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Human Research Ethics
Human Research Ethics Related page links: 
Hunter New England Human Research Ethics Rural Research Methods Support Group Clinical Trials Subcommittee Application Forms Newsletters Research Governance Contacts
HUNTER NEW ENGLAND HEALTH
PROCESS FOR ETHICAL AND GOVERNANCE
REVIEW OF HUMAN RESEARCH
It is an Australian Government requirement that all institutions where research involving humans participants is conducted must establish a Human Research Ethics Committee to review such research and ensure that such research meets the requirements of the National Statement in Ethical Conduct in Human Research 2007 before it commences.
Hunter New England Health was created on 1 January 2005, following the merger between Hunter Health, New England Area Health Service and the Lower Mid North Coast local government areas of Gloucester, Greater Taree City and Great Lakes. (See Map: http://www.hnehealth.nsw.gov.au/about_us/hunter_new_england_map/)
Hunter New England Health is a participant in the NSW Health system for single ethical and scientific review of multicentre research. Under this system lead HRECs will be accredited to undertake the single review of multi-centre research on behalf of all sites within NSW Health. Multicentre research is defined as “Research to be conducted at more than one site within NSW Health and within the jurisdiction of more that one local HREC”. Lead HRECs will be accredited to review multi-centre research applications in one or both of the following areas:
- Clinical trials/interventional clinical research.
- General research (including epidemiological research, population health research, health services research, qualitative research, clinical research of a non-interventional nature and other general categories of research).
The Hunter New England Human Research Ethics Committee is accredited to be a Lead Human Research Ethics Committee for the purposes of multicentre review in both clinical and general research. Please see http://www.health.nsw.gov.au/healthethics/multicentre_research.html for more details.
Public health organisations retain responsibility for authorising the commencement of research to be undertaken within their institutions. Please see below for a description of the Research Governance process for Hunter New England Health.
The Hunter New England Human Research Ethics Committee (HNEHREC) reviews research:
- where patients/clients or employees of Hunter New England Health are involved as participants;
- That research is conducted by staff of Hunter New England Health;
- Personal health data or tissue samples in the custody of Hunter New England Health are involved;
- Such research utilises resources of Hunter New England Health;
- Any submissions it received under the system of single ethical and scientific review of multicentre review within NSW Health; and
approve that research when it is in accordance with the National Statement in Ethical Conduct in Human Research 2007.
There are two subcommittees to assist and provide advice to the Hunter New England Human Research Ethics Committee:
- The Rural Research Methods Support Group, which undertakes a methodological review of applications for all rural research throughout the Hunter New England Area Health Service prior to consideration by the Hunter New England Human Research Ethics Committee; and
- The Clinical Trials Subcommittee which undertakes pharmacological and/or methodological review of applications for clinical trials prior to consideration by the Hunter New England Human Research Ethics Committee.
The Process
- Applications should be submitted to the Research Ethics Unit located at the HNE Health Headquarters by the last working day of the month.
- Applications are then reviewed to determine whether an application needs to be considered by the Rural Research Methods Support Group or the Clinical Trials Subcommittee or if it has already undergone appropriate review to allow direct progress to the HNEHREC In exceptional circumstances an application may need to be reviewed by both the Rural Research Methods Support Group and the Clinical Trials Subcommittee prior to being considered by the Hunter New England Human Research Ethics Committee.
- The Clinical Trials Subcommittee will usually meet the second Wednesday of each month except January.
- The Rural Research Methods Support Group, will usually meet the second Thursday of each month except January.
- The Hunter New England Human Research Ethics Committee will usually meet the third Wednesday of the month except January.
- A response to the researchers will be sent within a week of the meeting of the Hunter New England Human Research Ethics Committee
- Where necessary the response may be considered by one of the subcommittees involved in the initial review or by the Hunter New England Human Research Ethics Committee.
- Note: That both approval from the Hunter New England Human Research Ethics Committee and completion of research governance processes for Hunter New England Health are required before the research can commence. Please see below.
