Quality Assurance

Quality Management System (QMS) and certification against ISO9001:2008

In 2009, the HRA launched a quality management system and achieved (and continues to achieve) certification  against ISO9001:2008 for HRA Quality Assurance (QA) activities.

User satisfaction

The HRA invites feedback from users of its services and those using the REC service in the Devolved Administrations. This allows us to continually monitor and assess our performance and identify what is working well and areas for improvement.

  • Applicants and sponsors are invited to complete our online feedback survey and rate a number of aspects including the website, IRAS, helpfulness of the correspondence they have received and their views of the Committee meeting they attended.
  • Members of our committees are routinely asked for their views on current issues and ways in which they think our services can be improved through the Chairs and Members feedback form.

We produce bi-annual User Satisfaction public reports of our work, highlighting  actions or proposed actions from HRA Management based on feedback received.

For past copies please contact hra.qa@nhs.net.

Accreditation Scheme for Research Ethics Committees (RECs)

In 2007 we established a three year rolling accreditation programme in order to audit UK RECs against agreed standards as detailed in Standard Operating Procedures (SOPs) and Governance Arrangements for Research Ethics Committees (GAfREC).  RECs are issued with an audit decision – full accreditation, accreditation with conditions (low risk non-compliance identified requiring an action plan) or provisional accreditation (high and low risk issues requiring an action plan).

We produce bi-annual accreditation reports.

For past copies please contact hra.qa@nhs.net

Shared Ethical Debate

We developed the Shared Ethical Debate (ShED) process in 2007 in order to address possible inconsistency in the review of applications to UK RECs.  As part of the ShED procedure, an application is sent to a sub-group of RECs and  their reviews are analysed. Results and trends of the ShED exercises are shared with the RECs, operational teams and the training department in order to develop HRA policies and guidance.

Quality Control

HRA Operational Managers undertake annual Quality Control checks on RECs against agreed standards. This includes a meeting observation of a REC meeting.

If you require further information relating to the work of the HRA Quality Assurance department please contact hra.qa@nhs.net