Code of Human Research Ethics

Transcription

1 Code of Huma Research Ethics

2 If you have problems readig this documet ad would like it i a differet format, please cotact us with your specific requiremets. Tel: ; mail@bps.org.uk. Published by The British Psychological Society, St Adrews House, 48 Pricess Road East, Leicester LE1 7DR. The British Psychological Society 2014

3 Cotets 1. Backgroud Itroductio Defiitio of terms Why priciples? 6 2. The Priciples Respect for the autoomy, privacy ad digity of 8 idividuals ad commuities 2.2 Scietific itegrity Social resposibility Maximisig beefit ad miimisig harm Risk Valid Coset Cofidetiality Givig Advice Deceptio Debriefig Priciples of Best Practice i Ethics Review The priciples 27 Idepedece 27 Competece 27 Facilitatio 28 Trasparecy ad accoutability The role of a Research Ethics Committee The costitutio of a Research Ethics Committee Traiig ad developmet of Research Ethics Committee members Moitorig Devolved ethics review 30 Code of Huma Research Ethics 1

4 10. Further Guidace Safeguards for workig with vulerable populatios Childre Persos lackig capacity Idividuals i a depedet or 32 uequal relatioship 10.2 Research withi the Natioal Health Service How to decide if your research requires 33 NHS approval The remit of NHS RECs Applyig for ethics review The olie applicatio process (IRAS) Idepedet practitioers Studet Research Ackowledgemets 41 2 The British Psychological Society

5 1. Backgroud The revised British Psychological Society Ethical Priciples for Coductig Research with Huma Participats were published i This was a widely used documet; may istitutios ad research fudig bodies have used it to iform their ow research ethics policies ad practices. Sice that time, additioal supplemetary guidace documets have also bee published to support members coductig research i umerous differet cotexts. The Society appreciates that the uderstadigs of ethics i research are costatly developig; i additio, other chages with sigificace for research ethics, such as the advet of the statutory regulatio of professioal psychological services by the Health ad Care Professios Coucil (HCPC), have take place. The revisios of the Society s ow Code of Ethics ad Coduct (2006, 2009) have also iflueced thikig i this area. For these reasos, this Code of Huma Research Ethics has bee produced. The Workig Party, Ethics Committee ad Research Board thak all those people who were ivolved i its creatio (see Ackowledgemets at the back of this documet) ad ecourage idividuals ad departmets to use it as a resource for their ow thikig ad the cotiued developmet of ethical behaviour i psychological research. Professor Joh Oates Coveor, Workig Party o the Code of Research Ethics Dr Richard Kwiatkowski Member of the Ethics Committee Dr Lisa Morriso Coulthard BPS Lead Policy Advisor Code of Huma Research Ethics 3

6 1.1 Itroductio This Code of Huma Research Ethics sets out a set of geeral priciples that are applicable to all research cotexts ad are iteded to cover all research with huma participats. Priciples of coduct for psychologists i professioal practice ad workig with o-huma aimals are to be foud i the Society s Code of Ethics ad Coduct ad other advisory documets prepared by the Society (such as the Guidelies for Psychologists Workig with Aimals). It may also be helpful to cosult the HCPC guidace. Researchers should respect the rights ad digity of participats i their research ad the legitimate iterests of stakeholders such as fuders, istitutios, sposors ad society at large. There are umerous reasos for behavig ethically. Participats i psychological research should have cofidece i the ivestigators. Good psychological research is oly possible if there is mutual respect ad trust betwee ivestigators ad participats. Psychological ivestigators are potetially iterested i all aspects of huma behaviour ad experiece. However, for ethics reasos, some areas of huma experiece ad behaviour may be beyod the reach of experimet, observatio or other form of psychological itervetio. Ethics guidelies are ecessary to clarify the coditios uder which psychological research ca take place. However, as stated i the Code of Ethics ad Coduct, o Code ca replace the eed for psychologists to use their professioal ad ethical judgemet (2009, p.4, h). Fudametally, thikig is ot optioal (2009, p.5, k). The priciples outlied i this Code of Huma Research Ethics supplemet the geeral ethics priciples i the Society s Code of Ethics ad Coduct. Both sets of priciples are tools for makig reasoed judgemet. Members of the Society are expected to abide by both the Code of Ethics ad Coduct ad also this Code of Huma Research Ethics. Members should also draw the priciples to the attetio of research colleagues who are ot members of the Society. Members should ecourage colleagues, other orgaisatios with whom they work ad all researchers whom they supervise 4 The British Psychological Society

7 (e.g. research assistats ad postgraduate, udergraduate, A-level ad GCSE studets) to adopt them. Additioal guidace o specific aspects of psychological research ethics ca be foud o the Society s website ( ad queries about research ethics that caot be aswered by referece to this Code of Huma Research Ethics or the additioal guidace o the Society s website, ca be addressed to the Society s Research Ethics Referece Group via research-ethics@bps.org.uk. 1.2 Defiitios of terms Throughout this Code of Huma Research Ethics, the followig terms are used: Research is defied as ay form of disciplied equiry that aims to cotribute to a body of kowledge or theory. Research ethics refers to the moral priciples guidig research from its iceptio through to completio ad publicatio of results. Research Ethics Committee (REC) refers to a multidiscipliary, idepedet body resposible for reviewig research proposals ivolvig huma participats to esure that their digity, rights ad welfare are protected. The idepedece ad competece of a REC are based upo its membership, its rules regardig coflicts of iterest ad o regular moitorig of ad accoutability for its decisios. Protocol refers to a filed documet which specifies for a research project the procedures for recruitig participats ad gatherig ad maagig data, with which all project staff agree to comply. Huma participat is defied as icludig livig huma beigs, huma beigs who have recetly died (cadavers, huma remais ad body parts), embryos ad foetuses, huma tissue ad bodily fluids ad huma data ad records (such as but ot restricted to medical, geetic, fiacial, persoel, crimial or admiistrative records ad test results icludig scholastic achievemets). Participat It is ow commo practice to refer to a perso who serves as a data source for research as a participat. This recogises Code of Huma Research Ethics 5

