Study Proposals

1. Complete the standard format for study proposals (part 1)

2. Design the 2 page questionnaire to be used for identified cases (examples below)

3. Complete the WPSU form (part 2) to accompany the proposal

• Please return proposal and questionnaire to: Ms Heather O’Connell, WPSU Administrator, Child Health Directorate Office, University Hospital of Wales, Heath Park, CARDIFF CF14 4XW or email heather.oconnell@wales.nhs.uk

Closing dates for this are 1 April and 1 October.

• The proposal, questionnaire and form will be considered for inclusion by the Steering Committee of the WPSU at their meetings in May and November. You may be required to provide further information or answer specific questions at this stage. Your attendance at this meeting is important.
• When approved, arrangements are made for starting the study and including the condition on the WPSU card.

If you have any questions regarding the WPSU please do contact Heather O’Connell on (029) 2074 3946 on Tuesdays, Wednesdays and Thursdays.

FORMAT FOR PROJECT PROPOSALS Part 1

The Steering Committee have decided on the following standard format for study proposals:

• Background

• Objectives

• Criteria for inclusion, including the case definition

• Information required on individual cases

• Will patient confidentiality be maintained?

• Duration of study

• Will additional contact with the patient be required?
• Purposes for which the data collected will be used/ Questions the study aims to answer

• References

• Authors

WPSU Proposal form part 2

• All WPSU studies (except audit) must have ethical approval. Do you have ethical approval? When your study receives ethical approval, WPSU would appreciate a copy of the confirmation letter with the approval number.

• Details of financial/academic support

• Likely number of notifications

• Do you have complementary sources of ascertainment to validate the data collected through WPSU?

• Details of other possible sources of data ie consultants working in other specialities to whom WPSU could temporarily mail cards on your behalf to improve case ascertainment.

SUBMISSION GUIDELINES

Each proposal should be submitted on one sheet of A4 paper to the Welsh Paediatric Surveillance Unit Steering Committee.
The questionnaire is to accompany the proposal when submitted for approval and for preference should be one sheet of A4 paper (maximum two sheets).
Please remember to complete part 2 as fully as possible as these answers may influence acceptance by the WPSU.
Please read the page on Useful Information to ensure that your proposed study is suitable to be conducted under the WPSU parameters.

Please return proposal and questionnaire to: Ms Heather O’Connell, WPSU Administrator, Child Health Directorate Office, University Hospital of Wales, Heath Park, CARDIFF CF14 4XW.

Closing dates: 1 April and 1 October

Useful Information

• WPSU collects only new cases of the condition you are studying.

• You will be sent details of the notifiers name and address for each notification and you then send your questionnaire to the notifier.

• Patient confidentiality must be maintained. Data to be stored electronically must be anonymised:

• WPSU provide a unique number per notification for identification purposes, for you to put at the top of each questionnaire.

• It is your responsibility to write to notifiers promptly and to contact them regularly for incomplete or missing data.

• Address should not be collected but full postcode can be collected for epidemiological analysis.

• If you intend to follow up the notifications at a later date you must stress in your questionnaire that this is your intention and that therefore doctors should record the WPSU number and the patients details.

• An Annual Progress Report will be required.

• A Report for the WPSU Annual Report will be required on completion of your study.

Factors that favour acceptance by the British Paediatric Surveillance Unit (BPSU) which WPSU also follow:

• Scientific importance

• Rarity of the condition, though short-term or geographically limited studies of commoner disorders are considered

• Proposals with outcomes of clear importance to public health

• Uniqueness. Priority will not be given if similar studies have recently been undertaken or if other data sources are readily available (although BPSU encourages the use of alternative data sources for validation and completeness of reporting)

• Attention to detail, in terms of clear achievable objectives, practicability, patient confidentiality and resources

• Practicality and limited workload placed on the reporting paediatrician

• Ethical approval

Factors for Specialist Registrars to consider

• The WPSU is a very interesting and useful way of collecting project data (and can lead to publications)

• You will receive support from the Steering Committee but remember:

• You need to consider carefully your outcomes and whether they are feasible

• You will need a minimum of 12 months data

• You will need to collate and process the data you collect

• A report will be required for the WPSU Annual Report (example attached)

• Consider joint applications if you rotate posts six monthly, ie with a Consultant colleague and/or one other Specialist Registrar.

