Ethical Issue for Observational Research

8/4/2019 Ethical Issue for Observational Research

1/111

Deveped jn Nana Heah and Medca Research Cnc

Asraan Research CncAsraan VceChancers Cmmee

Nana Saemen n EhcaCndc n Hman Research


2/111

Endorsed March 2007

Reprinted October 2007

Australian Government 2007

Paper-based publicationsThis work is copyright. Apart rom any use as permitted under the Copyright Act 1968,no part may be reproduced by any process without prior written permission rom theCommonwealth available rom the Attorney-General's Department. Requests and inquiriesconcerning reproduction and rights should be addressed to the Commonwealth CopyrightAdministration, Attorney General's Department, Robert Garran Oces, National Circuit,Canberra, ACT, 2600 or posted at: http://www.ag.gov.au/cca

ISBN Print: 1864962690

Australian Government 2007

Electronic documentsThis work is copyright. You may download, display, print and reproduce this material inunaltered orm only (retaining this notice) or your personal, non-commercial use or usewithin your organisation. Apart rom any use as permitted under the Copyright Act 1968,all other rights are reserved. Requests or urther authorisation should be directed to theCommonwealth Copyright Administration, Attorney General's Department, Robert GarranOces, National Circuit, Canberra, ACT, 2600 or posted at: http://www.ag.gov.au/ccaOnline: 1864962755

To obtain details regarding NHMRC publications contact:Email: [email protected]: Toll Free 13 000 NHMRC (13 000 64672) or call 02 6217 9000Internet: http://www.nhmrc.gov.au


3/111

NAtioNAl StAtEMENt oN EtHiCAl CoNDuCt iN HuMAN RESEARCH | iii

CoNtENtS

CoNtENtS

the Nana Saemen : A user Gde 1

Preame 3

Prpse, scpe and ms hs dcmen 7

Secn 1 Vaes and prncpes ehca cndc 11

Secn 2 themes n research ehcs: rs and enef, cnsen 15

Chapter 2.1 Risk and benet 15

Chapter 2.2 General requirements or consent 19

Chapter 2.3 Qualiying or waiving conditions or consent 23

Secn 3 Ehca cnsderans specfc research mehds

r feds 25

Chapter 3.1 Qualitative methods 25

Chapter 3.2 Databanks 29

Chapter 3.3 Interventions and therapies, including clinical and non-clinical

trials, and innovations 33

Chapter 3.4 Human tissue samples 39

Chapter 3.5 Human genetics 41

Chapter 3.6 Human stem cells 47

Secn 4 Ehca cnsderan specfc parcpans 51

Chapter 4.1 Women who are pregnant and the human oetus 51

Chapter 4.2 Children and young people 55

Chapter 4.3 People in dependent or unequal relationships 59

Chapter 4.4 People highly dependent on medical care who may be unable

to give consent 61

Chapter 4.5 People with a cognitive impairment, an intellectual disability,

or a mental illness 65

Chapter 4.6 People who may be involved in illegal activities 67


4/111


5/111

tHE NAtioNAl StAtEMENt: A uSER GuiDE

NAtioNAl StAtEMENt oN EtHiCAl CoNDuCt iN HuMAN RESEARCH | 1

tHE NAtioNAl StAtEMENt:

A uSER GuiDE

This National Statement on Ethical Conductin Human Research (National Statement) isintended or use by:

any researcher conducting research withhuman participants;

any member o an ethical review body

reviewing that research;

those involved in research governance;and

potential research participants.

This brie guide describes the structure othe document and suggests how each othese groups might use it. Note that reviewbody reers both to Human Research EthicsCommittees (HRECs) and to non-HREC reviewbodies.

The Preamblesets out the historical contexto the National Statement. This is ollowed bya brie explanation o its purpose, scope andlimits. The document then has ve sections, withmultiple chapters in Sections 2 to 5.

Section 1: Values and principles o ethical

conductsets out values and principlesthat apply to all human research. It isessential that researchers and review

bodies consider these values and

principles and be satised that theresearch proposal addresses and

reects them.

Section 2: Themes in research ethics:

risk and benet, consentdiscusses theconcept o risk in research and the roleo participants consent themes in allhuman research and is again essentialfor all users.

Chapter 2.1 will help researchers and

reviewers to understand and describethe level o risk involved in the plannedresearch, and how to minimise, justiy

and manage that risk, and (with reerenceto Chapter 5.1) what level o ethicalreview is suitable.

Chapters 2.2 and 2.3 will help toidentiy the inormation that needs tobe disclosed to participants. It will help

researchers to drat inormation orparticipants and plan the consent process(or develop a proposal or waiver oconsent). And it will help reviewersto assess the suitability o the proposedconsent process.

All o Section 2 will help participantsunderstand what inormation theyare entitled to receive, and whattheir participation in research willcharacteristically involve.

Section 3: Ethical considerations specic

to research methods or eldswill helpresearchers and reviewers to identiyethical matters specic to the researchmethods proposed.

Section 4: Ethical considerations specic

to participantswill help researchersand reviewers to identiy ethical mattersrelating to specic categories o researchparticipants. Participants in these

categories will also nd this Sectionvaluable.

Section 5: Processes o research

governance and ethical reviewwillhelp those involved in researchgovernance to understand theirresponsibilities or research ethics andethical review and monitoring o humanresearch, and provides criteria or theiraccountability. Chapter 5.2 will helpresearchers and reviewers to identiy

their responsibilities in relation to theethical review o research.


6/111

tHE NAtioNAl StAtEMENt: A uSER ES GuiDE

2 | NAtioNAl StAtEMENt oN EtHiCAl CoNDuCt iN HuMAN RESEARCH

This National Statement does not exhaust theethical discussion o human research. Evena single research eld covers a multitude o

dierent situations about which the NationalStatement will not always oer specicguidance, or to which its application maybe uncertain. Where other guidelines andcodes o practice in particular research eldsare consistent with the National Statement,researchers and members o ethical reviewbodies should draw on them when necessaryto clariy researchers ethical obligations inparticular contexts.


7/111

PREAMblE


PREAMblE

EtHiCAl bACkGRouND

All human interaction, including the interactioninvolved in human research, has ethicaldimensions. However, ethical conduct is morethan simply doing the right thing. It involvesacting in the right spirit, out o an abidingrespect and concern or ones ellow creatures.This National Statement on ethical conduct

in human research is thereore oriented tosomething more undamental than ethical dosand donts namely, an ethos that shouldpermeate the way those engaged in humanresearch approach all that they do in theirresearch.

Human research is research conducted withor about people, or their data or tissue. It hascontributed enormously to human good. Muchhuman research carries little risk and in Australiathe vast majority o human research has beencarried out in a sae and ethically responsiblemanner. But human research can involvesignicant risks and it is possible or things togo wrong. Sometimes risks are realised despitethe best o intentions and care in planning andpractice. Sometimes they are realised becauseo technical error or ethical insensitivity, neglector disregard. On rare occasions the practiceo research has even involved the deliberateand appalling violation o human beings notoriously, the Second World War experiments

in detention and concentration camps.

This range o possibilities can give rise toimportant and sometimes dicult ethicalquestions about research participation. Twoconsiderations give urther weight to thosequestions. First, research participants may enterinto a relationship with researchers whom theymay not know but need to trust. This trust addsto the ethical responsibility borne by thosein whom it is placed. Secondly, many whocontribute as participants in human research do

so altruistically, or the common good, without

thought o recompense or their time and eort.This underscores the importance o protectingresearch participants.

Since earliest times, human societies havepondered the nature o ethics and itsrequirements and have sought illumination on

ethical questions in the writings o philosophers,novelists, poets and sages, in the teaching oreligions, and in everyday individual thinking.Refection on the ethical dimensions o medicalresearch, in particular, has a long history,reaching back to classical Greece and beyond.Practitioners o human research in manyother elds have also long refected uponthe ethical questions raised by what they do.There has, however, been increased attentionto ethical refection about human researchsince the Second World War. The judgmento the Nuremberg military tribunal includedten principles about permissible medicalexperiments, since reerred to as the NurembergCode. Discussion o these principles led theWorld Medical Assembly in 1964 to adopt whatcame to be known as the Helsinki Declaration,revised several times since then. The variousinternational human rights instruments thathave also emerged since the Second WorldWar emphasise the importance o protectinghuman beings in many spheres o community

lie. During this period, written ethicalguidelines have also been generated in manyareas o research practice as an expression oproessional responsibility.

