index | site contents | practice charter | who's who | contact | news | health information | travelling | teaching | useful links

Research Policy

Overall aims and objectives

We aim to undertake and be involved with high quality research that addresses questions that are relevant to the delivery of good care for our patients.

We have a commitment to:

• Formulating research questions from uncertainties arising in everyday practice.
• Hosting and collaborating in high quality primary care research projects.
• Disseminating research findings and using sound evidence to inform our daily Practice.
• Involving patients, their families and carers and users in the research.
• Respect for participants dignity, rights, safety and well-being.
• Valuing diversity within society.
• Personal and scientific integrity.
• Leadership
• Honesty
• Accountability
• Openness
• Clear and supportive management

Standards

We have accepted the principals and guidance as laid down in Research Governance Framework for Health and Social Care.

We will:

• Ensure all research has ethical approval where appropriate.
• Respect patient autonomy, confidentiality and ensure those involved in research give fully informed consent. The dignity, rights, safety and well-being of participants will be the primary consideration in any research study.
• Ensure high standards at all stages of the research process.
• Existing sources of evidence will be considered carefully prior to undertaking research to avoid unnecessary duplication or carrying out research that does not contribute something useful to existing knowledge.

Use of and adherence to research protocols

We will ensure good record keeping and documentation of research process.

Appropriate use and protection of patient data is paramount. All involved in research will be aware of their ethical and legal duties in this respect, in particular probity of data collection and analysis process.

Developing an awareness of primary care research throughout the clinical and administrative team.

Quality research culture

We fully endorse the key qualities of a research culture described in Research Governance Framework for Health and Social Care (March 2001):

• presentation of results for peer review and publication in peer reviewed journal
• submission to peer review of the practice activity
• any risk should be kept to a minimum and clearly explained to the relevant ethics committee and all participants

Dr Charles Campion-Smith is notified and has approved of all research in our organisation.

We will have written agreements with any research partners, including universities about the allocation of responsibilities for collaborative research.

We will ensure that all staff involved in research are aware of the Research Governance Framework.

Where appropriate research will be linked with clinical governance in our Practice and PCT.

Dr Charles Campion-Smith will monitor all research in which we participate.

We have a procedure where all adverse events in research are recorded and the subject of significant event review.

Dr Charles Campion-Smith, through personal supervision is responsible for the detection of any research misconduct and for taking appropriate action.

Compliance with the Research Governance Framework will be included in the employment contracts of any staff involved in research.

All research, including any undertaken by students will, where appropriate have Local Research Ethics Committee approval. In cases of uncertainty the advice of peers active in Primary care research, the Wessex Primary Care Research Network (WReN) or the Dorset RDSU will be sought.

For all ongoing research Dr Charles Campion-Smith will ensure compliance with arrangements for obtaining informed consent and other procedures in accordance with LREC approval.

The Practice may sometimes host research for which we are the sponsor. This work will all be developed with external consultation that will include assessment of the competence of the researchers.

When considering invitations to collaborate or participate in research we will use the WReN "Rapid Guide to Assessing Research Requests" and the WReN check list "Does the study involve fair and lawful processing of patient data" (see appendix 1&2).

We aim to involve patients and users of the service in the development and execution of the research process including protocol development, execution and review and dissemination of outcomes.

Any research undertaken by students within the Practice will require approval by Dr Charles Campion-Smith and his partners.

Any student engaged on research will be required to have a nominated research supervisor as sponsor.

The Practice is registered under the Data Protection Act and anyone involved in research is required to be aware of the act and other guidance about informati on handling including Caldicott regulations.

Where appropriate, correspondence will remind patients of this registration and their rights under the Act.

The Practice's recognition as a Research and Development Practice is mentioned in the latest practice information leaflet and will also be included in other practice information such as a Practice web site and waiting room notice board. We do not feel there is any need to make this information available in any language other than English given the ethnic mix of our Practice population.

Our aim will be to write up and publish (in peer reviewed journals preferably) and/or present all research undertaken at the Practice.

Any arrangements with external funders of work will be made in writing with copies kept at the Practice.

We will, with appropriate advice undertake to cost research work appropriately and ensure probity of financial management.

Financial arrangements

All payments received for research activity will be identified as will all costs.

An annual financial statement of income and expenditure for Practice research activity will be prepared and will form part of the Practices annual audited accounts.

Intellectual property rights (IPR)

We will develop systems for the identification of intellectual property and clarification of ownership, exploitation and income issues. All research active staff will have a working knowledge of the implications of IPR. All research active staff have a clause relating to IPR ownership in their contracts.

Health and Safety

All those involved in research in the Practice are aware of their responsibilities under Health and Safety legislation to themselves and others.

Accepting invitations for Research Participation.

Questionnaires

A decision on individually addressed questionnaires is left to the staff member involved.

A decision to complete will usually depend on:

• Time commitment
• Importance of research
• Likelihood of useful/relevant outcome
• Interest of staff member

2. Projects hosted by the practice

We may receive requests for active participation/patient recruitment in research. Dr Campion-Smith will review requests initially, using the two WReN guides (see above and Appendix 1&2) and will discuss these with all involved team members before a decision is made.

Priority will be given to:

• Studies where the Practice is an active collaborator
• WReN network projects
• Research originating from other WReN members
• Studies where the outcome is likely to be of major importance

There will also be consideration of:

• The commitment needed to participate.
• Whether there is sufficient support and adequate funding for the practice.
• The number of other current research projects active in the practice.
• The impact of the research on
  1. the practice staff,
  2. the patients.

