Research Methods Midterm

Beneficence

researchers have an ethical responsibility to maximize the potential benefits of their research while minimizing possible harm to participants

- IRB: risk is minimal; surveys take 10 minutes.

Human Subjects Research

Involves living people and either interaction with them or identifiable private information about them.

- Work that uses only public materials or public aggregate data is not human subjects research.

Havasupai Diabetes Study

researchers collected blood samples from the Havasupai Tribe for diabetes research but later used them for other studies without proper informed consent.

Nazi Experimentation

Unethical medical experiments conducted on concentration camp prisoners during World War II without their consent, often causing severe suffering or death.

- led to the creation of the Nuremberg Code (1947)

The National Research Act

(founded from Tuskegee) It established the National Commission for the Protection of Human Subjects (which later wrote the Belmont Report) and required Institutional Review Boards (IRBs) to oversee federally funded human subjects research.

Nuremburg Code

A set of 10 ethical principles established after the Nazi experiments. Emphasizes voluntary informed consent, minimizing harm, and ensuring participants can withdraw from research at any time.

Declaration of Helsinki

World Medical Association's international ethical guidelines. Evolving framework by physicians that allows proxy consent to ethically regulate modern clinical and therapeutic research.

Exempt Risk

research that falls into specific low-risk categories and is exempt from most federal IRB requirements. xamples include certain anonymous surveys, educational research, and studies using existing data.

Belmont Report

What IRBs use has the three principles of respect for persons, beneficence, justice

Tuskegee Syphilis Study

40 year study by U.S. Public Health Service and CDC withheld standard penicillin treatment from rural

Black men without their consent

Respect for persons

treating persons as autonomous agents and protecting those with diminished autonomy (informed consent)

- IRB: written consent before enrollment, with the right to withdraw at any time without affecting care.

Minimal Risk

the probability and magnitude of harm from participating in a research study are not greater than those encountered in daily life

Justice

fair distribution of burdens and benefits

- IRB: all eligible patients are invited, not only those who are easiest to reach

Harm Reduction

public health approach that aims to minimize the negative health and social consequences of risky behaviors rather than requiring people to stop those behaviors entirely. Examples include needle exchange programs and distributing naloxone to prevent overdose deaths.

Institutional Review Board

A committee at each institution where research is conducted to review every experiment for ethics and methodology.

Research Misconduct

fabrication, falsification, plagiarism, or other practices that deviate from those that are commonly accepted within the scientific community for conducting or reporting research

Secondary data

information that already exists somewhere, having been collected for another purpose

Assent

agreement from someone who

cannot legally consent (a minor)

Expedited

faster review process for research that involves no more than minimal risk and falls into specific eligible categories. -- Instead of review by the full IRB committee, the study is reviewed by the IRB chairperson or designated experienced reviewers.

Full

A review process in which a study is evaluated by the full IRB committee, generally because it involves greater than minimal risk to participants. The committee evaluates the study's risks, benefits, informed consent procedures, and protections for participants before granting approval.

Informed Consent

happens before enrollment and explains the study's procedures, risks, benefits,

confidentiality, compensation, the right to withdraw, and who to contact.

Research Violation

An action that breaks established research ethics guidelines, regulations, or approved study procedures, potentially putting participants' rights, safety, or well-being at risk.

Transgression

an act that goes against a law, rule, or code of conduct; an offense

Principal Investigator

The lead researcher responsible for designing, conducting, and overseeing a research study, ensuring it follows ethical guidelines, IRB requirements, and research regulations. The PI is ultimately responsible for protecting participants' rights, safety, and well-being.

Research Lead

The person responsible for coordinating and managing the day-to-day activities of a research study

Research Investigator

A researcher involved in conducting a study, including collecting data, analyzing results, and following research protocols and ethical guidelines.

Animal cells

generally does not qualify as human subjects research and is subject to different ethical regulations.