But what is the justication or ethical researchguidelines as extensive as this NationalStatement, and or its wide-reaching practicalauthority?

The National Statement has been extendedto address many issues not discussed in the

previous version, or discussed in less detail.This is in response to requests or clearer


8/111

PREAMblE


guidance or those conducting research andthose involved in its ethical review. At the sametime, without compromising the protection o

participants, the revised National Statementprovides or greater fexibility in the practice oethical review, depending on the type and areao research and the degree o risk involved.

Research oten involves public interactionbetween people that serves a public good.There is, thereore, a public responsibilityor seeing that these interactions are ethicallyacceptable to the Australian community. Thatresponsibility is acknowledged and given eectin the wide-reaching authority o this National

Statement, which sets out national standards orthe ethical design, review and conduct o humanresearch. Its content refects the outcome owide consultation with Australian communitieswho participate in, design, conduct, und,manage and publish human research.

Research gvernance

The National Statement should be seen inthe broader context o overall governance o

research. It not only provides guidelines orresearchers, Human Research Ethics Committees(HRECs) and others conducting ethical reviewo research, but also emphasises institutionsresponsibilities or the quality, saety and ethicalacceptability o research that they sponsor orpermit to be carried out under their auspices.

Responsibility or the ethical design, reviewand conduct o human research is in actexercised at many levels, by: researchers (andwhere relevant their supervisors); HRECs and

others conducting ethical review o research;institutions that set up the processes o ethicalreview, and whose employees, resources andacilities are involved in research; undingorganizations; agencies that set standards; andgovernments. While the processes o ethicalreview are important in this eld, individualresearchers and the institutions within whichthey work hold primary responsibility or seeingthat their research is ethically acceptable.

In addition to this National Statement, theAustralian code or the responsible conduct

o research 20071 (theResearch Code) has

an essential role in promoting good researchgovernance. The Research Code sets downthe broad principles o responsible andaccountable research practice, and identies theresponsibilities o institutions and researchersin areas such as data and record management,publication o ndings, authorship, confict ointerest, supervision o students and researchtrainees, and the handling o allegations oresearch misconduct.

Ahrs hs Nana SaemenThis National Statement has been jointlydeveloped by the National Health and MedicalResearch Council (NHMRC), the AustralianResearch Council (ARC) and the AustralianVice-Chancellors Committee (AVCC). This jointundertaking refects a widely shared convictionthat there is a need or ethical guidelines that aregenuinely applicable to all human research; andit gives expression to the shared responsibilityor ethically good research described above.

The National Health and Medical ResearchCouncil Act1992(NHMRC Act) establishes theNHMRC as a statutory body and sets out itsunctions, powers and obligations. Section 10(1)o the Act requires the Chie Executive Ocerto issue human research guidelines preciselyas developed by the Australian Health EthicsCommittee (AHEC) and provided to the CEO bythe Council. AHEC is established by the NHMRCAct as a Principal Committee o the NHMRC. Allthe guidelines in this National Statement that are

applicable to the conduct o medical researchinvolving humans are issued by the NHMRC inullment o this statutory obligation.

1 This is the proposed revision o theJoint NHMRC/AVCC Statement and Guidelines on Research

Practice(1997).


9/111

PREAMblE


The Australian Research Council Act 2001(ARC Act) establishes the ARC to providethe responsible Minister with advice and

recommendations about research, includingwhich research programs should receivenancial assistance. The unctions o the ARCalso include administering the regimes onancial assistance or research and providingor the unding o research programs.

The Australian Vice-Chancellors Committee(AVCC) is the council o Australias universityvice-chancellors (or presidents). Its purpose isto advance higher education through voluntary,cooperative and coordinated action, and to serve

the best interests o Australias universities and,through them, the nation. The AVCC acts as aconsultative and advisory body or all universityaairs, making submissions to public inquirieso interest to the university sector, and preparingstatements on major issues.


10/111


11/111

PuRPoSE, SCoPE AND liMitS o tHiS DoCuMENt


The purpose o this National Statement isto promote ethically good human research.Fullment o this purpose requires thatparticipants be accorded the respect and

protection that is due to them. It also involvesthe ostering o research that is o benet to thecommunity.

The National Statement is thereore designed toclariy the responsibilities o:

institutions and researchers or the ethicaldesign, conduct and dissemination oresults o human research; and

review bodies in the ethical review oresearch.

The National Statement will help them to meettheir responsibilities: to identiy issues o ethicsthat arise in the design, review and conducto human research, to deliberate about thoseethical issues, and to justiy decisions aboutthem.

use hs Nana Saemen

This National Statement must be used to inormthe design, ethical review and conduct o human

research that is unded by, or takes place underthe auspices o, any o the bodies that havedeveloped this National Statement (NHMRC,ARC, AVCC).

In addition, the National Statement sets nationalstandards or use by any individual, institutionor organisation conducting human research.This includes human research undertaken bygovernments, industry, private individuals,organisations, or networks o organisations.

Wha s research?

There is no generally agreed denition oresearch; however, it is widely understood toinclude at least investigation undertaken togain knowledge and understanding or to trainresearchers. The British Research AssessmentExercise (RAE) denition o research issomewhat wider:

Research includes work o directrelevance to the needs o commerce,industry, and to the public and voluntarysectors; scholarship; the inventionand generation o ideas, images,perormances, arteacts including design,

where these lead to new or substantiallyimproved insights; and the use oexisting knowledge in experimentaldevelopment to produce new orsubstantially improved materials, devices,products and processes, including designand construction. It excludes routinetesting and routine analysis o materials,components and processes such as orthe maintenance o national standards,as distinct rom the development o newanalytical techniques. It also excludes the

development o teaching materials that donot embody original research.2

PuRPoSE, SCoPE AND liMitS o tHiS

DoCuMENt

PuRPoSE

2 Higher Education Funding Council orEngland, Scottish Higher Education FundingCouncil, Higher Education Funding Councilor Wales, & Department or Employment andLearning Northern Ireland (2005) RAE 2008:

Guidance to Panels, p.28. At http://www.rae.ac.uk/pubs/2005/01/rae0105.doc, accessed27th October 2006


12/111



To enable comparative assessment o academicactivity, this denition sought to include thewidest range o creative and experimental

activities. Many items in the denition areuncontentious, but there may be disagreementabout some or example, the invention andgeneration o newimages, perormances,arteactswhere these lead to new orsubstantially improved insights since thiscould count poetry, painting and perorming artsas research.

For the purposes o this National Statement, twourther questions are more important than anydenition o research:

What is humanresearch?

When and by what means does humanresearch, or other activities such asquality assurance or improvement, orclinical audit, need ethical review? (SeeWhen does quality assurance in health

care require independent ethical review?

NHMRC 2003.)

Wha s hman research?

Human research is conducted with or aboutpeople, or their data or tissue. Humanparticipation in research is thereore to beunderstood broadly, to include the involvemento human beings through:

taking part in surveys, interviews or ocusgroups;

undergoing psychological, physiologicalor medical testing or treatment;

being observed by researchers; researchers having access to their

personal documents or other materials;

the collection and use o their bodyorgans, tissues or fuids (eg skin, blood,urine, saliva, hair, bones, tumour andother biopsy specimens) or their exhaledbreath;

access to their inormation (inindividually identiable, re-identiable

or non-identiable orm) as part o anexisting published or unpublished sourceor database.

The term participants is thereore used verybroadly in this National Statement to includethose who may not even know they are the

subjects o research; or example, where theneed or their consent or the use o their tissueor data has been waived by a Human ResearchEthics Committee (HREC).

In addition, the conduct o human researchoten has an impact on the lives o otherswho are not participants. When this impactis reasonably oreseeable, it may raise ethicalquestions or researchers and or those ethicallyreviewing research.

When s ehca revew needed?

Institutions are responsible or establishingprocedures or the ethical review o humanresearch. That review can be undertaken atvarious levels, according to the degree o riskinvolved in the research (see Section 2: Themesin research ethics: risk and benet, consent, andChapter 5.2: Responsibilities o HRECs, other

ethical review bodies, and researchers). Researchwith more than a low level o risk (as dened

in paragraph 2.1.6, page 18) must be reviewedby an HREC. Research involving no more thanlow risk may be reviewed under other processesdescribed in paragraphs 5.1.18 to 5.1.21 (page79). Institutions may also determine that somehuman research is exempt rom ethical review(see paragraphs 5.1.22 and 5.1.23, page 79).

