Bioscience Research and Development — Health Science & Technology Study Notes

Bioscience Research

The systematic study of living systems (cells, microbes, plants, animals, humans) to generate reliable knowledge.

Research and Development (R&D)

The process of turning discoveries into usable products or practices that perform consistently and safely.

Observation and Problem Identification

The first step in the research process where a pattern or need is noticed.

Research Question

A clear, testable question formulated from an observation or need.

Hypothesis

A testable statement predicting a relationship between variables.

Study Design

The method selected to fairly test the hypothesis in research.

Data Collection

The process of measuring outcomes using validated tools.

Analysis and Interpretation

Determining what the data mean and assessing the confidence in the findings.

Communication

Sharing methods and results so others can evaluate and reproduce the research.

Iteration

The process of refining questions and findings based on results.

Independent Variable

The factor that is manipulated or changed in a study.

Dependent Variable

The measured outcome that is affected by changes in the independent variable.

Confounder

A variable that can create a misleading association between independent and dependent variables.

Control

A comparison condition designed to isolate the effect of the independent variable.

Negative Control

A control group that is expected to show no effect.

Positive Control

A control group that is expected to show a known effect.

Correlation vs. Causation

The distinction that correlation does not imply causation.

Randomized Controlled Trials (RCTs)

Studies designed to support causal conclusions by randomly assigning subjects to different groups.

Observational Studies

Research methods where researchers do not assign exposures but observe existing conditions.

Translational Research

Research that connects basic biology discoveries to patient care and back.

Reproducibility

The ability of an independent team to reanalyze data and achieve the same results.

Replicability

The ability of an independent team to repeat an experiment and achieve consistent findings.

Robustness

The ability of findings to hold under varying conditions.

Informed Consent

A process ensuring participants understand the study's purpose, procedures, risks, and benefits.

Respect for Persons

Ethical principle emphasizing treat individuals as autonomous agents.

Beneficence

Ethical goal of maximizing benefits and minimizing harms.

Justice

Ethical principle of fair selection of participants in research.

Biosafety

Preventing unintentional exposure to pathogens or hazardous materials.

Biosecurity

Preventing theft, misuse, or intentional release of biological agents.

Aseptic Technique

Methods to prevent microbial contamination in laboratory settings.

Good Laboratory Practice (GLP)

Quality systems emphasizing reliable processes and documentation.

Standard Operating Procedures (SOPs)

Written instructions to ensure consistent and accurate lab procedures.

Quality Control (QC)

Operational checks during work to ensure processes meet defined criteria.

Quality Assurance (QA)

System-level oversight to ensure that processes produce products of quality.

Intellectual Property (IP)

Legal rights to inventions and creations in research and development.

Positive Predictive Value (PPV)

The proportion of true positives among all positive test results.

Negative Predictive Value (NPV)

The proportion of true negatives among all negative test results.

Sensitivity

The proportion of true positives correctly identified by a diagnostic test.

Specificity

The proportion of true negatives correctly identified by a diagnostic test.

Analytical Performance

How an assay behaves in controlled lab conditions.

Clinical Performance

How well a test predicts disease or outcome in real patients.

Data Integrity

Ensuring that data is accurate, reliable, and properly recorded.

Root Cause Analysis

Investigating and determining the underlying cause of a problem.

Corrective and Preventive Actions (CAPA)

Procedures to correct issues and prevent their recurrence in lab processes.

Batch Effect

Variability in results caused by differences in handling samples across different times or conditions.

Hypothesis Testing

Assessing whether observed differences could occur by chance under a null hypothesis.

Error Bars

Graphical representation of the variability of data around a reported measurement.

Descriptive Statistics

Statistics that summarize and describe the characteristics of a dataset.