Integrity and Leadership in Research for Health and Healthcare
| Module title | Integrity and Leadership in Research for Health and Healthcare |
|---|---|
| Module code | HPDM149Z |
| Academic year | 2023/4 |
| Credits | 15 |
| Module staff | Dr Anne-Marie Russell (Lecturer) |
| Duration: Term | 1 | 2 | 3 |
|---|---|---|---|
| Duration: Weeks | 12 | 0 | 0 |
| Number students taking module (anticipated) | 46 |
|---|
Module description
This is a fully online module.
During this module, you will draw from your own experience / research context, to develop a critical and reflexive understanding of key topics related to undertaking clinical research in a structured approach, with the highest regard for participants’ rights and data integrity.
You will critically explore the fundamental principles of the conduct and governance of research to gain a better understanding of planning, patient recruitment, piloting, and feasibility assessment alongside advanced communication skills. By the end of the module, you will be equipped to identify the skills and knowledge that are necessary to be an inclusive research leader.
Module aims - intentions of the module
This module will enable you to critically examine infrastructures, regulatory frameworks and policies that shape clinical research. You will be equipped to engage in Patient and Public Involvement and Engagement (PPIE) appreciating equality, diversity and inclusivity as requisite to producing a meaningful and collaborative evidence base. You will critically appraise the knowledge, skills and behaviour required of clinical researchers reflecting on rigour and integrity in the research process and demonstrate an understanding of the dilemmas clinical researchers inevitably encounter as they lead clinical research delivery. You will then develop skills in the management of financial data, as well as improving your understanding of organisational research cultures.
Intended Learning Outcomes (ILOs)
ILO: Module-specific skills
On successfully completing the module you will be able to...
- 1. Students will be able to demonstrate an in-depth knowledge of the infrastructure and regulatory frameworks that enable and support clinical research in the NHS; DHSC and NIHR.
- 2. Critically evaluate data management plans and processes to ensure data quality and integrity;
- 3. Demonstrate knowledge of ethical principles and governance processes and be able to apply these by critiquing documents sent for approval.
- 4. Demonstrate a rudimentary understanding of data analysis as applied to research project delivery.
- 5. Evaluate the lifecycle of a study, developing critiques of processes from consent to publication.
ILO: Discipline-specific skills
On successfully completing the module you will be able to...
- 6. Develop key relationships with colleagues and patients as research partners and participants through critical awareness of Public and Patient Involvement and Engagement in research.
- 7. Demonstrate fundamental understanding of how Public and Patient Involvement influences positive and effective clinical research delivery.
- 8. Comprehensively understand resource management and local / regional priorities in your own area of clinical research delivery.
ILO: Personal and key skills
On successfully completing the module you will be able to...
- 9. Critically appraise a research protocol demonstrating a practical understanding of how to recruit and retain participants in a study.
- 10. Reflect critically on the challenges of project management and leading a clinical research team.
- 11. Take a reflexive stance to critically evaluate how all participants rights are met within your community of research practice.
Syllabus plan
Whilst the module’s precise content may vary from year to year, an example of an overall structure is as follows:
This module is intended to develop your critical and reflexive understanding of clinical research, how it is structured, implemented and monitored to ensure integrity and a person-centred approach. You will develop your understanding of the structures and frameworks of clinical research, as well as an overview of how research can be done well, while retaining a person-centred focus and striving for continuous improvement. This module lays a foundation for learning across the programme. The module will include online study sessions alongside engagement in online forum discussions with your peers as a learning community and independent learning. To achieve the learning outcomes of this module, you will:
- Develop understanding of the infrastructure enabling and supporting clinical research in the NHS, DHSC and NIHR
- Consider good Clinical Practice:
- Including core regulatory frameworks,
- Management of Investigational Medicinal Products and Devices (CTIMP),
- Non CTIMP trials
- Informed Consent.
