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Sample Protocol
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Sample Protocol (Ethics and the written submission)
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Does your audit or project involve the collection and description of data from
individual patients?
YES / NO
If you answered “Yes” describe what steps you have taken to
ensure that patient confidentiality is protected.
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Does your audit or project use a methodology that involves approaching patients
for interviews or completion of questionnaires?
YES / NO
If you answered “Yes” then proceed to question 3
If you answered “No” then proceed to question 4
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Are patients to be approached on the basis of confidential information, such as
a diagnosis?
YES / NO
If you answered “Yes” to questions 2 and 3 then ethical
approval from your Local Research Ethics Committee is required.
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Is your written work in the form of an audit, discussion paper, plan for new
service, notes review, clinical case study, or literature review?
YES
/ NO
If you answered “Yes” then ethical approval from your
Local Research Ethics Committee is NOT required.
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If you are planning a questionnaire study 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)
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If you are planning a research project ethical approval will normally be
required.
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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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(Page last updated on 05/01/05)
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