2. Principles for the Protection of Human Rights

3. Beneficence Primary goal of health care as doing good for clients under our care. Good care requires that the HCP take a holistic approach to the client including beliefs, feelings, and wishes.

4. Nonmaleficence Requirement that HCP do no harm to their clients, either intentionally or unintentionally. Opposite side of the concept of beneficence.

5. Autonomy Self-determination, independence and freedom. Right to make health-care decision for himself or herself, even if the health- care provider does not agree with those decisions. In research: Withdraw from participation in the study

6. Justice Obligation to be fair to all people Distributive justice-individuals have the right to be treated equally regardless of race, gender, marital status, etc. – In research in the selection for the study – and in the course of the study

7. Full Disclosure – Subjects must know the nature of the study and their rights

8. Right to Privacy Maintained through anonymity – Identity is not known to the researcher Or confidentiality – Identity is known but never disclosed

9. Requirements for Informed Consent

10. 1.Subject Status Subjects must be told that any data they provide will be used in research

11. 2.Study Purpose In terms they can understand

12. 3.Type of data that will be collected

13. 4.Sponsorship Who is sponsoring the research Is it a degree requirement?

14. 5.Subject Selection How names were obtained

15. 6.Procedures Description of procedures

16. 7.Potential Risks or Costs Any foreseeable risks? Treatments that would be made available for injury

17. 8.Potential Benefits For subjects as well as to others Stipends must be specified

18. 9.Voluntary Consent Participation must be voluntary and failure to comply must not result in any losses

19. 10.Right to Withdraw Subjects may withdraw at any time or refuse to provide any piece of information

20. 11.Alternatives Availability of alternative treatments, if any

21. 13.Contact Information Information about whom the subject could contact in the event of further questions, comments, or complaints

22. Basing Nursing Practice on Research Why research? What's in it for you?

23. To advance nursing's scientific (or research-based) knowledge that knowledge which separates us from other professions

24. ... And to be accountable to the public we serve...

25. Accountability demands careful attention to the ethics of what we do Our world has a sad history of abuse of research subjects

26. The Nazi Medical Experiments 1933 to 1945

27. These were... atrocious medical experiments performed by the Third Reich in Europe. Subjects -- many were Jews -- were prisoners of war and considered racially “valueless”. Subjected to untested drugs and operations (without anesthesia), malaria, poisons etc.

28. Nuremberg Perpetrators of these experiments were brought before the Nuremberg Tribunal Nuremberg Code developed to assure the protection of subjects from harm

29. Declaration of Helsinki Adopted in 1964 and revised in 1975 Built on the Nuremberg Code was an additional step to protect human rights Was lacking, however...

30. From the mid 1950s to the early 1970s Conducted at Willowbrook, an institution for the mentally retarded on Staten Island in New York Children were deliberately infected with the hepatitis virus. The Willowbrook Study

31. Jewish Chronic Disease Hospital Study In the 1960s in Brooklyn, NY Looked at patients’ responses to the injection of live liver cancer cells.

32. Between 1932 and 1972 Sponsored by the U.S. Public Health Service Investigated the effects of syphilis among 400 men from a poor African- American community Medical treatment was deliberately withheld The Tuskegee Syphilis Study

33. were established as a result of these breaches of ethical conduct Administered by the Department of Health and Human Services Laws Regulating Research

34. Institutional Review Boards IRB Office of Regulatory Compliance (ORC)

35. IRB approval Tedious and time-consuming Many government regulations to protect the innocent – particularly vulnerable populations such as children and invalids

36. Which studies require IRB approval? All No nurse should circulate any questionnaire without having IRB approval for the study!