Embed Size (px)
Citation preview
K:\Med Admin\02-03¤t\Ethics - Eastern Health\All Correspondence\2017 studies\Advertising External Research\My Aid Gastroenterology 2017 Page 1 of 1
Approval to Recruit at Eastern Health
12 January 2017 Ms Sarah Chivers Hepatology Coordinator Department of Gastroenterology and Hepatology Eastern Health Level 2, 5 Arnold Street Box Hill 3128 Dear Sarah,
My Actively Informed Decision for Ulcerative Colitis (myAID) Principal Investigator: Dr Susan O’Connor Eastern Health Contact Person: Sarah Chivers Eastern Health Site: Box Hill HREC Approval: HREC/15/LPOOL/358 (South Western Sydney Local Health District HREC) Thank you for your email with respect to recruitment of participants at Box Hill Hospital for the study being undertaken at Liverpool Hospital NSW. It is understood that Dr Daniel van Langenberg and Dr Mayur Garg will oversee recruitment of patients. The study will be advertised (approved flyer) and discussed with appropriate patients at the Inflammatory Bowel Disease Clinics conducted at Eastern Health by Gastroenterologists and Inflammatory Bowel Disease Nurses. If the patient agrees to participate, their details will be provided by the IBD nurse to the study coordinators based at Liverpool Hospital and be contacted directly by them for consent and completion of the on-line questionnaires and faecal sample collection over a period of 12 months. It is anticipated that recruitment will continue until 1st Feb 2019 with an intention to recruit up to 40 participants. The Associate Professor Amanda Nicoll as Director of the Department of Gastroenterology and Hepatology has approved the recruitment of participants at Box Hill. Kind Regards
Chris Rose’Meyer Manager Eastern Health Office of Research and Ethics
Eastern Health HREC Ph: 03 9895 3398 Fax: 03 9094 9610 Email: [email protected] www.easternhealth.org.au/research
SSA Authorisation 16-CRGH-296
16 November, 2016 Professor Rupert Leong c/- Ms Sasha Ruban Department of Gastroenterology CONCORD RGH Dear Professor Leong, HREC reference number: HREC/15/LPOOL/358 SSA reference number: SSA/16/CRGH/296 Project title: Controlled trial of a decision aid for ulcerative colitis patients: Enhancing patients’ quality of life, empowerment, quality of decision making and disease control Thank you for submitting an application for authorisation of this project. I am pleased to inform you that the delegate of the Chief Executive has granted authorisation for this study to take place at the following site:
Concord Repatriation General Hospital The participant documents approved for use at this site are: Liverpool Hospital Participant Information Sheet & Consent Form Version 6.0 dated 23 September 2016 The following conditions apply to this research project. These are additional to those conditions imposed by the Human Research Ethics Committee that granted ethical approval:
1. Proposed amendments to the research protocol or conduct of the research which may affect the ethical acceptability of the project, and which are submitted to the lead HREC for review, are copied to this office.
2. Proposed amendments to the research protocol or conduct of the research which
may affect the ongoing site acceptability of the project, are to be submitted to this office.
3. Please note that you are responsible for making the necessary arrangements (eg identity pass) for any researcher who is not employed by the Sydney Local Health District and is conducting the research on-site at CRGH.
Yours sincerely,
Virginia Turner Research Governance Officer, Concord Repatriation General Hospital
Contact: Sydney Local Health District (SLHD) Research Office
Concord Repatriation General Hospital (CRGH) Building 20, Hospital Road Concord NSW 2139 Telephone: (02) 9767 5622 Email: [email protected]
Our Ref: (SSA Authorisation SSA/16/CRGH/296)
CONCORD
REPATRIATION GENERAL
HOSPITAL
ssa approval letter.doc 1 | P a g e
3 November 2016 Professor Jane Andrews Department of Gastroenterology and Hepatology Royal Adelaide Hospital Dear Professor Andrews, HREC reference number: HREC/15/LPOOL/358 SSA reference number: SSA/16/TQEH/367 Governance reference number: 8398 Project title: Controlled trial of a decision aid for ulcerative colitis patients: Enhancing patients’ quality of life, empowerment, quality of decision making and disease control RE: Site Specific Assessment Review Thank you for submitting an application for authorisation of this project. I am pleased to inform you that authorisation has been granted for this study to commence at the Royal Adelaide Hospital, SA. The following conditions apply to the authorisation of this research project. These are additional to those conditions imposed by the Human Research Ethics Committee that granted ethical approval to this project:
1. Authorisation is limited to the site/s identified in this letter only. 2. Project authorisation is granted for the term of your project outlined in Section 9 of the
SSA, or until the project is complete (whichever date is earlier). 3. The study must be conducted in accordance with the conditions of ethical approval
provided by the lead HREC, SA Health policies, and in conjunction with the standards outlined in the National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research (2007).
4. Proposed amendments to the research protocol or conduct of the research which may affect the ethical acceptability of the project, and which are submitted to the HREC for review, are copied via email to this Research Governance Office;
5. Proposed amendments to the research protocol or conduct of the research which only affects the ongoing site acceptability of the project, are to be submitted via email to this Research Governance Office;
6. For all clinical trials, the study must be registered in a publicly accessible trials registry prior to enrolment of the first participant.
7. Proposed amendments to the research protocol or conduct of the research which may affect both the ongoing ethical acceptability of the project and the site acceptability of the project are to be submitted to this Research Governance Office after a HREC decision is made.
8. A copy of this letter should also be maintained on file by the Coordinating Principal Investigator as evidence of project authorisation.