• Consider this to be a long-term project of at least two years

EXAMPLE PROPOSAL 1

TITLE: Epidemiology, diagnosis and management of septo-optic dysplasia in Wales.

BACKGROUND
Septo-optic Dysplasia is the association of optic nerve hypoplasia with agenesis of the septum pellucidum and is often associated with disturbed hypothalamic/pituitary function resulting in growth hormone deficiency, diabetes insipidus and trophic hormone deficiencies. Seizures and mental retardation are common. Precise diagnosis is difficult in many cases as some of these abnormalities may be absent at the outset or their onset delayed for several years. Regular follow up and meticulous investigations for endocrine and other associated abnormalities are required. More recently, a novel gene has been implicated in the familial form. Genetic analysis and counselling may be important for parents wishing to have further children. Visual impairment may be so severe in some children as to require the full range of multidisciplinary support for blindness.

OBJECTIVES
1. To identify all children both new and existing cases with septo-optic dysplasia in Wales,
2. To establish the incidence and prevalence of the condition,
3. To establish the extent to which they have been investigated and abnormalities identified,
4. To determine the service requirement across Wales in order to establish a need for developing a network of service providers and to develop clinical guidelines.

INCLUSION CRITERIA
All children and adolescents from ( 0 – 16) years of age with a diagnosis of optic nerve hypoplasia (established or suspected).

INFORMATION REQUIRED IN INDIVIDUAL CASES

1. Demographic details, including DOB, sex, height, weight etc.
2. Clinical details,
3. Details of visual impairment and ophtholmological findings,
4. CT and MRI findings,
5. Endocrine evaluation,
6. Developmental assessments,
7. Services and counselling provided.

DURATION OF THE STUDY: 2 YEARS

WILL ADDITIONAL CONTACT WITH THE PATIENTS BE REQUIRED: NO

PURPOSES OF THE DATA THAT WILL BE COLLECTED:

To meet the above objectives and to assess the extent to which the services are required to support these patients.

REFERENCES
Masera N,et al.Arch Dis Child 1994: 70: 51-54
Williams JL, et al.Ultrasound Med 1985:4;265-266.
Dattani MT, et al. Acta Paediatrica, supplement, 88(433):49-54, 1999 Dec.

INVESTIGATORS:
Dr Prema Sastry, Associate specialist community paediatrician (vision), Cardiff,
Dr John Gregory, Paediatric Endocrinologist, UHW Cardiff.
Mrs L. Beck, Consultant Ophthalmologist, UHW, Cardiff.

EXAMPLE STUDY QUESTIONNAIRE

WPSU Case number: (You complete this)……………

Please keep a record of the child's details and the study number at the top of this form in your WPSU folder. Please ring our office on (your number) if you have any problems with the form. Thank you for your time.

Name of reporting doctor: .....(You complete this from WPSU notification slip)...................................
Month/Year of Report:……… (You complete this from WPSU notification slip).................................

Date of Birth:

Date of diagnosis:
Sex:

Postcode:
Hospital:

(Information you require)

Please return this form to (Your name and address)

EXAMPLE QUESTIONNAIRE 1

SEPTO-OPTIC DYSPLASIA QUESTIONNAIRE WPSU No…………..

HOSPITAL:………………………………………CONSULTANT: …………………………………
POST CODE ………………..
DOB:…………………………………………………… SEX: …………………………………

LABOUR AND DELIVERY:
GESTATION ………………………………….. BIRTH WEIGHT…………………………
ANY COMPLICATIONS? (please specify)

FAMILY HISTORY:
CONSANGUINITY: yes no unknown
F/H of OPHTHALMIC DISORDERS yes no unknown

VISION:
WHEN WAS THE OCULAR/VISION PROBLEM FIRST DETECTED? (date)……….
CORRECTED VISUAL ACUITY: RIGHT………………. LEFT………………………..
IS THE CHILD ABLE TO FIX OR FOLLOW:   yes no
RESULTS OF FUNDOSCOPY: NORMAL ( )   ABNORMAL ( )
IS OPTIC NERVE HYPOPLASIA PRESENT? Yes no
IS THE CHILD REGISTERED   BLIND OR   PARTIALLY SIGHTED? Please specify.

