Code Of Human Research Ethics - BPS
Code of Human Research Ethics
If you have problems reading this document andwould like it in a different format, please contact uswith your specific requirements.Tel: 0116 2254 9568; email mail@bps.org.uk.Published by The British Psychological Society, St Andrews House,48 Princess Road East, Leicester LE1 7DR. The British Psychological Society 2014ISBN: 978-1-85433-762-7
on of terms51.3Why principles?6The Principles62.1Respect for the autonomy, privacy and dignity ofindividuals and communities82.2Scientific integrity92.3Social responsibility102.4Maximising benefit and minimising harm113.Risk134.Valid Consent155.Confidentiality226.Giving Advice237.Deception248.Debriefing269.Principles of Best Practice in Ethics Review279.1The arency and accountability27272728289.2The role of a Research Ethics Committee289.3The constitution of a Research Ethics Committee299.4Training and development of Research EthicsCommittee members299.5Monitoring309.6Devolved ethics review30Code of Human Research Ethics1
10.Further Guidance3110.1 Safeguards for working with vulnerable populations3110.1.1Children3110.1.2Persons lacking capacity3210.1.3Individuals in a dependent orunequal relationship3210.2 Research within the National Health Service3310.2.1How to decide if your research requiresNHS approval3310.2.2The remit of NHS RECs3410.2.3Applying for ethics review3510.2.4The online application process (IRAS)3510.3 Independent practitioners3611.Student Research3712.Acknowledgements412The British Psychological Society
1. BackgroundThe revised British Psychological Society Ethical Principles forConducting Research with Human Participants were published in 1990.This was a widely used document; many institutions and researchfunding bodies have used it to inform their own research ethicspolicies and practices. Since that time, additional supplementaryguidance documents have also been published to support membersconducting research in numerous different contexts. The Societyappreciates that the understandings of ethics in research areconstantly developing; in addition, other changes with significancefor research ethics, such as the advent of the statutory regulation ofprofessional psychological services by the Health and CareProfessions Council (HCPC), have taken place. The revisions of theSociety’s own Code of Ethics and Conduct (2006, 2009) have alsoinfluenced thinking in this area. For these reasons, this Code ofHuman Research Ethics has been produced.The Working Party, Ethics Committee and Research Board thank allthose people who were involved in its creation (see Acknowledgementsat the back of this document) and encourage individuals anddepartments to use it as a resource for their own thinking and thecontinued development of ethical behaviour in psychological research.Professor John OatesConvenor, Working Party on the Code of Research EthicsDr Richard KwiatkowskiMember of the Ethics CommitteeDr Lisa Morrison CoulthardBPS Lead Policy AdvisorCode of Human Research Ethics3
1.1 IntroductionThis Code of Human Research Ethics sets out a set of general principlesthat are applicable to all research contexts and are intended to coverall research with human participants. Principles of conduct forpsychologists in professional practice and working with non-humananimals are to be found in the Society’s Code of Ethics and Conduct andother advisory documents prepared by the Society (such as theGuidelines for Psychologists Working with Animals). It may also be helpfulto consult the HCPC guidance.Researchers should respect the rights and dignity of participants intheir research and the legitimate interests of stakeholders such asfunders, institutions, sponsors and society at large.There are numerous reasons for behaving ethically. Participants inpsychological research should have confidence in the investigators.Good psychological research is only possible if there is mutualrespect and trust between investigators and participants.Psychological investigators are potentially interested in all aspects ofhuman behaviour and experience. However, for ethics reasons, someareas of human experience and behaviour may be beyond the reachof experiment, observation or other form of psychologicalintervention. Ethics guidelines are necessary to clarify the conditionsunder which psychological research can take place. However, asstated in the Code of Ethics and Conduct, ‘ no Code can replace theneed for psychologists to use their professional and ethicaljudgement’ (2009, p.4, h). Fundamentally, ‘thinking is not optional’(2009, p.5, k).The principles outlined in this Code of Human Research Ethicssupplement the general ethics principles in the Society’s Code ofEthics and Conduct. Both sets of principles are tools for makingreasoned judgement. Members of the Society are expected to abideby both the Code of Ethics and Conduct and also this Code of HumanResearch Ethics. Members should also draw the principles to theattention of research colleagues who are not members of the Society.Members should encourage colleagues, other organisations withwhom they work and all researchers whom they supervise4The British Psychological Society
