National Ethics National Ethics Application FormApplication Form

(NEAF)(NEAF)

What is 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 NEAFOrigins 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

Development of NEAFDevelopment 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 NEAFGoals 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 NEAFImplementation 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

Research plan, information

results, benefits, risksParticipants, who, what they will do,

recruitment, consentCTN/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)

NEAF

QUESTIONS

Project title,description, research & participant types

Researcher(s) details

Completing a NEAF Completing a NEAF applicationapplication

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, consentCTN/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

NEAF

QUESTIONS

Project title,description, research & participant types

Researcher(s) details

HREC(s)

Research plan, information

results, benefits, risks

Participants, who, what they will do,

recruitment, consentCTN/CTX

Human tissue

Genetics

Dependent relationships

Resources/funding

NEAF

QUESTIONS

Project title,description, research & participant types

Researcher(s) details

HREC(s)

Completing a NEAF Completing a NEAF ApplicationApplication

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, consentCTN/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

NEAF

QUESTIONS

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

NEAF

QUESTIONS

Project title,description,research & participant types

Researcher(s) details

HREC(s)

NEAF HelpNEAF Help

• Quickstart guideQuickstart guide• on-line Help buttonon-line Help button• FAQs buttonFAQs button• additional support available by additional support available by

emailing emailing neafassist@nhmrc.gov.au, or

• telephoning 1800 823 993telephoning 1800 823 993

www.neaf.gov.au

Username: HESUser

Password: HES9575

NEAF and the National NEAF and the National StatementStatement

NEAF SECTIONSNEAF SECTIONS

Section 1 Title and SummarySection 2 ResearchersSection 3 Project Section 4 Project specificSection 5 ParticipantsSection 6 Participants specificSection 7 Funding/ResourcesSection 8 HREC reviewSection 9 SignaturesSection 10 Attachments

National Statement 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

NEAF and National StatementNEAF and National StatementNEAFSection 1 Title &

SummarySection 2 ResearchersSection 3 ProjectSection 4 Project

specificSection 5 ParticipantsSection 6 Participants

specificSection 7

Funding/ResourcesSection 8 HREC reviewSection 9 SignaturesSection 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 Essential elements in National StatementStatement

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 NEAF & National Statement in HREC Reviewin 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, 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 Title & summaryNEAF Title & summary

1.1 Title1.2 Description of project in

plain language1.3 Types of research 1.4 Categories of research

participants1.5 Research techniques

JustificationJustificationNEAF SUB-SECTIONS2.1 Principal researcher2.2 Associate researchers2.3 Other personnel

relevant to the research project

2.4 Certification researchers

2.5 Training of researchers

3.1 Duration and location3.2 Detailed research

plan3.3 Research significance3.4 Peer review10.1 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)

JusticeJusticeNEAF SUB-SECTIONS3.5 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)

BeneficenceBeneficenceNEAF SUB-SECTIONS3.7 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/Risks3.13 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)

Justice & Beneficence in Justice & Beneficence in specific projectsspecific projects

NEAF SUB-SECTIONS4.1 Clinical trials

under CTN/CTX4.2 Clinical research

not CTN/CTX4.3 Administration of

drug, not clinical research4.4 Research involving

ionising radiation 4.5 Research involving

human embryos/ gametes4.6 Research involving

human samples4.7 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 STATEMENT12.1- 12.13, 13 Clinical trials,

Innovation

10 Ionising radiation

11 ART

15 Human tissue samples

16 Human genetics17 Deception, concealment

9 Aboriginal & Torres Strait Islander peoples

1.21 overseas

Respect for personsRespect for personsNEAF SUB-SECTIONS5.2 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: in specific Respect for persons: in specific projectsprojects

NEAF SUB-SECTIONS6.1 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 STATEMENT2.26 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 ReviewHREC Review

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

NEAF on-lineNEAF on-line

www.neaf.gov.au

NEAF and Revised National NEAF and Revised National StatementStatement

NEAF, Revised National Statement NEAF, Revised National Statement &&

HREC Review HREC ReviewNEAF 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 Title & summaryNEAF Title & summary

1.1 Title1.2 Description of project in

plain language1.3 Types of Research 1.4 Categories of research

participants1.5 Research techniques

JustificationJustificationNEAF SUB-SECTIONS

2.1 Principal researcher2.2 Associate researchers2.3 Other personnel

relevant to the research project

2.4 Certification researchers

2.5 Training of researchers

3.1 Duration and location3.2 Detailed research plan3.3 Research significance3.4 Peer review10.1 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)

JusticeJusticeNEAF 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

BeneficenceBeneficence

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/Risks3.13 Monitoring

NATIONAL STATEMENT (RVD)

• Risks minimised 1.3

• Risks balanced by benefits 1.6

• Suspend/modify if risks emerge 1.7

Justice & Beneficence in specific Justice & Beneficence in specific projectsprojects

NEAF SUB-SECTIONS4.1 Clinical trials

under CTN/CTX4.2 Clinical research

not CTN/CTX4.3 Administration of

drug, not clinical research4.4 Research involving

ionising radiation 4.5 Research involving

human embryos/ gametes4.6 Research involving

human samples4.7 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

methods3.2 Limited

disclosure3.3 Databanks3.4 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

RespectRespectNEAF SUB-SECTIONS5.2 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: in specific projectsRespect: in specific projectsNEAF SUB-SECTIONS4.9 Aboriginal and

Torres Strait Islander Peoples6.1 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

HREC ReviewHREC Review

NEAF SUB-SECTIONS3.13 Monitoring7.2 Duality of

interest8.1 HREC(s) to

receive proposal; researchers, sites for each HREC.

8.2 Research overseasUndertakings & 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-lineNEAF on-line

www.neaf.gov.au