The new article highlights the aspects related to compensation for participation in a clinical investigation, contact details to be communicated by study participants, and also the voluntary nature of participation and subjects’ rights associated thereto.
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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, 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 existing regulatory framework and has been agreed upon with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to compensation study subjects are entitled to receive for their participation in a study, as well as contact details to be provided to potential study participants. The document also pays special attention to the voluntary nature of participation in clinical trials.
The document also covers aspects related to contact details to be included in the informed consent. In particular, the applicable regulation, namely 21 CFR 50.25(a)(7) requires informed consent to include an explanation of whom to contact for answers to pertinent questions about the research subject’s rights and whom to contact in the event of a research-related injury to the subject.
The consent document should provide clear instructions on reaching out to the right individuals for questions related to the research, the rights of research subjects, and scenarios of research-related injuries to the subject, as explained by 21 CFR 50.25(a)(7). The appropriate section should include such details as names or offices, emails, and phone numbers. The FDA recommends that the point of contact for subjects’ rights should ideally be separate from the research team. Suitable contacts might be the IRB Office, the Patient Advocate Office, or other qualified staff.
Moreover, there should be clarity on emergency contacts, potentially offering 24/7 availability. If there are any alterations to the contact data during the clinical investigation, parties responsible for clinical investigation (study sponsors) are obliged to update subjects on such changes without undue delay – for instance, by providing updated cards with relevant contact details
OTS Software Change Requirements
In accordance with the applicable regulatory requirements, in certain cases, changes to the OTS software used in a medical device would require a new 510(k) submission due to the significance of the impact such changes would have. Under the general rule, the conditions under which a new or changed medical device, including OTS software, will require a new 510(k) are the same as for a device not involving OTS software.
As further explained by the authority, the final decision on whether a new 510(k) submission is required or not should be based on numerous important factors, such as the intended use of the device, the functionality of the OTS software it employs, as well as the risks associated with its use and whether they are properly mitigated. In this respect, the authority also refers to separate guidance documents named “Deciding when to submit a 510(k) for a change to an existing device” and “Deciding when to submit a 510(k) for a software change to an existing device” for additional clarifications.
In accordance with regulation 21 CFR 50.25(a)(8), it is also important to include a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Based on the above, it is vitally important to ensure that study subjects understand their right to voluntarily choose to partake in the clinical investigation or to cease their involvement at any stage without facing any penalties or loss of entitlements. The consent process should not contain any language that restricts the subject’s rights in this regard.
In cases where there are specific procedures for withdrawal from the study, such procedures should be clearly described. It is important to mention that, as explained by the authority, even if a subject decides to withdraw from a study that’s under an investigational new drug application (IND) or investigational device exemption (IDE), the data up to the point of their withdrawal remains integral to the study and cannot be deleted. When feasible, the withdrawal and its date should be documented by the site staff involved in the relevant investigation.
In summary, the present FDA guidance provides an overview of the most important elements of informed consent and highlights the key points to be taken into consideration by the parties responsible for clinical investigations in order to ensure compliance thereto. The authority pays special attention to the scope of rights study participants should have and also to the way information about such rights should be communicated to them before initiating a clinical investigation.
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