(e.g. research assistants and postgraduate, undergraduate, A-leveland GCSE students) to adopt them.Additional guidance on specific aspects of psychological researchethics can be found on the Society’s website (www.bps.org.uk), andqueries about research ethics that cannot be answered by referenceto this Code of Human Research Ethics or the additional guidance onthe Society’s website, can be addressed to the Society’s ResearchEthics Reference Group via research-ethics@bps.org.uk.1.2 Definitions of termsThroughout this Code of Human Research Ethics, the following termsare used:‘Research’ is defined as any form of disciplined enquiry that aims tocontribute to a body of knowledge or theory.‘Research ethics’ refers to the moral principles guiding researchfrom its inception through to completion and publication of results.‘Research Ethics Committee (REC)’ refers to a multidisciplinary,independent body responsible for reviewing research proposalsinvolving human participants to ensure that their dignity, rights andwelfare are protected. The independence and competence of a RECare based upon its membership, its rules regarding conflicts ofinterest and on regular monitoring of and accountability for itsdecisions.‘Protocol’ refers to a filed document which specifies for a researchproject the procedures for recruiting participants and gathering andmanaging data, with which all project staff agree to comply.‘Human participant’ is defined as including living human beings,human beings who have recently died (cadavers, human remains andbody parts), embryos and foetuses, human tissue and bodily fluidsand human data and records (such as but not restricted to medical,genetic, financial, personnel, criminal or administrative records andtest results including scholastic achievements).‘Participant’ It is now common practice to refer to a person whoserves as a data source for research as a ‘participant’. This recognisesCode of Human Research Ethics5
their active role and replaces the term ‘subject’ which has beenviewed as portraying people as passive recipients rather than activeagents. While the extent of active ‘participation’ in the research overand above providing information will of course vary greatly from oneproject to another, the use of the term ‘participant’ also serves toacknowledge the autonomy and agency of the individual incontributing to the research, and their right to withdraw at any timewithout penalty. We recognise that the term ‘subject’ has currency incertain contexts, such as describing research designs (e.g. ‘withinsubjects).In psychological research it is also relevant to acknowledge that aparticipant’s understanding of the experience they have while takingpart in the research will often be a valuable additional source ofinformation and may well help to enrich the interpretation offindings.People other than the individuals who are primary data sources maybe also need to be included in the consideration of the ethics ofresearch. For example, parents and other relatives, and friends andcolleagues may potentially be affected by research, and the ethicalconduct of research will often need to be informed by the interestsof other stakeholders as well, as noted above.1.3 Why principles?Research that involves humans addresses a wide range of topics andutilises many different methodologies. The types and severities ofrisks associated with human research range widely; from innocuous,anonymised at source data gathering on non-sensitive topics, toresearch carrying multiple high-level risks that demand very detailedethics protocols and close attention to risk obviation, minimisationand management, along with adequate liability cover. Humanresearch also involves a wide variety of target populations, some ofwhich are vulnerable, lack full competence to consent or areotherwise associated with heightened risks. Increasingly, humanresearch crosses institutional, professional and national boundaries,bringing further complication into the application of appropriateethics protocols and review processes.6The British Psychological Society
