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Sample Protocol
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Ethics and the written submission
All forms of written submission, whether COGPED audit or NPMS, may relate to or
contain confidential patient data. From the ethical point of view there are two
separate considerations that need to be made.
1. One is the question of good practice: i.e. what steps have been taken to
protect the confidentiality of participant, and does the audit or project pose
any threat to the rights, safety, dignity and well-being of the subjects? It is
recommended that all GPRs planning to submit written work for summative
assessment should write a brief but formal protocol at an early stage which
includes identification of the ethical issues, and to discuss this with
colleagues and perhaps the local Local Research Ethics Committee (LREC) chair.
This is to ensure that the rights, safety, dignity and well-being of the
subjects of an audit or NPMS project are protected. Please
click here for a sample protocol
2. The other is whether ethical approval should be obtained before the audit or
project is undertaken.
LREC approval is not required for:
a straight-forward audit that contains no patient-identifiable data, and has a
methodology that does not involve going back to the patient for additional
interviews or questionnaires
questionnaire studies in which participants are randomly invited to participate
on an “opt-in” basis, and the questions do not involve confidential
information, then REC approval is not required (e.g. leaving questionnaires in
the waiting room about such issues as access, use of nurse practitioners etc)
LREC approval is required for:
questionnaire studies in which participants are selected and approached on the
basis of confidentially held information (e.g. they have a particular
diagnosis).
research projects
If there is doubt about whether a particular piece of work requires ethical
approval then the GPR should contact the chair of the LREC, or COREC
http://www.corec.org.uk for a decision. The result of this enquiry
should be included in the written report. It is therefore a matter of good
research management within the overall educational time – ie recognising this
as an issue and thinking ahead.
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