Ethical Issues & Vulnerable Populations: Community, Academic & Research Views

1. Ethical Issues & Vulnerable Populations:Community, Academic & Research Views Clinical Research Professionals of BC Vancouver BC, April 2010 Dr. James Frankish Senior Scholar, Professor, & Director UBC Centre for Population Health Promotion Research Board Member, Lookout Emergency Aid Society 3X MacDonald’s Employee-of-the-Month

2. Recent & Current Projects • Training-Related Research & ActivitiesResearch Training Program in Population Health Intervention Research • Homelessness & Poverty-Related ResearchSupportive Housing for Persons with Mental Illness & AddictionsInner-City Inclusivity, Olympics & HealthRural-Urban Migration, Homelessness & Health Services/StatusHealth Professionals’ Attitudes toward Homeless PersonsUse of Health & Social Services by Homeless Persons • Health Literacy, & Literacy & Health ResearchHealth Literacy in School ChildrenHealth Literacy in Street-Involved YouthHealth Literacy in Multicultural Seniors • Health-System Reform & Marginalized GroupsHealth Regions & Nonmedical Determinants of HealthChildren Living with HIV/AidsAdolescents' Concepts of Depression & Related Help-Seeking • Measuring the Health of CommunitiesCommunity Coalitions & the 2010 GamesMeasuring Community Capacity

3. Perspectives on Ethics & Health Research • Values & Evidence • Community Research • Ethical Principles • Tri-Council Policy Statement (TCPS) Tutorial • BC Legislation • UBC Behavioural Research Ethics Board

4. The Core Issue • Morally acceptable ‘ends’ AND morally acceptable means to those ‘ends’ • Translation: you need a good reason to do research, & while you are doing it – you need to be ethical... ‘the ends don’t justify the means’ • Ethics is about beliefs. It is about rules of behavior & human duty, morals and values. Human research ethics are a set of principles to help guide researchers to develop and do research in a way that is safe, respectful, responsible and of high quality. Australian Government ( 2005 ). Keeping Research on Track: A guide for Aboriginal and Torres Strait people about health and research ethics. http://www.nhmrc.gov.au • Who decides? • How is it decided? • Objects of Interest and Standards of Acceptabililty

5. Definition of CBPR • “A collaborative process that equitably involves all partners in the research process & recognizes unique strengths that each brings. CBPR begins with a research topic of importance to the community with the aim of combining knowledge for social change.” • Minkler’s Ethical ChallengesAchieving a true “community-driven” agendaInsider-outsider tensionsReal and perceived racism (Power)Limitations of “participation”Issues involving the sharing, ownership, and use of findings and actions. Ref: Minkler (2004). Ethical Challenges for the “outside” researcher in CBPR.

6. Common Problems in Research • Irrelevance to community • Poor methodology (waste of resources) • Research is not giving back • Communities feel over researched • Communities feel coerced • Communities are lied to • Insensitivity to community concerns or issues • Benefits to community are minimal

7. Basic Premises • Power in research is related to knowledge of a ‘truth’ • Some forms of knowledge generation are more credible than others • Some “knowers” are more credible than others • ‘Evidence’ generated by ‘credible’ means is more real and powerful • People who generate knowledge by credible means are more powerful • Evidence generated by ‘questionable’ means is unethical • Evidence generated by ‘questionable knowers’ is unethical • Power is maintained by controlling the creation of knowledge • Ethics (policies) are a means of exercising power.

8. ‘Surfacing’ the Values Underlying Research Ethics • Facts are interpreted within existing paradigms and world views, Kuhn 1970 • Constructs exist within the minds of those creating operational definitions to describe behavior (reality) Kerlinger, 1986 • Individuals responsible for research and ethics hold a core set of 'values'. • These 'values' represent preferences shared and transmitted within a community; and related principles, goals or standards. • Certain values may be in conflict across communities.

