The article covers additional questions industry representatives may have with respect to informed consent and specific aspects associated thereto. In particular, the aspects addressed include the involvement of children and non-English speakers.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the concept of informed consent.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the applicable legislation and has been agreed with the authority in advance.
In particular, the present article provides an overview of the Frequently Asked Question section of the aforementioned guidance document whereby the authority provides explanations on specific matters associated with the existing legal framework.
Enrolling a Child into a Clinical Investigation: Key Considerations and Regulations
When planning to enrol a child in a clinical investigation, there are certain regulatory guidelines and ethical considerations to be taken into account. The FDA has outlined specific regulations in 21 CFR part 50, subpart D, ensuring the protection of children involved in clinical trials.
- Parental or Guardian Permission: Before enrolling a child, permission from parents or guardians is mandatory.
This permission should comply with the informed consent requirements outlined in 21 CFR part 50.
However, in certain cases, the Institutional Review Board (IRB) can allow investigations to proceed with the permission of only one parent if the risk to the child is minimal. - Child Assent: Alongside parental permission, it is also important to seek the child’s assent when applicable.
This implies the child’s positive agreement to be part of the investigation, rather than mere non-objection.
The IRB is responsible for deciding when and how children should give their assent based on their age, maturity, and psychological state.
The process of obtaining assent should be in a language that the child comprehends. - Exceptions: There are circumstances where the requirement for a child’s assent can be bypassed. For instance, if the investigation offers a direct health benefit available only through the study. But even in these situations, parental consent requirements remain mandatory.
- Transition to Legal Age: Children who mature to legal age during the study should be approached for their independent informed consent for further research interventions.
- Special Provisions for Mature or Emancipated Minors: Some jurisdictions may recognize certain minors as mature or emancipated, giving them the legal authority to consent to specific medical treatments.
In research contexts related to these treatments, these minors can provide their consent without needing parental or guardian approval.
Protections for Wards of the State
In accordance with the applicable legislation, children who are wards of the state or other entities require special treatment.
If they are to be enrolled in certain high-risk clinical investigations, the study should either relate to their status as wards or be conducted in places like schools, where most participants are not wards.
In cases where wards are included, an advocate, distinct from the guardian, must be appointed for the child’s best interests.
This advocate should possess expertise in relevant fields, such as pediatric medicine, law, or child psychology, and be well-informed about the study’s potential risks and benefits.
The role of the advocate remains distinct from other parties, such as the clinical investigators.
Inclusion of Non-English Speaking Subjects
The scope of the document also covers the regulatory matters associated with the involvement of study participants who do not speak English.
According to the guidance, when involving non-English speaking participants in clinical trials, it is vitally important to ensure that they receive all relevant information in a language they comprehend.
Ethically, they shouldn’t be excluded solely due to language barriers.
Investigators and IRBs must ensure that translated consent documents are in place, and there are appropriate translation services available during the research process.
Furthermore, the authority explicitly states that it is the sole responsibility of the investigators to predict which languages might be needed and prepare consent documents accordingly.
The FDA emphasizes that informed consent is not a one-time procedure but an ongoing conversation throughout the research duration.
If the investigators foresee the inclusion of participants who might not understand English, they should proactively submit translated consent documents (in anticipated languages) to the IRB.
This should be done even before the initial review.
Alongside, a clear plan on how oral communication interpreters would be made available during the research is also required. For instance, if investigators predict potential participants who speak Spanish or Russian, both translated documents and interpreter services in these languages should be arranged.
In summary, the present FDA guidance addresses certain specific situations parties responsible for clinical investigations may face.
The document highlights the key points to be taken into consideration when involving children as study participants and also outlines the relevant considerations related to non-English speaking participants and the approach to be followed in order to ensure the proper protection of their rights and interests.
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