Introduction to Responsible Conduct of Research (RCR)

1. Introduction to Responsible Conduct of Research (RCR) Jo Ellen Sherow Office of Research Compliance

2. RCR Responsibility • "Research mentors, laboratory directors, department heads, and senior faculty are responsible for defining, explaining, exemplifying, and requiring adherence to the value systems of their institutions." Responsible Science: Ensuring the Integrity of the Research Process. Vol. 1:7, NAS, 1992.

3. Federal RCR Content Areas • Conflict of Interest and Commitment • Human Subjects • Animal Subjects • Publication Practices and Responsible Authorship • Data Acquisition, management, Sharing and Ownership • Mentor/Trainee Responsibilities • Peer Review • Collaborative Science • Research Misconduct

4. RCR in Practice • Responsible conduct of research needs to be integrated in the entire research effort – it is not a single point in time effort • Planning • Conducting • Reporting • Reviewing

5. Honorarium • Means any payment made in consideration for any speech given, article published, or attendance at any public or private conference, convention, meeting, social event, meal, or similar gathering. “Honorarium” does not include ceremonial gifts or awards that have insignificant monetary value; unsolicited gifts of nominal value or trivial items of informational value. Ohio Revised Code 102.01

6. The Legislative Framework of RCR • Federal Regulations • Animal Welfare Act • National Research Act • Health Research Extension Act • State Ethics Law

7. Other RCR Criteria • Institutional Policy • Professional Standards • Personal Ethics

8. The Planning Phase How does RCR apply prior to beginning research?

9. Determine what regulations and guidelines apply to your research: • Do you use humans? • Consult with the IRB office. • Do you use animals? • Consult with the IACUC office and Laboratory Animal Resources • Do you have a potential conflict of interest? • Consult with the Director of Research Compliance

10. Other considerations • What are the professional standards that apply to my work? • What are the Ohio University policies and procedures that my work will intersect? • Think broadly – (e.g. export controls, space utilization, procurement, etc.)

11. Know your Requirements • Do you know what a human subject is? An animal subject? • What is the IRB and the IACUC? • Understanding your responsibilities: • Regulatory requirements • Training • Following the rules • Accepting responsibility

12. Area 1: Protection of Human Subjects • Founded on three principles • Beneficence • Respect for persons • Justice • Important take away messages: • The researcher is not permitted to determine if the research is exempt – it must be submitted and that determination made by the compliance office. • Not all interactions with humans are research.

13. Area 2: Welfare of Laboratory Animals • Founded on three principles • Reduction • Refinement • Replacement • Important take away messages: • Animal use includes teaching, testing and research • Animal use sites are inspected twice per year • Animal use includes observation “bird watching” • Animal use includes use outside of Ohio University

14. Area 3: Conflicts of Interest • There are different types of conflicts • Financial conflicts • Conflicts of commitment • Conflicts of interest • Important take away messages: • Conflicts are not inherently “bad” • There are reporting thresholds that require disclosure • Disclosure is required for funded projects • Disclosure is your friend.

15. Specialized Training Available • Navigating the IACUC • Navigating the IRB • Navigating Conflict of Interest These have detailed regulatory requirements and a more comprehensive overview is offered at special training sessions each quarter.

16. The Conduct Phase What needs considered with respect to RCR as you and your colleagues conduct the research?

17. Data Management • What are the requirements? • Funding agency, Ohio University, Legislative • Ownership of the Data • Is this clear to all involved? • Do you own the data or does Ohio University? • What are the sponsor requirements? • What about graduate students and postdocs?

18. Mentor/Trainee Considerations • Who has responsibility for what part of the research? • Does everyone understand their responsibilities? • Have you thought out the supervision of trainees? • Recognize that trainees have desired outcomes and need to be able to work toward those • Remain aware of what is occurring

19. Collaborative Research Considerations • Who is in charge of project management? • Who is writing up the results? • Who will be listed as authors, who as acknowledgements? • Recognize that different collaborators have different interests • Recognize any cultural differences that could impact the project

20. Data Management

21. Who manages the data? • Establish at the start of the project • Assure that there is agreement among the team • Special consideration for graduate students: • Publishing rights

22. Ownership of Data • Recognize that external funds are not the property of the PI – they are provided to Ohio University • Ohio University generally owns research conducted at Ohio University • Some funding agencies have restrictions on the right to use data, these are generally different between public and private entities

23. Collection of Data • The reliability of your methods impacts the reliability of your results • Data is the foundation of future research • Sloppy work not only wastes resources, it can resemble misconduct • If you fail to gain the appropriate permissions, you may not be allowed to use the data you have collected!

24. Protection of Data • Storage Methods • Consider disaster planning • Back up • Access • If your permissions to collect has authorization or confidentiality requirements they must be followed! • Retention • NIH requires 3 years, but some agencies require up to 7 years • Know what the agency AND institutional requirements are

25. Grant or Contract? • Grants usually require research to be done and reports filed, but the data remains under control of the institution • Contracts generally require the researcher to deliver a service or product. • Know which you are working under since the rights to publish and use results later can be very different.

26. Sharing Data • Release of preliminary data is not generally required • Exception: If public health is endangered • Data can be held until researchers publish their work, unless there was an agreement to release it in some other time frame at the start of the work • Once published general practice is that all data is available to other researchers.

