| Semester 1 Credit Value: | 20 |
| ECTS Credits: | 10.0 |
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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. It is designed to prepare students to plan and conduct original clinical research by providing them with specific knowledge and enabling them to develop an understanding of the legislation and the necessary paperwork and permissions required for the clinical research.
- Introduction to clinical research
- Overview of research governance framework and legislation
- Good Clinical Practice in research training
- Process to gain relevant study approvals
- Ethical principles & dilemmas
- History of research ethics
- The informed consent process
- Regulatory compliance during active study and study closedown
- Consumer involvement
Upon completion of this module students will be able to:
• describe current legislation relating to different forms of clinical research;
• identify the current issues related to governance in different forms of clinical research;
• comply with local and national regulations and processes for obtaining permissions and approval for clinical research;
• recognize and comply with the need for good clinical practice in research;
• recognize the need for effective governance in clinical research;
Upon completion of this module students will be able to:
• apply knowledge of ethical principles and theories to clinical research projects.
• prepare and evaluate the required paperwork for real clinical research projects
• Apply the principles of Good Clinical Practice (GCP) - in the delivery of a clinical research project
| Category | Activity | Number | Length | Student Hours | Comment |
|---|---|---|---|---|---|
| Guided Independent Study | Assessment preparation and completion | 80 | 1:00 | 80:00 | Preparation for formative and summative assessments. |
| Scheduled Learning And Teaching Activities | Lecture | 18 | 1:00 | 18:00 | Ethics, legislation, governance, approvals, PIS sheet, consent form, IRAS applications |
| Guided Independent Study | Directed research and reading | 95 | 1:00 | 95:00 | Reading self-directed. |
| Scheduled Learning And Teaching Activities | Workshops | 7 | 1:00 | 7:00 | Mock ethics committee (2hrs) and completion of online GCP training (5hrs) |
| Total | 200:00 |
In lectures, students will learn fundamental principles of research governance and Good Clinical Practice as they apply to current clinical research. Students will also take part in a practical mock ethics committee.
The format of resits will be determined by the Board of Examiners
| Description | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|
| Written exercise | 1 | M | 50 | Production of a completed Consent Form and Participant Information Sheet using a given protocol |
| Written exercise | 1 | M | 50 | Complete key questions from a NHS Research Ethics Committee application form using a given protocol |
| Description | Semester | When Set | Comment |
|---|---|---|---|
| Written exercise | 1 | M | Production of a Personal CV using the IRAS Template |
| Prof skill assessmnt | 1 | M | Practical IRAS assessment during workshop |
Using a given protocol and Health Research Authority guidance students will produce a research CV (formative), participant information sheet and consent form (summative). They will also launch an application process for research approvals via IRAS (formative) and complete key answers from the application form (summative). All exercises will assess vital skills needed in practical clinical research to become an independent researcher.
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Disclaimer: The information contained within the Module Catalogue relates to the 2022/23 academic year. In accordance with University Terms and Conditions, the University makes all reasonable efforts to deliver the modules as described. Modules may be amended on an annual basis to take account of changing staff expertise, developments in the discipline, the requirements of external bodies and partners, and student feedback. Module information for the 2023/24 entry will be published here in early-April 2023. Queries about information in the Module Catalogue should in the first instance be addressed to your School Office.