r&d handbook.pdf - noclor

8/10/2019 R&D Handbook.pdf - Noclor

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R&D HANDBOOKNORTH CENTRAL LONDON RESEARCH CONSORTIUM & LONDON

WEST MENTAL HEALTH CONSORTIUM


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FOREWORD

This handbook has been designed to act as a reference point for experienced researchers and offer guidance andsupport to those researchers with little or no experience.

The R&D office provides other support to researchers and this handbook should not be seen as the sole source ofhelp, however, it is a good starting point for any researcher embarking on a study. It provides information on theR&D office and the resources that researchers can tap into and a step by step guide to project registration andobtaining Trust management approval. The book also brings to your attention relevant guidelines such as theHelsinki Declaration, data protection and health & safety.

For those new to research the handbook contains guidance on how to conduct a literature search and writing aprotocol and checklists of things to be done before and during the project.

This book is by no means a comprehensive overview of all the issues that need to be addressed when undertaking

a research project. Further information can be found at the website, http://www.noclor.nhs.uk, which contains a pdfversion of the handbook for researchers to download.

If you have any questions about the research process, or need any other help please contact us at one of theaddresses below:

North Central London Research Consortium London West Mental Health R&D Consortium3rdFloor, West Wing R&D OfficeSt Pancras Hospital THQ, St Bernards Wing

4 St Pancras Way Uxbridge RoadLondon NW1 0PE Middlesex UB1 3EUTel: 020 3317 3756 Tel: 020 8354 8735/8

Website: www.noclor.nhs.uk
http://www.noclor.nhs.uk/http://www.noclor.nhs.uk/http://www.noclor.nhs.uk/


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R&D HANDBOOK

1 INTRODUCTION TO R&D 5

2 THE CONSORTIUMS 6

3 THE R&D OFFICE 6

4 RESPONSIBILITIES OF KEY PEOPLE AND ORGANISATIONS INVOLVED IN RESEARCH 7

6 PROJECT PROCEDURES FLOWCHART 9

7 BEFORE THE PROJECT STARTS 10

The main steps in setting up a project 10

Developing your research idea 10

Resource implications 10

Service manager/clini cal directo r approval 10

Peer review 11

Ethics commit tee approval 11

Appl ication for funding/grant applicat ion procedure for Imper ial Col lege employees 11

R&D Director approval/project initiation 12 Project completion 12

Dissertation 12

Differentiating audit , service evaluation and research 13

Indemnity 15

Consumer involvement 16

Project management and performance 17

Commercial project sorter 19

Commercial research cont racts 20

External regulation of research 21

Checklist of everything to be done before the project starts 22

8 DURING THE PROJECT

Ethical Review 23 Getting informed consent 24

Research consent form 27

Agreement for the donation of blood or t issue samples 28

The Data Protection Act 1998 29

Health and Safety regulations 31

Record Keeping 32

Project auditing 33

Intellectual property rights 34

Research fraud and misconduc t 35

Complaints procedure 36

Checklist of everything to be done during the project 37

9 AFTER THE PROJECT

Presenting your research findings 38

Development of projects 40

Storage of project information 41

Adverse even ts & adverse drug reactions repor ting procedure 42

Checklist of everything to be done after the project 43

APPENDICES

Appendix 1: Factsheet 1 Literature Searching 44

Appendix 2: Factsheet 2 Writ ing a Proposal/Protocol 46

Appendix 3: Factsheet 3 Peer Review 48

Appendix 4: Factsheet 4 Research Passpor ts 49

Appendix 5: Factsheet 5 NIHR Grant Cost ings Flowchart 52

Appendix 6: Declarat ion of Helsink i 53

Useful Contacts list 56


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5

INTRODUCTION

Research and development has traditionally been a part of daily life within NHS Trusts especially teaching

hospitals and those with strong university links. To protect the R&D component within the NHS from 1997 R&Dactivity has been recognised as a distinct body in the allocation of funding, separate from patient care. Moneyallocated has to be properly managed and accounted for.

The Department of Health (DoH) invests in research to support government objectives for public health, healthservices and social care, as well as contributing to the government science strategy, and needs R&D to ensurethat:

Policies for health, health care and social care is based on reliable evidence of needs and of what works bestto meet those needs;

Improved interventions are developed to promote health, treat ill-health and provide social care; Information is available to those responsible for health and social care services on what works and what does

not, and on proven ways of improving quality, access and efficiency.

The NHS R&D Strategy can be found on the DoH website address below:

http://www.dh.gov.uk/en/researchanddevelopment/index.htm

Its aim is to support a knowledge-based health service in which clinical, managerial and policy decisions are basedon sound information about research findings and scientific developments. The research programmes under thisstrategy focus on the needs of the health service.

The research strategy Best Research for Best Health, published by DH in January 2006, set out a 5-year Researchand Development Strategy for the NHS in England. A key component of the strategy included setting up a phasedimplementation of new funding programmes over 3 years starting from April 2006, so that by 2009/10 all NHS R&Dwill be funded through the new National Institute for Health Research (NIHR). To assist Trusts during this period

the Department of Health allocated Transitional R&D Funding to all previous recipients of NHS R&D SupportFunding at reducing levels over this period to enable the NHS to plan for the effects of transition. At the same timethey are awarding and allocating an increasing amount of NHS research funding through the new National Institutefor Health Research (NIHR) research programmes.

R&D in the NHS must maintain high standards, scientific, financial and ethical, transparent decision makingprocesses, and clear allocation of responsibilities and robust monitoring arrangements.

As an organisation the Consortiums recognise the need for a system that allows new ideas and improvements totreatments/services to be tested, evaluated and then put in to practice and R&D funding within both Trusts is usedwith this mind.
http://www.dh.gov.uk/en/researchanddevelopment/index.htmhttp://www.dh.gov.uk/en/researchanddevelopment/index.htmhttp://www.dh.gov.uk/en/researchanddevelopment/index.htm


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6

THE ORGANISATIONS

NORTH CENTRAL LONDON RESEARCH CONSORTIUM & LONDON WEST MENTALHEALTH R&D CONSORTIUMS

The R&D Committees of the Trustshave overall responsibility for the strategic direction, decision making and thealignment of research themes with national, regional and local policy priorities.

The Directors of R&D have executive responsibility for the R&D function, chairing the R&D Committees andreporting on R&D work to the Trust Board. The management of R&D across the trusts is the responsibility of theR&D Directors, Assistant Director and the R&D office.

R&D Office is essentially responsible for ensuring that the core functions of R&D are fulfilled, ensuring that allresearch associated with the Consortium is of high quality, ethically sound and of benefit to the patient.

THE R&D OFFICE

The office provides a number of important functions including:

The collection and collation of essential information about all research within the Trust that involves TrustPatients or uses Trust resources directly or indirectly

Registers all projects on to the R&D database Costs registered projects Administers Clinical Projects Peer Review Groups Ensures procedures for research governance are followed

A particular priority is to ensure researchers have an understanding of the research process when starting aproject. To facilitate this we offer help in:

Writing the research protocol Peer review of the protocol Identification of possibilities for external funding and expert advice (if needed) when submitting a grantapplication Support when submitting to the research ethics committee Costing the project A source of advice and support to enable the researcher to undertake quality research

The office aims to act as a reference point for experienced researchers and offer guidance and support to thoseresearchers with little or no experience.