8 their active role ad replaces the term subject which has bee viewed as portrayig people as passive recipiets rather tha active agets. While the extet of active participatio i the research over ad above providig iformatio will of course vary greatly from oe project to aother, the use of the term participat also serves to ackowledge the autoomy ad agecy of the idividual i cotributig to the research, ad their right to withdraw at ay time without pealty. We recogise that the term subject has currecy i certai cotexts, such as describig research desigs (e.g. withisubjects). I psychological research it is also relevat to ackowledge that a participat s uderstadig of the experiece they have while takig part i the research will ofte be a valuable additioal source of iformatio ad may well help to erich the iterpretatio of fidigs. People other tha the idividuals who are primary data sources may be also eed to be icluded i the cosideratio of the ethics of research. For example, parets ad other relatives, ad frieds ad colleagues may potetially be affected by research, ad the ethical coduct of research will ofte eed to be iformed by the iterests of other stakeholders as well, as oted above. 1.3 Why priciples? Research that ivolves humas addresses a wide rage of topics ad utilises may differet methodologies. The types ad severities of risks associated with huma research rage widely; from iocuous, aoymised at source data gatherig o o-sesitive topics, to research carryig multiple high-level risks that demad very detailed ethics protocols ad close attetio to risk obviatio, miimisatio ad maagemet, alog with adequate liability cover. Huma research also ivolves a wide variety of target populatios, some of which are vulerable, lack full competece to coset or are otherwise associated with heighteed risks. Icreasigly, huma research crosses istitutioal, professioal ad atioal boudaries, brigig further complicatio ito the applicatio of appropriate ethics protocols ad review processes. 6 The British Psychological Society

9 For these reasos, the developmet of detailed ad specific regulatios o the hadlig of ethics issues i huma research by researchers, with the aim of coverig all evetualities, is see by may ethicists as a ultimately flawed directio of travel. As soo as oe ew set of regulatios is fialised, a ew method or topic of research is likely to emerge that is ot covered. The existece of legthy, detailed ad prescriptive professioal or istitutioal regulatios raises the risk of researchers followig the letter, but ot the spirit, of the regulatios ad may i cosequece lead to research beig carried out that is ethically flawed. Overly detailed regulatios may also make it more difficult for RECs to egage with the uaces of the ethics of idividual cases. A solutio to such serious issues is a retur to first priciples. Ethical research coduct is, i essece, the applicatio of iformed moral reasoig, fouded o a set of moral priciples. I commo with the Society s Code of Ethics ad Coduct, this Code of Huma Research Ethics itroduces the otio of uderlyig priciples to iform psychological research practice. By opely statig the values that uderpi our professio, at this historical poit, we make them available for discussio ad debate, as well as allowig the possibility of clarificatio ad chage. Moreover, locatig the resposibility for developig adequate ethics protocols firmly ad squarely with researchers themselves ca be achieved by appealig to explicit, core priciples at a sufficietly high level of abstractio that the likelihood of idividual cases fallig outside of them is miimal. It is i this spirit that the followig priciples have bee developed: Respect for the autoomy, privacy ad digity of idividuals ad commuities. Scietific itegrity. Social resposibility. Maximisig beefit ad miimisig harm. Code of Huma Research Ethics 7

10 2. The Priciples 2.1 Respect for the autoomy, privacy ad digity of idividuals ad commuities Value statemet: Psychologists value the digity ad worth of all persos equally, with sesitivity to the dyamics of perceived authority or ifluece over others ad with particular regard to people s rights icludig those of privacy ad self-determiatio (Code of Ethics ad Coduct, 2009, p.10). Adherece to the cocept of moral rights is a essetial compoet of respect for the digity of persos. Rights to privacy, selfdetermiatio, persoal liberty ad atural justice are of particular importace to psychologists, ad they have a resposibility to protect ad promote these rights i their research activities. As such, psychologists have a resposibility to develop ad follow procedures for valid coset, cofidetiality, aoymity, fair treatmet ad due process that are cosistet with those rights. Ethics stadards: Psychologists have respect for the autoomy ad digity of persos. I the research cotext this meas that there is a clear duty to participats. For example, psychologists respect the kowledge, isight, experiece ad expertise of participats ad potetial participats. They respect idividual, cultural ad role differeces, icludig those ivolvig age, disability, geder reassigmet, marriage ad civil partership, pregacy ad materity, race (icludig colour, atioality, ethic or atioal origi), religio ad belief, sex, sexual orietatio, educatio, laguage ad socio-ecoomic status. Give this level of respect psychologists are aturally willig to explai the ature of the research to which participats are beig asked to cotribute, ad to avoid ay ufair, prejudiced or discrimiatory practice, for example, i participat selectio or i the cotet of the research itself. 8 The British Psychological Society