| MEETING DATES - 2007 | |||
| SUBMISSION CLOSING DATE | CLINICAL TRIALS SUBCOMMITTEE | RURAL RESEARCH METHODS SUPPORT GROUP | HUMAN RESEARCH ETHICS COMMITTEE |
| 31 JULY | 8 AUGUST | 9 AUGUST | 22 AUGUST |
| 31 AUGUST | 12 SEPTEMBER | 13 SEPTEMBER | 18 SEPTEMBER |
| 30 SEPTEMBER | 10 OCTOBER | 11 OCTOBER | 24 OCTOBER |
| 31 OCTOBER | 13 NOVEMBER | 14 NOVEMBER | 21 NOVEMBER |
| 30 NOVEMBER | 5 DECEMBER | 5 DECEMBER | 12 DECEMBER |
| MEETING DATES - 2008 | |||
| SUBMISSION CLOSING DATE | CLINICAL TRIALS SUBCOMMITTEE | RURAL RESEARCH METHODS SUPPORT GROUP | HUMAN RESEARCH ETHICS COMMITTEE |
| 31 JANUARY | 13 FEBRUARY | 14 FEBRUARY | 20 FEBRUARY |
| 29 FEBRUARY | 12 MARCH | 13 MARCH | 19 MARCH |
| 31 MARCH | 9 APRIL | 10 APRIL | 16 APRIL |
| 30 APRIL | 14 MAY | 15 MAY | 21 MAY |
| 30 MAY | 11 JUNE | 12 JUNE | 18 JUNE |
| 30 JUNE | 9 JULY | 10 JULY | 16 JULY |
| 31 JULY | 13 AUGUST | 14 AUGUST | 20 AUGUST |
| 29 AUGUST | 10 SEPTEMBER | 11 SEPTEMBER | 17 SEPTEMBER |
| 30 SEPTEMBER | 8 OCTOBER | 8 OCTOBER | 15 OCTOBER |
| 31 OCTOBER | 12 NOVEMBER | 13 NOVEMBER | 19 NOVEMBER |
| 28 NOVEMBER | 10 DECEMBER | 11 DECEMBER | 17 DECEMBER |
| APPLICATIONS ARE DUE ON THE LAST WORKING DAY OF EACH MONTH (except December as the Committee and its subcommittees do not meet in January) Late applications will not be accepted |
Procedures for human research proposals involving both the University of Newcastle and Hunter New England Health
The University of Newcastle and Hunter New England Health have an agreement whereby the decision of the Human Research Ethics Committee (HREC) of one institution will be accepted by the other institution. The agreement became effective on 1 January 2006 and applies to applications for ethics approvals lodged after that date. Please see
http://www.newcastle.edu.au/research/human/newproc.html.
Application forms
For multi-centre research the submission to a Lead HREC must be on the National Ethics Application form and this form must be filled in online via http://www.ethicsform.org/au as this version of the form interfaces with the NSW Health Research Ethics Database (AU RED) which is a web-based research tracking and management mechanism that will underpin the new system.
Single-site research that is, research to be conducted only within Hunter New England Health) may be submitted either on the National Ethics Application Form or the Hunter New England Human Research Ethics Committee application form (Version June 2007). The later form has been revised to reduce duplication with the site specific assessment form.
The Site Specific Assessment form should be completed online via http://www.ethicsform.org/au for multi-centre research as this version of the form interfaces with the Research Ethics Database (AU RED) which is a web-based research tracking and management mechanism that will underpin the new system. For single-site research where the ethics application has not been submitted on the NEAF, the SSA form may be downloaded from the forms page below. For more details about the Research Governance processes for Hunter New England Health see below.
There are different forms for applications for variations/amendments for approved protocols and renewal applications if a protocol is to continue past the approval period (either three or five years), as specified on the original letter of approval.
Please see the links for the committee and subcommittee and application forms for more details of the process involved.
Submission Requirements:
For applications for Ethics Approval of Human Research from the Hunter New England Human Research Ethics Committee, this is contingent on whether the project is;
- a single site project only being conducted in Hunter New England Health;
- a multi-centre trial where the ethics application is being made to the Hunter New England Human Research Ethics Committee as a lead HREC; or
- a multi-centre trial where the ethics application is being made to another Lead HREC.
(i) a single site project only being conducted in Hunter New England Health
The application for ethics approval from the Hunter New England Human Research Ethics Committee should be submitted as per normal on the last working day of the month. At this stage, applications may be submitted on either the National Ethics Application Form which should be completed online at http://www.ethicsform.org/au or the Hunter New England Human Research Ethics application form (Version June 2007).
In addition, the Site Specific Assessment Form must be completed (again it should be completed online at http://www.ethicsform.org/au if the ethics application has been completed on the NEAF or if the ethics application has been completed on the Hunter New England Human Research Ethics Committee Ethics Application form it may be downloaded from the forms page below,) and submitted for review in order for the protocol to be authorised to commence in Hunter New England Health.
It is recommended that the ethics application and the site specific assessment forms be submitted concurrently.
