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.
More information can be found on the joint Univerity If Aberdeen & NHS Grampian Clinical Research Governance & Quality Assurance Website
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.
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.
For more information go to the University of Aberdeen website
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.
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.
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.
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).
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.
Before R&D management approval is given, evidence of funds to cover the cost of the research is required.
NHS Grampian Endowment Funds
The Florence Nightingale Foundation
NHS Laboratory Testing
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 email@example.com or 01224 553096) for electronic or paper copies.
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.'
The Knowledge Network (previously eLibrary)
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: firstname.lastname@example.org
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.
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 email@example.com :
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 (firstname.lastname@example.org, tel 01224 555847) for further information.
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 (email@example.com, tel 01224 555847) for further information.
Further information on the support the data management team can provide can be found here.
Templates can be found on the joint University of Aberdeen/NHSG research governance website