NON OPHTHALMIC DEFECTS: (If YES, please indicate the age at which it was detected)

HEARING IMPAIRMENT  yes no
LEARNING DIFFICULTY  yes no
DELAYED WALKING   yes no
DELAYED SPEECH   yes no
HYPOPITUITARISM   yes no
HYPOTHYROIDISM   yes no
ADRENAL INSUFFICIENCY  yes no
ADH INSUFFICIENCY   yes no
OTHER (please specify)  -------------------------

ANY TREATMENT/INTERVENTION (for non-ophthalmic conditions)? Please give details.

HAVE THESE INVESTIGATIONS BEEN UNDERTAKEN?
   Normal / Abnormal / Not done.
GH   ----------/--------------/-------------
TFT   ----------/--------------/-------------
CORTISOL  ----------/--------------/-------------
ACTH   ----------/--------------/-------------
FSH LH   ----------/--------------/-------------
OSMOLALITY  ----------/--------------/-------------
EEG   ----------/--------------/-------------
INTRA CRANIAL IMAGING-------/-------------/------------
SCREENING FOR GENETIC MUTATION  done not done

HAS A STATEMENT OF SPECIAL EDUCATIONAL NEEDS BEEN COMPLETED? Yes no

PLEASE RETURN THE COMPLETED QUESYIONNAIRE TO: DR PREMA SASTRY, SPLOTT CLINIC, SOUTH PARK ROAD, SPLOTT, CARDIFF, CF2 2LU.
THANK YOU FOR YOUR HELP.

EXAMPLE PROPOSAL 2

TITLE: NON TYPE 1 Diabetes Mellitus. Epidemiology, diagnosis, and management of type 2 diabetes in children in Wales.

BACKGROUND
The rising prevalence of childhood obesity has been well documented. Obesity is associated with insulin resistance and hyperinsulinaemia. Type 2 diabetes mellitus (T2DM) develops as a result of relative ÿ cell failure in the context of marked insulin resistance and has been reported with increased frequency in children across the world. In the UK there have been anecdotal reports of T2DM in both Asian and White adolescents but a survey of British paediatricians in 2000 led to the first published case reports. The development of diabetes during childhood is often assumed to be due to profound insulin deficiency (T1DM) so that in cases of T2DM the actual metabolic defect remains unrecognised. This may result in inappropriate counselling and treatment and a failure to address other important consequences of underlying hyperinsulinaemia. A prospective study is therefore required to determine the incidence of T2DM within a UK population.
OBJECTIVES
To identify all children diagnosed with non-Type 1 diabetes mellitus (type 2, MODY, and diabetes secondary to another pathology e.g. cystic fibrosis) over a one-year period. From this we aim to identify the incidence of children diagnosed with type 2 diabetes in Wales. We also aim to determine the need for clinical guidelines on the assessment and management of these children.
INCLUSION CRITERIA
All children and adolescents under 16 years of age who are diagnosed with diabetes mellitus according to the criteria of the American Diabetes Association ( Fasting Plasma Glucose > 7.0 mmol/L or random/2 hour (OGTT) plasma glucose >11.0mmol/L) over a one year period in Wales, that does not appear to be typical T1DM:
Type 2 diabetes mellitus- if 3 of the following are fulfilled
1 Obese – (BMI>95th percentile)
2 Signs of insulin resistance – acanthosis nigricans, PCOS
3 Family History of T2DM in 1st and 2nd degree relative
4 Asian or Afro-Caribbean origin
5 Pubertal (or age >10 yrs)
Maturity onset diabetes of the young MODY – suspect if
1 Autosomal dominant pattern or inheritance –DM in 2, ideally 3 generations
2 DM diagnosed < age 25 yrs in at least 1 family member
3 Not obese or overweight
DM secondary to steroid therapy or other drugs eg chemotherapy
DM secondary to other disease processes eg Cystic Fibrosis, syndromic obesity

