Responsible Conduct of Biomedical Research Michael J. Leibowitz, M.D., Ph.D. Professor, Molecular Genetics, Microbiology & Immunology UMDNJ-Robert Wood Johnson Medical School April 25, 2008

Definition of Scientific Misconduct Fabrication Falsification Plagiarism Other definitions (not meeting the standards of the scientific community) no longer widely used

Experimental Data Who owns them? Dated and signed Not removable or erasable How keep computerized data?

Publishing a Paper Why publish? When you ready to publish? Who should be an author? What is your responsibility? How do you avoid plagiarizing? Where to submit? Who reviews? What to expect from peer review? How to respond to reviewer critiques? What are your responsibilities as a reviewer?

Fabrication and Falsification Unlike plagiarism, obviously wrong and requires conscious action by the wrong- doer How can this be prevented? -Supervisors -Reviewers -Other researchers

Falsification and Fabrication Is it ever possible to omit data from analysis? Must all data be published?

Definition: Plagiarize “to steal or pass off as one’s own (the ideas or words of another)” “to present as one’s own an idea or product derived from an existing source.” Webster’s Seventh New Collegiate Dictionary

Definition: Copyright “the exclusive legal right to reproduce, publish and sell the matter and form of a literary, musical or artistic work.” Note that this includes scientific publications. Webster’s Seventh New Collegiate Dictionary

Who owns a publication? All authors? Senior (first) author? Submitting (PI) author? Employer(s) of authors? Funding agencies? Publisher?

Why is plagiarism the most widespread infraction despite being the easiest to detect? Many authors may not know the rules! Computers make plagiarism easy! “Self-plagiarism” is still plagiarism!

How to use the work of others appropriately Reference Citation When is permission needed? From whom?

Permission to Re-Publish is Not Automatic “The rightsholder did not grant rights to reproduce this item in electronic media. For the missing item, see the original print version of this publication. Figure 3. cat-scratch disease showing inflammation of the lymph node. Division of Pediatric Surgery, Brown Medical School. Accessed August 17, 2007, at Catscratch.html.” Catscratch.html P.M. Rabinowitz et al., American Family Physician 76: 1318 (2007).

Conflict of Interest Science should be unbiased Financial conflict of interest Funding sources as conflict of interest –Results of Industry vs. Government funded research Professional advancement Expert reviewer may be conflicted Confidentiality; responsibility of grant and publication reviewers Who should review?

Responsibility of Whistleblowers You should be vigilant and responsible. False accusations may constitute misconduct! Whistleblowers and accused have rights Think globally, act locally Seek advice before taking action Role of the Ombudsman

Special Topics IACUC: Protection of animal subjects IRB: Protection of human subjects Chemical safety Radiation safety Containment of hazardous or infectious agents Right to know laws

Responsible Research Involving Human Subjects History -Nuremburg Code -Tuskegee Syphilis Study -Belmont Report (1978) -All human experimentation must be approved by an Institutional Review Board -Outsourcing does not bypass ethics requirements

Three Principles for Treatment of Human Subjects Respect for persons Beneficence Justice

Informed Consent Voluntary: problems with prisoners, students, employees, children, etc. No undue inducements Must be understandable to subject Risks and potential benefits must be presented accurately Right to withdraw at any time Deception is generally not allowed