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April 19, 2023 1

Development of Nursing Research

April 19, 2023 2

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

April 19, 2023 3

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

April 19, 2023 4

Scientific research uses: Empirical data (data gathered through the

sense); And is a systematic, orderly, and objective

method of seeking information.

April 19, 2023 5

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.

April 19, 2023 6

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.

April 19, 2023 7

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.

April 19, 2023 8

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.

April 19, 2023 9

Foundations of

Nursing ResearchResearch

Fifth Edition

Chapter 2

Ethical Issues in Nursing Research

Rose Marie Nieswiadomy

April 19, 2023 10

Learning Objective 1 Discuss some of the unethical studies that

have been documented in the literature

April 19, 2023 11

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.

April 19, 2023 12

Learning Objective 2 Trace the development of ethical codes

and guidelines

April 19, 2023 13

The Nuremberg Code, 1947

After a result of prisoner research, the need for ethical guidelines becomes clear.

Criteria for research identifiedo Researcher must inform subjects about the

studyo Research for the good of societyo Research based on animal experimentso Researcher must avoid injury to subjectso Researcher must be qualified to do researcho Subjects or researcher can stop study if

problems occur

April 19, 2023 14

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

April 19, 2023 15

Learning Objective 3 Appreciate the role of institutional review

boards

April 19, 2023 16

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.

April 19, 2023 17

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

April 19, 2023 18

Learning Objective 4 Identify the elements of informed consent

April 19, 2023 19

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

April 19, 2023 20

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

April 19, 2023 21

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

April 19, 2023 22

Debriefing Is a meeting with research participants

that ensures their understanding of the reasons and the justification for the procedures used in the study.

April 19, 2023 23

Research Identification Research name and qualifications Sponsor or sponsoring agency Confusion if nurse caregiver is also

researcher

April 19, 2023 24

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

April 19, 2023 25

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

April 19, 2023 26

Study Procedures Place Time commitments Procedure format Debriefing, if necessary

April 19, 2023 27

Potential Risks Physical Psychological Privacy issues

April 19, 2023 28

Potential Benefits Nuremberg Code Society benefits Subjects plus others

April 19, 2023 29

Compensation Monetary incentives Examples of other types

o Testso Travel

Compensation and biases

April 19, 2023 30

Alternative Procedures Treatment Control Group Hawthorne Effect

April 19, 2023 31

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

April 19, 2023 32

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

April 19, 2023 33

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

April 19, 2023 34

Learning Objective 5 Recognize unethical research

April 19, 2023 35

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

April 19, 2023 36

Learning Objective 6 Act as a patient advocate during research

investigations

April 19, 2023 37

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.