GTAC is the UK national research ethics committee (REC) for gene therapy clinical research according to the Medicines for Human Use (Clinical Trials) Regulations 2004. It is the only UK ethics committee empowered to approve clinical trials of gene therapy products according to the definition given in Part IV of Directive 2003/63/EC (amending Directive 2001/83/EC):

L159/88 "… [a] gene therapy medicinal product shall mean a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. The vector can also be included in a human or animal cell.“

Under the Clinical Trials Regulations, GTAC is required to provide an ethical opinion on applications for use of products that fall within the above definition within 90 days of receipt of a valid application.

GTAC is a UKECA recognised REC and wishes to approve clinical trials that use certain gene therapy related products that are not covered under the legal definition above (for instance, antisense applications), as well as cell therapies derived from stem cell lines. In these instances, GTAC is required to provide an ethical opinion within 60 days of receipt of a valid application.

GTAC Decision tree - download in Portable Document Format

Applicants are encouraged to consult this decision tree before submitting to the Committee. There are 3 Categories into which applications may fall.

Category 1 are trials which GTAC will review and no transfer will be considered.

Category 2 are trials which will be decided upon by a case by case analysis. The view of the applicant may be taken into consideration here providing they can make a convincing case for their study to be transferred. However, please contact the Secretariat first.

Category 3, trials that fall into this category are mostly likely to be transferred outside of GTAC.

Applications that can be considered for transfer must be made using the Integrated Research Application System (IRAS).

All gene therapy clinical trials must continue to be submitted to GTAC who will make the final decision regarding review. Applicants who believe their trial falls into category 3 are expected to contact the GTAC Secretariat prior to submission in order to discuss their application.

Application forms

GTAC Conditions of Approval in Portable Document Format

IRAS application form for submission to GTAC

Application form for GTAC submissions (updated May 2007)

• in Rich Text Format
• in Portable Document Format

Guidance & Application Form for Named Patient Use of Gene Therapy Products:

• in Rich Text Format
• in Portable Document Format

• Applicants are required to seek a favourable site-specific assessment (SSA) from the local NHS Research Ethics Committee for each site where the research will take place. Applications for SSA should be made using Part C of the NHS REC application form, available from www.nresform.org.uk. The form may be submitted to the relevant RECs by the principal investigator for each site, together with his/her CV, once the GTAC secretariat has acknowledged receipt of the application to GTAC and confirmed that it is valid. An application for SSA should also be made when applicants seek to add a new site to an existing study.
  
  Further information is available from the Central Office for Research Ethics Committees at www.nres.npsa.nhs.uk/.

Covering form for applications for approval of substantial amendments to existing trials (this is the form also used by EMEA):

• in Word 97 Format
• in Rich Text Format.

Covering forms for annual safety and progress reports:

• Progress report form:
  in Portable Document Format
  in Word 97 format
  in Rich text Format
  
  
• Safety report form:
  in Portable Document Format
  in Word 97 format
  in Rich text Format

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