The Research Governance Framework for Health and Social Care, published by the Department of Health, came into effect in April 2004. Its scope is stated as follows:
"The framework applies to all research that relates to the responsibilities of the Secretary of State for Health. This is, research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non-departmental Public Bodies and the NHS, and research undertaken by or within social care agencies. It includes clinical and non-clinical research; research undertaken by NHS or social care staff using the resources of health and social care organisations; and any research undertaken by industry, charities, research councils and universities within the health and social care systems that might have an impact on the quality of those services."
The second edition, published in 2004, has now been archived but is available on the National Archives website: Research Governance for Health and Social Care.
Researchers may find the flow chart on types of Research Governance and Ethics Review helpful in deciding whether NRES REC review is necessary. You may also find this ethical review document published by the National Research Ethics Service (NRES) useful in working out whether your research is covered by Department of Health policy and/or legislation.
If you are planning to undertake Research that is covered by the Research Governance Framework for Health and Social Care, see UEA's Research Governance Guidance document. These Guidelines will tell you what you need to do to have UEA sponsorship of your study confirmed, and obtain UEA sponsor authorisation for your IRAS applications. It also contains guidance for research which is covered by legislation (whether or not it is covered by the Research Governance Framework) which will require submission to a National Research Ethics Service Research Ethics Committee.
NNUH/UEA Joint Standard Operating Procedures (SOPs)
The NNUH and UEA Joint Standard Operating Procedures (SOPs) apply to all healthcare research sponsored by NNUH or UEA which falls within the scope of the Research Governance Framework for Health and Social Care. They are mandatory for all research covered by the Medicines for Human Use (Clinical Trials) Regulations 2004 (CTIMPs). For non-CTIMPs they are recommended as guidance and good practice.
The SOPs are available via the NNUH R&D webpages.
All staff should check the NNUH R&D website regularly for information relating to the implementation of new or revised versions of SOPs. Staff must ensure that they are adequately trained in new procedures and must make sure that all copies of superseded versions are promptly withdrawn from use.
For more details, contact firstname.lastname@example.org or 01603 591486.