A judgement that a human research proposalmeets the requirements o this NationalStatement and is ethically acceptable must bemade beore research can begin and beore ull

unding or the proposal is released.

Ehcs and aw n hman research

Human research is governed by Australianlaw that establishes rights or participants andimposes general and specic responsibilitieson researchers and institutions. Australiancommon law obligations arise rom therelationships between institutions, researchersand participants. Contractual arrangements mayimpose obligations on research unders andinstitutions.


13/111



This National Statement ocuses on the ethicalaspects o the design, review and conduct ohuman research. Research ethics is only part

o an institutions responsibilities or researchgovernance. Compliance with legal obligations(statutory or otherwise) orms another part,which is not within the scope o the NationalStatement.

Some human research is subject to specicstatutory regulation, at Commonwealth and Stateand Territory levels. The National Statementidenties some specic Commonwealthlegislation that reers to the National Statement.The National Statement does not identiy State

and Territory laws that may be relevant tohuman research, such as those relating to use oinormation held by state or territory authorities,use o human tissues, guardianship, and illegaland unproessional conduct.

The responsibilities set out in this NationalStatement are intended to be consistent withthe international human rights instruments thatAustralia has ratied.

It is the responsibility o institutions and

researchers tobe aware o both general andspeciclegal requirements, wherever relevant.


14/111


15/111

SECtioN 1: VAluES AND PRiNCiPlES o EtHiCAl CoNDuCt


SEC tioN 1: VAluES AND PRiNCiPlES

o EtHiCAl CoNDuCt

iNtRoDuCtioN

The relationship between researchers andresearch participants is the ground on whichhuman research is conducted. The values setout in this section respect or human beings,

research merit and integrity, justice, andbenecence help to shape that relationship asone o trust, mutual responsibility and ethicalequality. For this reason, the National Statementspeaks o research participants rather thansubjects.

While these values have a long history, theyare not the only values that could inorm adocument o this kind. Others include altruism,contributing to societal or community goals,and respect or cultural diversity, along with the

values that inorm Values and Ethics: Guidelinesor Ethical Conduct in Aboriginal and Torres

Strait Islander Health Research(NHMRC 2003).

However, the values orespect, research meritand integrity, justice, and benecence havebecome prominent in the ethics o humanresearch in the past six decades, and theyprovide a substantial and fexible rameworkor principles to guide the design, reviewand conduct o such research. This NationalStatement is organised around these values, and

the principles set out in paragraphs 1.1 to 1.13give them practical expression.

Among these values, respect is central. Itinvolves recognising that each human beinghas value in himsel or hersel, and that thisvalue must inorm all interaction betweenpeople. Such respect includes recognising thevalue o human autonomy the capacity todetermine ones own lie and make ones owndecisions. But respect goes urther than this.It also involves providing or the protection

o those with diminished or no autonomy, as

well as empowering them where possible andprotecting and helping people wherever itwould be wrong not to do so.

Reerence to these values throughout the

National Statement serves as a constant reminderthat, at all stages, human research requiresethical refection that is inormed by them. Theorder in which they are considered refects theorder in which ethical considerations commonlyarise in human research.

Research merit and integrity are discussed rst.Unless proposed research has merit, and theresearchers who are to carry out the researchhave integrity, the involvement o humanparticipants in the research cannot be ethicallyjustiable.

At a proound level, justice involves a regardor the human sameness that each personshares with every other. Human beings havea deep need to be treated in accordance withsuch justice, which includes distributive justiceand procedural justice. In the research context,distributive justice will be expressed in theair distribution o the benets and burdenso research, and procedural justice in air

treatment in the recruitment o participantsand the review o research. While benet tohumankind is an important result o research,it also matters that benets o research areachieved through just means, are distributedairly, and involve no unjust burdens.

Researchers exercise benecence in severalways: in assessing and taking account othe risks o harm and the potential benetso research to participants and to the widercommunity; in being sensitive to the welare and

interests o people involved in their research;and in refecting on the social and culturalimplications o their work.


16/111



Respect or human beings is the common threadthrough all the discussions o ethical values.Turning to itas the nal value is a reminder that

it draws together all o the ethical deliberationthat has preceded it.

The design, review and conduct o researchmust refect each o these values.

GuiDEliNES

Research mer and negr

1.1 Research that has merit is:(a) justiable by its potential benet,

which may include its contributionto knowledge and understanding,to improved social welare andindividual wellbeing, and to theskill and expertise o researchers.What constitutes potential benetand whether it justies research maysometimes require consultation withthe relevant communities;

(b) designed or developed usingmethods appropriate or achievingthe aims o the proposal;

(c) based on a thorough study o thecurrent literature, as well as previousstudies. This does not exclude thepossibility o novel research orwhich there is little or no literatureavailable, or research requiring aquick response to an unoreseen

situation;(d) designed to ensure that respect or

the participants is not compromisedby the aims o the research, bythe way it is carried out, or by theresults;

(e) conducted or supervised bypersons or teams with experience,qualications and competence thatare appropriate or the research; and

() conducted using acilities andresources appropriate or theresearch.

1.2 Where prior peer review has judged thata project has research merit, the questiono its research merit is no longer subject

to the judgement o those ethicallyreviewing the research.

1.3 Research that is conducted with integrityis carried out by researchers with acommitment to:

(a) searching or knowledge andunderstanding;

(b) ollowing recognised principles oresearch conduct;

(c) conducting research honestly; and

(d) disseminating and communicatingresults, whether avourable orunavourable, in ways that permitscrutiny and contribute to publicknowledge and understanding.

Jsce

1.4 In research that is just:

(a) taking into account the scope and

objectives o the proposed research,the selection, exclusion andinclusion o categories o researchparticipants is air, and is accuratelydescribed in the results o theresearch;

(b) the process o recruiting participantsis air;

(c) there is no unair burden oparticipation in research on

particular groups;(d) there is air distribution o the

benets o participation in research;

(e) there is no exploitation oparticipants in the conduct oresearch; and

() there is air access to the benets oresearch.

1.5 Research outcomes should be made

accessible to research participants in away that is timely and clear.


17/111



benecence

1.6 The likely benet o the research mustjustiy any risks o harm or discomort toparticipants. The likely benet may be tothe participants, to the wider community,or to both.

1.7 Researchers are responsible or:

(a) designing the research to minimisethe risks o harm or discomort toparticipants;

(b) clariying or participants thepotential benets and risks o the

research; and(c) the welare o the participants in the

research context.

1.8 Where there are no likely benets toparticipants, the risk to participantsshould be lower than would be ethicallyacceptable where there are such likelybenets.

1.9 Where the risks to participants are nolonger justied by the potential benets

o the research, the research must besuspended to allow time to considerwhether it shouldbe discontinued orat least modied. This decision mayrequire consultation between researchers,participants, the relevant ethical reviewbody, and the institution. The reviewbody must be notied promptly osuch suspension, and o any decisionsollowing it (see paragraphs 5.5.6 to 5.5.9,page 9192).

Respec

1.10 Respect or human beings is a recognitiono their intrinsic value. In humanresearch, this recognition includes abidingby the values o research merit andintegrity, justice and benecence. Respectalso requires having due regard or thewelare, belies, perceptions, customsand cultural heritage, both individual andcollective, o those involved in research.

1.11 Researchers and their institutions shouldrespect the privacy, condentialityand cultural sensitivities o the

participants and, where relevant, o theircommunities. Any specic agreementsmade with the participants or thecommunity should be ullled.

1.12 Respect or human beings involves givingdue scope, throughout the researchprocess, to the capacity o human beingsto make their own decisions.

1.13 Where participants are unable tomake their own decisions or havediminished capacity to do so, respector them involves empowering themwhere possible and providing or theirprotection as necessary.

Appcan hese vaes andprncpes

Research, like everyday lie, oten generatesethical dilemmas in which it may be impossibleto nd agreement on what is right or wrong.In such circumstances, it is important that all

those involved in research and its review bringa heightened ethical awareness to their thinkingand decision-making. The National Statementis intended to contribute to the development osuch awareness.

This National Statement does not exhaust theethical discussion o human research. Thereare, or example, many other specialised ethicalguidelines and codes o practice or specicareas o research. Where these are consistentwith this National Statement, they should beused to supplement it when this is necessary orthe ethical review o a research proposal.