11 For these reasos they accept that idividuals may choose ot to be ivolved i research, or if they agree to participate they may subsequetly request that their data be destroyed. Uder such circumstaces researchers will comply with ay requests that ay related data be destroyed, ad removed from ay datasets. Where there are ecessary time limits o data withdrawal, for example up to a poit at which data are aggregated, these limits should always be made clear to participats. Psychologists respect the autoomy of idividuals by makig reasoed judgmets about ay actios i the course of their research that will have a impact o the autoomy of participats, eve temporarily, ad will always avoid ay processes ad procedures where ay log-term impairmet or perceived impairmet of autoomy might result. A reasoed balace should be struck betwee protectig participats ad recogisig their agecy ad capacity. Researchers will respect the privacy of idividuals, ad will esure that idividuals are ot persoally idetifiable, except i exceptioal circumstaces ad the oly with clear, uambiguous iformed coset. They will respect cofidetiality, ad will esure that iformatio or data collected about idividuals are appropriately aoymised ad caot be traced back to them by other parties, eve if the participats themselves are ot troubled by a potetial loss of cofidetiality. Where a participat wishes to have their voice heard ad their idetity liked with this, researchers will edeavour to respect such a wish. I their research, as i all other professioal dealigs, psychologists will seek to esure that people s rights are respected ad protected. 2.2 Scietific itegrity Value statemet: Research should be desiged, reviewed ad coducted i a way that esures its quality, itegrity ad cotributio to the developmet of kowledge ad uderstadig. Research that is judged withi a research commuity to be poorly desiged or coducted wastes resources ad devalues the cotributio of the Code of Huma Research Ethics 9

12 participats. At worst it ca lead to misleadig iformatio beig promulgated ad ca have the potetial to cause harm. Ethics stadards: Psychologists are committed to esurig that the scietific ad scholarly stadards of their research are accoutable ad of sufficietly high quality ad robustess. Quality relates primarily to the scietific desig of the research ad the cosideratio of potetial risks of harm ad protocols for addressig such difficulties (should they arise). It is importat that the aims of the research are as trasparet as possible to esure that it is clear what the research iteds to achieve. Judgemets of scietific value must be appropriate withi the cotext i which the research is beig coducted (e.g. the status of the researcher studet, lecturer, seior researcher). See also Sectio 11 o studet research. 2.3 Social resposibility Value statemet: The disciplie of psychology, both as a sciece ad a professio, exists withi the cotext of huma society. Accordigly, a shared collective duty for the welfare of huma ad o-huma beigs, both withi the societies i which psychology researchers live ad work, ad beyod them, must be ackowledged by those coductig the research (see also the Code of Ethics ad Coduct). Psychology educatio, sciece ad practice are fouded upo freedom of equiry ad debate. However, this freedom must be exercised i a maer cosistet with ethics priciples. I whatever social cotext they work, psychologists should ackowledge the evolutio of social structures i relatio to societal eed ad be respectful of such structures. Uwarrated or uecessary disruptio should be avoided uless the psychologist judges that the beefits of itervetio outweigh the costs of such disruptio (for example, i the protectio of vulerable idividuals or groups); (see also Sectio 1: Respect, of the Code of Ethics ad Coduct). 10 The British Psychological Society

13 Ethics stadards: The aim of geeratig psychological kowledge should be to support beeficial outcomes. Such outcomes ca be broadly defied as those that ot oly support ad reflect respect for the digity ad itegrity of persos (both idividually ad collectively) but also cotribute to the commo good. Accordigly, psychologists must be able to work i partership with others (icludig professioal colleagues, research participats, ad other persos); be self-reflective; ad be ope to challeges that questio the cotributios of psychological kowledge to society. Psychology researchers eed to be aware of their persoal ad professioal resposibilities, to be alert to the possible cosequeces of uexpected as well as predicted outcomes of their work, ad to ackowledge the ofte problematic ature of the iterpretatio of research fidigs. They should always work withi the limits of their professioal competece. 2.4 Maximisig beefit ad miimisig harm Value statemet: I accordace with Ethics Priciple 3: Resposibility of the Code of Ethics ad Coduct, psychologists should cosider all research from the stadpoit of the research participats, ad ay other persos, groups or commuities who may be potetially affected by the research, with the aim of avoidig potetial risks to psychological well-beig, metal health, persoal values, the ivasio of privacy or digity. Ethics stadards: Psychology researchers should seek to maximise the beefits of their work at all stages, from iceptio through to dissemiatio. Harm to research participats must be avoided. Where risks arise as a uavoidable ad itegral elemet of the research, robust risk assessmet ad maagemet protocols should be developed ad complied with. Normally, the risk of harm should be o greater tha that ecoutered i ordiary life, i.e. people should ot be exposed to risks greater tha or additioal to those to which they are exposed i their ormal lifestyles. Where a tesio arises betwee the legitimate eeds of research ad the avoidace of risk, reasoed Code of Huma Research Ethics 11

