All serious adverse events, and those as defined in the clinical trial protocol, must be reported to the Administrative Officer, Research Directorate, Southern Health within 60 days of the date of the event on the Consultative Council for Human Research Ethics (CCHRE) Adverse Events report form which may be downloaded at http://health.vic.gov.au/cchre/applications/applications_how_to.htm 

Any serious adverse event, such as death or injury, should be reported to the Administrative Officer, Research Directorate, Southern Health within twenty-four hours or as soon as practicable.

In the event of a death of a Southern Health patient who was enrolled in a research study, it will be mandatory from 16 August 2010 for the death notification to be entered into the new Riskman module.  Further information can be obtained from the Southern Health Intranet under 'Risk Man - Incidents, Complaints & Feedback'

Quarterly, biannual or summary adverse event reports provided by sponsors of clinical trials may be submitted accompanying the Consultative Council for Human Research Ethics (CCHRE) Summary Adverse Events Form.  http://health.vic.gov.au/cchre/applications/applications_how_to.htm

Prior to submitting to the Research Directorate, please ensure  that all of the documents are single-sided (this includes the SAE report from the sponsor) and that all staples are removed.  Then please clip all of the documents together.  Any documents that are not submitted according to this request will be returned to researchers for re-submission.

Researchers are required to provide a report to the HREC 12 months after approval has been obtained for their research project and every year thereafter until the project ceases.  The information recorded by researchers in these reports is summarised and presented in the annual report to the HREC.  A reminder will be sent out by the Research Directorate.  The relevant Consultative Council for Human Research Ethics (CCHRE) progress report form can be downloaded and completed http://health.vic.gov.au/cchre/applications/applications_how_to.htm .  A copy of the self audit tool is available here

• If a project is continuing a Progress Report Site Report is required with any other relevant documentation;
•  If a project is completed both a Progress Report Site Report and Final Report is required;
• If a project is a multi-site SERP project the above guidelines are relevant but the CPI cover Sheet is also required;

• HREC Progress Report CPI Cover Sheet (87kb, MS Word)
• HREC Progress Report Site Report (82kb, MS Word)
• HREC Final Report (91kb, MS Word)

Prior to submitting to the Research Directorate, please ensure that all of the documents are single-sided and that all staples are removed.  Then please clip all of the documents together.  Any documents that are not submitted according to this request will be returned to researchers for re-submisson.

If the Sponsor requests a Southern Health Research Ethics Committee Approval Form to be completed (post approval) please forward a copy of yellow form for checking and signature by the HREC Administrative Officer

Researchers are required to maintain files in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines and the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007) projects may be audited in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007) and the Australian Code for the Responsible Conduct of Research.

For further information on Research Governance click here.

Committee membership is constituted in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007) and consists of lay members, a Lawyer, a Minister of Religion and members representing the relevant disciplines, who have scientific/research backgrounds. The representative of the relevant department/discipline may be approached by the researcher prior to the committee meeting to ensure that the representative (or his/her alternate) will be in attendance at the meeting. They will be able to provide further information on the committee, the interview and procedures to be followed.

Each committee comprises:

• a chairperson
• at least two members who are lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work
• at least two members with current research experience that is relevant to research proposals to be considered at the meetings they attend
• at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional
• at least one member who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion
• at least one member who is a lawyer.

Requests from Pharmaceutical Companies for lists of HREC members’ names and positions are quite common. Researchers are advised that it is a policy of the Board of Southern Health that this information cannot in any circumstances be released. However, a standard letter is provided at the time of final approval, stating that the committee is legally constituted in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007). This is acceptable to pharmaceutical companies.

Should a researcher have a concern regarding the HREC’s consideration of their research project, the matter should be referred, in writing, to the Executive Director of Medical Services, Corporate Services, Southern Health, Monash Medical Centre, Locked Bag No. 29, Clayton, 3168.

Any complaints regarding the conduct of a research project should be made in writing to the Director, Research Services.

If the research project involves a researcher who is external to Southern Health please complete a Form 7 and submit along with 1-page curriculum vitae of the researcher's qualifications.

In addition, external researchers will be required to provide evidence of a current Police check. Those researchers who will be conducting research involving participants under the age of 18 years will be required to provide evidence of a current ‘Working with Children Check (WWC)’ identification card or provide evidence of current registration with the Victorian Institute of Teaching (VIT).

Researchers must maintain a file of original signed consent forms, for audit and monitoring in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007).

Researchers must maintain a detailed file of names and addresses of all patients involved in drug trials and projects involving the use of therapeutic devices.

File management for multicentre trials includes keeping a master copy and notifying the HREC of amendments and reports of adverse events from other study centres.

The estimated cost of the project should be supported by a brief statement showing the make-up of the estimate irrespective of whether Southern Health resources are being utilised or not.

If funding anticipated at the time of submitting the research proposal does not materialise and the project does not proceed, the Administrative Officer of the Research Directorate should be notified immediately in writing.

If funding has been sought from a commercial organisation, details will need to be provided including a copy of the Investigator Agreement, Clinical Trial Agreement, or Letter of Agreement for supply of study drug. 

