What topics and skills are typically covered in a basic biomedical research course?

Basic Course in Biomedical Research: Core Topics and Skills

A comprehensive basic course in biomedical research must cover eight fundamental skill areas: literature review methodology, hypothesis formulation with statistical power considerations, research protocol development including ethical considerations, data collection and management, statistical analysis techniques, scientific presentation and publication, risk-benefit analysis, and research ethics including data integrity and conflict of interest management. 1

Essential Core Competencies

Literature and Knowledge Assessment

• Conduct comprehensive and systematic literature searches to determine the exact state of knowledge before undertaking new investigation 1
• Develop skills in summarizing and interpreting published studies, including identifying potential sources of bias and methodological flaws 1
• Learn to identify gaps in knowledge within a research problem that merit investigation 1

Hypothesis Development and Study Design

• Formulate testable hypotheses with specific, measurable goals ensuring that statistical power is achievable 1
• Understand strengths and weaknesses of different clinical research study designs (observational, experimental, prospective, retrospective) 1
• Develop research protocols that specify inclusion/exclusion criteria, outcome measures, power analysis, and data analysis plans 1

Protocol Development and Implementation

• Master the complete research plan development including study design, appropriate controls, subject recruitment, ethical considerations, informed consent procedures, privacy protection, data collection modes, and institutional approval processes 1
• Learn grant writing skills for intramural and extramural funding applications 1
• Understand how to determine resources needed and implement a research plan effectively 1

Data Management and Analysis

• Prepare routine data forms and maintain accurate research records 1
• Develop analytical methods and procedural skills, particularly for handling artifacts, missing data, outliers, and statistical inference 1
• Apply appropriate statistical analyses to research data, understanding basic statistical methods used in biomedical research 1
• Learn to assess, analyze, and replicate data to establish support or refutation of hypotheses 1

Research Ethics and Regulatory Compliance

• Master research ethics principles including data acquisition/management, data protection, conflicts of interest, publication practices, authorship, and scientific conduct 1
• Understand governmental and industry standard regulatory requirements in study design 1
• Learn to identify ethical challenges and potential conflicts of interest in research 1
• Complete all institutional review board requirements and understand principles of informed consent and assent 1, 2

Scientific Communication

• Develop skills in both oral and written presentation of results, recognizing that no investigation is complete until reported as a full paper in peer-reviewed journals 1
• Learn to prepare abstracts for submission to national meetings and present findings at scientific conferences 1
• Master manuscript preparation for publication in peer-reviewed journals 1

Risk-Benefit Assessment

• Conduct risk-benefit analysis regarding both individual subject and societal implications 1
• Understand practical costs of prediction errors and implications of research outcomes 1

Institutional Requirements and Support

Training Environment

• Training must occur in institutions with adequate staff and facilities for research, with access to both clinical divisions and basic biomedical science departments 1
• Essential institutional support includes expertise in epidemiological methods, outcome evaluation, biostatistics, and biomedical ethics 1
• Access to research administration overseeing human subject protection committees and grant proposal assistance is mandatory 1
• Free electronic access to library systems with full-text articles and journals is required 1

Faculty and Mentorship

• Faculty must include multiple members with proven investigative skill demonstrated by published original research in peer-reviewed journals 1
• At least one full-time faculty member should demonstrate skill as a clinical investigator 1
• Adequate mentorship with passionate mentors who can provide project support is essential 1

Training Duration and Levels

Tiered Training Approach

The American College of Cardiology guidelines describe three research training levels 1:

• Level 1 (Clinical Practice Focus): 6-12 months (up to 18-24 months) devoted to specific projects, which can be undertaken concurrently with clinical training 1
• Level 2 (Teaching and Clinical Investigation): Minimum 18-24 months dedicated to clinical investigation 1
• Level 3 (Basic or Advanced Research): Substantive commitment requiring extended dedicated research time 1

Contemporary Research Standards

Reproducibility and Rigor

• Understand principles of experimental design including appropriately powered studies, validated reference standards, and dose/concentration response curves 1
• Learn methodology for cross-study analysis and meta-analyses of research findings 1
• Master data analysis, reporting, sharing, and publication standards to ensure reproducibility 1

Specialized Methodologies

• For machine learning and predictive modeling: understand data preprocessing, validation strategies, and appropriate metrics for model performance 1
• For clinical trials: participate in the full range of activities from design through analysis and publication 1

Common Pitfalls to Avoid

• Insufficient preparation in biological, epidemiological, and physical sciences before beginning research training 1
• Choosing projects without adequate institutional resources or expertise available 1
• Accepting published data uncritically without understanding study limitations 1
• Failing to complete investigations through to peer-reviewed publication 1
• Inadequate attention to ethical principles and regulatory compliance 2, 3, 4, 5