(ii) a multi-centre trial where the ethics application is being made to the Hunter New England Human Research Ethics Committee as a lead HREC
For multi-centre trials where it has been decided to submit to the Hunter New England Human Research Ethics Committee as a lead HREC, the co-ordinating investigator should complete the National Ethics Application form via http://www.ethicsform.org/au.
In addition the Site Specific Assessment Form must be completed (again it should be completed online at http://www.ethicsform.org/au) and submitted for review in order for the protocol to be authorised to commence in Hunter New England Health.
It is recommended that the ethics application and the site specific assessment forms be submitted concurrently.
(iii) a multi-centre trial where the ethics application is being made to another Human Research Ethics Committee as a lead HREC
Where ethics approval is being obtained for a multi-centre research project from another Lead HREC, only the Site Specific Assessment Form must be completed (again it must be completed online at http://www.ethicsform.org/au) and submitted for review in order for the protocol to be authorised to commence in Hunter New England Health.
The Site Specific Assessment form may be completed at anytime but a copy of the Lead HREC approval letter for the study must be received before the site specific Assessment can be finalised.
Documentation required
(i) For the Ethics Application
The number of copies of documents required for an Application to the Hunter New England Human Research Ethics Committee is as follows:
| Checklist & Application form All other attachments (see below) | Original + 25 copies 10 copies |
Applications must be collated so that there are twenty five (25) sets of the following documents in the following order:
- Checklist;
- Application Form (either the HNEHREC form with relevant appendices or the National Ethics Application Form to be completed online via http://www.ethicsform.org/au )
- Information Statement
- Consent Forms
- Advertisement
- Surveys, questionnaires, interview schedules as required (if <5 pages);
Please only include the Appendices A B, or C if they are required (indicated in the relevant section of the application form)
Applications may be photocopied double-sided, however please keep each part separate (that is, for example, do not copy the first page on the information sheet on to the back of the last page of the application form):
There should be ten (10) copies of other attachments which may be kept separate or attached to the first ten copies of the collated applications. These attachments may be:
- Surveys, questionnaires, interview schedules as required (if >5 pages);
- Clinical Trial Protocol
- Funding Application (a synopsis is acceptable if full application > 20 pages)
- Investigational Drug Brochures, Device Manuals or Product Information, Patient Diaries
(ii) For the Site Specific Assessment to be undertaken in order for a research project to be authorised to commence in Hunter New England Health.
| Site Specific Assessment Form Indemnification (if required) | 1 Original 2 Originals signed by the sponsor |
** An additional copy of any document listed on the Checklist of the Site Specific Assessment Form that has already been submitted as part of the application to the Hunter New England Human Research Ethics Committee, will be not required when the Site Specific Assessment Form is submitted concurrently with an application for ethics approval is submitted the Hunter New England Human Research Ethics Committee.
Fees:
Some applications to the Hunter New England Human Research Ethics Committee incur a fee in accordance with the NSW Health unter NHPolicy Directive HREC and Research Governance: Fee Policy for Review of Commercially Sponsored Research (pdf)
Note: an updated fee schedule for Hunter New England Health will be issued shortly.
Dr Nicole Gerrand
Professional Officer (Research Governance and Ethics)
Tel: 4921 4950
Ms Michelle Lane
Administrative Officer
Tel: 4921 4943
Email
hnehrec@hnehealth.nsw.gov.au
Postal Address
Hunter New England Human Research Ethics Committee
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Location
Hunter New England Health Research Ethics Unit
Administration Building
Lookout Road
New Lambton NSW 2305
GUIDELINES AND LEGISLATION
National Statement in Ethical Conduct in Humans Research 2007.
(http://www.nhmrc.gov.au/publications/synopses/e72syn.htm)
Human Research Ethics Committee Handbook
www.nhmrc.gov.au/publications/synopses/e42syn.htm
NSW Health Information Privacy Code of Practice
www.health.nsw.gov.au/privacy/
Lawlink NSW - Privacy website
www.lawlink.nsw.gov.au
NSW HEALTH POLICY DIRECTIVES
Operations Manual for NSW Health HRECS (pdf)
GL2006_021: Requirements of the Human Tissue Act 1983 in relation to research and use of tissue
Model privacy addition to HREC application form (pdf)
Privacy information sheet for researchers (pdf)
Annual privacy reporting form for HRECs to privacy NSW (pdf)
Model for Single Ethical & Scientific Review of Multi-Centre Research (pdf)
HREC and Research Governance: Fee Policy for Review of Commercially Sponsored Research (pdf)
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