Whether planning a Research Project, Service Evaluation or Staff Survey, it is important to think carefully at an early stage as to how you plan to carry out your work.
A well thought out protocol will provide the Scientific Review Group with the right amount of information to enable them to agree to the study proceeding to the next stage of the Governance Process.
Poorly designed protocols are one of the most common stumbling blocks for researchers, preventing them from moving their projects on. This can be frustrating as well as causing lengthy delays that could have been avoided if the design was correct in the first place.
Additional advice on designing your study can be obtained from the Gloucestershire Research Team.
Other Things to Consider
It is important that you are sure of the project type that you are working on to also ensure that you explore all appropriate reviews, approvals and guidance you will require in addition to the main three of Scientific Review, Ethical Review and R&D Governance Approval.
Clinical Trials of Investigational Medicinal Products (CTIMPs)
Trials that involve drugs as an investigational product will require review by the Medicines and Healthcare products Regulatory Agency (MHRA) as well as the NHS Ethics and the appropriate trust. The MHRA issues a Clinical Trials Authorisation (CTA) that you will need before the study can recruit participants.
The application for the CTA can be made at the same time as NHS Ethical Review and through the IRAS website
Further information about the MHRA and their process can be found on their website.
The conduct of CTIMPs is governed by UK Law, so it is vital that all involved understand their roles and responsibilities.
The UK Law governing CTIMPS is the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended.
Good Clinical Practice
Good Clinical Practice Training is a Legal Requirement as per the Medicines for Human Use (Clinical Trials) Regulations for an Investigator or clinical researcher responsible for obtaining consent from research participants.
The Gloucestershire R&D Consortium, however, believes that all studies should be run to these standard to ensure consistency in quality and it is considered appropriate for all researchers to be trained in Good Clinical Practice (as it related to research).
Further details on the training requirements can be found in R&DSOP02 – Training and advice can be sought from the Gloucestershire Research Team.
No projects should be undertaken where there is an identified cost to the trust hosting that project. Essentially, all research should be cost neutral.
Seek advice from the Research Governance Team as soon as possible if you are unsure how to cost a research project.
Studies that involve taking of new tissue samples or using existing samples may require consideration of the provisions of the Human Tissue Act.
The Human Tissue Authority (HTA) oversees the Act, and provides guidance on when Human Tissue Licenses are required for research and for what research (involving human tissue) requires ethical review.
Full details of what constitutes Human Tissue, the Human Tissue Act and licensing requirements are available at the HTA website.
A useful guide to the effects of the Act on Research can be found in this section of the HTA Website which also includes links to Code of Practice 9 – Research and some FAQs
Mental Capacity Act
Any study that involves participants who may not have capacity to consent, or may lose capacity to consent during the conduct of the study will need to be designed with consideration of the Mental Capacity Act 2005.
The Mental Capacity Act sets out guidance around checking whether potential participants have capacity to offer consent and then around identifying suitable personal or professional consultees who can provide opinions on whether a person would give consent.
Information about the Mental Capacity Act can be found here
This also includes links to other guidance including a Code of Conduct.
The only exceptions to this are CTIMPs which are governed by UK Law under the Medicines for Human Use (Clinical Trial) Regulations 2004 as amended.
The Data Protection Act 1998 sets out what you can and can’t do with Personal Identifiable Data (PID) and it is just as important in relation to Research as it is for routine clinical practice.
Any PID collected for a research study will need to be collected, stored, retained or destroyed as per the Data Protection Act and its main principles.
The 8 principles can be found here: http://www.legislation.gov.uk/ukpga/1998/29/schedule/1
Further information and advice around protection of data can be obtained from the Information Commissioner’s Office
TOP TIPS for researchers when thinking about how to develop proposals.
Some studies may generate new ideas, devices or innovations that would be suitable for commercial exploitation. However, to do so effectively, requires careful planning and consideration of issues such as copyright and patents.
The Gloucestershire Hospitals NHS Foundation Trust has a Trust Innovation Lead (TIL) who can advise on any projects that may involve exploitable intellectual property. The Trust Innovation Lead can be contacted on 03004 22 2800.
Researchers who are not currently employed on a substantive NHS Contract may require and Honorary Research Contract or Letter of Access to work in this trust on approved research/service evaluations.
The need for such a contract/letter will depend on the study and the activity that the individual will be undertaken.
A research passport is the collection of documentation that a researcher’s employing organisation can produce to assure NHS organisations of that individuals pre-engagement checks (such as CRB Checks and Occupational Health Clearance) to help speed up issuing the required contracts.
More details of the Research Passport System can be found here, including an algorithm to help decide whether or not the intended activity requires a contract.
If you're not sure, please contact the Gloucestershire Research Governance Team on 03004 22 5463.