Operational Research Policy

 

Ely Bridge Surgery

 

We are grateful to Three Swans Surgery  (www.3swanssurgery.nhs.uk) for allowing adaptation of their operational policy for our use. Like them, we are also happy for other research organizations to copy and adapt this policy to suit their own needs. If you do wish to use elements from the policy then please let us know as this can be used by us in our own annual report. If you have any comments or improvements then please let us know; research@elybridge.co.uk

Overall aims and objectives

We aim to undertake high quality primary care research which addresses questions that are relevant to the delivery of good care for our patients.

We have a commitment to:

Generating research questions relevant to daily practice.
Collaborating with and hosting high quality primary care research projects.
Disseminating research findings and using research evidence in our daily practice
Involving patients/consumers in the research process
Training of key staff in research methods
Accountability
Openness
Clear and supportive management

 

Standards

 

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

Ensure all research has ethical approval
Respect patient autonomy and confidentiality and ensure those involved in research give fully informed consent.
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.

A Research Governance Proforma is available for all current projects (link)

 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 will have written agreements with any research partners, including universities about the allocation of responsibilities for collaborative research, published on this site, as part of the Research Governance proforma (link).
We will ensure that all staff involved in research are aware of the Research Governance Framework.
We have a procedure where all adverse events in research are recorded and the subject of significant event review.
Compliance with the Research Governance Framework will be included in the employment contracts of any staff involved in research.
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.
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.
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 information handling including Caldicott regulations.
Where appropriate, correspondence will remind patients of this registration and their rights under the Act.
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 Research for Participation

 

Questionnaires

 

A decision of 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

 

Projects hosted by the practice

 

We receive many research requests for active participation/patient recruitment.

All documentation is circulated round relevant PHCT staff members.

The decision to participate will be made at a Monday meeting when other team members can be involved in the decision. It is essential that all research undertaken in the organization is subject to this approval and that the standard information outlined below is held in the research office. Priority will be given to the following:

Whether we are active collaborators
NISCHR CRC network projects
Research originating from departments or individuals with whom we have an established relationship
Research where the outcome is likely to be of major importance
Research relevant to one our existing areas of interest

Also taken into account will be

a.      The commitment needed to participate

b.     Whether there is sufficient support for the practice.

c.      The number of other current research projects active in the practice.

d.     The impact of the research on i) the practice staff ii) the patients.

All research should have prior ethical approval and not involve breach of confidentiality. The research methodology should be appropriate to the question.

 

Confidentiality

 

We collaborate with outside researchers. 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 or equivalent.

 

When we are asked to help find suitable participants for research projects we do not to divulge names and addresses to outside organizations for research purposes.

Whenever possible searches and generating of address labels will be completed in house. 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). Only in exceptional circumstances will names and addresses be supplied to outside organizations e.g. when it is technically impossible to complete the work in the surgery. To release such information constitutes a breach of confidentiality. All patients registering with the practice are given information about the uses of computerized data held on them; there are notices in the waiting rooms and information in the users guide. It is arguable whether this constitutes sufficient consent and therefore release of such information should be carefully considered and only agreed if there are no viable alternatives and there is a sufficient public interest argument to support this action. We will then 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.

 

Many research projects 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. 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. There will be no discrimination against those electing not to participate.

 

Consent will be sought both before and after consultations that are recorded. When video or audio recordings are made the recordings are held in a secure place and erased following the research project for which they were required

  

Access to Records

In accordance with the latest GMC recommendations our policy is:

 

Access by outside researchers

 

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.

 

Access to anonymised patient data.

 

Specific consent is not needed for access to anonymised data used for research purposes. For instance we are contributors to a national database of patient information The General Practice Research Database owned by the Department of Health and anonymised information is regularly collected from the practice computer.

 

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 standardize 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 that may identify the patient is removed from the records by a member of our own staff before a copy is supplied to the researchers.

 

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 will not be supplied to outside organizations.

 

All patients registering with the Practice are given information about the uses of computerized data held on them and the Practice's involvement in research; there are notices in the waiting rooms 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 standardize 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 http://www.gmc-uk.org

Personal information in medical research available from www.mrc.ac.uk

 

Complaints and adverse events

 

Any complaints and adverse events arising from research activity are held in a file in the research office. Significant complaints will be subject to 'critical event audit'. We have a programme of monthly critical event audits. See file held in library.

 

Research Participants

 

Copies of all consent forms are held in the respective project master file in the research office.

 

In order help us make a decision regarding accepting a project for hosting in the practice the principal investigator is asked to complete an application form which details:

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
The commitment for the practice team which will include 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

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

A copy of approval from the LREC.
A copy or summary of the protocol and study materials.
A completed core R&D project data-set available from the website www.researchinformation.nhs.uk
Confirmation of written agreements detailing the relative roles and responsibilities of the research sponsor, the principal investigator and the host organization
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 organization

Once a project has been accepted for hosting by the practice or members of the primary health care team. As researchers 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.