Efficacy vs. The Tick Box Culture: Ethical Training & Reflection in Higher Education

1. Researcher Efficacy vs. The Tick Box Culture; A Place for Ethical Training andReflection in Global Higher Education Joe Gazdula

2. Efficacy • a method of achieving something, to produce the intended result (Cambridge English Dictionary, 2017) • The ability to produce a desired or intended result (Oxford Dictionaries, 2017)

3. Researcher • Someone whose job is to study a subject carefully, especially in order to discover new information or understand the subject better. (Cambridge Dictionary, 2017)

4. Ethics • Moral principles that govern a person's behaviour or the conducting of an activity. (Oxford Dictionaries, 2017)

5. So: • https://www.youtube.com/watch?v=X-jxEX1XQpY

6. The conundrum Henrietta Lacks: • Patient at JHU • Cells taken without consent • the first immortalized cell line • Patented 10,000 times • Reproduced • Responsible for many modern treatments:Polio Vaccine –Aids combo. • Received £0

7. John Hopkins University Johns Hopkins Medicine sincerely acknowledges the contribution to advances in biomedical research made possible by Henrietta Lacks and HeLa cells. It’s important to note that at the time the cells were taken from Mrs. Lacks’ tissue, the practice of obtaining informed consent from cell or tissue donors was essentially unknown among academic medical centers. Sixty years ago, there was no established practice of seeking permission….. The laboratory that received Mrs. Lacks’s cells had arranged many years earlier to obtain such cells from any patient diagnosed with cervical cancer as a way to learn more about a serious disease…. Johns Hopkins never patented HeLa cells, nor did it sell them commercially or benefit in a direct financial way’

8. What do we mean by ‘ethics’ then? • The moral principles guiding research (ESRC, 2004). • Sets of moral principles or norms that are used to guide moral choices of behaviour and relationships with others (Blumberg et al, 2005 in Gray, 2014:130). • See The Helsinki Principles.

9. Helsinki Principles (Basic) Individual right to self determination Right to make informed decisions (initially and during research) Researchers duty is to individual participant whose welfare MUST take precedence over interests of science or society Ethical considerations take precedence over laws and regulations Surrogate consent when participant is not capable of giving consent (e.g. mentally, physically or by virtue of age) ( Adapted from Grant, 2017)

10. The University Response • Research guidelines • The Research Ethics Committee • The Research Ethics Process • The Researchers Code of Conduct • The Adherence to The Code of Conduct Agreement • The Consent Form • The Research Ethics Tick Box – Series!

11. Key tensions in research ethics • The Tick Box Approach v Trained Supervisors • Balancing scientific concerns with research ethics • Most scientifically valid approach isn’t always most ethical • Individual rights vs. public benefit • Inclusion vs. exploitation • International settings • Should ethics guidelines apply universally? • New technologies (e.g. genomics, internet) • Are challenging prevailing norms around research ethics

12. Ethics Processes in Universities (Schrag 2011) • To avoid/mitigate litigation? (Lincoln and Tierney, 2004).or to do ethically founded research? • The respect for academic freedom within these corporations is desirable, but not indispensable … Institutional Review Boards can forestall the public image problems and protect the institution’s reputation by weeding out politically sensitive studies before they are approved. (Moss, 2007: 803-804)

13. Schrag (2011) Critiques Ethics Comittees. • 1) ethics committees impose silly restrictions • 2) ethics review is a solution in search of a problem, • 3) ethics committees lack expertise, • 4) ethics committees apply inappropriate principles, • 5) ethics review harms the innocent, and 6) better options exist.

14. Isomorphism Schrag critique: Hedgecoe 2012 • generalize from the issues • and problems associated with ethics review in a particular jurisdiction (for example, • higher education institutions in the US) and claim that these problems are • representative of ethics review in general,

15. Hedgecoe 2012 • the best recent scholarship in this area which explores the contextual and structural elements that shape decision-making within specific national contexts (e.g. Van Den Hoonaard, 2011),

16. there is a lack of empirical evidence as to the benefit of research ethics review • Social science and ethics review: A question of practice not principle • Stuart G. Nicholls 2012

17. Maxine Robertson The case for ethics review in the social sciences: Drawing from practice at Queen Mary University of London • focusing upon avoiding harm, emphasizes notions of care to both • participants and researchers.

18. Tim Bond 2012 Ethical imperialism or ethical mindfulness? Rethinking ethical Review for social sciences • ethical review is only one component in a number of ethical strategies designed to promote ethical mindfulness as integral to social science research. • Parallel views and remedies pervade the most comprehensive international consideration of social research ethics (Mertens and Ginsberg, 2009).

19. Bond • problematic areas - it appears that these problems are at their most acute when social scientists are reviewed by panels more used to biomedical research or quantitative research and misapply these expectations to qualitative research.

