Conducting Clinical Research

Learning Outcomes

Learning Outcomes

Having successfully completed this module you will be able to:

• Critically explore issues in relation to ethics, governance, data protection in the conduct of clinical and health research
• Where relevant, critically evaluate your own clinical research practice, considering both your personal development needs and your practice context
• Demonstrate an understanding of evidence relevant to the conduct of research in clinical and health settings.
• Critically examine the delivery of clinical and health research, demonstrating an understanding of the impact of research and development policies, governance and regulations on project delivery
• Identify potential challenges in, and devise recommendations for, conducting appropriate and feasible clinical and health research

Content for this module may include:

1.Research roles and responsibilities

2.Managing research in clinical practice

3.Ethical issues relating to the conduct of research in clinical practice, including for example local and national ethical approval process, data utilisation, risk assessments and Research Governance.

4.Processes for NHS patients/staff, use of routine NHS data and data collection outside the NHS

5.Consideration of data recording, storage archiving and data protection

6.Conduct of research in health and clinical setting, including for example sampling approaches, access, recruitment, retention, consent, working in teams and with gatekeepers

7.Time management, project management tools, good practice, record keeping, report writing

8.The regulatory environment – national and international

Teaching and learning methods

The format of taught sessions may include lectures and workshop/seminars, which will draw on expertise and examples of recent and ongoing clinical and health-related research in the University and NHS, self directed learning, and independent study supported by web resources, including Blackboard.

Resources & Reading list

Internet Resources

Department of Health: Research governance framework for health and social care.

Textbooks

Portney IG (2009). Foundations of Clinical Research. Applications to Practice. Upper Saddle River NJ: Pearson Prentice-Hall.

Lenfant C (2016). Clinical Research in Practice: a guide for the bedside scientist. London: Jones & Bartlett Publishers.

Assessment strategy

The formative assessment will comprise a group activity reviewing examples of research conduct challenges and developing recommendations.

Completion of the summative assessment for this module, as follows:

You will presented with 5 scenarios representing challenges or issues relevant to the conduct of research in clinical or health settings.

You will choose 3 of the 5 scenarios for your assignment, providing a brief rationale for your choice.

You will discuss solutions to the chosen scenarios, supporting your recommendations with critical appraisal of relevant literature and with reference to relevant policy and legislation

The assignment will be 3,500 words +/-10%. In total

Feedback Method

For the formative assessment, students will receive verbal feedback from the group facilitator.

For the summative assessment, students will receive detailed written feedback highlighting strengths of the assignment and areas for development.

A pass mark of 50% must be achieved in this summative assessment to successfully complete this module.

Formative

This is how we’ll give you feedback as you are learning. It is not a formal test or exam.

Summative

This is how we’ll formally assess what you have learned in this module.

Repeat Information

Repeat type: Internal