Resource index: All categories
On this site you will find practical help with implementation of the Data Protection Act (1998), Section 60 of the Health & Social Care Act (2001), the common law of confidentiality, the Human Tissue Act (2004) and Human Tissue Authority codes of practice, and all associated guidance.
A:
- Amendments
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IRAS Amendment Guidance for all Review Bodies
Guidance on submitting amendments to review bodies via IRAS.
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NRES Information on adding a new site
For all with NHS REC approval adding a new study site.
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NRES Notification of Amendments
Guidance on requirements for notifying NRES of study amendments
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- Approvals
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Department of Health Guidance: NHS permission for R&D involving NHS patients, 2nd edition
DH notes explaining what is expected of the NHS when considering permission for research that involves patients on a Primary Care Trust's NHS list, many of the points are also relevant to NHS Trusts.
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ESRC Ethics framework (pdf)
Framework outlining structure and function for university research ethics committees.
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Gene Therapy Advisory Committee website
Information on remit and application to GTAC.
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Integrated Research Application System (IRAS)
Link to the new Integrated Research Application System for research in the Health Service.
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NHS Information Centre: Medical Research Information Service
The Medical Research Information Service provides health information to support medical researchers.
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NHS R&D Site-Specific Information form
For use for application to any NHS organisation, links to IRAS application form
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NRES and NHS R&D Forum joint bulletins
Information on the transfer of SSA for NHS sites.
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NRES: About the IRAS application form
Information about the application form for all NHS RECs.
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NRES: Applying for ethical review by an NHS REC
Information on submitting a proposal for review by an NHS REC.
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NRES: Contact list
Contact details for all NHS research ethics committees
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NRES: Defining research
Guidance to help define whether a project is research, audit or service evaluation.
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NRES: Link to old NRES application form
Old on-line application form for all NHS RECs
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NRES: The remit of NRES
NRES web pages outlining the remit of NHS RECs
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Nuffield Council on Bioethics publication
The Ethics of Research Related to Healthcare in Developing Countries.
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Privacy Advisory Committee for Scotland
Web site on PAC remit, application process and Information Statistics Division
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Privacy Advisory Committee for Scotland application form
Link to PAC application form
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UK Stem Cell Tool Kit
A regulatory tool for those conducting human stem cell research in the UK.
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UKCRC - Streamlining Information Requirements for Permissions and Approvals
Overview of National Systems for Streamlining R&D Permissions
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- Archiving
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Department of Health Guidance: Retention of Records (pdf)
Guidance for research in the NHS on data archiving.
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UK Biobank website
Information on UK Biobank.
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- Audit
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Information Commissioner's Office Guidance on Data Protection Audits (pdf)
For all organisations holding identifiable personal data.
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