ethics guidance notes2 by CO324l33

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           Submitting to R&D and ethics – answers to frequently asked questions


1. Filling in the COREC form

The COREC form is filled in online at www.corecform.org.uk.

Use the COREC checklist to ensure you submit a valid application – notice that there are two versions: one for
clinical trials of medicinal products and one for non-clinical trials. Bear in mind that the whole procedure of
going through Ethics will take a minimum of 2-3 months.

For more information and guidance on filling in the form, have a look at the COREC website,
www.corec.org.uk, it is very helpful.


2. Obtaining sponsorship

To obtain sponsorship (=responsibility / nothing to do with money) for a non-commercial project:

    a) If you are external to BLT or QMUL, ask your employer to write a letter of sponsorship.

    b) If you are a student you need to contact your University/College to provide you with the letter of
       sponsorship. If you are a student at QMUL, request QMUL sponsorship from the Joint R&D Research
       Ethics Administrator (David Jackson) when you submit your project.

                “City University London” students needing sponsorship letter should contact
                Aquila Muir
                Academic Administrator for Research
                St Bartholomew School of Nursing & Midwifery
                24 Chiswell Street
                London EC1Y 4TY
                A.Muir@city.ac.uk
                0207 040 5796

    c) If you are BLT or QMUL staff, contact the Joint R&D Research Ethics Administrator to check who your
       sponsor should be. This depends on the funder, your type of employment contract and the nature of
       the study. Then download a Conditions of sponsorship letter from
       http://www.bartsandthelondon.nhs.uk/research/rd_submission.asp, sign it (the Principal Investigator’s
       signature) and send it back to us. This letter needs to be submitted along with everything in
       paragraph 3.


3. Obtaining BLT/QMUL indemnity

Always submit to R&D before you submit to ethics. To obtain provisional R&D approval from the
Joint R&D Office you need to send us electronic and signed hard copies of the following documents:

   Parts A, B and SSI of the COREC form
   The project protocol.
   Patient information sheet
   Patients’ consent form (http://www.bartsandthelondon.nhs.uk/research/seeking_consent.asp)
   PI’s CV (dated and signed)
   Questionnaire (if applicable)
   Any other document you are sending to COREC.
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   A completed and signed (PI’s signature) DPA form (Data Protection Act 1998), download from
    http://www.bartsandthelondon.nhs.uk/research/rd_submission.asp
   A covering letter requesting provisional R&D approval.

We will then provide you with a provisional R&D approval letter. The COREC application is then submitted by
you – this does not happen via the R&D Office.

Once you have ethics approval, send us a copy of the approval letter and we will issue you with final R&D
approval. Only then are you fully covered and able to begin your research.

4. Statistical advice

A letter from a statistician will greatly support your ethics application. The Joint R&D Office employs a full time
statistician, who can help you. Please contact Fiona Warburton (Fiona.warburton@bartsandthelondon.nhs.uk)
020 7882 7262. This service is free of charge. How to book an appointment with:
http://www.bartsandthelondon.nhs.uk/research/statistical_support.asp.


5. Local answers to specific questions on the COREC form


Part A
A 29 What arrangements have been made for participants who have special communication
needs?
Sarah.Mudd@bartsandthelondon.nhs.uk (Health Advocate) can help you. Also, the Consumers for Ethics in
Research (CERES), www.ceres.org.uk, have translated leaflets into different languages to try and involve
people who speak little or no English. These are available to download from
http://www.bartsandthelondon.nhs.uk/research/advocacy_services.asp.

A 59 Sponsor details if BLT or QMUL:

Organisation: Barts and The London NHS Trust or Queen Mary, University of London (only one
organisation please)

Address:        Joint R&D Office
                3rd Floor Rutland House                    Tel: 020 7882 7260
                42-46 New Road                             Fax: 020 7882 7276
                Whitechapel                                Email: Gerry.Leonard@bartsandthelondon.nhs.uk
                London, E1 2AX

                UK contact section for QMUL/BLT sponsored projects.

                Gerry Leonard
                Joint R&D Office
                3rd Floor Rutland House                    Tel: 020 7882 7260
                42-46 New Road                             Fax: 020 7882 7276
                Whitechapel                                Email: Gerry.Leonard@bartsandthelondon.nhs.uk
                London, E1 2AX



SSI Form
Name of NHS REC responsible for SSA:




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        East London and City REC

Name of NHS care organisation to which application is being made for permission to
conduct the research:

and

6. Give the name of the NHS site within or through which the research will take place under the responsibility of
the PI or Local Collaborator.

        Barts and The London NHS Trust/Queen Mary University of London

27. Is there a contact point where potential participants can seek independent advice about
participating in the study?

For research involving BLT patients:
Patient Advisory Liaison Service (PALS), tel 020 7377 6335 or email pals@bartsandthelondon.nhs.uk

If there is no other appropriate local individual or agency who can offer independent advice (such as a
clinician or manager independent of the research study), do not add anything other than PALS here.

