Module Catalogue 2024/25

Pre Requisite Comment

None

Co Requisite Comment

None

Aims

This module aims to familiarise students with the legal and ethical issues surrounding different forms of clinical research and with the principles of research governance and delivery. The module is designed to prepare students to plan and conduct original clinical research by providing them with specific knowledge and enabling them to develop understanding of the subject as well as a portfolio of skills to this end.

Outline Of Syllabus

-       Introduction to clinical research and its importance
-       The infrastructure supporting clinical research in the NHS setting. Research Governance and sponsorship
-       Approvals to conduct research in the NHS
-       Good Clinical Practice
-       Leadership and project management in research
-       Research ethics and integrity
- Informed consent process and participant information
-       Regulatory compliance during active study
-       Consumer involvement (Patient and Public Involvement in research)

Intended Knowledge Outcomes

Upon completion of this module students will be able to:

• Assess and compare current legislation relating to different forms of clinical research;
• Appraise the current issues related to governance in clinical research;
• Comply with the local and national regulations and processes for obtaining permissions and approval for clinical research;
• Justify the need for good practice in clinical research;
• Defend the need for effective leadership and governance in clinical research.

Intended Skill Outcomes

Upon completion of this module students will be able to:

• Argue knowledge of ethical principles and theories to clinical research projects;
• Arrange and evaluate required paperwork for real clinical research projects;
• Apply the principles of GCP, broader legislation, and policy, in the leadership and delivery of a clinical research project.

Teaching Rationale And Relationship

Students will learn fundamental principles of research governance and Good Clinical Practice as they apply to current clinical research. The curriculum will be delivered via Canvas VLE through a series of guided learning opportunities including e-based lectures or tutorials. Teaching will also take the form of reflective learning activities such as wiki's, discussion board and synchronous webinars. Assessments will be submitted to the Canvas VLE.

Assessment Rationale And Relationship

Complete sections of an IRAS form from a protocol (summative). Rationale: To demonstrate understanding of where approvals to conduct research are needed from, and appraise the ethical issues, risks and mitigations during conduct of clinical research.

Participant information sheet and consent form (summative). Rationale: ability to interpret and distil a protocol and translate this into a format suitable for patients, using appropriate language. These exercises will assess vital skills needed in practical clinical research to become an independent researcher and an integral member of a research team.

In order to pass this module, students are required to achieve an overall pass mark of 50 or above for both the IRAS form along with the Participant information sheet and consent form in the module as well as the module overall. The resit will require the undertaking of the same assignment, using a different protocol that will already have been introduced during the module. If any resit is undertaken, the overall module mark will be capped at 50.

A participation grade is included to encourage and reward the student's engagement with the collaborative activities. Should a student fail the participation assessment and have to undertake a re-sit to pass the module overall, they will have to complete a different form of assessment. The student will be asked to look at 2 participation activities as identified by the module leader /team and submit a 500 word written summary (approx. 250 words per activity).

Development of a project plan including a gantt chart, with a feasible recruitment plan mapped to study time-lines (formative). Rationale: ability to understand the project as a whole and demonstrate understanding of the concurrent and interconnected nature of the various elements, and the milestones that need to be achieved to demonstrate compliance with the legal framework (e.g. recruitment cannot start until approvals are in place, follow up continues from the last patient recruited etc). This also will focus on the importance of feasibility (a critical barrier to research reaching target).

General Notes

N/A