KAAP400 Test 1

Define the research process and what its potential applications are

Cyclical, can be applied in any field

Steps:

• Make observations/read related research literature

• Formulate research questions

• Formulate research hypothesis

• Plan and conduct study

• Analyze data and evaluate results

• Results either suggest a follow-up study or a new research interest emerges

What are the key characteristics of research?

Systematic: follows clear plan/method

Objective: minimizes personal bias

Replicable: can be repeated by others to verify results

Evidence-based: relies on data, not opinions

“SORE”

Identify different types of research in health sciences

Basic: expands knowledge without immediate practical application

Applied: solves real-world problems

Quantitative: uses numbers and statistics

Qualitative: explores perceptions, behaviours, or experiences

Experimental: researchers manipulate variables to test their effect

Observational: researchers watch and record without interfering

Lab: research takes place in controlled settings where precise measures can be made, and conditions can be replicated

Field: research conducted in a natural setting, observing real-world behaviour without interference

Mixed methods: incorporation of multiple, different types of research methodologies

What is the importance of ethics in the research process?

Accountability and trust: ethical practices make researchers accountable to the public and regulatory bodies which is vital for maintaining confidence in scientific findings

Scientific quality: ethical lapses often lead to poor-quality data and invalid results

Compliance: adherence to ethical guidelines is usually a legal requirement for funding

What is the definition of research?

Fundamental definition: “Gathering and analyzing a body of information or data and extracting new meaning from it or developing unique solutions to problems or cases.”

As knowledge creation: “Research is creating new knowledge.”

As curiosity: “Research is formalized curiosity. It is poking and prying with a purpose.”

As observation: “Research is seeing what everybody else has seen and thinking what nobody else has thought.”

As process: “Science is a way of thinking much more than it is a body of knowledge.”

What is research?

Systematic investigation to generate new knowledge/validate existing knowledge

Answers questions across different fields

Follows planned, EB methods

Driven by curiosity, observation, and critical thinking

Conducted ethically, respecting participants and data, and designed to consider and maximize societal impact. Research is not done in a vacuum—it impacts people, communities, policies, etc.

Define evidence-based practice (EBP)

The process of combining the best available research evidence with your clinical knowledge and skill to make patient/population-centered decisions within the context of a given healthcare situation

What are the three steps of EBP?

Review evidence

Analyze evidence

Translate latest evidence

What is the goal of EBP?

to incorporate the best scientific information, clinical experience, and patient perspectives/preferences into clinical practice

True or false: EBP never changes, even with the introduction of new, potentially better, treatments

False. EBP is constantly evolving

(ie: modern heart surgery recovery shifted from long bed rest to aggressive early mobility)

What are the core principles of ethics?

Voluntary consent: participants must freely volunteer and fully understand the research

Avoid unnecessary suffering: experiments should not cause physical or mental harm

Risk vs. benefit: the potential benefits must »» the risks

Qualified researchers: experiments should be conducted only by scientifically competent individuals

Right to withdraw: participants can end their participation at any time

What are the three core principles in the Belmont Report (1979)?

Respect for persons

Beneficence

Justice

RBJ, applies for human subjects

What kinds of reforms did studies like the Tuskegee Syphilis Study bring about?

Led to reforms in U.S. clinical research laws, including establishing institutional review boards (IRBs) and informed consent regulations

Issues: researchers did not obtain informed consent/participants weren’t part of the study; participants were never told they had syphilis

Cure/treatment for syphilis (penicillin) became the standard in the 1940s, but researchers actively withheld or prevented treatment

What kind of reforms did the Nazi medical experiments bring about?

Nazi ‘doctors’ experimented on concentration camp prisoners without consent, often resulting in permanent injury

Led to establishment of the Nuremberg Code (1947)

Code established voluntary participation, avoidance of unnecessary suffering, risk vs. benefit, qualified researchers, and the right to withdraw as ethical requirements

Define ethics

A set of shared norms of conduct that guide decisions about what is acceptable/unacceptable behavior

Applied to all aspects of research

Who reviews human subject research?

Institutional Review Board (IRB)

Who reviews animal subject research?

Institutional Animal Care and Use Committee (IACUC)

What did the Milgram Obedience Study observe?

Studied obedience to authority to understand how regular people participated in WWII atrocities (Nazi soldiers saying they were ‘just following orders’)

Experiment measured “how far” participants would go under pressure from authority

What are the levels of IRB review?

exempt review: applies to certain minimal-risk studies (ie: anonymous educational surveys)

• Still requires IRB confirmation and approval

expedited review: covers minimal-risk studies using procedures like non-invasive measures or existing data

full board review: required for studies involving more than minimal risk or vulnerable populations and is reviewed by the full IRB committee

Define privacy and confidentiality/data security

privacy: related to how information is collected

confidentiality/data security: involves protecting research data from unauthorized access/breaches

What are adverse events in research?