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KEY RESPONSIBILITIES OF CHIEF INVESTIGATOR, INVESTIGATORS

AND OTHER RESEARCHERS

Develop ethical proposals

Seek ethics committee approval Conduct research to agreed protocol

Submit proposed changes to the protocol to the LREC and research sponsor

Conduct research in accordance with guidance and legal requirements e.g. data protection

Ensure patient welfare while they are in the study

Deliver feedback of results to participants

Ensure controlled trials are registered

Obtain approval from R&D director and appropriate clinical director

Inform care professionals are informed of their patients participation in the study

Ensure research involving a service user, carer or child under the care of the local authority must have arrangements in

place for dealing with any disclosures

Obtain agreement from local authority that the service user can be invited to participate in the study

Ensure each member of the research team has the right experience/qualifications

Make data and documentation available for auditing purposes

Ensure appropriate arrangements are made for archiving data on completion of study

Produce interim reports on progress and outcomes are produced

Disseminate findings of the study to the public and the scientific community

Peer review publications

Conferences

Seminars/workshops

Feedback sheets

Ensure arrangements are in place for the management of resources for the study including intellectual property

RESPONSIBILITIES OF RESEARCH SPONSOR

Ensuring research ethics committee approval obtained

Assuring the scientific quality of proposed research

Quality of research environment where research to take place

Ensuring research team have appropriate skills to undertake the study

Have arrangements in place for the management and monitoring of research

Appropriate arrangements are in place for the registration of trials

Intellectual property rights and their management are addressed in terms and conditions

Written agreement identifying responsibilities of all those involved in research including the sponsor, principal investigator

and care provider.

Systems are in place to alert the appropriate bodies of any significant developments e.g. adverse reaction to medication.

Arrangements for dissemination of findings. Ensuring studies comply with the Research Governance Framework

RESPONSIBILITIES OF RESEARCH ETHICS COMMITTEES

Ensuring that the proposed research is ethical and respects the dignity, rights, safety and well-being of participants

Have clearly defined remits and terms of reference that are consistent with the system of ethics committees established

through the powers of the Secretary of State for Health;

Have clearly defined arrangements for appointing and replacing members;

Have and meet clear performance targets;

Are adequately resourced, supported and trained;

Provide clear and independent advice, within their remit and terms of reference;

Ensure researchers are kept informed of the progress of the study


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RESPONSIBILITIES OF ORGANISATIONS PROVIDING CARE

Retain responsibility for the quality of all aspects of participants care whether or not some aspects of care are part of a

research study.

Be aware and maintain a record of all research work being undertaken through or within the organisation, including

research undertaken by students as part of their training. Ensure patients or users and carers are provided with information on research that may affect their care.

Be aware of any current legislation relating to research work and ensure that these are implemented effectively within the

organisation.

Ensure that all research has been approved by an appropriate research ethics committee.

Ensure that all research has an identified sponsor who understands, accepts and is able to discharge their duties as set out

in this framework.

Ensure that written agreements are in place regarding responsibilities for all research involving an external partner, funder

and/or sponsor, including agreement with the University or other employer in relation to student supervision.

Ensure that the necessary links with clinical governance and best value processes are made.

Ensure that non-NHS employed researchers hold honorary NHS contracts where appropriate and that there is clear

accountability and understanding of who is responsible for what.

Put in place and maintain the necessary systems to identify and learn from errors and failures.

Put in place and maintain the necessary systems to process, address and learn lessons from complaints arising from any

research work being undertaken through or within the organisation.

Ensure that significant lessons learnt from complaints and from internal enquiries are communicated to funders, sponsors

and other partners.

Permit and assist with any monitoring, auditing or inspection required by relevant authorities.

RESPONSIBILITIES OF TRUSTS AND UNIVERSITIESEMPLOYING RESEARCHERS

Compliance with all current employment and health and safety legislation.

Demonstrating the existence of clear codes of practice in other areas for their staff and mechanisms to monitor and assesscompliance.

Ensuring that the principal investigator and/or other research staff are aware of, understand and comply with this

framework.

Discharging their agreed role in the management and monitoring of work undertaken by their organisation.

Demonstrating systems for continuous professional development of staff at all levels.

Having agreements and systems in place to identify, protect and exploit intellectual property.

Ensuring that they are able to compensate anyone harmed as a result of negligence on the part of their staff and, if they

have agreed to do so, for non-negligent harm arising from the research.

Having in place systems to detect and address fraud, and other scientific or professional misconduct by their staff.

Having in place systems to process, address and learn lessons from any complaints brought against their employees.

Permitting and assisting in any investigation arising from complaints received in respect of actions taken by their

employees.


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AFTER APPROVAL Progress Reports, Project

Review and Final Reports Amendments Audi ts Accruals

RESEARCHER Researcher receives letter of

approval from R&D Office tobegin project

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R&D APPROVAL FORPROJECT

Will be signed off by the R&Doffice once all the requirementshave been met by theresearcher

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PROVIDE THENECESSARY APPROVALS Including your ethics approval

letter and any additionalapprovals that may be required,such as NIGB, MHRA CTA andMoJ approvals

8

SUBMIT CONTRACTS For the appropriate funded

studies

6

OBTAIN PEER REVIEW Get your project peer reviewed

and submit to R&D office CRB if needed Research Passport/Honorary

Contract

4

COMPLETE IRAS FORMS For Forms & Guidelines Start filling in IRAS Forms

online athttp://www.myresearchproject.o

rg.uk (and submit ifappropriate)

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HONORARYCONTRACTS/RESEARCH

PASSPORTS Gain the necessary contract to

satisfy NHS organisationalchecks

CRB clearance if needed

3

REGISTER WITH THE R&DOFFICE

By submitting the requireddocuments

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SERVICE MANAGERSSUPPORT

Gain support from theapplicable services for yourstudy by submitting acompleted Feasibility Form tothe R&D office

5

10 STEPS

PROJECTREGISTRATION

NORTH CENTRAL LONDON RESEARCH CONSORTIUM & LONDON WEST MENTAL HEALTH

R&D CONSORTIUM

*CRB = Criminal Records BureauIRAS = Integrated Research Application SystemNIGB = National Information Governance Board for Health and Social CareMHRA CTA = Medicines and Healthcare products Regulatory Agency Clinical Trial AssessmentMoJ = Ministry of Justice

CONTACT THE R&DOFFICE

To confirm funding,

sponsorship arrangements andthe requirements forregistration

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http://www.myresearchproject.org.uk/http://www.myresearchproject.org.uk/http://www.myresearchproject.org.uk/http://www.myresearchproject.org.uk/


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The Trusts suppor t for your research project is conditional on fulfill ing the criteria set out above.

a) Peer review

This process is essentially an assessment of your research proposal by suitably qualified or experiencedreviewers. Below is a list of the areas the reviewer will look at (this is by no means a comprehensive list):

Is the subject original? Is the background to the study adequate? Is the design of the study appropriate? Have the appropriate power calculations been used to determine the sample size? Are the details of the methods clear and consistent? Is the method of selecting the sample clearly described? Is the sample representative of the population being studied? Are the outcome measures, measuring what the study says they are? Are the statistical methods appropriate? Have the appropriate costings been made? Is the timescale realistic (both in terms of time commitment of key researchers and in terms of length of

project)? Is there inclusion of plans to implement findings and dissemination of results?

(see APPENDIX 3 for further details).

b) Ethics Committee approval

All research, which involves the following, will need approval by the Local Research Ethics Committee (LREC):

NHS patients, i.e. those subjects recruited by virtue of their past or present treatment by the NHS includingthose treated under contract with the private sector.

Foetal material and in vitro fertilisation involving NHS patients. The recently dead in NHS premises. Access to records of past and present NHS patients. The use of, or potential access to, NHS premises or facilities (including NHS staff).

It is also important to note that the provisions of the Helsinki Declaration govern all research on humans (seeAPPENDIX 6).

Essentially the role of the ethics committee is to ensure that the welfare and dignity patients and others whoare taking part in research are protected. They will ensure that participants are not tested unnecessarily,misinformed or ill-treated in any way.

At the back of the handbook is a list of contact numbers for all the LRECs that cover the Consortiums.

c) Application for funding

You may at this stage feel that it is appropriate to apply for external funding. The R&D office issue a fundingbulletin monthly which lists all kinds of funding sources including charitable trusts and foundations and NHS

funding schemes. Alternatively you can contact the R&D Office for advice. Funding is usually applied forbefore ethics approval due to time constraints of funding submission deadlines. If this is the case, funding willbe offered by the organisation on the understanding that ethics approval will be applied for and received.

