Responsible Conduct of Research Workshop Howard University October 24, Why RCR?

What is Responsible Conduct of Research (RCR)? 2 o Guidelines and Regulations o Plagiarism o Institutional Review Board (IRB) / Human and Animal Subjects o Ethical Reasoning / Conflict of Interest o Data Management o Authorship and Publication Practices / Collaborative Research o Mentorship o Informed Consent o Intellectual Property

Why is RCR Important? 3 Federal Regulations University Policies Best Practices Legal and Ethical Consequences of Noncompliance – University – Business – Individual – Society

What’s the right thing to do? 4 Examples to consider Michael Sandel, Justice Henrietta Lacks and “Immortal Cells” “Quick and Dirty” Dissertation

Michael Sandel, Justice 5 Professor of Philosophy at Harvard whose book and PBS series, asks: If you had to choose between (1) killing one person to save the lives of five others and (2) doing nothing even though you knew that five people would die if you did nothing—what would you do? What would be the right thing to do? This is an extreme example, and one for which there is no “right” answer. But it captures the moral dilemma that we sometimes face in less stark terms.

Henrietta Lacks and “Immortal Cells” 6 February 1, 1951, Baltimore resident Henrietta Lacks diagnosed with cervical cancer at Johns Hopkins University Hospital February 9, 1951, radium treatment begun; another tissue sample taken and given to Dr. George Gey, head of tissue culture research at JHUH Within days, Henrietta Lacks’s cancer cells had multiplied “like nothing anyone had seen”. They were “immortal” and Dr. Gey eventually shared them with research colleagues around the world--and beyond.

Henrietta Lacks and “Immortal Cells” 7 October 4, 1951, Henrietta Lacks died at JHU Hospital; she was 31 years old October 4, 1951, Dr. George Gey appeared on national television and displayed a vial of “HeLa” cells and discussed the possibility that research could find a cure for cancer 1975, Henrietta’s daughter-in-law learned from someone who “worked with them” in a Washington, DC laboratory that the cells were still alive

Henrietta Lacks and “Immortal Cells” HeLa cells had become standard reference cells and used in research that led to Salk polio vaccine in 1950s.

Henrietta Lacks and “Immortal Cells” 9 Have been used in cancer research, study of HIV-AIDS, the effects of radiation and toxic substances, gene mapping, and many other investigations Rebecca Skloot, The Immortal Life of Henrietta Lacks, Random House (2010)

Henrietta Lacks and “Immortal Cells” 10 Moral and Ethical Issues Informed Consent Not uncommon at the time that researchers did not inform subjects or patients about the nature of their investigations, or (as in the Tuskegee experiment), of their potential consequences. Guidelines and regulations have been established to assure informed consent.

Henrietta Lacks and “Immortal Cells” 11 Moral and Ethical Issues Compensation What is morally or legally due to a person (or their estate) if something of commercial value is developed from their cells? Unresolved issue being debated now by medical ethicists.

Henrietta Lacks and “Immortal Cells” Does it matter that Henrietta Lacks was an African American woman of modest means, many of whose family members today lack health insurance?

“Quick and Dirty” Dissertation 13 Plagiarism is a real problem with real consequences in scientific research, for students, faculty, and professionals An outstanding Howard student submitted their application for oral defense of dissertation to the Graduate School Subsequently student’s department asked that the defense be postponed pending an investigation Investigation found student copied substantial portions of the dissertation from student at another university without their knowledge

“Quick and Dirty” Dissertation 14 Confronted with the facts the student confessed and expressed regret The student’s advisor, committee, and departmental graduate faculty requested that the student be dismissed from the Graduate School The student was dismissed and notified that he cannot return to graduate study at Howard University

Why is RCR Important? 15 Legal and Ethical Consequences of Noncompliance University Business Individual Society

Thank you! 16