Professional Members of the Independent Scientific Advisory Committee (ISAC)
Information Pack for Applicants
Closing date: Midnight on Sunday 18 June 2017
Reference No: IS17P
Message to Applicants
May 2017
Dear Applicant
Thank you for your interest in these positions and for reading our applicant information pack.
The Independent Scientific Advisory Committee is responsible for reviewing the scientific merit of research applications proposing use of data from the MHRA Clinical Practice Research Datalink (CPRD). The ISAC provides advice to the MHRA on the feasibility, quality and public health value of the research that it considers.
ISAC is now seeking professional members who have strong track records in the following areas of expertise:
Cancer EpidemiologyCardiovascular Research
Child Health
General Practice/Primary Care
Genetic Epidemiology /Precision or Stratified Medicine / Health Informatics
Machine Learning
Medical Statistics
Pathology (Laboratory testing)
Pharmacology/Pharmacovigilance / Public Health & Epidemiology
Psychiatry
Respiratory Medicine
Surgery
Women’s Health
I do hope you are excited by the challenges these opportunities present and that you will be encouraged to apply.
If you would like to have an informal discussion to find out more about the role, please contact the ISAC Secretariat () and we will be more than happy to assist you.
Once again many thanks for your interest.
Yours sincerely
CPRD/MHRA
Members of the Independent Scientific Advisory Committee (ISAC)
Overview
Indicative timetable
Advert: 10 May 2017
Closing date: Midnight on Sunday 18 June 2017
Shortlisting/Appointment: 21 June 2017
ISAC
The ISAC is a non-statutory expert advisory body established in 2006 by the Secretary of State to provide advice on research related requests to access data from the MHRA Clinical Practice Research Datalink (CPRD).
Role of ISAC
1. Consider and provide advice to the MHRA on the feasibility, quality and public health value of research studies proposing use of anonymised patient level data from the CPRD.
2. Provide timely and high quality peer reviews on the scientific (medical, epidemiological, methodological) merit of research protocols proposing access and use of CPRD data.
3. Highlight important ethical or confidentiality issues that may arise during access and/or use of CPRD data in research studies, taking into consideration input from the Confidentiality Advisory Group or research ethics committees.
4. Advise on, and contribute to, the scientific content of guidance relating to the development of research protocols proposing access and use of data from the CPRD.
5. Review internal workings of the Committee, to ensure consistency, efficiency and high standards of peer-review are maintained.
6. Advise on other specific issues as requested by the MHRA and/or CPRD.
Scope of Research Protocols Submitted to ISAC
These include observational research studies not limited to the following:
§ Extended feasibility studies (descriptive, hypothesis generating) using retrospective data.
§ Epidemiological studies: Cross-sectional, case-control, cohort, drug utilisation studies and other relevant studies.
§ GP questionnaire studies
§ Patient level meta-analysis
§ Studies involving bio-sample collections from patients
§ Studies involving collection of patient reported outcomes
§ Patient questionnaire studies
§ Cluster randomised trials
§ Longitudinal follow-up studies of patients previously participating in a registered clinical trial.
These do not include studies subject to clinical trial regulatory approval.
Professional Membership
The role of professional members is primarily to appraise research protocols for scientific and methodological integrity and provide feedback to the Chair in a timely manner. The role also involves attending ISAC meetings, participating in strategies to enhance the performance of the committee, and providing comments on the ISAC Annual report.
For further information relating to appointment of Members see Annex A.
Essential Criteria:
· Recent experience in health related practice and research.
· Experience in the use of CPRD data or related data sources.
· A demonstrable track record within your field whether public, private or voluntary sector.
· Previous experience on other Committees (public, private, voluntary)
· The ability to readily assimilate complex information and extensive experience as a peer reviewer in your field.
· Excellent interpersonal and communication skills.
· Proven ability to work both independently and as part of a multidisciplinary team.
· Proven ability to work to tight deadlines and targets.
· Attention to detail and accuracy.
We encourage applications from individuals with considerable expertise and research experience in:
Cancer EpidemiologyCardiovascular Research
Child Health
General Practice/Primary Care
Genetic Epidemiology /Precision or Stratified Medicine / Health Informatics
Machine Learning
Medical Statistics
Pathology (Laboratory testing)
Pharmacology/Pharmacovigilance / Public Health & Epidemiology
Psychiatry
Respiratory Medicine
Surgery
Women’s Health
Diversity and equality of opportunity
We value and promote diversity and are committed to equality of opportunity for all and appointments made on merit.
Key contacts:
For information regarding the role of ISAC and its posts, please contact:
ISAC Secretariat
Clinical Practice Research Datalink
Level 5
151 Buckingham Palace Road
Victoria
London
Tel: 020 3080 7182
Email:
Please quote reference IS17P on all correspondence.
For further details on how to make an application, please see Annex B.
Annex A. Appointment of Members
Method of working
Protocol Review
Most research protocols are reviewed between meetings across a virtual working environment. Committee members will be asked to provide reviews on a range of disease and/or therapeutic areas and not just their own areas of specialism. Where decisions on a research protocol cannot be reached intersession these are scheduled for discussion at the earliest face-to-face ISAC meeting.
Meetings
Four face to face meetings are held per annum at the MHRA office in London or at an alternative venue, if needed. Members may attend meetings by phone but they are not considered to be present with respect to quorate numbers.
