Research
Governance Protocol for Ely Bridge
Summary
of Key Responsibilities of People and Organizations Accountable for the Proper
Conduct of a Study.
Please
complete every section on this form, failure to do so may result in the delay of
the project being approved.
ALL INFORMATION ON THIS DOCUMENT
REQUIRES TO BE CHECKED AND SIGNED BY THE PRINCIPAL INVESTIGATOR OR THE SITE
STUDY CO-ORDINATOR TO ENSURE THE ACCURACY OF THE DATA.
|
Title
of Project (inc acronym) |
|
Proposed
start date |
|
Proposed
finish date |
|
Why
the research is needed |
|
Principal
investigator (PI) |
Principal
investigator's contact details
|
|
Multidisciplinary
(details of anyone other than the PI) who is involved in the research i.e.
research asst etc) |
|
Ethical
approval (whether required and obtained) |
|
Medicines
Control Agency |
|
Medical
Devices Agency |
|
Sponsor |
|
Employing
organizations (of all staff involved in the project) |
|
Care
organizations (e.g. any other practices involved in the research, all
organizations providing health or social care in Wales) |
|
Support
required (e.g. if CAPRICORN was the sponsor it may be that you would
require some admin support etc) |
|
Support
offered ( e.g. any outside grants etc) |
|
Principal
research question |
|
Methodology |
|
Sample
group description (e.g. how many respondents will be recruited? male or
female, age groups etc) |
|
Consumer
involvement in design, conduct, analysis and reporting of the research
(This is an area as you can imagine is not fully exploited and is being
looked at closely) |
|
Methods
of dissemination |
|
Literature
search (attach) |
|
Identify
any health and safety risks (e.g. if researcher is to interview
respondents in their own home or indeed any uncontrolled environment you
may wish to have some safety element included, I can provide an example) |
|
Arrangements
in place for obtaining patient consent if required (what are they) |
|
Arrangements
in place for patient confidentiality and what are they |
|
Details
of any deviation from REC approval prior to project start date |
|
The
project protocol must be attached to this document |
|
Ensure
that any indemnity arrangements are in place for this research |
Additional
comments:
The
ethical approval form must be attached along with REC number and a copy of the
protocol.
The
study should in accordance with Research Governance Framework must be audited
mid term.