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Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials
1Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation, Children's Mercy, 2401 Gillham Rd., POB 2.M02.47, Kansas City, MO, 64108, USA. srahman@cmh.edu.
Paediatric Drugs
|July 18, 2019
Summary
Ensuring informed consent in research is challenging due to complex permission/assent/consent (PAC) forms. Strategies to improve PAC understanding yield mixed results but can enhance participant satisfaction.
Area of Science:
- Clinical Research Ethics
- Human Subjects Protection
- Health Literacy
Background:
- Informed consent is crucial for human subjects research.
- Complex permission/assent/consent (PAC) forms hinder participant understanding.
- Vulnerable populations (children, low literacy) are at higher risk.
Purpose of the Study:
- Examine strategies to improve informed PAC.
- Evaluate effectiveness across diverse populations.
- Identify methods to enhance participant comprehension and satisfaction.
Main Methods:
- Reviewed strategies for simplifying PAC forms.
- Assessed multimedia PAC delivery tools.
- Analyzed participant engagement methods (testing, rewards, third-party communication).
Main Results:
- Findings on comprehension improvement are mixed across settings.
- Strategies show potential in reducing anxiety and increasing satisfaction.
- Challenges persist in designing, implementing, and evaluating PAC strategies.
Conclusions:
- Accommodating diverse participants requires refining PAC strategies.
- Engaging knowledgeable team members is essential.
- Continued research is needed to optimize informed consent processes.
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