To help us decide on any externally proposed research we will require the following information:

• Who is the research sponsor and principal investigator
• The source of research funding
• The research question, clearly stated
• That the project has ethics approval
• An outline of the methodology with brief justification
• Arrangements for ensuring gaining of informed consent and maintaining patient confidentiality
• The commitment for the practice team including what we will be expected to do, timescale and what support (financial or practical) is available.
• The commitment for patients consenting to participate and any risks which may be encountered.

The principal investigator is asked to complete an application form which gives these details (Appendix 3), and provide a copy of approval from the LREC, a copy or summary of the protocol and study materials and a completed core R&D project data-set available from the NHS Research Information web site.

Once a project is accepted by the practice in order to meet our obligations for research governance the principal investigator is asked to provide:

• Confirmation of written agreements detailing the relative roles and responsibilities of the research sponsor, the principal investigator and the host organisation.
• Any checks and controls on protocol adherence and data quality.
• Confirmation of honorary NHS contracts for research staff engaged in direct patient care.
• Details of who is liable for the project and any relevant indemnity arrangements for the practice.
• Mechanism for complaints/adverse events monitoring.

Responsibilities of the host organisation

Once a project has been accepted for hosting by the Practice or members of the primary health care team we have the following responsibilities:

• Ensuring our patients receive appropriate care whilst participating in the research
• Protection of the integrity and confidentiality of clinical records
• The conduct of the research in the practice
• Adherence to the protocol
• Reporting of protocol violations to the principal investigator
• Monitoring and recording adverse events and complaints
• Maintenance of proper records in order to meet our commitments to research governance, NRR, SFS and annual report.

Confidentiality and consent

All research workers are bound by a code of confidentiality in the same way as workers within the NHS. Any researchers working within the practice will be asked to sign a confidentiality agreement (we use the same form for students and other temporary staff).

Any researchers having direct patient contact will be expected to hold an honorary NHS contract.

Research projects may involve patient recruitment during attendance at the surgery. In these circumstances informed consent is obtained in the usual way by the provision of information sheets and verbal explanation.

When we are asked to help find suitable participants for research projects we do not to divulge names and addresses to outside organisations for research purposes without patients' specific consent. Any approach to patients to seek consent to pass names to the researchers will come from the Practice who already have access to this information. Only after this preliminary consent is given will patients' names be passed on to researchers.

On occasion patients with specific conditions or in particular age bands are needed. These groups may be identified by use of the computer age sex register and disease register. After identification these groups will be contacted, usually by letter from the Practice, and asked if they are interested in participation. Those interested will usually contact the researcher directly.

Researchers may be allowed to come to the surgery and, after signing a confidentiality agreement, be allowed to undertake the work in the building (having access only to names and addresses and not clinical information). Copies of all consent forms are held in the respective project master file.

Access to Records

In accordance with the latest GMC recommendations our policy for access by outside researchers is:

Where access to records is requested by researchers from outside the practice we will obtain the individuals consent prior to allowing access.

All researchers working in the practice are bound by a code of confidentiality and all should sign a confidentiality agreement before starting work here.

Specific consent is not needed for access to anonymised data used for researchpurposes.

In all cases where information is held by the researcher we will require written confirmation that the database is erased following the specific project for which it is released and will be used for no other purpose. Patients' names and addresses not be supplied to outside organisations.

All patients registering with the Practice are given information about the uses of computerised data held on them and the Practice's involvement in research; there are notices in the waiting rooms (appendix 2) and information in the Practice guide.

There will never be discrimination against those patients electing not to participate in any research.

Sometimes it is important for researchers to check written records, for instance to see how often our patients have attended for a condition after being given an information leaflet. We will try and extract the relevant data ourselves but often in order to standardise methodology it is important that a member of the research team undertakes the data extraction.

In these instances when specific consent has not been obtained all information which may identify the patient is removed from the records by a member of our own staff before a copy is supplied to the researchers. For further details see:

• GMC draft guidance on research
• Personal information in medical research (PDF)

  Complaints and adverse events

  Any complaints and adverse events arising from research activity are held in a subdivision of the Practice complaints file in the managers office. Significant complaints will be subject to 'critical event audit'.

  Roles and Responsibilities

  Dr Charles Campion-Smith

  Lead researcher and contract holder.

  Accountable to the NHSE for overall research activity and financial probity. Accountable to partners Should be kept aware of all research activity including:

  • Work under development
  • Funding applications
  • Progress reports of ongoing projects
  • Dissemination and publication Collaborative research
  • Hosted research

  Holds list of current research activity at reception.

  Information includes nature of project, approximate start and finish dates, contact numbers if problems, details of allowable access to confidential patient information.

  Mrs Helen Austin

  Research assistant accountable to Dr Campion-Smith and partners.

  Shares responsibility for supervision of research activity

  Responsible for supervision and daily management of research activity

  Liases with other members of staff involved in research activity.

  Directly supervises own research activity

  Others

  Any other clinical and non-clinical staff involved in research activity are responsible to Dr Campion-Smith for day to day running of projects etc.

  Return to Research.

  ---

  index | site contents | practice charter | who's who | contact | news | health information | travelling | teaching | useful links	Search:
  Produced and hosted by Arboris.