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Frequently asked questions Making a Submission What is the difference between the Committee and the Panel? Who is the Chief Investigator? When are the submission, meeting and notification dates? How many copies of the application do I submit? Where do I submit my application? Do projects approved by another institution need to be ratified by UNSW HREC? Period of approval, modifications and reporting How long is my approval valid for? What if I want to make changes/amendments to the protocol? What are my responsibilities for annual reporting of HREC-approved projects? How should I report a serious adverse event? Common concerns raised by the HREC How do I ensure non-coercive recruitment of research participants? How do I ensure protection of participants’ privacy and confidentiality? Should I adhere to the Participant Information Statement and Consent Form proforma? What constitutes a “conflict of interest”? What is an acceptable reward to research participants? How should I ensure that research participants receive feedback about the results of the study? Is the Head of School/Department/Unit's signature required before submission? Making a Submission What is the difference between the Committee and the Panel? There are two methods by which research projects involving human participants are reviewed at UNSW. The first is by the Human Research Ethics Committees (HRECs) which review all projects containing significant ethical concerns. The second is review by one of nine discipline-based Human Research Ethics Advisory (HREA) Panels which are concerned with research which has minimal ethical impact. For more information visit the guidelines page of this web site. Who is the Chief Investigator? If the project is to be undertaken by an Honours/Masters/PhD student, then the supervisor will be considered the Chief Investigator. The student may be nominated as a co-investigator. Any investigator mentioned in Consent Forms and/or Participant Information Sheets must be readily available to answer queries the participants may have. If a registered medical practitioner is taking responsibility for an invasive procedure conducted on behalf of the investigators, then this should be indicated in Section 9 of the Application Form and a letter of agreement enclosed. All correspondence will be sent to the Chief Investigator. The Chief Investigator is responsible for ensuring that all co-investigators are fully informed of communications from the HREC. When are the submission, meeting and notification dates? The Human Research Ethics Committee on the third Tuesday of every month. Submission dates are two weeks earlier. Researchers can expect feedback 1 week after the meeting date. For more information visit the meeting dates page of this website. Each HREA panel has different meeting dates and submission dates, for more information on each panel visit the panel page of this website. How many copies of the application do I submit? 1 original application including all associated documents (eg: questionnaires, letters of support, Participant Information Statement and Consent Forms) bulldog clipped as 1 complete pack. 12 copies of application and attachments stapled as 12 complete packs. 4 copies of the grant application. For more information on copies and format visit the copies page of this website Each HREA Panel has a different requirement, for more information visit the panel page of this website. Where do I submit my HREC application? HREC ratifications Ratification documents can be scanned and emailed to the Ethics Secretariat at ethics.sec@unsw.edu.au. Or posted to the Ethics Secretariat address below. If you are emailing documents please do not post hard copies as well unless requested by the Ethics Secretariat. HREC applications Deliver HREC applications and copies to: Ethics Secretariat, UNSW Grants Management Office Rupert Myers Building, Level 3 The University of New South Wales SYDNEY NSW 2052 HREA Panel Panel applications are to be delivered each panel. For more information visit the panel page of this website. Do projects approved by another institution need to be ratified by UNSW HREC? Projects approved by another HREC which involve UNSW staff, students or facilities must be ratified by the UNSW HREC. The Chief Investigator should forward copies of the original application and the approval letter to the UNSW HREC. If your project is not affiliated with UNSW visit this page of the UNSW website. How long is my approval valid for? HREC approvals are valid for 5 years. HREA Panel approvals are valid for 12 months. Under exceptional circumstances you may apply for a 12 month extension using the Application for Extension form. What if I want to make changes/amendments to the protocol? Modifications can be made during the course of an approved research project. The Chief Investigator should detail the modifications in a letter to the HREC or HREA Panel and attach relevant documents (e.g. updated Participant Information Sheet and Consent Form). If the proposed amendment is substantial, the HREC or HREA Panel may opt to treat it as a new project. In this event, a new application will be required. Panel modifications are to be sent directly to the panel convenor. For more information visit the panel page of the UNSW website. HREC modifications can be emailed to the Ethics Secretariat at ethics.sec@unsw.edu.au. Or post to: Ethics Secretariat, UNSW Grants Management Office Rupert Myers Building, Level 3 The University of New South Wales SYDNEY NSW 2052 If you are emailing documents please do not post hard copies as well unless requested by the Ethics Secretariat. What are my responsibilities for annual reporting of HREC-approved projects? The Ethics Secretariat will send out an annual monitoring form to all researchers. The data are required for assessment of compliance and for mandatory reporting. Failure to complete annual monitoring forms will result in withdrawal of HREC approval. How should I report a serious adverse event? A serious adverse event is defined as serious or unexpected harm (physical, psychological, financial, social or cultural) to a researcher or research participant. These must be reported to the HREC within 72 hours using the SAE Proforma. See question 6.1 of the HREC application form and associated hotlinks. How do I ensure non-coercive recruitment of research participants? The initial contact with participants should be at “arm’s length”. This is particularly important where the potential participants are in dependent relationships with researchers. (See questions 3.2, 3.3 and 3.4 of the HREC application form and associated hotlinks.) How do I ensure protection of participants’ privacy and confidentiality? There is legislation at Commonwealth and State levels that governs the identification, collection, use or disclosure of information of a personal nature, either identifiable or potentially identifiable, about individuals without their consent (see Section 4 of the HREC application form and associated hotlinks.) Should I adhere to the Participant Information Statement and Consent Form proforma? The proforma has been carefully designed to include information relevant to the major ethical issues involved in research participation. (See Section 7 of the HREC application form and associated hotlinks.) It is recommended that the Participant Information Statement and Consent Form be prepared in close accordance with the proforma. What constitutes a “conflict of interest”? Any affiliation with, or involvement in, any organisation or entity with a direct interest in the project. These associations need to be disclosed in the Participant Information Statement. (See questions 8.2 of the HREC application form and associated hotlinks.) What is an acceptable reward to research participants? Volunteers may be paid for inconvenience, or reimbursed for out-of-pocket expenses, and time spent, but such payments must not be so large as to be an inducement to participate. For some studies a non-monetary recompense (e.g. taxi vouchers or gift vouchers) may be more appropriate than a cash payment. See the NHMRC website for more information: NS1.10 Coercion, inducements Cp9-10 1.10 Coercion, inducements How should I ensure that research participants receive feedback about the results of the study? A plain language summary of the research results should be distributed or made available to research participants (e.g. via a newsletter sent electronically or a flyer provided at the research facility). Is the Head of School/Department/Unit signature required before submission? The HREC will not consider applications without the signature of the appropriate senior officer not associated with research. Note: this person should be both independent of the research and of equal, or more, senior academic status than the Chief Investigator. |
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UNSW Sydney NSW 2052, Telephone: (+61 02) 9385 7230 CRICOS Provider Code 00098G AUTHORISED BY Director UNSW Grants Management Office Page last updated: 16th July, 2008 |
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