Cabrini Institute - Human Research Ethics - Instructions To Applicants
a Application form
The application form (attachment 1) is available on the Cabrini Health website at http://www.cabrini.com.au/cabriniinstitute/humanresearchethics.asp. It is designed to be completed electronically then printed and submitted in hard copy. Applicants should use as much space as necessary to give a full and complete answer to each question. If a section is not relevant to your research, please answer “not applicable” at the start of the section and remove the page break so that the next section may begin immediately.
Cabrini Health’s Mission Statement, the Annual Report, and these guidelines should be read by all intending investigators. Intending applicants should also familiarise themselves with
- the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research http://www.nhmrc.gov.au/publications/synopses/_files/e72.pdf
- Chapter 6: Research of Catholic Health Australia’s Code of Ethical Standards for Catholic Health and Aged Care Services in Australia (2001); and
- Privacy Act 1988 (Commonwealth); and the Health Records Act 2001 (Victorian).
Other useful references include
- NHMRC’s Making Decisions about Tests and Treatments: Principles for Better Communication between Healthcare Consumers and Healthcare Professionals (2005);
- International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice;
- The Joint NHMRC/ARC/UA Australian Code for the Responsible Conduct of Research 2007 at http://www.nhmrc.gov.au/index.htm
b Deciding whether ethics approval is necessary
Not all projects require full review by the CHREC. Expedited approval processes apply to quality assurance and low risk projects. Risks (see Chapter 2.1 on page 15 of the 2007 National Statement) must by assessed by the Manager, CHREC (and not the researcher). Please see Appendix A “Processes for Review of Human Research Applications”
If the project is quality assurance please read the NHMRC document “When does quality assurance in health care require independent ethical review?” available on http://www.nhmrc.gov.au/publications/synopses/e46syn.htm. Attachment 3 is a checklist to assist you. Please complete the checklist and send it to Anne Spence along with a project protocol and any patient information.
The CHREC has formal agreements with Deakin and Monash Universities regarding mutual recognition. Please talk to Anne Spence if you need to use this agreement.
Please also read the Cabrini Hospital inpatient registration form and the Cabrini privacy statement “What happens to information about you?”. These documents give clear guidance about how patient information may be used. If you propose using the information in any other way or for any other purpose, please seek the approval of the CHREC. If you require access to hospital medical records for quality assurance purposes, please seek the approval of the Medical Director of Cabrini Health.
c Submission of applications
Sixteen (16) compiled copies of applications (including the attachments listed in ‘e’ below) must be submitted to the Cabrini Human Research Ethics Committee. Font should be no smaller than 12 point and applications should be clipped or stapled.
E-mail submissions cannot be accepted.
All completed paperwork is to be sent to:
Anne Spence
Cabrini Human Research Ethics Committee
Cabrini Clinical Education and Research Institute
183 Wattletree Road
MALVERN VIC 3144
For any enquiries regarding ethics applications please contact: Anne Spence on 9508 1376 or Janet Rattray on 9508 1416.
Only compiled applications received in the complete form by the due date will be processed for the following Human Research Ethics Committee meeting. The submission dates for this year are listed previously.
d Submission fees
This fee schedule below is effective from 1 October 2007.
Fees for submission of your application are as follows:
Commercially Sponsored Initial Proposal $4,800 +gst
Commercially Sponsored Protocol Amendments $550 +gst
Unsponsored Initial Proposal $300 +gst
Document Administration Fee* $100 +gst
In all cases the Manager of the CHREC reserves the right to negotiate the submission fee.
Submission fees are required at the time your application is submitted. Fees may be paid by
- cheque made payable to Saint Frances Xavier Cabrini Hospital – Cabrini Clinical Education and Research Institute or
- direct deposit to Saint Frances Xavier Cabrini Hospital– Cabrini Clinical Education and Research Institute
BSB number: 033 059
Account number: 12 2820
A complying tax invoice will be issued on receipt of the fee. Our ABN is 33 370 684 005.
e Review of the Science
Are you a student? Does this project form part of your tertiary study? If so, you must ask your university supervisor and the head of the relevant Cabrini Department (that might be two different people or it could be the same person) to write a letter of endorsement to accompany the application stating that he/she has reviewed the scientific methodology of the study and that methodology is appropriate.
f Attachments
Please attach to each of the 16 application forms the following documents in this order:
- a flow chart of the study processes;
- a full project protocol outlining all procedures; and details of data collection, storage and analysis;
- patient information (PICF) summarising the project for participants, written in plain language (grade 8 reading level) – see chapter 2.2 and paragraph 3.3.13 of the 2007 National Statement;
- a consent form/s;
- a copy of the approval from any other ethics committees that have approved the project;
- a letter of support from any hospital department/personnel expected to provide support to the project e.g. pharmacy; nursing;
- for student projects – letter/s of endorsement regarding the scientific method;
- the project budget;
- CVs for any member of the research team who has not previously submitted a proposal;
- advertisements;
- all relevant tools and questionnaires.