INFORMATION REQUIRED IN INDIVIDUAL CASES
Demographic details including a unique anonymised identification number, hospital number, ethnicity, and family history.
Clinical details including presenting symptoms, height, weight, pubertal status and additional clinical features.
Results of laboratory investigations undertaken.
Details of initial treatment given.
DURATION OF STUDY: 1 year
WILL ADDITIONAL CONTACT WITH THE PATIENTS BE REQUIRED: Yes, a follow up questionnaire will need to be completed 12 months post diagnosis to determine the clinical course and examine more closely those for whom the type of diabetes was not clear at diagnosis. (All these young people will be routinely followed up on a regular basis in the out patient departments.)
PURPOSES OF THE DATA THAT WILL BE COLLECTED
To meet the aims and objectives of the study and to determine the likely implications of this evolving problem for services currently managing childhood diabetes.
REFERENCES
Ehtisham S, Barrett TG, Shaw NJ Type 2 Diabetes Mellitus in UK Children, an emerging problem. Diab Med 17(12) 867-71 2000 Dec.
Ehtisham S, Kirk J, et al Prevalence of Type 2 Diabetes in Children in Birmingham BMJ 322(7299):1428, 2001, June 9.
Ehtisham S, Barrett T Ann Clin Biochem 2004 41 10-16.

EXAMPLE QUESTIONNAIRE 2

JUVENILE IDIOPATHIC ARTHRITIS QUESTIONNAIRE

WPSU NO:……………... Date of Notification:…………………….
DOB:…………………....
SEX:…………………….
DATE OF DIAGNOSIS:……………………………..
HOSPITAL:…………………………………………..
SUB-TYPE OF JUVENILE ARTHRITIS – indicate
• Oligoarticular
• Extended oligoarticular
• Polyarticular rheumatoid factor negative
• Polyarticular rheumatoid factor positive
• Systemic onset
• Psoriatic arthritis
• Enthesitis-related arthritis
• Other (unclassified) – describe

A brief description of the severity of the child’s disability:
……………………………………………………………………………………………
……………………………………………………………………………………………
……………………………………………………………………………………………
Extra articular disease
• Uveitis
• Vasculitis
• Pleural effusions/Pericarditis
• Other (please specify) ……………………………………………………
•
Treatment provided for JIA
Drug treatment – please specify:
• Analgesia
• Non-steroidal anti-inflammatory drug
• Disease modifying drug (e.g. Methotrexate)
• Biological agent (e.g. Anti-TNF)
•
Physiotherapy (specify paediatric or adult provision): paediatric/adult
Occupational Therapy (specify paediatric or adult): paediatric/adult
Orthotics
Joint Injection
Surgery

Has the child been statemented?: ……………………..
Is the child also being seen elsewhere for the management of their Juvenile Arthritis? – which Unit? ……………………………………………………

Please return the completed questionnaire to:
Dr J P Camilleri, Rheumatology Department, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW

BPSU Confidentiality Guidelines. WPSU follow these guidelines. Useful reading.

PATIENT CONFIDENTIALITY & DATA HANDLING – REQUIREMENTS, GUIDANCE & ADVICE FOR
THE BPSU INVESTIGATOR

Royal College of Paediatrics and Child Health, 50 Hallam Street, London W1W 6DE.
Tel: (020) 7 307 5671 Fax: (020) 7 307 5694 Email:

bpsu@rcpch.ac.uk

Index

7a BPSU Investigators Code of Conduct on Patient Confidentiality

7b Guidance for BPSU Investigators on Patient Confidentiality

7c Requirements for BPSU Investigators on Data Handling and Patient Confidentiality

Appendix 7a

BPSU Investigators Code of Conduct on Patient Confidentiality

1. Introduction

In what follows the term BPSU refers to the Unit itself, its Executive Committee and studies conducted through the BPSU.

1.1 Much of the work of the undertaken through the BPSU involves the collection, analysis, reporting and storage of information on patients, including activities involved in communicable disease surveillance. . In order to discharge these functions effectively it is often necessary for the BPSU to collect and process person-identifying health-related data.

