ETHICAL CHALLENGES OF CONTEMPORARY ACADEMIC RESEARCH

1. ETHICAL CHALLENGES OF CONTEMPORARY ACADEMIC RESEARCH Leonard M. Fleck, Ph.D. Michigan State University

2. CASE STUDY: tPA and NINDS • Better ways to treat stroke/ brain attack • Two types of stroke; what tPA does • Benefits of tPA/ risks of tPA • Three-hour treatment window • Must do CT scan to rule out hemorrhagic stroke • Results of NINDS trial:11-13% absolute benefit from tPA • BUT, can these results be duplicated in the community?

3. CASE STUDY: tPA and NINDS • Genentech paid for a good part of the NINDS trial • Genentech refused access to raw trial data by all outside researchers • Clinical ethics issue: Should presumed consent in the ER be enough? • Research ethics issue: If you were a grad ass’t and knew true data on “three-hour window” what should you do?

4. 0 of 5 Answer Now Presenting the results of this research in the most favorable light possible is what everyone does; hence, I do not believe that this way of presenting data is open to justified moral criticism. • Strongly Agree • Agree • Neutral • Disagree • Strongly Disagree

5. 0 of 5 Answer Now Patients are supposed to give informed consent in the light of their assessment of the risks and benefits of taking tPA in the midst of a stroke. But their ability to give true informed consent is undermined by the way in which this research data was presented in prominent medical publications, which makes this presentation morally objectionable. • Strongly Agree • Agree • Neutral • Disagree • Strongly Disagree

6. 0 of 5 Answer Now If I were a grad student working in a lab where clinical data from the NINDS trial was being analyzed, and if I became aware of the misleading way in which this data was being presented in research papers, I would be morally obligated to confront the PI and demand that NIH be informed by him. • Strongly Agree • Agree • Neutral • Disagree • Strongly Disagree

7. 0 of 5 Answer Now If the PI explained to me that the contract with Genentech gave them complete ownership rights to the data, and that the lab was dependent upon millions of dollars of future funding from Genentech, then I would understand that I had no moral right to report this manipulation of data to NIH. • Strongly Agree • Agree • Neutral • Disagree • Strongly Disagree

8. Case • In May of 2009 it was reported Japanese researchers had successfully added genes to monkeys that caused them to glow green under a flourescent light. Further, this trait was passed to subsequent generations. The goal of the research is to produce strains of primates with Parkinson’s, Huntington’s, etc. in order to test new treatments.

9. 0 of 5 Answer Now I find this “green monkey” research totally repugnant; it is an abuse of animals that ought never be permitted. • Strongly Agree • Agree • Neutral • Disagree • Strongly Disagree

10. 0 of 5 Answer Now If I were working in a lab where this sort of research were being done, I would feel I had the moral right to contaminate the research at various crucial points so that the researchers could never achieve successful results. My conscience would tell me this was the right thing to do. • Strongly Agree • Agree • Neutral • Disagree • Strongly Disagree