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

Year 3 - Ethics and 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 (23)
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1

What is the role of healthcare research?

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

2

What is a clinical audit?

- A clinical audit is a way to understand whether a service is meeting defined standards of best practice

- Help to enforce good clinical practice

- Produce internal recommendations for any necessary improvements

- A clinical audit is therefore designed to answer the question "does this service reach a predetermined standard?".

3

What is the overall use of a clinical audit?

1) Determine whether a service reaches a predetermined standard
2) Help to enforce/improve good clinical practice

4

What are the five stages of a clinical audit?

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

5

What is a service evaluation?

A service evaluation is a way to define or measure current practice within a service.

"what standard does this service achieve?".

6

What is the overall use of a service evaluation?

The results of the service evaluation help towards producing internal recommendations for improvements that are not intended to be generalised beyond the service area.

7

What should a protocol contain in research?

Clearly defined questions, aims and objectives.

A full description of the methodology used and will help the researchers ensure adherence to it.

8

What is the primary aim of medical research?

The primary aim is to derive generalisable new knowledge.

9

Research Governance Framework?

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

10

What is a research sponsor?

Institution or organisation; ultimate responsibility for the initiation, management, financing (or arranging the financing) for that research.

11

What is the role of the research sponsor?

- Confirm that everything is ready for the research to begin

- Responsibility for putting and keeping in place arrangements to initiate, manage and fund the study

- Research protocol, research team and research environment have passed appropriate scientific quality assurance

- The study has ethical approval before it begins

- For clinical trials involving medicines, seeking a clinical trial authorisation and making arrangements for investigational medicinal products. (The Medicines for Human Use (Clinical Trials) Regulations 2004 specify the responsibilities that have to be taken by or on behalf of sponsors of trials involving medicines)

- Arrangements are kept in place for good practice in conducting the study, and for monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions.

12

What is the role of the research sponsor?

- Confirm that everything is ready for the research to begin

- Responsibility for putting and keeping in place arrangements to initiate, manage and fund the study

- Research protocol, research team and research environment have passed appropriate scientific quality assurance

- The study has ethical approval before it begins

- For clinical trials involving medicines, seeking a clinical trial authorisation and making arrangements for investigational medicinal products. (The Medicines for Human Use (Clinical Trials) Regulations 2004 specify the responsibilities that have to be taken by or on behalf of sponsors of trials involving medicines)

- Arrangements are kept in place for good practice in conducting the study, and for monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions.

13

What is co-sponsorship?

Delegation of duties of sponsor in particular those relating to monitoring of the research and provision of insurance or indemnity, should also be provided.

14

Who is uncharge of ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.

The research sponsor or co-sponsor

15

If a full NRES REC opinion is not required who would review your research?

Reviewed instead by an internal ethics committee such as CERB (CLSM Ethics Review Board) or by the Rowett Institute of Nutrition & Health or School of Psychology ethics committees.

16

Who approves research based of ethics?

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

17

What is does the NRES Research Ethics Committees review?

- 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

18

Where should ethic review application be submitted?

Through the Integrated Research Application System (IRAS).

19

If research projects raise no material ethical issues where should they be submitted for NRES REC approval?

Using the Proportionate Review Service (PRS).

20

What does R&D do?

- Ensure research is conducted to high scientific, ethical and financial standards

- Provide guidance to researchers undertaking non-commercial & commercial research involving NHS Grampian

- Guide researchers through all the processes involved in research

- Direct researchers to sources of further information

21

In 2014/2015 how may projects were overseen by R&D NHS Grampian?

In 2014/15 R&D helped manage and oversee 521 individual non-commercial research projects which have recruited over 5000 patients.

22

What does the R&D process ensure?

• 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.

23

What are the functions of the R&D?

- Processing of research projects prior to issuing R&D permission, research passports, Central Portfolio Management System (CPMS)

- Gathering required documentation for proposed research in NHS Grampian including ethics and researchers

- Liaison with commercial companies
Management of commercial research
- feasibility
- contracts
- R&D permissions
- Amendments

- Costings and finance

- Permissions for non-commercial research
NHS costs for grant applications,

- Contracts

- Amendments

- Non-commercial enquiries