A theoretical Research Ethics and Governance Application

You will be required to submit an individually written assignment at the end of the module (Semester 1, Week 13). A theoretical research ethics and governance application will be constructed by students and will form the basis for this assignment. Within the context of this, you will be required to: critically evaluate the theoretical and philosophical underpinnings of the methodological approach, critically evaluate the impact of relevant contextual issues for the study and formulate solutions by applying appropriate legal, ethical and governance processes/frameworks. This assignment will assess all learning outcomes and carries 100% of the module mark with a word limit of 4,000. The assignment will be submitted electronically through BlackBoard by 4pm Friday

Summative Assessment (100%)

You will be required to submit an individually written assignment at the end of the module (Semester 1, Week 13).  A theoretical research ethics and governance application will be constructed by students and will form the basis for this assignment.  Within the context of this, you will be required to: critically evaluate the theoretical and philosophical underpinnings of the methodological approach, critically evaluate the impact of relevant contextual issues for the study and formulate solutions by applying appropriate legal, ethical and governance processes/frameworks.  This assignment will assess all learning outcomes and carries 100% of the module mark with a word limit of 4,000.   The assignment will be submitted electronically through BlackBoard by 4pm Friday

Assessment Criteria

Summative Assessment (100%) Students will be assessed on their ability to:

  • Demonstrate a comprehensive and critical understanding of key theoretical/philosophical underpinnings of clinical research.
  • Demonstrate a comprehensive and critical understanding of relevant contextual issues within clinical research.
  • Demonstrate a comprehensive and critical understanding of the relevant ethical considerations and the governance aspect within clinical research.
  • Make argued conclusions regarding appropriate strategies in order to address contextual issues and dilemmas.
  • Adhere to the School of Health & Social Care guidelines for presentation and referencing.

Task

  1. Read and familiarise yourself with the project protocol on BB
  2. Work through the assignment template named ‘Assessment Proforma’ drawing together the content you have explored throughout the module to build a critical appraisal of the project protocol (see example below)

Remember!

  • Cite your sources! You need to demonstrate depth and breadth of reading. The online content is merely a stepping stone!

 Research Ethics Considerations[1]

Section A – Project and team details
1. Project team roles and responsibilities
To answer this question you will need to firstly think about who should be in a research team (reflect back on the activity earlier in the module about the roles and responsibilities of the research team). Who should be involved at different stages of the study and what are their responsibilities? Don’t forget to provide reference to appropriate sources.

 

Secondly you need to apply that learning to the information in the study protocol – in your opinion, do they have the right people in the right roles? What are the strengths and limitations of the study protocol you are assessing?

 

Apply this logic to each question below.

 

Section B – Study details
2. Study procedures
 

 

3. Participant information
 

 

4. Informed consent
 

 

Section C – Study risks
5. Risks to participants
 

 

6. Risks to study team
 

 

7: Withdrawal from study
 

 

8. Preserving confidentiality and privacy
 

 

9. Safe storage, archiving, and destruction of data
 

 

10. Breaching confidentiality
 

 

Section D – Study sponsor and dissemination
11. Study sponsor
 

 

12. Dissemination activity
 

 

The form for this assignment is a modified version of the School of Health and Life Sciences’ Ethical Approval Form at Teesside University.

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