14 judgemet should be applied, based o the priciples i this Code of Huma Research Ethics. If uavoidable additioal risks are preset, researchers should assess these risks for their probability ad severity, ad put i place measures to obviate, miimise ad maage such risks. Psychologists eed to be sesitive to the potetial impact of their itervetios, for example, to the possibility of idividual distress that may be caused uwittigly, to the dager of ormalisig uhelpful behaviours or to creatig self-doubt. A differece i power ievitably exists betwee researchers ad participats, eve if researchers seek to miimise it. Sesitivity is, therefore, essetial, ad cautio is usually ecessary. I cojuctio with the previous sectio of this Code of Huma Research Ethics it may be that researchers will eed to cosider the costs to the idividual participat versus potetial societal beefits. This is a difficult balace to strike ad should be arrived at by careful ad explicit aalysis, ad where appropriate, wider cosultatio with experieced colleagues, the relevat REC or user group(s). Further discussio of risk i psychological research ca be foud i the followig sectio. 12 The British Psychological Society

15 3. Risk Risk ca be defied as the potetial physical or psychological harm, discomfort or stress to huma participats that a research project may geerate. This is a importat cosideratio i psychological research, where there is a wide rage of potetial risks. These iclude risks to the participat s persoal social status, privacy, persoal values ad beliefs, persoal relatioships, as well as the adverse effects of the disclosure of illegal, sexual or deviat behaviour. Research that carries o physical risk ca evertheless be disruptive ad damagig to research participats (both as idividuals or whole commuities/categories of people). It is importat to ackowledge that it ca be difficult to determie all potetial risks at the outset of a piece of research. However, researchers should edeavour to idetify ad assess all possible risks ad develop protocols for risk maagemet as a itegral part of the desig of the project, ad esure that appropriate levels of ethics review are sought. The followig research would ormally be cosidered as ivolvig more tha miimal risk: Research ivolvig vulerable groups (such as childre aged uder 16; those lackig capacity; or idividuals i a depedet or uequal relatioship); Research ivolvig potetially sesitive topics (such as participats sexual behaviour; their legal or political behaviour; their experiece of violece; their geder or ethic status); Research ivolvig a sigificat ad ecessary elemet of deceptio; Research ivolvig access to records of persoal or cofidetial iformatio (icludig geetic or other biological iformatio); Research ivolvig access to potetially sesitive data through third parties (such as employee data); Code of Huma Research Ethics 13

16 Research that could iduce psychological stress, axiety or humiliatio or cause more tha miimal pai (e.g. repetitive or prologed testig); Research ivolvig ivasive itervetios (such as the admiistratio of drugs or other substaces, vigorous physical exercise or techiques such as hyposis) that would ot usually be ecoutered durig everyday life; Research that may have a adverse impact o employmet or social stadig (e.g. discussio of a employer, discussio of commercially sesitive iformatio); Research that may lead to labellig either by the researcher (e.g. categorisatio) or by the participat (e.g. I am stupid, I am ot ormal ); Research that ivolves the collectio of huma tissue, blood or other biological samples. Some research may pose risks to participats i a way that is legitimate i the cotext of that research ad its outcomes. For example, research to reveal ad critique fudametal ecoomic, political or cultural disadvatage ad exploitatio may ivolve elemets of risk. Further, some research may be cosidered legitimate if the loger-term gais outweigh the short-term immediate risks to participats (provided that these risks are miimal ad either have lastig effects or iduce prologed persoal discomfort). I istaces where a elemet of risk is a uavoidable elemet of the research desig, a detailed case outliig the cost-beefit aalysis ad the risk maagemet protocol should be submitted to the REC. Risk aalysis should ot oly be cofied to cosiderig the iterests of the primary participats, but should also cosider the iterests of ay other stakeholders. Where appropriate, the use of risk aalysis tools may offer a useful way of idetifyig, quatifyig ad maagig potetial hazards. 14 The British Psychological Society

17 4. Valid Coset I accordace with the Code of Ethics ad Coduct, researchers should esure that every perso from whom data are gathered for the purposes of research cosets freely to the process o the basis of adequate iformatio. They should be able, durig the data gatherig phase, freely to withdraw or modify their coset ad to ask for the destructio of all or part of the data that they have cotributed. The way i which coset is sought from people to participate i or otherwise cotribute data for research should be appropriate to the research topic ad desig, ad to the ultimate outputs ad uses of the aalyses. It should recogise i particular the wide variety of data types, collectio ad aalysis methods, ad the rage of people s possible resposes ad sesitivities. The priciple of proportioality should apply, such that the procedures for coset are proportioal to the ature of participatio ad the risks ivolved. For example, for data from existig datasets where coset was properly gaied i the iitial collectio ad this coset covers the uses of data proposed, o further coset will ormally be eeded. For aoymised-at-source, o-sesitive data, coset may be cosidered to have bee give by the act of participatio or by tickig a box, for example. Nevertheless, the risks ivolved i some aoymised-at-source research, for example, web-based research o sesitive topics such as sexual behaviours, will require carefully prepared prior iformatio ad clear coset processes. Whe research ivolves the collectio of idetity capturig data o sesitive topics, usig video or audio recordig, or other methodologies where a idividual may be idetifiable, it is importat to cosider additioal iformed coset procedures. These procedures eed to be related to both the ature of the data collected ad the ultimate use of the data. Separate iformed coset agreemets for data collectio ad the dissemiatio of the study s results may be required. Code of Huma Research Ethics 15

