El Mito de Pigmaleon y Galatea

NHS

Royal F re e Local R e s e a r c h E thics C om m itee C hief E x ecu tiv es office P o n d S tre e t London H a m p ste a d London N W 3 2Q G 08 July 2002 Miss Hilary Harvey Nuffield C entre RNTNE

Royal Free H am pstead NHS Trust 330 Grays Inn Road

Kings Cross London W C1X8DA

Dear Miss Harvey

The role o f self-cognitfons in the em otional and behavioural d ifficu lties o f children with hearing im pairm ents

Ethics R eference 5990 (P le a se quote on ALL co r re sp o n d en ce )

I am pleased to be able to inform you that your recent submission to the Royal Free Hospital & Medical School Local Research Ethics Committee h as now received approval by Chairman's Action, on the provisio that a copy of the parent consent form is sent to the teacher. The letter to the teacher states that the study h as been

approved by Royal Free & Medical LREC

This approval will be formally documented at the next meeting of our full committee/MREC sub commitee.

This approval is for one year from the date of this letter. W e also require to be notified of the completion of the project and to be sent a copy of any subsequent publication. Extension of this period will be dependent on the submission of a brief synopsis of the progress of the project together with an estimation of the time required for its ultimate completion.

In addition we require that;

(a) You inform the committee immediately of any information received by yourself or of any information of which you becom e aware which would cast doubt upon, or alter, any information contained in the original application, or any am ended later

application, submitted to the committee which would raise questions about the safety and/or continued contact of the research. This would include the reporting of aÿ "adverse events" of which you become aware. These "adverse events" should afso

Royal Free Hampstead

NHS

Royal F re e Local R e s e a rc h Ethics C om m itee C h ief Executives office P ond S tre e t London H a m p ste a d London NW3 2Q G

be reported to the person who provided independent review of the original application. (b) All those involved in the study appreciate the importance of maintaining

confidentiality and that they comply with the Data Protection Act 1998.

(c) All proposed amendments to the protocol, that have a bearing on the treatment or investigation of patients or volunteers, are submitted to the committee for approval. (d) The conduct of the study complies with good clinical research practice as outlined in the ICH GCP guidelines.

(e) A copy of the patient consent form and information sh eet be lodged in the clinical notes.

This approval does not mean that the study may commence. The study may only begin following approval by the Trust through the office of the Director of Research & Development (please contact Zoe Spyvee on extension 8304).

P lease note the code number (above) that the submission has been given and quote this in all correspondence.

Yours sincerely

KJV^

Rosem ary Brown

Ethics Committee Secretary

Royal Free Local Research Ethics Committee

cc: Mr John Farrell, H ead of Pharm acy Services Ms Zoe Spyvee, R esearch and Development Officer

NHS

R oyal Free H a m p s te a d

N HS T ru st

Clinical Governance Support C entre Royal Free Hospital Pond S tre et London NW3 2Q G Tel:020 7830 2816 Fax:020 7830 2233 zoe.spyvee@ rfh.ntham es.nhs.uk

09 September 2002

Miss Hilary Harvey Nuffield Centre RNTNE

Sub department of Clinical Health Psychology UCL

Gower Street London WC1E6BT

Dear Miss Harvey

T he role of self-cognitions In the emotional and behavioural difficulties of children with hearing im pairm ents

P ro ject ID: 5990 (Please quote on ALL co rresp o n d en ce)

E th ic s ID: 5990

ROYAL FREE TRUST APPROVAL FOR R&D PROJECTS (Reissued for new address)

1 am pleased to inform you that following submission of your R&D registration form your project has been approved by the R&D department. This letter ensures that you and the researchers working with you holding trust contracts are indemnified by the trust, under department of health HSG (96) 48, for non commercial research only. This means you can now proceed with your project.

In addition to ensuring your study complies with good clinical research practice as outlined in the ICH GCP guidelines we require the following;

Patient contact - only trained researchers holding a trust contract (honorary or full) are allowed to make contact with patients.

Informed Consent - Only the lead researcher or other trained researcher should obtain signed consent and in accordance with the ethics committee requirements. The original signed consent form should be kept on file and informed consent will be monitored by the trust at intervals and you will be required to provide the relevant documentation.

Confidentiality - All those involved in the study appreciate the importance of maintaining confidentiality and that they comply with the Data Protection Act 1988.

Amendments - The R&D office needs to be kept informed of any changes to the project for example regarding patient recruitment, funding, personnel changes or your project status. If changes are made to the protocol they will need to be considered by the ethics committee.