20. Nathan Emmerich 2013 • Between the accountable and the auditable: Ethics and ethical governance in the social sciences

21. Stark L (2007) Victims in our own minds? IRBs in myth and practice. Law & Society Review 41(4): 777–786. complex role in social scientific

22. Emmerich 2016 research (Crowhurst and kennedy-macfoy, 2013) the proper function of a REC is compromised when it acts as a gatekeeper. • Universities are comparable but mutually independent institutions and, • whilst they sometimes act in a coordinated and collective manner, they do not • always do so. NHS and NRES work may not – and in my view does not - provide an • appropriate model for the ethical governance of university researchers

23. RECs. However, if they elect to do so, then these responsibilities should be clearly • distinguished from their primary task, the ethical review of research proposals. • The reason for this is that, for both scientific and ethical reasons, the review of • research proposals ought to be conducted in a manner that is principled, independent • and, preferably, transparent manner, one that is structured in such a way as to • distinguish between ethics review and broader matters of research governance • (Iphofen, 2009). Regardless of whether this ideal is being met in practice (Stark, • 2011), it may be that, for this reason alone, it would be wiser not to involve RECs in either reputation management or gatekeeping (Hedgecoe, 2015);

24. Crane, A. 1999 Journal of Business Ethics July 1999, Volume 20, Issue 3, pp 237–248 Are You Ethical? Please Tick Yes □ Or No □ On Researching Ethics in Business Organizations Crane, A. Journal of Business Ethics (1999) 20: 237. doi:10.1023/A:1005817414241

25. Informed Consent (Hayden, 2012) AS RESEARCHERS FIND MORE USES FOR DATA, INFORMED CONSENT HAS BECOME A SOURCE OF CONFUSION. SOMETHING HAS TO CHANGE Hayden, (2012) NATURE VOL. 486 Research ethics Paper 2011 The return of individual research findings in paediatric genetic research Kristien Hens1, Herman Nys1, Jean-Jacques Cassiman2, Kris Dierickx1

26. Trust and regulatory organisations: The role of local knowledge and facework in research ethics review Adam M. HedgecoeSocial Studies of Science First Published June 13, 2012 R. Dingwall / Medical Sociology online 1 (2006) 51-58 www.medicalsociologyonline.org 51 Confronting the Anti-Democrats: The Unethical Nature of Ethical Regulation in Social Science

27. Tick Boxes • Bureaucracy and Beyond: the Impact of Ethics and Governance Procedures on Health Research in the Social Sciences • by Kate ReedUniversity of Sheffield • Sociological Research Online 12(5)18

28. 2012 Wassenaar and Mamotte • Ethical Issues and Ethics Reviews in Social Science Research   Douglas R. Wassenaar and Nicole Mamotte The Oxford Handbook of International Psychological Ethics • principled and pragmatic objections. Mattingly, 2005; Reissman, 2005) object to the ethical universalism implicit in ethics review • According to Redwood and Todres (2006), the fundamental principles of biomedical research mentioned above have been translated into practical guidelines for risk/benefit analysis, informed consent, and confidentiality, and are assumed to be universal and therefore problematic • They argue that such ethical universalism is problematic because ethical guidelines and procedures constructed in one context are exported to other contexts, particularly in the developing world, without modification (Mattingly, 2005; Reissman, 2005).

29. 2012 Wassenaar and Mamotte • Other principled and partially pragmatic objections include the argument that ethics review of social science research is generally derived from biomedical review (Cribb, 2004; D’Agostino, 1995; Hoeyer, Dahlager, & Lynöe, 2005; Illinois White Paper, 2003; Israel, 2004; Schrag, 2009; Whittaker, 2005). • It cannot be used to argue that social science should be judged on different moral standards than biomedical research • Another principled objection is that ethics review is not necessary in social science research, as social science research carries far lower risks to research participants than biomedical research (Cribb, 2004; Oakes, 2002; Schrag, 2009).

30. Exemptions from Ethics Review • While guidelines on exemption from ethics review are somewhat ambiguous (Pritchard, 2001), there are some types of study that in most countries would be exempted from ethics review. Studies without human participants or those based on information already in the public domain are the clearest examples of such studies.

31. Elements of Ethical Research • there are four widely accepted philosophical principles that are applied in various ways to research ethics. These are: Autonomy and Respect for the Dignity of Persons; Nonmaleficence; Beneficence; and Justice. These four philosophical principles frequently find embodiment in the requirements of informed consent, risk/benefit determinations, and fair subject selection, and form the cornerstone of most REC deliberations (Hemmings, 2006).