These ethical guidelines are not simply aset o rules. Their application should not bemechanical. It always requires, rom eachindividual, deliberation on the values andprinciples, exercise o judgement, and anappreciation o context.


18/111


19/111

SECtioN 2: tHEMES iN RESEARCH EtHiCS: RiSk AND bENEit, CoNSENt

CHAPtER 2.1 : RiSk AND bENEit


SECtioN 2: tHEMES iN RESEARCH

EtHiCS: RiSk AND bENEit, CoNSENtTwo themes must always be considered inhuman research: the risks and benets oresearch, and participants consent. For thisreason, the two themes are brought together in

CHAPtER 2.1: RiSk AND bENEit

iNtRoDuCtioN

this section, beore discussion in the ollowingsections o ethical considerations specic todierent research methods and categories oparticipants.

identiying any risks;

gauging their probability and severity;

assessing the extent to which they can beminimised;

determining whether they are justied by

the potential benets o the research; and

determining how they can be managed.

Assessment o risks engages:

researchers, who need to identiy, gauge,minimise and manage any risks involvedin their project;

institutions, in deciding the appropriatelevel o ethical review or researchprojects;

Human Ethics Research Committees(HRECs) and other ethical review bodies(see paragraph 5.1.7, page 78), inreviewing research proposals and makingjudgements on whether risks are justiedby potential benets; and

participants perceptions o risks andbenets. These perceptions are a actorto be considered by review bodies indeciding whether the risks are justied by

the benets.

The conduct o research in Australia ischaracterised by high ethical and scienticstandards, and the dangers to participants havebeen ew. The continued promotion o ethicallygood human research the purpose o thisNational Statement will help to maintain these

standards.Application o the values in Section 1, inparticular the value o benecence, requires thatrisks o harm to research participants, and toothers, be assessed. Research will be ethicallyacceptable only i its potential benets justiythose risks.

While this chapter provides guidance on theassessment o risk, such assessment inevitablyinvolves the exercise o judgment.

Wha s rs?

A risk is a potential or harm, discomort orinconvenience (discussed below). It involves:

the likelihood that a harm (or discomortor inconvenience) will occur; and

the severity o the harm, including itsconsequences.

Assessmen rs

Assessment o risks involves:


20/111




Harm, dscmr and ncnvenence

Research may lead to harms, discomorts and/orinconveniences or participants and/or others.

No list o harms can be exhaustive, but onehelpul classication identies the ollowingkinds o potential harms in research3:

physical harms: including injury, illness,pain;

psychological harms: including eelingso worthlessness, distress, guilt, anger orear related, or example, to disclosureo sensitive or embarrassing inormation,

or learning about a genetic possibility odeveloping an untreatable disease;

devaluation o personal worth: includingbeing humiliated, manipulated or in otherways treated disrespectully or unjustly;

social harms: including damage to socialnetworks or relationships with others;discrimination in access to benets,services, employment or insurance; socialstigmatisation; and ndings o previouslyunknown paternity status;

economic harms: including the impositiono direct or indirect costs on participants;

legal harms: including discovery andprosecution o criminal conduct.

Less serious than harm is discomort, which caninvolve body and/or mind. Discomorts include,or example, minor side-eects o medication,the discomorts related to measuring bloodpressure, and anxiety induced by an interview.

Where a persons reactions exceed discomortand become distress, they should be viewed asharms.

Less serious again is inconvenience. Exampleso inconvenience may include lling in a orm,participating in a street survey, or giving up timeto participate in research.

3 Adapted rom National Bioethics AdvisoryCommission, Ethical and Policy Issues in Research

Involving Human Participants, Bethesda, 2001pp.7172

Examples o risks to non-participants includethe risk o distress or a participants amilymember identied with a serious genetic

disorder, the possible eects o a biographyon amily or riends, or inectious diseaserisks to the community. Some social researchmay carry wider social or economic risks; orexample, research in a small community intoattitudes to specic subpopulations may leadto unair discrimination or have eects onsocial cohesion, property values, or businessinvestment.

Harms that may arise rom research misconductor raud, and harms to members o research

teams rom other orms o misconduct (orexample, harassment or bullying) are addressedprimarily in the Australian code or theresponsible conduct o research. These ormso misconduct may, o course, also lead topotential harms to participants.

lw rs and negge rs research

The expression low risk research describesresearch in which the only oreseeable risk is

one o discomort. Research in which the risk orparticipants is more serious than discomort isnot low risk.

The expression negligible risk researchdescribes research in which there is nooreseeable risk o harm or discomort; and anyoreseeable risk is no more than inconvenience.

Requirements or the ethical review o low riskresearch and negligible risk research are set outin paragraphs 5.1.18 to 5.1.23, page 79.

Gagng rs

Gauging risk involves taking into account:

the kinds o harm, discomort orinconvenience that may occur;

the likelihood o these occurring; and

the severity o any harm that may occur.

These judgements should be based on theavailable evidence. The evidence may be

quantitative or qualitative. In either case, theprocess needs to be transparent and deensible.


21/111




For those gauging the severity o the harm,the choices, experience, perceptions, valuesand vulnerabilities o dierent populations o

participants will be relevant.

Mnmsng rs

In designing a research project, researchershave an obligation to minimise the risksto participants. Minimising risk involvesan assessment o the research aims, theirimportance, and the methods by which they canbe achieved.

Where a researcher or review body judges that

the level o risk in a research proposal is notjustied by the benets, either the researchaims or the methods by which they are to beachieved, or both, will need to be reconsideredi the research is to proceed.

D he enes js he rss?

Research is ethically acceptable only when itspotential benets justiy any risks involved inthe research.

Benets o research may include, or example,gains in knowledge, insight and understanding,improved social welare and individualwellbeing, and gains in skill or expertise orindividual researchers, teams or institutions.

Some research may oer direct benets to theresearch participants, their amilies, or particulargroup/s with whom they identiy. Where this isthe case, participants may be ready to assume ahigher risk than otherwise. For example, peoplewith cancer may be willing to accept research

risks (such as treatment side-eects) that wouldbe unacceptable to well people. Those ethicallyreviewing research should take such willingnessinto account in deciding whether the potentialbenets o the research justiy the risks involved.

For ethical review bodies, there can be aproound tension between the obligationon the one hand to give maximum scope toparticipants reedom to accept risk, and on theother to see that research is conducted in a waythat is benecent and minimises harm.

Managng rss

When risks have been identied, gauged andminimised, and the research has been approved,the risks must then be managed. This requiresthat:

researchers include, in their researchdesign, mechanisms to deal adequatelywith any harms that occur; and

a monitoring process is in place andcarried out (see Chapter 5.5: Monitoringapproved research, page 9192).

The greater the risk to participants in any

research or which ethical approval is given, themore certain it must be both that the risks willbe managed as well as possible, and that theparticipants clearly understand the risks they areassuming.

GuiDEliNES

2.1.1 Institutions that choose to establish levelso ethical review other than by HREC or

research that carries low or negligible risk(see paragraphs 5.1.18 to 5.1.23, page 79)should use this chapter (i.e. Chapter 2.1)to inorm their identication o the levelo risk.

2.1.2 Risks to research participants are ethicallyacceptable only i they are justied by thepotential benets o the research.

2.1.3 Steps to arriving at a judgement onthe ethical acceptability o risks shouldinclude:

(a) identiying the risks, i any;

(b) assessing the likelihood and severityo the risks;

(c) identiying whom (participants and/or others) the risks may aect;

(d) establishing the means orminimising the risks;

(e) identiying the potential benets;

and() identiying to whom benets are

likely to accrue.


22/111




2.1.4 In determining the existence, likelihoodand severity o risks, researchers andthose reviewing the research should

base their assessments on the availableevidence, whether qualitative orquantitative. They should considerwhether to seek advice rom otherswho have experience with the samemethodology, population and researchdomain.

2.1.5 In considering whether the potentialbenets o the research justiy the risksinvolved, those reviewing research shouldtake into account any willingness by

participant populations to assume greaterrisks because o the potential benets tothem, their amilies, or groups to whichthey belong.

2.1.6 Research is low risk where the onlyoreseeable risk is one o discomort.Where the risk, even i unlikely, is moreserious than discomort, the research isnot low risk.

