Nursing Theory and Research

• Theory and research share a fundamental relationship in quantitative and qualitative studies

Quantitative Studies

• Theories offer a framework for study design, hypothesis creation, and variable selection
• Research validates theories by analyzing relationships between variables
• Theories predict outcomes, and research either confirms or rejects these predictions via hypothesis-driven methods
• Orem's Self-Care Deficit Theory measures the effect of nursing interventions on patient self-care

Qualitative Studies

• Theory comes from data, rather than being the basis for testing
• Qualitative studies explain experiences, processes, or social interactions
• Theory is implicitly understood, rather than explicitly stated
• Grounded Theory Research makes new theories from patterns that are observed in the data

Theoretical Framework

• Research generates data that supports, refines, or challenges existing theories, furthering the evolution of nursing knowledge
• Provides a blueprint for research, ensuring alignment with established knowledge
• Defines key concepts and relationships
• Guides the selection of study variables

Research Design and Methodology

• Determines whether a study tests theory quantitatively or develops it qualitatively
• Aids in choosing the most suitable data collection methods

Types of Theories Used in Research

• Grand Theories are broad and abstract, e.g., Roy's Adaptation Model
• Middle-Range Theories are specific and focus on particular concepts, e.g., Symptom Management Theory
• Practice Theories are situation-specific and guide nursing interventions
• A study on social support in patients with chronic illness may use Cassel's Social Support Theory to examine the impact of interpersonal connections on health outcomes

Historical Events Influencing Ethical Codes and Regulations

• Several unethical research studies have shaped the development of modern ethical codes and regulations
• In the Tuskegee Syphilis Study (1932-1972), African American men were denied treatment for syphilis to study the progression of the disease
• Nazi Medical Experiments during WWII caused the creation of the Nuremberg Code (1947)
• In the Guatemala STD Study (1946-1955), U.S. researchers deliberately infected prisoners and mentally ill patients with syphilis
• In the Willowbrook Hepatitis Study (1950s-1970s), mentally disabled children were intentionally infected with hepatitis
• In the Jewish Chronic Disease Hospital Study (1960s), patients were injected with live cancer cells without informed consent

Regulatory Responses

• The Nuremberg Code (1947) established voluntary consent as essential
• The Declaration of Helsinki (1964, revised multiple times) sets ethical principles for medical research involving humans
• The Belmont Report (1979) introduced respect for persons, beneficence, and justice as core ethical principles
• U.S. DHHS Regulations (updated 1973) requires Institutional Review Boards (IRBs) for research oversight
• The Tri-Council Policy Statement (TCPS2) outlines ethical principles for human research in Canada, emphasizing:

Ethical Principles

• Emphasizes respect for persons by ensuring voluntary participation and informed consent and protecting vulnerable populations (e.g., children, mentally incompetent individuals)
• Concern for Welfare - research minimizes risks and maximizes benefits and subjects should not face unnecessary harm or privacy violations
• Justice is ensured through fair selection of research participants and preventing exploitation of vulnerable populations

Additional Ethical Considerations

• Informed Consent - Participants must understand the study and agree without coercion
• Privacy and Confidentiality - Personal data should be protected (as per HIPAA and TCPS2 guidelines)
• Risk-Benefit Analysis - IRBs should approve studies to ensure risks do not outweigh potential benefits

Ethical Role as an Advanced Practice Nurse (APN)

• In a clinical trial testing a new cancer drug, fully informed consent, fair participant selection, and a risk-benefit assessment must be ensured before proceeding
• Protecting Human Subjects - Ensure that research participants understand risks and benefits before consenting, and advocate for vulnerable populations
• Upholding Ethical Standards - Follow ethical guidelines from the American Nurses Association (ANA), Belmont Report, and TCPS2 and ensure compliance with IRB-approved protocols
• Ensuring Privacy and Confidentiality - Protect patient data under HIPAA and institutional policies and maintain anonymous or de-identified data where applicable
• Promoting Evidence-Based Practice - Improve patient care by using research findings and identify gaps in current research and advocate for studies addressing clinical needs
• Preventing Research Misconduct - Avoid data fabrication, falsification, or plagiarism and report ethical violations if they occur in a research setting
• Advocating for Ethical Clinical Trials - Ensure equitable subject selection and fair distribution of benefits and risks and educate patients on their rights in clinical research
• In a clinical trial, an APN should clarify their rights to a patient expressing confusion about their participation, make sure they understand the consent process, and advocate for their autonomy in decision-making

Conclusion

• Theory and research are interconnected
• Quantitative studies validate theories, while qualitative studies develop them
• A theoretical framework provides study structure and guidance
• The Tri-Council Policy Statement (TCPS2) outlines key principles: respect for persons, welfare, and justice
• Advanced Practice Nurses ensure research is done ethically, protects participants, and promotes actions based on evidence

Explore the relationship between theory and research in nursing, contrasting quantitative methods that validate theories and qualitative methods that generate them. Learn how studies support, refine, or challenge existing theories, advancing nursing knowledge. The theoretical framework provides a blueprint for structuring the research.