Stan Korenman, M.D. Professor of Medicine Associate Dean, Ethics

Transcription

1 Ethics in Patient-Oriented Research Stan Korenman, M.D. Professor of Medicine Associate Dean, Ethics

2 M261: Responsible Conduct of Clinical and Translational Research Sep 29 Introduction to Research Ethics Stan Korenman The responsibilities of Institutions Ann Pollack Oct 6 Professionalism and the Ethical Imperatives of Clinical Research Neil Wenger Oct 13 Protection of Research Subjects IRB Sharon Friend Oct 20 Research Monitoring Laurie Shaker-Irwin Technology Transfer Kathryn Atchison Oct 27 Genetics and Stem Cell Researc Leslie Raffel Nov 3 Responsible Conduct of Community and International Research Roger Detels Nov 10 Privacy and Confidentiality TBN Nov Receive 17 Malfeasance Exam and Misconduct Stan Korenman, Ombuds Tom Kosakowski Nov 24 Pre Thanksgiving Holiday Dec 1 Conflicts of Interest: Built-in Bias. Stan Korenman

3 What is Science? Science is the systematic study of nature. It involves all of nature and all the tools we use to study nature Systematic study means the use of the scientific method

4 A Picture of the Corpus of Science An advance

5 A Paradigm Shift An advance

6 What Is the Scientific Method? Hypothesis directed.or is it? Experiments. or observations Conclusions tentative Educated skepticism. Prove it Each report contributes to the corpus Each scientist is ethically responsible to preserve and enhance the corpus

7 Science As A Problem 1. Dangers Nuclear Energy Global warming Chemicals-CFCs, PCBs, Bisphenol A, Safety of transgenic plants and animals Violations of Privacy and confidentiality 2. Research Misconduct 3. Risks and Misuse of Human Research 4. Ever Changing Conclusions

8 Responsibilities Of Science 1. Reason is the instrument of societal development, and scientific investigation may be the ultimate expression of human reason. 2. The public supports science to better understand nature and help humanity. 3. Society s increasing dependence on scientific inquiry for advances and for policymaking, conveys on science a great responsibility to maintain its integrity. 4. Thus, in carrying out its public trust, science operates in the realm of human duty i.e. in ethics.

9 Definition of Ethics The science of morals; the department of study concerned with the principles of human duty. EMERSON Nature, Idealism Wks. (Bohn) II. 164 Ethics and religion differ herein; that the one is the system of human duties commencing from man; the other, from God Oxford Dictionary

10 Ethics: Study of Moral Behavior 1) CONSEQUENTIALIST ETHICS- Various forms of Utilitarianism; The act is unimportant look for greatest good in the outcome Making the utilitarian judgement for each act is hard work essentially impossible To make decisions easier, create rules. Rules comparing goods and greatest goods often lead to injustices as well as irreconcilable differences of opinion. What is a life really worth?

11 2. DEONTOLOGICAL ETHICS We know instinctively what s right- hard-wired Rules like ten commandments, but values are cultural and change over time, so must rules behaviors towards women and minorities Conflicting rules, legal and moral Golden Rule operates for every act TO MAKE THIS WORK OUT LOTS OF RIGHTS ARE DEFINED Life, liberty, property Autonomy, privacy, justice Obligations to others. You can t put a value on a life.

12 Ethical Dilemma Mary and Jody are conjoined twins. They, together have one heart and one pair of lungs. Surgery will permit Jody to survive and be reasonably normal while Mary must die. Without surgery, both will die in a month or so What to do? CONSEQUENTIALISTS Operate DEONTOLOGISTS - Let them both die because you must not violate the principle Thou shall not kill

13 Is It Wrong to Use Unneeded Frozen Embryos As Research Tools Deontological argument: This is living human tissue with the potential to be a person- don t mess with it. Utilitarian argument: These blastocysts have zero chance of becoming a person and using them may result in a lot of good for a large number - use them. These people are talking past each other.

14 Rational Decision-making Behavioral psychologists have learned a great deal about human preferences and decision-making Even what we think of as carefully considered rational decisions are influenced by external factors. Framing the Decision Architecture of choice opportunities greatly influences the outcome.

15 Compliance Professionals Robert Cialdini: Influence; 6 Principles Reciprocation Gifts Consistency It s Standard Social Proof Kobe does it Liking Really nice team Authority MD won t harm me Scarcity Don t miss out

16 The End of Philosophy In an op-ed piece in the NY Times David Brooks pronounced the end of Philosophy because if our decisions are based on method of presentation and outside influences, then they can t be called rational decisions at all. Do you agree with this? Is there a remedy?

17 Pope John Paul II, The preeminence of the profit motive in conducting scientific research ultimately means that science is deprived of its epistemological character, according to which its primary goal is discovery of the truth. The risk is that when research takes a utilitarian turn, its speculative dimension, which is the inner dynamic of man s intellectual journey, will be diminished or stifled. 3/25/02

18 Research Integrity Research integrity is essential for achieving scientific excellence and for earning the public's trust. Integrity embodies above all an individual scientist s commitment to intellectual honesty and personal responsibility and an institution's commitment to maintaining an environment that promotes responsible conduct. Civilized vs survivalist behavior.

