Medical Ethics and Regulations BIOL5456

• Academic Session: 2024-25
• School: MVLS College Services
• Credits: 20
• Level: Level 5 (SCQF level 11)
• Typically Offered: Semester 1
• Available to Visiting Students: No

Short Description

This course will cover the ethical considerations in clinical research and associated laws, regulations and compliance legislation. The ethical approvals and regulations at both the national and international level will be covered.

Timetable

This course runs in Semester 1 and will be delivered online live.

Excluded Courses

None

Co-requisites

None

Assessment

Assessment will consist of:

1. Individual written assignment (50%, 1500-2000 words) [ILO1, ILO2].
2. Project output (50%, 1500-2000 words) [ILO1 - ILO4].

Course Aims

The specific aims of this taught course are:

• To allow students to develop comprehensive knowledge of the ethical approvals required for clinical trials at both national and international level.
• To allow students to develop comprehensive knowledge of clinical trial national and international laws for drug product and device development.
• To provide students with a comprehensive understanding of the importance of clinical trial regulations and compliance legislation.
• To equip students with the necessary skills to evaluate representation and equity in clinical trials.

Intended Learning Outcomes of Course

By the end of this course students will be able to:

1. Critically evaluate the ethical approval process involved in a clinical trial.
2. Critically evaluate appropriate clinical trial governance and regulations.
3. Evaluate clinical trial related conduct and compliance with applicable regulatory requirements.
4. Appraise the legal and regulatory frameworks in a clinical trial.

Minimum Requirement for Award of Credits

Students must submit at least 75% by weight of the components (including examinations) of the course’s summative assessment.