18 Researchers should esure that the protocol they follow for seekig, takig ad recordig coset is appropriate to local customs, legal frameworks ad cultural expectatios, ad to the ature of the research ad its topic, while adherig to the priciple of validity. While writte coset, as described below, will be the usual approach, other methods, such as audio-recorded verbal coset or implied coset (for example, i choosig to iput resposes to a aoymous olie survey o a o-sesitive subject), may be preferable if based o a careful cosideratio of the research cotext. It is always importat that coset should be documeted i a auditable record. Assessmet of risk A prior assessmet of potetial risks should iform the preparatio of the iformatio to be give to potetial participats ad the procedures for seekig coset. This assessmet should be used to determie the appropriate form of coset ad the ature of ay risk maagemet required. Whe i exceptioal circumstaces harm, uusual discomfort, or other egative cosequeces for the idividual s future life might occur, the ivestigator must iform the participats clearly of these additioal risks prior to coset. For all research where risks are preset, secure liability isurace should be i place to adequately cover the levels of possible harm idetified i the risk aalysis. Who ca give coset? (see also Sectio 10.1) The coset of participats i research, whatever their age or competece, should always be sought, by meas appropriate to their age ad competece level. For childre uder 16 years of age ad for other persos where capacity to coset may be impaired the additioal coset of parets or those with legal resposibility for the idividual should ormally also be sought. I special circumstaces such as where it may be importat that views of such participats or fidigs about them should ot be suppressed, the ratioale for ot seekig paretal coset should be clearly stated ad approved by a REC. 16 The British Psychological Society

19 I the case of very youg childre, ad persos with very limited competece, their asset should be regularly moitored by sesitive attetio to ay sigs, verbal or o-verbal, that they are ot wholly willig to cotiue with the data collectio. If valid coset caot be obtaied from adults with severe impairmets i uderstadig or commuicatio, the ivestigator should cosult a perso well-placed to appreciate the participat s reactio, such as a member of the perso s family, ad must obtai the disiterested approval of the research from idepedet advisors. Where the research falls withi the regulatory framework of the Metal Capacity Act, the Adults with Icapacity (Scotlad) Act or relevat legislatio i Norther Irelad, approval must be sought from a recogised REC. Where competece to coset is i questio, it should be assessed usig a systematic procedure such as egagig the potetial participat i a dialogue to explore their uderstadig of what it is that they are cosetig to. This process may usefully iclude offerig a choice to which the respose idicates whether the idividual is capable of makig decisios based o likely outcome. I relatio to the gaiig of coset from childre ad youg people i school or other istitutioal settigs, where the research procedures are judged by a seior member of staff or other appropriate professioal withi the istitutio to fall withi the rage of usual curriculum or other istitutioal activities, ad where a risk assessmet has idetified o sigificat risks, coset from the participats ad the gratig of approval ad access from a seior member of school staff legally resposible for such approval ca be cosidered sufficiet. Where these criteria are ot met, it will be a matter of judgemet as to the extet to which the differece betwee these criteria ad the data gatherig activities of the specific project warrats the seekig of paretal coset from childre uder 16 years of age ad youg people of limited competece. Code of Huma Research Ethics 17

20 Whe research is beig coducted with detaied persos, particular care should be take over iformed coset, payig attetio to the special circumstaces which may affect the perso s ability to give free iformed coset. Iformig participats Givig potetial participats sufficiet iformatio about the research i a uderstadable form requires careful draftig of the iformatio sheet. It is recommeded that at least oe pilot test of the processes for iformig ad debriefig participats be carried out with a aïve perso havig a literacy level at the lower ed of the rage expected i the plaed research sample. I certai circumstaces the aims of the research may be compromised by givig full iformatio prior to data collectio. I such cases, it should be made clear that this is the case i the iformatio sheet ad the meas by which the withheld iformatio will be give at the coclusio of data collectio should be specified. The amout of iformatio withheld ad the delay i disclosig the withheld iformatio should be kept to the absolute miimum ecessary. The iformatio sheet give to potetial participats for them to keep should ormally offer a clear statemet of all those aspects of the research that are relevat for their decisio about whether or ot to agree to participatio. The followig list offers a series of headigs for cosideratio. Not all of these will be relevat i specific cases. The aim(s) of the project. The type(s) of data to be collected. The method(s) of collectig data. Cofidetiality ad aoymity coditios associated with the data icludig ay exceptios to cofidetiality, for example, with respect to potetial disclosures. Compliace with the Data Protectio Act ad Freedom of Iformatio Act. 18 The British Psychological Society

21 The time commitmet expected from participats. The right to declie to offer ay particular iformatio requested by the researcher. The opportuity to withdraw from the study at ay time with o adverse cosequeces. The opportuity to have ay supplied data destroyed o request (up to a specified date). Details of ay risks associated with participatio. If appropriate, a statemet that recompese for time ad icoveiece associated with participatio will be give, without specifyig the amout or ature of such recompese beyod the reimbursemet of icurred expeses such as travel costs. The ame ad cotact details of the Pricipal Ivestigator. The ame ad cotact details of aother perso who ca receive equiries about ay matters which caot be satisfactorily resolved with the Pricipal Ivestigator. Details of ay isurace idemity for the research. Ay debriefig that is plaed. How the data will be used ad plaed outcomes. Potetial beefits of the research. How the results of the research will be made available to participats. Which of these headigs are appropriate, ad the extet of iformatio give uder each, will deped o the ature of the research. The laguage should be clear ad accessible to people with limited literacy, usig short words ad seteces, writte i the active voice, ad avoidig the use of techical terms. Sufficiet time should be give for potetial participats to absorb ad cosider the iformatio give about the research ad what is expected of their participatio before they are asked to make a decisio regardig participatio. Code of Huma Research Ethics 19

