1. 15 September 20151 Development of Nursing Research

2. 15 September 20152 Summary  Nursing research is defined as “the systematic, objective process of analyzing phenomena of importance to nursing”  It includes studies concerning: - nursing practice; -nursing education; - nursing administration, and - nurses themselves

3. 15 September 20153 Source of nursing knowledge  Has come from:  1. tradition  2. authority  3. trail and error  4. scientific research

4. 15 September 20154  Scientific research uses:  Empirical data (data gathered through the sense);  And is a systematic, orderly, and objective method of seeking information.

5. 15 September 20155  Basic research: generate new knowledge  Applied research: uses the knowledge to solve the immediate problems  Most nursing research studies have been applied research  The most important goal for conducting nursing research is the promotion of evidence-based nursing practice.  Other goals for conducting research are to ensure credibility of nursing profession, provide accountability for nursing practice, and document the cost effectiveness of nursing care.

6. 15 September 20156  Quantitative research: is concerned with objectivity, tight controls over the research situation, and the ability of to generalize findings.  Qualitative research: is concerned with the subjective meaning of an experience to an individual.  Outcome research:  Focuses on measurable outcomes of interventions with certain patient populations.

7. 15 September 20157 Role of nurses in nursing research:  Principle investigator  Members of research team  Identifiers of researchable problems  Evaluators of research findings  Users of research findings  Client advocate during the study  Participant in research  Research utilization of research findings.

8. 15 September 20158 Priorities for future nursing research  Research concerned with health promotion and preventive health practices for all age groups.  Health care needs of high risk groups  Life satisfaction of individuals and families  And the development of cost effective health care system.  Replication studies should be a high priority for nursing research.  Replication studies: involve repeating a study with all the essential elements of the original study held intact. Different samples and settings may be used.

9. 15 September 20159 Research Foundations of Nursing Research Fifth Edition Chapter 2 Ethical Issues in Nursing Research Rose Marie Nieswiadomy

10. 15 September 201510 Learning Objective 1  Discuss some of the unethical studies that have been documented in the literature

11. 15 September 201511 Unethical Research Studies  Examples of how prisoners were used  infecting women prisoners with syphilis, having them impregnated by male prisoners, then dissecting the live babies and mothers.  Draining the blood from prisoners’ veins and substituting horse blood.  Exploding gas gangrene bombs next to prisoners tied to stakes.

12. 15 September 201512 Learning Objective 2  Trace the development of ethical codes and guidelines

13. 15 September 201513 The Nuremberg Code, 1947  After a result of prisoner research, the need for ethical guidelines becomes clear.  Criteria for research identified o Researcher must inform subjects about the study o Research for the good of society o Research based on animal experiments o Researcher must avoid injury to subjects o Researcher must be qualified to do research o Subjects or researcher can stop study if problems occur

14. 15 September 201514 Other Ethical Codes  Universal Declaration of Human Rights, 1948  The Belmont Report – 1979 o Respect for Persons: participants should have autonomy and self-determination o Beneficence: participants should be protected from harm o Justice: participants should receive fair treatment

15. 15 September 201515 Learning Objective 3  Appreciate the role of institutional review boards

16. 15 September 201516  agencies may have other research committees that review research proposals  Some institutions have nursing researching committees specifically concerned with nursing research in that particular institution.

17. 15 September 201517 Research Guidelines for Nurses  Human Rights Guidelines for Nurses in Clinical and Other Research:  These guidelines address the rights of research subjects and nurses involved in research  Subjects must be protected from harm  Their privacy should ensured, and their dignity preserved

18. 15 September 201518 Learning Objective 4  Identify the elements of informed consent

19. 15 September 201519 Informed Consent  Concerns with subjects’ participation in research in which they have full understanding of the study before the study begins.  Say it In other words: the subjects agree to participate in studies about which they have complete understanding about the study before the study begins.  Protects rights of research subjects  Receives full explanation of the study  Allows time for clarification  Submits permission by signed name

20. 15 September 201520 Major Elements of Informed Consent  Researcher is identified and credentials presented  Subject selection process is described  Study purpose is described  Study procedures are discussed  Potential risks are described  Potential benefits are described  Compensation, if any, is discussed  Alternative procedures, if any, are disclosed

21. 15 September 201521 Major Elements of Informed Consent  Anonymity or confidentiality is assured  Anonymity: no one can identify the subjects in a study.  Confidentiality: the researcher will protect the subjects’ identities.  Right to refuse or withdraw from the study without penalty is assured  Offer to answer all Questions is made  Means of obtaining study results is presented

22. 15 September 201522 Debriefing  Is a meeting with research participants that ensures their understanding of the reasons and the justification for the procedures used in the study.

23. 15 September 201523 Research Identification  Research name and qualifications  Sponsor or sponsoring agency  Confusion if nurse caregiver is also researcher

24. 15 September 201524 Subject Selection Process  Other names for “subject”  Selection goal—unbiased sample  Subjects told how they are selected  Women, men, ethnic, and cultural groups  NINR and funding opportunities

25. 15 September 201525 Study Purpose  Language and reading level  Open and honest with explanation  Enough information for informed consent

26. 15 September 201526 Study Procedures  Place  Time commitments  Procedure format  Debriefing, if necessary

27. 15 September 201527 Potential Risks  Physical  Psychological  Privacy issues

28. 15 September 201528 Potential Benefits  Nuremberg Code  Society benefits  Subjects plus others

29. 15 September 201529 Compensation  Monetary incentives  Examples of other types o Tests o Travel  Compensation and biases

30. 15 September 201530 Alternative Procedures  Treatment  Control Group  Hawthorne Effect

31. 15 September 201531 Right to Refuse/Withdraw  Re-explain the voluntary aspect  No penalty for withdrawal  Always able to drop at any time

32. 15 September 201532 Question Opportunities  At time of informed consent  Available by phone or email  Always there to answer questions

33. 15 September 201533 Final Results  Subjects may receive study results  How to obtain these results  Publication plans must be given  Date when results are available

34. 15 September 201534 Learning Objective 5  Recognize unethical research

35. 15 September 201535 Citations for Misconduct  Issues of coercions  Deceptive language on consent forms  Falsification of documents  Conflict of interest issues

36. 15 September 201536 Learning Objective 6  Act as a patient advocate during research investigations

37. 15 September 201537 Patient Advocate Role  Protect privacy and dignity of subjects and to protect them from harm.  Be able to answer patient’s questions about Clinical trial. Clinical trial: are research studies conducted to evaluate new treatments, new drugs, or new or improved medical equipment.