Undertaking Research


This section provides a guide through the stages involved in developing a high quality research proposal. The exact format of a proposal will depend on the type of work and the funding body to be submitted to but all follow the same basic development procedures.

 
 

Audit or Research   

Literature Searching

Clinical Research Facilities

Pharmacy

Consent Forms / Patient Information Sheets

Peer Review

Grant Application

Protocol

Funding Opportunites

Statistics & Data

Laboratories

Templates

 

AUDIT OR RESEARCH

What is the difference between audit, research and service evaluation?

Research; "Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods" Research Governance Framework, 2006


Audit;  "Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, process and outcomes of care are selected and systematically evaluated against explicit criteria." NICE, 2002


Service Evaluation; "The rigourous and systematic collection of research data to assess the effectiveness of organisation, service and programmes in achieving predefined objectives." A Bowling,1997

Audit projects and service evaluations being undertaken within NHS Grampian must be registered with the Clinical Effectiveness Unit prior to commencement (link accessable from an NHSG computer only).

It is important that as a researcher you understand the difference between an audit and a research project. The documents below provide some guidance on determining whether your project is research, audit or service evaluation. If you are still in doubt, for further advice, contact the North of Scotland Research Ethics Service (NOSRES) or the Clinical Effectiveness Unit  (link accessible from an NHSG computer only)

The HRA, along with the MRC, have developed an online took kit to help researchers decide if their project is classsed as research or not.

Further information on research & evaluation also available on Grampian Health Improvement Network and a new web based evaluation tool is also available.

 

CLINICAL RESEARCH FACILITIES (CRF's)

There are many clinical areas within NHS Grampian where research is supported, for example cardiovascular, dermatology, diabetes, epidemiology, mental health, neurology, oncology, paediatrics, to name but a few. The facilities available in each area vary, but all are conducive for carrying out high quality research. The staff involved in research work for either or both NHS Grampian and University of Aberdeen and have a wealth of experience in their area of research. NHS Grampian aims to promote these areas as centres of excellence for clinical research by raising their profile locally and nationally.
 

CRF, Health Sciences Building

CRF Building The University of Aberdeen has a CRF on the ground floor of the Health Sciences Building where research is carried out by both NHS Grampian and University staff.  The University CRF is suitable for 'ambulatory' clinical research of major diseases and disorders such as osteoporosis, Alzheimer's and dementia, urological cancers, respiratory conditions and sports related injuries.                                   

The CRF  has research nurses employed to work on various studies and are available to researchers who wish to carry out research in the building and in other research facilities within NHSG. Researchers from the university, NHS Grampian or any other research organisation can request access to use the facilities.                

For more information go to the University of Aberdeen website

 

CONSENT FORM & PIS

General guidance on format and content of a PIS and consent form is provided on the HRA websitePatient Information Sheet (PIS)

 

The Patient Information Sheet (PIS) is a document designed to provide the potential participant with sufficient information to allow that person to make an informed decision on whether or not they want to take part. A PIS forms the basis of an investigator's contract with a patient and is the patient's record of what they have agreed to. The PIS should therefore be designed to include as much information as possible relevant to the participants' involvement in the study.

Information sheets must be approved by the ethics committee and any amendments to the PIS must also be approved.

Consent Forms

Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular research study, after having been informed of all aspects of the study that are relevant to their decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

Further guidance on Informed consent can be found on the University of Aberdeen website

Consent forms must be approved by the ethics committee and any amendments to the form must also be approved.

 

GRANT APPLICATION

 

NHS Grampian must evidence the availability and cost of any research using NHS resources. This is called 'NHS Service Support Costs', and is used to cover overheads associated with the research; e.g. costings for staff time, additional tests, x-rays, clinic accomodation etc. For further information on service support costs click here or go to the NHS support page on the CSO website by clicking here.

Please contact the R&D Office at an early stage to discuss this with Dr Susan Ridge (s.ridge@nhs.net, tel 01224 553728).
 

