Study information

Integrity and Leadership in Research for Health and Healthcare

Module titleIntegrity and Leadership in Research for Health and Healthcare
Module codeHPDM149Z
Academic year2024/5
Credits15
Module staff

Ms Josephine Studham (Convenor)

Duration: Term123
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:

�       Research Ethics

�       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 ActivitiesGuided independent studyPlacement / study abroad
12138N/A

Details of learning activities and teaching methods

CategoryHours of study timeDescription
Scheduled Learning & Teaching activities12Synchronous 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 Study24Online learning e.g. NIHR learn etc
Guided Independent Study27ELE learning activities (lectures, quizzes, podcasts etc.)
Guided Independent Study27Reading/web-based research
Guided Independent Study60Assessment preparation

Formative assessment

Form of assessmentSize of the assessment (eg length / duration)ILOs assessedFeedback method
Participation in online learning groups: tutor group / learning communities.Regular contributions, sharing good clinical research practices with progressive demonstration of understanding.1,2,3,4,5,7,9Peer 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.6,7,8,10,11Verbal

Summative assessment (% of credit)

CourseworkWritten examsPractical exams
10000

Details of summative assessment

Form of assessment% of creditSize of the assessment (eg length / duration)ILOs assessedFeedback method
NIHR Good Clinical Practice e-learning module (pass/fail)0e-learning module completion.AllOnline via module produced feedback.
E-poster 75SENDA compliant recruitment e-poster 1-9Verbal / written
Critical reflection on e-poster development process.25500 words3,7,10,11Written
0
0
0

Details of re-assessment (where required by referral or deferral)

Original form of assessmentForm of re-assessmentILOs re-assessedTimescale for re-assessment
E-poster Outline strategy, recruitment materials (1500-words)1-9Typically, within 6 weeks of the result.
Critical reflection on E-poster development processCritical reflection (500-words)3,7,10,11Typically, 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)

 

Indicative learning resources - Other resources

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

Key words search

Patient participation, person-centred, research delivery

Credit value15
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