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National Ethics Application Form (NEAF)

National Ethics Application Form (NEAF). What is NEAF?. Web-based human research ethics application form Hosted on a dedicated website For any research project involving human participants

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National Ethics Application Form (NEAF)

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  1. National Ethics Application Form (NEAF)

  2. What is NEAF? • Web-based human research ethics application form • Hosted on a dedicated website • For any research project involving human participants • To meet National Statement on Ethical Conduct in Research Involving Humans and other national guidelines • Dynamic – expands/contracts in response to answers • Complete proposals as PDF, XML or Access* data files • Developed by NHMRC with the support of ARC, AVCC

  3. Origins of NEAF • 2001 - Melbourne meeting with developers of Victorian DHS Common form • Encouragement that AHEC build on their work toward a national form • Discussions with similar outcomes with developers of common form used by NSW universities

  4. Development of NEAF • Steering group - wide representation • Working Party - members from health institutions & universities, WA, TAS, Vic, QLD & NSW • WP developed text & logic • Steering Group + targeted consultation on text • IT contract let & web-based form built • Testing & feedback • Final adjustments made

  5. Goals of NEAF • To collect all information that HRECs need in order to be satisfied that a research proposal meets relevant national ethical guidelines • To assist researchers by links to guidelines, reference material & help in answering questions • Promote timely, consistently comprehensive ethical review • Facilitate ethical review of multi-site research projects

  6. Implementation of NEAF • May 2006 – - brochure & mail-out to all HRECs - NEAF now accessible on www.neaf.gov.au • May-July 2006 – - information/demonstration sessions arranged in all States and territories - with key ethics personnel in health & medical institutions and universities

  7. Project title,description, research & participant types N E A F Q U E S T I O N S Researcher(s) details Research plan, information results, benefits, risks Participants, who, what they will do, recruitment, consent CTN/CTX Clinical research Non-clinical research with drug Language other than English Ionising radiation Children Human embryos Intellectual or mental impairment Human tissue Deception Genetics Dependent relationships Deception Aboriginal & Torres Strait Islander research Collectivities Workplace Participants overseas Conducted overseas Resources/funding HREC(s)

  8. Completing a NEAF application Suppose a research project that is • a Phase III clinical trial • that involves a genetic sub-study for • an adult population that will include • people in dependent relationships (patients).

  9. Project title,description, research & participant types N E A F Q U E S T I O N S Researcher(s) details Research plan, information results, benefits, risks Participants, who, what they will do, recruitment, consent CTN/CTX Clinical research Non-clinical research with drug Language other than English Ionising radiation Children Human embryos Intellectual or mental impairment Human tissue Deception Genetics Dependent relationships Deception Aboriginal & Torres Strait Islander research Collectivities Workplace Participants overseas Conducted overseas Resources/funding HREC(s)

  10. Project title,description, research & participant types N E A F Q U E S T I O N S Researcher(s) details Research plan, information results, benefits, risks Participants, who, what they will do, recruitment, consent CTN/CTX Human tissue Genetics Dependent relationships Resources/funding HREC(s)

  11. Completing a NEAF Application Suppose a research project that • involves a survey • of an identifiable adult population • that is known not to include: • people who have mental or intellectual impairments, are in dependent relationships or who are Aboriginal and Torres Strait Islander people.

  12. Project title,description,research & participant types N E A F Q U E S T I O N S Research plan, information results, benefits, risks Researcher(s) details Participants, who, what they will do, recruitment, consent CTN/CTX Clinical research Non-clinical research with drug Language other than English Ionising radiation Children Human embryos Intellectual or mental impairment Human tissue Deception Genetics Dependent relationships Deception Aboriginal & Torres Strait Islander research Collectivities Participants overseas Workplace Resources/funding Conducted overseas HREC(s)

  13. Project title,description,research & participant types N E A F Q U E S T I O N S Research plan, information results, benefits, risks Researcher(s) details Participants, who, what they will do, recruitment, consent Resources/funding HREC(s)