For non-commercially funded research the research costs included in grant applications will need to beapproved by the Trust prior to submission of the application to the funding body, or in the case of universitystaff, prior to the application being signed off by the grants office. Each funding body will have their ownguidelines and procedures for making a grant application. You should ensure that you follow their instructionsclosely when completing and returning your form to maximise your chances of being successful in yourapplication. It is a good idea to check whether the funding body you are applying to has previously fundedresearch in your area of interest. There may be other more suitable sources of funding.

(See APPENDIX 5)

d) R&D Director/nominated person approval project starts


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This is the last stage of project registration. Once the above tasks have been successfully completed the R&DDirector can approve the project and it can be started.

The R&D office will send you written notification to inform you that the project has been successfully approved.

5. Project completion

Proper time management of the project will ensure the project is completed on time and within budget. Duringthe project course the R&D office will monitor the progress of the study (see the section on project auditing).

6. Dissemination

As a researcher you are responsible for ensuring that a wide audience hears the results of your research.There are a number of ways to do this such as conferences, seminars and publications (see the section onpresenting your research findings).


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DIFFERENTIATING AUDIT, SERVICE EVALUATION AND RESEARCH

* Service development and quality improvement may fall into this category.

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RESEARCH SERVICE

EVALUATION

CLINICAL AUDIT SURVEILLANCE USUAL PRACTICE

(in public health)

The attempt to derivegeneralizable newknowledge includingstudies that aim togenerate hypotheses aswell as studies that aimto test them.

Designed andconducted solely todefine or judge currentcare.

Designed andconducted to produceinformation to informdelivery of best care.

Designed to manageoutbreak and help thepublic by identifying andunderstanding risksassociated.

Designed to investigateoutbreak or incident tohelp in disease controland prevention.

Quantitative research:Designed to test ahypothesis.Qualitative research:Identifies/exploresthemes following

establishedmethodology.

Designed to answer:What standard doesthis service achieve?

Designed to answer:Does this service reacha predeterminedstandard?

Designed to answer:What is the cause ofthis outbreak?

Designed to answer:What is the cause ofthis outbreak? andtreat.

Addresses clearlydefined questions, aimsand objectives.

Measures currentservice withoutreference to a standard.

Measures against astandard.

Systematic, statisticalmethods to allow timelypublic health action.

Systematic, statisticalmethods may be used.

Quantitative research -may involve evaluatingor comparinginterventions,particularly new ones.Qualitative research -usually involvesstudying howinterventions andrelationships are

experienced.

Involves an interventionin use only. The choiceof treatment is that ofthe clinician and patientaccording to guidance,professional standardsand/or patientpreference.

Involves an interventionin use only. The choiceof treatment is that ofthe clinician and patientaccording to guidance,professional standardsand/or patientpreference.

May involve collectingpersonal data andsamples with the intentto manage the incident.

Any choice of treatmentis based on clinical bestevidence or professionalconsensus.

Usually involvescollecting data that areadditional to those forroutine care but mayinclude data collectedroutinely. May involvetreatments, samples orinvestigations additionalto routine care.

Usually involvesanalysis of existing databut may includeadministration ofinterview orquestionnaire.

Usually involvesanalysis of existing databut may includeadministration of simpleinterview orquestionnaire.

May involve analysis ofexisting data oradministration ofinterview orquestionnaire to thoseexposed.

May involveadministration ofinterview orquestionnaire to thoseexposed.

Quantitative research study design mayinvolve allocatingpatients to interventiongroups.

Qualitative research uses a clearly definedsampling frameworkunderpinned byconceptual ortheoretical justifications.

No allocation tointervention: the healthprofessional and patienthave chosenintervention before

service evaluation.

No allocation tointervention: the healthprofessional and patienthave chosenintervention before

audit.

Does not involve anintervention.

May involve allocationto control group toassess risk and identifysource of incident buttreatment unaffected.

May involverandomisation.

No randomisation. No randomisation. No randomisation. May involverandomisation but notfor treatment.

Normally requires RECreview. Refer towww.nres.npsa.nhs.uk/applications/apply/for more information.

Does not requireREC review.





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Key discriminants are:

1. IntentThe primary aim of research is to derive generalizable new knowledge, whereas the aim of audit and serviceevaluation projects is to measure standards of care. Research is to find out what you should be doing; audit is tofind out if you are doing planned activity and assesses whether it is working. Some projects may have more thanone intent, in which case a judgement will need to be made on the primary aim of the project.

2. Treatment/service

Neither audit nor service evaluation uses an intervention without a firm basis of support in the clinical or healthcommunity.

3. AllocationNeither audit nor service evaluation allocate treatment or service by protocol. It is a joint decision by the clinicianand patient.

4. RandomisationIf randomisation is used, it is research.

LOCAL ACTION

Research activity should not be undertaken without appropriate ethical (and managerial) approval. Theseguidelines are intended to assist those undertaking projects intended to be an audit to steer clear of the boundariesthat define research. If in doubt, staff should contact the Research and Development Unit for advice. An opinion(where appropriate based on advice from members of the Local Research Ethics Committee) on whether the workto be undertaken should be properly considered by the local research ethics committee or classed as audit (andnot requiring ethical review) will then be provided.


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INDEMNITY

All research involving human subjects carries a potential for harm to the patient. In most cases, the risks arenegligible, but in others, particularly where novel compounds are administered, it is not possible to be sure of theunintended consequences or side effects arising from interactions with other medications.

Indemnity is designed to protect participants in trials. It cannot remove risks but it can ensure that there is someway to deal with the consequences of adverse and unpredictable events arising during research involving humans.Ethics committees will usually wish to know what arrangements are in place to protect research participants. Thepossible forms of indemnity available depend on the sponsorship of the research.

a. NHS indemni tyAll non-commercial projects, whether internally or externally funded are covered by NHS indemnity (insurancecover), provided they have received R&D management approval. If you have not registered your projectwith the R&D Office then you do not have indemnity for your research.

b. Commercial indemnityProjects funded by a commercial organisation eg pharmaceutical company will be indemnified by them.However, an agreement between the Trust and the company signed by the Chief Executive or R&D Director

and a representative of the company, is needed. This indemnifies the Trust against claims and proceedingsarising from the study. The form should be produced by the company, based on the model agreement drawnup by the NHS in consultation with the Association of the British Pharmaceutical Industry (ABPI).

c. Research undertaken by university employeesThe university is able to implement insurance to cover any claims that might arise from patients or theirrelatives who consider themselves harmed by participation in a research project, however it is funded orsupported. All grant or contract negotiations that pass through the university offices are eligible for thisinsurance.

Honorary contract holders may be able to offer this cover to their trial participants by negotiation with the grantsand contracts office.

d. Charity sponsored researchMost major charities have insurance to cover non-negligent harm arising from research participation. They canproduce copies of insurance certificates should these prove necessary.

e. Research Counci l or Government sponsored researchAs public bodies, these organisations are prevented from insuring against non-negligent risks. They usuallyoffer to do their best to overcome the effects of harm caused by research participation but cannot issue anyguarantees.

f. Research undertaken by Trust employeesTrusts cannot insure against non-negligent harm, nor can they offer to deal with any claims that arise otherthan by the standard complaints mechanisms. Patients involved in a trial run by Trust employees, withoutcharity or commercial funding, receive very little assurance other than that their adverse responses will be

treated as competently as possible.


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CONSUMER INVOLVEMENT

Involving consumers in the research process has become an important part of NHS R&D strategy. This means notonly including consumers/patients as the subject of research but making them part of the whole process. Theyshould be involved at each stage of the process: from determining what kind of research should be carried out to

disseminating the results.

The benefits of consumer involvement are:

The research may be more relevant and reliable because service users are involved.

Consumers may have knowledge and expertise which can improve the research.

Involvement will enhance consumers understanding of research and its potential benefits to patient care.

As a researcher you should be thinking about whether consumer involvement would be appropriate when you aredeveloping your research idea. However, there should only be consumer involvement where it would be a potentialbenefit to the research.

Examples of how consumers can be invo lved in research

As members of project steering groups advising on the design, process and dissemination of research.

