GENERAL INFORMATION FOR
RVEEH HUMAN RESEARCH & ETHICS COMMITTEE
Role and Membership of the Committee
The Royal Victorian Eye & Ear Hospital’s Human Research and Ethics Committee (HREC) is a multi-disciplinary committee established in accordance with National Health and Medical Research Council (NHMRC) requirements. The NHMRC National Statement on Ethical Conduct in Human Research (2007) sets out principles for the conduct of research involving humans, and gives a clear indication of the issues that HRECs will consider in determining the scientific merit of, and ethical issues raised by a project proposal.
It is a requirement of the National Health & Medical Research Council that all medical or scientific research done on humans must be reviewed and approved by a properly constituted ethics committee. All research involving humans should conform to the NHMRC National Statement.
The Royal Victorian Eye & Ear Hospital’s Human Research Ethics Committee is constituted and operates according to the National Statement on Ethical Conduct in Human Research (NHMRC; 2007).
Membership of the Committee consists of as far as possible equal numbers of men and women, at least one-third of whom are non RVEEH employees of the Royal Victorian Eye & Ear Hospital.
The committee shall include the core members:
· The Chair;
· at least two members who are lay people, one man, one woman, who have no affiliation with the Royal Victorian Eye & Ear Hospital, and are not currently involved in medical, or legal work;
· at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people, a nurse or allied health professional;
· at least one member who performs a pastoral care role in a community - for example a Minister of Religion, Aboriginal elder;
· at least one member who is a lawyer, where possible one who is not engaged to advise the institution; and
· at least two members with current research experience, that is relevant to the type of research to be considered at the meetings they attend;
The RVEEH HREC meets bi-monthly.
Forms/Templates
To ensure you are using the latest version of the template forms, please download the document directly from the Research & Ethics website each time you prepare a new application.
Applications
The RVEEH HREC has agreed to adopt the Victorian Department of Health Common Application Form (CAF). This form will be the preferred form accepted at RVEEH. The National Ethics Application Form (NEAF) will also be accepted for multi-site trials. A simplified audit application form is also available to submit for projects where no patient consent is required. Refer to the HREC Guidelines for Research Eligible for Streamlined Review.
For all research where participants are to be involved, full ethical review is required and you will be required to complete and submit a full application to the Ethics Committee for review and approval. Ethical approval can be granted for up to 5 years.
If the application is not complete or if necessary supporting information is not provided, the application will be returned to the Principal Investigator.
The application must be lodged no later than the submission close date for the next HREC meeting. The research must not start before ethical approval has been granted.
Researchers are advised that it is essential to present the project in terms which will be understood by the lay people.
An RVEEH staff member must be a member of the research team. Any researchers involved in the project who are non-RVEEH employees must complete the HREC Privacy Declaration Form for External Researchers. Please refer to the External Researchers section for further information.
If any researcher listed in the application is not known to RVEEH HREC, a curriculum vitae should be provided.
Ensure that ALL questions are answered. Attachments must be labelled with version number and date.
If you require hospital resources to conduct your research project, please ensure you submit a Head of Supporting Department Declaration form for each hospital department involved.
The Committee requires researchers to preserve the confidentiality of information about research subjects, and to ensure the confidentiality of records. Confidential or personal information obtained for research projects must not be used for purposes other than those specified in the approved protocol.
An application fee may apply for clinical trial projects or external/unaffiliated studies. Refer to the Ethics Committee Fees.
Forms to be used
All applicants are required to complete one of the following forms. To ensure that you are using the latest version, you must download one of the relevant modules and review the corresponding guidelines each time you wish to submit a new application to the committee:
· Victorian Department of Health Common Application Form
This form is preferred for proposals being considered by the committee and includes:
· Module 1 – Core Application Form
· Any other modules relevant to your project
Ø Module 2 – Projects involving drugs and therapeutic devices
Ø Module 3 – Human tissues
Ø Module 4 – Ionising radiation
· National Ethics Application Form
This form is usedto assist the facilitation of review of multi-site/centre proposals. Applications using this form will be accepted for review by the committee in the case of multi-centre research projects.
· RVEEH Audit Application Form
This form is used for projects that do not require participant consent. Refer to the HREC Guidelines for Research Eligible for Streamlined Review.
All submissions must complete and submit:
· Cover Sheet for New Application – RVEEH Site Specific
For projects that involve a drug or device, refer to the Clinical Trials Information section.
Participant Information and Consent Forms
It is essential (except where consent is specifically waived or for a retrospective study) that appropriate informed consent be obtained from each subject participating in the research project. A range of template consent forms are provided. The consent form, which is a legal document, is to be signed by the participant in the presence of a witness who should be over the age of 18 years old. It is preferable that the witness be independent ie not a member of the research team, and the role of the witness is to attest to the voluntary independent signing of the consent form by the participant free from any coercion. The witness is not expected to testify as to whether the participant understood the Patient Information Sheet, as that is a matter for the Investigator and Participant.
All research where the participant is below 18 years of age requires a Consent form for Minors (to be used by Parent/Court Appointed Guardians of minors).
Participants aged 18 years and over do not require parent/guardian consent and a Participant Information and Consent Form should be provided.
Participants who are evaluated by the investigator as having the maturity and understanding sufficient enough to grasp the nature and consequences of the project should be provided with a Participant Information and Consent Form to allow them to give their consent in addition to parental consent.
If the application involves the use of a drug or device, you will need to submit the Participant Information & Consent Form for Clinical Drug/Device Trials.
Supporting Departments and Services
A separate Declaration by Head of Supporting Department form must be completed and signed off by the Department Head for each service department/unit involved in the research project.
