What Is Informed Consent?
The process by which a clinical trial participant is provided with detailed information about the study — including its purpose, procedures, risks, benefits, and alternatives — and voluntarily agrees to participate.
Why It Matters for Supplement Brands
Informed consent is an ethical requirement for all human clinical trials. When evaluating studies for substantiation, verifying that proper informed consent and ethics approval were obtained is a basic quality check. Studies without ethics approval should not be used in substantiation dossiers.
How It Works
The informed consent process must include:
1. **IRB/Ethics approval**: The study protocol must be reviewed and approved by an Institutional Review Board (IRB) or ethics committee before any participants are enrolled. 2. **Written consent**: Participants must sign a consent form that clearly explains the study in plain language. 3. **Voluntary participation**: Participants must be free to withdraw at any time without penalty. 4. **Risk disclosure**: All known risks and potential adverse effects must be disclosed. 5. **Ongoing consent**: If new information emerges during the study that could affect a participant's willingness to continue, they must be informed.
Studies conducted without proper informed consent or ethics approval violate the Declaration of Helsinki and should not be cited as substantiation evidence.
Common Mistakes to Avoid
- ✗Not checking whether a study received IRB/ethics committee approval before citing it
- ✗Citing studies from jurisdictions with less rigorous ethical oversight without additional scrutiny
- ✗Using results from studies that were retracted due to ethical violations
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