Vacancies Capenhurst Independent Ethics Committee Medical and Lay Members 24th May 2010
Capenhurst Independent Research Ethics Committee (CIREC)
The Capenhurst Independent Research Ethics Committee is launching a recruitment drive for new membership.
CIREC are looking for Medical Expert volunteers and Lay member volunteers who would be able to join their Committee. A lay member should not have a health professional or allied health professional background nor been involved in medical research projects. The committee meets once a month at the Capenhurst Technology Park during the evening. Training is available and you will receive travel expenses and a small allowance for your time.
All studies of investigational medical products (new medicines) involving human volunteers require approval by the Competent Authorities before a trial can commence. The competent authorities in this case being the UK regulatory authority (MHRA) and a recognised Research Ethics Committee.
One such independent ethics committee is the Capenhurst Independent Ethics Committee (CIREC). CIREC is recognised by the UK government for the review of Phase I studies.
Phase I studies are the first stage of human trials, which entail, but are not limited to, the study of safety, pharmacokinetic and pharmacodynamic data gathered from trials conducted on healthy human volunteers.
An ethics committee is composed of up to 18 members who are drawn from a range of occupations, are of differing ages, religious beliefs and ethnic groups. The committee represents a mix of both expert and lay members.
The aim of an ethics committee is to ensure the protection of the rights, safety, dignity and well-being of research participants/volunteers, whilst facilitating and promoting ethical research which is of potential benefit to science and society.
For more information and an informal discussion please contact: Mr Lee Armstrong (CIREC Chair) by telephone on 0151 347 4280 or by email at cirec@aapec.org.uk
Vacancy Yorkshire Independent Ethics Committee Lay Member
Yorkshire Independent Ethics Committee
All research studies involving human subjects must, by law, be approved by an ethics committee thereby safeguarding the rights, safety and well being of participants. The Yorkshire Independent Ethics Committee reviews clinical research trials in healthy volunteers conducted outside the NHS.
The committee comprises experts and lay members and there is a vacancy for a ‘lay’ member for this committee.
The committee plays an important role in clinical trial research. The committee must approve confidential documents before trials of new drugs in healthy volunteers can start. This safeguards the rights, safety and well-being of human subjects involved in a drug trial.
The committee members include experts from a health professional background and lay members. A lay member should not have a health professional background or have been involved in medical research projects.
You will be expected to attend about 10 of the 12 scheduled committee meetings per year.
Meetings are currently held monthly on Tuesday in the evening in Leeds
You will receive training and support on joining the committee as well as travel expenses and a small allowance for your time.
You will be required to complete an application form and attend a short interview.
For further details please contact: Mrs Kirsty Benn-Harris by telephone on 0113-3846083 or by email at yirec@aapec.org.uk
IRAS, RED and Standard Operating Procedures Version 4.0
All IECs are operating to the National Research Ethics Service Standard Operating Procedures Version 4.0 which have been updated in consultation with the IECs. All IEC Co-ordinators can now access the Research Ethics Database (RED) which maps legal timelines and ethical decisions and records application history for each protocol submission. The AAPEC now strongly recommends that applicants submit a completed IRAS form along with the usual study documentation for review by all IECs. This should be done as a matter of routine from 1st January 2010. See link: AAPEC letter on use of IRAS.
AAPEC & ABPI Site Specific Assessment Training Event
20th March 2009
Feedback from delegates states that the SSA Training was successful in achieving its purpose as well as their personal objectives for the day. The presentations were considered well-balanced and the event generally very worthwhile.
The purpose of the SSA Training was to ascertain the precise remit of REC responsible for Site Specific Assessments (SSA) and how to undertake such an assessment.
The programme provided an opportunity to discuss the SSA in the context of the MHRA Accreditation Scheme as well as learning about CROs responsibilities. This event also included a section on IRAS and SSA Guidance from NRES as well as a presentation by Dr Richard Timer from ABPI on new guidance on insurance and ethics committees remit.
More information can be found under Learning and Development.
Guidance on Serious Breaches of Protocol.
13 February 2009
Serious non-compliance with the Regulations - co-ordination of follow-up action by ethics committees and MHRA
The above guidance has been developed and agreed by the Clinical Trials Collaboration Group established under the terms of the Memorandum of Understanding between MHRA, NRES and GTAC.
ABPI Phase 1 Guidelines
The Association of British Pharmaceutical Industry released the electronic version of the ABPI Phase 1 Guidelines 2007. The Guidelines can be downloaded from the ABPI website http://www.abpi.org.uk/recent.asp.