  14. NEAF Help • Quickstart guide • on-line Help button • FAQs button • additional support available by emailing neafassist@nhmrc.gov.au, or • telephoning 1800 823 993

  15. www.neaf.gov.au

  16. Username: HESUser Password: HES9575

  17. NEAF and the National Statement

  18. NEAF SECTIONS Section 1 Title and Summary Section 2 Researchers Section 3 Project Section 4 Project specific Section 5 Participants Section 6 Participants specific Section 7 Funding/Resources Section 8 HREC review Section 9 Signatures Section 10 Attachments

  19. National Statement Chapter 1 principles, values, processes to which ALL proposals should comply Chapters 2 & 3 HRECs Chapters 4 - 9 categories of participants Chapters 10 - 19 types of research

  20. NEAF Section 1 Title & Summary Section 2 Researchers Section 3 Project Section 4 Project specific Section 5 Participants Section 6 Participants specific Section 7 Funding/Resources Section 8 HREC review Section 9 Signatures Section 10 Attachments NATIONAL STATEMENT Chapter 1 - principles, values, processes Chapters 2 & 3 - HRECs Chapters 4 to 9 - specific to type of participants Chapters 10 to 19 - specific to type of research NEAF and National Statement

  21. Essential elements in National Statement Justification 1.1, 1.4, 1.13, 1.15. Justice 1.5, 1.6, 1.18 Beneficence 1.3, 1.14, 1.17, 1.19, 1.20 Respect for persons 1.2, 1.4, 1.7, 1.8, 1.9, 1.10, 1.11, 1.12 HREC review 1.16

  22. NEAF SECTIONS 1 (Title, description, research type & participant categories) 2 (Researchers) & 3 (Project) + Attachments 3 (Project), 5(Participants & 7(Funding) 3 (Project) & 4 (Project Specific) 5 (Participants) & 6(Participants Specific) + Participant information elements 8 (HREC Review) NATIONAL STATEMENT Project application: 2.13 Justification: 1.1, 1.4, 1.13, 1.15. Justice: 1.5, 1.6, 1.18 Beneficence: 1.3, 1.14, 1.17, 1.19, 1.20 Respect for persons: 1.2, 1.4, 1.7, 1.8, 1.9, 1.10, 1.11, 1.12 HREC review: 1.16 NEAF & National Statement in HREC Review

  23. NEAF Title & summary 1.1 Title 1.2 Description of project in plain language 1.3 Types of research 1.4 Categories of research participants 1.5 Research techniques

  24. NEAF SUB-SECTIONS 2.1 Principal researcher 2.2 Associate researchers 2.3 Other personnel relevant to the research project 2.4 Certification researchers 2.5 Training of researchers 3.1 Duration and location 3.2 Detailed research plan 3.3 Research significance 3.4 Peer review 10.1 List of attachments (generated) NATIONAL STATEMENT Researcher integrity (1.1) Researchers’ skills, experience & facilities (1.15) Research based on adequate study, prior work (1.13) Respect take precedence over expected benefits (1.4) Results to be published (1.18) Justification

  25. NEAF SUB-SECTIONS 3.5 Source & description of information about participants 3.6 Use of information about participants 3.10 Reporting individual results to participants and others 5.1 Participant description 7.1 Project Funding, Support NATIONAL STATEMENT Fair distribution of benefits/burdens of participation, Recruitment fair, Inclusion/exclusion criteria relevant (1.5) risks balanced by benefits or if no benefits, risks minimal (1.6) results disclosed to participants (1.18) Justice

  26. NEAF SUB-SECTIONS 3.7 Storage of information during & after project 3.8 Ownership of information collected & resulting from project 3.9 Disposal of information 3.11 Dissemination of final results 3.12 Benefits/Risks 3.13 Monitoring NATIONAL STATEMENT Risks minimised (1.3) Risks balanced by benefits (1.14) Suspend/modify if risks emerge (1.17) Use of records protect privacy & cultural sensitivities (1.19) Storage of records & follow up studies (1.20) Beneficence