Determining the focus of research topics or questions.

Undertaking interviews particularly interviewing other service users.

Contributing to data analysis

Reviewing consent forms, information sheets, questionnaires and reports.

If you are applying for an NIHRgrant please contact the Research Design Service (RDS) London User

Involvement Officer for more information:

Carol Porteous, User Involvement Officer, RDS London, 7th Floor Capital House 42 Weston Street, London SE1

3QD | [email protected]| 020 7848 6763
mailto:[email protected]:[email protected]


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PROJECT MANAGEMENT AND PERFORMANCE

The next stage in planning your research project should be to identify which resources you will require to carry theproject out, and how to manage those resources. This will make it easier for you to complete your project on timeand within your budget limits. It will also enable your progress to be monitored more effectively.

Time managementThe first step in planning the use of resources should be to organise your time. The best way of starting thisprocess is to create a project timetable or milestone chart. This will include the key targets and milestones whichyou are intending to achieve during the course of your project. To produce the timetable or chart you should:

List all the activities involved in carrying out your research. For example, data collection, application for ethicsapproval, etc.

Discuss and agree your milestones and targets with other colleagues involved in the project.

Agree on a realistic deadline with colleagues for the completion of each activity. For example, four weeks toanalyse the data.

Below is an example of a basic chart:

Activi ty Approximate number of weeks

1. Produce a questionnaire 8

2. Obtain ethical approval 6

3. Draw a sample population 8

4. Recruit patients and obtain consent 14

5. Obtain pre-intervention data 4

6. Collect post-intervention data 4

7. Code and enter data 4

8. Analyse data 6

9. Write up the project 10

StaffingCompiling your activity list will help you identify which activities will need to be carried out by other members ofstaff. For example, you may decide that you need staff who have specific skills and experience in those activities,e.g. setting up a new database, taking blood samples.

Once you have done this, you should find out if there are any existing members who already carry out these tasksand who can be contracted to do extra work for your project, or whether you will need to recruit people specificallyfor these tasks.

Staffing should be discussed with your colleagues on the project before any decisions are made.

Recruitment of staff will depend on the amount of funding available, so you must make allowances for all the costs

involved in employing someone. Funding availability will also affect the length of their contracts, as well as theterms and conditions.

If you are going to employ staff, the next step should be to write a job description. This should comprise an outlineof the job, the responsibilities involved, and the qualifications and experience required. If you are unsure about anyof the legal aspects of employing a member of staff, then it would be advisable to contact someone in your

Personnel department.

Budget managementBudget management plays a vital part in the successful completion of your project. There are a number of ways ofachieving this, depending on how complex your project is. For example, you may decide that you need a tailor-made software package, or a spreadsheet package like Excel. A budget plan, however, may be the most

appropriate method for many projects.

Your first step should be to list all the activities involved in the project together with your estimates of how muchshould be spent on each activity. You should also include the actual funding which you have received, as there


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may be a discrepancy between the funding requested and the funding obtained. Costs may also have changed inthe time between making your estimates and receiving funding.

Each time you commit expenditure, for example order a piece of equipment, you should record this against thebudget available. When the equipment is received, the actual amount paid for it should be compared against thesum committed, and adjusted if necessary. This will provide you with a record of the budget, commitments andactual expenditure. Below is an example of a simple budget control plan for one year (overspends are shown inbrackets):

Date Item Budget

Cost

Balance

Salaries

01/04/01-31/03/02 Salaries 30,000

28,000 2,000less than expected

Capital

30/04/01

01/06/01

Computers

Printers

2,000

-

1,500

550______

2,050 (50)spent over budget

Consumables

01/04/01-31/03/02

01/04/01-31/03/02

Photocopying

Postage

150

100

200

120

(50)spent over budget

(20)spent over budget

Overheads

01/04/01 Overheads 3,200

3,200 on target

TOTAL 35,450 33,570 1,880

Using a budget control plan as above will help you to organise your budget under specific budget areas. Thebalance of 1,880 in the above plan can now be transferred to Year 2 of the project. When planning the nextyears budget, allowances should be made in the costings for price changes. Your Finance department may alsohelp with budget management.

Project reviewPart of the project management process should be a review of the progress and resources of a project, using theoriginal project plan as a yardstick. This will make it easier for you to spot any problems and to take action morequickly.


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COMMERCIAL PROJECT SORTER

1. Is the project a phase II or phase III or IV trial of a new

treatment or procedure?

NO YES This is a commercial project and the Trustis obliged to recover the full cost ofhosting the research.

2. Is the project a phase I/II study with IP and publicationrights held by the sponsor?

NO YES This is also a commercial trial and Trustcosts must be recovered.

3. Is the project a phase I/II study with IP and publicationrights held by the PIs employer?

NO YES Not commercial for costing purposes butstill requires indemnity from sponsor.

4. Is the project a contribution in kind of medication orequipment to a project sponsored by another party?

NO YES Not commercial but indemnity needed

from supplier to cover the application oftheir product.

5. Is the project a donation to research funds or salaryfor research staff w ith no added strings o r undue obligations?

NO YES Not commercial, normal registration rulesapply.

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COMMERCIAL RESEARCH CONTRACTS

If you have a commercial research contract, you must also comply with the following:

RegistrationAll commercial projects must be registered by the Trust.

Approval The Trust has to be satisfied that the commercial contract offers sufficient cost recovery for the Trust, offers nothreat to critical services, has low risks or adequate compensation mechanisms for treating adverse events,and there are no hidden costs, before a project can be approved.

Record keeping There are extra requirements for commercial research. Case report forms (CRFs) for each patient act as thetrigger for payments. The standards of record keeping required are very high and form part of mostcommercial research contracts.


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EXTERNAL REGULATION OF RESEARCH

In spite of the internal review mechanisms, it is essential to register projects with the appropriate authority and havetheir permission to proceed.

The regulatory body which is most likely to affect your research is the Medicines and Healthcare ProductsRegulatory Agency (MHRA). They regulate unlicensed drugs used for research. They can be contacted at:

Medicines and Healthcare Products Regulatory Agency (MHRA)tel: 020 7084 2000 (weekdays 0900 1700)website: www.mhra.gov.uk

For anyone new to working with this body, the best approach is to seek advice from colleagues already familiarwith their ways of working.

You should still complete the other parts of the registration process while you are waiting for external regulatoryapproval.
http://www.mhra.gov.uk/http://www.mhra.gov.uk/http://www.mhra.gov.uk/


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CHECKLIST OF THINGS TO BE DONE BEFORE THE PROJECT STARTS

Develop your research idea

Conduct a literature review

Choose an appropriate research method

Seek statistical advice

Write a research proposal

Obtain management approval

Complete relevant forms

Get the project peer reviewed

Obtain ethics approval

Apply for funding if appropriate and send a copy of the grant application to the R&D office

Ensure there are clear arrangements for project management

Think about ways to report your findings

Ensure your project is covered by the Trusts insurance or commercial organisation where appropriate


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ETHICAL REVIEW

All proposed research that involves patients, their samples or data must be reviewed and cleared by a localresearch ethics committee (LREC) before work can commence. Even if you have approval from a MulticentreResearch Ethics Committee, local authorisation is still required.

Review and clearance are also required for research that seeks data from Trust employees in the form of a surveyor questionnaire.

At the moment, active steps are underway to harmonise the actions and processes of ethics committees, but in themeantime local rules still apply. Every local committee has its own application form, guidance notes and scrutinyprocess, and you will need to be familiar with each of these.

Which committees you apply to will depend on where you are conducting your research. There are threecommittees which carry out ethical reviews of research which comes under the auspices of the London WestMental Health R&D Consortium. These are:

Ealing LREC

(Contact Alene Pointon on 020 3311 7255)

Riverside LREC(Contact Atul Patel on 020 3311 7282)

St Marys LREC(Contact Rosalind Cooke on 020 3311 7251)

There is one committee which carries out ethical reviews of research under the auspices of NoCLoR:

Camden & Islington LREC(Contact Katherine Ouseley on 020 7794 0500 ext. 36906)

If you are unsure about which LRECs to apply to (you may need to apply to more than one), contact the R&DOffice who will be able to advise you.

