Ethics, Integrity, and Regulatory Considerations
This domain covers the rules governing research and the use of evidence: ethical principles, consent, oversight bodies, regulatory frameworks, and research integrity. HS 326 tests applied judgement, so you must recognise which principle is at stake, which regulation applies, and what must happen before a study starts or a paper is published.
Ethical frameworks
- Belmont Report: respect for persons (autonomy, extra protection for those with diminished autonomy), beneficence and non-maleficence, and justice in the distribution of burdens and benefits.
- Declaration of Helsinki and the CIOMS guidelines govern human-subjects research; ICH-GCP E6 governs trial conduct, documentation, and monitoring.
- Clinical equipoise: randomization is defensible only when the expert community is genuinely uncertain which arm is better.
Consent and oversight
- Core consent elements: purpose, procedures, risks, benefits, alternatives, confidentiality, compensation, voluntariness, contact details, and the right to withdraw.
- Vulnerable groups such as children, prisoners, pregnant women, cognitively impaired adults, and economically dependent people need assent, proxy consent, and additional safeguards.
- IRB or REB approval precedes any enrolment; amendments require re-approval. Emergency research may use an exception from informed consent with community consultation.
- Privacy law (HIPAA in the United States, GDPR in Europe) governs identifiable data, de-identification, and biobanking; broad consent needs defined governance.
Integrity
Fabrication, falsification, and plagiarism are the three cardinal misconduct categories; questionable practices such as ghost authorship, salami slicing, p-hacking, and image duplication fall short of fraud but still require correction. ICMJE authorship requires substantial contribution, drafting or critical revision, final approval, and accountability, not merely funding or data access. Register trials before enrolment and report per CONSORT; undisclosed conflicts of interest undermine trust even when the science is sound.
Worked example
A resident wants to survey patients about wait times and publish the results. Although the study is low-risk and observational, it still requires IRB review, a consent or waiver-of-consent justification, a data protection plan for identifiers, and disclosure of any funding. Publishing without approval breaches institutional policy and journal ethics requirements.
Traps that cost marks
- Assuming anonymous surveys are automatically exempt from review.
- Offering payment so large it becomes undue inducement.
- Listing a department head as author merely for providing access to patients.
- Treating a consent form as a legal waiver rather than an ongoing process.
- Ignoring reporting obligations for adverse events and protocol deviations.