15 September Development of Nursing Research

15 September 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

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

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

15 September  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.

15 September  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.

15 September 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.

15 September 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.

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

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

15 September 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.

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

15 September 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

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

15 September  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.

15 September 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

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

15 September 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

15 September 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

15 September 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

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

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

15 September 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

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

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

15 September Potential Risks  Physical  Psychological  Privacy issues

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

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

15 September Alternative Procedures  Treatment  Control Group  Hawthorne Effect

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

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

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

15 September Learning Objective 5  Recognize unethical research

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

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

15 September 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.