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Copy of Principles

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Karolina Rucinska

on 27 January 2016

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Transcript of Copy of Principles

Research Governance and Ethics: principles and practice
What you need to know about obtaining the right approvals for your research project.

IRAS
Regulatory context and history
Dear sir:

Some time ago you were given a thorough examination and since that time we hope you have gotten a great deal of treatment for bad blood. You will now be given your last chance to get a second examination. This examination is a very special one and after it is finished you will be given a special treatment if it is believed you are in a condition to stand it.

REMEMBER THIS IS YOUR LAST CHANCE FOR SPECIAL FREE TREATMENT. BE SURE TO MEET THE NURSE.”




Non-compliance

Principles
Practice
Helen Falconer
Research Governance Officer

Source: Jones, J. Bad Blood Free Press, New York 1981. Quoted in Pence, GE. Classic Cases in Medical Ethics (4th ed.) 2004. p.282. McGraw-Hill, New York
Falsification Plagiarism
Misconduct Fabrication
Mismanagement
Nuremberg Code
Mental Capacity Act

Declaration of Helsinki

Professional Ethics

Human Tissue Act

Good Clinical Practice

Data Protection Act

Research Governance Framework

EU Clinical Trial Directive

Scope
“All research that is concerned with the protection and promotion of public health”
Protects Patients

Scientific Quality

Good Research

Benefit to NHS

Misrepresentation
Cardiff University Research Integrity & Governance Code of Practice
Ethics
Independent ethical scrutiny
All research involving human participants, human tissue or data must be subject to ethical review
School Research Ethics Committee (REC) or NHS REC
NHS patients (or their data)= NHS REC
Quality
Independent scientific/peer review
Transparency

Accountability
Responsibility
Honesty
Openness
Rigour
Excellence
Respecting others

Safety
Adherence to Health and Safety regulations
Lone working policy
Safety of all involved (both the researchers and the participants) is paramount

Research data
Systems to protect IP
Access to research findings
Secure storage



Data
Roles and Responsibilities

The company, institution or organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research.

For student projects, Cardiff University will be the Sponsor


Chief Investigator (CI)
Understand Protocol

Principal Investigator (PI)

The individual responsible for the conduct of the research at a research site.

Sponsor 

Individual responsible for the conduct of the whole project.

Training staff

Record of recruitment

Record data

Equipment maintenance

Protect Trial Subjects

Product Accountability

Safety Reporting

Monitoring

Communication
Lab evaluations

Before applying for approvals
Accurate costing
Support costs?
NISCHR support
Portfolio
Pathway to portfolio
Funding secured prior to application to REC and R&D Office

Scientific Review
Every proposal for health and social care research must undergo independent peer review.


Level of review dependent of type of project:

MSc/PhD– review by supervisor and/or course director

Scientific review required prior to application for NHS Ethics and R&D approval
Peer review should be
Proportionate

Independent
Expert
Applying for Sponsorship

Funding

Provides details of project for Sponsor Risk Assessment/insurance;

Must be signed by CI/PI (usually your supervisor). This confirms CI/PI is aware of RG requirements;

Send along with your research protocol/proposal, evidence of peer review, Patient Information Sheets and Informed Consent Forms, questionnaires etc.


Advanced Project Information Proforma (APIP) form (Sponsorship application)
Is your study research?
Protocol and project documents
Title
1.Abstract/summary
2.Background or rationale of the project
8. Participant Information Sheet (PIS/PIL) and
9.Consent Form
3. Aims / objectives
4. Design and methods (including
statistical analysis)
5.Ethical considerations
6.Benefits of the study
7.Resources and costs
Supporting documents:

Costs, agreements, laboratory instructions, scientific review

hra.nhs.uk/resources/before-you-apply/consent-and-participation/consent-and-participant-information/


Download APIP from
Send documents to
resgov@cardiff.ac.uk
Sponsorship review
Tips
Forms
Commencing research
Approvals in place
During your research
Maintain a Study Master File
Keep your data secure
Archiving
falconerhe@cardiff.ac.uk
resgov@cardiff.ac.uk
We're all good people, aren't we?
Maintain your approvals
Integrity
Finance & Indemnity
Adequate insurance provisions
Project is financially viable

How is your study defined by the NHS?
Defined as RESEARCH
Does your study measure existing standards of clinical care?
Does it:

Aim to derive generalizable new knowledge?

Aim to find out what
should
be happening (rather than what's happening)?

Involve randomization?

Test a hypothesis?

Address clearly defined questions, aims and objectives?

Collect data or involve processes which are additional to routine care?



Does it involve any of the following?

 NHS patients, or relatives of patients, as participants, recruited through the NHS?
 Adults lacking mental capacity to consent?
 Accessing patient data (identifiable or anonymous)?
 The collection of human tissue samples?


Ethical approval from NHS Research Ethics Committee
Does it involve NHS Staff as participants?
NHS R&D Approval
Your study is likely to be defined as
service evaluation
. Contact the R&D Department of the relevant Health Board/Trust to verify this and register the study.

Does it involve human participants (either as patients or staff)?
Obtain Ethical approval from University School Research Ethics Committee (SREC).
Does your study aim to assess whether current practice is working/meeting expected standards?
Your study is likely to be defined as
clinical audit.
Contact the R&D Department of the relevant Health Board/Trust to verify this and register the study.

Does it involve human participants (either staff or patients)?

If your study is classified as research...
Things to consider before applying for Sponsorship
Search 'APIP' on the Cardiff University home page or contact resgov@cardiff.ac.uk
Data
NHS Involvement
Tissue samples
Full transcript