2.1.7 Research is negligible risk where there is

no oreseeable risk o harm or discomort;and any oreseeable risk is no more thaninconvenience. Where the risk, even iunlikely, is more than inconvenience, theresearch is not negligible risk.

2.1.8 The greater the risks to participants inany research or which ethical approvalis given, the more certain it must be boththat the risks will be managed as well aspossible, and that the participants clearlyunderstand the risks they are assuming.


23/111


CHAPtER 2.2 : GENERAl REquiREMENtS oR CoNSENt


CHAPtER 2.2: GENERAl REquiREMENtS oR

CoNSENt

iNtRoDuCtioN

Respect or human beings involves giving duescope to peoples capacity to make their owndecisions. In the research context, this normallyrequires that participation be the result oa choice made by participants commonlyknown as the requirement or consent. This

requirement has the ollowing conditions:consent should be a voluntary choice, andshould be based on sucient inormation andadequate understanding o both the proposedresearch and the implications o participationin it.

What is needed to satisy these conditionsdepends on the nature o the project, andmay be aected by the requirements o thecodes, laws, ethics and cultural sensitivities othe community in which the research is to beconducted.

Variations o these conditions may be ethicallyjustied or some research. Respect or humanbeings must, however, always be shown in anyalternative arrangements or deciding whetherpotential participants are to enter the research.

It should be noted that a persons consent toparticipate in research may not be sucient tojustiy his or her participation.

This chapter provides guidelines on therequirement or consent. Chapter 2.3: Qualiyingor waiving conditions or consentthen discussesand provides guidelines on conditions underwhich the requirement may be qualied orwaived.

GuiDEliNES

2.2.1 The guiding principle or researchers is

that a persons decision to participate inresearch is to be voluntary, and basedon sucient inormation and adequate

understanding o both the proposedresearch and the implications oparticipation in it. For qualicationso this principle, see Chapter 2.3:Qualiying or waiving conditions or

consent, page 23.

2.2.2 Participation that is voluntary and basedon sucient inormation requires anadequate understanding o the purpose,methods, demands, risks and potentialbenets o the research.

2.2.3 This inormation must be presented inways suitable to each participant (seeparagraph 5.2.16, page 84).

2.2.4 The process o communicatinginormation to participants and seekingtheir consent should not be merely amatter o satisying a ormal requirement.The aim is mutual understanding betweenresearchers and participants. This aimrequires an opportunity or participantsto ask questions and to discuss theinormation and their decision with othersi they wish.

2.2.5 Consent may be expressed orally, inwriting or by some other means (or

example, return o a survey, or conductimplying consent), depending on:

(a) the nature, complexity and level orisk o the research; and

(b) the participants personal andcultural circumstances.

2.2.6 Inormation on the ollowing mattersshould also be communicated toparticipants. Except where theinormation in specic sub-paragraphs

below is also deemed necessary or apersons voluntary decision to participate,


24/111




it should be kept distinct rom theinormation described in paragraphs 2.2.1and 2.2.2:

(a) any alternatives to participation;

(b) how the research will be monitored;

(c) provision o services to participantsadversely aected by the research;

(d) contact details o a person to receivecomplaints;

(e) contact details o the researchers;

() how privacy and condentiality willbe protected;

(g) the participants right to withdrawrom urther participation at anystage, along with any implications owithdrawal, and whether it will bepossible to withdraw data;

(h) the amounts and sources o undingor the research;

(i) nancial or other relevantdeclarations o interests o

researchers, sponsors or institutions;(j) any payments to participants;

(k) the likelihood and orm odissemination o the research results,including publication;

(l) any expected benets to the widercommunity;

(m) any other relevant inormation,including research-specicinormation required under otherchapters o this National Statement.

2.2.7 Whether or not participants will beidentied, research should be designed sothat each participants voluntary decisionto participate will be clearly established.

Renegang cnsen

2.2.8 In some research, consent may need tobe renegotiated or conrmed rom time

to time, especially where projects arecomplex or long-running, or participantsare vulnerable. Research participants

should be told i there are changes to theterms to which they originally agreed,and given the opportunity to continue

their participation or withdraw (seeparagraphs 5.2.16 and 5.2.17, page 84).

Cercn and pressre

2.2.9 No person should be subject to coercionor pressure in deciding whether toparticipate. Even where there is no overtcoercion or pressure, consent mightrefect deerence to the researchersperceived position o power, or tosomeone elses wishes. Here as always,a person should be included as aparticipant only i his or her consent isvoluntary.

Remrsng parcpans

2.2.10 It is generally appropriate to reimbursethe costs to participants o taking part inresearch, including costs such as travel,accommodation and parking. Sometimesparticipants may also be paid or time

involved. However, payment that isdisproportionate to the time involved,or any other inducement that is likely toencourage participants to take risks, isethically unacceptable.

2.2.11 Decisions about payment orreimbursement in kind, whether toparticipants or their community, shouldtake into account the customs andpractices o the community in which theresearch is to be conducted.

Where hers need e nvved nparcpan decsns

2.2.12 Where a potential participant lacksthe capacity to consent, a person orappropriate statutory body exercisinglawul authority or the potentialparticipant should be provided withrelevant inormation and decide whetherhe or she will participate. That decision

must not be contrary to the personsbest interests. Researchers should bear


25/111




in mind that the capacity to consent mayfuctuate, and even without that capacitypeople may have some understanding o

the research and the benets and burdenso their participation. For implications othese actors, see Chapter 4.2: Childrenand young people, Chapter 4.4: Peoplehighly dependent on medical care who

may be unable to give consent, andChapter 4.5: People with a cognitive

impairment, an intellectual disability, or

a mental illness.

2.2.13 Within some communities, decisionsabout participation in research may

involve not only individuals but alsoproperly interested parties such asormally constituted bodies, institutions,amilies or community elders. Researchersneed to engage with all properlyinterested parties in planning theresearch.

Cnsen re se daa andsse n research

2.2.14 Consent may be:(a) specic: limited to the specic

project under consideration;

(b) extended: given or the use o dataor tissue in uture research projectsthat are:

(i) an extension o, or closelyrelated to, the original project;or

(ii) in the same general areao research (or example,genealogical, ethnographical,epidemiological, or chronicillness research);

(c) unspecied: given or the use odata or tissue in any uture research.

The necessarily limited inormationand understanding about researchor which extended or unspeciedconsent is given can still be

sucient and adequate or thepurpose o consent (see paragraph2.2.2).

2.2.15 Extended or unspecied consent maysometimes need to include permissionto enter the original data or tissue into a

databank or tissuebank (see paragraph3.2.9, page 31).

2.2.16 When unspecied consent is sought,its terms and wide-ranging implicationsshould be clearly explained to potentialparticipants. When such consent is given,its terms should be clearly recorded.

2.2.17 Subsequent reliance, in a researchproposal, on existing unspeciedconsent should describe the terms o thatunspecied consent.

2.2.18 Data or tissue additional to those coveredby the original extended or unspeciedconsent will sometimes be needed orresearch. Consent or access to suchadditional data or tissue must be soughtrom potential participants unless theneed or this consent is waived by anethical review body.

Decnng cnsen and whdrawng

cnsen

2.2.19 People who elect not to participate in aresearch project need not give any reasonor their decision. Researchers shoulddo what they can to see that peoplewho decline to participate will suer nodisadvantage as a result o their decision.

2.2.20 Participants are entitled to withdrawrom the research at any stage. Beoreconsenting to involvement in the

research, participants should be inormedabout any consequences o suchwithdrawal.


26/111


27/111


CHAPtER 2.3 : quAliyiNG oR WAiViNG CoNDitioNS oR CoNSENt


CHAPtER 2.3: quAliyiNG oR WAiViNG

CoNDitioNS oR CoNSENtiNtRoDuCtioN

Consent to participate in research must bevoluntary, and based on sufcient inormationand adequate understanding o both the proposedresearch and the implications o participation in it.

The requirement or consent may sometimesbe justifably waived. In this case research

participants will characteristically not know thatthey, or perhaps their tissue or data, are involvedin the research.

Limited disclosure to participants o the aimsand/or methods o research may also sometimesbe justifable. This is because in some humanresearch (or example, in the study o behaviour),the aims o the research cannot be achieved ithose aims and/or the research method are ullydisclosed to participants.