- Understand research governance:
â?« Research Ethics
â?« Safety Reporting in Clinical Research (Including CTIMP and non-CTIMP Studies)
- Consider the role of the data and safety management board and trial steering committee
- Understand how clinical research teams can be led and managed
- Establishing and maintaining oversight through the life cycle of a study
- Interaction from Health Research Authority including Research Ethics Committee (REC), HRA and the R&D / R&I Governance role.
- Data management, quality and integrity
- Understand the importance of data integrity and quality
- Consider the management of data queries at site
- Explore how public and patient involvement and engagement influences good clinical research delivery including how to strengthen
- Patient and public involvement in research governance and research delivery.
- Participant recruitment
- Identifying potential research participants / PPIE collaborators
- Screening processes
- Informed consent, including differences between clinical and clinical research consent
- Equality, diversity & inclusion (including addressing underserved communities)
- Peer reflection to learn from the shared experience.
- Evaluate local policies and standard operating procedures in the context of national guidance and regulation
- Ways of forming and delivering the leadership of clinical research
- Navigating study set up
- Project management in clinical research
- Feasibility assessment
- Appraising Clinical Research protocols, resource management, local/regional and priorities
- Finance management.
Learning activities and teaching methods (given in hours of study time)
| Scheduled Learning and Teaching Activities | Guided independent study | Placement / study abroad |
|---|---|---|
| 12 | 138 | N/A |
Details of learning activities and teaching methods
| Category | Hours of study time | Description |
|---|---|---|
| Scheduled Learning & Teaching activities | 12 | Synchronous online group learning days with other students, module lead and practitioner facilitators. Working together to develop understanding in line with ILOs, group discussions, tutorials and presentations (facilitator and student). |
| Guided Independent Study | 24 | Online learning e.g. NIHR learn etc |
| Guided Independent Study | 27 | ELE learning activities (lectures, quizzes, podcasts etc.) |
| Guided Independent Study | 27 | Reading/web-based research |
| Guided Independent Study | 60 | Assessment preparation |
Formative assessment
| Form of assessment | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|
| Participation in online learning groups: tutor group / learning communities. | Regular contributions, sharing good clinical research practices with progressive demonstration of understanding. | 1,2,3,4,5,7,9 | Peer and facilitator interactions in online discussions. |
| Reflection on a discussion with a potential participant about their involvement in a research study. | 5-10 min verbal / audio reflection. | 6,7,8,10,11 | Verbal |
Summative assessment (% of credit)
| Coursework | Written exams | Practical exams |
|---|---|---|
| 100 | 0 | 0 |
Details of summative assessment
| Form of assessment | % of credit | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|---|
| NIHR Good Clinical Practice e-learning module (pass/fail) | 0 | e-learning module completion. | All | Online via module produced feedback. |
| E-poster | 75 | SENDA compliant recruitment e-poster | 1-9 | Verbal / written |
| Critical reflection on e-poster development process. | 25 | 500 words | 3,7,10,11 | Written |
| 0 | ||||
| 0 | ||||
| 0 |
Details of re-assessment (where required by referral or deferral)
| Original form of assessment | Form of re-assessment | ILOs re-assessed | Timescale for re-assessment |
|---|---|---|---|
| E-poster | Outline strategy, recruitment materials (1500-words) | 1-9 | Typically, within 6 weeks of the result. |
| Critical reflection on E-poster development process | Critical reflection (500-words) | 3,7,10,11 | Typically, within 6 weeks of the result. |
Re-assessment notes
The NIHR Good Clinical Practice e-learning module is a pass/fail component and the overall module mark would be capped at 49% until this has been passed. You can re-take this component as many times as you need to in order to ‘pass’.
Please also refer to the student handbook
Indicative learning resources - Basic reading
- Aarons, G. A., M. G. Ehrhart, L. R. Farahnak and M. Sklar (2014). "Aligning leadership across systems and organizations to develop a strategic climate for evidence-based practice implementation." Annu Rev Public Health 35: 255-274.
