1. HSS3101 Health Research Lecture #4, Sept. 23 rd & 25/26 th, 2013 Kerry-Anne Hogan RN PhD

2. What are ethics? Ethics refers to well based standards of right and wrong that prescribe what humans ought to do, usually in terms of rights, obligations, benefits to society, fairness, or specific virtues. Ethical standards also include those that enjoin virtues of honesty, compassion, and loyalty. And, ethical standards include standards relating to rights, such as the right to life, the right to freedom from injury, and the right to privacy.

3. Right to Privacy and Confidentiality To ensure anonymity, explain to the subject that most researchers are interested in group data and that individual scores are compiled with others. Individuals are identified by number rather than by name. Subjects need to understand the importance of the data being gathered; if the project is deemed important enough, the subject may be willing to sacrifice some privacy.

4. Right to Privacy and Confidentiality The health science researcher should treat all data confidentially and ensure that: 1.All data is returned anonymously and directly to the research office. 2.All data is restored by number 3.Unneeded material is destroyed upon completion of the project. Audio and Video Recordings Precludes anonymity, this does not mean that they should not be employed in research However, it does mean that the researcher should follow 7 guidelines when utilizing such recordings.

5. Nazi medical experiments 1930s & 40s Freezing / Hypothermia Genetics Infectious Diseases Interrogation and Torture Killing / Genocide High Altitude Pharmacological Sterilization Surgery Traumatic Injuries

6. General Ethical Dilemmas in Human Research Nuremberg Code – Established in 1947 – Attempted to provide guidelines to prevent future atrocities in human research. Scrutinize the objectives, justification, and methodology of your study with ethical eyes. Failure to consider ethical dilemmas is inexcusable.

7. Nuremberg Code 1.The voluntary consent of the human subject is absolutely essential 2.The experiment should be such as to yield fruitful results for the good of society 3.The anticipated results will justify the performance of the experiment. 4.Avoid all unnecessary physical and mental suffering and injury 5.Protect the experimental subject against even remote possibilities of injury, disability, or death 6.Be conducted only by scientifically qualified persons. 7.Subject should be at liberty to bring the experiment to an end. 8.Scientist in charge must be prepared to terminate study.

8. Tuskegee Syphilis Study 1932-1972 400 black men Untreated syphilis Sponsored by the US Public Health Treatment withheld Subjects told “bad blood” Study progress of disease

9. Codes of Ethics Nuremberg Code Declaration of Helsinki Belmont Report (American) Canadian Nurses Association (CNA, 2002) – as do all professions Tri-Council Policy Statement (this is Canadian)

10. Justification to Experiment on Humans In any research effort, there must be substantial justification for the need to experiment with humans, including the implications for usage of results. The Nuremberg Code suggests 10 principles to be addressed in justification and methodology. The Nuremberg Code provided a start in protecting the rights of human subjects, and it has served as a foundation for other documents, such as the Helsinki Declaration, which is used worldwide.

11. Declaration of Helsinki A set of ethical principles for the medical community regarding human experimentation Consent/proxy consent Respect for the individual, their right to self determination and the right to make informed decisions regarding participation in research Special vigilance for vulnerable populations Risk vs benefits

12. Justification to Experiment on Humans Argument about justification revolves around the interests of: – The health sciences – The subjects or patients – The community Acquisition of knowledge and full understanding of any truths are not morally objectionable Not every method is allowable simply because it potentially increases knowledge and understanding.

13. The Belmont Report (NOTE: this is American and NOT testable) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subject Research – Released in 1979 – Addressed 3 ethical issues Justice Respect for persons Beneficence Has since been revised This policy now governs federally supported research

14. Ethical Dilemma in Conducting Research: A situation in which the rights of study participants are in direct conflict with requirements for a rigorous study.

15. Responsibility for Harmful Consequences Research (DHHS) guidelines require that each subject be told of any “attendant discomforts and risks reasonably to be expected”. Though the health science researcher cannot hope to predict all risks and consequences, he or she should make an effort to communicate all known ones.

16. Nontherapeutic and Therapeutic Research Nontherapeutic Research – May be no apparent benefit for the human subjects Therapeutic Research – At least the experimental group may benefit.

17. Ethical Principles from the Tri-Council Policy 1. Principle of Beneficence: Above all, do no harm Right to protection from harm and discomfort – Beneficence—maximize good – Non-maleficence —minimize harm Right to protection from exploitation

18. 2. Principle of Respect for Human Dignity Right to self-determination (absence of coercion) Right to full disclosure (absence of deception or concealment) Ethical Principles from the Tri-Council Policy (cont.)

