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1 WWW.VU.EDU.AU UNDERSTANDING & MANAGING THE HUMAN RESEARCH ETHICS APPLICATION PROCESS A practical guide to the ethics application process Presented by: Anthony Benka Manager, Research Ethics and Biosafety
2 Topics Human Research Ethics The basics Guidelines for Researchers Research Code & National Statement The Review of Ethics Applications Planning Ethics Review Process Reporting on Progress Resources
3 Human Research Ethics The basics
4 What is human research? Human research is: 1.research conducted with people 2.research conducted about people 3.research dealing in their data or tissue
5 Values and principles of human research ethics A robust foundation for researchers. Research merit and integrity: research must be worthwhile, have value to the community. Respect for human beings: recognises that each human being has value in him/herself. Beneficence: the obligation to maximise possible benefits and minimise possible harms Justice: addressing the resolution of the question of who ought to receive the benefits of research and bear its burdens
6 Participants: Who are they? Defining participants People who are the principal focus of the research Whom the research impacts (concurrently or retrospectively).
7 Participants in human research taking part in surveys, interviews, or focus groups; undergoing psychological, physiological or medical testing or treatment being observed by researchers researchers having access to personal documents or other materials the collection and use of body organs, tissues or fluids or exhaled breath access to information (individually identifiable, re-identifiable of non- identifiable form) as part of an existing published or unpublished source or database. Human research is broad and involves participants in a wide range of manners:
8 Before You Start What you need to know
9 The Australian Code for the Responsible Conduct of Research The only research worth performing is that which is conducted with integrity. All researchers are required to comply with The Australian Code for the Responsible Conduct of Research Part A - The principles & practices of responsible research conduct of research -Responsibilities, Managing research data, Supervision, Publication & dissemination of findings, Authorship, Peer review, CoI & Collaborative research. Part B – Breaches, research misconduct and resolving allegations Researchers should obtain a copy of the Code of Conduct for Research and familiarise themselves its requirements. Obtain a copy at: http://research.vu.edu.au/rcc.phphttp://research.vu.edu.au/rcc.php
10 The National Statement on Ethical Conduct in Human Research To promote ethically good research This requires: respect and protection to be accorded to participants foster research that is beneficial to the community To clarify the responsibilities of: institutions & researchers for the ethical design, conduct and dissemination of results of human research review bodies in the ethical review of research Researchers must be familiar with the NS requirements if: researcher conducting research with human participants; Obtain a copy at: http://www.nhmrc.gov.au/publications/synopses/e72syn.htm
11 The Big Picture Who will deal with my application?
12 Ethics & Biosafety Administration Group – Our Services Administer the policies and procedures established by the Committees and those established by Commonwealth and State legislation, relevant codes. Report to Commonwealth and State authorities, regulatory agencies. Resource reviews and inspections of facilities, and ensure currency of scientific establishment licenses. Provide specialist information and advice to committee members, staff and research students regarding human research ethics, animal experimentation and animal welfare, and gene technology and biosafety. Promulgate the requirements of Codes of Conduct for Research and the National Statement to facilitate improvements to research at VU Administer all ethics applications for AEEC, IBC & HRECs (central & faculty based) Conduct initial review of all applications. Service committees and develop agendas Notify researchers of committee outcomes Monitor compliance with ethics and regulatory requirements (projects, facilities/infrastructure.) Manage allegations of ethical breaches Receive all requests (eg amendments, extensions) to approved projects
13 Who Reviews Ethics Applications? Human Research Ethics Committees Victoria University Human Research Ethics Committee (VUHREC) Review: non-minimal risk applications applications from other institutions Faculty based sub-committees Review: minimal risk applications –risks of discomfort negligible risk –inconvenience
14 Committee Structure Deals with ‘non- minimal’ risk applications. Eg. projects involving children, special groups, intrusive techniques or very sensiti v e material is reviewed at this level. Ratifies Faculty HREC decisions, manages membership, implements procedure and formulates responses to NHMRC. Reviews resolutions from minutes and anomalies that may arise from VUHREC. Review ‘Minimal Risk’ applications, amendments & extensions requested. Other applications forwarded to VUHREC. Faculty HRECs make recommendations on procedures to VUHREC Develops policy and procedure for existing and emerging issues.