Confidentiality

the act of holding information in confidence, not to be released to unauthorized individuals

Deception

Allowed only when necessary and approved by

an IRB, followed by debriefing.

Incentives

Incentives should not be so large that they create undue influence on a participant's voluntary decision.

Anonymity

When research data cannot be linked to a participant's identity, even by the researchers.

Common Rule

Turns the Belmont Report principles into a set of federal regulations. establishes requirements for informed consent, IRB review, and participant protections.

Biospecimens

- Biological materials collected from humans, such as blood, tissue, saliva, or DNA

- Identifiable biospecimens are subject to human subjects research protections.

Dissent

When a participant, particularly a child or someone unable to legally provide informed consent, expresses unwillingness or refusal to participate in research.

- should be respected even if adult gave permission

What makes research empirical

bases its conclusions on data collected through systematic observation or measurement rather than personal opinions or assumptions.

conceptualization

The process of defining what an abstract concept means in a research study.

operationalization

The process of turning an abstract concept into something that can be observed and measured.

null vs alternative hypothesis

Predicts no relationship or difference between variables

vs predicts that a relationship or difference exists.

positive and negative relationships

Both variables increase or decrease together vs as one variable increases, the other decreases.

curvilinear and absent relationships

The relationship changes direction at some point vs no consistent relationship exists between the variables.

ontology

What is real or true? (positivism, subjectivism, etc.)

epistemology

How do we know? (empiricism, experiential)

methodology

What is the best way to go about learning? (quant data, qual data, participatory)

Evidence hierarchy

Systematic Reviews & Meta-Analyses, randomized controlled trials (RCTs), cohort studies, case-Control Studies, cross-sectional studies, case reports

convergent design

A mixed methods approach in which quantitative and qualitative data are collected during the same period and then compared or combined.

explanatory sequential

mixed methods approach that collects quantitative data first, followed by qualitative data to help explain the quantitative findings.

exploratory sequential

mixed methods approach that collects qualitative data first and uses those findings to guide a later quantitative study.

what is not human subjects research

Research that does not involve living individuals through interaction, intervention, or identifiable private information. Examples include studies using public aggregate data or publicly available documents.

Boolean Operators

Words such as AND, OR, and NOT used to combine or exclude search terms when searching academic databases.

Grey Literature

Research or information produced outside traditional academic publishing, such as government reports, dissertations, policy briefs, and nonprofit reports.

Injustice

The unfair distribution of research risks, burdens, or benefits among individuals or populations, violating the Belmont Report's principle of justice.

Systematic Review

A review that uses a structured, transparent, and replicable process to identify, evaluate, and synthesize research on a specific question.

Literature Review

summary and analysis of existing research on a topic to identify what is already known, gaps in knowledge, and areas needing further investigation.

Meta- Analysis

A statistical method that combines quantitative results from multiple studies to produce an overall estimate of an effect or relationship.

Journal Impact Factor (citation factor)

A measure of how frequently articles in a particular academic journal are cited on average. It reflects journal-level citation activity, not necessarily the quality of an individual study.

Rapid Review

A type of evidence review that simplifies or speeds up parts of the systematic review process to provide findings more quickly.

Null Finding Bias

A tendency for studies reporting no statistically significant effects or relationships to be less likely to be published or emphasized than studies with significant findings.

Search Connectors

Words or symbols used to connect search terms, including Boolean operators such as AND, OR, and NOT.

Cochrane

An international organization that produces systematic reviews of healthcare research to help inform evidence-based medical and public health decisions.

Natural Experiment

examines the effects of an event, policy, or circumstance that occurs naturally, without researchers controlling who receives the exposure or intervention.

H-index

A measure of a researcher's publication output and citation impact. 10 on this index means the researcher has at least 10 publications cited at least 10 times each.

Scoping Review

maps the available research on a broad topic to identify key concepts, types of evidence, and gaps in knowledge.

