Brighton and Sussex Joint Clinical Research Office

JCRO governance

JCRO Management Group
The JCRO is managed by a JCRO Management Group, chaired by the Head of JCRO, with representation from all Partners. The group meets every 6 months. The group allows for continuous review and feedback between partners.

News

Four Years On: Key Insights from the PSRP

The Pre-sponsorship Review Panel has now moved into its 5th year of activity. The panel is a joint undertaking between Brighton and Sussex Universities as well as Sussex Partnership and University Hospitals Sussex NHS Foundation Trusts, designed to review clinical research applications and make a recommendation for sponsorship. We have welcomed 143 applications from researchers since its introduction. The focus has ranged from studies developing Electronic vending machines for delivering HIV and STI testing kits to studies evaluating outdoor swimming for the reduction of anxiety and depression symptoms. As the previous deputy chair, I have found it a privilege to learn about such novel, exciting approaches to improving healthcare. 

The panel has a loyal membership including clinical academics, trial managers and individuals with lived experience. Also sitting on the panel are statisticians, research nurses and research professionals with comprehensive understanding of the local patch. Reviewers are well-placed to advise on the research design and management issues that could limit the implementation of a project or the conclusions that can be drawn. 

“As a non-specialist, it's really interesting finding out about different aspects of medical science and research. I am always struck with how research always has the care of the participants as fundamental.” Tony Murray, Lay Member

Over the years we have noticed common areas of feedback in the reviews we provide. Many of these issues are easily avoidable with a bit of attention before submission. Here are some of the most common pitfalls – and how to fix them:

1. Use a Protocol Template
   Most sponsoring organisations have a protocol template that can be used to organise your information, ensuring that important information is not missed out. The HRA also provide protocol templates for different types of studies (see the website here).
2. Use HRA-Approved Transparency Wording
   Ensure your participant information sheets (PIS) include standard Health Research Authority (HRA) GDPR compliant transparency wording. This wording is available online and must be included in all submissions to the HRA.
3. Ensure Proper Document Formatting
   A requirement for HRA approval is that all documents are version controlled. Every submitted document must include the version number, date, page numbers, and the IRAS number in its footer
4. Match Outcomes to Study Type
   If your study is a feasibility trial, make sure you specify feasibility outcomes. Avoid using terms or measures that imply definitive testing of effectiveness unless that is clearly part of your study design. For further information about feasibility and pilot studies, please visit the PAFS website here.
5. Clarify Data Withdrawal Points
   Be consistent and specific about when and how participants can withdraw their data, making sure this is clear and transparent in the Patient Information Sheet Conflicting information across documents can confuse reviewers and participants alike.
6. Recruiting Participants Who Lack Capacity? Follow MCA Guidance
   If your study includes participants who may lack the capacity to consent, consult the Mental Capacity Act (MCA) specific provisions for research. Using incorrect terminology or weak justification for inclusion will be reviewed negatively by the research ethics committee. 
7. Avoid Digital Exclusion
   Consider the needs of participants who may have limited access to technology or internet services. Offer alternative ways to participate to avoid excluding these groups.
8. Be Inclusive of Non-English Speakers and those with different communication needs
   This might include offering translations or interpreters where appropriate. You may also provide Easy-Read versions of participant documents. 
9. Request Consent for Audio Recording
   If you will be recording participant interviews or focus groups, you should request consent for this as a statement on the consent form. Your protocol and participant documents should also clearly outline how recordings will be securely stored, accessed, and eventually disposed of.
10. Address Potential for Coercion
    Clearly explain how you will minimize the risk of coercion, especially in vulnerable populations or hierarchical settings such as hospitals or schools. In interventional studies, this may mean that informed consent for a study is received by someone outside of the usual care team. 
11. Timeline Transparency
    In your PIS, provide a clear and realistic timeline of what participants can expect from the study – including the duration of their involvement and follow-up, if any.
12. Remove Tracked Changes
    Before submission, ensure that all guidance text, tracked changes and comments are fully removed from your documents. Submitting clean, final versions helps present your work professionally.

The PSRP are currently welcoming new members. Please get in touch at psrp@sussex.ac.uk if you would like to be considered for an initial chat.

How we can help

The JCRO provides research management support and advice across the project life-cycle. 

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