9. Community Partnership Research & Ethics “The gathering of information and its subsequent use are inherently political. In the past, Aboriginal people have not been consulted about what information should be collected, who should gather that information, who should maintain it, and who should have access to it. The information gathered may or may not have been relevant to the questions, priorities and concerns of Aboriginal peoples. Because data gathering has frequently been imposed by outside authorities, it has met with resistance in many quarters .” (Royal Commission on Aboriginal Peoples, 1996)

10. Four Critical Issues • Establishing a basis for rules of evidence in community-based research • The search for appropriate indicators of ‘truth’ in community-based research • Appropriate theoretical-base for ‘evidence’ in community-based research • Establishing the relations between evidence and ethics in community-based research

11. Facts et al. • Data – raw facts • Information – organized presentations of facts • Knowledge – organized application of information • Wisdom – just, fair applicationof knowledge

12. Three Forms of Knowledge • Instrumental knowledge – traditional scientific approaches • Interactive knowledge – derived from sharedliving experiences • Critical knowledge – derived from reflection on what is right and just. Park, 1993

13. Ethics Definitions and Stances • Ethics - derived from the Greek ethos, meaning character, custom, or usage, or morality ( from the Latin synonym meaning manner, custom or habit), is the philosophical study of normative behavior, the “shoulds” and “oughts”, the “rights” and “wrongs” of our conduct.” (Penslar, 1995 ). • Normative ethics: deals with how we should make our ethical decisions. • Meta-ethics: deals with the meaning of ethical terms, ex. Evil, good, bad, ought, should, fairness, duty, etc. • Utilitarianism (Bentham, Mills): An action is moral if it produces the greatest amount of utility (benefit) for the greatest amount of people. • Relativism (Nietzsche): There are many moralities, not one objective one.

14. Ethics Definitions and Stances • Deontology: do what is right, some acts are wrong regardless of the results that they might achieve. • Consequentialist research: focused on the results of the action, do what will achieve the greatest good. • Virtue ethics: focuses on character or the moral quality of the actors rather than what those people did.

15. Ethical Frameworks(Flinders 1992)

16. Raphael’s Propositions • What counts as evidence is contested • Ideology, values and principles strongly influence what is seen as evidence • Decision making should draw upon local evidence even when conclusions from the literature are available

17. Raphael’s Guidelines • Be as explicit as possible about your values and principles • Recognize tensions between structural and individual determinants of health and between values and facts • Whenever possible, use multiple sources of evidence • Use truth criteria associated with each form of knowledge • Be a reflective practitioner. Raphael, 2000.

18. Sources of Bias • Ethnocentrism: problem of not being able to relate to others who don’t think like you do. • Going native: problem of thinking too much like the group you are studying. • Interpersonal relationships with stakeholders: getting too cozy with those who you are hired to judge. • Financial ties to the evaluand: its hard to bite the hand that feeds you. • Internal vs. external evaluators: in terms of bias it is clear which one is more biased (who has more to loose?).

19. TCPS Statementhttp://www.pre.ethics.gc.ca/english/tutorial • Free & Informed Consent • Respect for Vulnerable Persons • Privacy/Confidentiality • Justice & Inclusiveness • Balancing Harms & Benefits • Minimizing Harm • Maximizing Benefit

20. BC Legislation • BC’s new Personal Information Protection Act regulates collection, use and disclosure of personal information in the private sector • It covers physicians and other health professionals • It also covers private sector organizations such as medical laboratories, pharmacies and private clinics • You can only use personal information for the purpose for which it was originally collected • But you can also use if for a consistent purpose. This requires a reasonable and direct connection to original purpose. New use must also be necessary for your work.

21. Protection of Privacy - PIPA • An organization may only disclose personal information about an individual without consent if • the disclosure is in the interests of the individual and consent cannot be obtained in a timely way, • the disclosure is needed for medical treatment • the information disclosed is solely for the purposes for which the information was previously collected • the research cannot be accomplished unless the personal information is provided in an individually identifiable form • the disclosure is on condition that it will not be used to contact persons to ask them to participate in research • linkage of the information to other information is not harmful

22. Protection of Privacy - FOIPPA • A public body may disclose personal information for a research purpose, only if • the research cannot reasonably be accomplished unless that information is provided in identifiable form or the research has been approved by the commissioner • the information is not be used for the purpose of contacting a person to participate in the research • any record linkage is not harmful to the individuals • or the person has signed an agreement relating to confidentiality of personal information.

