What Makes Research on Children Ethical?
Experimental Design domain · Lesson 18 of 20 · Biomedical Innovations (BI)
Today's goal: Explain why a pediatric study needs IRB approval, parental informed consent, child assent, and genuine equipoise, and apply these rules to decide whether a proposed cleft study could ethically run.
What a finished product looks like
This is a model of the work you should turn in. Use it to check your own: match the structure and the level of detail, do not copy it. Your wording should be your own.
1. Equipoise: It does NOT exist. We already know repairing a cleft palate helps, so there is no genuine uncertainty about repair versus no repair.
2. Violation: The 'no repair ever' arm would knowingly withhold a treatment known to help, harming those children. An IRB would reject it because the study is not fair to randomize and violates the duty to protect participants.
3. Ethical redesign: Compare two acceptable options that are genuinely uncertain, such as repair at 6 months versus 12 months (as TOPS did), or two accepted surgical techniques. Now chance decides between two reasonable choices, not between help and harm.
How this was built, step by step
The finished product above did not appear all at once. Here is the path from the question to the turned-in work, so you can follow the same steps.
- 1Start from today's question: What has to be true before scientists are allowed to study a baby like Mateo?
- 2Work the Model and the Explore questions to reason it out before writing anything.
- 3Pull the specific evidence the product needs from the reading and any database you used.
- 4Write it up in the required format: A junior researcher proposes: randomly assign 200 babies with to get repair surgery, or to get NO repair surgery ever, and compare their speech at age 5. As bioethicist: (1) state whether equipoise exists here (do we already know whether repairing a cleft palate helps?); (2) name which protection this study violates and why an IRB would reject it; (3) rewrite the comparison so the study could ethically run (think about what TOPS actually compared).
- 5Check it against the rubric, then submit.
| Criterion | Proficient | Developing | Beginning |
|---|---|---|---|
| Complete | Every required part of the artifact is present and filled in. | Most parts are present, but one is missing or left blank. | Several parts are missing. |
| Accurate | The science and data are correct and match the evidence. | Mostly correct, with a small factual slip. | Key science or data is wrong. |
| Scientific reasoning (CER) | States a claim, backs it with specific evidence, and explains the reasoning. | Has a claim and evidence, but the reasoning is thin or missing. | Gives an answer with no evidence or reasoning. |
| Professional communication | Clear, organized, and labeled the way a clinician or scientist would write it. | Readable but disorganized or missing labels. | Hard to follow. |
| Submitted | Turned in the right way (Schoology for routine work) and confirmed. | Turned in, but in the wrong place or unconfirmed. | Not turned in. |
- CompleteProficient: Nothing is left blank: the model fills every part of "A junior researcher proposes: randomly assign 200 babies with cleft palate to get repair surgery, or to get NO repair surgery ever, and compare their speech at age 5. As bioethicist: (1) state whether equipoise exists here (do we already know whether repairing a cleft palate helps?); (2) name which protection this study violates and why an IRB would reject it; (3) rewrite the comparison so the study could ethically run (think about what TOPS actually compared).".
- AccurateProficient: Every number and claim matches the case evidence.
- Scientific reasoning (CER)Proficient: It names a claim, cites the specific evidence, and explains the reasoning, not just the answer.
- Professional communicationProficient: It is organized and labeled like a real chart note.
- SubmittedProficient: It would be turned in on Schoology and confirmed.
WebXam problem for today's skill
One exam-style question that uses exactly what you practiced today. Try it before you reveal the answer, then read why each choice is right or wrong.
Tap an answer to see the full explanation. Nothing is recorded or graded.