Research involving limited disclosure covers a

spectrum, rom simply not ully disclosing ordescribing the aims or methods o observationalresearch in public contexts, all the way to activelyconcealing inormation and planning deceptiono participants. Examples along the spectruminclude: observation in public spaces o everydaybehaviour; covert observation, or example o thehand-washing behaviour o hospital employees;undisclosed role-playing by a researcher toinvestigate participants responses; tellingparticipants the aim o the research is one thing

when it is in act quite dierent. At the beginningo that spectrum (or instance, observation inpublic spaces), limited disclosure research shadesinto research or which waiver o consent mightbe sought.

GuiDEliNES

lmed dscsre

2.3.1 Where limited disclosure does not involveactive concealment or planned deception,ethical review bodies may approve researchprovided researchers can demonstrate that:

(a) there are no suitable alternativesinvolving uller disclosure by whichthe aims o the research can beachieved;

(b) the potential benefts o the researchare sufcient to justiy both the limiteddisclosure to participants and any riskto the communitys trust in research

and researchers;(c) the research involves no more

than low risk to participants (seeparagraph 2.1.6, page 18), and thelimited disclosure is unlikely to aectparticipants adversely;

(d) the precise extent o the limiteddisclosure is defned;

(e) whenever possible and appropriate,ater their participation has ended,

participants will be:(i) provided with inormation about

the aims o the research and anexplanation o why the omissionor alteration was necessary; and

(ii) oered the opportunity towithdraw any data or tissueprovided by them.

2.3.2 Where limited disclosure involves activeconcealment or explicit deception, and the

research does not aim to expose illegalactivity, researchers should in additiondemonstrate that:

(a) participants will not be exposed to anincreased risk o harm as a result othe concealment or deception;

(b) a ull explanation, both o the realaims and/or methods o the research,and also o why the concealmentor deception was necessary, will

subsequently be made available toparticipants; and


28/111


CHAPtER 2.3 : quAliyiNG oR WAiViNG CoNDitioNS oR CoNSENt


(c) there is no known or likely reasonor thinking that participants wouldnot have consented i they had been

ully aware o what the researchinvolved.

2.3.3 Where research involving limiteddisclosure aims to expose illegal activity(see paragraph 4.6.1, page 67), theadverse eects on those whose illegalactivity is exposed must be justied bythe value o the exposure.

2.3.4 Only a Human Ethics Research Committee(HREC) can review and approve researchthat:

(a) involves active concealment orplanned deception; or

(b) aims to expose illegal activity.

Waver

2.3.5 Only an HREC may grant waiver oconsent or research using personalinormation in medical research, orpersonal health inormation. Other review

bodies may grant waiver o consent orother research.

2.3.6 Beore deciding to waive the requirementor consent (other than in the case oresearch aiming to expose illegal activity),an HREC or other review body must besatised that:

(a) involvement in the researchcarries no more than low risk (seeparagraphs 2.1.6 and 2.1.7, page 18)

to participants;(b) the benets rom the research justiy

any risks o harm associated withnot seeking consent;

(c) it is impracticable to obtain consent(or example, due to the quantity,age or accessibility o records);

(d) there is no known or likely reasonor thinking that participants wouldnot have consented i they had been

asked;

(e) there is sucient protection o theirprivacy;

() there is an adequate plan to protect

the condentiality o data;

(g) in case the results have signicanceor the participants welare there is,where practicable, a plan or makinginormation arising rom the researchavailable to them (or example, viaadisease-specic website or regionalnews media);

(h) the possibility o commercialexploitation o derivatives o the

data or tissue will not deprive theparticipants o any nancial benetsto which they would be entitled;

(i) the waiver is not prohibited by State,ederal, or international law.

2.3.7 Beore deciding to waive the requirementor consent in the case o research aimingto expose illegal activity, an HREC mustbe satised that:

(a) the value o exposing the illegal

activity justies the adverse eectson the people exposed (seeparagraph 4.6.1, page 67);

(b) there is sucient protection o theirprivacy;

(c) there is sucient protection o thecondentiality o data; and

(d) the waiver is not otherwiseprohibited by State, ederal, orinternational law.

2.3.8 Given the importance o maintainingpublic condence in the researchprocess, it is the responsibility o eachinstitution to make publicly accessible(or example in annual reports) summarydescriptions o all its research projectsor which consent has been waivedunder paragraphs 2.3.6 and 2.3.7. Waiverdecisions under paragraph 2.3.7 shouldnot be made publicly accessible until the

research has been completed.


29/111

SECtioN 3: EtHiCAl CoNSiDERAtioNS SPECiiC to RESEARCH MEtHoDS oR iElDS

CHAPtER 3.1 : quAlitAtiVE MEtHoDS


CHAPtER 3.1: quAlitAtiVE MEtHoDS

SECtioN 3: EtHiCAl CoNSiDERAtioNS

SPECiiC to RESEARCH MEtHoDS oRiElDS

iNtRoDuCtioN

Qualitative research involves disciplinedinquiry that examines peoples lives,experiences and behaviours, and the storiesand meanings individuals ascribe to them.4 Itcan also investigate organisational unctioning,relationships between individuals and groups,and social environments.

This approach to research can involve thestudied use and collection o a variety oempirical materials such as case studies,personal experience, lie stories, interviews,observations, and cultural texts. It may bringnew insights into the experiences o individuals,

groups or communities, or into issues suchas environmental change, public policies andplanning. Qualitative research may also havequantitative elements or aspects.

Qualitative research contributes to thedevelopment o new knowledge by:

enabling researchers to gain a betterunderstanding o complex concepts orsocial processes;

investigating how communities andindividuals interpret and make sense otheir experiences;

This section discusses various research methodsand elds. Some chapters are a result o theurther expansion o this revised NationalStatement beyond health and medical research.The ocus is on general principles the sectionis not intended to be exhaustive. It refectsthe interdisciplinary nature o many types oresearch and the use, in some research projects,o a number o dierent research methods.

Human research may be conducted onlywith ethical approval. Section 5 describes theprocesses that institutions may use to providethat approval. Those processes include ethicalreview by Human Research Ethics Committees(HRECs) or other ethical review bodies,according to the risks o the research (seeparagraphs 5.1.6 to 5.1.8, page 78).

Ethical review by an HREC is required orany research that involves more than low risk(paragraph 5.1.6, page 78). It is also required or

research discussed in Chapter 3.3: Interventionsand therapies, including clinical and non-

clinical trials, and innovations, Chapter 3.5:Human genetics, and Chapter 3.6: Human stemcells, as well as or research discussed in severalchapters o Section 4.

As stated at the end o Section 1, this NationalStatement does not exhaust the ethicaldiscussion o human research. Even a singleresearch eld covers a multitude o dierentsituations about which the National Statementwill not always oer specic guidance, or towhich its application may be uncertain. Whereother guidelines and codes o practice inparticular research elds are consistent with theNational Statement, researchers and memberso ethical review bodies should draw on them

when necessary to clariy researchers ethicalobligations in particular contexts.

4. Denzin NK & Lincoln YS (eds) 2000 Handbook oQualitative Research, Sage: Caliornia


30/111




eliciting contextual data in order toimprove the validity o quantitative toolssuch as surveys.

Cmmn sed appraches daacecn n aave research

Data in qualitative research can be collectedusing a range o approaches. The ollowing aresome common examples.

Interviews involve researchers talkingto one or more participants, wherethe categories o response are ocusedbut not necessarily pre-determined.

Interviews are usually recorded byaudio- or video-tape, or notes. Theserecords are research data in themselves,but also may be transcribed. Interviewsare usually conducted in locationsmutually acceptable to participants andinterviewers.

Interviews can take many orms,including:

> structured interviews, which ollow a

set list o questions;> semi-structured interviews, which

use an interview guide listing a seto issues to be explored;

> unstructured interviews, whichinvolve spontaneous generationo questions in the natural fow ointeraction, and where the interviewis driven by the interviewee ratherthan the interviewer.

The reason or choosing an inormantor interview may vary. For example:

> Key inormant interviewsareconducted with individuals orgroups with specic knowledgeor expertise about the issue beinginvestigated; or example, interviewswith political leaders about historicalevents in which they playedimportant roles.

> Sample inormant interviewsareconducted with people whoseexperience or expertise is taken

as representative o a broadergroup; or example, interviewswith ordinary people about their

experiences during a time o socialturmoil or diculty, or interviewswith employees o a particular rm.

Life story or oral history caninvolve structured, semi-structured orunstructured interviews. This is a ormo research commonly undertaken in thehumanities.