  27. NEAF SUB-SECTIONS 4.1 Clinical trials under CTN/CTX 4.2 Clinical research not CTN/CTX 4.3 Administration of drug, not clinical research 4.4 Research involving ionising radiation 4.5 Research involving human embryos/ gametes 4.6 Research involving human samples 4.7 Research involving genetic testing / genetic research 4.8 Research involving deception, concealment, covert observation 4.9 Research involving Aboriginal and Torres Strait Islander peoples 4.10 Research on Workplace practices or relationships 4.11 Research conducted overseas NATIONAL STATEMENT 12.1- 12.13, 13 Clinical trials, Innovation 10 Ionising radiation 11 ART 15 Human tissue samples 16 Human genetics 17 Deception, concealment 9 Aboriginal & Torres Strait Islander peoples 1.21 overseas Justice & Beneficence in specific projects

  28. NEAF SUB-SECTIONS 5.2 Participant experience 5.3 Relationship of researchers to participants 5.4 Recruitment 5.5 Consent process 10.2 Participant information elements NATIONAL STATEMENT Regard for welfare, rights, customs & heritage etc (1.2) Respect for dignity take precedence over expected benefits, knowledge (1.4) Consent based on adequate information & competent (1.7) Consent voluntary (1.10) and clearly established? (1.9) Refuse freely (1.8) Withdraw consent & know consequences (1.12) Respect for persons

  29. NEAF SUB-SECTIONS 6.1 Research in Australia involving persons with primary language other than English (LOTE) 6.2 Research involving children and/or young people 6.3 Research involving persons with an intellectual or mental impairment 6.4 Research involving deception, concealment or covert behaviour 6.5 Research involving persons in dependent relationships 6.6 Research involving collectivities 6.7 Research conducted overseas NATIONAL STATEMENT 2.26 Interpreters 4.1 – 4.4 Children 5.1 – 5.4 Intellectual or mental impairment 17 deception, concealment 6.1 – 6.10, 7.1 – 7.3 dependent relationships, medical care 8.1 – 8.2 Collectivities 1.21 overseas Respect for persons: in specific projects

  30. NEAF SUB-SECTIONS 8.1 HREC(s) to receive proposal; researchers & sites for each HREC. 8.2 Research overseas 9 Undertakings & signatures (page(s) generated) NATIONAL STATEMENT 1.16 review required 3.1 – 3.8 multi-centre review 2.35, 2.37, 2.38 researcher obligations HREC Review

  31. NEAF on-line www.neaf.gov.au

  32. NEAF and Revised National Statement

  33. NEAF SECTIONS 1 (Title, description, research type & participant categories) 2 (Researchers) & 3 (Project) + Attachments 3 (Project), 5(Participants & 7(Funding) 3 (Project) & 4 (Project Specific) 5 (Participants) & 6(Participants Specific) + Participant information elements 8 (HREC Review) NATIONAL STATEMENT ESSENTIALS Project application: 5.2.23-25 Justification: 1.1, 1.2 Justice: 1.3, 1.4 Beneficence: 1.5, 1.6, 1.7 Respect for persons: 1.8, 1.9, 1.10 HREC review: 5.1.3 - 6 NEAF, Revised National Statement & HREC Review

  34. NEAF Title & summary 1.1 Title 1.2 Description of project in plain language 1.3 Types of Research 1.4 Categories of research participants 1.5 Research techniques

  35. NEAF SUB-SECTIONS 2.1 Principal researcher 2.2 Associate researchers 2.3 Other personnel relevant to the research project 2.4 Certification researchers 2.5 Training of researchers 3.1 Duration and location 3.2 Detailed research plan 3.3 Research significance 3.4 Peer review 10.1 List of attachments (generated) NATIONAL STATEMENT(RVD) Researcher integrity 1.2 Researchers’ skills, experience & facilities 1.1(e),(f) Research based on adequate study, prior work 1.1(a - c) Respect take precedence over expected benefits 1.1(d) Results to be published 1.2(d) Justification

