Transcript Research Ethics Information Session June 2013

Ethics Forum – June 2013
Andrew Thornton
Chairman, HREC
Royal Adelaide Hospital
HREC Issues & Pressures
> Workloads
> Additional requirements and processes
due to on-line forms
> Transitioning to electronic filing by
electronic submissions of all
documentation.
> Additional requirements and processes
due to SA Health Policies
> Issues with linking research into
governance, delegations of authority,
credentialing, accreditation
> National Approach (formerly HoMER).
We need your help!
> We are working towards making more
use of electronic media and less hard
copy.
> We are trying to balance the needs of SA
Health policy against the need to keep
the committee functioning effectively and
against the needs of researchers.
> We need everyone’s help to keep the
workloads manageable and to avoid
mistakes happening.
For new submissions involving
an investigational drug or device
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NEAF (through on-line forms only)
Cover letter/Investigator’s Statement (1 electronic + 2 hard copies)
Protocol (1 electronic copy and 2 hard copies)
Informed Consent Documents (1 electronic copy and 2 hard copies)
Investigator’s Brochure/Product Info (1 electronic and 1 hard copy)
IDSC Form A (1 electronic copy)
IDSC Form B (1 electronic copy)
Pharmaceutical Checklist (1 electronic copy)
Questionnaires (1 electronic copy)
Advertising material (1 electronic copy)
Any other material (1 electronic copy)
CTN Form (1 hard copy)
Radiation Safety Report (1 electronic copy and 1 hard copy)
EPA Notification Form (1 electronic copy and 1 hard copy)
Invoicing Form (1 electronic copy and 1 hard copy)
The submission must be complete with ALL documentation
Other new submissions which
require full committee review
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NEAF (through on-line forms only)
Cover letter (1 electronic copy and 1 hard copy)
Protocol (1 electronic copy and 1 hard copy)
Informed Consent (1 electronic copy and 1 hard copy)
Advertising material (1 electronic copy)
Questionnaires (1 electronic copy)
Any other material (1 electronic copy)
Radiation Safety Report (1 electronic copy and 1 hard copy)
EPA Notification Form (1 electronic copy and 1 hard copy)
Invoicing Form (1 electronic copy and 1 hard copy)
Any other material (1 electronic copy)
The submission must be complete with ALL documentation.
For LNR studies which are
suitable for expedited review
> Check with Heather whether the study is appropriate for
expedited review.
> Cover letter (1 electronic copy and 1 hard copy)
> Protocol (1 electronic copy and 1 hard copy)
> Informed Consent (1 electronic copy and 1 hard copy)
> Questionnaires (1 electronic copy)
> Advertising material (1 electronic copy)
> Any other material (1 electronic copy)
> Radiation Safety Report (1 electronic copy and 1 hard copy)
> EPA Notification form (1 electronic copy and 1 hard copy)
> There will be an on-line LNR form shortly.
> There will be an on-line LNR SSA form shortly.
Amendments
> Electronic
• Request For Review Of Updated
Documentation
• Cover letter to give broad overview of reason for
change and point to the detailed summary
• Summary of changes
• Amended documentation
• Detailed summary of changes including old text,
new text and rationale (electronic).
> Hard Copy
• Cover letter
• Amended Information Sheet
IBs (including Addendums) or
Equivalent documentation
> Electronic
• Request For Review Of Updated Documentation
• Cover letter
• Amended documentation
> Hard copy – nil
> Remember that somewhere there must be a
statement from the PI to indicate whether the new
information changes the risk/benefit of the study or
creates any additional issues which the committee
should be aware of.
Safety information (SUSARS,
DSUR, etc, SAE, Protocol
violations, DSMB reports, etc)
> Electronic
• Request For Review Of Updated Documentation
• Cover letter
• Relevant documentation.
> Hard copy – nil
> Remember that somewhere there must be a
statement from the PI to indicate whether the new
information changes the risk/benefit of the study or
creates any additional issues which the committee
should be aware of.
For other notifications (Annual
reports, Close-outs, etc)
> Electronic
• Cover letter
• Relevant documentation
> Hard copy - nil
General requirements…1
> Make sure that all of the appropriate documents are
submitted.
> Make sure the appropriate documents are listed in
exactly the way you need them to be approved,
either in a cover letter, email, or in another form
such as the new “Request For Review Of Updated
Documentation”
> Submit the document list in MS-Word format
> Submit other documents as PDF’s which are
searchable not as scanned documents.
> Use “track changes” for all document changes.
> If any submitted documents have a password, we
must know what that password is.
General requirements…2
> Submit the cover letter or cover page with scanned
signatures or preferably use an electronic signature for
the PI – please check that there is some control on the
use of the signature
> Tell us how you are submitting, ie “electronic only” or
“hard copy to follow” (in the email, not the subject line).
> Don’t send unnecessary hard copy – it will go in the
bin.
> Please don’t assume that we know what has gone on
before – put the new submission in context.
> CDs should be labelled with the RAH Study Number
and the PI name and submitted in SOFT covers, not
hard covers.
Email requirements
> Subject Line – include REC # and short description of
contents/documents submitted only
> In the email body (or in the “Request for Review…”)
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Full title of Protocol and REC Protocol No.
Name and title (Mr., Ms., A/Prof, Dr) of PI
Indication of what is to be reviewed/submitted
List of documents submitted for review, and listed how
they are to be approved.
> In the email or associated documentation, there must
be contact name and return address location.
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Name: Dr Mary Smith,
Dept: Dept of Ingrowing Toenails,
Location: Level 1, Thornton Block.
Phone: 8222-4139
Invoicing issues
> If there is a change to the Invoicing Details
please notify us promptly of:
• Contact person
• Name of Sponsor
• Address where the Invoices are to be sent
> A new Invoice Form or the new “Request
for Review of Updated Documentation”
must be provided for every related study
News on the “National Approach”
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July 2013?
Single ethical review
Multiple governance reviews
CPI responsibilities
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Submitting all documents*
Coordinating with all sites
Liaising with sponsor
Preparing generic SSA
> PI responsibilities
• Preparing specific SSA
• Dealing with local RGO
*Note that we are happy with a generic Information Sheet
– provided that the text is the same at all sites, it is not
necessary to submit customised Information Sheets
Other issues
> Committee recruitment
> Committee feedback