INSTRUCTIONS TO APPLICANTS FOR
CALVARY HEALTH CARE ADELAIDE (CHCA) HUMAN RESEARCH ETHICS COMMITTEE (HREC) APPROVAL
Applicants should review the NHMRC National Statement on Ethical Conduct in Human Research (2007) at the guidelines for the Protection of Privacy in the Conduct of Medical Research prior to completing this application. Please also refer to the CHCA website:
The NHMRC Guidelines on Ethical Matters in Aboriginal Health Research should also be read if proposals involve Aboriginal or Torres Strait Islander people. Proposals to conduct health-related research involving Aboriginal people or communities in South Australia need to be submitted to the Aboriginal Health Council of South Australia AHREC.
Institutions must see that any human research they conduct or for which they are responsible is:
(a) designed and conducted in accordance with the Australian Code for the Responsible Conduct of Research(2007); and
(b) ethically reviewed and monitored in accordance with The National Statement on Ethical Conduct in Human Research (2007).
and, for clinical trials - Therapeutic Goods Administration (TGA) Note for Guidance on Good Clinical Practice
In parallel, Little Company of Health Care (LCMHC) institutions have regard to the Code of Ethical Standards for Catholic Health and Aged Care Services in Australia(2001), and National Policy no 5.2.1 Ethical research and reporting requirements.
Comprehensive annual reporting is provided by each HREC to the National Health and Medical Research Council.
SUBMISSION PROCESS
If you have received ethical approval from another HRECthis does not allow you to undertake your research at Calvary Health Care Adelaide. You must supply a separate application to Calvary Health Care Adelaide HREC.FULL HREC REVIEW
The chief investigator submits a covering letter addressed to the CEO of the relevant hospital where the research is to be conducted at Calvary Health Care Adelaide, together with15 hard copies of the complete final protocol/proposal. This MUST include ALL attachments, supporting information and confirmation of cost estimates and agreement as to a funding sourcebefore it can be considered.
Completion of the HREAwhich is available at is required for all submissions. TheHREAhas been developed to be recognised by all Australian Human Research Ethiccs Committees in order to help researchers appreciate the ethical aspects of their research and enable the HREC to fully understand any ethical implications.
Please complete and submit:
The HREAand the CALVARY HEALTH CARE ADELAIDE RESEARCH PROPOSAL SUBMISSION and DECLARATION (pages 3-6)
Low or negligible risk EXPEDITED REVIEW
The HREC Chair has the delegation to approve proposals under an Expedited Review system in an ‘out of session’ process between meetings of the Committee. This may be considered in circumstances where the research is low and negligible risk (where the foreseeable risk to participants is no more than one of discomfort), non-interventional and aligns with NHMRC current guidelines and practice, and for some quality assurance activities.
It is explicitly stated in the National Statement on Ethical Conduct in Human Research 2007 that projects involving the following must be considered by a full committee andtherefore CANNOT be expedited:
- Randomisation and ‘blinding’ participants and researchers to the identity of agents being compared
- Interventions and therapies
- Human genetics and/or stem cells
- Women who are pregnant and the human foetus
- People highly dependent on medical care who may be unable to give consent
- People with a cognitive impairment, an intellectual disability, or a mental illness
- Aboriginal and Torres Strait Islanders
Completion of the HREAwhich is available at is required for all submissions. The HREAhas been developed to be recognised by all Australian Human Research Ethics Committees in order to help researchers appreciate the ethical aspects of their research and enable the HREC to fully understand any ethical implications.
Please complete and submit:
The HREAand the CALVARY HEALTH CARE ADELAIDE RESEARCH PROPOSAL SUBMISSION and DECLARATION (pages 3-6)
For both FULL HREC REVIEW and EXPEDITED REVIEW
Send to:CHCA Human Research & Ethics Committee,
Room 22 Connery House
c/o Calvary North Adelaide Hospital, 89 Strangways Terrace
North Adelaide SA 5006.
Meetings are scheduled approximately every 6-8 weeks with HREC members required to have the opportunity to review a protocol for a minimum of 10 business days prior. An electronic copy of all documents should also be sent to the HREC Chair within a single email:
Fees may be payable once the proposal is received. Where appropriate an invoice will be sent.
