1. APPLYING TO THE ETHICS COMMITTEE
Who is the Co-ordinating Investigator and who is the Principal Investigator?
The Co-ordinating Investigator is the person who takes overall responsibility for the research project and submits the project for ethical and scientific review. They are responsible for ongoing communication with the ethics committee and passing on any outcomes from this to the Principal (site) Investigators, if the research is multi-centre. For single centre research, Co-ordinating Investigator and Principal Investigator are synonymous.
Can a student be the Co-ordinating Investigator on an ethics application?
It is preferable that the supervisor of a student project is named as the Co-ordinating Investigator, not the student. Contact the Executive Officer of the Ethics Committee if you would like to discuss this.
How long do I need to keep my research data for? (HREA section Q3.14 along with the Section 8.0 of the Research Data management Plan (RDMP))
The minimum recommended period for retention of research data is 5 years from the date of publication. However, for clinical trials, research data should be retained for 15 years after the closure of the study, or longer if necessary (in line with Note for Guidance on GCP annotated with TGA comments CPMP/ICH/135/95).
Will the data I collect and store for my project be in identifiable form? (HREA section 3, questions Q3.1- Q3.4)
No - in most cases you will collect and store the data in a “re-identifiable” form i.e. individual participant data will carry a “code”. The link between the code and identifiable information such as name, address or MRN will be held in a separate secure location. The data is held in a re-identifiable form to allow for audit of data by sponsors, regulatory authorities or the ethics committee or for data linkage purposes. Make sure your questionnaires, surveys and data collection tools all carry a code rather than any identifying information. Remember that “non-identifiable data” is data from which identifiers have been permanently removed and from which a specific individual could not be identified.
What are some other tips for making a submission to the Ethics Committee? (Submit the study Protocol)
• Ensure that the study title is consistent throughout the application, Participant Information Sheet & Consent Form
• Use plain language in the Participant Information Sheet; avoid technical language
• Put version numbers and dates on all your documents
• Put page numbering on your documents
• Ask someone to proof read your submission
• Researchers who are also Head of Department (HOD) will need to get someone else to sign the HOD declaration
• Don’t underestimate the value of a good covering letter
How soon will it take for my project to be approved?
Once the minutes of the Ethics Committee meeting are checked, correspondence is issued to applicants. This will usually occur within 7 days of the HREC’s meeting date.
The Ethics Committee does its best to provide you with a final ethical opinion on your project within 60 days of the submission date. For a Low and Negligible Risk (LNR) application this will happen within 30 days of the date of submission. The “clock” is turned off while the submission is back in your hands to respond to the Ethics Committee’s queries.
Remember you can’t start your project at a public hospital until your Site Specific Assessment (SSA) form for that hospital has been authorised.
2. APPLYING TO THE RESEARCH GOVERNANCE OFFICER
Some tips for completing a Site Specific Assessment (SSA) application
If you are unsure of anything, phone the Research Governance Officer on 02 95157899
Write a cover letter to include anything you feel the SSA does not fully cover
SSA form Question 3 – always describe the role of the Investigators clearly in the SSA (rather than repeating their title). The RGO needs to know who is recruiting; who is consenting; who is carrying out study procedures.
SSA form Question 9 - give details of any hospital department whose resources may be utilised as part of the research - and provide the appropriate Head of Department signature(s) at declaration (c).
Discuss with the RGO the necessary requirements for non-SLHD employees
3. What do I need to know about submitting clinical trial documents?
The Form of Indemnity, Insurance Certificate and Clinical Trial Research Agreement (CTRA) should all have the Sponsor’s name listed exactly the same on each document
4. Ensure the Insurance Certificate:
Is current. (If it expires within one or two months please request confirmation from the Sponsor that a new Certificate will be issued
lists the Australian Sponsor’s name
lists Clinical Trials as being covered and/or the name of the particular clinical trial
is for $20 million Australian Dollars (commercial) or $10 million Australian dollars (collaborative)
5. Ensure the Clinical Trial Agreement:
Has the correct name, address and ABN number for the Institution on page 1. (Never list the hospital or your department as the Institution. The Institution is always Sydney Local Health District Level 11 KGV Building, Camperdown NSW 2050 ABN 17 520 269 052)
Has the Sponsor’s signature on the signature page and that the Principal Investigator does not sign in the section for the Chief Executive
That the HREC which approved the ethics application is listed as the Responsible HREC in Schedule 1
Has only approved Special Conditions in Schedule 4 or 7. Special conditions are reviewed and approved by the NSW, Qld, Vic and SA Health Departments (the SEBS States). Please supply evidence of the letter of approval and a copy of the Special Conditions or emailed correspondence
6. When do I need to complete a CTN form?
A CTN needs to be submitted online to the Therapeutics Goods Administration (TGA) when you are conducting a study which involves:
A product not listed on the Australian Register of Therapeutic Goods (https://www.tga.gov.au/australian-register-therapeutic-goods) including any new formulation of an existing product or any new route of administration
Use of a registered or listed product outside the conditions of its marketing approval
7. Do I have to wait for the TGA to acknowledge my CTN form before I can start?
The CTN Scheme is a notification scheme and, as such, no TGA approval is given. A clinical trial is deemed to have been notified as soon as the sponsor has completed the online CTN form and forwarded it to the TGA with the relevant fee. The TGA website says: “…. legally, a sponsor does not have to wait for the TGA's acknowledgment letter before commencing the trial. However, it may be advisable for sponsors to wait for the TGA's acknowledgment in case there is anything, such as incomplete information on the CTN form that might invalidate the notification”.