Adverse events (AEs): any unexpected harm to participants must be reported immediately to the IRB (ie: accidental disclosure of sensitive health or location data)

What is a continuing review?

A review that evaluates risk, consent procedures, and adherence to approved protocol

Some (not all) studies remain in ongoing review to ensure participant protection

Define non-compliance

Failure to follow IRB-approved protocols

• consequences include: suspension of research, loss of funding, institutional penalties, etc…

True or false: if you have IRB approval, you do not need to adhere to broader responsibilities (ie: honest/integrity in data analysis, proper authorship, and disclosure of conflicts of interest)

False. You must always adhere to broader responsibilities

What scandal was Anil Potti in the center of?

Lied about/faked cancer research data

Lied on resume about being a “Rhodes Scholar”

Had 11 papers retracted, 7 papers corrected

Highlighted importance of peer review—two bioinformatic statisticians were the ones to raise the alarm

What are the takeaways from the Declaration of Helsinki (DOH)?

Research papers involving human participants must explicitly state that the studies were conducted following its ethical principles

Emphasizes informed consent, risk-benefit assessment, protection of vulnerable populations, serves as cornerstone for global research regulations

international

What are the principles of responsible conduct of research (RCR)?

Human and animal research ethics

Data management and integrity

Mentorship and collaboration

Publication and authorship

Conflicts of interest

Define responsible conduct of research (RCR)

The practice of research with integrity, honesty, transparency, and accountability

What were some of the research frauds and scandals discussed in class?

Bharat Aggarwal: claimed curcumin could kill cancer cells

He Jiankui: claimed to have created CRISPR (“designer") babies

Anil Pohatt: lied about data and credentials

Ranga Dias: claimed to have discovered superconducting materials at room temperature; falsified data, plagiarized grant applications and PhD thesis

Elizabeth Holmes: Theranos, claimed to be able to perform hundreds of blood tests on a single drop of blood

True or false: 20% of scientists admitted to having fabricated, falsified, or modified data or results at least once

False. 2% admitted this, but the truth is probably around ~5%

What are predatory journals?

Tend to lack rigorous peer review and exploit the open-access model, poses threat to the integrity of scientific research

“Pay for play”

Term coined by Jefferey Beall

Define scientific dishonesty

Falsification of data

Fabrication of data

Selective reporting of data

‘p-hacking’: trying multiple analyses to get significant results

Making hypothesis after results are known

Improper sharing and authorship practice

What is the importance of data management and integrity?

Accurate and transparent data management: critical for reproducibility, reliability, and credibility of research

Poor management can = errors, misinterpretation, and ethical breaches

Explain authorship and publication ethics

Authorship criteria: significant contributions to study design, data collection, analysis, or manuscript writing

Avoid gift authorship: including someone who made minimal contributions

Proper acknowledgement: credit other people in acknowledgements if not authors

Simply performing routine tasks (ie: data entry) doesn’t automatically = authorship

Discuss authorship at start of project and revisit as roles evolve

What is self-plagiarism?

occurs when you reuse your own previously published work without proper citation or disclosure

failure to disclose misleads readers about novelty

What is a conflict of interest?

Occurs when a researcher’s personal, financial, or professional interests could compromise (or appear to compromise) their objectivity in conducting, analyzing, or reporting research

Core principles for responsible use of AI in research

Accountability

Verification

Transparency and disclosure

Data security

Mitigation of bias

Originality

Define cultural competence in research

Designing and conducting studies that respect and respond to the cultural, social, and demographic diversity of participants

What are the stages of a research study?

Literature review → research question → hypotheses → research design → data collection → analysis → interpretation → dissemination

How do researchers choose a scientific topic?

Interest and expertise

Literature gaps

Relevance and impact

Feasibility

Collaboration opportunities

Career alignment

Pilot and refine

What does PICO stand for?

P: Population/patient/problem

I: Intervention/issue

C: Comparison/Control (optional)

O: Outcome of interest

not all research topics fit PICO

What is a Boolean Search?

Boolean search: based on logic system by George Boole, 3 cores (and, or not)

Steps of conducting a literature review

1. Start Broad

2. Narrow the topic

3. Define a research topic

Synthesize, don’t summarize

What is the anatomy of a research article?

Abstract

Introduction

Methods

Results

Discussion

What are the types of hypotheses?

