Ethical

Question 1

Irb

Answer 1

Nursing Research: IRB Essentials
IRB (Institutional Review Boards) Overview

Definition:
A committee of researchers, medical professionals (like nurses), and community members who act as the “gatekeepers” of research.

Main Function:

• Ethical Oversight: Ensures the safety, rights, and well-being of human participants.
• Permission: Grants initial, ongoing, and continuing approval for studies.
• Authority: Can stop or terminate a study if ethical violations occur.

Key Distinction:

• Ethical vs. Scientific: IRB approval means a study is ethically sound (safe and respectful), but it does not necessarily guarantee the study is scientifically strong (e.g., small sample sizes or bias could still exist).

What to Look For in Research:

• Always check the Methods or Ethical Considerations section for an IRB approval statement or protocol number.
• Look for mentions of informed consent.

Why It Matters for Nurses:

• Provides a baseline of trust before considering a study’s results.
• Nurses often have the opportunity to serve as IRB members to review study proposals.

Question 2

As a nurse its your job to critically apraise the studies you use in your practice

Answer 2

The Nurse’s Ethical Responsibility
As a nurse, your role involves critical appraisal. You are expected to look at published research and studies within your clinical agency to ensure they respect participant rights.

Specifically, you should look for:

Participant Selection: Were the people in the study chosen fairly and ethically?

Participant Treatment: How were they treated during the actual study?

The “Methods” Section: This is the specific part of a research paper where these ethical details are usually documented.

Question 3

Why irb started

Answer 3

Ethics History: Nazi Experiments & Outcomes
Historical Ethical Violations: Nazi Medical Experiments

Context:
Occurred during the Third Reich (Nazi Germany, 1933–1945). These atrocities are a primary reason modern research ethics (IRBs and informed consent) exist.

Nature of the Violations:

• Unethical Treatment: Prisoners and “subjects” were forced into experiments against their will (no voluntary consent).
• Extreme Harm: Included exposure to freezing temperatures, untested drugs, and torture, often resulting in death or permanent disability.
• Targeting the Vulnerable: Participants were selected based on race, ethnicity, or disability rather than scientific necessity.
• Lack of Oversight: There was no independent committee or ethical framework to stop the harm.

Major Global Outcomes:

1. Nuremberg Code (1947): The first major international document to mandate voluntary consent and require that research must avoid unnecessary suffering.
2. Declaration of Helsinki: A medical “rulebook” that prioritized the welfare of the individual over the interests of science or society.

Nursing Application:
Nurses must be “gatekeepers.” When appraising a study, check the Methods section to ensure current practices don’t mirror these historical failures by confirming IRB approval and participant rights.

Question 4

Teskegee

Answer 4

Ethics History: Tuskegee Syphilis Study
Tuskegee Syphilis Study (1932–1972)

Overview:
A highly unethical clinical study conducted by the U.S. Public Health Service involving 600 African American men in Alabama. It is a landmark case of medical racism and ethical failure.

Key Ethical Violations:

• Deception: Participants were told they were being treated for “bad blood” and were never informed of their actual syphilis diagnosis.
• Lack of Informed Consent: Men were never told they were part of a research study or informed of the risks involved.
• Withholding Treatment: Even after penicillin became the standard cure for syphilis in the 1940s, researchers deliberately withheld it to observe the “natural progress” of the disease.
• Exploitation: The study targeted a vulnerable, rural, and impoverished population.

Major Global Outcomes:

• The Belmont Report (1979): Created as a direct response to this study, establishing the three core ethical principles: Respect for Persons, Beneficence, and Justice.
• National Research Act: Led to the requirement of Institutional Review Boards (IRBs) for all human subject research.

Nursing Application:

• Advocacy: Nurses must ensure patients are never deceived about their diagnosis or treatment.
• Mistrust: Understanding this history helps nurses navigate and address medical mistrust within marginalized communities.
• Informed Consent: Nurses often witness or facilitate the consent process; it must be truly “informed” and voluntary.

Question 5

The tuskegee timeline

Answer 5

The Tuskegee Timeline (1932–1972)

1932: The Start
The U.S. Public Health Service begins the study with 600 Black men in Macon County, Alabama. They are told they are being treated for “bad blood,” but in reality, the researchers just want to track the natural course of untreated syphilis.

1940s: The Turning Point (Penicillin)
Penicillin is discovered and becomes the gold standard cure for syphilis. Instead of treating the men, researchers actively withhold the drug. They even contact local doctors and the military to ensure the participants don’t receive it elsewhere.

