sean jennings: research ethics and governance
TRANSCRIPT
of
Dr. Sean Jennings,
Research Ethics and Governance
Sponsorship
The sponsor is:
“Individual, organisation or group taking on
responsibility for securing the arrangements
to initiate, manage and finance a study.”
The DH Research Governance Framework lists
13 separate sponsor responsibilities, with an
additional 7 for Clinical Trials of Investigatory
Medicinal Products (CTIMPs).
Research Governance
“Research Governance” describes the
institutional systems for supporting researchers
in making sure our research is:
– safe
– high quality
– Compliant with regulations
– ethical
The research governance team:
Support researchers right across the
university in meeting regulatory, funder
and gatekeeper requirements
Provide specialist support for Clinical
Trials.
Make sure that we meet sponsor
responsibilities.
Sponsorship
Ethics review
NHS Research Management and
Development (R&D) approval
Things that need to happen before
your research project starts:
Sponsorship
Ethics review
CTIMPs: Clinical Trial Authorisation
Eudract number
Contracts and agreements- MTA if
transferring tissue or materials between
institutions
NHS Research Management and
Development (R&D) approval
Things that need to happen before
your research project starts:
Things that need to happen after you
start:
Inform REC and Governance Team about
substantial amendments
For University sponsored projects annual
reports should be sent to the ethics
committee and to the Governance Team.
Any tissue collected needs to be properly
logged, so that we know where it came
from and what happened to it.
Run the project and keep
paperwork up to date
To apply for sponsorship:
Fill in the sponsor application form at
http://www.rcs.bham.ac.uk/governance/
Needs ink signatures
Send it to Jane Barclay:
– Research Support Group,
Room 119, Aston Web B-block
To apply for sponsorship
We’ll normally issue provisional
sponsorship within 3 or 4 days (exception
for CTOC).
We will not issue confirmation of
sponsorship until we have completed
checks.
Checks prior to sponsor
confirmation:
confirmed:
– ethics approval
– Insurance
– finance
– Signed university forms– submitted
SAF and sponsorship forms
– Any other required approvals
Other things:
For a clinical trial of an intervention you
will need a lot of agreements put in place.
For a clinical trial of an investigatory
medicinal product there are additional
requirements:
– Register on Eudract
– Clinical Trials Authorisation
Other things:
If you are running a clinical trial not
through a Clinical Trials Unit, then the
decision on sponsorship will be taken by
the Clinical Trials Oversight Committee–
and this may take a month or so.
If you are running a clinical trial of any
sort you will need a number of
agreements...
Possible agreements...
Funding agreement.
Coordination agreement
Site agreements
Drug supply agreements
Technical agreements...
The Governance Team is:
Dr. Brendan Laverty
[email protected] ext. 47618
Head of Research Governance and Ethics
Dr. Sean Jennings
[email protected] ext. 58011
Research Governance Officer
Ms. Jane Barclay
[email protected] ext. 43698
Research Governance Administrator