Committee Support
The ISAC is supported in the conduct of its business by the CPRD ISAC Secretariat.
Time commitment
You will be required to attend four meetings per year plus review research study protocols between meetings, as requested by the Chair. On average, members may be requested to review 1-2 research applications per month.
Remuneration
· You will receive a meeting attendance fee of £174 plus the cost of travel and subsistence expenses in line with rates set centrally.
· Those appointed will also be eligible to claim allowances, at rates set centrally, for travel and subsistence costs necessarily incurred on ISAC business.
Tenure of office
Initial appointment will be for 2 years. The appointment can be renewed at the end of the first period of office subject to consistently good performance. There should therefore be no expectation of automatic reappointment. The maximum total term is 4 years.
Training
Induction is provided following appointment to the Committee. In role training is also provided.
Accountability
Members are appointed by the Chair of the MHRA and are accountable to the MHRA for their performance.
Disqualification for appointment
There are circumstances in which an individual may not be considered for appointment. They include:
· people who have received a prison sentence or suspended sentence of 3 months or more in the last 5 years;
· people who are the subject of a bankruptcy restrictions order or interim order;
· in certain circumstances, those who have had an earlier term of appointment terminated;
· anyone who is under a disqualification order under the Company Directors Disqualification Act 1986; and
· anyone who has been removed from trusteeship of a charity.
Further advice about disqualification for appointment can be provided by contacting the ISAC Secretariat ()
Register of Interests
You should note particularly the requirement to declare any conflict of interest that arises in the course of ISAC business, and need to declare any relevant business interests, positions of authority or other connections with organisations relevant to the business of ISAC.
Standards in public life
You will be expected to demonstrate high standards of corporate and personal conduct. All successful candidates will be asked to subscribe the code of conduct for Board Members of Public Bodies. You can access this document at:
http://www.bl.uk/aboutus/governance/blboard/Board%20Code%20of%20Practice%202011.pdf
Annex B. Making an Application
Overview
The appointment of Professional Members is an MHRA appointment. The selection panel will make recommendations on appointments to the Chair of the MHRA. The Chair of the MHRA will make the final decision and will make appointments.
How to apply
All applicants are required to complete the ISAC Members Application form and must also submit a copy of their CV, as part of the application process. Application forms are available online via the CPRD website (http://www.cprd.com/ISAC/). Please search for the vacancy IS17P.
Applicants should also arrange to provide two references in support of their application. The latter should be forward directly to the CPRD by the referees, on or before the application closing date.
Alternative formats of the application form and information pack are available on request from:
ISAC Secretariat
Clinical Practice Research Datalink
Level 5
151 Buckingham Palace Road
Victoria
London
Tel: 020 3080 7182
Email:
The Appointments team must receive your completed application form, CV and references before midnight on Sunday 18 June 2017. All applications will be acknowledged by email after the closing date.
Your personal information
Your personal information will be held in accordance with the Data Protection Act 1998. You will not receive unsolicited paper or electronic mail as a result of sending any personal information. No personal information will be passed on to third parties for commercial purposes.
When we ask you for personal information, we promise we will:
· Only ask for what we need and not collect too much or irrelevant information;
· Ensure you know why we need it;
· Protect it and insofar as is possible, make sure nobody has access to it who shouldn't;
· Ensure you know what choice you have about giving us information;
· Make sure we don't keep it longer than necessary; and
· Only use your information for the purposes you have authorised.
We ask that you:
· Provide us with accurate information; and
· Inform us as soon as possible of any changes or if you notice mistakes in the information we hold about you.
If you apply for a post, we will share some of the information you provide with the members of the selection panel for the post to which you applying, so that your application form and CV can be assessed.
Panel members are identified in the section below on “How we will handle your application”.
Any information that you may provide for the purposes of monitoring the fairness of the appointment process will not be used in the selection process. This information will not be shared with the selection panel assessing your application.
How we will handle your Application
We will deal with your application as quickly as possible and will advise you of the likely timetable at each stage. After the closing date for applications:
· Your application and CV will be assessed to see whether you have the expertise required at the appropriate level for the post for which you have applied. We will rely on only the information you provide on your application form and CV to assess whether you have the experience required. Please ensure that you provide evidence to support how you meet all of the relevant criteria, which are identified in the overview section;
· Your application may be “long-listed”, subject to the volume of applications received, before it is passed to the shortlisting panel for consideration. You should be aware that in this situation, your application might not be considered in full by all of the panel;
· The panel will select the people who have demonstrated that they best meet the essential criteria and these will be recommended to the Chair of MHRA who will make the final decision;
· We will write to let you know whether or not you have been selected for appointment to the Committee.
· If you are successful, you will receive a letter from the Chair of MHRA appointing you as Professional Member of ISAC; and
· If you are unsuccessful, you will be notified by the CPRD Secretariat.
· Please email the ISAC Secretariat for feedback on your application, if required.
Queries
For queries about your application, please contact:
ISAC Secretariat
Clinical Practice Research Datalink
Level 5
151 Buckingham Palace Road
Victoria
London
Tel: 020 3080 7182
Email:
If you are not completely satisfied
CPRD will aim to process all applications as quickly as possible and to treat all applicants with courtesy. If you have any complaints about the way your application has been handled, please send us an email using .
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