Standards for informed consent

Essential elements for informed consent

Participants of clinical trials and studies always retain ownership of their data and hence control over how it can be used. Access to this data is given by way of informed consent whereby potential participants are made aware of various aspects of the research objectives, procedures, risks and benefits and then decide if they are happy for their data to be used.

The procedure has two main areas that could be problematic when it is applied in a data sharing context. First, it is often difficult to explain omics in simple language. Second, it can be difficult, if not impossible, to provide information about the potential uses of such data or who will have access to it given the rapid development of both science and technology. Informed consent should also offer the clear option for the participant to withdraw from the research at any time which in turn presents its own issues.

For projects linking data to RD-Connect, we recommend that the original informed consent documents contain the following essential elements :

Elements-for-IC-of-biobanks-and-observational-studiesRetrospective consent

One issue faced by rare-disease projects is that of using ‘historically collected’ biomaterial samples – those collected from patients before the project began.

In some cases, the consent which patients gave for the use of these samples did not include permission to share data widely and/or give consent for omics research and genetic sequencing. This was often because these uses were simply not envisaged at the time the sample was taken. Data-sharing and omics technologies are now key to rare-disease research and therefore RD-Connect’s objectives. With this in mind, the Rare Disease Patient and Ethics Council (RD-PEC) and Patient Advisory Council (PAC) have worked closely with those involved in the associated research projects NeurOmics and EURenOmics, as well as the wider rare-disease patient community, to establish recommendations which will ensure that as many as possible of these precious historic sample collections may be used. Consultation with patient groups and researchers using the samples has highlighted the determination to find ways to overcome barriers put in place by out-of-date or incomplete consent.

As a result of this consultation, the RD-PEC and PAC have drawn up the following procedures to provide a guide to those wanting to use already collected (historic) samples:

Retrospective consent_2

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