Focus groups o participants discuss aset o research questions or topics. Thismay entail the researcher acting as amoderator or the discussion.

Observation involves the researcherobserving participant/s in their ownenvironment, or in the environmentbeing studied. Data collection throughobservation can be structured orunstructured, with the observer as acollaborative participant (participantobservation) or external to theenvironment.

Archival research reers to materialsthat are usually but not necessarilydeposited in ocial or private libraries orarchives.

On-line researchincludes conductingon-line real-time group discussions usingweb-based chat-room technology (alsoknown as E-groups) through the use oelectronic bulletin boards and moderatedemail groups. On-line recruitment oparticipants provides the opportunity orextensive global participation in research.Data collection and dissemination canalso be utilised on-line.

Action researchis oten community- ororganisation-based and is carried out inthe eld. This approach involves testingideas in practice as a means o improvingsocial, economic or environmentalconditions and increasing knowledge.Action research proceeds in a spiral o

steps consisting o planning, action, andevaluation. It provides a basis or urtherplanning o critically inormed action.


31/111




Values, principles and themes that must

inform the design, ethical review and

conduct of all human research are set out in

Sections 1 and 2 of this National Statement.The guidelines and headings below show

how those values, principles and themes

apply specically in research that is the

subject of this chapter.

GuiDEliNES


3.1.1 A range o relationships betweenparticipants and researchers may developas a result o the duration and nature othe interaction. Where such relationshipsthreaten to compromise the research role,researchers must consider whether tomodiy those relationships, or to modiyor even discontinue the research.

3.1.2 Where a researcher has proessionalskills (or example, counselling) thatbecome relevant to the relationship witha participant, the researcher needs todecide, when continuing the research,whether:

(a) it is ethically acceptable to exercisethose skills; or

(b) to reer that participant to anotherproessional.

3.1.3 Researchers have a duty to inormparticipants whenever they are acting in a

non-research proessional role.3.1.4 Qualitative research emphasises the

signicance o particular contexts andsettings. It is not necessary to be ableto generalise the results o qualitativeresearch. Even so, qualitative researchshould aim to provide a sucientlydetailed account and/or analysis to enableothers to determine whether there areother circumstances to which the ndingsmay be applicable.

3.1.5 I a sampling strategy is used, themost common type is purposivesampling, which aims at the selection

o inormation-rich cases relevant to theresearch question. While random andrepresentative sampling are not precluded

in qualitative studies, many samplingrames are grounded in the specic aimso the research question.

3.1.6 The rigour o a qualitative study shouldnot be judged on sample size. Whensampling is appropriate, the objectivesand theoretical basis o the researchshould determine the size o the sampleand the sampling strategy. For example,some qualitative methods use a principleo saturation, where sampling occurs

until no new inormation is beingobtained. This is only one o severalcriteria or assessing sample size.

3.1.7 Research proposalsthat include samplingshould clearly describe the recruitmentstrategy and criteria or selectingparticipants.

3.1.8 The rigour o qualitative research shouldbe assessed primarily by criteria o qualityand credibility o data collection and

analysis,and not by matters o validityand reliability as dened in research

designs that employ quantitative methods.

Jsce

3.1.9 The criteria or inclusion and exclusiono participants in qualitative researchare oten complex. For this reason,researchers should state these criteriaclearly and be able to justiy them (seealsoparagraphs 3.1.14 to 3.1.16).

benecence

3.1.10 Participants are oten easily identiable(or example, as members o smallcommunities or groups, or as keyinormants), and the inormation theyprovide may be sensitive. For thesereasons, care should be taken thatparticipants are not identiable by theinormation they provide, unless they

have agreed to be identied. Special care


32/111




should be taken to protect the identityo participants when disseminatinginormation and storing material.

3.1.11 Where possible, participants shouldbe inormed about any potential to beidentied in the results o research eveni identiers, such as name and address,are removed.

3.1.12 Qualitative research that exploressensitive topics in depth may involveemotional and other risks to bothparticipant and researcher. There shouldbe clear protocols or dealing withdistress that might be experienced byparticipants.

3.1.13 Predicting what topics are likely tolead to distress will not always be easy.Researchers should have sucienttraining to help them in making suchpredictions.

3.1.14 Qualitative research may involve methodso data collection that require thedevelopment o personal relationshipswith participants. Researchers should

refect on the impact that they may haveon the participants and vice versa, andas ar as possible should describe in theresearch proposal any anticipated impacto this nature.

Respec

3.1.15 Researchers should consider whetherrespect or the participants requires thatthe accuracy or completeness o each

interview transcript should be veried bythe relevant participant beore analysis iscomplete.

3.1.16 The method o providing consent inqualitative research depends on variousactors, including the type o research,its level o sensitivity, its cultural context,and the potential vulnerability o theparticipants. In some contexts, theprotection o vulnerable participantsmay avour a ormal, written process

o consent; in other contexts, an oralprocess.

3.1.17 In some circumstances, consent may beimplied by participation, or example thereturn o a survey, or the answering o a

verbal question (see alsoparagraph 2.2.5,page 19).


33/111


CHAPtE R 3.2 : DAtAbANkS


This chapter covers a wide range o data typesand methodologies. Given that the nature odata, data collection, research methodologiesand data usage may change over time,the chapter presents principles rather thanprescriptions.

Types o research that commonly make use odatabanks include epidemiology, pathology,genetics and social sciences.

The term databanks, as used in this NationalStatement, includes databases.

Wha are daa?

Data are pieces o inormation, or example:

what people say in interviews, ocusgroups, questionnaires, personal historiesand biographies;

analysis o existing inormation (clinical,social, observational or other);

inormation derived rom human tissuesuch as blood, bone, muscle and urine.

Data identiability

Data may be collected, stored or disclosed inthree mutually exclusive orms:

individually identiable data,where the identity o a specic individual

can reasonably be ascertained. Examples oidentiers include the individuals name, image,date o birth or address;

re-identiable data, rom whichidentiers have been removed and replaced bya code, but it remains possible to re-identiy aspecic individual by, or example, using thecode or linking dierent data sets;

non-identiable data, which havenever been labelled with individual identiers or

rom which identiers have been permanentlyremoved, and by means o which no specicindividual can be identied. A subset o

non-identiable data are those that can belinked with other data so it can be known thatthey are about the same data subject, althoughthe persons identity remains unknown.

This National Statement avoids the termde-identied data, as its meaning is unclear.While it is sometimes used to reer to a recordthat cannot be linked to an individual (non-identiable), it is also used to reer to a recordin which identiying inormation has beenremoved but the means still exist to re-identiythe individual. When the term de-identieddata is used, researchers and those reviewingresearch need to establish precisely which othese possible meanings is intended.

tsse and daa

With advances in genetic knowledge and data

linkage, and the prolieration o tissue bankso identied material, human tissue samplesshould always be regarded as, in principle, re-identiable.

The increased ability to link data has greatlyenhanced the contribution that collectionso data can make to research, as it enablesresearchers to match individuals in dierent datasets without being able to identiy the person.For example, in epidemiological research(concerned with the study o populations),

inormation about individuals and groups maybe collected so that eatures o groups o peoplecan be investigated. These data may or maynot have originally been obtained or researchpurposes.

banng

While most data are collected, aggregatedand stored or a single purpose or activity.Permission may sometimes be sought rom

participants to bank their data or possible usein uture research projects.

CHAPtER 3.2: DAtAbANkS

iNtRoDuCtioN


34/111


35/111


CHAPtE R 3.2 : DAtAbANkS


3.2.8 Some uses o data in a databank may bedetrimental to people to whom the datarelate. Researchers and/or custodians

should consider denying or restrictingaccess to some or all o the data or thoseuses.

Cnsen

3.2.9 When collecting data or deposit in adatabank, researchers should provideclear and comprehensive inormationabout:

(a) the orm in which the data will be

stored (identiable, re-identiable,non-identiable);

(b) the purposes or which the data willbe used and/or disclosed; and

(c) whether they will seek:

(i) specic, extended orunspecied consent or utureresearch (see paragraphs 2.2.14to 2.2.16, page 21); or

(ii) permission rom a review bodyto waive the need or consent(see paragraphs 2.3.5 and 2.3.6,page 24).

3.2.10 Researchers should recognise that datastored in an identiable orm cannot beused in research that is exempt romethical review.