- Barr, J. & Dowding, L. (2016) Leadership in health care. 3rd edition. London: Sage
- Chaudoir, S. R., L. G. Dugan and C. H. I. Barr (2013). "Systematic review factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures." Implement Sci 8(22).
- Christensen, C.M, Bohmer, R. & Kenagy, J. (2000) Will disruptive innovations cure health care? Harvard Business Review Sept 103-111
- Dale, B., Van der Wiele,T., & Van Iwaarden, J. (2007) Managing Quality 5th ed FT/Prentice Hall
- Francis, R (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Executive summary London: The Stationery Office https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/279124/0947.pdf
- Gopee, N. & Galloway, J. (2014) Leadership & management in healthcare. 2nd edition. London: Sage
- Jacobs, S. R., B. J. Weiner and A. C. Bunger (2014). "Context matters: measuring implementation climate among individuals and groups." Implement Sci 9: 46.
- Kotter, J.P (1995) Leading change: Why transformation efforts fail. Harvard Business Review March 59-67
- Kotter, J.P (1999) What Leaders Really Do. Boston, MA: Harvard Business Review Books
- Monitor (2013) Closing the NHS funding gap: how to get better value health care for patients https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/284044/ClosingTheGap091013.pdf
- Hawe, P. 2015. Lessons from complex interventions to improve health. Annu Rev Public Health, 36, 307-23.
- Hooper, A. & Potter, J. (2000) Intelligent Leadership. London: Random House Business Books
- Slack, N., Brandon-Jones, A., and Johnston R. (2011) Essentials of Operations Management, FT Prentice Hall.
Indicative learning resources - Web based and electronic resources
- ELE:
- Module ELE Page (https://vle.exeter.ac.uk/course/view.php?id=13713)
- CMH Postgraduate Programmes FAQs page (https://vle.exeter.ac.uk/course/view.php?id=7584)
- Master’s Level Learning Induction Course (https://vle.exeter.ac.uk/course/view.php?id=7584§ion=1)
- Medicine LibGuides (https://libguides.exeter.ac.uk/MedicineHomePage)
- NIHR Learn – sign up with your Exeter email (https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/)
- Introduction to Research: https://learn.nihr.ac.uk/course/view.php?id=459
- Next Steps in Research: https://learn.nihr.ac.uk/enrol/index.php?id=682
- Getting into Research – Primary Care: https://learn.nihr.ac.uk/enrol/index.php?id=938
- Research Delivery e-learning Modules: https://learn.nihr.ac.uk/mod/page/view.php?id=9555
- Health Education England e-learning - Sign up with your Exeter email: https://populationwellbeingportal.e-lfh.org.uk/login
Indicative learning resources - Other resources
- Barrett A, Kajamaa A, and Johnston J. (2020), How to be reflexive when conducting qualitative research. Clin Teach, 17: 9-12. https://doi.org/10.1111/tct.13133
- House of Commons Science and Technology Committee Research integrity Sixth Report of Session 2017–19 Report 26 June 2018 https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/350/350.pdf
- UKRIO Code of Practice for Research UK Research Integrity Office, Sussex Innovation https://ukrio.org/publications/code-of-practice-for-research/
- HRA UK Policy Framework for Health and Social Care Research Last updated on 30 Oct 2020
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/
- Erasmus Universiteit Rotterdam; ‘Dilemma Game: Professionalism and Integrity in Research’ https://www.eur.nl/sites/corporate/files/24708_integriteitsspel_interactief_2016.pdf
- COPE: https://publicationethics.org/about/our-organisation
| Credit value | 15 |
|---|---|
| Module ECTS | 7.5 |
| Module pre-requisites | None |
| Module co-requisites | HPDM150Z and HPDM151Z |
| NQF level (module) | 7 |
| Available as distance learning? | Yes |
| Origin date | 21/10/2021 |
| Last revision date | 27/04/2022 |