1962: Continued Neglect
The study hits the 30-year mark. Even though the death rate among the participants is significantly higher than the control group, the researchers decide to keep going.

July 1972: The “Backlash”
A front-page story in the Washington Star (and later the New York Times) exposes the study to the world. The public is horrified that the government deliberately allowed citizens to suffer and die for “science.”

November 1972: The End
Under massive pressure from the public and the medical community, the study is finally shut down.

Question 6

Willbrook

Answer 6

Study Note: The Willowbrook Hepatitis Study (1950s–1970s)
1. The Core Violation: Coercion

The Situation: Willowbrook was “closed” to new admissions due to overcrowding.

The “Bus” Tactic: The Research Ward remained open. Parents were told the only way to get their child into the facility was to consent to the hepatitis study.

Ethical Term: Lack of Voluntary Consent. This is “undue inducement”—offering a basic need (housing/care) in exchange for participation in a risky study.

2. The Researcher’s Defense (Dr. Krugman)

Krugman used the “Structure” of his ward to justify the “Process” of his research.

The Claim: “The kids are better off in my ward.”

Justification 1: Cleaner environment and higher nurse-to-patient ratio.

Justification 2: Since they would likely catch hepatitis anyway in the general wards, it was “safer” to give it to them under medical supervision.

3. Ethical Red Flags for Nursing Research

Vulnerability: The subjects were children with intellectual disabilities. Modern ethics requires extra protection for these groups, not exploitation of their situation.

Beneficence vs. Maleficence: The study violated the “Do No Harm” rule. Intentionally infecting healthy subjects with a pathogen is almost never ethically justifiable in nursing practice today.

Justice: The burdens of the research (the illness) were placed on a marginalized group, while the benefits (the vaccine/knowledge) were for the general public.

Question 7

Jewish chronic disease

Answer 7

Study Note: Jewish Chronic Disease Hospital Study (1963)
1. The Core Violation: Deception & Secrecy

The Situation: Researchers injected live cancer cells into 22 elderly patients.

The Deception: Patients were told they were getting a “skin test” or injection, but they were not told it contained cancer cells.

Ethical Term: Lack of Informed Consent. The subjects were denied “Full Disclosure,” meaning they didn’t have the facts needed to make a decision.

2. Violation of Self-Determination

Patient Rights: Every patient has the right to decide what happens to their body (Autonomy).

The Breach: By keeping the study secret from the patients, their doctors, and the hospital’s own research committee, the researchers acted as “judge and jury” over the patients’ lives.

3. The “Scientific” Justification (The Defense)

The researchers tried to justify their actions by claiming:

The cells would be rejected anyway (testing the immune system’s “detection” speed).

Telling the patients would “unnecessarily scare them.”

The Nursing Reality: Fear is not an excuse to lie. A nurse’s duty is to provide the truth so the patient can choose.

4. Vulnerable Populations

The Targets: Elderly patients, many with dementia.

Why it’s Unethical: These patients were “convenient” because they were less likely to ask questions or remember the procedure. Modern ethics mandates that we protect those who cannot protect themselves.

Question 8

Nuremberg code

Answer 8

Study Note: The Birth of Research Standards
1. The Philosophy Shift: “Subject” vs. “Participant”

Old View (“Subject”): A person is a passive object used for data. The researcher has all the power.

Modern View (“Participant”): A person is an active, voluntary partner. This emphasizes their Autonomy and their right to choose.

2. The Nuremberg Code (1947)

Developed after World War II to address the horrific experiments conducted by Nazi doctors. It created the first international “Commandments” for human research.

The Top “Commandments” for Nursing Research:

Voluntary Consent is Essential: No coercion, no force, no secrets.

The Right to Withdraw: A participant can quit the study at any time for any reason.

Avoid Unnecessary Harm: Researchers must protect participants from physical and mental suffering.

Societal Benefit: The research must be important and unable to be done any other way.

Question 9

Declaration of helenski

Answer 9

Study Note: The Declaration of Helsinki (1964)
1. The Big Picture

Created by: World Medical Association (WMA).

Purpose: The “ethical playbook” for medical research involving human subjects.

Key Focus: Protecting the health, privacy, and dignity of the participant.

2. The Critical Distinction

The Declaration separates research into two buckets based on intent:

Therapeutic Research:

Goal: To treat/cure the participant.

Benefit: The person has a chance to get better from the experimental treatment.

