1. Ethics in Biostatistics Jessie McKinney Richard Kennedy

2. Principles of Biomedical Ethics Autonomy Autonomy –Ability to make decisions free from interference by others and personal limitations –Requires liberty and agency Nonmaleficience Nonmaleficience –“Above all, do no harm”

3. Principles of Biomedical Ethics Beneficience Beneficience –Obligation to act for the benefit of others Justice Justice –Fair and equitable distribution of risks and benefits

4. Ethics for Biostatisticians??? Biostatisticians are part of biomedical field Biostatisticians are part of biomedical field Collaboration within a team raises several ethical problems Collaboration within a team raises several ethical problems Biostatisticians may be aware of Biostatisticians may be aware of –Data fabrication –Deceptive reporting of results –Suppression of data –Deceptive design or analysis

5. Collaboration brings… Accountability Accountability –Responsibilities of team members to each other Authorship Authorship –Based on significant contribution to work –Requires acceptance of responsibility to the general scientific community Conflict of interest Conflict of interest –Potential conflicts must be disclosed Data sharing Data sharing –Reporting quality of data –Maintaining confidentiality –Clearly describing ownership of data

6. Knowledge of Fraud Ranstam and colleagues (2000) surveyed 442 members of the International Society of Clinical Biostatistics Ranstam and colleagues (2000) surveyed 442 members of the International Society of Clinical Biostatistics Members from 31 countries, mostly European Union Members from 31 countries, mostly European Union Fraud was defined as “a deliberate attempt to mislead others in the design, conduct, analysis, or reporting of a study” Fraud was defined as “a deliberate attempt to mislead others in the design, conduct, analysis, or reporting of a study” Response rate only 37% but Response rate only 37% but 51% of respondents knew of fraudulent projects 51% of respondents knew of fraudulent projects Ranstam et al., Controlled Clinical Trials, 2000

7. Knowledge of Fraud Ranstam et al., Controlled Clinical Trials, 2000 Aspect of Fraud Aspect of Fraud Number (%) Consider the main motive for fraud not financial but career and power Consider the main motive for fraud not financial but career and power 126 (76) Believe the impact of fraud on the progress of medical science to be important or a major problem Believe the impact of fraud on the progress of medical science to be important or a major problem 104 (65) Do not know if the organization they work for has a system for handling suspected fraud or not, or do know that such a system does not exist 103 (63) Know of at least one fraudulent project in the proximity during the last 10 years 81 (51) 81 (51) Have been engaged in a project in which fraud took place or was about to take place 49 (31) 49 (31) Have been requested to support fraud 20 (13) 20 (13) Have participated as an expert in a formal investigation on suspected fraud 19 (12) 19 (12)

8. ASA Ethical Guidelines Professionalism Professionalism Responsibilities to Funders, Clients, and Employers Responsibilities to Funders, Clients, and Employers Responsibilities in Publication and Testimony Responsibilities in Publication and Testimony Responsibilities to Research Subjects Responsibilities to Research Subjects Ethical Guidelines for Statistical Practice

9. ASA Ethical Guidelines Responsibilities to Research Team Colleagues Responsibilities to Research Team Colleagues Responsibilities to Other Statisticians or Statistical Practitioners Responsibilities to Other Statisticians or Statistical Practitioners Responsibilities Regarding Allegations of Misconduct Responsibilities Regarding Allegations of Misconduct Responsibilities of Funders, Clients, and Employers Responsibilities of Funders, Clients, and Employers

10. Acknowledgements Survey questions drawn from Scientific Integrity by F. Macrina and Ranstam J, et al. “Fraud in medical research: An International Survey of Biostatisticians” Control Clin Trials 2000; 21:415-27 Survey questions drawn from Scientific Integrity by F. Macrina and Ranstam J, et al. “Fraud in medical research: An International Survey of Biostatisticians” Control Clin Trials 2000; 21:415-27 Some cases drawn from ASA Committee on Professional Ethics website http://www.tcnj.edu/~ethcstat/ Some cases drawn from ASA Committee on Professional Ethics website http://www.tcnj.edu/~ethcstat/ http://www.tcnj.edu/~ethcstat/ Some cases drawn from Thall PF. “Ethical issues in oncology biostatistics” Stat Methods Med Res 2002; 11(5):429-48. Some cases drawn from Thall PF. “Ethical issues in oncology biostatistics” Stat Methods Med Res 2002; 11(5):429-48.