SWAHS HREC, Nepean Campus:

Scientific Advisory Committee (SAC) & Human Research Ethics Committee (HREC)

The SWAHS HREC Nepean Campus, has been accredited as a Lead HREC in the NSW Health system of single ethical and scientific review, in the categories of Clinical Trials/interventional research and General Research.

The SWAHS HREC Nepean Campus is constituted and functions in full compliance with the National Statement on Ethical Conduct in Human Research (March 2007).

Applications for all research projects are initially assessed by the Scientific Advisory Committee, Nepean, (SAC, Nepean) prior to being considered by the Human Research Ethics Committee (HREC).

The role of the SAC is to assess the scientific value, methodological validity, sampling criteria and safety of all research proposed to be undertaken in SWAHS. The SAC may also draw the attention of the HREC to specific ethical issues.

The HREC has the delegated authority to make decisions concerning the ethical acceptability of research and innovative therapy proposals. The composition of the Committee is in accordance with the requirements of the National Statement on Ethical Conduct in Research Involving Humans. However, the HREC has the capacity to seek advice from individuals or organizations if necessary. The HREC also has the capacity to invite researchers to a meeting to discuss their applications.

Quality Assurance/Improvement projects, will be assessed by expedited review, after determination of whether the proposal meets the criteria for a QA project, based on the NHMRC’s Guidelines, “When Does QA in health care require independent ethical review”. Minimal risk projects will also receive expedited review. If in doubt, please contact the Research & Ethics Officer.

CONTACTS:

Research & Ethics Officer:Marietta Coutinho; telephone (02) 47 34 3441; fax: (02) 47 34 1365; email: ethics@wahs.nsw.gov.au OR CoutinM@wahs.nsw.gov.au

Human Research Ethics Committee:

Chairperson: Dr. Jim Kalantar; to be paged via Switch (02) 47 34 2000 or email Kalantarj@wahs.nsw.gov.au

Deputy Chairperson : Dr. Louise Cole, to be paged via Switch (02) 47 34 2000 or email: Colel@wahs.nsw.gov.au

Scientific Advisory Committee:

Chairperson: Dr Ian Seppelt; to be paged via Switch (02) 47 34 2000 or email: seppelt@med.usyd.edu.au

Deputy Chairperson : Dr. Bernard Champion; email: bernardchampion@med.usyd.edu.au

HREC DOCUMENTATION & INFORMATION:

Please note the following:

Researchers can contact any one of the above personnel, to clarify any doubts regarding HREC submissions.
HREC fees as mandated by NSW Health Department, must be submitted along with HREC applications.
Agenda closing dates will be strictly adhered to.

The HREC’s Standard Operating Procedures.
Agenda closing dates
HREC application form version dated June 2007.
For multi-centre research, the use of the National Ethics Application Form (NEAF) is mandatory. NEAF is available on a dedicated website: www.neaf.gov.au or via the NSW Health Department’s Health Research & Ethics website. There will be a six-month phasing out period of the current HREC application form, after which the use of NEAF will be mandatory for all types of research, with effect from January 2008.
Details of required number of copies.
PIS and Consent Form Guidelines and templates.
HREC Fee policy (subject to change on implementation of the Lead HREC model for single ethical and scientific review.
SAE reporting form.
Annual/Progress/Final Reporting form.
Amendments Form.

Some Statements, Guidelines and Laws used in considerations

NHMRC National Statement on Ethical Conduct in Research Involving Humans (the New National Statement version dated…..
The Research Ethics Handbook (Commentary on the National Statement) [warning 1.7 MB]
Declaration of Helsinki, but see NHMRC’s position on the Declaration
ICH Good Clinical Practice Guidelines
NSW Privacy and Personal Information Protection Act 1998, and Section 41 Directives from the NSW Privacy Commissioner (researchers using NEAF will not be required to provide a privacy form, as NEAF carries the relevant ‘Privacy’ questions)

Useful links:

www.doh.health.nsw.gov.au

For guidance on completing an on-line application form, an on-line Site Specific Assessment (SSA) form and details of mandatory policies for the system of single ethical and scientific review.

MEMBERS OF SWAHS HREC, NEPEAN CAMPUS.

Dr. Jim Kalantar Gastroenterologist	HREC Chair
Dr. Louise Cole Intensive Care Physician. Sub-Dean of Education, Nepean Clinical School, University of Sydney	Deputy Chairperson
Prof. Lesley Wilkes Professor of Nursing	Member with knowledge of, and current experience in the areas of research regularly considered by the HREC
Ms. Jenny O’Baugh CNC- Cancer Care Research	Member with knowledge of, and current experience in the areas of research regularly considered by the HREC
Dr. George Condous Obstetrician & Gynaecologist	Member with knowledge of, and current experience in the areas of research regularly considered by the HREC
Mr. Vittorio Cintio A/Director Allied Health & Social Work	Member with experience in the care and counselling of people.
Ms. Hannah Liao-Loon Director of Pharmacy	Member with experience in pharmacology and clinical trials.
Mr. Joe Grassi Lawyer	Legal member
Fr. Tim Hogan Priest	Religious member
Mr. Stewart Mitchell Retired teacher	Layman
Mr. Graham Renshaw Real Estate Agent	Layman
Mrs. Theresa Ockenden	Laywoman

MEMBERS OF THE SWAHS SCIENTIFIC ADVISORY COMMITTEE,
NEPEAN CAMPUS (CORE SCIENTIFIC COMMITTEE):

Dr. Ian Seppelt	Chairperson. Intensive Care Physician. Director of SWAHS Clinical Research Centre.
A/Prof Martin Weltman	Associate Professor Of Medicine
Dr. John Taper	Haematologist/Oncologist
Dr. Brian Orr	Medical Oncologist
Dr. V. Casikar	Neurosurgeon
Dr. Tillman Boesel	Anaesthetist
Clinical Trials Pharmacist, Nepean	Clinical Trials Pharmacist, Nepean
Dr. Bernard Champion	Endocrinologist
Dr. Bill Brakoulias	Psychological Medicine
Ms. Hannah Liao-Loon	Director Of Pharmacy-Western Cluster
Dr. Jim Kalantar (or Nominee)	Cross-over of Membership from the HREC

Research Network