Please inform the R&D Office about the outcome of your application(s) for ethics committee approval.


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GETTING INFORMED CONSENT

To obtain their written informed consent, you must ensure that participants have as much relevant information aspossible about the study before signing the consent form. This should be done by speaking directly to participants,

as well as providing them with an information sheet. Participants should be given sufficient time to decide whetherto give their consent. You will be asked to explain what you have done to ensure informed consent as part of yourapplication to the LREC.

Below is a checklist of points to remember when seeking consent:

(Questions marked with the symbol [*] apply to research in patients only.)

Have you given the participant an verbal explanation of the proposed research project? Have you given the information sheet to the participant? Have you told the participant that he/she will be kept informed of all relevant information which becomes available during

the course of the study? Did your verbal explanation to the participant include:

~ That this is a research project?~ Participation is voluntary?~ The aims of the project?~ The likely duration of the participants involvement?~ The expected benefits to the participant* and/or others?~ The expected nature of the drug, device or intervention being tested?~ The procedures which will be involved in participation?~ That the participant may instead receive a reference treatment or placebo?~ What alternative standard medical therapy is available?*~ What risks

1, inconvenience, discomfort or distress may reasonably be anticipated for this participant: the level and the

likelihood?~ That there may be some unforeseen risks?~ That a refusal to participate may be given without reasons and will not affect the care which will be given to the

participant*?~ That the participant may be withdrawn from the study if the investigating physician considers this is necessary in the

best interests of the participant?~ That personal information may be scrutinised during audit by competent authorities and properly authorised people, but

all personal information will be treated as strictly confidential and will not be made publicly available?~ That information generated by the study may be published but that no details will be divulged from which the

participant could be identified?~ That some information will be retained for a period after the end of the trial?~ What compensation arrangements are available?~ Whom to contact in an emergency and how?~ What activities if any must be avoided during participation (e.g. driving, operating machinery, drinking alcohol, sport,

pregnancy, breast feeding), after participation (e.g. blood donation, participation in another trial) and for what period?

1Healthy volunteers should know all, even remote, risks. Patients should as a minimum be made aware of all material

risks.

Has the participant given authorisation to approach his/her GP and for permission for the GP to disclose medicalinformation?

Is or has the participant been involved in any other research studies? Is or has the participant recently been taking, or does he/she intend to take, any other medicines or preparations? Have you allowed the participant sufficient time to consider the matter on his/her own, to discuss with others if wished, or

ask you questions? In your opinion, has the participant understood and consented to take part in this research?

Vulnerable groups

Research into mental health may involve participants who have difficulty in giving informed consent. You will beasked by the LREC to explain what special arrangements you have made to deal with their consent, and whatsteps will be taken to ensure an appropriate level of understanding is achieved. For more advice, please contactyour LREC.


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Non-English speaking participants

If your research involves groups who may have particular difficulties in the use of English, you must take specialmeasures to ensure their informed consent, for example by providing a patient information sheet in their mothertongue. For more advice, please contact your LREC.

Consent for use of t issue and other bodily materials

You should use a separate consent form for the use of patients tissue and other bodily materials. You should alsoseek guidance from your LREC on consent for their use and retention.

Writing a patient information sheet

The sheet should be written in clear, non-technical language and be easily understood by a lay person. It shouldcontain information under the headings below. Remember to include an invitation paragraph at the beginning, andto thank patients for agreeing to take part in the study. This is a summary of the information provided by LRECs.For more comprehensive information, please contact your LREC.

Study title ~ include a simplified title if the original title is not self-explanatory. The patient information sheet should be

dated and given a version number.

What is the purpose of the study? ~ describe the aim and background of the study.

Why have I been chosen? ~ explain how the subject was chosen and how many other subjects will be studied.

Who is organising the study? ~ indicate, where appropriate, the organisation/company sponsoring or funding the study,and the study duration.

What will happen to me if I take part? ~ indicate how long the patient will be involved in the study, how often they willneed to visit a clinic and the duration of visits, if reasonable travelling expenses will be paid where appropriate, what exactlywill happen (e.g. blood tests, X-rays, interviews, etc), if their diet will be restricted, if they will be able to drive, etc.Whenever possible you should draw a simple flowchart or plan indicating what will happen at each visit. What are thepatients responsibilities? Set down clearly what you expect of them. Give simple explanations of the research methods

(randomised trial, blind trial, crossover trial, placebo).

What i s the d rug/device? (if applicable) ~ include a short description of the drug or device and its stage of development.Give patients in drug trials a card with details of the trial, for them to carry at all times.

Are there other ways of t reat ing my condit ion? ~ tell patients what alternative treatments are available.

Are there any disadvantages in tak ing part in this study? ~ explain any likely known side effects to the subjects. If theysuffer these or any other symptoms, they should report them to you when you next meet. Give them a contact number tophone if they become concerned.

What are the possible risks of taking part? ~ list known side effects using simple, understandable terms. For anunlicensed drug, explain that there may be unknown side effects. For studies where there could be harm to an unborn childif the patient was pregnant or became pregnant during the study, explain that pregnant women or those planning pregnancymust not take part, and a pregnancy test will be carried out before the study. Women who could become pregnant during

the study should use effective contraception. In certain circumstances, however, it would be inappropriate and insensitiveto bring up pregnancy (e.g. in the case of terminal illness). Men should be warned if a treatment could damage their spermwhich could lead to the risk of a damaged foetus. If insurance status could be affected by taking part in the study, explainto patients with private medical insurance that they should check with the company before agreeing to take part in thestudy. State what happens if you find a condition of which the patient was unaware. Is it treatable? What are you going todo with the information? What might be uncovered?

What are the possible benefits of taking part? ~ do not exaggerate the possible benefits to the particular patient duringthe course of the study, e.g. by saying they well be given extra attention, as this could be seen as coercive. Explain thatyou hope the treatments will benefit their particular condition but that this cannot be guaranteed, and that the informationfrom the study could help you treat future patients with this condition more effectively. Let patients know if the treatment willnot be available to them after the study. If there is no clinical benefit to the patient, tell them that they will be informed ofany important new information which might affect their willingness to continue taking part. Explain that you will withdrawthem from your study if at any time you consider it in their best interest, and give them the reasons why. Tell them that

arrangements will be made for their care to continue.

Is my doctor being paid for including me in the study? ~ this means payment other than that to cover necessaryexpenses (e.g. laboratory tests arranged locally by the researcher). You could say that the sponsors of the study will pay


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the hospital department or research fund for including the patient in the study, or that the patients doctor will be paid forincluding the patient in the study.

What happens when the t rial stops? ~ inform patients of any treatments which will be available to them once the trial isover. They should also be told if they will no longer have access to the study drug.

Are there any restrict ions on what I might eat or do? ~ tell patients about any dietary restrictions and any medications tobe avoided, as well as whether they should avoid giving blood.

What if something goes wrong? ~ where there are no ABPI (Association of the British Pharmaceutical Industry) or otherno-fault compensation arrangements, and the study carries risk of physical or significant psychological harm, patientsshould be informed that there are no special compensation arrangements if they are harmed during the study, but if theyare harmed due to someones negligence, they may have grounds for legal action. Patients should be told that they havethe normal NHS complaints mechanisms available to them, if they want to complain about any aspect of the way they havebeen approached or treated during the study. Where there are ABPI or other no-fault compensation arrangements, youshould let patients know that compensation for any injury caused by taking part in the study will be in accordance with theguidelines of the ABPI, and that guidelines are available on request. You also need to consider how complaints are goingto be dealt with, as well as distinguish between complaints from patients about treatment by staff and something like areportable serious adverse event.

