Core Curriculum
Module 9: Research Ethics
Core Topics
Informed consent, IRB oversight, privacy protections, safety monitoring, regulatory phases, and scientific integrity — the ethical framework for human subjects research.
📄 9.1 Informed Consent for Research
Informed consent is a process ensuring voluntary participation based on clear understanding.
Required Elements
- Purpose, procedures, duration
- Risks and benefits
- Alternatives to participation
- Right to withdraw without penalty
Vulnerable Populations (Enhanced Protections)
- Children: Parental permission + child’s assent
- Pregnant women: Direct benefit or minimal fetal risk
- Prisoners: Additional IRB scrutiny (coercion risk)
- Cognitively impaired: Legally authorized representative + assent
📌 The Belmont Report: respect for persons, beneficence, justice — foundational for informed consent.
🔒 9.2 Privacy and Data Protection
HIPAA governs protected health information (PHI) – 18 identifiers (name, SSN, medical record number, etc.). De‑identification removes these. IRB may waive authorization for minimal risk research.
- Data security: encryption, access controls, secure storage ensure confidentiality.
- IRB waiver: permitted if research involves minimal risk and cannot practicably be conducted without access to PHI.
📊 Example: Using de‑identified EHR data for retrospective chart review may qualify for exempt or expedited review.
🏛️ 9.3 Institutional Review Boards (IRBs)
Levels of Review
- Exempt: Minimal risk, anonymous surveys, de‑identified data
- Expedited: Minimal risk, standard procedures (blood draw, non‑invasive imaging)
- Full Board: More than minimal risk
Approval Criteria
- Risks minimized and reasonable relative to benefits
- Equitable subject selection
- Proper informed consent
📌 IRB’s primary role: protect rights and welfare of human subjects.
🛡️ 9.4 Interim Analysis and Safety Monitoring
Data Safety and Monitoring Board (DSMB): independent committee reviewing interim data to recommend continuation, modification, or early stopping.
- Stopping rules: pre‑specified boundaries for efficacy (clear benefit), futility (unlikely to show benefit), or safety (harm).
- Adverse event reporting: collect all adverse events; Serious Adverse Events (SAEs) (death, hospitalization) require immediate notification.
📈 Example: A trial may stop early if an interim analysis shows overwhelming benefit, allowing earlier availability of effective treatment.
💊 9.5 Regulatory Issues and Drug Development
Phases of Clinical Trials
- Phase I: Safety, dosing – small group (healthy volunteers)
- Phase II: Efficacy, safety – larger patient group
- Phase III: Confirm efficacy, compare to standard – large RCT
- Phase IV: Post‑marketing surveillance – rare/long‑term AEs
Ethical Placebo Use
Placebo acceptable when:
- No proven therapy exists
- Withholding standard treatment does not pose risk of serious or irreversible harm
📝 9.6 Scientific Integrity and Professionalism
Research Misconduct (Prohibited)
- Fabrication: making up data
- Falsification: manipulating data or methods
- Plagiarism: using others’ work without credit
Conflict of Interest (COI)
- Financial or personal relationships that could bias research
- Must be disclosed and managed
Authorship Criteria (ICMJE): substantial contribution to design/data, drafting/revising, final approval, and accountability for all aspects.
📌 Integrity ensures public trust in medical literature.