22 Documetig coset Coset, whether i a verbal recordig, electroic or hard copy form, should iclude a explicit statemet cofirmig that iformatio about the research has bee give to the participat ad has bee uderstood. It is importat that participats do ot misuderstad ay collectio of health-related data from them as costitutig ay form of medical screeig. Such misapprehesios might lead them to be less vigilat i relatio to seekig medical attetio for risks or symptoms of illess. Normally, where writte coset is take, two copies of a coset form should be siged by the researcher ad the cosetig participat, ad/or their paret/guardia. Oe copy should be retaied by the participat ad the other stored by the researcher. The copy retaied by the participat should give cotact details of a perso who may be cotacted i the case of ay queries arisig. For certai types of research, for example where there are idetifiable risks, it will also be appropriate for the coset to be witessed ad siged by a idepedet third party. All records of coset, icludig audio-recordigs, should be stored i the same secure coditios as research data, with due regard to the cofidetiality ad aoymity protocols of the research which will ofte ivolve the storage of persoal idetity data i a locatio separate from the liked data. It is crucial that participatio i a research study is ot coerced i ay way, for example, through offerig disproportioate rewards for cosetig or idicatig disicetives for ot cosetig. Coercio ifriges the huma right to autoomy ad coerced participatio compromises the validity of research data. Ivestigators should realise that they are ofte i a positio of real or perceived authority or ifluece over participats. For example, they may be gatherig data from their studets, employees or cliets, from prisoers or from other detaied or vulerable people. This relatioship must ot be allowed to exert pressure o people to take part i or remai i a ivestigatio ad the potetial for a power relatioship to bias the data should be cosidered. Similarly, where people i positios of power over potetial participats, for example, school teachers or 20 The British Psychological Society

23 priso staff, serve as gatekeepers or recruiters for research, the potetial for coercio arisig from the power relatioships should be recogised ad steps take to avoid it. However, it is acceptable, ad i may cases proper, for reasoable recompese for attedace, travel, other icurred costs ad the time ad icoveiece of participatio to be offered. Need for reewal of coset Where the research requires a substatial commitmet of time or repeated data collectio sessios, such as i logitudial studies, it will ofte be appropriate to seek reewed coset from participats. This also recogises that coset should be a ogoig process ad that a fuller appreciatio of the research ad the ature of participatio will ofte become more apparet to participats durig the course of their ivolvemet with the research. Participats should be give iformatio as to whom they may cotact i the evet of ay issues arisig i the course of the research that caot be resolved with members of the project team. Such a cotact should be both idepedet of the project team ad also i a positio to take appropriate actio if issues are raised by participats. Code of Huma Research Ethics 21

24 5. Cofidetiality Subject to the requiremets of legislatio, icludig the Data Protectio Act, iformatio obtaied from ad about a participat durig a ivestigatio is cofidetial uless otherwise agreed i advace. Ivestigators who are put uder pressure to disclose cofidetial iformatio should draw this poit to the attetio of those exertig such pressure. Participats i psychological research have a right to expect that iformatio they provide will be treated cofidetially ad, if published, will ot be idetifiable as theirs. I the evet that cofidetiality ad/or aoymity caot be guarateed, the participat must be wared of this i advace of agreeig to participate. The duty of cofidetiality is ot absolute i law ad may i exceptioal circumstaces be overridde by more compellig duties such as the duty to protect idividuals from harm. Where a sigificat risk of such issues arisig is idetified i the risk assessmet, specific procedures to be followed should be specified i the protocol. Further details o matters cocerig cofidetiality will be foud i the Society s Code of Ethics ad Coduct, Sectio The British Psychological Society

25 6. Givig Advice I some kids of ivestigatio the givig of advice is ethical if this forms a itrisic part of the research, is agreed with the participat ad has bee subject to ethics review i advace. I other circumstaces, however, a researcher may obtai evidece suggestig the existece of psychological or physical problems of which a participat may appear to be uaware. I such a case, the ivestigator has a resposibility to discuss this with the participat if the ivestigator believes that by ot doig so the participat s future well-beig may be edagered. Where there is a idetified risk of such evidece emergig it is good practice to prepare a protocol i advace ad establish a appropriate referral route. If, i the ormal course of psychological research, or as a result of problems detected as above, a participat asks for advice about educatioal, persoality, behavioural or health issues, cautio should be exercised. If the issue is serious ad the ivestigator is ot competet to offer assistace, the appropriate source of professioal advice should be recommeded. Further details o the givig of advice will be foud i the Society s Code of Ethics ad Coduct. Code of Huma Research Ethics 23