Confidentiality who will know I am taking part in the study? ~ obtain the patients permission to allow restrictedaccess to their medical records and to information collected about them during the study. Explain that all information

collected about them will be kept strictly confidential. For drug company sponsored research, inform patients that theirmedical records may be inspected by the company sponsoring (and/or the company organising) the study for the purposeof analysing the results. They should also be told that their records may be looked at by people from the company andfrom regulatory authorities to check that the study is being carried out correctly. Advise patients participating in drugcompany sponsored research that otherwise their name will not be disclosed outside the hospital/GP surgery. For otherresearch, patients should be told that all information which is collected about them during the research will be kept strictlyconfidential, and that any information about them which leaves the hospital/surgery will be anonymised so that they cannotbe recognised from it.

GP Notification ~ for studies not conducted by a GP, explain to the patient that their GP will be notified of their participationin the trial. You must seek the patients agreement to this. In some instances, agreement from the patient that their GPcan be informed is a precondition of entering the trial.

LREC Approval ~ give the name of the Local Research Ethics Committee which approved the study.

What will happen to the results of the study? ~ what arrangements have been made to inform the patients about theresults of the research? Where can they obtain a copy of the published results? Will they be told which arm of the trial theywere in?

Contact for further information ~ you should give the patient a contact point for further information. This can be yourname or that of another doctor/nurse involved in the study. You should also give them the name of an independentperson, ie someone who is not involved in the study.

Consent forms

Your consent forms should be written in simple, non-technical language on your organisations headed paper. Onthe following page is an example of a general consent form as well as one for the donation of blood or tissue

samples:


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RESEARCH CONSENT FORM

Version Number:

Title of Project:

Name of Researcher:

(The patient should complete the whole of this sheet himself/herself) Please circle YES or NO

Have you read the patient information sheet? YES NO

Have you had the opportunity to ask questions and discuss the study? YES NO

Have you received satisfactory answers to all your questions? YES NO

Who have you spoken to?

Do you understand that your participation is voluntary,

and that you are free to withdraw from the study:at any time; without having to give a reason;without affecting your future medical care, or legal rights?

YES NO

Are you willing to allow access to your medical records? YES NO

Have you been told that strict confidentiality will be maintained: YES NO

Do you agree to take part in this study YES NO

Name of patient date signature

Name of person taking consent date signature(if different from researcher)

Researcher date signature

27


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AGREEMENT FOR THE DONATION OF BLOOD OR TISSUE SAMPLES

Please circle YES or NO

Have you been told how your blood or tissue samples will be used YES NO

For research? YES NO

For teaching? YES NO

To develop commercial diagnostic or therapeutic agents? YES NO

For other reasons? (please describe)

Who have you spoken to? (write name)

Do you understand that if you do not want your samplesto be used for these purposes you are free not to sign this form,and this will not affect your medical care?

YES NO

Do you agree to donate any blood or tissue samples takenduring the course of your treatment under the direction of:

(Consultants name) ? YES NO

Do you agree to assign all right, title and interest in these samples to:

(Organisations name) ? YES NO

Name of patient date signature

Name of person taking consent date signature(if different from researcher)

Researcher date signature


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THE DATA PROTECTION ACT 1998

Anyone processing data about other living individuals must have a clear legal purpose for doing so. The

processing must be fair to the individual and they must be kept informed of the collection, use and distribution oftheir personal data, and in some cases, their express consent is necessary. Individuals have certain access rightsto their personal data, whether its stored electronically or as written records in structured files. All processing ofpersonal data must be registered. Please contact your Data Protection Registrar/Officer for advice (see below fordetails).

Complying with the Act

You must ensure that all data:

is obtained and processed fairly and lawfully; is processed only for specific legal purposes; is adequate, relevant and not excessive for those purposes; is accurate and kept up to date; is kept safe from unauthorised access, accidental loss or destruction; is processed in accordance with the rights of Data Subjects; is not transferred outside the European Economic Area without due safeguards unless the Data Subject has

given their consent.

Sensitive personal data

Sensitive personal data must normally be processed only with the Data Subjects explicit consent. The Act definessensitive as information, facts, intentions or opinions relating to the racial or ethnic origin of the Data Subject, theirpolitical opinions, religious beliefs, membership of a Trade Union, physical or mental health, sex life, commission oralleged commission of any offence. Where sensitive personal data is processed for research purposes, explicitconsent is not required if the results of the research are not used to take decisions about that person, and no

substantial damage or distress is likely to be caused to that person by processing those data.

How will the Act affect the way I do research?

Where personal data is used for research purposes, there should be an adequate review before processing, toensure that the requirements of the Act are being met.

Data Subjects whose personal data is to be used in research should be fully informed that their data will beused in this way, and for what purposes.

With a few exceptions, Data Subjects have a right to object to the processing of their personal data where theycan establish that this processing would cause them significant damage or distress.

Particular care should be taken when the processing involves sensitive personal data as the Act lays downspecific conditions for this.

Processing of personal data which has been coded or anonymised, but for which links to a person can still be

made by reference to a key to the code or to other identifiers, is still subject to the Act. The Act applies equally to written records held in a structured filing system, microfiche records and video

recordings as well as to computerised records. Reviews must be made of the processing to ensure that compliance with the Act is being maintained at least

annually. In whatever form personal data is held, it should be kept securely with the level of security dependent on the

sensitivity of the personal data.

Are there any cases where I dont need to comply?

The following exemptions only apply to data used for research purposes:

Personal data may be processed for purposes other than that for which it was originally obtained, if the

processing does not lead to decisions being made about an individual, eg prognosis or treatment, and is notlikely to cause substantial damage or distress to any individual. That data may also be held indefinitely.

Where the results of processing personal data for research purposes do not identify a data subject, that datasubject does not have a right of access to that data.


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Unless other living individuals can be identified from the processing of data about individuals who are no longerliving, it is exempt from compliance with the Act and this processing does not have to be registered.

Personal data which is anonymised is also exempt from compliance with the Act and the registration process.This exemption applies only where there can be no processing which could link the data to a specific individual,eg by reference to an identifier; coded data is not exempt from compliance or registration.

Confidentiality

If you are going to examine a patients medical records as part of your research, you must reassure them that onlyinformation directly relevant to the study will be extracted, and that it will be used strictly for research purposes.The patient should also be told that only study personnel will have access to this information. Special precautionsare needed when using audio or video recording to ensure confidentiality and anonymity.

Record keeping

All documentation, forms and any other research information must be kept in a secure place. It is also stronglyadvised that you keep a log book of your work during the research project. All research information must beavailable for future auditing purposes.

Getting more information and advice

More information and advice on data protection can be obtained from:

NoCLoR R&D Office WLMHT R&D Office020 3317 3756 020 8354 8738http://www.noclor.nhs.uk/Default.aspx?tabid=112

Your LREC can also give guidance on data protection issues.
http://www.noclor.nhs.uk/Default.aspx?tabid=112http://www.noclor.nhs.uk/Default.aspx?tabid=112http://www.noclor.nhs.uk/Default.aspx?tabid=112


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HEALTH AND SAFETY REGULATIONS

Health & Safety regulations cover all aspects of the working environment. As a researcher you may also

encounter particular hazards during the course of your research. It is important that you are aware of thesehazards and take precautions to prevent them. Your manager or supervisor will have a copy of your departmental Health & Safety policy which will have

detailed regulations affecting your own particular working environment. You should be familiar with this policy,as well as the general Trust Health & Safety policy.

Complying with the regulations

Under the direction of your manager or supervisor you must ensure that you follow all safety instructions and:

take reasonable care for the health & safety of yourself and of others who may be affected by your acts oromissions at work;

not intentionally or recklessly interfere with or misuse anything provided in the interests of health, safety or

welfare; enable the employer to exercise their duty of care; co-operate with the Trust in ensuring that procedures for safe working practices are observed; familiarise yourself with the Trust and departmental Health & Safety policies, and any supplementary

documents produced by management, by participating in various forms of appropriate training provided; observe safety rules at all times; wear the appropriate safety equipment and use appropriate safety devices where applicable; report all hazards to your manager; report immediately to your manager all accidents or dangerous occurrences and damage regardless of whether

persons are injured or not; be aware of the preventative measures you can take to minimise the risk of fire and what to do on discovering

a fire and on hearing the fire alarm.