Appendix 1
ESSENTIAL DOCUMENTS CHECKLIST
Appendix 2
GUIDELINES ON CONTENT AND USE OF INFORMATION SHEETS FOR RESEARCH PARTICIPANTS
Appendix 3
GUIDELINES FOR PAYMENT OF VOLUNTEERS
Appendix 4
Schedule of fees
Application Form for Ethical and Scientific Review of a Research Project involving Human Participants
This form must accompany the HREA
CALVARY HEALTH CARE ADELAIDE (CHCA) HUMAN RESEARCH ETHICS COMMITTEE (HREC)
Application form forResearch Proposal
SECTION 1. TITLE OF THE PROJECT / PRINCIPAL INVESTIGATOR1.1 / PROJECT TITLE
State the full title of the project
SHORT TITLE
State the short title of the project (if applicable)
1.2 / PROJECT TYPE
High Risk Low risk Negligible risk
1.3 / CAPACITY IN WHICH CALVARY HEALTH CARE ADELAIDE IS TO BE INVOLVED IN THE STUDY:
Access to CHCA Premises/Equipment
Access to CHCA Medical Records
Access to CHCA Patients/staff
Access to CHCA Biospecimens
Access to HPS Pharmacy
Access to CHCA Other Data
Advertising of study
“Other”, please state:
1.4 / WHICH CALVARY HEALTH CARE ADELAIDE HOSPITALS ARE TO BE INVOLVED IN THE STUDY?
Calvary North Adelaide Hospital
Calvary Wakefield Hospital
Calvary Central Districts Hospital
Calvary Rehabilitation Hospital
1.5 / Does the research comply with CHCA site-specific policies/requirements (e.g. wording related to the use of contraception in participant information and consent documents)?
Yes No
If no, please give an explanation.
Researchers external to CHCA may contact the Research Office for a copy of relevant research policies.
1.6 / PRINCIPAL INVESTIGATOR (Where a student is involved Senior Staff must be listed)
Name & Title/Position: /
Ph no(s): / Fax:
Email:
Department:
Staff Member Visiting Medical Officer (VMO)
Other: please specify
Address for correspondence:
1.7 / What benefit is there to Calvary Health Care Adelaide?
1.8 / What benefit is there to your work area?
1.9 / What benefit is there to you?
SECTION 2. RESOURCES
Calvary Health Care Adelaide (CHCA) may incur costs in providing support for your research over and above those costs associated with standard care. Any additional routine care costs to be met by CHCA are to be clearly identified and detailed. This includes both the ‘actual’ costs and ‘in kind’ support. Confirmation of cost estimates and agreement as to a funding source are to be provided in the covering letter to the Chief Executive Officer of the relevant CHCA hospital in the first instance.
2.1 / PROJECT FUNDING / SUPPORT
Is a body external to Calvary Health Care Adelaide involved in the initiation or support of the project?
Yes No
If yes, Name of body/organisation:
Contact person:
Phone: Fax: Email:
Is there a contract? Yes No
If yes, please indicate the type of contract: NoneOtherMedicines Australia Standard Sponsor Medical Technology Association of Australia CTRAMA Clinical Research Organisation (CRO)MA Clinical Research Group (CRG)Medicines Australia Phase 4
If other, provide detail:
Please provide a copy of the Clinical Trial Research Agreement (CTRA) to the Research Officefor review prior to execution
The form of CTRA to be used depends upon the sponsor of the trial:
- trials conducted by commercial sponsors require the MA Standard CTRA – Commercial Sponsor;
- trials where there is a Contract Research Organisation (CRO) acting as the Local Commercial Sponsor, require the MA CRO-CTRA;
- trials conducted by non-commercial sponsors (universities, research institutes/clinical research group (CRG) or public hospitals, etc) require the MA CRG-CTRA.
Accordingly, the CTRA must:
- reflect each party’s role and responsibilities in relation to the clinical trial;
- require the PI to be accredited at CHCA site; and
- include the PI as a party to the CTRA so that the obligations and responsibilities set out in the CTRA are binding.
2.2 / Insurance and Indemnity
For commercially sponsored studies, the sponsor is responsible for arranging satisfactory insurance cover to indemnify the site, investigator and participants.
For Investigator-initiated studies, a copy of the Principal Investigator and Co-Investigator Medical Registration Certificate, personal medical insurance cover and written evidence of support from the Site CEO must be provided.