Example: Testing a new insulin type on a diabetic patient to see if it stabilizes their blood sugar better.

Nontherapeutic Research:

Goal: To gain knowledge for science.

Benefit: No direct medical benefit to the participant; it helps future patients.

Example: Taking extra blood samples to “map” how a disease works in the body.

3. The “Ethics Math” (Risk vs. Benefit)

Researchers MUST design studies where the Potential Benefits > Risks and Burdens.

If the risk to the patient is too high compared to what science will learn, the study is unethical and should not be done.

Question 10

Outcome

Answer 10

Nursing Research: Evaluating Outcomes of Care
Donabedian’s Model: Structure, Process, and Outcomes

1. Structure (The Setup)
   The environment and resources.
   Includes: Facilities, equipment, staff qualifications, and organizational policies.
2. Process (The Action)
   What is actually done for the patient.
   Includes: Clinical actions, patient education, and adherence to protocols (e.g., COVID-19 safety measures).
3. Outcomes (The Results)
   The final effects on health status.
   Includes: Recovery rates, functional status (ADLs), and patient satisfaction.

Key Influencing Factors:

• Time Dependency: Some results are immediate, while others are long-term or permanent.
• Patient Factors: Genetics, age, lifestyle (smoking/diet), and pathophysiology.
• Environmental Factors: Air quality, public policies, and occupational hazards.

Critical Appraisal Tip:
Always check if researchers accounted for patient and environmental factors that might have influenced the causal link between the process and the outcome. Outcomes are a shared responsibility between providers, patients, and the community.

Question 11

Proximal and distal

Answer 11

Proximal and Distal Nursing Outcomes
Nursing Research: Outcomes

Proximal Outcomes

• Definition: Immediate or direct results of nursing care.
• Characteristics: Closely tied to specific interventions; low influence from external factors.
• Examples: Pain reduction after medication, stabilization of vital signs, improvement in clinical signs/symptoms.

Distal Outcomes

• Definition: Long-term or broad results removed from the immediate care setting.
• Characteristics: Influenced by external “nontreatment” factors (environment, socioeconomic status, upbringing).
• Examples:
  
  • Quality of Life (QOL): Overall physical, psychological, social, and spiritual well-being.
  • Long-term functional status.
  • Readmission rates.

Note: While nursing care contributes to distal outcomes, they are more difficult to control because they are affected by the patient’s life outside the clinical setting.

Question 12

Structure

Answer 12

The “Structure” Breakdown

Think of the Structure as the “stage” where the nursing care happens. Before the “play” (the care) can even start, the stage is already set.

The Human Element
This is about the people you’re working with. It’s the number of staff on the floor and their educational background. Is it a team of seasoned RPNs, or is everyone a brand-new grad? This is “given” to you the moment you clock in.

The Physical Environment
This is the literal “stuff” around you. It’s the size of the hospital, how old or new the building is, and even the comfort of the patient rooms. It includes the instruments and tools—like whether you have top-of-the-line IV pumps or older equipment that’s finicky.

The Invisible Rules
This is the “energy” of the workplace. It’s the hospital policies and, most importantly, the amount of autonomy you are allowed. Can you make clinical decisions based on your knowledge, or is every move strictly controlled by a rigid hierarchy?

Question 13

Structure revised

Answer 13

Nursing Research: Donabedian Model (Structure)
The Donabedian Model: Structure, Process, and Outcomes

1. Structure (The “Ingredients”)
   Definition: The setting and resources available to provide care. Researchers compare “like structures” (e.g., comparing two hospitals) to see how different resources lead to different results.

Key Structural Variables:

• Patient-to-Nurse Ratio: How many patients each nurse handles.
• Skill Mix: The balance of RNs, RPNs/LPNs, and assistants.
• Education Level: Percentage of BSN-prepared nurses.
• Work Environment: Staff autonomy, safety culture, and organizational support.

2. The Research Logic
   To identify a “dangerous” or “high-quality” facility, researchers use this formula:

• Constant: Same Process (e.g., both clinics provide primary care or the same surgery).
• Variable: Different Structure (e.g., one has better staffing than the other).
• Discovery: If the Outcomes are different, we can prove the Structure caused the difference.

3. Public Accountability & Transparency

• Government Mandate: Facilities are required to report quality data to standardized metrics.
• Public Tools: “Hospital Compare,” “Nursing Home Compare,” and “Home Health Compare” allow the public to see these structural variables and outcomes to make informed choices.