Umbrella Review

summarizes and compares findings from multiple existing systematic reviews and meta-analyses.

Publication Bias

studies with statistically significant or positive findings are more likely to be published than studies with negative or nonsignificant results.

PRISMA

Preferred Reporting Items for Systematic Reviews and Meta-Analyses. A set of reporting guidelines used to make systematic reviews and meta-analyses more transparent and complete.

Henrietta Lacks

A woman whose cancer cells were collected in 1951 without her knowledge or consent and used to create the HeLa cell line, which became important in medical research.

debriefing

explaining the study's true purpose and procedures to participants after their participation, especially when deception was used.

Conceptual Framework

A diagram or model showing the expected relationships between concepts or variables in a study, including possible mediators and moderators.

Confounding

When a third variable is associated with both the independent and dependent variables, potentially creating or distorting an observed relationship.

Description

aims to describe the characteristics, behaviors, or conditions of a population or situation. (what)

Evaluation

Research that assesses how well a program, policy, or intervention works or achieves its intended goals.

Extraneous Variable

variable other than the independent variable that may influence the dependent variable but is not the main focus of the study.

Mediating

explains how or why an independent variable affects a dependent variable.

Moderating

changes the strength or direction of the relationship between an independent and dependent variable.

Spurious

apparent relationship between two variables that is actually explained by a third variable rather than a direct connection between them.

steps of a search strategy

overview of the topic to choosing search terms and databases, then applying Boolean operators, truncation and limits. Judge sources by timeframe, quality and fit with your question.

Acquiescent Response Set Bias

Agreeing or disagreeing with most or all statements regardless of their actual opinions

Content Validity

extent to which a measurement includes all important aspects of the concept it is intended to measure.

Face Validity

extent to which a measurement appears, on the surface, to measure what it is supposed to measure.

Hawthorne Effect

When participants change their behavior because they know they are being observed or studied.

Inter-rater Reliability

The degree to which different researchers or observers produce consistent results when measuring or evaluating the same thing.

Interval

Numerical data with equal distances between values but no true zero point. Example: temperature in Celsius.

Nominal

Data organized into categories that have no meaningful order. Example: blood type or insurance type.

Non-response Bias

When people who do not participate in a study differ systematically from those who do, potentially making the results unrepresentative.

Ordinal

Data organized into categories with a meaningful order, but the differences between categories are not necessarily equal. Example: satisfaction ratings from very dissatisfied to very satisfied.

Random

Unpredictable variation in measurement that causes results to differ inconsistently from the true value.

Ratio Data

Numerical data with equal intervals and a true zero, allowing meaningful comparisons of ratios. Example: age, weight, or number of doctor visits.

Reliability

The consistency of a measurement, or whether it produces similar results when repeated under similar conditions.

Social Desirability Bias

When participants give answers they believe are socially acceptable rather than reporting their true behaviors or opinions.

Systematic error

consistent error in measurement that causes results to be biased in a particular direction.

Test-retest Reliability

measures the consistency of a test or measurement tool when administered to the same group of people on two separate occasions

Validity

extent to which a measurement accurately measures the concept it is intended to measure.

Sampling Structure

overall organization and process used to select participants from a population, including the sampling frame and sampling method.

Snowball Sampling

A nonprobability sampling method in which existing participants recruit or refer other potential participants. Often used for hard-to-reach populations.

Internal Validity

accurately shows a true cause-and-effect relationship between an independent variable and a dependent variable

External Validity

extent to which research findings can be generalized to other populations, settings, or situations.

Probability

sampling method in which every member of the population has a known, nonzero chance of being selected.

Sampling Bias

When certain members of a population are systematically more or less likely to be included in a sample, making it unrepresentative.

Stratified Random

divides a population into subgroups (strata) and randomly selects participants from each subgroup to ensure representation.

Invalid Sample

sample that cannot adequately support the intended conclusions because of problems such as bias, inappropriate selection, or insufficient coverage.