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 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

Origins of NEAF 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

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

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

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

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

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).

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

Research plan, information results, benefits, risks Participants, who, what they will do, recruitment, consent CTN/CTX Human tissue Genetics Dependent relationships Resources/funding NEAFQUESTIONSNEAFQUESTIONS Project title,description, research & participant types Researcher(s) details HREC(s)

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.

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

Research plan, information results, benefits, risks Participants, who, what they will do, recruitment, consent Resources/funding NEAFQUESTIONSNEAFQUESTIONS Project title,description,research & participant types Researcher(s) details HREC(s)

NEAF Help Quickstart guideQuickstart guide on-line Help buttonon-line Help button FAQs buttonFAQs button additional support available by ing oradditional support available by ing or telephoning telephoning

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NEAF and the National Statement

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

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

NEAF and National Statement 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

Essential elements in National Statement Justification 1.1, 1.4, 1.13, 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 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, 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 Title & summary 1.1Title 1.2Description of project in plain language 1.3Types of research 1.4Categories of research participants 1.5Research techniques

Justification 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)

Justice NEAF SUB-SECTIONS 3.5 Source & description of information about participants 3.6 Use of information about participants 3.10Reporting individual results to participants and others 5.1Participant description 7.1Project 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)

Beneficence NEAF SUB-SECTIONS 3.7Storage 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 3.12Benefits/Risks 3.13Monitoring 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)

Justice & Beneficence in specific projects NEAF SUB-SECTIONS 4.1Clinical trials under CTN/CTX 4.2Clinical research not CTN/CTX 4.3Administration of drug, not clinical research 4.4Research involving ionising radiation 4.5Research involving human embryos/ gametes 4.6Research involving human samples 4.7Research involving genetic testing / genetic research 4.8Research involving deception, concealment, covert observation 4.9Research involving Aboriginal and Torres Strait Islander peoples 4.10Research on Workplace practices or relationships 4.11Research conducted overseas NATIONAL STATEMENT , 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

Respect for persons NEAF SUB-SECTIONS 5.2 Participant experience 5.3 Relationship of researchers to participants 5.4 Recruitment 5.5 Consent process 10.2Participant 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: in specific projects NEAF SUB-SECTIONS 6.1Research in Australia involving persons with primary language other than English (LOTE) 6.2Research involving children and/or young people 6.3Research involving persons with an intellectual or mental impairment 6.4Research involving deception, concealment or covert behaviour 6.5Research involving persons in dependent relationships 6.6Research involving collectivities 6.7Research 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

HREC Review NEAF SUB-SECTIONS 8.1HREC(s) to receive proposal; researchers & sites for each HREC. 8.2Research overseas 9Undertakings & 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

NEAF on-line

NEAF and Revised National Statement

NEAF, Revised National Statement & HREC Review 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: 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:

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

Justification 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)

Justice NEAF SUB-SECTIONS 3.5 Source & description of information about participants 3.6 Use of information about participants 3.10Reporting individual results to participants and others 5.1Participant description 7.1Project 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

Beneficence NEAF SUB-SECTIONS 3.7Storage 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 3.12Benefits/Risks 3.13Monitoring NATIONAL STATEMENT (RVD) Risks minimised 1.3 Risks balanced by benefits 1.6 Suspend/modify if risks emerge 1.7

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

Respect NEAF SUB-SECTIONS 5.2 Participant experience 5.3 Relationship of researchers to participants 5.4 Recruitment 5.5 Consent process 10.2Participant 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 , & 12 Consent voluntary and clearly established Refuse freely Withdraw consent & know consequences Extended & unspecified consent Qualifying/waiving consent

Respect: in specific projects NEAF SUB-SECTIONS 4.9 Aboriginal and Torres Strait Islander Peoples 6.1Research in Australia involving persons with primary language other than English (LOTE) 6.2Research involving children and/or young people 6.3Research involving persons with an intellectual or mental impairment 6.4Research involving deception, concealment or covert behaviour 6.5Research involving persons in dependent relationships 6.6Research involving collectivities 6.7Research 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

HREC Review NEAF SUB-SECTIONS 3.13 Monitoring 7.2 Duality of interest 8.1HREC(s) to receive proposal; researchers, sites for each HREC. 8.2Research 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

NEAF on-line