15 Planning your Research Project Planning your research
16 Managing Research Projects & Ethics Manage your time carefully Project Management Projects are unique, complex and have connected activities Understand a) time b) resources c) quality Factor in the ‘ethics application process’ into your research project Committee meetings are deadline driven Submission deadlines are crucial Addressing amendments may take more time than expected
17 Ethics Review Process Process Preparation Submission Notification
18 Ethics Application Process Application Submission Risk Assessment Minimal or Non Minimal Risk Faculty or University HREC HREC Assessment Approved Minor Amendments Withheld Referred Ethics Notification
19 Preparation Carefully read the instructions in the Application Form Complete the Ethics Application Checklist Familiarise yourself with the Guidelines for Applications before submitting the application Ensure all questions in your application are appropriately answered Ensure the Declaration Form page is completed by all relevant parties Principal Investigator should be satisfied that the application is in a suitable form for submission Late submission is simply not acceptable; Committees will not assess proposals that have not been circulated with the meeting papers. Proposals finished in a mad scramble tend to be poorly developed and in consequence often need resubmission.
20 Submission What must I submit? An electronic application to the EBG (Faculty Ethics Officer) One approved original application (authorised by all parties to research) and twelve duplicate applications to the EBG. Applications will not be processed without the appropriate authorisation! Information to Participant form/s Participant Consent form/s Copies or concise descriptions of surveys/tests/questions/certified translations Supporting Documentation Eg. Ethics approvals and/or letters of approval from other organisations, etc. What happens to my application? Initial review of submission by the Ethics Officer. The Officer then liaise with the Chair, Faculty HREC and/or with Ethics & Biosafety Manager to decide on the proposal’s level of risk Details entered into the HRE Dbase (HRETH # is generated for individual applications) Application is placed on the following HREC Agenda
21 How & When Will I Be Notified? Following the HREC meeting: The HREC Secretary will notify the PI within 14 days of the HREC meeting E-mail notification to PI (usually 4 – 6 working days) Hard copy Ethics Notification letter will be posted to the PI, signed by the Chair of the HREC (project may only commence if approval granted) If I do not hear from the HREC? 1.Check with the project’s Principal Investigator 2.Contact the relevant Ethics Officer 3.Quote your HRETH Number (allocated upon submission)
22 The Committee’s Decision Defined Approved HREC has granted ‘Ethics Clearance.’ Your project has been Approved and you may commence your research. Conditional Approval with Minor Amendments Your application requires amendments as stipulated in the Ethics Notification letter (forwarded to PI). You will be required to address the amendments and resubmit the application: 1.a response to the items listed in the Ethics Notification 2.one original signed copy of the resubmitted application 3.one resubmitted application with changes highlighted (tracked changes) 4.soft copy of the amended application with all relevant attachments The resubmitted application is to be forwarded to the HREC Chair via the relevant Ethics Officer. Specific changes to the submission must be clear. You Cannot Commence Research Project
23 The Committee’s Decision Defined Withheld The Committee has expressed concern regarding the research project. You will need to address the amendments outlined in the Ethics Notification letter You will need to contact the nominated liaison person to discuss the HREC’s concerns. You will need to revise the application addressing the issues raised and resubmit the application: 1.response to the items listed in the Ethics Notification (12 copies) 2.one original signed copy of the resubmitted application 3.ten (12) resubmitted applications with changes highlighted (tracked changes) 4.soft copy of the amended application with all relevant attachments RE DO the Declaration Form with all the necessary signatures prior to resubmitting the application to the Ethics Officer who will place it on the Agenda for the next Ethics Committee meeting. Ensure that you have amended all relevant dates, as it is likely that the dates on your original submission are no longer valid. You Cannot Commence Research Project
24 The Committee’s Decision Defined Referred The Committee has deemed the nature of the application not suitable for that Committee’s review. The application has been sent another HREC for assessment (eg. Victoria University Human Research Ethics Committee to assess Non-Minimal Risk issues that were not apparent in the original submission). All correspondence should be referred to that HREC. Rejected The Committee deems the research project as ethically flawed. It has very serious concerns and regards the project unacceptable. The HREC will issue an Ethics Notification letter outlining its concerns and the applicable section of the National Statement that it has based its decision. A liaison person (normally the Chair) will be nominated as a contact. You Cannot Commence Research Project You may only commence your research project when you have received Ethics Approval
25 Responding to the Committee When do I need to respond following amendments? The Committee would normally expect that a revised application would be submitted within two months of the date of notification. If you are unable to submit your amended application within this timeframe, please notify the Ethics Officer in writing.
26 Afterwards Reporting on progress, changes and adverse events
27 Annual/Final Reports Researchers are obligated to submit an annual report outlining the progress of the research project. Continued approval is contingent upon submission of the report. Upon completion of the research project, researchers must submit a Final Report to the approving HREC.