NHS Service Support

 
Financial support is received each year from the Scottish Executive to support research within NHS Grampian. This is known as "NHS Service Support" and covers the additional costs of supporting research within NHS Grampian which are not covered by funding from other sources. These are clinical costs, ie extra patient care costs which will end once the research is finished, eg additional:
 
  • staff time which includes pre-project and post-research administration
  • patient visits including in-patient days;
  • recruitment time at clinics and clinic time for additional investigations;
  • blood tests, sample collection, X-rays, scans etc.
 
Each year the CSO requires the R&D Office to submit the above information for each research project involving NHS Grampian to justify the support provided by the CSO to NHS Grampian. The extent of this financial support is related therefore to the amount of research done and it is vitally important that "Support Costs" for all research projects are carefully calculated; if not the resource awarded to NHS Grampian may fall. Making such calculations is one of the major functions of the R&D Office and is one of the reasons why it is important that we have a register of all project applications and protocols. 
 
Any grant application that has a requirement for NHS service support must be submitted to the R&D Office for costing, approval and signature prior to submission to the grant funding body. A protocol or draft grant application, where applicable, should be submitted to the R&D Office at least 2-3 weeks before deadline. Please let the R&D Office know as soon as external funding is received. Researchers who apply for external funding and are not successful should also notify the R&D Office of this outcome and indicate whether a further grant application will be submitted.
 
If applicable, all researchers should also submit their grant applications through the relevant University Finance Office.

Sometimes indirect costs / overheads are negotiable (e.g. in the case of commercially funded work and some non-commercial funders), this also needs to be discussed with the R&D Office at the earliest opportunity. 

All NHS costs must be also be recovered under commercial contracts, and these are calculated by the Commercial Research Manager (tel 01224 554958).

Protocols

All research studies need a protocol describing how the research will be conducted. This defines the research question, why it is important and how it will be answered. The study will be regulated by NHS Grampian and external agencies in accordance with what the researcher says in this document.

Award letter

Before R&D management approval is given, evidence of funds to cover the cost of the research is required.

 

FUNDING OPPORTUNITIES

 

NHS Grampian Endowment Funds

The Charter and associated operating instructions are available on the intranet from the NHS Grampian Finance Department.
 
 
Due to circumstances outwith our control there has be a substantial delay in applications for the new funding round being made available, we can only apologise for any inconvenience this has caused. 
 
The new application forms and guidance notes for 2015/16 will be made available and circulated in April and sufficient time will be given for submission.  The funding time frame will be moved to accommodate the delay.
 

External Funding Opportunities

RD Funding website.

University of Aberdeen (Research & innovation)

Medical Research Council

National Institute for Health Research

The Florence Nightingale Foundation

The Florence Nightingale Foundation raises funds to provide scholarships for nurses and midwives to enable them, through study, to promote innovation in practice and to extend knowledge and skills to meet changing needs.
 

LABORATORIES

 

NHS Laboratory Testing

The Laboratory Medicine Clinical Group of NHS Grampian provides all local laboratory services for clinical trials conducted in NHS Grampian.
 
The Unit Operational Manager for Laboratory Medicine (Dr George King, 01224 552469, georgeking@nhs.net) must be contacted prior to the commencement of ALL research studies involving laboratory medicine departments for official approval and authorisation. For commercially sponsored studies a copy of the protocol should be sent to the R&D Office in the first instance for distribution to relevant departments involved.

 

Laboratory medicine based at ARI consists of the following departments - Clinical Biochemistry, Haematology, Medical Microbiology, Immunology, Genetics and Pathology. The Laboratories operate in accordance with Clinical Pathology Accreditation Scheme Standards CPA.  A pack, consisting of biochemistry and haematology reference ranges and information relating to the other departments including laboratory accreditation information can be obtained from the R&D Office. Please contact Audrey Imray (Email a.imray@nhs.net  or 01224 553096) for electronic or paper copies.

 

LITERATURE SEARCHING

 

It is essential to review existing literature to ensure the proposed research does not duplicate other work unnecessarily. The Research Governance Framework states 'Research which duplicates other work unnecessarily or which is not of sufficient quality to contribute something useful to existing knowledge is in itself unethical.'