Core Chain:
Structure (Resources) -> Process (Actions) -> Outcome (Results)

Question 14

When nursing used to be art

Answer 14

Study Note: Clinical Management & Standards of Care
Clinical Management & Evidence-Based Practice (EBP)

Nursing has shifted from an “Art” (intuition-based) to a “Science” (evidence-based). This means moving from undefined, personal methods to measurable, clinical definitions where anyone testing the patient gets the same objective result.

1. The Three Focus Areas of Evaluation
   When we evaluate how care is managed, we look at:

• Standards of Care: The benchmarks or “yardsticks” we use to measure quality.
• Practice Styles: How clinicians deliver care and how it affects outcomes.
• Costs of Care: Managing resources and money effectively while keeping patients safe.

2. Tools for Standardizing Care
   These tools make care consistent everywhere:

• Clinical Guidelines: Step-by-step rules and “best practices” all nurses should follow for specific conditions.
• Care Maps / Clinical Pathways: A timeframe or “calendar” for care (e.g., what to do in the morning vs. night to reach recovery).
• Care Bundles: A “package deal” of 3-5 specific steps. CRITICAL: These are “all-or-nothing”—you must do every step in the bundle for it to work.

3. The “Who” Behind the Rules
   These organizations create the standards we follow:

• AHRQ: Funds the research and makes the guidelines to ensure they are valid.
• CDC: Creates the rules for Infection Control and safety.
• CMS: Sets the rules for how treatments are paid for and monitored.
• Specialty Groups (e.g., Oncology Nursing Society): Create rules for treating specific diseases.
• CNO (College of Nurses of Ontario): The main regulator that turns these guidelines into the laws you must follow as a nurse.

4. Donabedian’s Model for Quality
   Quality is judged in three parts:
5. Structure: The building, equipment, and staff.
6. Process: What the nurse actually does (Following the Standards of Care).
7. Outcome: Did the patient get better?

Question 15

Sampling definition

Answer 15

Outcomes Research Sampling Definitions
Outcomes Research Sampling

Core Definition:
Outcomes research focuses on the “real world” rather than a controlled lab. It studies how healthcare services and nursing interventions actually affect a diverse population.

Key Features:

• Heterogeneous Samples: Unlike standard trials, these use a “mixed bag” of participants (different ages, health statuses, and comorbidities) to reflect real-world clinical practice.
• Treated vs. Untreated: Researchers compare those who received care to those who did not (the “invisible” group) to determine the actual impact of the intervention.
• Large Databases: Used as sample sources because it is difficult to manually locate and follow up with untreated individuals.
• Representativeness: The goal is for the sample to be as much like the target population as possible so results are practical for nurses.

Why it’s unique:

• Random Sampling is Rare: Since outcomes have often already happened, researchers act more like detectives looking at existing data rather than directors controlling a study.

Question 16

The data base’s researchers use to find patients

Answer 16

Think of it like two different folders in a hospital’s computer system:

1. Clinical Databases

These are created by the people actually providing the care (nurses, doctors, and hospitals).

What’s inside: Real-time nursing notes, electronic health records (EHRs), and details from specific research protocols.

The “Specialty” Folders: Some of these are dedicated to specific diseases (like a database just for Breast Cancer or Heart Failure).

Why they matter: They allow researchers to see the link between what a nurse did (like specific wound care) and how the patient actually turned out over a long period.

2. Administrative Databases

(Note: Your text mentions these as the second broad category). These are usually more about the “business” and “organization” side of healthcare.

What’s inside: Insurance claims, billing information, and hospital discharge summaries.

Why they matter: Since almost every patient has insurance or a billing record, these databases are massive. They are great for finding those “untreated” people or seeing broad trends across thousands of patients at once.

Question 17

Administrative databases

Answer 17

Administrative Database Definitions
Administrative Databases in Outcomes Research

Core Definition:
These databases are created for non-clinical purposes, primarily for “the business side” of healthcare, such as billing, insurance claims, and hospital management.

Key Features:

• Focus on Costs and Coding: Instead of descriptive nursing notes, they use standardized codes (like ICD-10) to track diagnoses and the cost of treatments.
• Large Scale: Because they are used for insurance and government billing, they contain data on massive groups of people across entire cities or countries.
• Geographic Variations: Researchers use this data to see if certain areas have higher rates of disease or different healthcare needs.

How Researchers “Measure” Disease (Proxy Data):
Since these files don’t have descriptions, researchers look at:

1. Length of Stay (LOS): How many days the patient was in a bed.
2. Total Cost: Higher costs usually signal more severe or “heavy” illness.
3. Resource Use: The number of tests or specialized units (like ICU) required.