1.2 Under their contracts of employment all employees have a duty to observe general rules regarding confidentiality of information concerning patients. To enable employees to meet this contractual requirement, consistent with also enabling the BPSU to discharge its functions as outlined in 1.1 above, employees should handle patient data in accordance with the principles contained in the Data Protection Act 1998, and also the “Caldicott Principles” which are outlined below.

2. Caldicott Principles
Employees of the BPSU and those employed to facilitate surveillance should ensure that patient-related information is handled in accordance with “Caldicott Principles” (outlined in the recommendations of the Caldicott Committee’s Report on the Review of Patient-Identifiable Information, published in December 1997).

Principle 1 – Justify the purpose(s)
Every proposed use or transfer of patient-identifiable information within or from the BPSU should be clearly defined and scrutinised to ensure that there is no alternative to the use of such data; continuing use will be reviewed regularly by the BPSU Executive, and the relevant “Caldicott Guardian” to ensure that the use remains justified.

Principle 2 – Don’t use patient-identifiable information unless it is absolutely necessary Patient-identifiable information items should not be used unless there is no alternative and its use is necessary for the medical management of the individual or for the protection of the Public Health. Administrative convenience is not a reason for using such material.

Principle 3 – Use the minimum necessary patient-identifiable information where use of patient-identifiable information is considered to be essential, each individual item of information should be justified with the aim of reducing identifiability.

Principle 4 – Access to patient-identifiable information should be on a strict need to know basis. Only those individuals who need access to the patient-identifiable information should have access to it, and they should only have access to the items they need to see.

Principle 5 – Everyone should be aware of their responsibilities All facilitators of the BPSU who handle patient-identifiable information (both clinical and non-clinical staff)

should ensure that they are aware of their responsibilities and obligations to respect patient confidentiality.

Principle 6 – Understand and comply with the law.
Every use of patient identifiable information must be lawful. The principal investigator, as advised by the BPSU Executive and its Caldicott Guardian, is responsible for ensuring that the project as a whole complies with legal requirements.

3. Practical Measures
Management and staff at all levels are responsible for taking all reasonable steps when carrying out their normal day to day duties to ensure adherence to the Caldicott Principles on patient confidentiality, including:
• Arrangements for storage and disposal of patient information (manual and computerised) must protect confidentiality.
• Appropriate security measure to protect computer-based and manual information must be devised and installed.
• Care should be taken to ensure that unintended breaches of confidentiality do not occur e.g. by not leaving files, fax machines or computer terminals unattended, double checking to avoid transmitting information to the wrong person, not allowing sensitive conversations to be overheard and guarding against people seeking information by deception.
• Where a non-NHS agency or individual is contracted to carry out NHS or BPSU facilitated functions the contract must draw attention to the obligations on patient confidentiality and require information to be treated and stored to specified standards and used only for the purposes consistent with the terms of the contract.
• Where anonymised information would be suitable for a particular purpose, patient-identifiable information should be omitted wherever possible.
• Patients who feel that confidentiality may have been breached should be advised to pursue any complaint through their NHS Trust Complaints Procedure.

4. Breaches of Confidentiality
Any alleged breach of confidentiality will be regarded as a potentially serious disciplinary offence, which will be investigated and dealt with formally under the guidelines of the NHS Trust or institute Disciplinary Policy and Procedure. Where the allegation is substantiated and found to constitute gross misconduct (e.g. where the breach is found to be deliberate) this will result in summary dismissal.

Disciplinary action short of summary dismissal may be appropriate in other circumstances. In any case where the breach of confidence is committed by a health professional, he/she may also be subject to action by the relevant regulatory/professional body e.g. GMC, UKCC, CPSM (HPC – Health Professions Council – with effect from 1 October 2000). Employees also have the right and duty to raise any concerns they may have about possible breaches of confidentiality by colleagues or clients. Employees who raise such concerns in good faith will not be penalised.