Are there any special precautions I should take?

This is an indication of some of the precautions which researchers in particular should take. You should consultyour departmental Health & Safety policy for more comprehensive information.

Anyone working within the Forensic Services is to be aware of the hazard that exists due to locked fire exits atthe respective sites/hospitals.

Safety instructions must be followed when using potentially hazardous materials. All potentially hazardous materials must be stored correctly. Any equipment used must be done so correctly and according to the operating instructions. All equipment must be stored correctly. Any broken equipment must be reported. Hygiene requirements must be adhered to.

Anyone working in the community with clients should be aware of the risks.

Getting more information and advice

More information and advice on health & safety can be obtained from:

NoCLoR R&D Office WLMHT R&D Office020 3317 3756 020 8354 8738


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RECORD KEEPING

It is essential that if separate records are kept that this be explicitly signposted in the main record. Your clinicalcolleagues and records staff must be able to access all parts of the clinical record. On balance, you are advised

very strongly not to keep separate records.

Maintaining Separate Clinical and Research Records

For trials of medicines, investigators must keep records of clinical information according to Good Clinical Practicestandards. The Medicines and Healthcare products Regulatory Agency (MHRA) recommends that a trial protocolspecify which clinical events are to be recorded in the clinical notes as well as on Case Report Forms. Theresearch records enable research teams to assess which adverse events to report to the MHRA and the ethicscommittee and to make the safety reports required by law.

Guidance recommends that other clinical research not covered by the clinical trials regulations should also observethe internationally recognised principles of Good Clinical Practice. One of these is that all clinical trial informationshall be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification.While the Care Record Service aims to drive up the quality of routine healthcare records, at present these do notmeet all the requirements for research records. You should therefore use properly maintained and approvedseparate research records but again ensure that vital information about the patients clinical condition, treatmentand special characteristics (e.g. allergies) is replicated in the main, formal care record.

People give consent to take part in research separately from their consent to treatment. Research may revealmedical information about a research participant that is not known to the treating clinicians. It is for that person todecide whether the researchers should disclose the medical information to clinicians for incorporation in medicalrecords. This is because researchers owe research participants a duty of confidentiality separate from theconfidential relationship between patient and clinician.

Guidelines do allow sponsors and investigators to take urgent safety measures in order to protect the subjects of aclinical trial against any immediate hazard to their health or safety. However, doctors may have a duty ofconfidentiality to a trial participant that could conflict with the duty to ensure that the clinical notes contain allinformation that might be relevant to the patients care. This situation is most likely if the doctor is an investigatorbut not the treating clinician. To avoid this, I recommend that trialists consider routinely including consent to thissort of disclosure in the patient information sheet. I have indicated further guidance below.

Acting as an Expert Witness

The Crown Prosecution Service (CPS) and the Association of Chief Police Officers (ACPO) have publishedguidance for expert witnesses entitled Guidance Booklet for Experts. This sets out obligations that apply to allexperts in criminal cases, which can be summarised in the key actions of retain, record and reveal. You shouldalso be aware of other advice that is available on information disclosure and acting as a professional witness.Details of these and the CPS/ACPO guidance, with weblinks, can be found below:

CPS/ACPO Guidance Booklet for Experts

Confidentiality: NHS Code of Practice, November 2003, sets out the policy and principles governing access topatient information, and obligations and standards governing its use.

GMC guidance: Good Medical Practice sets out the duties of doctors, including record keeping. Acting as an expertwitness explains how the principles set out in Good Medical Practice apply to the work of the medical expertwitness. 0-18 years: guidance for all doctors refers specifically to childrens confidentiality.

Research records: The MHRAs guidance
http://www.cps.gov.uk/publications/docs/experts_guidance_booklet.pdfhttp://www.cps.gov.uk/publications/docs/experts_guidance_booklet.pdfhttp://www.cps.gov.uk/publications/docs/experts_guidance_booklet.pdfhttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4069253http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4069253http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4069253http://www.gmc-uk.org/guidance/ethical_guidance/index.asphttp://www.gmc-uk.org/guidance/ethical_guidance/index.asphttp://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinical%20Practice/Frequentlyaskedquestions/index.htmhttp://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinical%20Practice/Frequentlyaskedquestions/index.htmhttp://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinical%20Practice/Frequentlyaskedquestions/index.htmhttp://www.gmc-uk.org/guidance/ethical_guidance/index.asphttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4069253http://www.cps.gov.uk/publications/docs/experts_guidance_booklet.pdf


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PROJECT AUDITING

The R&D Office will audit 10% of research projects a year. If your project is audited, a member of the R&D Office

will come and talk to you about it. They will also want to see your research files and log book. The audit isintended to be supportive to the researcher, but it is also designed to ensure the following:

Consent forms match the number of participants Informed consent has been obtained from the participants Ethics approval has been obtained The project is properly supervised Good records are kept All research documentation is kept in a central file Participant confidentiality is safeguarded Any changes to the protocol have been approved Any critical incidents/adverse events have been reported If you are not employed directly by the Trust that you have an honorary contract

Interim report

As well as the random audit of some projects, all researchers will be asked to complete an interim report roughlyhalfway through the course of their project. You will be asked to provide information on the following:

Title of study Summary of major achievements Milestones for the coming year project plan Introduction to the project Whether the project has started and when it started Number of patients recruited (proposed/actual) Number of patients completing study (proposed/actual) Number of patient withdrawals because of:

~ Lack of efficacy~ Adverse events~ Self-withdrawal~ Non-compliance~ Other

Whether there have been any untoward events Whether any untoward events have been notified to the R&D Office Whether there have been any obstacles or delays in the project Whether there have been any amendments to the study Whether these amendments have been notified to the LREC Whether the study has finished Summary of current findings Whether the findings have been disseminated, or how you plan to disseminate them Publications

Submitted conference presentations

Update form

You will also be sent a yearly update form which will ask for basic information on all your current research projects,as well as your contact details and any publications or research in press.


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INTELLECTUAL PROPERTY RIGHTS

What is Intellectual Property (IP)?

Intellectual property is the product of creativity that is unique and novel and which has an owner, such as inventions, ideas,computer software, processes, data or written work.

What is Intellectual Property Rights (IPR)?

These are the legal rights, which allow the owners of items of IP to exercise control over the exploitation of these rights. Itmeans the owners can prevent other people taking advantage of their IP. The main purpose of R&D in the NHS is to promoteevidence-based practice and policy within the organisation; central to this is that R&D funded by the NHS must be widely andeffectively disseminated. Sometimes NHS funded R&D not only produces results that add to the evidence, but also results thatcan also be commercially exploited, which will benefit the NHS and patient health care in general. It is the responsibility of theNHS to help ensure that the IP is properly managed and exploited; ownership of IP normally rests with those best able to exploitit, generally the organisation carrying out the R&D.

NoCLoRs Intellectual Property Rights Policy can be found here.

If you have any queries or would like more detailed information about IP or IPR please contact Angela Williams on 020 33173765 or email [email protected]
http://www.noclor.nhs.uk/Portals/0/IP%20Policy%20Version1.docmailto:[email protected]:[email protected]://www.noclor.nhs.uk/Portals/0/IP%20Policy%20Version1.doc


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RESEARCH FRAUD AND MISCONDUCT

Research fraud

The Trusts expect you to demonstrate the scientific integrity of your research. Research projects are subject toa random audit, so you will be required to show that all your data records and consent forms are in order.

It is in your interests to ensure that the conduct of your research is as transparent a process as possible, bykeeping a project logbook or diary for example. This will make any accusations of fraud less likely.

Should evidence of fraud be found during the audit, the Trusts will take action in line with its disciplinaryprocedure. A full copy of the Trusts Disciplinary Procedure can be obtained from the R&D Office.

Misconduct

All employees of the Trusts are required to abide by the Code of Conduct below:

Whilst work ing for the Trusts, each member of s taff is expected to:

1. Respect the rights and dignity of those people who look to us for services.

2. Accept and abide by the principle that each and every individual within the Trusts will be accorded equal opportunity(ies)and that any discriminatory practice, sexual or racial, harassment, or bullying will not be tolerated.