19 Definition of Research Integrity "Research integrity may be defined as active adherence to the ethical principles and professional standards essential for the responsible practice of research."

20 Active Adherence By active adherence we mean adoption of the principles and practices as a personal credo, not simply accepting them as impositions.

21 Principles Honesty, The golden rule, Trustworthiness, High regard for the scientific record. While we encourage vigorous defense of one s ideas and work, ultimately research integrity means examining the data with objectivity and being guided by the results rather than by preconceived notions. NAS Res Integrity

22 Practices Honesty, fairness and proficiency in 1. proposing, performing, and reporting research 2. representing contributions to research proposals and reports 3. peer review Collegiality in scientific interactions, communications and sharing of resources Avoidance and disclosure of conflicts of interest Protection of human subjects Humane care of animals Adherence to the mutual responsibilities of mentors and trainees

23

24 Social Responsibility Do science and scientists have ethical responsibilities to society beyond discovering truths and developing solutions to problems? Do they have a responsibility to report results, whatever the predicted consequences. Do they have an ethical responsibility to defend science (Intelligent Design)

25 Responsible Conduct of Research Social responsibility Performance Reporting Mentoring Communication Conflicts of interest

26 Social Responsibility We make it possible and politicians use it for good or evil. Scientists must be involved in social development derived from science and technology, health care reform, global warming, pollution of the earth. Can t predict the consequences of discoveries and inventions Nuclear fission, Internet, Genetics, Cloning, Medicine, Ecology, Sociology

27 Responsible Performance A. Experimental design is most critical 1. Openness 2. Adequate controls 3. Objective end points 4. Criteria for rejecting data We now have (brute force biology), a different design B. Complete and accessible records Privacy and security (think huge databases) C. Play by the rules Human and animal subjects, OSHA, Radiation Safety, HIPAA, etc.

28 Ownership of Data Data include any information obtained during the process of research, no matter in what form it is produced, or in what form it is stored. Medical information - belongs to the research participant and must be protected for privacy Grants University owns it and shares with PI Drug studies with the sponsor and sometimes the investigator Trainees own no data, not even what they worked on

29 Types Of Research Exploratory Small experiments Few controls Frequent changes of conditions Multiple systems Prepare for definitive study Definitive Large experiments Comprehensive controls Optimized conditions One system Publish We now have brute force biology and observational studies with different designs.

30 NIH Rules on Sharing NIH reaffirms its support for data sharing, believing that it is essential for expedited translation of research results. Timely release and sharing of the final research data from NIH-supported studies for use by other researchers. Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are required to include a plan for data-sharing or state why data sharing is not possible. The timely release of information must be no later than the acceptance for publication of the main findings from the final data set.

31 Responsible Reporting A. Full attribution and citation of sources B. Relevant data included or absence explained C. Technical information for replication included or available online. D. Authors all contributing and responsible (in their own domain). E. Data reported only once as original work

32 Authors All Contributing And Responsible GOOD STUFF Initial idea Research plan Regular review Doing the work Analyzing results Writing it up LESS IMPORTANT Provides funding Provides probes, cells, transgenics, clones Occasional advice Does an assay Paper once-over First authorship requires both major work and major writing

33 Rules for Publishing Clinical Trials in Major Journals Registration at inception Disclosure of all author conflicts of interest to institution, participants, editors Roles of sponsor and investigators in the experimental design, collection, analysis, and interpretation of data, and of writing of the report Grassley Determination that the authors had full access to the data

34 Your Other Job, Peer Review Review of: Grants Publications Appointments Promotions IRB submissions SCRO submissions RAC submissions Data monitoring Require: Objective review Expert assessment Openness to innovation Withdrawal if possible conflict of interest Absolute confidentiality

35 Responsible Communication The most difficult situations between scientists are due to failure to communicate, sometimes accidental, sometimes deliberate. The rupture of trust between individuals or groups usually cannot be repaired, to everyone s disadvantage. Terms of collaboration Sharing of resources Patent and licensure Authorship

36 Mentoring The job of the mentor is to facilitate the success of the trainee. If you don t believe that, then don t take on trainees. (Trainees, try to find a mentor who cares about your success.) Explicit moral climate. We do science right! Science needs ethical guidance from leaders Enthusiasm for innovation and failures. What can we learn? rather than, you made a mistake! Openness. You can talk about your work. Explicit guidelines for records, data management, authorship

37 Irresponsible Conduct of Research Social responsibility Performance Reporting Mentoring Communication Conflicts of interest Proposing research to degrade others Fabrication, falsification Plagiarism Exploiting, abusing trainees Secrecy Failure to disclose

38