Annual Reporting
The Human Research & Ethics Committee is required to monitor all approved research in accordance with the National Statement on Ethical Conduct in Human Research (2007). Part of the monitoring process includes the review of progress reports.
Researchers are required to submit a progress report to the HREC for each research project approved by the HREC. Reports are usually due on the anniversary of approval, but occasionally they are requested at a more frequent interval.
The Research Ethics Office (REO) will notify researchers about the due date of the progress reports at least 4 weeks in advance.
Ethics approval is ongoing but will lapse if the progress report is not received by the anniversary of the approval date, or, is not deemed satisfactory by the Committee.
If the Committee is not satisfied with the progress report, researchers will be informed about subsequent action.
Amendments and Modifications
From time to time amendments are required to research projects. It is the responsibility of the Principal Investigator to seekand receiveHREC approval for any modification or change to be made to the approved studyPRIOR to implementation.
This includes (but is not limited to):
· Changes to the protocol
· Changes in recruitment strategies
· Changes toInformation Statements and Consent Forms
· Changes to (or additional)letters, advertisements, questionnaires etc
· Changes in Investigators
Failure to conduct research according to a currently ethically approved protocol risks researchers’ legal indemnity, right to publication and opportunity to seek future funding.
An application fee may apply for clinical trial projects or external/unaffiliated studies. Refer to the Ethics Committee Fees.
Investigator Brochure Revisions
Principal Investigators are required to submit an Investigator Brochure Revision form to the Human Research and Ethics Committee with any revised Investigator’s Brochures that relates to a clinical trial that they are conducting.
Adverse Events
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that:
· results in death;
· is life-threatening;
· requires in-patient hospitalisation or prolongation of existing hospitalisation;
· results in a persistent or significant disability/incapacity;
· is a congenital anomaly/birth defect; or
· is a medically important event or reaction.
An event should be considered unexpected if the nature, severity or frequency of that event is not consistent with the information in the Investigator’s Brochure if the product or device being trialled is unapproved or if it is not documented in the current Australian Product Information if the product is approved for marketing.
Researchers must report adverse events where necessary, to the appropriate authorities including the HREC. Refer to the HREC Procedure for Reporting and Handling of Adverse Events Related to Research.
Single Adverse Event Reporting Form
This form must be submitted to HREC for all internal SAEs (occurring to RVEEH participants) and External SAEs (occurring to participants from other sites) if the information impacts the continued ethical acceptability of the trial or requires documentation to be updated.
Periodic Adverse Event Reporting Form
This form must be used to accompany the provision of quarterly, biannual or summary adverse event reports provided by sponsors of clinical trails.
Notification of SAEs
Researchers are obliged to notify the HREC within 24 hours of all serious or unexpected adverse events relating to participants in approved research projects at RVEEH. Reports involving participants in project sites outside RVEEH must be submitted to the Research Ethics Office as soon as possible.
Please refer to the NHMRC AHEC Position Statement – Monitoring and reporting of safety for clinical trials involving therapeutic products – May 2009 for further information.
Final Reporting
Reports are due on the completion of a project or if the research is discontinued before the expected date of completion. The Principal Investigator is required to submit a final report, along with any publications developed. The HREC has adopted a policy that five (5) years is a reasonable period of time in which to conduct a single research project. If, after five years, the project has not been completed, a full application form (reapplication) must be submitted to the HREC for consideration.
Protocol Deviation or Violation Reporting
Where a deviation or violation of a HREC approved protocol has occurred, the breach must be reported immediately to the Research Ethics Office. Refer to the HREC Procedure for Protocol Deviation or Violation Reporting for further information.
External Researchers
As per the RVEEH HREC Operating Procedures, all research projects considered by the RVEEH HREC must have an RVEEH staff member listed as an associate researcher. A research project that is initiated by external researchers must include an RVEEH staff member. This person will be responsible for the conduct of research at RVEEH sites.
Researchers who are not RVEEH staff members, and wish to be involved in research conducted at RVEEH, must complete a Privacy Declaration for External Researchers form. If non-RVEEH staff members require access to RVEEH medical records for research purposes, then an Approval to Access Medical Records for Research Purposes form also needs to be completed and submitted.
If the researcher is not known to HREC, a curriculum vitae should also be provided.
Clinical Trials Information
A project is considered a drug/device trial if it involves allocating participants to an intervention that is a medical device, medicine or other therapeutic good, whether or not the product is approved for the particular use under investigation.
For all clinical trials which are conducted under the Therapeutic Goods Association (TGA) Clinical Trial Notification (CTN) Scheme, the application will need to be submitted to the Hospital’s Insurers prior to approval being granted. Refer to the Victorian Managed Insurance Authority (VMIA) Guidelines for Clinical Trials for Victorian Public Hospitals. Please ensure that you download and read these Guidelines prior to submitting your application for a clinical trial.
Commercially sponsored applications are usually accompanied by an indemnity statement, an insurance certificate and a Clinical Trial Research Agreement. There are certain requirements regarding the wording of these documents and applicants and commercial sponsors should be familiar with these. Any agreement that is not submitted using one of these templates will not be accepted by RVEEH. Please ensure that the documents are signed by sponsor and researcher prior to submitting to REO. The relevant documents are listed below:
Clinical Trial Research Agreements
The Victorian Managed Insurance Authority (VMIA) in collaboration with interstate health departments and industry agencies, have approved Medicine's Australia Standard Clinical Trial Research Agreements. In addition, the VMIA in collaboration with the Medical Technology Association of Australia have approved a Clinical Trial Research Agreement for clinical trials involving devices.
Indemnity
RVEEH accepts the Medicine’s Australia Standard Form of Indemnity for clinical drug trials and for studies involving a device accepts the Medical Technology Association of Australia Standard Form of Indemnity.