Ethics Forum – June 2013

1. Ethics Forum – June 2013 Andrew Thornton Chairman, HREC Royal Adelaide Hospital

2. 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).

3. 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.

4. For new submissions involving an 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

5. Other new submissions which require 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.

6. 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.

7. 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

8. As MS-Word Document

11. 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.

12. 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.

13. For other notifications (Annual reports, Close-outs, etc) • Electronic • Cover letter • Relevant documentation • Hard copy - nil

14. 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.

15. 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.

16. Email 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

17. 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

18. 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

19. Other issues • Committee recruitment • Committee feedback