28. Please provide a copy on headed paper of the participant information sheet and consent form that will be used
locally.
This must be the same generic version submitted to/approved by the main REC for the study while including relevant
local information about the site, investigator and contact points for participants (see guidance notes).

Site              Patient Information Sheet.
Queen             What happens if there is a problem?
                  Queen Mary University of London has agreed that if you are harmed as a result of your participation in the study,
Mary              you will be compensated, provided that, on the balance of probabilities, an injury was caused as a direct result of
University        the intervention or procedures you received during the course of the study. These special compensation
                  arrangements apply where an injury is caused to you that would not have occurred if you were not in the trial.
of London
                  These arrangements do not affect your right to pursue a claim through legal action.

                  Please also add the following if dealing with patients

                  Please contact Patient Advisory Liaison Service (PALS) if you have any concerns regarding the care you have
                  received, or as an initial point of contact if you have a complaint. Please telephone 020 7377 6335, minicom 020
                  7943 1350, or email pals@bartsandthelondon.nhs.uk, you can also visit PALS by asking at any hospital reception.

                  For healthy volunteers
                  If you have a complaint please contact:
                  The Complaints Officer
                  c/o Chief Operating Officer for the Barts and The London,
                  Queen Mary School of Medicine and Dentistry
                  Wardens Office
                  32 Newark Street
                  Whitechapel
                  London E1 2AA

Barts and         What happens if there is a problem?
                  We would not expect you to suffer any harm or injury because of your participation in it. If you are harmed by
The London        taking part in this study, there is no special compensation arrangement. If you are harmed due to someone’s
NHS Trust         negligence, then you may have grounds for legal action but you may have to pay your legal costs. Regardless of
                  this, if you wish to complain or have any concerns about any aspect of the way you have been approached or
                  treated during the course of this study, the normal National Health Service complaints mechanisms should be
                  available to you.

                  Please contact Patient Advisory Liaison Service (PALS) if you have any concerns regarding the care you have
                  received, or as an initial point of contact if you have a complaint. Please telephone 020 7377 6335, minicom 020
                  7943 1350, or email pals@bartsandthelondon.nhs.uk, you can also visit PALS by asking at any hospital reception.




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6. Some clarification on Data Protection issues.


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If you are transferring data to the States or any other country outside the EEA, you should make this crystal
clear on the consent form by including this clause:

I give permission for (Principle Researcher) to hold/transfer data to the USA and in particular to the
      XYZ Corp; (specify address)
      ABC Corp: (specify address)
and process information relevant to my participation in this trial. I understand that this will include data
transfer to countries outside Europe where the Data Protection Act is not enforced and the data protection
laws are not as stringent. However, as stated in the patient information leaflet they have undertaken to treat
your information as confidential."

The Trust DPA guardian, Nicola Gould has pointed out that the participants need to be made explicitly aware
that their data will be transferred outside the EEA and agree to it.

Also, regarding the consent form, please do not use phrases such as “ data will be handled by responsible
adults”. Adults are meant to be responsible, by adding an adjective such as responsible, it does little but
querying precisely this.

For more information please contact Nicola Gould (Nicola.gould@bartsandthelondon.nhs.uk)

7. Contacts

MHRA, Medicines and Healthcare products Regulatory Agency          http://www.mhra.gov.uk/
http://medicines.mhra.gov.uk/,


East London and the City Research Ethics Committee 1.
(the reference number will include __/Q0603/__)

Coordinator: Sandra Burke
Telephone: 0207 655 6718
E-mail: sandra.burke@nelondon.nhs.uk


East London and the City Research Ethics Committee 2.
(the reference number will include __/Q0604/__)

Coordinator: Sandra Grote
Telephone: 020 7655 6612.
E-mail: sandra.grote@nelondon.nhs.uk.

East London and the City Research Ethics Committee 3.
( the reference number will include __/Q0605/__ )

Coordinator: Lesley Parry
Tel: 020 7655 6622.
E-mail: lesley.perry@nelondon.nhs.uk

Postal Address:
3rd Floor




     
Aneurin Bevan House,


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81 Commercial Road,
Aldgate,
London,
E1 1RD.
Fax: 020 7655 6655.



Acronyms
Research Ethics Committee (REC)
Central Office for Research Ethics Committees (COREC)
Main Research Ethics Committee (MREC)                           Local Research Ethics Committee (LREC)
Governance Arrangements for Research Ethics Committees (GAfREC)
Good Clinical Practice (GCP).
International Conferences on harmonisation, Good Clinical Practice (ICH-GCP)
EU Directive Trial (EUD)
Central Allocation System (CAS)
Chief Investigator (CI)                                 Principal Investigator (PI)
Strategic Health Authorities are now known as ‘domains’
Clinical Trial Authorisation (CTA)
MHRA, Medicines and Healthcare products Regulatory Agency         http://www.mhra.gov.uk/
 http://medicines.mhra.gov.uk/,
CCTA
Hope this helps, should you have any more queries, please e-mail the Ethics Interface Facilitator.




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