9. Notification of completion of the study at this site is to be provided to this Research Governance Office.
Central Adelaide Local Health Network Research Office
Level 4, Women’s Health Centre North Terrace, Adelaide SA
Australia 5000 T : 08 8222 3839
ssa approval letter.doc 2 | P a g e
If University personnel are involved in this project, the Principal Investigator should notify the University before commencing their research to ensure compliance with University requirements including any insurance and indemnification requirements. We wish you every success in your research project. Yours sincerely
Bernadette Swart Manager, CALHN Research Office Ph: 8222 3890 Email: [email protected] Email: Health.ResearchGovernanceIP&[email protected]
Human Research Ethics Committee
Level 3, St John of God House 177-179 Cambridge St
WEMBLEY WA 6014 T: (08) 9382 6940
The St John of God Health Care Human Research Ethics Committee is constituted and operates in accordance with the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research (2007)
Core Members
Clin Prof Dr Simon Dimmit BMedSc (Hons) MBBS FRACP FCSANZ
Chair
Ms Tracey Piani RN BA (Hons)
Member with current experience in the professional care of humans
Fr Joe Parkinson STL PhD
Member who performs a pastoral care role
Mr Eric Heenan BLaws (Hons) The Honorable Q.C.
Member who is a lawyer that is not engaged to advise the institution
Dr Janie Brown BNurs MEd PhD
Member with current relevant research experience
Sr Leonie O’Brien BEd MPS
Laywoman with no affiliation to the institution
Dr Ben Carnley MBBS FRACP FRCPA
Member with current relevant research experience
Mr Hamish Milne BA (Hons) MPhil MBA GAICS FAIM
Layman with no affiliation to the institution
Other Members
Prof Sally Sandover BSc MPH
Community member with higher education and research administration experience
Mr Patrick O’Connor MPsych (Clinical) MBA
Community member with expert knowledge in clinical psychology
Mr Jeffrey Williams RN BSc
Hospital Representative Expert knowledge in Quality and Risk
Management, public hospital management
Mr Colin Keogh BSW MAPP GCLCC
Hospital Representative Expert knowledge in Mission and culture
Ms Mary Rigby BSc (Nurs) MBioethics
Hospital Representative Expert knowledge in nursing,
particularly in palliative care & oncology
…/2
22 April 2017 Professor Ian Lawrance Inflammatory Bowel Disease Dept, SJG Hospital Subiaco 12 Salvado Rd SUBIACO WA 6008 Dear Professor Lawrance,
Re: Controlled trial of a decision aid for ulcerative colitis patients: Enhancing patients’ quality of life, empowerment, quality of decision making and disease control (Our ref: 1138)
Thank you for your email reply of 18 April 2017, addressing the queries raised by the St John of God Health Care (SJGHC) Human Research Ethics Committee (“the Committee”).
The Committee has reviewed your reply out of session and is satisfied that there are no outstanding issues. Further to the letter of 12 April 2017, I am pleased to confirm, that the Committee has granted ethical approval of your study via an expedited review process as per section 5.1.7 of the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (NHMRC, 2007) (“the National Statement”).
The HREC approval period is from 22 April 2017 to 1 February 2019. Should an extension of this timeframe be required, you must seek continued approval from the Committee before the expiry of this time period.
In accordance with NHMRC guidelines, the Participating Site/ Principal Investigator is responsible for:
1. Notification to the HREC of any adverse events or unexpected outcomes that may affect the continuing ethical acceptability of the study;
2. The submission of any proposed amendments to the study or previously-approved documents;
3. The submission of an annual progress report for the duration of the study which is due on the anniversary of HREC approval;
4. Reporting of any protocol deviations or violations, together with details of the procedure(s) put in place to ensure the deviation or violation does not recur;
5. Notification and reason for ceasing the study prior to its expected date of completion (if applicable);
6. The submission of a final report and translation of results (including publications) upon completion of the study.
The following documents have been reviewed and approved:
Title Version Date
Liverpool Hospital Patient Information Sheet 6.0 23/09/16
myAID baseline survey
myAID patient flyer 1.0 11/10/16
UCPDA Local Protocol 3.0 09/09/16
UCPDA PSOA Approval Form 2.7 12/2016
You are reminded that this letter constitutes ethical approval only. You must not commence this research at SJGHC until separate authorisation in writing has been obtained.
I wish you well with your research.
Yours sincerely,
Clinical Professor Dr Simon Dimmitt Chairman St John of God Health Care Human Research Ethics Committee
cc. Taryn Quartermaine, Oncology Clinical Trial Unit, SJG Subiaco
Ground Floor, 111 Coventry Street, South Melbourne, VIC 3205 T. 03 9205 6500 F. 03 9690 0633 E. [email protected]
22 April 2017 Professor Ian Lawrance Inflammatory Bowel Disease Dept, SJG Hospital Subiaco 12 Salvado Rd SUBIACO WA 6008 Dear Professor Lawrance,
Re: Controlled trial of a decision aid for ulcerative colitis patients: Enhancing patients’ quality of life, empowerment, quality of decision making and disease control (Our ref: 1138)
I refer to the letter of 22 April 2017, advising of the St John of God Health Care (SJGHC) Human Research Ethics Committee approval of the above study.
I am in receipt of the SJGHC Participating Site Operational Approval Form (PSOA) from St John of God Subiaco Hospital (“the participating site”) and understand that the study will be progressed through your private consulting rooms based at St John of God Subiaco Clinic.
I now confirm final approval for your study to be conducted at the participating site.
I wish you well with your research.
Yours sincerely,
Dr Mark Lubliner Director of Medical Services St John of God Health Care
cc. Taryn Quartermaine, Oncology Clinical Trial Unit, SJG Subiaco
