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Copy of Principles
Transcript of Copy of Principles
What you need to know about obtaining the right approvals for your research project.
Regulatory context and history
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.”
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
Mental Capacity Act
Declaration of Helsinki
Human Tissue Act
Good Clinical Practice
Data Protection Act
Research Governance Framework
EU Clinical Trial Directive
“All research that is concerned with the protection and promotion of public health”
Benefit to NHS
Cardiff University Research Integrity & Governance Code of Practice
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
Independent scientific/peer review
Adherence to Health and Safety regulations
Lone working policy
Safety of all involved (both the researchers and the participants) is paramount
Systems to protect IP
Access to research findings
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)
Principal Investigator (PI)
The individual responsible for the conduct of the research at a research site.
Individual responsible for the conduct of the whole project.
Record of recruitment
Protect Trial Subjects
Before applying for approvals
Pathway to portfolio
Funding secured prior to application to REC and R&D Office
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
Applying for Sponsorship
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
2.Background or rationale of the project
8. Participant Information Sheet (PIS/PIL) and
3. Aims / objectives
4. Design and methods (including
6.Benefits of the study
7.Resources and costs
Costs, agreements, laboratory instructions, scientific review
Download APIP from
Send documents to
Approvals in place
During your research
Maintain a Study Master File
Keep your data secure
We're all good people, aren't we?
Maintain your approvals
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?
Aim to derive generalizable new knowledge?
Aim to find out what
be happening (rather than what's happening)?
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
. 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
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 firstname.lastname@example.org