Pharmacy AI · Module 5 · Unit 1 · Practical 2 — Ethics Committees & Regulatory Oversight

Ethics Committee (IEC/IRB) Approval Simulation

Aim — To understand the ethics review process and evaluate whether a clinical trial protocol meets ethical and regulatory requirements — recommending approval, modification or rejection. Duration 60 minutes · 8 protocol dossiers · 20-mark rubric · Pass 50%.

Protocol —

Role —

Score —

Result —

◐ Theme

New to ethics review? Start here

An Ethics Committee exists for one purpose — to protect the rights, safety and well-being of the participants. Review every protocol in this order:

Is the science sound? A study that cannot answer its question exposes people to risk for nothing — and can never be ethical.
Do the benefits justify the risks? Never approve an unfavourable risk–benefit ratio, or a placebo arm that withholds effective treatment in a serious illness.
Is consent genuinely free and informed? Understandable language, the right to withdraw, and no payment so large it becomes an undue inducement.
Are vulnerable participants protected? Children, pregnant women, prisoners, and economically disadvantaged people need extra safeguards.
Are compensation and insurance in place? Under the New Drugs & Clinical Trials Rules 2019 these are mandatory.

Then separate fixable paperwork (→ Approved with Modifications) from unethical design (→ Rejected). Unsure? Open “Need a hint?” in the committee room.

Student tasks

The three committee decisions

Decision	When it applies	Example
✅ Approved	All checklist domains adequate; no changes required	Complete dossier, sound science, valid consent, insurance in place
⚠ Approved with Modifications	Deficiencies that can be corrected on paper without changing the ethics of the study	Missing compensation clause, ICF too technical, unclear data-handling procedure
❌ Rejected	A fundamental ethical violation in the design itself	Coercive payment, unfavourable risk–benefit, unsafe placebo arm, unprotected vulnerable group

Committee membership must be multidisciplinary — medical, pharmacy, legal and lay/community members. The Principal Investigator must not vote on their own protocol (conflict of interest).

Faculty assessment rubric

Criteria	Marks

Ethics fail: recommending Approved for a protocol carrying a fundamental ethical violation fails the station regardless of total marks — that is the decision an ethics committee exists to prevent.

Committee member & protocol assignment

Candidate name

Registration no.

Your committee role

Protocol under review

Committee decision report & assessment

Complete the review in the committee room and submit to generate your assessment, then write and submit your report.