Healthcare Research Sponsorship Research Ethics and NHS Approval for Clinical Research

Question 1

Why is healthcare research done?

Answer 1

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

Question 2

What is the primary aim of healthcare research?

Answer 2

Primary aim is to derive generalizable new knowledge

Question 3

Why is a research governance framework used for research?

Answer 3

• 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

Question 4

What does MHRA stand for?

Answer 4

Medicines and Healthcare Products Regulatory Agency

Question 5

Who authorises all clinical trials in the UK?

Answer 5

Medicines and Healthcare Products Regulatory Agency (MHRA)

Question 6

What is a research sponsor?

Answer 6

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

Question 7

What are examples of potential research sponsors?

Answer 7

• Main funder of research
• Employer of chief investigator
• Educational institution

Question 8

When must the prospective sponsor be named by?

Answer 8

Before submitting application through IRAS

Question 9

What is a research sponsor’s role?

Answer 9

• 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

Question 10

How is ethical approval achieved?

Answer 10

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

Question 11

What does NRES RECs stand for?

Answer 11

NRES Research Ethics Committees

Question 12

Why are research ethics considered?

Answer 12

• 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

Question 13

What do ethical committees review?

Answer 13

• 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

Question 14

Applications for ethical review through what?

Answer 14

Integrated Research Application System (IRAS)

Question 15

What does IRAS stand for?

Answer 15

Integrated Research Application System

Question 16

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

Answer 16

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

Question 17

What does PPI stand for?

Answer 17

Patients and public involvement

Question 18

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

Answer 18

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

Question 19

What does a research and development division do?

Answer 19

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

Question 20

What are functions of the research and development division?

Answer 20

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

Question 21

What does the research and approval process ensure?

Answer 21

• 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.

Question 22

Why is a clinical audit done?

Answer 22

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

Question 23

What is the process of a clinical audit?

Answer 23

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

Question 24

Clinical audit is designed to answer what question?

Answer 24

“does this service reach the standard”

Question 25

Why is a service evaluation done?

Answer 25

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

Question 26

Service evaluation is deigned to answer what question?

Answer 26

“what standard does this service achieve”