26 7. Deceptio To may outside the psychology professio, ad to some withi it, the idea of deceivig the participats i research is see as quite iappropriate. The experiece of deceptio i psychological research may have the potetial to cause distress ad harm, ad ca make the recipiets cyical about the activities ad attitudes of psychologists. However, sice there are very may psychological processes that are modifiable by idividuals if they are aware that they are beig studied, the statemet of the research focus i advace of the collectio of data would make much psychological research impossible. There is a differece betwee withholdig some of the details of the hypothesis uder test ad deliberately falsely iformig the participats of the purpose of the research, especially if the iformatio give implies a more beig topic of study tha is i fact the case. This Code of Huma Research Ethics expects all psychologists to seek to supply as full iformatio as possible to those takig part i their research, recogisig that providig all of that iformatio at the start of a perso s participatio may ot be possible for methodological reasos. If the reactio of participats whe deceptio is revealed later i their participatio is likely to lead to discomfort, ager or objectios from the participats the the deceptio is iappropriate. If a proposed research study ivolves deceptio, it should be desiged i such a way that it protects the digity ad autoomy of the participats. Where a essetial elemet of the research desig would be compromised by full disclosure to participats, the withholdig of iformatio should be specified i the project protocol that is subjected to ethics review ad explicit procedures should be stated to obviate ay potetial harm arisig from such withholdig. Deceptio or covert collectio of data should oly take place where it is essetial to achieve the research results required, where the research objective has strog scietific merit ad where there is a appropriate risk maagemet ad harm alleviatio strategy. 24 The British Psychological Society

27 Studies based o observatio i atural settigs must respect the privacy ad psychological wellbeig of the idividuals studied. Uless those observed give their coset to beig observed, observatioal research is oly acceptable i public situatios where those observed would expect to be observed by stragers. Additioally, particular accout should be take of local cultural values ad of the possibility of itrudig upo the privacy of idividuals who, eve while i a ormally public space, may believe they are uobserved. See also the relevat sectios of the Code of Ethics ad Coduct ad the Society s guidace o web-based research. Code of Huma Research Ethics 25

28 8. Debriefig As outlied i the Code of Ethics ad Coduct (Sectio 3.4), whe the research data gatherig is completed, especially where ay deceptio or withholdig of iformatio has take place, it is importat to provide a appropriate debriefig for participats. I some circumstaces, the verbal descriptio of the ature of the ivestigatio will ot be sufficiet to elimiate all possibility of harmful after-effects. For example, followig a experimet i which egative mood was iduced, it would be ethical to iduce a happy mood state before the participat leaves the experimetal settig. 26 The British Psychological Society

29 9. Priciples of Best Practice i Ethics Review This sectio of the Code of Huma Research Ethics sets out priciples for ethics review outside of the Natioal Research Ethics Service (NRES) system because the ethical coduct of research is cocered with broader issues tha simply the coduct of research with participats; it icludes the ecessary elemet of idepedet review of ethics protocols. I may situatios, such as i uiversity psychology departmets, there will be a local resposibility to esure that ethics review complies with curret best practice ad with the expectatios ad requiremets of sposors, fudig bodies ad other stakeholders. 9.1 The priciples Idepedece The ethics review process should be idepedet of the research itself. Value statemet: This priciple highlights the eed to avoid coflicts of iterest betwee researchers ad those reviewig the ethics protocol, ad betwee reviewers ad orgaisatioal goverace structures. It is coditioed by the fourth priciple, which requires recogitio of the resposibility of RECs ad the eed to formulate this clearly. It also ivokes the eed for exteral membership of RECs (eschewig the problematic term lay ). It is importat to recogise the distictio betwee the review of research ethics ad the subsequet goverace of approved research, sice idepedece is a core priciple i the review process while differet cosideratios may apply i the ogoig goverace of research oce approved through a ethics review process. Competece The ethics review process should be coducted by a competet body. Value statemet: This secod priciple addresses the eed for research protocols to be properly evaluated by reviewers with Code of Huma Research Ethics 27

30 appropriate expertise, ad highlights the eed for careful cosideratio of the rage of membership ad ethics specific traiig of RECs. Facilitatio The review process should facilitate the uderstadig ad implemetatio of ethical practices. Value statemet: I additio to the core duty of respodig to applicatios for ethics review with costructive resposes, this priciple ivokes a resposibility to educate, iform ad support researchers i the developmet of their research protocols. RECs should be resposive ad avoid delayig valuable research. Trasparecy ad accoutability The review process should be accoutable ad ope to scrutiy. Value statemet: RECs eed to recogise their resposibilities ad to be appropriately located withi orgaisatioal structures that give trasparecy to the REC operatio ad procedures to maitai ad review stadards. 9.2 The role of a Research Ethics Committee (REC) A REC is ormally resposible for: reviewig all research ivolvig huma participats coducted by idividuals employed withi or by that istitutio; esurig that ethics review is idepedet, competet ad timely; protectig the digity, rights ad welfare of research participats; cosiderig the safety of the researcher(s); cosiderig the legitimate iterests of other stakeholders; makig iformed judgemets of the scietific merit of proposals; ad makig iformed recommedatios to the researcher if the proposal is foud to be watig i some respect. 28 The British Psychological Society

