Regulatory requirements and approvals

Research at BSUH is conducted in accordance with strict policies and procedures, to ensure high standards are maintained. This regulation of health research provides participants with assurance that the research that they take part in is of high quality, and it also ensures that the results of research can be relied on and used as evidence to inform future decisions about healthcare and treatment.

The information that follows will help you plan and prepare before you apply for your research approvals. Not doing so may mean that you encounter unnecessary delays and complexity.

Minimum requirements

As a minimum, all research studies must:

  • Have a sponsor – to ensure an individual or organisation takes responsibility for confirming there are proper arrangements in place to initiate, manage, monitor and finance the study.
  • Have ethical approval – to protect the dignity, rights and safety of participants
  • Have Health Research Authority (HRA) approval – to ensure governance and legal compliance
  • Have management permission from the NHS organisation hosting the research – to ensure the site has assessed, arranged and confirmed its capacity and capability to deliver the study

Your study may require review by other regulatory bodies. Further information to help you determine if additional approvals are necessary can be found here.

Once your study has sponsorship, it is recommended that you apply for the other approvals in parallel. Applications should be made using the Integrated Research Application System (IRAS), for which you will need to have an IRAS account.

Steps in the approval process

The precise steps involved in the approval process may change in response to new directives. The following information therefore serves as a guideline, but we strongly recommend contacting the before undertaking any research activity to ensure compliance with current requirements.

Further information

The HRA has produced a couple of one-slide simplified summary diagrams illustrating the study set-up process from both the sponsor and the local site perspective.

The HRA has also produced a wide range of training resources, including slides, checklists, flowcharts, leaflets, e-learning.

There are also several HRA/CRN webinars, hosted on the BrightTALK website. You need to create a free account to access these.

Working with human tissue