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Proportionate Review Service

What is proportionate review?

Review by an NHS Research Ethics Committee (REC) is required for research within the scope of the UK Health Departments’ Governance Arrangements for Research Ethics Committees (GAfREC).

At present, applications are normally reviewed by a full REC that consists of up to 18 members and meets 11 times a year.

 

Where a research study presents ‘no material ethical issues’ (for instance, where there is less risk, burden or intrusion to the participants), it can be reviewed and approved by a proportionate review sub-committee on behalf of the REC.  The sub-committee consists of three members of the REC, including at least one lay member.  The application is reviewed by the sub-committee within 10 days of receipt of a valid application, either at a meeting or by correspondence. 

If a favourable opinion is given, the researcher receives a letter confirming ethical approval by the REC in the same way as for review by full committee.  

The sub-committee may refer the application to full committee if there are material ethical issues requiring further consideration within the usual 60 day time-scale.

Research suitable for proportionate review is determined by the No Material Ethical Issues Tool, which is summarised below.

 

At present, this service is run as a pilot and only available in certain areas. The draft harmonised Governance Arrangements for Research Ethics Committees (GAfREC) published for comment by the Department of Health makes provision for Proportionate Review to be introduced by the Research Ethics Service.  When the harmonised GAfREC is finalised, we envisage introducing the service more widely.



What are the benefits of proportionate review?

  • Offers ethical review in proportion to the risks and ethical issues involved in the research being undertaken.

  • Enables the Research Ethics Service to provide an efficient and responsive service.
  • Allows researchers undertaking projects raising no material ethical issues to receive a favourable ethical opinion more promptly and reduces project time-lines.
  • Makes better use of the time of volunteer members of ethics committees, allowing full committee meetings to concentrate on research raising more significant issues.

 


How we determine if research has ‘no material ethical issues’

 


Research involving any of the following sources is suitable for proportionate review:

  • Data or tissue that is anonymous to the researcher;

  • Existing tissue samples already taken with consent for research;
  • “Extra tissue” (e.g. further blood taken at the time of routine sampling or tissue taken during “clinically directed” operation);
  • Questionnaires that do not include highly sensitive areas or where accidental disclosure would not have serious consequences;
  • Interviews/focus groups that do not include highly sensitive areas or where accidental disclosure would not have serious consequences;
  • Surveying the safety or efficacy of established non-drug treatments, involving limited intervention and no change to the patients’ treatment;
  • Research involving children may be considered for proportionate review where it meets the above criteria.

The following types of application always require review at a full REC meeting:

  • Clinical trials of investigational medicinal products (CTIMPs);

  • Clinical investigations of medical devices prior to CE marking;
  • Research involving adults lacking capacity and subject to the Mental Capacity Act 2005;
  • Invasive basic science studies involving healthy volunteers;
  • Research involving exposure to ionising radiation which could be additional to that received in routine clinical care for any participant;
  • Research tissue banks;
  • Research databases;
  • Prison research;
  • Studies funded by the US Department for Health and Human Services.
 
 
 
 

You can view the No Material Ethical Issues Tool (pdf, 64 KB) on the NRES website.