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Write a protocol and patient information sheets


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.