Attach details of investigator(s) medical indemnity for medical research and clinical trials or confirmation of Waiver of Exclusion.
Is evidence of adequate insurance cover attached?
Yes No(If no please give an explanation)
3. DECLARATION AND SIGNATURES
RESEARCH GOVERNANCE AT CALVARY HEALTH CARE ADELAIDE
Awareness of the importance of respect for ethical codes is a requirement for all those involved in human research. Researchers should familiarise themselves with the NHMRC / AHEC National Statement on Guidelines for Research Involving Humans 2007:
Investigators have ethical and legal responsibilities towards research participants and must observe the following guidelines:
I hereby declare that this project complies with the guidelines listed below (tick boxes).
1. / The research must conform with generally accepted moral and scientific principles.
2. / The investigator must be satisfied that the possible advantage to be gained from the investigation justifies any discomfort and risk involved.
3. / If possible, the investigation should be based on prior laboratory and animal experiments.
4. / The investigator must be mindful at all times of his or her duty towards the participant, respecting his or her personality, rights, wishes, beliefs, consent and freedom.
5. / The research shall be conducted by suitable qualified persons with appropriate clinical competence, having available facilities for the proper conduct of the work and for dealing with emergencies.
6. / New therapeutic or experimental procedures which are at the stage of early evaluation and which may have long-term effects shall not be undertaken unless appropriate provision has been made for long-term observation and care.
7. / Before any investigation involving a human participant is undertaken, the participant, or a person nominated by that participant, shall have given free and informed consent. The investigator is responsible for providing the participant, or his or her nominated person, with sufficient information about the purposes, methods, demands, risks, inconveniences, and discomforts of the investigation.
8. / If possible, consent should be obtained in writing. Such consent should include a declaration that the person signing the form is over 18 years of age.
9. / The participant, or his or her nominated person, must be free at any time to withdraw consent to further participation.
10. / The investigator must discontinue or modify the investigations if, during the course of the investigation, it becomes apparent that continuation may be harmful.
11. / A guarantee of confidentiality given by the investigator shall continue to be binding on all persons having access to, or using the information provided.
12. / I will immediately report to the HREC anything that might warrant review of the ethical approval of the proposal (NS 2.37) Including:
Serious or unexpected adverse effects on participants;
Proposed changes in the protocol; and
Unseen events that might affect continued ethical acceptability of the project.
13. / I will inform the HREC, giving reasons, if the project is discontinued before the expected date of completion (NS 2.38);
I will not continue the research if ethical approval is withdrawn and will comply with any special conditions required by the HREC (NS 2.45);
I will adhere to the conditions of approval stipulated by the HREC and will cooperate with HREC monitoring requirements. At a minimum annual progress reports and a final report will be provided to the HREC.
The following clauses are not applicable to this investigation (explain below the reasons for these exclusions). 012345678910111213 012345678910111213 012345678910111213 012345678910111213 012345678910111213
NOTE
The above guidelines do not, in any way, absolve any investigator from any special issues of consent. This must be considered carefully including issues of privacy of health information.
Refer to: additional information
INVESTIGATOR SIGNATURE AND DECLARATION
The information supplied in this application is a true and accurate account of the project and is provided with sufficient clarity to enable review. I agree to conduct the research activity and handle data confidentially in accordance with the requirements of Calvary Health Care Adelaide (CHCA), the National Statement on Ethical Conduct in Human Research 2007; the Australian Code for the Responsible Conduct of Research (2007);the Code of Ethical Standards for Catholic Health and Aged Care Services in Australia (2001), and LCM Health Carenational policy no 5.2.1 Ethical research and reporting requirements.
I have read the application and confirm that this project: has been developed and will be conducted in accordance with relevant Calvary Health Care Adelaide standards, policies and codes of practice; has research merit; has adequate resources and appropriate leadership/supervision. I will only commence this research project after obtaining approval from the CHCA HREC and authorisation from the site CEO.
