Write a protocol and patient information sheets
Protocol
Every research project must have a protocol. The Health
Research Authority (HRA) defines a protocol as:
"an essential part of a research project. It is a full
description of the research study and will act as a 'manual' for
members of the research team to ensure adherence to the methods
outlined. As the study gets underway, it can then be used to
monitor the study's progress and evaluate its
outcomes". Visit HRA website
A research protocol must detail clearly all aspects of the
study design and methodology. It must detail procedures associated
with the entire study and be compliant with all relevant
regulatory, ethical and legal requirements. No two research
protocols will be the same, but there are common elements and items
that need to be addressed including, but not limited to the
background, rationale, design, population to be researched,
oversight, data collection, analysis and archiving of a
study.
A protocol is also a manual for the research team to ensure
they adhere to the methods outlined. Generally, your protocol
should include sufficient detail so that someone unfamiliar with
the study would be able to use it to conduct the study in your
absence, should they need to do so.
To support researchers the HRA has developed guidance and templates to assist you
with developing your research protocol. The protocol
should go into as much detail about the research project as
possible, to enable the review bodies to fully understand your
study. A protocol which contains all the elements that review
bodies consider is less likely to be delayed during the review
process because there will be less likelihood that the review body
will require clarification from the applicant.
When writing your protocol it is important to consider who
else needs to be consulted during this process; colleagues, support
departments, statisticians etc. For further information, see
Standard Operating
Procedures (SOPs).
You may be developing a protocol to submit with a grant
application. Click here for more information on grant
writing.
If you would like UH Bristol to act as Sponsor for your
proposed research project please also ensure the required standard
wording is included in your protocol. Please see our SOP, Writing a protocol to
GCP and guidance documents Standard
Wording for IMP Protocols and Standard
Wording for Non-IMP Protocols.
Prepare your study consent and participant information
sheet
Your Participant Information Sheet (PIS) should describe
clearly what a participant should expect if they agree to take part
in your study. A consent form should normally be used to record the
consent process and a participant's agreement to take part in your
study. When designing your consent form you should
consider what precisely you are asking potential participants to
give their consent for.
The HRA, together with the Medical Research Council (MRC),
provides an online tool that gives guidance on the
preparation of participant information sheets (PIS) and consent
forms as well as providing examples, templates and useful links.
Other resources can also be found on the HRA website.
It's also important that you explain to people how you will be using
their personal data, and what their rights are under the law.
The HRA has produced recommended wording for documents provided to
participants to fulfil transparency requirements under the recently
implemented General Data Protection Regulation for health and
care research. For UH Bristol sponsored
research the required wording can be found on the HRA
website - transparency wording.
