Ethics Forum – May 2012
Andrew Thornton
Chairman, HREC
Royal Adelaide Hospital
Types of studies
>Drug Trials
>Device Trials
>Other clinical studies which require full
committee review
>Low and negligible risk research
>Audits
Full studies conducted at
single site (RAH)
> The study should be submitted through online forms designating RAH committee.
> The ethics/science of study should be
reviewed at RAH.
> A Site Specific Assessment must be
completed for RAH.
> Amendments, IBs should be submitted to
RAH through on-line forms.
> Annual Reports, SUSARs, SAEs etc should
be submitted to RAH as normal
Full studies conducted at
multiple sites within SA Health
> Only one application and one ethical review
is necessary.
> The main PI (coordinating CPI) may choose
a committee to review the study but this
should generally be at the CPI’s institution.
> The study should be submitted through online forms designating the lead committee.
> A separate Site Specific Assessment must
be completed at each site.
> Amendments, IBs, SUSARs, Annual
Reports, etc should be submitted to the
approving HREC only.
Connections: On-line Forms and AU-RED
Researcher
On line HREC
submission
HREC
Submission
Code
AU-RED
Database
HREC
Submission
Code
Researcher
On line SSA
submission
HREC
Office
SSA
Submission
Code
Governance
Office
Completing the HREC process
– RAH Submissions
> Complete the IDSC checklists.
> The REC checklist and yellow ethics form
and not required but all the documents you
want approved must be listed in the cover
letter (electronic submission)
> Submit 2 hard copies of the cover letter
protocol and PIS.
> Submit all documents electronically as
searchable (not scanned) PDF documents
(CD preferred)
> Complete the CTN (as appropriate).
> Let the HREC know that you have submitted
the study and quote the submission code.
Completing the HREC process
– Other documents
> Amendments: Submit on-line plus one hard
copy plus electronic version (CD preferred)
> IBs: Submit on-line plus one hard copy plus
electronic version (CD preferred)
> SUSARs: submit as now including one
electronic copy (CD preferred)
> SAEs, Annual reports: submit as now
including one electronic copy (CD or email)
> General advice: if the submission is large,
submit on a CD so that it can be filed.
Completing the submission
process - SSA
> Obtain an SSA submission code from the
on-line forms website.
> Let the Governance Officer know that
there is an SSA for RAH and quote the
submission code and the HREC
reference number which has been
allocated.
> Complete the CTA
> Complete the CTN (as appropriate).
Warning! Warning!! Warning!!!
> Submitting through on-line forms does not
alert Heather or Bernadette to the fact
that something has been submitted.
> For any on-line submission (Protocol,
Amendment, IB, etc) you must let
Heather know by email.
> For any governance submission through
on line forms you must let Bernadette
know.
Low and negligible risk
research (LNR)
At this time…
> Studies may be submitted through on-line
forms.
> Studies may also be submitted in the
traditional way (hard copy plus electronic
submission by email or CD).
> The HREC Chair will decide if the study
qualifies as LNR.
> The HREC Chair will decide if the study
requires an SSA.
> Heather will complete the entry onto the
ethics database (AU-RED).
Audits
At this time…
> Studies should be submitted in the
traditional way (electronic submission by
email or CD).
> The HREC Chair will decide if the study
qualifies as an Audit
> Audits are not required to be entered into
ethics research database.
Future
> We will publish the updated instructions
on the intranet/internet.
> We will review the IDSC checklists.
> We will work with SA Health to iron out
some issues with on-line forms.
> A simple on-line LNR ethics form will be
developed to allow on-line submission
> A simple on-line LNR SSA form will be
developed.
> The system will be available Australiawide to all single submission.