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

Question 1

Supporting patients and researchers to carry out research is done how?

Answer 1

• Risk assessment
• Safety for patients
• Improving care for patients

Question 2

Health care research encovers a wide variety of health care such as what?

Answer 2

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

Question 3

important aspect of health care research is that the _______ is at the centre but there can be huge numbers of clinical and non-clinical disciplines supporting researchers to undertake that work

Answer 3

patient

Question 4

anyone undertaking healthcare research is going to need to go through this approval process

what people may this be?

Answer 4

• NHS patients
• NHS staff
• NHS facilities
• NHS data

Question 5

picture showing different evaluations

Answer 5

Question 6

what is a clinical audit?

Answer 6

• A way to understand whether a clinical 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 the standard?”.

Question 7

what is a service evaluation?

Answer 7

• A way to define or measure current practice within a service.
• The results of the service evaluation help towards producing internal recommendations for improvements that are not intended to be generalised beyond the service area.
• A service evaluation is designed to answer the question “what standard does this service achieve?”.

Question 8

• ______ ____ and ______ _________ examine how standard care is delivered locally
• Decisions around what treatment regime, care or services to follow and administer are made jointly by the care _________ and patient/service user
• Used to ________ care where survey/evaluation/audit is conducted

Answer 8

Clinical Audit

Service Evaluation

professional

improve

Question 9

What is healthcare research?

Answer 9

• The primary aim is to derive generalisable new knowledge
• Clearly defined questions, aims and objectives
• Has a protocol which contains a full description of the methodology used and will help the researchers ensure adherence to it
• Results of the research, or the theories gained from the research, should apply beyond the sample of the population upon which the research is based

Question 10

healthcare research:

• Generates new _________
• Care or service is determined by following a set ________ then this is research
• Generalisable or __________ - not just specific to your practice

Answer 10

knowledge

protocol

transferable

Question 11

Research Governance Framework

Improves research quality and safeguards the public by what ways?

Answer 11

• enhancing ethical and scientific quality (unethical to ask patients to take part in poorly run research)
• promoting good practice
• reducing adverse incidents and ensuring lessons are learned
• forestalling poor performance and misconduct

Question 12

when you do a project you often think about the start but what are the the different steps involved?

Answer 12

Question 13

What is a sponser?

Answer 13

• But its not costing anything
• But I am doing it in my own time
• But I don’t work for NHS Grampian
• I have a sponsor
• I am a student and don’t get paid

Question 14

what is a research sponser and their role?

Answer 14

• Institution or organisation; ultimate responsibility for the initiation, management, financing (or arranging the financing) for that research.
• May be the main funder of the research, the employer of the chief investigator, the educational institution (e.g. for student research), or the care organisation where the research is to take place.
• Any research requiring the collaboration of the NHS must have an individual or organisation willing and able to take on the responsibilities of the research sponsor.
• Before submitting an application through IRAS, the prospective sponsor(s) must be named in the relevant section

Question 15

what are the responsibilities of the research sponser?

Answer 15

• Takes primary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting
• 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
• It is the responsibility of the CI to ensure that the sponsor(s) are aware of their proposal and accept these responsibilities

Question 16

what is the sponsers role?

Answer 16

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
• 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

Question 17

what is the different stages involved (previosuly shown set up) during the conduct of the study?

Answer 17

Question 18

what is ethics approval?

Answer 18

• Ethical review is achieved through the review of research taking place within the NHS by NRES Research Ethics Committees (NRES RECs)
• NRES RECs give their opinion about the proposed participant involvement and whether the research is ethical
• The majority of research conducted within the NHS requires ethical review
• If a full NRES REC opinion is not required, your research may be 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

Question 19

what is the role of research ethics?

Answer 19

• Protect participants and researchers from harm
• Preserve the rights and dignity of participants
• Create a culture of mutual respect and trust between participants and researchers
• Provide reassurance to the participants, wider public and funders regarding the ethical conduct of research
• Maintain the integrity and reputation of the researchers and host institution(s)

Question 20

what does committee review?

Answer 20

• 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 21

What is IRAS and PRS?

Answer 21

• Applications can only be made through the Integrated Research Application System (IRAS)
• Research projects which raise no material ethical issues may apply for NRES REC approval using the Proportionate Review Service (PRS)
• Ethics Committees will consider researcher’s plans for Patient and Public Involvement (PPI) as part of the ethical review process
• Specific ethical approval does not need to be sought when involving the public in trial design and management activities

Question 22

Why do I need Research & Developmental to approve when I have Ethics approval?

Answer 22

Permissions

Research Passports

Training

Support for researchers

Quality Assurance: Monitoring and Audit

Research Nurses

Funding and contracts

Reporting

Question 23

What does R&D do?

Answer 23

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

Question 24

What are R&D functions?

Answer 24

• Processing of research projects prior to issuing R&D permission, research passports,
• Gathering required documentation for proposed research in NHS Grampian including ethics and researchers

Question 25

the R&D approval proccess ensures what?

Answer 25

• 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 (research ethics committee)
• 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