Fundamentals of Informed Consent: COVID-19 observational studies e-learning module.
Developed in response to a request for new learning resources in support of the ISARIC (CCP-UK Clinical Characterisation Protocol for Severe Emerging Infection’) COVID related research study, this module, accessible on NIHR Learn, will be useful for all clinical staff, without prior GCP or research knowledge/training, who are being asked to support the consenting of patients into observational COVID-19 studies.
NIHR Learn is accessible to all with an NHS, NIHR, UK academic or similar address. You can find a guide for accessing Learn here.
Coronavirus: Learning for the Health and Care Workforce
Health Education England’s e-Learning for Healthcare (HEE e-LfH) team have published a suite of resources for the health and care workforce in response to COVID-19. It will shortly be linked to from the NIHR Learn site.
Research Practice in Clinical Settings
This is one of a number of learning needs in relation to nationally approved and adopted COVID research studies. You can find it on NIHR Learn.
You can find it here.
Information and Guidance
National Institute of Health Research (NIHR)
Government support for research related to COVID-19 (26 March 20)
Dr Louise Wood’s statement regarding resources and research staff redeployment (Published 16 March, updated 19 March)
Department of Health and Social Care (DHSC)
COVID-19: Guidance for Health Professionals
All healthcare staff are advised to follow their organisation guidelines. For reference the Department of Health & Social Care (DHSC) has shared the information they have sent to NHS organisations & healthcare workers on behalf of them and Public Health England.
National Health Service (NHS)
Health Research Authority (HRA)
The HRA has put together a dedicated section of their website with everything you need to know about COVID-19 and research including how to apply for fast track approval, how to amend an existing study and the use of patient data.
Useful article on the vaccine development process
The clinical development process for a novel preventive vaccine: An overview
This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA).
The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed.
The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.
Medicines & Healthcare products Regulatory Agency (MHRA)
The MHRA is producing guidance for industry covering the coronavirus (COVID-19) outbreak.
NIHR Innovation Observatory
The Health Foundation: COVID-19 Research Programme
The Health Foundation’s new COVID-19 Research Programme is now open for applications. Funding is prioritised for UK-focused projects that explore how health and social care service delivery has changed in light of COVID-19 and the impact of COVID-19 on health inequalities and the wider determinants of health.
Open for applications until 30 September 2020.
Visit The Health Foundation website for more information.