5. Training and Further Information and Advice
The principal investigator is responsible for ensuring that all employees are provided with appropriate information and guidance on patient confidentiality and specific arrangements for handling patient-related data e.g. during induction and on-the-job training programs. Employees have a duty to attend induction and other relevant training programs that are arranged for them.

Duty of confidentiality with regard to patient data

1 The BPSU and those who facilitate its use have a common law duty of confidentiality to patients and a duty to support professional ethical standards of confidentiality.

2 Every facilitator of the BPSU has a personal common law duty of confidentiality to patients and to the BPSU.

3 In addition, health professionals (including medical, scientific, nursing and technical staff) have, by virtue of professional regulation, an ethical duty of confidentiality.

4 Any alleged breach of patient confidentiality should be considered seriously. It needs to be reported to the BPSU Executive immediately. Any substantiated breach may lead to the termination of the surveillance project. ln addition, where the breach of confidence is committed by a health professional, he/she may be subject to action by the relevant regulatory/professional body.

5 Employees also have a right and duty to raise any concerns they may have about possible breaches of confidentiality by colleagues or clients. Employees who raise such concerns in good faith will not be penalised.

Appendix 7b

Guidance for BPSU investigators on patient confidentiality

Introduction

The aim of the BPSU is to facilitate the work of surveillance projects that are involved in the collection, storage, analysis, and reporting of information on patients. In some studies particularly those involved in communicable diseases, surveillance groups may offer diagnostic test on individual patient specimens. To undertake these projects effectively it is often necessary to collect and process some patient identifying data.

Under the agreement with the BPSU, which investigators sign before starting a project, there is a duty to observe general rules regarding confidentiality of information concerning patients. The BPSU strongly advises that all investigators handle patient data in accordance with the principles of the Caldicott Committee Report on the Review of Patient-Identifiable Information (attached), those contained in the Data Protection Act 1998 and in the attached BPSU statement.

Below are a series of questions investigators should ask themselves when planning to handle data. If further advice or further information were required, the BPSU Scientific Coordinator would be pleased to help. The BPSU will routinely ask all investigators to complete a questionnaire providing information about issues relating to data confidentiality in their project.

Actions required for good data management practice

1. Identifying patient data
• Collect only the minimum amount of identifying data to undertake the project?
• Can you justify all the identifying information you are seeking?
2. Data storage
• Store patient identifiable data (electronic and paper) such as initials, date of birth, postcode, hospital number in a way that is unlinked to the clinical data?
3. Data handling
• Make sure the handling and access to the data (electronic and paper) is restricted to only those with direct involvement in the project?
• Be aware of your hospital/research institution policy on storing archive paperwork?
4. Data security
• Make sure that data is secured in a lockable cabinet and room?
• Electronic storage – are the data on a networked computer, if yes who can access this?
• Make sure the data files password protected? These should be changed regularly
• If data is not inputted into the system for more than 10 minutes the screen should revert to screen saver mode
• Make sure electronic data is backed up regularly – at least weekly, preferably daily
5. Risk assessment
• Possible leaks to the data flow system you have put in place should be considered
• Put into place arrangements to deal with confidential data when investigators are on holiday
• Confidential correspondence/data should be shredded at the earliest opportunity
6. Data exchange
• Data exchanged by email or disc should be anonymised. Where this is not the case encryption should be used.

Appendix 7c

Requirements for BPSU Investigators on Data Handling
and Patient Confidentiality

Introduction

Under the agreement with the BPSU, which investigators sign before starting a project, there is a duty to observe general rules regarding confidentiality of information concerning patients. The BPSU asks all investigators handle patient data in accordance with the principles of the Caldicott Committee Report on the Review of Patient-Identifiable Information (attached), those contained in the Data Protection Act 1998 and in the attached BPSU statement.

As part of the BPSU Phase 2 application Procedure and after taking advice from the Patient Information Advisory Group we ask you to complete the questionnaire over leaf in relation to data handling.

Depending on how these questions are answered the BPSU may contact you in order to advise you on how to improve your data handling procedures. You will be required to complete this questionnaire if extensions to the surveillance period are requested.

Please note the BPSU will wish to undertake a yearly review of your data handling procedures and may also undertake a site inspection.

