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24 July 2008 6
June 2008 From 1st May 2008, amendments to the Clinical Trials Regulations
have come into force. Included in these are new arrangements for the way the Gene
Therapy Advisory Committee (GTAC) operates. In future, GTAC will transfer gene
therapy proposals to other Research Ethics Committees, if the proposal is deemed
to be 'low genetic risk'. This decision will be taken by the Chair, vice Chair
or alternate vice Chair and will be based upon an agreed decision tree.
Decision tree Download in Portable Document Format  Applicants
are encouraged to consult this tree when submitting to the Committee. There are
3 Categories that applications may fall into.
- Category 1 are
trials which GTAC will review and no transfer will be cansidered.
-
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. For
further information please consult the SOPs for the transfer of gene therapy clinical
trials
31 January 2008 On 29 January 2008
a single, integrated application system was launched which will simplify applying
for approval or permission to conduct a piece of research in the Health Service.
The system allows researchers to enter information about their study in one place
and is designed to save time and effort by preventing duplication of information
in separate application forms for each type of approval. GTAC supports the development
of the new integrated research application system (IRAS). For more information,
please see the IRAS website at: www.myresearchproject.org.uk Researchers
applying to GTAC are welcome to use either the GTAC application form or the new
IRAS form. However please note that the GTAC application form will be phased out
during summer 2008 at which time GTAC will only accept submissions made with the
new IRAS form. 30 October 2007 - The
Vector Directory details UK, EU and US suppliers of the vectors commonly
used in gene therapy, and gives guidance to researchers seeking to have vectors
manufactured for clinical trials. It is intended to help researchers bring the
advances in genetics more quickly to the patient's bedside.
April
2007 - UKCRC Regulatory and Governance Advice Service
The UKCRC have established a Regulatory and Governance Advice Service to provide
practical help with the legislative and good practice requirements that govern
clinical research in the UK. The Service supports local advice providers, such
as NHS R&D and university R&D offices, to provide consistent and authoritative
advice to their research communities, and so the first port of call for any researcher
with a query should be these local offices. The Advice Service is supported by
GTAC in partnership with a number of other regulatory and governance bodies. Further
information on the UKCRC R&G Advice Service can be obtained from the website:
www.ukcrc-rgadvice.org. 12
March 2007 1
July 2006
8 July 2005 | |
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