31 9.3 The costitutio of a Research Ethics Committee A REC should ormally: be multidiscipliary; iclude both me ad wome; iclude at least oe appropriately traied exteral member with o affiliatio with the departmet, uiversity or research istitutio; be comprised of members with a broad experiece of ad expertise i the areas of research regularly reviewed by the REC; ad must have the cofidece ad esteem of the research commuity; iclude least oe member with specialist kowledge i ethics; iclude idividuals who reflect the ethic diversity of the local commuity; users of specialist health, educatio or social services where these are the focus of research activities; idividuals with experiece of professioal care or cousellig; ad idividuals with specific methodological expertise relevat to the research they review; ad be costituted so that coflicts of iterest are avoided. This would ormally mea that a REC comprises at least seve members 9.4 Traiig ad developmet of Research Ethics Committee members The success of a REC relies largely o the degree to which research orgaisatios are able to build appropriate structures ad create a culture that recogises the cetral place that ethics review occupies i good research practice. Ethics traiig plays a cetral role i this process; such traiig should be o-goig ad become a itegral part of research practice. Successful RECs require agreed miimum stadards of traiig ad competece, which may be achieved through programmes at Code of Huma Research Ethics 29

32 istitutioal, faculty, departmetal or research cetre/uit level. The aim of the traiig should be to provide idividuals with cofidece i their abilities to coduct thorough ad cosistet ethics scrutiy of psychological research. 9.5 Moitorig All research orgaisatios should establish appropriate procedures to moitor the coduct of research which has received ethics approval util it is completed, ad to esure cotiuig review where the research desig aticipates possible chages over time that might eed to be addressed. Moitorig should be proportioate to the ature ad degree of risk associated with the research. It should iclude cosideratio of best-practice procedures for the secure holdig ad preservatio (or destructio where appropriate) of the data. Where a REC cosiders that a moitorig report raises sigificat cocers about the ethical coduct of the study, it should request a full ad detailed accout of the research for full ethics review. Where it is judged that a study is beig coducted i a way that is uethical, it should cosider the withdrawal of its approval ad require that the research should be suspeded or discotiued. 9.6 Devolved ethics review I may orgaisatios ethics review of idividual protocols is devolved to departmetal level committees. I the case of psychological research this will ofte mea that a departmet will have a devolved resposibility for reviewig protocols origiatig withi the departmet. To avoid coflicts of iterest ad to assure best practice i ethics review, it is essetial that resposibility for the coduct of ethics review should reside with a properly costituted committee with lay membership. 30 The British Psychological Society

33 10. Further Guidace This sectio gives cosideratio to aspects of huma research ethics where additioal risks are likely to be preset. Further iformatio o these ca be foud i the Ethics sectio of the Society s website Safeguards for workig with vulerable populatios Special safeguards eed to be i place for research with vulerable populatios. Vulerable populatios iclude childre uder the age of 16, people with learig or commuicatio difficulties, patiets i care, people i custody or o probatio, ad people egaged i illegal activities, such as drug abuse. I accordace with the Priciple of Respect for the Autoomy ad Digity of Persos ad the Code of Ethics ad Coduct, psychologists should esure that participats from vulerable populatios (such as childre, persos lackig capacity, ad those i a depedet or uequal relatioship) are give ample opportuity to uderstad the ature, purpose ad aticipated outcomes of ay research participatio, so that they may give coset to the extet that their capabilities allow. Methods that maximise the uderstadig ad ability to coset of such vulerable persos to give iformed coset should be used wheever possible. Researchers should esure that they are aware of the provisios of the Metal Capacity Act 2005 ad/or other legislatio applicable i the locatio(s) of the research ad ay requiremets with respect to ethics review of research, the provisio of adequate liability cover, ad the special requiremets for gaiig valid coset. Researchers should also be aware of ad respod to the eed for appropriate crimial records disclosures ad clearaces whe their research ivolves cotact with vulerable people Childre If the vulerable perso is uable to give iformed coset, coset should be sought from those persos who are legally resposible or appoited to give coset o behalf of persos ot competet to Code of Huma Research Ethics 31

34 coset o their ow behalf, seekig to esure that respect is paid to ay previously expressed prefereces of such persos. I research with childre uder the age of 16, ad i specific circumstaces as described above i Sectio 4 o Valid Coset, researchers should esure that parets or guardias are iformed about the ature of the study ad give the optio to withdraw their child from the study if they so wish. The priciple of moitorig the asset of the child will also apply Persos lackig capacity I the specific case of persos lackig capacity to give valid coset, willig ad fully iformed coset for participatio should be sought from a legally resposible proxy; ad research without coset from a perso should ormally oly occur if the research activity is cosidered to provide direct beefit to that perso. Specific regulatio applies to cliical trials. Further cosideratio ad guidace o this matter is provided i the Society s guidelies o Coductig research with people ot havig the capacity to coset to their participatio Idividuals i a depedet or uequal relatioship Psychologists should be particularly diliget i establishig the valid coset of ay perso who is i a depedet or uequal relatioship to them (e.g. studet or cliet) ad should esure that appropriate cosets are obtaied from ay gatekeepers to participats, for example school pricipals, parets or legal guardias. Udergraduate participatio i psychological experimets is ot required for Society accreditatio. It has to be recogised, however, that most psychological research ivolves huma participats ad that courses i psychology eed to acquait studets with appropriate methods for carryig out such research. Participatio by studets i psychological research provides them with valuable experiece, ot just with methodology but also with the ethics problems that ca arise whe carryig out experimets ad other forms of research. Ideed, it ca be argued that it is uethical for psychology studets or graduates to carry out research with others 32 The British Psychological Society