BPSU KEY QUESTIONS REGARDING DATA MANAGEMENT TO BE COMPLETED BY THE LEAD INVESTIGATOR

1. Data registration
• Does you organisation have a data security policy                                             Yes   No
• If yes please supply the names of those responsible
for its maintenance (available from your IT office)

• Is your organisation registered with the Data Protection registry                        Yes   No
• If yes please supply a copy of the registration
(available from your IT office)

2. Data storage
• Identify the type of system and application to be Networked Standalone Laptop
used for information processing

• Mark how the computer(s) will be protected Firewall Password Virus protector

• Are you storing patient identifiable data (electronic and paper) Yes No
such as initials, date of birth, postcode, hospital number in
a way that is linked to the clinical data?

3. Data handling
• Identify those who will be handling and have access to the data
(electronic and paper)
• What is your hospital/research institution policy on storing archive
paperwork?

• How long will the patients identifiable information be retained? (Please provide justification)

• How long will the clinical data be retained?

4. Data security
• Are data secured in a lockable cabinet and room? Yes No
• Electronic storage – are the data on a networked computer, Yes No
if yes who can access this?

• Are the data files password protected? Yes No

• How often are passwords changed?

• How often are electronic data backed up? Yes No

5. Risk assessment
• Have you considered possible leaks to the data flow system Yes No
you have put in place?
• What happens to confidential data/correspondence
when investigators are on holiday?

• Is confidential correspondence/data to be shredded Yes No

• Describe the method of data destruction you will employ when you
have completed your work using patient identifiable data.

6. Data exchange
• Do you intend to pass patient identifiable data to co-investigators Yes No
• If yes do you intend to encrypt the data Yes No

.....................................................................................................

RESEARCH ETHICS

NRES advice

NRES advice is that, "if having considered the published guidance you are unsure whether your project should be classified as research, please seek advice from your R&D office in the first instance." The link is here:

http://www.nres.npsa.nhs.uk/applications/apply/is-your-project-research/?locale=en

MREC contact details

Research Ethics Committee

Multi-centre Research Ethics Committee for Wales

ChairDr Gordon Taylor

CoordinatorCorinne Scott

4th Floor

Churchill House

Churchill Way

Cardiff

CF10 2TW

Coordinator's Tel:029 2037 6829

Coordinator's Fax:029 2037 6824

Coordinator's emailmrec@bsc.wales.nhs.uk

Dr. Corinne Scott

OREC Manager, Wales / Co-ordinator, REC for Wales

Fourth Floor, Churchill House,

17 Churchill Way,

Cardiff CF10 2TW

Tel : 029 2037 6829 / 07766 917109

Fax : 029 2037 6824

E-mail : corinne.scott@bsc.wales.nhs.uk

Website : www.nres.npsa.nhs.uk

Example letter to seek written confirmation from REC for Wales

Dr Corinne Scott

REC for Wales

Fourth Floor, Churchill House, 17 Churchill Way,

Cardiff

CF10 2TW

[insert date]

Dear Dr Scott,

I am planning to undertake a project using anonymised patient data collected via the Welsh Paediatric Surveillance Unit and would be very grateful for advice on whether a full ethical submission is required for my project.

I am currently working at [insert name] Health Board, and my proposed project would collect data on [insert name of condition]. Please find the full proposal and data collection sheet for this project enclosed.

I have used the National Research Ethics Service tool and sought advice from {insert name] R&D Office, and have concluded that this project would fall under the description of Service Evaluation/Outcome Audit. However in order to satisfy Welsh Paediatric Surveillance Unit requirements, I am required to seek a written response from an Ethics Committee before commencing my project.

I hope this is sufficient information to enable you to come to a decision. Please do not hesitate to contact me if you need to know anything further

Yours sincerely,

USEFUL LINKS

NRES Defining Research Leaflet

www.nres.npsa.nhs.uk/applications/guidance/research-guidance/?entryid62=66985

NRES Defining Research Leaflet issue 3

http://webarchive.nationalarchives.gov.uk/20081112112447/http://nres.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=355

Governance arrangements for NHS Research Ethics Committees

www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPoli...