Working in partnership with the HRA

2013-14 has seen the Regulatory Support Centre’s secondment to the Health Research Authority (HRA) go from strength to strength with the launch of Consent and Participant Information Sheet Preparation Guidance in March 2014.

This online guidance has been designed for researchers and ethics committees to cover the principles of consent and how to prepare documents that support the consent process. Consent and Participant Information Sheet Preparation Guidance joins the two decision tools ‘Do I need NHS REC approval’ and ‘Is my study research’ to form a suite of online tools designed to inform and empower the user. These tools were developed by the Regulatory Support Centre on behalf of the Health Research Authority and are available from

We have also provided training to research ethics committee members in data and confidentiality.

“It will help Ethics Committee members, staff and researchers
find accurate answers quickly and efficiently.”

Looking forward

  • We will work with the HRA Confidentiality Advisory Group to develop online guidance exploring practicable alternatives to accessing confidential NHS information without consent, balancing research need with privacy.
  • We are also scoping how best to support the replacement of the Research Governance Frameworks; and communicate changes to the UK approvals processes.
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