Southern Health and Monash University have established a Mutual Acceptance Program (MAP), in order to facilitate the submission and review process for multi-centre research proposals. Researchers who require approval from the Human Research Ethics Committees of both institutions will be required to submit one application (along with a cover letter indicating that the application is being submitted under MAP) directly to Southern Health, which will act as the primary institution. Following review and approval by the Southern Health Human Research Ethics Committee, Monash University will act as an accepting institution. For further information on Mutual Acceptance Program please refer to the guidelines and flowcharts below.

• Southern Health Human Research Ethics Committee (SH HREC) & Monash
  University Human Research Ethics Committee (MU HREC) Mutual Acceptance Program: Review Process Operating Procedures
• Southern Health Human Research Ethics Committee (SH HREC) & Monash
  University Human Research Ethics Committee (MU HREC) Mutual Acceptance Program:  Post Approval Review Process Operating Procedures

Please see the application form for information on the requirements in respect of Privacy. There are extensive guidelines detailing the requirements and it is recommended that you read this carefully before completing. In addition, please note that there are specific privacy issues in respect of the following categories of research: 

• Access to Personal Information - in relation to epidemiological research, the collection of personal information must comply with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007)
• Access to Human Tissue Samples (eg urine, blood) -  the proposal must comply with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007). In addition, the Human Tissue Act 1982 (Vic) provides that blood and tissue may be donated for scientific purposes.
• Genetic Analysis - the relevant module of the application form must be completed and the proposal must comply with chapter 3.5 of the National Statement on Ethical Conduct in Human Research (NHMRC, 2007). Please note that an additional Patient Information Sheet and Consent Form for genetic research is required. In addition, the Privacy Act 1988 (Cth) impose requirements on the handling of personal information, and require that all patient information be de-identified with respect to storage and publication of results.

 The hospital insurer has advised that :

• the (insurance) policy does not indemnify any doctor acting in a private capacity where the practitioner is entitled to render a fee for services to a person and retain such fee in full.
• the hospital insurer will not indemnify a practitioner in instances where the entire fee for service is retained by the practitioner rather than the fee being paid into a Southern Health Special Purpose Fund from which the practitioner may ultimately benefit. Such benefit may be in the form of payment for conferences, overseas travel, bonuses etc. Should a practitioner see a patient in his/her private rooms and wish to enrol that patient in a research study in the public system, then so long as all procedures related to the study are conducted in the public hospital setting and no fee rendered, the patient would be considered to be a public patient for the purposes of the study and hence covered by the health service’s insurance. However, if consent was obtained in private rooms and a discussion of risks and benefits failed to warn of a material risk – and a fee for the consultation was rendered – the hospital insurers would not indemnify.
• due to the lack of clarity with some financial arrangements, it should be assumed that if patients are seen in a capacity that is not public, they should be, prima facie, classified as private.

Where private patients are being recruited for the project the application must be accompanied by submission of the following:

• doctors wishing to involve private patients should provide an acknowledgement that the hospital insurers are not at risk
• evidence that their medical defence organisation or professional indemnity insurer has agreed to provide insurance for the conduct of research and to provide insurance for participants in the event of any adverse event.

A Form 4B must be completed for projects involving Diagnostic Imaging.  In addition an extra copy of the application must be submitted to the Research Directorate by the HREC submission closing date.

• a covering letter from the principal investigator
• Amendment Form summarising the amendments and commenting on the implications of the amendment to the project and whether the changes warrant any revisions to the patient information sheet
• A document detailing the changes made, including all additions and changes to the text and strike through any deleted original text and highlight in bold or by underline any new text. A new version number and date is required in the footer of each page of any revised Patient Information Sheet.

An administrative fee of $660 (including GST) applies for any pharmaceutical company sponsor initiated protocol amendments in respect of drug trials. A tax invoice shall be raised by the Administrative Officer, Research Directorate at the time of lodgment. Please provide the name of the sponsor company together with a contact name and physical postal address for invoicing. 

A Form 6 and a Form 4 must be completed for projects where patient’s medical records will be accessed.

A Form 8 and a Form 4A must be completed for projects that involve access to Pathology Services.

It is a requirement that approval be sought from the heads of departments of services or facilities within Southern Health that may be used or accessed during the conduct of the research proposal. Evidence of approval must be provided in writing by the relevant department head and any associated costs involved in using or accessing those services must be taken into account when providing an estimate of the costs involved. Please download the relevant forms.

It is necessary that in projects involving patients with a cognitive impairment, an intellectual disability or a mental illness that the proposal evidences that the patient’s are competent to consent or alternatively please refer to the Southern Health Guidance on the Recruitment of Incompetent Patients Into Research. It is preferable that a psychiatrist that is not a member of the research team is involved in the consenting process.

Researchers must submit the revised Investigator Brochure with a Form 14: Revised Investigator Brochure form to the Administrative Officer. These are noted by the Medical Administrator to the committee and written acknowledgement of revised Investigator Brochures is sent to researchers.

It is recommended that researchers audit their own project procedures for compliane annually using the Research Governance Self Auditing Tool.  This should occur simultaneously when completing the Annual Report Form 13.  A copy of the Self Audit Tool can be downloaded here

• All applications must be submitted on the National Ethics Application Form and the Victorian Site Specific Module
• All applications must be booked through the Central Allocation System (CAS) (61 3) 9092 1983, Monday to Friday 10am to 5pm EST
• A research governance checklist does not need to be submitted unless Southern Health is a participating site
• All documents must be uploaded onto the online forms website