Please note that any attachments to the application form must include a footer indicating the name of the document, version number, date, page number and number of pages.
In addition, please provide two (2) copies of the investigator’s brochure.
And a single copy of:
- insurance details
- indemnity
- contracts/agreements
- CTN form/s.
g Advice for research participants
Trials involving medical therapies require a standard clause in the patient information, on the page with the contact details for the study personnel saying: We encourage you to discuss study participation with your family, friends and medical advisers. We recommend that you ask your medical advisers to contact the study investigator.
h Complaints
Please read Chapter 5.6 of the 2007 National Statement regarding handling complaints. An HREC must nominate a person to whom complaints from research participants, researchers, or other interested persons may be made in the first instance. This person or the HREC shall attempt to resolve these complaints.
Please note that all patient information (plain language statements) should include Anne Spence, (telephone 9508 1376) as the contact in the instance of a complaint relating to the ethical conduct of the project.
i Statement of CHREC review
Patient information (plain language statements) may also include a statement that:
The ethical aspects of this study have been reviewed by the Cabrini Human Research Ethics Committee and the study complies with the NHMRC’s National Statement on Ethical Conduct in Human Research.
j Guidelines for research in humans of reproductive age
The Cabrini Human Research Ethics Committee has concerns about any research studies involving drugs with potential side effects on the unborn child and the potential consequences of failed contraception in these circumstances. All women participating in studies involving drugs whose effect on the unborn child are unknown are required to have a pregnancy test prior to entering the study and to be informed they will be excluded from the study unless they use a medically reliable method of preventing conception for the duration of the study.
The patient information should include the following statement:
If you are a sexually active woman who is potentially fertile, you will be excluded from taking part in this study unless you are using a medically reliable method of preventing conception for the duration of the study. Should you become pregnant during the study you should notify your family doctor and the study doctor as soon as possible.
Equally, the male partner of a sexually active woman who is potentially fertile will be excluded from taking part in the study unless using a medically reliable method of preventing conception for the duration of the study.
The patient information (plain language statement) should include the following statement.
If you are the partner of a sexually active woman who is potentially fertile, you will be excluded from taking part in this study unless you are using a medically reliable method of preventing conception for the duration of the study.
k Guidelines for informing participants about the outcome of research
The Cabrini Human Research Ethics Committee notes that:
- the results of a study may not be available for many years and the relevance to the participant may become remote;
- the results may not be in the public domain; that is, they may remain the property of the sponsoring agency;
- it may be viewed that the release of results is not in the best interests of participants;
- confidentiality could be seen to be questionable if participants are contacted after studies are completed;
- researchers seldom have editorial control of publications;
- the ability to deliver results in a secure and confidential manner is dependant on many factors, including the ability of a researcher to maintain an accurate participant database.
Notwithstanding the above, and in line with paragraph 3.3.4 © of the 2007 National Statement, the CHREC believes that participants should have the opportunity to hear about the outcome of a study in which they participate where it is possible and appropriate and encourages researchers to consider this in study design.
l Payment of participants in research projects
The Cabrini Human Research Ethics Committee considers that it is appropriate to offer participants reimbursement for “direct out of pocket” expenses, (eg. travel expenses). The Committee encourages researchers to consider such reimbursement when planning clinical studies. Such reimbursements should be structured so as not to be considered an inducement to participants. It is also important that lack of reimbursement does not exclude patients from participation in a research study.
m Compensation for injury attributable to the study
If your study is sponsored, your patient information should include this paragraph:
“In the event that you suffer any injury attributable to the administration of a medicinal product within the study or any clinical intervention or procedure required under the study that would not have occurred but for your inclusion in the study, you will be compensated in accordance with the Medicines Australia Guidelines for compensation for injury resulting from participating in a company-sponsored research project. A copy of the Medicines Australia Guidelines is available to you from the research staff on request.”
