1. Research Ethics Review and Resources UNC Chapel Hill Douglas MacLean Feb. 27, 2008

2. UNC Mission The mission of the University is shaped in large measure by the constitutional and statutory mandates by which public higher education is established and maintained. Article IX of the Constitution of the State declares: –Sec. 8. Higher education. The General Assembly shall maintain a public system of higher education, comprising The University of North Carolina and such other institutions of higher education as the General Assembly may deem wise.... –Sec. 9. Benefits of public institutions of higher education. The General Assembly shall provide that the benefits of The University of North Carolina and other public institutions of higher education, as far as practicable, be extended to the people of the State free of expense.

3. UNC Mission, cont. The Higher Education Reorganization Act of 1971, which placed those 16 institutions under one governing board, asserted the basic objectives and purposes for the University of North Carolina: to foster the development of a well-planned and coordinated system of higher education, to improve the quality of education, to extend its benefits, and to encourage an economical use of the state's resources.

4. UNC Mission Statement The University of North Carolina is a public, multi-campus university dedicated to the service of North Carolina and its people. It encompasses the 16 diverse constituent institutions and other educational, research, and public service organizations. Each shares in the overall mission of the University. That mission is to discover, create, transmit, and apply knowledge to address the needs of individuals and society. …

5. UNC Mission Statement, cont. This mission is accomplished through instruction, which communicates the knowledge and values and imparts the skills necessary for individuals to lead responsible, productive, and personally satisfying lives; through research, scholarship, and creative activities, which advance knowledge and enhance the educational process; and through public service, which contributes to the solution of societal problems and enriches the quality of life in the State. In the fulfillment of this mission, the University shall seek an efficient use of available resources to ensure the highest quality in its service to the citizens of the State. …

6. UNC Mission Statement, cont. Teaching and learning constitute the primary service that the University renders to society. Teaching, or instruction, is the primary responsibility of each of the constituent institutions. The relative importance of research and public service, which enhance teaching and learning, varies among the constituent institutions, depending on their overall missions.

7. Review: Purpose of this course Increase knowledge of and sensitivity to issues surrounding research ethics Improve the ability of participants to reason about ethical choices

8. Review, cont. Research: –A systematic investigation, including development, testing and evaluatoin, designed to develop or contribute to generalizable knowledge. Practical Ethics: –A branch of philosophy that analyzes arguments about what is good and bad, right and wrong. Professional values: –Self-regulating –Pursue social goals

9. Review, cont. Voluntary informed consent –Legal capacity to give consent (no children or mentally impaired) –Genuinely free to exercise choice (no force, fraud, or deception) –Institutional Review Boards (IRB) (Designed to protect research subjects)

10. Review, cont. Authorship –Requires substantial participation –The following conditions are all necessary: Help to conceive design and method, or help to analyze and interpret data Help to draft article or revise its intellectual content. Approve final draft. –Does not justify authorship: Secured funding Generally supervised the group Has seniority or outstanding credentials

11. Review, cont. Avoiding authorship disputes –Communicate early and often –Acknowledge sponsor –If conflicts persist, send colleague in writing a detailed account of your perspective

12. Review, cont. Research misconduct –Falsification – altering data –Fabrication – creating data –Plagiarism – borrowing ideas or words without appropriate attribution Copyright (legal protection of intellectual property) –Original works of authorship (books, software) –Covers the particular expressioon of an idea in the work –The idea itself cannot be copyrighted.

13. Review, cont. Conflicts of interest https://cfx3.research.unc.edu/coi/coi_policy.cfm

14. Ethics Web Sites POLICY AND PROCEDURES ON ETHICS IN RESEARCH The University of North Carolina at Chapel Hill August 15, 1994 Policy Public trust in the integrity and ethical behavior of scholars must be maintained if research is to continue to play its proper role in our University and society. It is the policy of The University of North Carolina at Chapel Hill that research carried out by its faculty and staff be characterized by the highest standards of integrity and ethical behavior. It is further the policy of the University to inform fully all affected parties where misconduct in research sponsored by, or under the administrative supervision of, the University has occurred. … UNC CH Research Ethics Policies: http://www.unc.edu/campus/policies/ethics.html

15. Ethics Web Sites, cont. Research Ethics Resources 2007-08 Research Ethics Workshops and Seminars Spring 2008 A seven session, 1 credit course in research ethics will be offered by Douglas MacLean (UNC-CH Professor of Philosophy) this spring. In addition, the course materials are available online (http://openseminar.org/ethics/courses/73/index/screen.do) as an alternative for self-directed study. The 2007-08 CPC research ethics requirement will be satisfied for those completing the course for credit. For those choosing the self-directed option, one CPC RE workshop = one module. Please provide evidence of module completion for this option. Joint Duke-UNC Symposium with generous support from the Robertson Collaborative Fund Panel Discussion:Ethical Issues in Global Short-term Medical Outreach Pape Gaye, Senior Vice President of IntraHealth, IntraHealth International Dr. Jeffrey Baker, Duke UniversityJeffrey Baker Dr. Gail Henderson, Professor of Social Medicine, UNC-CHGail Henderson Tuesday: February 5, 2008 Hock Plaza Auditorium, Duke University (Free Parking Available at the Hock Plaza Parking Garage) 7:00 p.m. - 8:30 p.m. ---- Dessert Reception to follow The Pop Center: http://www.cpc.unc.edu/training/meth.html

16. The Parr Center for Ethics: http://parrcenter.unc.edu/

17. http://www.nih.gov/sigs/bioethics/IRB.html National Institutes of Health Ethics Web Sites, cont.

18. http://rcrec.org/ Responsible Conduct of Research Education Consortium

19. http://ethics.iit.edu/codes/

20. Data acquisition, management, ownership

21. Mentor / trainee responsibilities http://ccnmtl.columbia.edu/projects/rcr/rcr_mentoring/

22. Authorship and peer review http://ccnmtl.columbia.edu/projects/rcr/rcr_authorship/

23. http://www.primr.org/ Research involving use of humans

24. Research involving use of animals http://research.unc.edu/iacuc/links.php

25. Research misconduct http://ccnmtl.columbia.edu/projects/rcr/rcr_misconduct/

26. Conflict of interest and commitment http://www.nih.gov/about/ethics_COI.htm