For these reasons, the development of detailed and specificregulations on the handling of ethics issues in human research byresearchers, with the aim of covering all eventualities, is seen bymany ethicists as an ultimately flawed direction of travel. As soon asone new set of regulations is finalised, a new method or topic ofresearch is likely to emerge that is not covered. The existence oflengthy, detailed and prescriptive professional or institutionalregulations raises the risk of researchers following the letter, but notthe spirit, of the regulations and may in consequence lead toresearch being carried out that is ethically flawed. Overly detailedregulations may also make it more difficult for RECs to engage withthe nuances of the ethics of individual cases.A solution to such serious issues is a return to ‘first principles’.Ethical research conduct is, in essence, the application of informedmoral reasoning, founded on a set of moral principles. In commonwith the Society’s Code of Ethics and Conduct, this Code of HumanResearch Ethics introduces the notion of underlying principles toinform psychological research practice. By openly stating the valuesthat underpin our profession, at this historical point, we make themavailable for discussion and debate, as well as allowing the possibilityof clarification and change.Moreover, locating the responsibility for developing adequate ethicsprotocols firmly and squarely with researchers themselves can beachieved by appealing to explicit, core principles at a sufficientlyhigh level of abstraction that the likelihood of individual cases fallingoutside of them is minimal. It is in this spirit that the followingprinciples have been developed:nRespect for the autonomy, privacy and dignity of individuals andcommunities.nScientific integrity.nSocial responsibility.nMaximising benefit and minimising harm.Code of Human Research Ethics7
2. The Principles2.1 Respect for the autonomy, privacy and dignity ofindividuals and communitiesValue statement: ‘Psychologists value the dignity and worth of allpersons equally, with sensitivity to the dynamics of perceivedauthority or influence over others and with particular regard topeople’s rights including those of privacy and self-determination’(Code of Ethics and Conduct, 2009, p.10).Adherence to the concept of moral rights is an essential componentof respect for the dignity of persons. Rights to privacy, selfdetermination, personal liberty and natural justice are of particularimportance to psychologists, and they have a responsibility to protectand promote these rights in their research activities. As such,psychologists have a responsibility to develop and follow proceduresfor valid consent, confidentiality, anonymity, fair treatment and dueprocess that are consistent with those rights.Ethics standards: Psychologists have respect for the autonomy anddignity of persons. In the research context this means that there is aclear duty to participants. For example, psychologists respect theknowledge, insight, experience and expertise of participants andpotential participants. They respect individual, cultural and roledifferences, including those involving age, disability, genderreassignment, marriage and civil partnership, pregnancy andmaternity, race (including colour, nationality, ethnic or nationalorigin), religion and belief, sex, sexual orientation, education,language and socio-economic status.Given this level of respect psychologists are naturally willing toexplain the nature of the research to which participants are beingasked to contribute, and to avoid any unfair, prejudiced ordiscriminatory practice, for example, in participant selection or inthe content of the research itself.8The British Psychological Society
For these reasons they accept that individuals may choose not to beinvolved in research, or if they agree to participate they maysubsequently request that their data be destroyed. Under suchcircumstances researchers will comply with any requests that anyrelated data be destroyed, and removed from any datasets.Where there are necessary time limits on data withdrawal, forexample up to a point at which data are aggregated, these limitsshould always be made clear to participants.Psychologists respect the autonomy of individuals by makingreasoned judgments about any actions in the course of their researchthat will have an impact on the autonomy of participants, eventemporarily, and will always avoid any processes and procedureswhere any long-term impairment or perceived impairment ofautonomy might result. A reasoned balance should be struckbetween protecting participants and recognising their agency andcapacity.Researchers will respect the privacy of individuals, and will ensurethat individuals are not personally identifiable, except in exceptionalcircumstances and then only with clear, unambiguous informedconsent. They will respect confidentiality, and will ensure thatinformation or data collected about individuals are appropriatelyanonymised and cannot be traced back to them by other parties,even if the participants themselves are not troubled by a potentialloss of confidentiality. Where a participant wishes to have their voiceheard and their identity linked with this, researchers will endeavourto respect such a wish.In their research, as in all other professional dealings, psychologistswill seek to ensure that people’s rights are respected and protected.2.2 Scientific integrityValue statement: Research should be designed, reviewed andconducted in a way that ensures its quality, integrity and contributionto the development of knowledge and understanding. Research thatis judged within a research community to be poorly designed orconducted wastes resources and devalues the contribution of theCode of Human Research Ethics9