If your study is not sponsored, please substitute an appropriate paragraph.
n Genetics and pharmacogenetics studies
The Australian Law Reform Commission and the NHMRC’s Human Genetics Advisory Committee are currently reviewing these studies. Guidelines appear within the 2007 National Statement. Other useful references particularly regarding the insurance and employment implications for participants include:
- Genetic testing and privacy @ www.biotechnology.gov.au;
- “ACCC re-authorises life insurance bar on genetic testing” press release by Graeme Samuels on website of the Australian Competition and Consumer Commission;
- Life insurance products and genetic testing in Australia (Fact sheet 23A) from The Australasian Genetics Resource Book of 2007 @ www.genetics.edu.au;
- “Genetic information and life insurance products in Australia” of May 2003 produced by The Centre for Genetics Education @ www.genetics.com.au;
- “Life insurance and genetic testing in Australia” (Fact sheet of March 2002) of the Investment and Financial Services Association Limited;
- “The use of genetic information in insurance” section 25 of the Australian Law Reform Commission’s review of privacy; and
- ‘“Cancer in the family” and genetic testing: implications for life insurance’ by Lynch, Elly, et al in eMJA 2003; 179(9): 480-483.
Participants in any genetics studies need to be informed that any genetic testing information received would need to be declared in applications for life insurance. This may influence their decision to take part in genetic testing studies or sub-studies or on their decision to receive the information. Studies where genetic samples are not re-identifiable (except via the “genetic footprint”) would permit application for life insurance with honest declarations that testing has been done as part of a research study but that no results are obtainable to the participant or their treating doctors.
Where results are available to participants, please include the following paragraph:
“If you have chosen to be informed about genetic information AND the study has informed you that we have found genetic information relevant to you and your family, your insurance and employment may be affected”;
and please ensure the words “insurance” and “employment” are bolded.
o Consent
Chapter 2.2 of the 2007 National Statement is dedicated to the general requirements of consent. This Statement discusses consent to future use of data and tissue in research under section 2.2.14 on page 21. Consent may be specific; extended; or unspecified.
p The application form
See our guide to the application form
q Advertising
It is acknowledged that advertising on noticeboards within the hospital environment and within the media generally is an important aspect of recruitment for clinical trials. All advertising requires the approval of an Human Research Ethics Committee.
The advertisement may include a statement that this study complies with the NHMRC’s National Statement on Ethical Conduct in Human Research but may not state that this study was approved by the Cabrini Human Research Ethics Committee.
The CHREC would recommend the inclusion of a simple statement acknowledging that the study is pharmaceutically sponsored, where applicable.
r Risk management -- insurance and indemnity
Where projects fall within usual clinical care then Cabrini projects will be covered by the hospital’s insurance policy.
Any treatment by professionals (doctors or therapists) which exposes them to litigation will not be covered by the hospital’s insurance and must be the responsibility of the professional involved. All professionals involved in treatment should provide details of their professional indemnity cover and a record will be kept of this information. This is a requirement for all accredited medical practitioners at Cabrini and will be on record with the hospital. Any queries regarding indemnification of the medical professionals involved should be addressed to the practitioner’s medical defence/insurance organisation.
Any trial involving a new device, medication or biological agent must be fully indemnified by the sponsor and evidence of that indemnification will be kept on file. This indemnification needs to cover all aspects of the treatment and any potential future complications. Such cover must include the hospital and all trial personnel.
Cabrini Institute cannot allow any trials not fully indemnified to proceed.
Trials of currently approved drugs for a new indication (not currently listed) require decisions on a case by case basis. If a reasonable body of opinion exists among medical practitioners that this was a reasonable use of the medication, it would probably fit within usual clinical care.
Where the placebo arm of a controlled trial involves an invasive procedure which is not part of usual clinical care, a separate insurance policy would need to be in place to cover potential litigation. The “up front excess” requirements of hospital policies in Australia (up to $500,000 per claim) would mean that it would not be financially viable to carry out such trials at Cabrini. Trials where an invasive placebo arm leads on to active treatment at a later stage may be possible. Proposed studies would need to be reviewed by the Manager of the CHREC with the Executive Director of Cabrini Institute (and, in turn, our insurers).
s Monitoring
Under section 5.5 of the National Statement, the Cabrini Human Research Ethics Committee has the responsibility for monitoring your research. Such monitoring includes:
- audits/site visits/interviews to ensure compliance with conditions of approval
- completion of satisfactory annual and final reports
- submission of serious adverse event reports.
Further information
In accordance with paragraph 3.3.12 of the 2007 National Statement, all clinical trials must be registered. The Australian Clinical Trials website is at www.actr.org.au. Please advise registration number and date. If your trial has been registered on another registry, please advise.
If a project approved by the Committee does not commence within twelve months of being approved, such approval will lapse and the researcher will need to re-submit the project for approval. Equally, if progress reports (attachment 4) are not received as requested, approval will lapse.
For further information about any aspect of your application please contact Anne Spence on 9508 1376 or Janet Rattray 9508 1416.
Cabrini Institute offers a range of services which may interest you. This includes: assistance with development of your research proposal; occasional lectures and seminars; an annual research day; and small grants and scholarships. We endeavour to keep researchers informed of current events by circulation of flyers to researchers on our database.