Null hypothesis: States no effect of relationship exists

• Vitamin D supplementation has no effect on BP in adults

Alternative hypothesis: suggests a significant effect of relationship

• Vitamin D supplementation significantly changes BP in adults

Directional hypothesis: predicts the direction or the effect

• Vitamin D supplementation reduces BP in adults

Non-directional hypothesis: predicts an effect without specifying its direction

• ie: Vitamin D supplementation affects BP in adults

What are the control strategies in research design?

Control strategies: Approach for reducing alternative explanation

Strategy 1: Randomization

Strategy 2: Standardization

Strategy 3: Blinding in Applied Settings

Strategy 4: Reliability

What are the types of validity in research?

Internal validity: refers to how confidently we can say that the results of the study are caused by the variables being investigated, rather than by other factors or influences (confounding variables)

External validity: refers to how well results of a study can be generalized to other people, settings, or situations in the real world

Confounding variables: uncontrolled factors other than the IVs that influence the DVs

What is the Hawthorne Effect?

When participants change their behaviour simply because they know they are being studied

What is the difference between qualitative and quantitative research?

• Qualitative: lens that listens and interprets meaning (ie: perceived experience)

  • Collects non-numerical data to understand experiences, perspectives, or behaviours

  • Focus on meaning, experience, context over measurements

  • Open-ended questions, interviews, observations, etc.

• Quantitative: lens that measures and counts (ie: physiologic changes)

  • Collects and analyzes numerical data

  • uses structured methods to measure variables

  • objective, systematic approach

  • Experiments, surveys/questionnaires, structured observations

  • controlled environment

What are descriptive statistics?

Definition: describe and summarize data collected to show pattern or trends

“What does our data look like?”

Examples: mean, median, mode

What are inferential statistics?

Definition: test whether results are meaningful and can be generalized

“Infer beyond the data”

Examples: t-tests, ANOVA, regression

What are the pros and cons of quantitative research?

• Pros:

  • Scientific objectivity

  • Theory testing

  • Efficient analysis

  • Easy replication

  • Precise hypothesis testing

• Cons:

  • Controlled setting may not = real-world

  • Statistical expertise needed

  • Large samples required

  • Hypothesis focus

What are the pros and cons of qualitative research?

• Pros:

  • Deep understanding

  • Discover new insights

  • Captures real-life complexity

  • Practical application

• Cons:

  • Small sample sizes

  • Subjectivity and bias

  • Context-specific results

  • Time-intensive analysis

What are the ethical considerations for quantitative and qualitative research?

• Quantitative must protect:

  • Privacy

  • Risk exposure

  • Data integrity

• Qualitative must protect:

  • Emotional safety

  • Confidentiality

  • Accurate representation of voices

What is a case study?

• about death of analysis (DOES NOT REQUIRE A SUBJECT TO BE ALIVE)

• Allows researchers to explore unique or extreme cases in detail (ie: Albert Einstein)

What is historical research?

• examines past events, people, ideas, or practices to understand how they have changed over time

• Uses existing historical sources and records as evidence

• Researchers evaluate the credibility and accuracy of historical sources

• Can explain why and how changes occurred

What is a photo diary?

• a method where participants document their daily experiences, behaviours, or training using photos, videos, or digital logs

• Researchers analyze to understand patterns, motivations, and context

Define experimental design

“True” experimental design: research design where researchers actively manipulate one or more of the independent variables (IVs)

Strongest design when testing for causation

What is the purpose of experimental design in research?

preserve objectivity and standardization, make experiment replicable

What is the difference between a population and a sample?

• population: “whole group”, entire group of people/objects/events a researcher is interested in studying

  • Includes everyone/everything that meets the study criteria

• sample: smaller group (subset) that is selected from the population for your study

  • People who actually participate in the study

  • Denoted by ‘n’

  • Used to represent the larger population

Describe recruitment strategies

• participant recruitment: process of identifying, approaching, and enrolling individuals who meet eligibility criteria for a research study

  • Defining target population

    • Inclusion criteria/exclusion criteria

• Common strategies:

  • Advertisements

  • Clinical recruitment

  • Email lists or participants registries

  • Community outreach

  • Snowball sampling

• Most ideal strategy depends on a target population and study design

Describe sampling methods

• probability sampling: every member of the population has a known chance of being selected; helps create a sample more representative of the population

  • Skewed chances can = selection bias

• Types of probability sampling:

  • Simple random sampling: every member of the population has an equal chance of being selected

  • Stratified sampling: population is divided into groups (strata/subgroups) and participants are randomly selected from each group

  • Cluster sampling: researchers randomly select groups (clusters) and study everyone within those groups

  • Systematic sampling: researchers select every nth person from a list

• non-probability sampling: participants are selected without randomization (non-random)

  • Not everyone in the population has a known chance of being selected; used when time/access/resources are limited

• Types of non-probability sampling:

  • Convenience sampling: participants are selected because they are easy to access

  • Quota sampling: researchers recruit participants until specific group quotas are met

Define power analyses

• statistical method used to determine the probability that a study will detect the true effect (“power”) and to calculate the sample size needed to achieve that power

What are the core principles of experimental design

• randomization

• manipulation

• control

What are the components of research design?

