FDA Guidance on Informed Consent: IRBs – RegDesk

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 considered by medical device manufacturers and other parties involved 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 legislation and has been agreed with the authority in advance. 

The scope of the guidance covers, inter alia, the responsibilities of the parties involved. This includes a detailed description of the role and responsibilities of Institutional Review Boards. 

In-Depth Review of Informed Consent Materials

According to the guidance, concerning clinical investigations, all the parties involved and Institutional Review Boards (IRBs), clinical investigators, and sponsors have a shared duty to confirm that the informed consent process is both comprehensive and compliant with the applicable regulatory requirements.

The appropriate regulations set a baseline for what should be presented to prospective subjects for informed consent. 

Beyond this minimum requirement, consent forms may include additional information that might impact the subjects’ rights, welfare, or willingness to participate in a specific clinical study.

This additional information can have, inter-alia, such details as specific financial relationships and vested interests in the research.

By the applicable regulations, namely 21 CFR 56.109(a), the IRB has the authority to either approve, mandate modifications to or disapprove any research activities falling under the scope of IRB regulations.

As part of this role, the IRB can review and approve consent forms that meet all essential requirements outlined in 21 CFR part 50. 

Consent Process Review

It is important to mention that the role of the IRB is not limited to document approval; but extends to overseeing the entire consent process. 

Investigators should describe to the IRB how they plan to obtain informed consent. 

In its turn, the IRB should ensure this process occurs in an environment that minimizes the potential for coercion or undue influence, allowing adequate time for prospective subjects to consider their options and ask questions.

The IRB should have procedures in place to review new findings or modifications that arise during the study and affect participants’ rights or welfare. 

Identifying and Managing Revised Consent Forms

Apart from the responsibilities outlined, the IRB should have mechanisms in place to distinguish updated consent forms, to avoid the unintended use of outdated forms. 

In this respect, that authority also mentions that even though not mandatory, date stamps can be useful for identifying the most recent versions, so the parties involved are encouraged to use them.

In summary, the informed consent process in clinical investigations requires efforts from all the parties involved, IRBs, clinical investigators, and sponsors. 

The existing legal framework provides detailed rules and requirements to be followed for the protection of study participants.

The present guidance outlines the responsibilities of IRBs and their authorities in the context of informed consent.

Source

https://www.fda.gov/media/88915/download

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