participants. At worst it can lead to misleading information beingpromulgated and can have the potential to cause harm.Ethics standards: Psychologists are committed to ensuring that thescientific and scholarly standards of their research are accountableand of sufficiently high quality and robustness. Quality relatesprimarily to the scientific design of the research and theconsideration of potential risks of harm and protocols for addressingsuch difficulties (should they arise). It is important that the aims ofthe research are as transparent as possible to ensure that it is clearwhat the research intends to achieve.Judgements of scientific value must be appropriate within thecontext in which the research is being conducted (e.g. the status ofthe researcher – student, lecturer, senior researcher). See alsoSection 11 on student research.2.3 Social responsibilityValue statement: The discipline of psychology, both as a science anda profession, exists within the context of human society. Accordingly,a shared collective duty for the welfare of human and non-humanbeings, both within the societies in which psychology researchers liveand work, and beyond them, must be acknowledged by thoseconducting the research (see also the Code of Ethics and Conduct).Psychology education, science and practice are founded uponfreedom of enquiry and debate. However, this freedom must beexercised in a manner consistent with ethics principles.In whatever social context they work, psychologists shouldacknowledge the evolution of social structures in relation to societalneed and be respectful of such structures. Unwarranted orunnecessary disruption should be avoided unless the psychologistjudges that the benefits of intervention outweigh the costs of suchdisruption (for example, in the protection of vulnerable individualsor groups); (see also Section 1: Respect, of the Code of Ethics andConduct).10The British Psychological Society
Ethics standards: The aim of generating psychological knowledgeshould be to support beneficial outcomes. Such outcomes can bebroadly defined as those that not only support and reflect respect forthe dignity and integrity of persons (both individually andcollectively) but also contribute to the ‘common good’.Accordingly, psychologists must be able to work in partnership withothers (including professional colleagues, research participants, andother persons); be self-reflective; and be open to challenges thatquestion the contributions of psychological knowledge to society.Psychology researchers need to be aware of their personal andprofessional responsibilities, to be alert to the possible consequencesof unexpected as well as predicted outcomes of their work, and toacknowledge the often problematic nature of the interpretation ofresearch findings. They should always work within the limits of theirprofessional competence.2.4 Maximising benefit and minimising harmValue statement: In accordance with Ethics Principle 3: Responsibilityof the Code of Ethics and Conduct, psychologists should consider allresearch from the standpoint of the research participants, and anyother persons, groups or communities who may be potentiallyaffected by the research, with the aim of avoiding potential risks topsychological well-being, mental health, personal values, the invasionof privacy or dignity.Ethics standards: Psychology researchers should seek to maximise thebenefits of their work at all stages, from inception through todissemination.Harm to research participants must be avoided. Where risks arise asan unavoidable and integral element of the research, robust riskassessment and management protocols should be developed andcomplied with. Normally, the risk of harm should be no greater thanthat encountered in ordinary life, i.e. people should not be exposedto risks greater than or additional to those to which they are exposedin their normal lifestyles. Where a tension arises between thelegitimate needs of research and the avoidance of risk, reasonedCode of Human Research Ethics11
judgement should be applied, based on the principles in thisCode of Human Research Ethics. If unavoidable additional risks arepresent, researchers should assess these risks for their probability andseverity, and put in place measures to obviate, minimise and managesuch risks.Psychologists need to be sensitive to the potential impact of theirinterventions, for example, to the possibility of individual distressthat may be caused unwittingly, to the danger of ‘normalising’unhelpful behaviours or to creating self-doubt. A difference in powerinevitably exists between researchers and participants, even ifresearchers seek to minimise it. Sensitivity is, therefore, essential, andcaution is usually necessary. In conjunction with the previous sect
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