28 Amendments to Applications Approval and extensions to my research Approval normally granted for max. 2 years Extension requests to be forwarded to the original HREC that granted approval Submit letter outlining reason for extension, quoting HRETH number, Project Title, and progress to date. Extension will be contingent upon you submitting the required annual/progress report. Changes to my Research Project (Minor Amendments to approved projects) Minor amendment requests to be forwarded to the HREC that originally granted approval Submit letter outlining nature and reason for change, quoting HRETH number, Project Title, and progress to date. Submit updated application form including approved clean copy (by PI) and a tracked changes copy highlighting all changes. Send through an e-copy to the EBG Approval will be contingent upon you submitting the required annual report and meeting ethical standards
29 Resources EBG Website Guidelines
30 Human Research Ethics Web Page http://research.vu.edu.au/hrec.php Application Kit Application Guidelines, Application form, Participant Information form, Participant Consent form and Review questions Committee & Dates University & Faculty contact details Submission and meeting dates Membership HREC Terms of Reference Approved Projects Changes and Extensions to approved projects Annual project and Final reports Useful Links
31 Ethics & Biosafety Administration Group Mr Anthony Benka Manager, Research Ethics and Biosafety. Phone: 9919 4148 (Mondays, Wednesdays & Thursdays) VUHREC, AEEC, IBC, Feedback, Complaints, Adverse Events. Ms Lilian Tan Ethics Officer (Phone: 9919 4461) VUHREC Health, Engineering and Science HREC, AEEC. Ms Lauren Donley Ethics Officer (Phone: 9919 4781) Arts, Education and Human Development HREC Business and Law HREC IBC
32 Useful Links & Resources Human Research Ethics Web page http://research.vu.edu.au/hrec.php New Research in a New Era Training Program (Ethics Training Module) http://research.vu.edu.au/nrne/NRNE/ethics/web/index.html National Statement on Ethical Conduct in Research Involving Humans http://www7.health.gov.au/nhmrc/publications/synopses/e35syn.htm Human Research Ethics Handbook http://www.nhmrc.gov.au/publications/synopses/e42syn.htm http://www.nhmrc.gov.au/publications/synopses/e42syn.htm National Health and Medical Research Council http://www7.health.gov.au/nhmrc/ Office of the Privacy Commissioner (National Privacy Principles) http://www.privacy.gov.au/policy/index.html
33 Ethics Application form Tips for researchers
34 The Ethics Application Form What is expected? Read the instructions carefully Answer all questions Ensure language is clear and simple (avoid jargon) Proof read application and attachments Ensure you have all supporting documents (information forms, approvals, etc…) Time – dedicate ample time to understanding & developing the application Quality – approach the ethics process with the intent of submitting a high quality application (utilise all options & cover all items) Resources – seek out those who can assist (PI, Co-investigators, Experts and HREC members) Plan ahead.
35 The Ethics Application Form Responsibility Principal Investigator (PI) has overall responsibility for the research project Responsible for the preparation of the proposal. PI should not sign off on the proposal until he/she is satisfied that it is of suitable standard must sign off approving the application. Research Student It is normal for the student undertaking research for a higher degree to write the proposal with the guidance of their supervisor (normally the PI). Head of School/Department Responsible for final sign off - approving the project at the School/Dept level. While acknowledging that many proposals are completed only just in time to meet committee deadlines, the HREC has very little sympathy for poorly written proposals. It’s the Researcher’s responsibility to get it right. Poorly written applications will be withheld and/or withheld Delays generally result from poorly planned, poorly constructed applications.
36 What to remember
37 Why do I need approval? Ethics approval is essential Moral and legal requirement Professional practice Ethics review: an obstacle or an ‘insurance policy’? Experts from a variety of backgrounds review research applications Critical feedback Risk minimisation VU protects you Adverse events & complaints Delay or refinement? Addressing critical gaps in the project Respecting the rights of participants Identifying legal oversights Highlighting the obligations of a researcher Identify issues of safety (eg. researcher and participants)
38 Conduct & human research Human research ethics values and principles help guide researchers to develop and conduct research in a way that is: Safe Respectful Responsible High quality
40 WWW.VU.EDU.AU UNDERSTANDING & MANAGING THE HUMAN RESEARCH ETHICS APPLICATION PROCESS A practical guide to the ethics application process Developed by: Anthony Benka Manager, Research Ethics and Biosafety VU Research Office