3. Demonstrate their personal commitment to the Trusts philosophy and purpose and undertake the work which they areexpected to do, to the best of their ability, and to the satisfaction of the Trusts.

4. Work in a collaborative and co-operative manner with all Trusts personnel; be responsive to any emerging difficulties andpositive towards solutions.

5. Participate in mandatory training sessions and demonstrate a willingness to develop and apply new skills.

Working at the Trusts require all staff to support and honour rules and practices to ensure a safeenvironment for patients, staff and visitors. Each member of staff must:

6. Rigorously abide by the Trusts security rules, procedures and codes of practice and to report promptly any untowardincidents involving staff or patients.

7. Maintain the confidentiality and integrity of all the Trusts activities and not disclose to the media, or any other agency, anyinformation that breaches security or compromises patient confidentiality.

8. Demonstrate a shared responsibility for and observance of policies and procedures relating to Health & Safety and EqualOpportunities.

9. Rigorously abide by the Trusts Financial Regulations, Standing Orders, Standing Financial Instructions and Fraud and

Corruption Response Plan so far as they apply to individual work in the Trust.

10. Observe and comply with other Trust procedures and policies so far as they affect individuals work.

As an employee, each member of staff i s expected to :

11. Maintain their registration to practice with their professional body, if applicable, and to act in accordance with that bodyscode of professional conduct.

12. Recognise their wider role as responsible members of society so that personal conduct does not affect performance at worknor bring the Trusts reputation into disrepute as a result.

13. Declare, in writing, to their manager any local government officer membership, any conflict of interest including theinvolvement of any partner or family member with any of the Trusts current or future contracts.

14. Decline any gifts, inducements or inappropriate hospitality in accordance with NHS Standards of Business Conduct.

Breaches of this Code of Conduct may result in disciplinary action. Details of behaviour which constitutesmisconduct can be found in the Trusts Disciplinary Procedure.


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COMPLAINTS PROCEDURE

If your research project involves patients, you may have to deal with a complaint from a patient, their relative,friend, visitor, solicitor, the MHAC or an advocate.

Dealing with complaints in the first ins tance

Patients should be encouraged to raise issues of dissatisfaction or concerns at a local level in the first instance,and to be provided with a safe environment in which to do this. Responding to, and resolving complaints isbest carried out wherever possible on the spot, by the person receiving the complaint, swiftly and close to thepoint of care delivery.

Every effort should be made to resolve matters at ward or departmental level by frontline staff. This way ofdealing with complaints will reduce anxiety for the complainant and staff, save a great deal of time, energy andcost, and reduce the number of formal complaints that are often the result of a misunderstanding.

Dealing with verbal complaints

If resolution of a complaint cannot be achieved locally, or if the complaint is of a serious nature, or wherecomplainants clearly express a wish for intervention at a more formal level, then the formal complaintsprocedure will be initiated.

There are a number of sources of support available to the complainant to help them feel more comfortable inpresenting their concerns, eg advocacy. Staff should advise the patients of the options.

Formal complaints

Formal complaints may be in the form of a written letter, a phone call, a result of a discussion with acomplainant, or as a result of an unsatisfactory conclusion to a verbal complaint.

Full details of the formal complaints procedure can be obtained from the R&D Office.

For a full version of the NHS Whistleblowing Policy, please visit:

http://www.nhsdirect.nhs.uk/media.aspx?id=1357
http://www.nhsdirect.nhs.uk/media.aspx?id=1357http://www.nhsdirect.nhs.uk/media.aspx?id=1357http://www.nhsdirect.nhs.uk/media.aspx?id=1357


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CHECKLIST OF EVERYTHING TO BE DONE DURING THE PROJECT

Have you talked to patients about whats involved in the project?

Have you given patients an information sheet?

Have patients signed a consent form?

Have patients signed an agreement for the donation of blood or tissue samples?

Have you read and understood your data protection responsibilities?

Have you read and understood your Trust and departmental health & safety policies?

Are you keeping a log book during your project?

Do you have an activity and milestone chart?

Have you planned how your research findings will be disseminated?

Have you thought about initiating a development project?


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PRESENTING YOUR RESEARCH FINDINGS

It is important that you present your research findings in a way that is accessible to your intended audience.

Remember that language which is appropriate for members of your profession might not be suitable for patients forexample. Whether you write an article for a journal, or present your findings at a conference, you should always beconcise and to the point. The three main methods of presenting your findings are: publication; conference andthesis.

Publication

When you choose a journal for the publication of your findings, you should consider whether you will bereaching the right audience for your research.

Some journals will be aimed at a particular profession, for example the British Journal of Psychiatry, whileothers are less specialised.

It is also worth considering how frequently the journal is published, as it may be necessary for you to presentyour findings as soon as possible.

If you are presenting findings from a large research study, you should not try and include all your findings inone article. It would be advisable to publish several articles, each one presenting a particular point.

Once you have chosen the journal, you must follow their guidelines on the style, structure and content ofarticles.

Each journal will have different requirements regarding punctuation and the listing of references for example.You must adhere to these guidelines closely, if you want to increase your chances of being published.

It is also worth asking the advice of a more experienced researcher who has already had articles published.

When you have written your article, ask colleagues to read it and also check for any errors.

You can then submit it to the journal in the required format (e.g. floppy disk). The article will then be reviewed,and, if acceptable, it will be sent back to you for amendments if necessary.

You will then need to submit the revised version for final approval. If it is accepted, the journal will then holdthe copyright for your article, and you will need their permission to include it in another publication.

Conferences

Conferences provide researchers with the opportunity to give presentations as well as create poster displays topublicise their research findings.

Presentations can also be given in other forums such as lectures, workshops, symposia, etc.

Giving a presentation requires a great deal of preparation and practice.

Firstly, there is your audience to consider: you must ensure that your presentation will be appropriate for them.

Secondly, plan what you are going to say and how you are going to illustrate your points (eg visual aids).Check what visual aids are offered by the venue for your presentation.

Finally, rehearse your presentation in front of colleagues who are familiar with your subject and can giveconstructive comments. Remember to include any visual aids, which you may be using, in your rehearsal.

Poster displays should be well-designed and visually attractive. This may mean that you will not be able toinclude too much detail.

The conference organisers should give you guidelines about your display.


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At the conference, it would be a good idea to be available by your display at certain times to answer any

questions about your research.

Theses

A thesis is the appropriate form for presenting findings from academic research.

Guidelines for the format of theses should be given to you by your Universitys postgraduate department.


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STORAGE OF PROJECT INFORMATION

At the end of a project, there may be a need to keep the records of the research for a number of years. The

storage period is a matter for the primary contract. Sometimes storage periods of 15 years are specified in thecontract. Obviously, this can cause problems in terms of storage space. Everyone involved should try not tospecify such long storage periods. Case report forms should be returned to the commercial sponsor on completionof the trial. The minimum information essential to tracing trial participants should be retained outside the medicalnotes. All other useful information should be in the notes.

It is also very helpful to store lists of people who were in a particular trial in a place which is accessible to otherpeople in the department. This is very helpful in the case of product recalls where trial participants must becontacted to rule out a complication which may have arisen.

For non-commercial research projects, project information should be kept within the Trust for a minimum of 10years from completion of the project.


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ADVERSE EVENTS AND ADVERSE DRUG REACTIONSREPORTING PROCEDURE

An adverse event is any untoward incident wh ich may occur during the course of a research project. This

will include any incident likely to cause harm to the participant.

To report an adverse event:

1. If the adverse event involves a patient, inform the Medical Officer responsible for their care

2. Report the event to the Local Research Ethics Committee (or Committees)

3. Inform the R&D Office

An adverse drug reaction (ADR) is an incident where a direct association can be made between the administration

of a drug and the incident experienced. For example an ADR could be a patient experiencing anaphylaxis shortlyafter taking a drug. If t

r&d handbook.pdf - noclor

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