3.2.11 Any restrictions on the use o participantsdata should be recorded and the recordkept with the collected data so that itis always accessible to researchers whowant to access those data or research.

3.2.12 Researchers and custodians othe databank should observe anycondentiality agreement about storeddata with the participant, and custodiansshould take every precaution to preventthe data becoming available or uses towhich participants did not consent.


36/111


37/111


CHAPtER 3.3 : iNtERVENtioNS AND tHERAPiES, iNCluDiNG CliNiCAl AND NoNCliNiCAl tRiAlS, AND iNNoVAtioNS


Clinical research increasingly involves a rangeo dierent health proessionals studying a wide

range o matters, including disease preventionand causation, diagnostic methods, treatments,and eects o and response to illness. Suchresearch can occur in a number o settings,including public and private hospitals andclinics, other institutions or organisations,community settings, and general or specialistmedical practices.

This chapter ocuses especially on randomisedclinical trials, even though clinical trials are notalways randomised. Further, as noted below,randomisation may be used in other areas ohuman research (eg education research) andthereore some o the ethical issues outlined willbe relevant to such research.

At times it may be dicult to distinguish clinicaland related research rom quality improvementand clinical audit. In such situations, guidanceis available rom the NHMRC publication Whendoes quality assurance in health care require

independent ethical review?(NHMRC 2003).

innvans n cnca pracce

Innovations in clinical practice andcomplementary medicine include new diagnosticor therapeutic methods that aims to improvehealth outcomes but have not yet been ullyassessed or saety and/or ecacy. The spectrumo innovations may range widely rom minorvariations or extensions o existing methods, tonew indications, through to completely noveltechnologies. Where a proposed intervention

is innovative and/or experimental, this shouldalways be made clear to those who might besubject to it.

Whether a change in an individualsinvestigation or treatment is simply an

innovation or actually constitutes clinicalresearch is generally a matter or the responsibleclinicians judgement, guided by institutionalpolicies. Systematic evaluation o an innovationis research and requires ethical review.

Cnca and her ras

A clinical trial is a orm o human researchdesigned to nd out the eects o anintervention, including a treatment or diagnostic

procedure. A clinical trial can involve testing adrug, a surgical procedure, other therapeuticprocedures and devices, a preventive procedure,or a diagnostic device or procedure.

Clinical trials o new therapeutic substances aretypically categorised into Phase I, II , III or IVtrials. The ollowing denitions, adapted romthe Therapeutic Goods Administration (TGA),describe these phases in trials o medications:

Phase I studies involve the rst

administration o the medicine tohumans. Medicines are usually given tosmall numbers o healthy volunteers,but sometimes to people aected bythe disease the medicine is intended totreat. The purpose may be to determinethe medicines saety, pharmacokinetics,pharmacological activity, side eects,preerred routes o administration, orappropriate doses (or later studies). Thestudies are usually undertaken in centresequipped or specialised monitoring and

a high degree o surveillance.

CHAPtER 3.3: iNtER VENtioNS AND tHERAPiES,

iNCluDiNG CliNiCAl AND NoN-CliNiCAltRiAlS, AND iNNoVAtioNS

iNtRoDuCtioN

Cnca research


38/111




Phase II studies are typically the rsttrials o the medicine in people withthe health condition or which the

medicine is intended. The principal aimis to determine ecacy and saety andestablish an appropriate dosing regimen.These studies are undertaken in a smallnumber o closely supervised patientsand conducted by researchers regarded asspecialists in the health condition and itstreatment.

Phase III studies are undertaken i thePhase II studies indicate the medicinehas potential benets that outweigh any

hazards. The studies involve greaternumbers o patients with the healthcondition under study, and aim todetermine whether the medicine conersclinical benet in that health conditionand whether the incidence and nature oadverse eects are acceptable.

Phase IV studies are those undertakenater the medicine has been approvedor marketing or the treatment o aparticular disease or or a particular

indication. They may include studiesto compare the medicine with a widerrange o therapies, and may also urtherinvestigate the use o the medicine inthe normal clinical setting o the disease(which may dier markedly rom theconditions under which pre-marketingtrials were conducted). Such studies alsogather more comprehensive saety data,adding to the inormation known romthe pre-marketing studies.

In pharmaceutical and medical device trialsthere are established codes o good clinicalresearch practice that dene clearly what ismeant by a clinical trial or those purposes (seethe Australian code or the responsible conducto research). This chapters main application isto biomedical clinical trials, but it also appliesto any other interventions claiming therapeuticbenet. Trials involving experimentation withtherapeutic goods, whether drugs or devices,that are not yet registered, listed or entered on

the Australian Register o Therapeutic Goods(ARTG) are subject to regulation by the TGA.

Appcan randmsed ramehds her areas hmanresearch

Research methods intended to avoid or reducebias include randomisation and blindingparticipants and researchers to the identityo agents being compared. These researchmethods were rst applied to the study o newtherapies, and are now used in various otherelds including, or example, psychology andeducation. Researchers who propose to usesuch methods should be aware o the ethicalissues that may arise in the design and conducto such research. In particular, paragraphs 3.3.3and 3.3.6 will apply in all situations, while otherparagraphs may be relevant depending on thenature o the research and the relationshipbetween the researcher and potentialparticipants.

Research to which this chapter applies must

be reviewed and approved by a Human

Ethics Research Committee (HREC) rather

than by one of the other processes of ethical

review described in paragraphs 5.1.7 and

5.1.8 (page 78).

Values, principles and themes that must

inform the design, ethical review and

conduct of all human research are set out in

Sections 1 and 2 of this National Statement.

The guidelines and headings below show

how those values, principles and themes

apply specically in research that is the

subject of this chapter.

GuiDEliNES


3.3.1 Health care and medical institutionsshould establish standards to determinewhen an innovative intervention requiressystematic investigation to determine itssaety and ecacy.

3.3.2 When such systematic investigation is

required, it should be treated as clinicalresearch needing ormal consideration byan HREC.


39/111




3.3.3 Researchers should show that:

(a) the research is directed to answeringa specic question or questions;

(b) there is a scientically validhypothesis being tested that oersa realistic possibility that theinterventions being studied will be atleast as benecial overall as standardtreatment, taking into accounteectiveness, burdens, costs andrisks;

(c) the size and prole o the sample tobe recruited is adequate to answer

the research question; and

(d) the research meets the relevantrequirements o the CPMP/ICHNote or Guidance on Good Clinical

Practice(CPMP/ICH-135/95), ISO14155Clinical Investigation oMedical Devices, and the TGA.

3.3.4 Researchers must inorm the HREC o:

(a) any business, nancial or othersimilar association between a

researcher and the supplier o a drugor surgical or other device to beused in the trial;

(b) any other possible conficts ointerest; and

(c) any restrictions on publication.

3.3.5 In any clinical research, especially clinicaltrials, an HREC should be satised that:

(a) unding is sucient to conduct and

complete the trial as designed;

(b) any payment in money or kind,whether to institutions, researchersor participants, will not adverselyinfuence the design, conduct,ndings or publication o theresearch; and

(c) the acilities, expertise andexperience available are sucientor the trial to be conducted saely.

Jsce

3.3.6 The research methodology shouldprovide a rationale or the selectiono participants and a air method orecruitment (see paragraph 1.4, page 12).

Rss

3.3.7 In research without likely benetto participants, any known risk toparticipants should be lower thanwould be ethically acceptable wherethere are such likely benets. In rst-time-in-humans research projects, risks

are uncertain, and recruitment into thestudy should thereore be gradual andmonitored with special care.

3.3.8 In clinical research, where patient careis combined with intent to contributeto knowledge, any risks o participationshould be justied by potential benets towhich the participants attach signicance.

3.3.9 The prospect o benet rom researchparticipation should not be exaggerated,

either to justiy to an HREC a higher riskthan that involved in the participantscurrent treatment or to persuade aparticipant to accept that higher risk.

3.3.10 The use o a placebo alone or theincorporation o a non-treatment controlgroup:

(a) is ethically unacceptable in acontrolled clinical trial where:

(i) other available treatment has

already been clearly shown tobe eective; and

(ii) there is known risk o signicantharm in the absence otreatment;

(b) may be considered i there isgenuine uncertainty as to whethercurrently available treatments have anet clinical benet.

Ethical Issue for Observational Research

Documents

Transcript of Ethical Issue for Observational Research