Print Name:______
(Principal Investigator)
Signed:______ Dated: /
(Principal Investigator) dd/mm/yyyy
APPENDIX 1 - ESSENTIAL DOCUMENTS CHECKLIST
PLEASE REVIEW THE CHECKLIST AND ENSURE THAT ALL ESSENTIAL DOCUMENTS
ACCOMPANY YOUR SUBMISSION
Essential Documents / Submission TypeResearch Study Industry Sponsored / Research Study Investigator Initiated / Student Project
(Circle below)
Honours PhD
Masters Registrar / Quality Assurance / Data Audit / In-House Questionnaire
CEO approval letter / / / / / /
Final Study Protocol / / / / / /
Participant Information Sheet / / or NA / or NA / or NA / or NA
Participant Consent Form / / or NA / or NA / or NA / or NA
Liability Insurance Certificate of currency from sponsor1 / / or NA
Indemnity cover between the sponsor and the investigators /
Advertisements (If applicable) / or NA / or NA / or NA / or NA / or NA / or NA
Questionnaires, Surveys etc (If applicable) / or NA / or NA / or NA /
Up to date CV of all investigators and co-investigators if not previously known to CHREC / / / / / /
Annually - Copy of PI and Co-I Medical Registration Certificate and personal medical insurance cover / /
Evidence of Registration of the trial in a publicly accessible register e.g. Australian Clinical Trials Register2 / or pending / or pending
Other HREC approval (If applicable) / or NA / or NA / or NA / or NA / or NA / or NA
Any other participant/ study documentation / / / / / /
Indemnity cover between sponsor and CHREC / CHREC covered under Institutional Indemnity
Unapproved Drugs
Investigator Brochure3 / / or NA
CTN Form / / or NA
1 Product Liability Insurance Certificate to the minimum amount of AUD$10million for any one occurrence
2 National Statement on Ethical Conduct in Human Research (2007) Section 3.3.12.
3 If the investigational product is marketed and its pharmacology is widely understood by medical practitioners, an extensive IB may not be necessary. Where permitted by regulatory authorities, a basic product information brochure, package leaflet, or labelling may be an appropriate alternative, provided that it includes current, comprehensive, and detailed information on all aspects of the investigational product that might be of importance to the investigator. If a marketed product is being studied for a new use (i.e. a new indication), an IB specific to that new use should be prepared.Per the Note For Guidance on Good Clinical Practice CPMP/ICH/135/95
APPENDIX 2
GUIDELINES ON CONTENT AND USE:INFORMATION SHEETS FOR RESEARCH PARTICIPANTS
The HREC requires a Participant Information Sheet to be given to potential research participants to assist them in their decision about taking part. The Participant Information Sheet must accompany each Consent Form. In order to assist researchers in preparing Participant Information Sheet the National Participant Information and ConsentForm (PICF) Proforma is available to download at
Contact details of the HREC Chair, who is available to discuss general aspects of participation in a research project (telephone: 08 8239 9175) must be included.
______
PREGNANCY WORDING In accordance with the Code of Ethics of the Little Company of Mary Health Care GUIDELINES
Participants should be informed of the possible implications of participation in a research project both for themselves and for a developing foetus. The decision about how they ensure they do not become pregnant while participating in research is one for participants to make after consultation with their doctor and the researchers.
The format for how this issue is to be presented to potential research subjects in Information Sheets and Consent Forms is set out below. In some cases additional information might be required, e.g. because of particular drug interactions.
Patient information and consent form Statement where pregnancy must be avoided: Recommended template for Catholic Institutions
The effects of [Name of investigational product]on the unborn child and on the newborn baby are not known. Because of this, it is important that research project participants are not pregnant or breast-feeding and do not become pregnant during the course of the research project. You must not participate in the research if you are pregnant or trying to become pregnant, or breast-feeding. If you are female and child-bearing is a possibility, you will be required to undergo a pregnancy test prior to commencing the research project. If you are male, you should not father a child or donate sperm for at least [number]months after the last dose of study medication.
Both male and female participants must avoid pregnancy during the course of the research and for a period of [number]months after completion of the research project. You should discuss effective methods of avoiding pregnancy with your studydoctor.
[For female participants]If you do become pregnant whilst participating in the research project, you should advise your study doctor immediately. Your study doctor will withdraw you from the research project and advise on further medical attention should this be necessary. You must not continue in the research if you become pregnant.
[For male participants]You should advise your study doctor if you father a child while participating in the research project. Your study doctor will advise on medical attention for your partner should this be necessary.
APPENDIX 3