In clinical investigations of medical devices, obtaining proper informed consent is a cornerstone of ethical research and regulatory compliance. Under an Investigational Device Exemption (IDE), the FDA requires informed consent to ensure that participants understand the risks, benefits, and nature of the clinical trial. Compliance with these requirements is critical for the success of IDE submissions and for maintaining the integrity of clinical data.
At BioBoston Consulting, we help medical device sponsors design, review, and implement informed consent processes that meet regulatory expectations, ensuring trials are compliant, ethical, and inspection-ready.
What is Informed Consent in Clinical Investigations?
Informed consent is the process by which a participant voluntarily confirms their willingness to participate in a clinical investigation after being informed of all relevant aspects of the study. This includes:
- The purpose of the trial
- Potential risks and benefits
- Alternative treatment options
- The participant’s rights, including the ability to withdraw at any time
Proper informed consent ensures ethical participation and demonstrates compliance with FDA IDE regulations.
Key Requirements for Informed Consent Under IDE
- Comprehensive Disclosure
Sponsors must provide participants with clear, understandable information about:
- Device description and intended use
- Study objectives and procedures
- Known and potential risks and side effects
- Potential benefits and alternatives
- Contact information for questions or concerns
- Voluntariness
Participation must be entirely voluntary, with no coercion or undue influence. Participants should feel free to decline or withdraw without penalty or loss of benefits.
- Documentation
The informed consent must be documented in writing, signed, and dated by both the participant and the investigator. Electronic signatures are acceptable if compliant with FDA 21 CFR Part 11 requirements.
- Comprehension
Participants should be able to understand the information provided. Sponsors often use plain language and provide opportunities for questions to ensure comprehension.
- Continuous Process
Informed consent is not a one-time event; participants must be updated if new information arises that may affect their willingness to continue in the study.
Best Practices for Implementing Informed Consent
To ensure compliance and participant safety, sponsors should adopt these best practices:
- Develop a standardized informed consent template aligned with FDA IDE guidance
- Review consent forms with Institutional Review Boards (IRB) prior to study initiation
- Train study staff on proper communication and documentation procedures
- Maintain audit-ready records of all consent forms
- Monitor ongoing compliance and update participants as new risks or information emerge
How BioBoston Consulting Supports Informed Consent Compliance
At BioBoston Consulting, we provide comprehensive guidance for informed consent processes in clinical investigations under IDE:
- Reviewing and drafting informed consent forms compliant with FDA requirements
- Ensuring alignment with IDE submission documentation
- Advising on electronic consent processes compliant with 21 CFR Part 11
- Conducting training for investigators and study staff on proper consent procedures
- Assisting with IRB submissions and approvals
- Providing strategies to maintain ongoing compliance and audit readiness
Our services help sponsors navigate complex regulatory requirements while ensuring participant safety and ethical conduct.
Ensuring informed consent compliance is essential for the ethical and regulatory success of clinical investigations under an IDE. Proper documentation and communication reduce regulatory risk and enhance the credibility of clinical data.
👉 Partner with BioBoston Consulting today to develop compliant, clear, and effective informed consent processes for your clinical trials.
Contact BioBoston Consulting and ensure your clinical investigations are fully compliant, ethically sound, and inspection-ready.