Ethical Issues in Nursing Research

1. 2 Ethical Issues in Nursing Research

2. Learning Objectives • Discuss Some Of The Unethical Studies That Have Been Documented In The Literature • Trace The Development Of Ethical Codes And Guidelines • Appreciate The Role Of Institutional Review Boards • Identify The Elements Of Informed Consent

3. Learning Objectives Recognize Unethical Research Act As A Patient Advocate During Research Investigations Critique The Ethical Aspects Of A Study

4. Learning Objective OneDiscuss Some Of The Unethical Studies That Have Been Documented In The Literature

5. Unethical Research Studies at Concentration Camps • Victims not “real” • Drug effectiveness on wounds • The prediction of skeletal size

6. Unethical Studies in theUnited States • Exposure to disease • Children and cowpox • Mentally retarded children and hepatitis • Elderly patients and cancer

7. Unethical Studies in theUnited States (cont’d) • Experimental vaccines • American Indian children with hepatitis A • Foster children with AIDS • Minority children with measles

8. Unethical Studies in theUnited States (cont’d) • Leaving diseases untreated • African Americans with syphilis

9. Learning Objective TwoTrace The Development Of Ethical Codes And Guidelines

10. The Nuremberg Code, 1947 • A result of prisoner research • Criteria for research identified • Researcher must inform subjects. • Research for the good of society • Research based on animal experiments • Researcher must avoid injury to subjects. • Researcher must be qualified to do research. • Subjects or researcher can stop study if problems occur.

11. Other Ethical Codes • Universal Declaration of Human Rights, 1948 • The Declaration of Helsinki, 1964 • The Belmont Report, 1979 • Respect for persons • Beneficence • Justice • The Department of Health and Human Services (DHHS)

12. Research Guidelines for Nurses • Human Rights Guidelines for Nurses in Clinical and Other Research (1975, 1985) • Protects subjects from harm • Ensures privacy • Preserves subject’s dignity • Keep nurses fully informed

13. Research Guidelines for Nurses • Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research (Silva, 1995) • Research integrity • Reporting scientific misconduct

14. Learning Objective ThreeAppreciate The Role Of Institutional Review Boards

15. Institutional Review Boards (irbs) • 1981: DHHS published guidelines. • Guidelines led to IRBs. • Overseen by Office of Protection from Research Risk (OPRR) • Human research needs IRB approval.

16. Nursing Research and Guidelines • Nursing research committees • Policies vary agency to agency. • Be informed about institution’s specific requirements • Permission to conduct research can take time.

17. Learning Objective FourIdentify The ElementsOf Informed Consent

18. Informed Consent • Protects rights of research subjects • Receives full explanation of the study • Allows time for clarification • Submits permission by signed name

19. Major Elements ofInformed Consent • Researcher and credentials • Subject selection process • Study purpose • Study procedures • Potential risks • Potential benefits • Compensation, if any • Alternative procedures, if any

20. Major Elements ofInformed Consent (cont’d) • Anonymity or confidentiality • Right to refuse or withdraw • Questions addressed • Means of getting study feedback

21. Researcher Identification • Research name and qualifications • Sponsor or sponsoring agency • Confusion if nurse caregiver is also researcher

22. Subject Selection Process • Other names for “subject” • Selection goal—unbiased sample • Subjects told how they are selected • Women, men, ethnic, and cultural groups

23. Study Purpose • Presented clearly • Open, honest explanation • Enough information for informed consent

24. Study Procedures • Place • Time commitments • Procedure format • Debriefing if necessary

25. Potential Risks • Risks that might influence decision to participate • Physical and psychological discomforts • Invasion of privacy • Consult with experts

26. Compensation • Monetary incentives • Other incentives • Risk of bias • “Potential benefits” as “compensation”

27. Alternative Procedures • Treatment • Control group • Hawthorne effect

28. Anonymity or Confidentiality • Anonymity: no link between subjects and data • Confidentiality: protects subjects’ identities • Deletion of identification information • Data reported in aggregate.

29. Right to Refuse or Withdraw • Voluntary • No penalty for withdrawal • Able to withdraw at any time

30. Answer Questions • At time of informed consent • Available by phone or e-mail • Always there to answer questions

31. Means of Obtaining Results • Publication plans must be given. • Subjects may receive study results. • How to obtain these results • Date when results are available

32. Learning Objective FiveRecognize Unethical Research

33. Learning Objective SixAct As A Patient AdvocateDuring Research Investigations

34. Patient Advocate Role • Protect privacy and dignity of subjects • Clinical trial questions • Purpose • Work setting • Available brochures

35. Do No Harm • Physical harm • Psychological harm • Assume responsibility for study conditions

36. Vulnerable Populations • Children • Geriatric clients • Prisoners • Homeless • AIDS patients • Unconscious • Sedated • Assent (express agreement or refusal) considerations (comm. Limitations)

37. Learning Objective SevenCritique The Ethical Aspects Of A Study

38. Critiquing Ethical Aspects of a Study • Little mention in report

39. Critiquing Ethical Aspects of a Study (cont’d) • Guidelines for critiquing • Approved by IRB? • Informed consent obtained? • Provisions for anonymity and confidentiality? • Vulnerable subjects? • Coercion? • Benefits outweigh risks? • Subjects given opportunity to ask questions? • Results made available to subjects?