1. FOUNDATIONS OF NURSING RESEARCH Sixth Edition CHAPTER Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Ethical Issues in Nursing Research 2

2. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objectives 1.Discuss Some Of The Unethical Studies That Have Been Documented In The Literature 2.Trace The Development Of Ethical Codes And Guidelines 3.Appreciate The Role Of Institutional Review Boards 4.Identify The Elements Of Informed Consent

3. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objectives 5.Recognize Unethical Research 6.Act As A Patient Advocate During Research Investigations 7.Critique The Ethical Aspects Of A Study

4. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objective One Learning Objective One Discuss Some Of The Unethical Studies That Have Been Documented In The Literature

5. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Unethical Research Studies at Concentration Camps Victims not “real” Drug effectiveness on wounds The prediction of skeletal size

6. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Unethical Studies in the United States Exposure to disease –Children and cowpox –Mentally retarded children and hepatitis –Elderly patients and cancer

7. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Unethical Studies in the United States (cont’d) Experimental vaccines –American Indian children with hepatitis A –Foster children with AIDS –Minority children with measles

8. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Unethical Studies in the United States (cont’d) Leaving diseases untreated –African Americans with syphilis

9. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objective Two Learning Objective Two Trace The Development Of Ethical Codes And Guidelines

10. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy 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. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy 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. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy 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. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Research Guidelines for Nurses Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research (Silva, 1995) –Research integrity –Reporting scientific misconduct

14. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objective Three Learning Objective Three Appreciate The Role Of Institutional Review Boards

15. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy 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. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy 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. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objective Four Learning Objective Four Identify The Elements Of Informed Consent

18. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Informed Consent Protects rights of research subjects Receives full explanation of the study Allows time for clarification Submits permission by signed name

19. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Major Elements of Informed Consent Researcher and credentials Subject selection process Study purpose Study procedures Potential risks Potential benefits Compensation, if any Alternative procedures, if any

20. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Major Elements of Informed Consent (cont’d) Anonymity or confidentiality Right to refuse or withdraw Questions addressed Means of getting study feedback

21. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Researcher Identification Research name and qualifications Sponsor or sponsoring agency Confusion if nurse caregiver is also researcher

22. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Subject Selection Process Other names for “subject” Selection goal—unbiased sample Subjects told how they are selected Women, men, ethnic, and cultural groups

23. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Study Purpose Presented clearly Open, honest explanation Enough information for informed consent

24. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Study Procedures Place Time commitments Procedure format Debriefing if necessary

25. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Potential Risks Risks that might influence decision to participate –Physical and psychological discomforts –Invasion of privacy –Consult with experts

26. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Compensation Monetary incentives Other incentives Risk of bias “Potential benefits” as “compensation”

27. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Alternative Procedures Treatment Control group Hawthorne effect

28. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Anonymity or Confidentiality Anonymity: no link between subjects and data Confidentiality: protects subjects’ identities –Deletion of identification information –Data reported in aggregate.

29. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Right to Refuse or Withdraw Voluntary No penalty for withdrawal Able to withdraw at any time

30. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Answer Questions At time of informed consent Available by phone or e-mail Always there to answer questions

31. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy 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. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objective Five Learning Objective Five Recognize Unethical Research

33. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objective Six Learning Objective Six Act As A Patient Advocate During Research Investigations

34. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Patient Advocate Role Protect privacy and dignity of subjects Clinical trial questions –Purpose –Work setting –Available brochures

35. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Do No Harm Physical harm Psychological harm Assume responsibility for study conditions

36. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Vulnerable Populations Children Geriatric clients Prisoners Homeless AIDS patients Unconscious Sedated Assent (express agreement or refusal) considerations (comm. Limitations)

37. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Learning Objective Seven Learning Objective Seven Critique The Ethical Aspects Of A Study

38. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy Critiquing Ethical Aspects of a Study Little mention in report

39. Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research, Sixth Edition Rose Marie Nieswiadomy 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?