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)
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.
| 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. |
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.
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.
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 |
| CAPRICORN network projects |
| Research originating from other CAPRICORN members |
| 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
A
flow chart is attached detailing when it is ethical to provide confidential
patient information.
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 (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 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 (click
here for copy) 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. |