Useful links

 

Athens

The Cochrane Library

Pubmed

The Knowledge Network (previously eLibrary)

 

PHARMACY

The pharmacy department contributes to research by providing a specialist service through a unique clinical trial pharmacy department. The pharmacy department has a designated area, with restricted access, for the storage and dispensing of clinical trial material.  The area is equipped with a cold store should refrigerated storage be required.

Clinical trial pharmacists, technicians and assistants supply clinical trial drugs in accordance with trial protocols sponsored by the NHS, the University, academic institutions and by pharmaceutical companies. Pharmacy is involved in the design and development of locally sponsored trials and reviews protocols for every study that contains an Investigational Medicinal Product (IMP) that wishes to recruit patients within NHS Grampian. Pharmacy is also responsible for the storage and receipt of IMP's, destruction of returned and expired medication and taking care of questions and queries from all members of staff.

All drug related clinical trials must be conducted through the NHS Grampian Pharmacy Department. A copy of the study protocol and other relevant information (e.g. drug accountability logs) must be sent direct to the Clinical Trials Pharmacist(s) for review prior to trial acceptance. A signature from pharmacy is required on the SSI form

Pharmacy can be contacted through the following email address: nhsg.pharmacytrials@nhs.net

 

PEER REVIEW

All research must have documented evidence of peer review prior to submission to the Ethics Committee or to Research and Development for approval. The Research Governance Framework for Health and Community Care in Scotland (2006) states that, "All health and community care research should be subjected to rigorous review by recognised experts in the relevant fields able to offer advice on its quality which is independent of the researcher."

Externally funded research will usually have undergone peer review as part of the decision making process. The locally funded Endowment grant applications are also subjected to peer review as part of the application process.

For student research projects the university systems normally provide an adequate level of review.

Some smaller funding bodies may only have a minimal procedure, if any, and therefore it is essential that these research projects, as well as internally funded and unfunded research are peer reviewed. If a research project falls under these categories a competent person must review the research, preferably from outwith Grampian but can be from within Grampian if not involved in the project.

Documented evidence of peer review must be kept, along with any details addressing comments by the peer reviewer, and a copy sent to the Research and Development Office as part of the Management Approval process.

 

PROTOCOL

A protocol is a document that describes the objective(s), the background and rationale, formal design, methodology, statistical considerations, and organisation of a research study.  The protocol explains what will be done, when, how and why. 

The University of Aberdeen/NHS Grampian research governance website has an SOP and a template providing guidance on how to write a research protocol for CTIMP studies.

We are currently developing guidance for non-CTIMP protocols. Further guidance can be found in the following documents or contact Research Governance for help researchgovernance@abdn.ac.uk :

 SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials (BMJ)

The CONSORT Statement

 
 

STATISTICS & DATA

Statistics

All NHS Grampian employed staff have access to a part-time statistician working in the Institute of Applied Health Sciences of the University of Aberdeen. This intiative has been supported financially by NHS Grampian, through the R&D Office.

Researchers should get advice from a statistician before they apply for any source of funding.

Statisticians can give help with statistical requirements for grant applications, study design, data collection and processing, data quality and management, statistical analysis and assistance with ethics forms.

If you are an NHS Grampian employee and require statistical advice, whether planning a new research project or analysing an existing one, please contact Dr Joanne Rodger (joanne.rodger@nhs.net, tel 01224 555847) for further information.

 

Data Management

Any researchers in Grampian working on an eligibly funded project can access a level of data management support at no extra cost. This initiative has been financially supported through the R&D Office with the UK Clinical Research Collaboration (UKCRC) funding received via the Chief Scientist Office (CSO).

Please contact Dr Joanne Rodger (joanne.rodger@nhs.net, tel 01224 555847) for further information.

Further information on the support the data management team can provide can be found here.

 

TEMPLATES

Templates can be found on the joint University of Aberdeen/NHSG research governance website