Healthcare Research Sponsorship Research Ethics and NHS Approval for Clinical Research Flashcards Preview

Year 2: Medical Ethics & Law > Healthcare Research Sponsorship Research Ethics and NHS Approval for Clinical Research > Flashcards

Flashcards in Healthcare Research Sponsorship Research Ethics and NHS Approval for Clinical Research Deck (26)
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1
Q

Why is healthcare research done?

A
  • Prevent illness
  • Detect or diagnose illness
  • Treat illness
  • Improve quality of life
  • Support patients/staff
  • Improve clinical effectiveness
  • Value for money
2
Q

What is the primary aim of healthcare research?

A

Primary aim is to derive generalizable new knowledge

3
Q

Why is a research governance framework used for research?

A
  • Improves research quality and safeguards the public by:
    • Enhancing ethical and scientific quality
    • Promoting good practice
    • Reducing adverse incidents and ensuring lessons are learned
    • Forestalling poor performance and misconduct
4
Q

What does MHRA stand for?

A

Medicines and Healthcare Products Regulatory Agency

5
Q

Who authorises all clinical trials in the UK?

A

Medicines and Healthcare Products Regulatory Agency (MHRA)

6
Q

What is a research sponsor?

A

Is an institution or organisation responsible for initiation, management, financing (or arranging financing) for research

7
Q

What are examples of potential research sponsors?

A
  • Main funder of research
  • Employer of chief investigator
  • Educational institution
8
Q

When must the prospective sponsor be named by?

A

Before submitting application through IRAS

9
Q

What is a research sponsor’s role?

A
  • Confirm that everything is ready for research to begin
    • Puts in place and maintains everything to initiate, manage and fund study
    • Research protocol, team and environment pass appropriate scientific quality assurance
    • Study has ethical approval
    • For clinical trials involving medicines, seeking authorisation (Medicines for Human Use (Clinical Trials) Regulations 2004 specifies responsibilities)
    • Arrangements in place for good practice in conducting the study, monitoring and reporting
10
Q

How is ethical approval achieved?

A

Ethical review achieved through review of research taking place within NHS by NRES Research Ethics Committees (NRES RECs):

  • Gives opinion about proposed participant involvement and if research is ethical
  • Most research conducted within NHS require this
11
Q

What does NRES RECs stand for?

A

NRES Research Ethics Committees

12
Q

Why are research ethics considered?

A
  • Protect everyone from harm
  • Preserves rights and dignities of participants
  • Creates culture of respect and trust between researchers and participants
  • Provides rearrange to participants, public and funders
  • Maintains integrity and reputation of researchers and host institutions
13
Q

What do ethical committees review?

A
  • Relevance of trial
  • Trial design
  • Risks and benefits
  • Protocol
  • Suitability of the investigator and supporting staff
  • Quality of the facilities
  • Subject information
  • Consent procedure
  • Justification for including minors or adults unable to give informed consent
  • Insurance/ indemnity
  • Rewards or compensation for investigators and subjects
  • Subject recruitment
  • Registration on Public Database
14
Q

Applications for ethical review through what?

A

Integrated Research Application System (IRAS)

15
Q

What does IRAS stand for?

A

Integrated Research Application System

16
Q

Projects that raise no ethical issues may apply for what instead of using IRAS for ethical approval?

A
  • Projects that raise no ethical issues may apply for NRES REC approval using proportionate review service (PRS)
17
Q

What does PPI stand for?

A

Patients and public involvement

18
Q

Why do we need research and development approval when ethics are approved?

A
  • Permissions
  • Research Passports
  • Training
  • Support for researchers
  • Quality Assurance: Monitoring and Audit
  • Research Nurses
  • Funding and contracts
  • Reporting
19
Q

What does a research and development division do?

A
  • Ensures is high scientific and ethical standard
  • Provides guidance
  • Direct researcher to sources of information
20
Q

What are functions of the research and development division?

A
  • Processes research projections prior to issuing research and development permission
  • Gathers required documentation for proposed research in NHS
21
Q

What does the research and approval process ensure?

A
  • An appropriate study sponsor is identified
  • The scientific quality of the proposal (as required)
  • That there is a favourable ethical opinion from an appropriate REC
  • Appropriate regulatory authorisations are in place
  • Appropriate risk/benefit analysis
  • Provisions for appropriate insurance/indemnity
  • The financial and resource implications of the study are assessed
  • Appropriate trial registration
  • All researchers have substantive or honorary NHS GG&C contracts
  • All researchers are adequately qualified
  • Support department approval
  • Formal agreements or contracts with external bodies meet the requirements of the Board.
22
Q

Why is a clinical audit done?

A
  • Understand if clinical service is meeting standards of best practice
  • Help to enforce good clinical practice
  • Produce internal recommendations for improvements
23
Q

What is the process of a clinical audit?

A

1) Identify problem or issue
2) Set criteria and standards
3) Observe practice/data collection
4) Compare performance with criteria and standards
5) Implementing change

24
Q

Clinical audit is designed to answer what question?

A

“does this service reach the standard”

25
Q

Why is a service evaluation done?

A
  • Measures current practice within a service
  • Results produce internal recommendations for improvements
26
Q

Service evaluation is deigned to answer what question?

A

“what standard does this service achieve”