The process of submitting participant materials to Institutional Review Boards (IRBs) in the United States and Ethics Committees (ECs) in the European Union is a critical step in conducting clinical trials. This article will delve into the underlying regulations in both regions and highlight the key differences between them.
Underlying Regulations in the US
The submission of participant materials to IRBs in the US is governed by Title 21 of the Code of Federal Regulations (CFR), Parts 50 and 56. These regulations set out the requirements for IRB review and approval of research involving human subjects.
Part 50 outlines the requirements for informed consent. It stipulates that no investigator may involve a human being as a subject in research unless the investigator has obtained legally effective informed consent from the subject or their legally authorized representative.
Part 56 sets out the general standards for IRBs. It requires that each IRB be composed of at least five members with varying backgrounds to promote a complete and adequate review of research activities commonly conducted by the institution. It also requires that each IRB have written procedures for conducting its initial and continuing review of research and for reporting its findings to investigators and institutions.
Underlying Regulations in the EU
In the EU, the submission of participant materials to ECs is governed by several regulations and guidelines. One of these is the Clinical Trials Directive (2001/20/EC), which sets out the requirements for conducting clinical trials in the EU. This directive requires that all clinical trials be approved by an EC before they can begin.
Another important regulation is the General Data Protection Regulation (GDPR), which sets out rules for the processing of personal data, including health data. The GDPR requires that participant consent be obtained before their data can be used in a clinical trial.
The European Medicines Agency (EMA) also provides guidance on the format and content of clinical trial data that is submitted to it. This includes rules for participant data confidentiality and anonymization.
Key Differences Between US and EU Regulations
When it comes to submitting participant materials to IRBs and ECs, there are key differences between US and EU regulations One major difference is that in the EU, there is a single opinion for each Member State by a single Ethics Committee. This opinion must be given within 60 calendar days of receipt of a valid application. In the US, each institution may use whatever name it chooses for its IRB. Regardless of the name chosen, it is subject to FDA regulations when studies of FDA-regulated products are reviewed and approved.
Another difference lies in how personal data is handled. In the US, while informed consent is required, there are exceptions under which research may be conducted without obtaining consent from each individual subject. However, GDPR rules apply in the EU, requiring explicit consent from participants prior to using their data in a clinical trial.
The Importance of Participant-facing Materials in Research
Informed Consent Forms
Perhaps the most critical participant-facing documents in a clinical trial are Informed Consent Forms (ICFs). They serve to explain the trial to potential participants, including its purpose, duration, required procedures, and key contacts. ICFs also outline the risks and potential benefits of participation.
The process of informed consent is not merely about getting a signature on a form. It’s an ongoing, interactive process that takes place between the investigator and the participant. The ICF is a tool to facilitate this process, providing participants with written information that they can refer to throughout the trial.
Commonly used in clinical trials, recruitment materials can include flyers, advertisements, letters, and other materials used to recruit trial participants.
These materials must provide an accurate and balanced portrayal of the clinical trial. They should not overstate the benefits or understate the risks of participation. All recruitment materials must be reviewed and approved by an IRB or EC before they can be used.
Participant diaries or questionnaires are often used in clinical trials to record trial endpoints. These documents must be described in the study protocol and approved by an IRB or EC.
The design of the questionnaires can significantly impact the quality of data collected during the trial. Therefore, it’s important that they are easy for participants to understand and complete.
Digital Advertising Materials
The FDA considers digital advertising materials part of the informed consent process. This typically includes ad copy for digital channels, including Facebook, Twitter, paid search platforms, and banners.
Like all other participant-facing documents, digital materials must be reviewed and approved by an IRB or EC before they can be used.
Understanding the differences between US and EU regulations is crucial when preparing participant materials for submission to IRBs or ECs. Knowledge of these regulations ensures that submissions not only meet essential requirements but also increases the likelihood of approval.
Designed with IRBs and ECs front of mind, the Alethium Clinical Platform’s IRB submission tools provide a robust digital solution that delivers on-demand, system-generated, and verifiably accurate IRB application packages.
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