Andrew Thornton

Chairman, HREC

Royal Adelaide Hospital

Ethics Forum – June 2013Ethics Forum – June 2013

> 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).

HREC Issues & PressuresHREC Issues & Pressures

We need your help!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 For new submissions involving an investigational drug or devicean investigational drug or device

> 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 Other new submissions which require full committee reviewrequire full committee review

> 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 For LNR studies which are suitable for expedited reviewsuitable 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.

AmendmentsAmendments

> 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 IBs (including Addendums) or Equivalent documentationEquivalent 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, Safety information (SUSARS, DSUR, etc, SAE, Protocol DSUR, etc, SAE, Protocol violations, DSMB reports, etc)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 For other notifications (Annual reports, Close-outs, etc)reports, Close-outs, etc)

> Electronic• Cover letter• Relevant documentation

> Hard copy - nil

General requirements…1General 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…2General 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 requirementsEmail requirements

> Subject Line – include REC # and short description of contents/documents submitted only

> In the email body (or in the “Request for Review…”)• 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. • Name: Dr Mary Smith,

• Dept: Dept of Ingrowing Toenails,

• Location: Level 1, Thornton Block.

• Phone: 8222-4139

Invoicing issuesInvoicing 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”News on the “National Approach”

> July 2013?> Single ethical review> Multiple governance reviews> CPI responsibilities

• 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 issuesOther issues

> Committee recruitment> Committee feedback