• Variables

• Procedure

• Data collection and analysis

• Documentation

What is participant retention?

• Definition: the ability to keep participants involved in study until it’s completed

• Strategies to improve retention:

  • Maintaining regular communication with participants

  • Providing reminders for appointments or surveys

  • Offering incentives/compensation

  • Keeping study procedures convenient and flexible

  • Build rapport/trust with participants

What is sample size estimation?

• definition: the process of determining how many participants you need in a study to detect an effect reliably

• Need to calculate sample size and power

What are the important aspects of sample size estimation?

• Important aspects:

  • Sample size (n): number of people in a study

  • Significance level (alpha): probability of a false positive/Type I error

    • Type I error: false alarm/positive, detecting an effect when there isn’t one

    • Lower alpha = stricter test; less chance of a false positive

    • Typically requires larger sample size

  • Power (1-beta): calculated probability of detecting a true effect (beta) is the probability of making a Type II error

    • Common target: 80% (8/10) similar studies would detect the same effect

    • Low power: higher chance of Type II error (failing to detect a real effect aka “false negative”)

    • Larger sample sizes generally increase statistical power and reduce Type II error risk

    • Type II error: false negative, real effect does exist, study doesn’t detect it

What factors influence sample size?

• effect size

• statistical power

• significance level

• variability

What is the purpose of a pilot study?

• conduct a small-scale preliminary study before main study

• Tests feasibility of recruitment, procedures, and measures

• Provides preliminary data on variability and effect size

• Help refine study methods and materials

What is a pre-experimental design?

• definition: type of design where researchers introduce an intervention, but design lacks random assignment or true control group

• Weakest form of research design, provides very casual evidence

• Typically used for pilot studies, feasibility studies, preliminary investigations

Define One-group Pretest-Posttest designs

• a single group is measured before and after an intervention

• no control or randomization

• cannot establish causation

What are the types of “true” experimental designs?

• Pretest-posttest control group design:

  • participants randomly assigned to control or intervention group

  • measured before and after intervention

  • stronger causal evidence because baseline is established during pretest

  • requires more time/resources

• Posttest-only group design:

  • participants randomly assigned to control or intervention group

  • no pretest, just measure after intervention

  • assumes group was at a similar/same baseline

What is a factorial design?

• investigate two or more IVs simultaneously

• Example: exercise type (cardio and strength) and intensity (high vs low) effect on primary VO2 max

  • example of a 2×2 factorial design ^^

What is a repeated measure design?

• each participant is measured multiple times

• measures taken at different time points or under different conditions

• Each participant serves as own comparison

• Reduces variability

• used to compare different treatments or conditions

What are crossover designs?

• special type of design only used in true experiments

Each participant receives two or more interventions sequentially, with a wash out period (planned intervention-free period to ‘wash out’ effects of first intervention) in between them

• Randomization often used to determine the order of interventions

• The washout period is critical to prevent carryover effects from the first intervention

• Each participant serves as their own control

Define randomized control trial (RCT)

• research study that compares different treatments or interventions

  • participants randomly assigned to intervention or control groups

• helps identify if an intervention → observed effect

• Considered strong study design

Define blinding

• keeping participants and/or researchers unaware of group assignments

• Can be single (only participants don’t know), double (researchers also don’t know), or triple (even the statisticians don’t know)

What is the difference between placebo and sham effects?

• placebo: inactive treatment given to participant to mimic real intervention; no active ingredient

  • controls for participants’ expectations/psychological effects of receiving treatment that is ‘supposed to do something’

• sham: similar to placebo, refers to something ‘done’ instead of taken (ie: a device appears to stimulate the vagus nerve, but doesn’t actually)

What is the Solomon-4 Group design?

• design that tests pretest and posttest only

• lets us see if pretest affected the results (can bias participants; pretest effect)

• participants randomly assigned to 4 groups

What is a quasi-experimental design?

• research design in which the researcher manipulates an independent variable (IV), but does not randomly assign participants to group

  • no random assignment = harder to say if intervention caused outcome

• researchers still examine effects of intervention/treatment

• participants assigned to groups based on existing characteristics/groups

• Often used when random assignment isn’t ethical/practical (ie: a school implements a new physical activity program in one school (intervention) and compares student fitness outcomes to another school that does not implement the program (control)

  • groups are pre-existing so differences in baseline fitness, motivation, or socioeconomic status may affect results