Pros vs. Cons:

• Pros: Great for finding the “untreated” group and seeing broad trends.
• Cons: Lacks the “why” and the detailed clinical story written by the nurse.

Question 18

Outcomes

Answer 18

Outcomes Research Explanation
Outcomes Research vs. RCTs

• RCT (Randomized Controlled Trial): The “Gold Standard” for clinical research. Uses random assignment to create highly controlled, similar groups. Focuses on efficacy (Does the intervention work in a perfect setting?).
• Outcomes Research: Focuses on effectiveness (Does it work in the real world?). Frequently uses Quasi-Experimental or Observational designs. Looks at a “large mass of people” to be representative. Includes additional parameters: Cost, Timeliness, Convenience, and Patient Preferences.
• Why Quasi-Experimental? Used for hospital improvement because it works with “ready-made” groups (like existing wards or shifts) rather than shuffling patients randomly. It is more convenient and practical for studying social services and policy changes.
• Research Type: Primarily Quantitative (measuring numbers/results for the masses). Often used within Mixed Methods to combine big data with the human story (Qualitative).

Question 19

Prospective cohort

Answer 19

Prospective Cohort Overview
Prospective Cohort Study

• Core Concept: A longitudinal study that follows a group of similar individuals (a cohort) over time to see how certain exposures or experiences affect their future outcomes.
• The “Forward” Direction: It starts with a group of people who do not yet have the outcome being studied. Researchers watch them as they move forward in time.
• The “Assuming” Process: It captures the transition as participants move from their baseline state to assuming a new status, role, or condition.
• Key Terms:
  
  • Prospective: “Looking forward” (Starts now, ends in the future).
  • Cohort: The specific group sharing a characteristic (e.g., all students in a specific year).
  • Incidence: The rate at which new cases or “becomings” occur during the study.

Connection to Outcomes Research:

• Used to measure Effectiveness in the real world.
• Helps determine if a policy or intervention actually changes what people “become” over a long period.
• Requires large, representative samples of the “masses” to ensure the data is reliable.

Question 20

Stratified random sampling

Answer 20

Stratified random sampling Stratified random sampling is used in situations in which the researcher knows some of the vari- ables in the population that are critical for achiev- ing representativeness. Variables commonly used for stratification include age, gender, race/ethnicity, geographical region, and health status. For example, previous studies (hypothetically) have indicated col- lege athletes have better exercise habits than other college students. Your study is designed to test the efficacy of a smartphone app to increase exercise among college students. The app rewards the num- ber of steps taken each day with access to an online game. You may want to stratify your sampling frame by athletes/nonathlete. Stratification ensures that all levels of the identified variables are adequately represented in the sample by randomly selecting from each stratum. With stratification, researchers can use a smaller sample size to achieve the same de- gree of representativeness that is derived from using a larger sample selected through simple random sampling (see Table 9.1; Gray & Grove, 2021; Kazdin, 2017). When stratified random sampling is used, re- searchers should define the categories (strata) of the variables selected for stratification in the research report. For example, using race/ethnicity for stratifi- cation, the researcher may define four strata: white UNDERSTANDING NURSING RE… non-Hispanic, black non-Hispanic, Hispanic, and other. The population may be 60% white non-His- panic, 20% black non-Hispanic, 15% Hispanic, and 5% other. Researchers may select a random sample for each stratum equivalent to the target population proportions of that stratum. Thus a sample of 100 participants would need to include approximately 60 white non-Hispanic, 20 black non-Hispanic, 15 Hispanic, and 5 other. Alternatively, equal numbers of study participants may be randomly selected for each stratum. For example, if age is used to stratify a sample of 100 adult participants, the researcher may obtain 25 subjects 18 to 34 years old, 25 subjects 35 to 50 years old, 25 subjects 51 to 66 years old, and 25 subjects older than 66 years. With equal numbers of study participants in each group, the smaller groups are overrepresented, which can create error (Gray & Grove, 2021; Kazdin, 2017). Lee and colleagues (2021, Abstract section) con- ducted a correlational study “to investigate the changes in safe patient handling programs in hos- pitals, and nurses’ perceptions, work practices, and musculoskeletal symptoms by hospital characteris- tics after the passage of California’s safe patient handling legislation.” Data were collected using two cross-sectional surveys. This study included a strati- fied random sampling method that is described in Research Example 9.3.