For researchers interested in connecting with BioResource participants to deliver a study, find out more about the regulatory approvals required for each type of study.
When joining the BioResource, participants provide health and care information, access to health and other records, and a biological sample (usually blood or saliva).
Participant consent covers connecting with approved researchers to de-identified participant data and samples for the purposes of research.
Studies involving recall of participants, and studies using a local BioResource centre to facilitate their research appointments, will need to apply to the NHS Research Ethics Committee (REC) for an ethical favourable opinion and Health Research Authority (HRA) for HRA approval. Guidance on applying for Ethical review and HRA approval; can be found on the HRA website: Planning and improving research - Health Research Authority and Integrated Research Application System (IRAS)
Any centres, including the facility onsite at Cambridge University Hospitals (S2 Block), will need to be listed as research sites in the Integrated Research Application System (IRAS) application.
Once approved, local NHS Trust’s R&D department will need to review and issue Confirmation of Capacity & Capability (C&C). Approval from R&D is estimated to take 90 days from first submitting the local site pack to the time of the first volunteer, but this can vary between NHS Trusts.
Responsibility for obtaining this approval will lie with the study team/researcher, and not the BioResource. The BioResource may request that you make changes via modifications, to your study documents to ensure that they are suitable for use within the BioResource and with our volunteers.
BioResource must be kept informed of any modifications (substantial modifications, modification of an important detail, or a minor modification) in relation to the study.
Find out more about applying to access Recall or Samples.
De-identified samples already acquired and stored by the NIHR BioResource do not require further ethical opinion or HRA approvals, as these are covered under our ethical approval, however the researcher must comply with Human Tissue Authority requirements.
Futher information can be found on our Recall and Samples page.
Sharing of de-identified data held by the BioResource may be covered by the BioResource ethical approval.
In some instances, for example, where there is a risk a participant may be identified, or there is the need to contact a participant, then the researcher will need to obtain separate ethical opinion and HRA approvals, and potentially further consent from the participant.
Further terms and conditions regarding data access can be found on our Data page.