  36. NEAF SUB-SECTIONS 3.5 Source & description of information about participants 3.6 Use of information about participants 3.10 Reporting individual results to participants and others 5.1 Participant description 7.1 Project Funding, Support NATIONAL STATEMENT (RVD) Fair distribution of benefits/burdens of participation, 1.3(e)(f) Recruitment fair,1.3(c) Inclusion/exclusion criteria relevant 1.3(b) risks balanced by benefits or if no benefits risks minimal(1.3(a)(d-f) results disclosed to participants? 1.4 Justice

  37. NEAF SUB-SECTIONS 3.7 Storage of information during & after project 3.8 Ownership of information collected & resulting from project 3.9 Disposal of information 3.11 Dissemination of final results 3.12 Benefits/Risks 3.13 Monitoring NATIONAL STATEMENT (RVD) Risks minimised 1.3 Risks balanced by benefits 1.6 Suspend/modify if risks emerge 1.7 Beneficence

  38. NEAF SUB-SECTIONS 4.1 Clinical trials under CTN/CTX 4.2 Clinical research not CTN/CTX 4.3 Administration of drug, not clinical research 4.4 Research involving ionising radiation 4.5 Research involving human embryos/ gametes 4.6 Research involving human samples 4.7 Research involving genetic testing / genetic research 4.8 Research involving deception, concealment, covert observation 4.9 Research involving Aboriginal and Torres Strait Islander peoples 4.10 Research on Workplace practices or relationships 4.11 Research conducted overseas NATIONAL STATEMENT (RVD) 3.1 Qualitative methods 3.2 Limited disclosure 3.3 Databanks 3.4 Therapies & interventions, innovation 3.5 Human genetics 3.6 Human tissue samples 3.7 Human stem cells 4.7 Aboriginal & Torres Strait Islander peoples 4.8 People in other countries Justice & Beneficence in specific projects

  39. NEAF SUB-SECTIONS 5.2 Participant experience 5.3 Relationship of researchers to participants 5.4 Recruitment 5.5 Consent process 10.2 Participant information elements NATIONAL STATEMENT (RVD) Regard for welfare, rights, customs & heritage etc 1.8 Respect for dignity precedence over expected benefits, knowledge 1.1(d) Consent based on adequate information & competent 2.2.1 -2.2.6, 2.2.10 & 12 Consent voluntary 2.2.7-9 and clearly established 2.2.11 Refuse freely 2.2.16 Withdraw consent & know consequences 2.2.17 Extended & unspecified consent 2.2.13-15 Qualifying/waiving consent 2.2.18-23 Respect

  40. NEAF SUB-SECTIONS 4.9 Aboriginal and Torres Strait Islander Peoples 6.1 Research in Australia involving persons with primary language other than English (LOTE) 6.2 Research involving children and/or young people 6.3 Research involving persons with an intellectual or mental impairment 6.4 Research involving deception, concealment or covert behaviour 6.5 Research involving persons in dependent relationships 6.6 Research involving collectivities 6.7 Research conducted overseas NATIONAL STATEMENT (RVD) 4.1 Women who are pregnant & human fetus 4.2 Children and young people 4.3 People in dependent or unequal relationships 4.4 People highly dependent on medical care 4.5 Cognitive impairment, intellectual disability or mental illness 4.6 People who may be involved in illegal activities 4.7 Aboriginal & Torres Strait Islander peoples 4.8 People in other countries Respect: in specific projects

  41. NEAF SUB-SECTIONS 3.13 Monitoring 7.2 Duality of interest 8.1 HREC(s) to receive proposal; researchers, sites for each HREC. 8.2 Research overseas Undertakings & signatures (page(s) generated) NATIONAL STATEMENT (RVD) 5.1 Review required 5.2 HREC processes 5.3 Multi-centre review 5.4 Conflicts of interest 5.5 Monitoring approved research HREC Review

  42. NEAF on-line www.neaf.gov.au

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