Merton Stated that the disinterested pursuit of truth is the norm of science, expressed as: Universalism Communalism Disinterestedness Organized skepticism

12. 12 Perseverance and success, but for some increased: 1.Risk for unintentional bias 2.Willingness to cut corners 3.Willingness to commit serious misconduct Consequences of ambition

13. 13 The OSTP Definition of Misconduct “Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results… Research misconduct does not include honest error or differences of opinion.” http://www.unl.edu/research/orr/misconduct.shtml

14. 14 CONFLICTS OF INTEREST A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. http://www.unl.edu/research/orr/conflict.shtml

15. 15 Key Components of Regulations  The institution, not the federal government or the sponsor, has the primary responsibility to develop its own internal policies and procedures.  The institution is to designate an official to review disclosure of significant financial interest and manage conflicts of interest.  Investigators must disclose any "significant financial interest" to the institution.  The institution must report to the federal funders if it believes an investigator’s significant financial interest could affect the research.

16. 16 Goals of Federal Regulations  Manage  Reduce  Eliminate

17. 17 UNL Conflict of Interest Policy Annual conflict of interest disclosure and reporting by faculty members, officers of research, and officers of administration Research-specific conflict of interest disclosure and reporting in sponsored research supported by a business in which key personnel has ANY financial interest or holds executive position

18. 18 Human Research Protections Program National Research Act In July 1974, the passage of the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which established IRBs.

19. 19 HUMAN RESEARCH GONE AWRY Nazi Experiments (Nuremberg Code) Milgram Obedience Experiments Radiation Experiments Wichita Jury Taping Study Jewish Chronic Disease Cancer Study Thalidomide Tragedy Syphilis Experiment (PHS, Tuskegee)  Led to NRA (IRBs & Informed Consent) Jesse Gelsinger

20. 20 MAIN FUNCTION OF IRB REVIEW TO ASSURE THAT: RISKS ARE MINIMIZED AND REASONABLE IN RELATION TO ANTICIPATED BENEFITS. THERE IS INFORMED CONSENT. RIGHTS AND WELFARE OF SUBJECTS ARE MAINTAINED (i.e., Continuous).

21. 21 DRAMATURGICAL FUNCTION To become the subject as much as possible

22. 22 Human Research Protections Program IRB support Process Overview Training: CITI & In Person AAHRPP Electronic Submission

23. 23 THE ESSENTIAL DILEMMA Human dignity and social justice in an economically and politically unbalanced world

24. 24 The major responsibility for insuring ethical decision making in human research rests with the IRBs in terms of empowerment, flexibility and discretion.

25. 25 IRBs have ethical responsibility and legal authority.

26. 26 IRB Belmont Report Respect for Persons Beneficence Justice

27. 27 The research protection system fundamentally revolves around mutual trust.

28. 28 RESEARCH “RESEARCH” MEANS A SYSTEMATIC INVESTIGATION DESIGNED TO DEVELOP OR CONTRIBUTE TO GENERALIZEABLE KNOWLEDGE. 46.102 (d)

29. 29 HUMAN SUBJECT “Human subject” means a living individual about whom an investigator…conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. 46.102(f)

30. 30 Reasonable Expectations

31. 31 AUTHORITY OF IRB Requirement of review Approve, disapprove or modify Conduct continuing review At any time and in person if desired Must be done at least once per year Observe/verify changes Suspend or terminate approval

32. 32 CRITERIA FOR APPROVAL OF RESEARCH 45 CFR PART 46.111 To approve research, an IRB should determine that all of the following conditions exist: 1.Risks to subjects are minimized. 2.Risks are reasonable in relation to anticipated benefits, if any, to subjects and to advancement of knowledge. 3.Selection of subjects is equitable. 4.Informed consent will be sought. 5.Informed consent will be documented.

33. 33 CRITERIA FOR APPROVAL OF RESEARCH 45 CFR PART 46.111 6.Where appropriate, research plan makes adequate provision for monitoring the data collected to insure safety of subjects. 7.There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 8.Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects.

34. 34 Ensure that language and readability are appropriate to the subject.

35. 35 46.116 Consent - the Process Process of information exchange which should include: - written materials (CF, letters, debriefs) - verbal instructions - questions & answers after reading ICF with subject - setting/timing (family/friends consultation) - agreement/documentation - reaffirmation/re-consent

36. 36 ETHICS IN ETHNOGRAPHIC RESEARCH In a nutshell, researchers must make their research goals clear to the members of the community where they undertake their research and gain the informed consent of their consultants to the research beforehand. It is also important to learn whether the group would prefer to be named in the written report of the research or given a pseudonym and to offer the results of the research if informants would like to read it. Most of all, researchers must be sure that the research does not harm or exploit those among whom the research is done. http://www.aaanet.org/committees/ethics/ethics.htm

37. 37 “One is apt to think of moral failure as due to weakness of character: more often it is due to an inadequate ideal.” Richard Livingstone