32. And for Education As part of social science studies:

33. Carter (2009) the ‘tick box’ approach automatically identifies a research study as inherently more risky, forcing researchers into a defensive position and framing children as vulnerable even when the risks may be neglible and the risks of not doing the research are higher for children

34. What if he scientific approach isn’t always the most ethical? Research Ethics Committees To preserve their legitimacy, they need to acknowledge the inherent contestability of ethical decision-making and be prepared to engage in a debate where no single frame of reference, either scientific freedom or ethics, should have an a priori claim to be superior or to represent the truth, but a communicative consensus should be allowed to emerge from a debate among equals on the merit of their arguments. Hoecht 2011

35. The Hoecht Dilemma (2011) • ‘Researchers may be regarded as trained professionals with strong internalised norms of proper behaviour and can be largely trusted to make their own appropriate judgements about ethics in their research (and are willing to seek informal advice from academic peers in cases of doubt).’ • ‘Universities need RECs that scrutinise every piece of empirical research that involves human subjects on behalf of the government and the public who no longer trust researchers to conduct research with integrity of their own accord.’

36. Lack of UK Standardisation • ‘No overarching system or agreement about the ethical principles and processes of governance.’ • ‘A lack of standardisation across universities (for ethics research committees).’ Vadeboncoeur et al., (2016) ‘‘ethics creep’ Monaghanan et al., (2013 ‘A Global Problem’ Cleaton-Jones and Wassenaar (2010)

37. Towards a Model - Emanuel, Wendler, and Grady (2008). 8broad practical principles: • Collaborative Partnership, • Social Value, • Scientific Validity, • Fair Selection of Participants • FavorableRisk-Benefit Ratio, • Independent Ethical Review, • Informed Consent, • Ongoing Respect for Participants and Study Communities (Emanuel et al., 2008).

38. Collaborative Partnership(Emanuel et al., 2008) • This dimension encourages researchers to develop studies in collaboration with the target community or population and other relevant stakeholders • the participating community also shares the benefits of the research (Lairumbi et al., 2008 • Research should arise from an expressed community need, should involve the community in all stages of the research from study planning to implementation, and dissemination of results and should be considerate of the traditions, cultural practices, and values of the community (cf. Molyneux et al., 2005). There is a need to set up a “democratic representation of study communities” in connection to research teams (Marsh et al., 2008). This should involve regular yet varied opportunities for communication, interaction, and partnership-building between researchers and communities (Marsh et al., 2008)

39. Challenges • A challenge to community participation is (p. 275) deciding how the community should be represented in a manner that is well balanced and fair (Marsh et al., 2008) • Exceptions: e.g. principle could be research intended to reveal destructive processes (racism?) • Fieldworkers should also be seen as key collaborative partners

40. Gray et al 2016 towards a model • Are research ethics guidelines culturally competent? • Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on interdependence and trust. This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information.

41. Gray et al 2016 towards a model Maori researchers argue that the mainstream documents are culture-bound to the dominant culture, and thus not able to deliver culturally competent research. Although this study was done in New Zealand and the discussion has focused on New Zealand research ethics guidelines, we believe that our findings have relevance further afield. New Zealand is very much part of the western ethics community, with a similar structure of guidelines and review boards to other western countries.

42. Towards an iclusivecomprehensive? model • Early research by Grant (2015, 2016) and Grant and Gazdula (2017) in sub saharan A • 2000 (get the right number) research dissertations identify : • Ethics are can be fluid in the region.

43. suggests Researchers need a more personal model • The ethics becomes your ethics under a number of conditions. • When you claim it consistently. • When you own it through dissemination and discussion • When a continual dialogic approach is used with your supervisor • When you interact and engage with your specific research environment.

44. References • Cambridge English Dictionary (2017) http://dictionary.cambridge.org/dictionary/english/efficacy (Accessed 20/6/17) • Oxford Dictionaries (2017) https://en.oxforddictionaries.com/definition/efficacy (Accessed 20/6/17) • Exporting ethics: a narrative about narrative research in South India. • Riessman CK1.

45. Cleaton-Jones, P. Wassenaar, D.(2010) Protection of human participants in health research – a comparison of some US federal regulations and South African research ethics guidelines The South African Medical Journal Vol. 100 (11) Grant, G. (2015) Comparisons of Research Ethics in Sub-Saharan Africa and the UK,’ BESA Conference, Cardiff, UK Grant, G (2016) Using Phenomenogrophy to Investigate Transnational Education and Research Ethics, JEQR Conference, Las Vegas, USA. Grant, C. Gazdula, J (2017) Using Phenomenogrophy to Investigate Transnational Education and Research Ethics, Journal or Ethnographic and Qualitative Research (Accepted -under revision) Grant, C. and Gazdula, J. (2017) Hoecht, A. (2011) Whose ethics, whose accountability? A debate about university research ethics committees Ethics and Education Vol. 6, (3) 253–266 Vadeboncoeur, C. Townsend, N. Foster, C (2016)Variation in university research ethics review: Reflections following an inter-university study in England Research Ethics Vol. 12 (4) 217-233