27. Other Considerations • Large projects, such as a multi-center clinical trial, have special data management issues. • Do individual PI’s get to retain some control over their data? • Research funded by the Department of Defense may have data security and sharing issues. • Restrictions are usually heightened • Research where national security issues may be identified • Changing policies and regulations

28. Area 5: Mentoring • The key to mentor-trainee relationships is to set the ground rules at the beginning of the relationship. • Clearly state responsibilities • Provide adequate supervision and guidance • Recognize that trainees have agendas of their own • Mentors must understand their responsibility to their trainees, and trainees must be aware of their responsibility to their mentor. • Review these on a regular basis during the research project

29. Mentoring Issues for the Mentor • Expectations with respect to time commitments of the trainee • What will be the criteria for evaluation of the trainee? • What are the specific responsibilities of the trainee? • Determine ownership and authorship expectations BEFORE you begin

30. Mentoring

31. Mentoring Issues • Research environment • Is it collaborative or competitive? • Assure that everyone understand their responsibilities • Understand RCR and hold yourself to those standards, especially if things seem wrong

32. Collaborative Research

33. Special Issues with Postdocs • Mentors must be willing to allow postdocs to become independent researchers • Recognize that postdocs do not have the protections of either students or faculty • First authorship may be appropriate, but should be agreed upon at the beginning.

34. Collaborative Research • Requires diligence in management of relationships and duties • Goals • Roles • Data management • Authorship issues • Reporting • Presentations • Intellectual property • Methods to alter agreement

35. Managing Collaborative Ventures • Who is in charge? • Scientific • Financial • Training • Compliance • Reconcile interdisciplinary differences

36. The Reporting Phase • The purpose of research is to create results. • When the work is publicly funded there is a responsibility to share results for the public benefit. • Those results are of no public value if they are not shared. • Shared results form the structure on which future research is built.

37. Reporting Research • Foundation blocks for reporting research • Honesty • Accuracy • Efficiency • Objectivity

38. Authorship

39. Considerations • Authorship requires significant contribution to the project • Concept and design of the research • Responsibility for data collection and interpretation • Drafting the publication • Approving the final version of the publication • Other contributors can be listed in the acknowledgements

40. Authorship Order • Order of authorship should be an agreement among the research participants • Single most common authorship complaint in my office • Authors are generally listed in order of importance BUT some publications and/or disciplines use alpha order • Discuss this BEFORE you begin the work!

41. Publication Issues • Generally, “honorary authorship” is not an accepted practice • Not an author because they are chair, add “weight”, etc. • Duplicate publications • Rewriting the information for a different publication is not ethical without referencing the initial publication. • Distorts the research record, e.g. clinical trial results • Self-plagiarism • Publishing in smaller “bites” of information for the purpose of increasing the number of publications.

42. Area 8: Peer Review • Peer review is a critical part of the research chain • There can be public as well as professional consequences to peer evaluations • Peer review can influence • Which projects are funded • Which findings are published • Investigator status

43. Peer Review

44. Know the Requirements • Meet deadlines if you agree to do the review • Be diligent in assessing the quality • Use an open mind to assess the importance • Recognize and adhere to the confidentiality factor

45. Research Misconduct What is the difference between “research” misconduct and “academic” misconduct?

46. Survey suggests research misconduct is common Thu Jun 19, 2008 12:34am EDT WASHINGTON (Reuters) “Research misconduct at U.S. institutions may be more common than previously suspected, with 9 percent of scientists saying in a new survey that they personally had seen fabrication, falsification or plagiarism. The survey of 2,212 mainly biomedical scientists at 605 universities and other research institutions, published in the journal Nature on Wednesday, also showed that researchers are very reluctant to report bad conduct.” http://www.reuters.com/article/scienceNews/idUSN1846626420080619

47. What is Research Misconduct? • Know the research misconduct policies and standards • Research misconduct under federal guidelines focuses on: • Fabrication • Falsification • Plagiarism • Includes the proposing, performing, or reviewing phases. • Includes actions that: • Are a significant departure from accepted practices • Are committed intentionally, knowingly or recklessly • Are proven by a preponderance of the evidence

48. Universities Look for Lessons as Professor Awaits Sentencing Over Export-Law Violations • The Chronicle of Higher Education Tuesday, April 21, 2009 By PAUL BASKEN On May 13, John Reece Roth, a retired University of Tennessee professor, is expected to walk into a Knoxville courthouse and be sentenced to at least five years in prison for allowing unauthorized foreign citizens access to classified technology. Mr. Roth, 71, who taught electrical and computer engineering at the university's Knoxville campus, was convicted on charges involving his use of a Chinese graduate student on a Pentagon research contract. http://chronicle.com/daily/2009/04/16330n.htm

49. “Research Misconduct” vs. “Ethical Research” • Not all ethically questionable circumstances are prosecuted under the research misconduct policy • Academic misconduct • Criminal behavior • Violation of other institutional policies and procedures

50. Other Research Misconduct • The definition of research misconduct under Ohio University policy 19.048 also includes: “…or other practices that seriously deviate from those that are commonly accepted within the academic community for proposing, conducting, or reporting research” • Violation of other state, federal or institutional policies • Ethical allegations that are not defined within the scope of 19.048 or federal research regulations may still be academic misconduct and/or criminally liable