Item 32b: Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable.

Example

“In order to maximise site participation and limit barriers to trial enrolment, the core protocol of ASCOT ADAPT does not involve any mandatory collection of biological samples. Nonetheless, there are many important research questions related both to specific therapeutic interventions and the cohort of participants enrolled in ASCOT ADAPT, and sites and participants can elect to contribute samples towards a COVID-19 biobank. Biological specimens collected include respiratory viral swabs, peripheral blood mononuclear cells, serum and plasma, collected at timepoints from baseline to 14 days after enrolment. A tiered consent from participants may allow samples or information to be used for any approved research projects and may also allow for host genomic studies to be undertaken with stored samples.

Biological specimens collected for ASCOT ADAPT are stored in participating biobank facilities, with a central ‘virtual biobank’ catalogue of samples and consent. Samples are collected, processed and stored according to central laboratory procedures. Access to samples for ethics-approved protocols is considered through a central biobank committee, where guiding principles for access are equity and maximising scientific value. Storage of specimens is provided by the ASCOT ADAPT study, with retrieval and transport costs funded by external researchers accessing specimens" [494]. 

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Explanation

Ancillary studies involve the collection or derivation of data and biological specimens for purposes that are separate from the main trial. The acquisition and storage of data and biological specimens for ancillary studies are increasingly common in the context of clinical trials. Data and specimens may be used for a specified subset of studies or unspecified future research.

Ancillary studies have additional considerations relating to consent. Guidance for the creation of a simplified informed consent document for biobanking is available [495, 496].

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Participants can be given several options to consider with respect to their participation in ancillary research: consent for the use of their data and specimens in existing studies; consent for use in future research unrelated or related to the clinical condition under study; consent for sharing with other institutions; and consent to be contacted by trial investigators for future studies. This is commonly referred to as tiered consent. Participants should also be informed about whether their withdrawal from the ancillary research is possible (e.g., the data and specimens are coded and identifiable); what withdrawal means in this context (e.g., utilised specimens and data derived from them cannot be withdrawn); and what information derived from the specimen-related research will be provided to them, if any. 

If data or biological specimens collected from trial participants may be used for ancillary studies, the protocol should outline how the data and specimens will be collected and stored, and how consent will be obtained for their use.

Summary of key elements to address

• How consent will be obtained for using participant data and biologic specimens in specified or unspecified ancillary studies

• How the data and specimens will be collected and stored for ancillary studies