Ethics Committees and What They Need From You

Part of Clinical Research Coordinator (CRC) Training: Ethics and Participant Protection.

About 5 minutes. Free, in your language, no account needed.

Why this matters

An ethics committee can stop your study. It can also stop you, personally, from enrolling the person sitting in front of you, because an approval lapsed while nobody was watching the date.

Most sites treat the committee as a hurdle at the start of a trial. It is not. It is an oversight body for the whole life of the study, and keeping it informed is a coordinator's ongoing job.

What it is called

The same function has different names in different places.

• Institutional review board (IRB) — common in the United States.
• Research ethics committee (REC) — common in the United Kingdom and elsewhere.
• Independent ethics committee (IEC) — the general term used in international guidance.

They are all an independent group that reviews research involving people, in order to protect the rights, safety and wellbeing of participants. Membership normally mixes scientific and medical expertise with people from outside the research world, so that a study is judged by more than the people who want to run it.

What it does before your study starts

The committee reviews the study and decides whether it may proceed at your site. It looks at:

• Whether the science is sound enough to justify asking people to take part.
• Whether the risks are reasonable in relation to any expected benefit.
• Whether the participant-facing documents are honest, complete and readable.
• How participants will be identified and approached.
• How privacy and personal data will be protected.
• Whether any payment is fair without being an inducement.
• Whether extra safeguards are needed for participants who may be vulnerable.

The committee approves specific versions of specific documents. That is the detail sites get wrong. Approval is not a general blessing of the study. It attaches to version numbers and dates.

What it does while your study runs

Oversight continues after approval.

• Continuing review. Many committees require a periodic report and renew approval for a defined period. Let that lapse and study activity must stop until it is restored.
• Amendments. A change to the protocol, the consent form, or any participant-facing material must be submitted and, in almost all cases, approved before it is used.
• Safety information. Significant new safety information is submitted so the committee can decide whether participants must be told or the study changed.
• Deviations and unanticipated problems. Your protocol and local rules define which events must be reported and how quickly.
• Suspension or termination. The committee can halt a study that is not being run as approved or that has become unsafe.

What the committee needs from you, specifically

Submissions are usually prepared by the coordinator or a regulatory coordinator. Five habits prevent most problems.

1. Track version numbers. Keep a simple table: document, version, date approved, date implemented at the site, date withdrawn from use. Every consent form in circulation must be traceable to an approval.
2. Track expiry dates. Put continuing review deadlines in a calendar with a reminder well before the date. This is the single most common lapse at busy sites.
3. Nothing before approval. No advertisement, no screening call script, no leaflet, and no study-specific procedure until the relevant approval is in hand and filed.
4. File the correspondence. Approval letters, acknowledgments, safety letter receipts and any conditions attached to approval all belong in the site file. An approval you cannot produce is, for an inspector, an approval that does not exist.
5. Answer questions quickly and completely. A committee's question usually holds up the whole submission. Partial answers cost another review cycle.

The relationship with the regulator

An ethics committee and a regulatory authority are different bodies with different jobs, and you usually need both. The regulator authorizes the trial under national law. The ethics committee protects participants. Approval from one does not substitute for the other. Module 3 sets out how the regulatory side works.

In practice

Vantis Pharma issues an amendment to VT-201, adding a new laboratory test at each visit and updating the consent form to describe the extra blood draw.

Nadia does four things in order. She submits the amended protocol and the new consent form, version 4.0, to the ethics committee. She waits for written approval. She trains the site team on the change and records that training. Only then does she start using version 4.0, and she removes every copy of version 3.0 from the clinic that morning.

She then works through the participants already enrolled. Each one must be re-consented on version 4.0 before their next blood draw, because the study is now asking something of them that they did not agree to.

One participant declines the extra test but wants to continue in the study. Nadia does not guess. She asks Dr. Osei to discuss it and, with the sponsor, to confirm what the protocol allows.

The date of approval, the date of implementation, and the date each participant was re-consented are three different dates. Record all three.

Key takeaways

• An ethics committee, IRB or IEC is an independent body whose purpose is to protect the rights, safety and wellbeing of research participants, and whose membership deliberately extends beyond researchers.
• Approval attaches to specific document versions and dates, so a site must be able to trace every consent form in use back to a written approval.
• Oversight continues after approval through continuing review, amendments, safety reporting, and the power to suspend or terminate a study.
• Nothing participant-facing may be used before approval, including advertisements, screening scripts and leaflets.
• A lapsed continuing review stops study activity, which makes calendar tracking of expiry dates one of the highest-value habits a coordinator can build.