19. 3. Principle of Justice Right to fair treatment Right to privacy (confidentiality, anonymity) Ethical Principles from the Tri-Council Policy (cont.)

20. 4.Respect for free and informed consent 5.Respect for vulnerable persons Ethical Principles from the Tri-Council Policy (cont.)

21. Risk-benefit assessments Informed consent Confidentiality procedures Debriefings and referrals Treatment of vulnerable groups Institutional Review Boards and external reviews Procedures for Protecting Study Participants

22. Informed Consent Informed consent means that participants: have adequate information about the research can comprehend that information have free choice in deciding whether to participate in or withdraw from the study

23. Informed Consent (cont’d) Typical documentation: A consent form Implied consent (e.g., self-administered questionnaires) Process consent (qualitative studies)

24. Informed Consent: Truthtelling and Deception Informed consent entails making the subject fully aware of the research project and obtaining permission from the subject to go ahead with the project. Over time, informed consent has also come to mean the written document signed by the potential research subject, although oral permission is granted in some cases. Informed consent is designed to protect the inviolability of the subject.

25. Informed Consent: Truthtelling and Deception Functions of informed consent: – To promote individual autonomy – To protect the patient-subject’s status as a human being – To avoid fraud and duress – To encourage self-scrutiny by the researcher – To foster rational decision making There are 8 basic requirements of a written informed consent for adults.

26. Informed Consent: Truthtelling and Deception Some types of research in the health sciences require additional elements of consent. These elements are: Unforeseeable risks Additional costs Investigator termination Termination procedures New findings Number of subjects

27. Informed Consent: Truthtelling and Deception When research involves children (under 18 years of age), written parental permission should be obtained. Beginning in about junior high or middle school, the child’s written consent is needed in addition to parental consent. Children in lower grades should provide oral consent—a positive statement of willingness to participate—in addition to parental consent. If children experience undue stress, their participation should be discontinued.

28. Informed Consent: Truthtelling and Deception Requirements for informed consent are becoming more and more rigorous. The problem of informed consent for the researcher is difficult, with the major problem being that of application—how much information, how much consent.

29. Informed Consent and Double-Blind Studies The design of double-blind studies is simple and logical. One-half of the subjects are randomly selected to receive the experimental product while the other half is given a placebo, and the results are compared. Neither the researcher nor the subjects know who obtains the active substance or the placebo; hence the term double-blind. Although the researcher values this methodology to earn accurate results, it possesses many ethical dilemmas.

30. Special Treatment of Vulnerable Groups Children Mentally or emotionally disabled people Severely ill or physically disabled people Terminally ill people Institutionalized people Pregnant women

31. Vulnerable Target Groups: Elderly Critical knowledge gaps exist on several fronts when it comes to the elderly. Currently, there are no special regulations since the aging population is seen as a heterogeneous group except under two circumstances: cognitive impairment and institutionalization. The elderly population is less likely to engage in research if it is disruptive to their routine or fails to provide any benefit to them. Researchers cannot use age as a criterion of ability to consent.

32. External review Human subjects committees Institutional Review Boards (IRBs) – American; or can refer to hospital review Research Ethics Boards (REBs—in Canada)

33. Role of the Research Ethics Boards In reviewing the submission, the REB employs the following criteria: – Risks – Risks versus benefits – Subject selection – Informed consent – Safety and privacy – Additional considerations (i.e., standards of professional conduct, local laws and regulations, the mission of the institution)

34. Role of the REB Con’t After its review, the REB may approve, disapprove, request minor modifications, or request an external review. Accepted submissions require an annual review. Intent of the annual review is to determine whether changes requested in the past review have taken place The REB has the right to terminate or suspend the research based upon the annual review.

35. Other ethical issues Ethical use of animal subjects Research misconduct

36. Research Misconduct Truthfulness Scrupulousness Probity of funds

37. Publication of Unethical Research A research project does not become ethical because it produces valuable data – It is ethical or unethical from inception. Researchers must look beyond the results of an investigation into all the ethical aspects involved in research. – Only then can a fair and just decision be made about possible publications. As a professional, the health scientist must act in a fashion that is conducive to subject protection and growth of the professional. Publication is both a responsibility and a privilege.

38. Next Week Conducting experimental and quasi- experimental research Chapter 5