23. 10 Elements of Privacy Best Practices (CIHR) • Determining objectives & justifying data needed to meet them • Limiting collection of personal data • Determining if consent from individuals is required • Managing and documenting consent • Informing prospective participantsabout the research • Recruiting prospective researchparticipants • Safeguarding personal data • Controlling access & disclosureof personal data • Setting reasonable limits on retention of personal data • Ensuring accountability/transparency in management of datahttp://www.cihr-irsc.gc.ca/e/29072.html

24. Decisions Arising from Review • Approval – As required by the TCPS the Certificate of Approval will be issued for a term of one year. • Proviso– Some concerns need to be addressed before approval is given. The BREB authorizes the Chair to grant approval when concerns have been addressed. • Deferred – Based on documentation the BREB is unable to make a final decision. The decision is deferred for full board review • Not Approved – Researchers have the right to request, and Research Ethics Boards have an obligation to provide, reconsideration of decisions affecting a research project

25. Issues Re UBC Behavioural Research Ethics Board • UBC Policy • Rank & Qualifications • Minimal Risk Criteria • Recruitment • Inclusion/Exclusion Criteria • Informed Consent

26. Thorny Issues Re UBC Behavioural Research Ethics Board • Action Research: researchers investigating their own practice where dual relationships exist between the researcher and participant. • Autobiography: is of concern because of possible problems associated with obtaining initial and continuing consent of individuals mentioned in the narrative. • Deception: Research that involves deception requires completion of appendix 5 and justification of deception. Only research that meets the requirements of TCPS will be exempted from full disclosure at the time of consent.

27. Thorny Issues • Ethnographic Fieldwork- Researchers who work with First Nations- Have a right to know that they are being studied- it may not be possible to obtain approvals prior to arrival- Some anthropological fieldwork is exploratory in nature. - Describe the type of consent process • Expert interviews- Interviews with an expert in a similar position to the researcher (e.g., an academic, politician, owner or executive of a company, head of an NGO, or president of an association or union) and which are designed to obtain factual accounts of an event, a procedure, a process, history, and where there is minimal or no risk

28. Thorny Issues • Naturalistic Observation- “REB review is normally required for research involving naturalistic observation. Research involving observation of participants in political rallies, demonstrations or public meetings should not require REB review since it can be expected that the participants are seeking public visibility- Describe the nature of the activities, the environment, and the method of recording the activities to be observed. If the observation does not allow for the identification of the subjects, it will be regarded as minimal risk. If individuals will be identified you must justify the need for this.

29. Thorny Issues • Secondary Use of Data- secondary use of data (including data linkage) for research requires review and approval by the REB- use of previously collected research data in existing databases on anonymous individuals may receive expedited review- if identifying information is involved, application will be reviewed by full Board. Researcher must satisfy the BREB that: identifying information is essential to research, appropriate measures are taken to protect privacy of people and confidentiality of data, and people have not objected to secondary use. • If published data could be linked to individuals, the researcher should propose a strategy for obtaining consent or otherwise informing the subjects.

30. Videotaping • If any subjects in an experimental setting, which is videotaped decline to participate, researchers must take extra care to protect the rights of non-participants. On the one hand, it is unfair to require non-participants sit outside camera range if this also excludes them from participating in the activity or marginalizes them in some other way. On the other hand, subjects’ rights not to take part in the research must be respected. • In any case, electronically distorting the facial features of non-participants does not honor the subject’s wish not to participate. It is not a matter of non-identification but a matter of non-participation.

31. Payments, Lotteries & Draws • Consent must be free of undue influence from inducements. The amount or kind of payment should not be such that the subject will base his/her decision to participate on the potential material rewards. • Compensation offered is weighed against the amount of time and inconvenience to the subject on a case-by-case basis. It is considered coercive and thus unacceptable to have payment depend on completion of the project. • As an incentive to participate in studies, researchers may offer a chance at a prize in a draw. If such a draw does not include those who decline to participate.

32. Focus Groups: the consent form should note that only limited confidentiality can be offered in focus groups • Reportable Offences: Some research may involve an increased possibility of reports of child abuse. The Child, Family and Community Service Act of B.C. requires that anyone who has reason to believe that a child may be abused, neglected, or is for any other reason in need of protection, must report it to the Director or a designated social worker (Ministry of Children and Family Development). The BREB may require that a sentence be included in the consent form informing participants that reports or allegations of abuse must be reported to the proper authorities.

33. Common Problems in Research • Insensitivity to community concerns or issues • Irrelevance to community • Poor methodology (waste of resources) • Research is not giving back • Benefits to community are minimal • Communities feel over researched • Communities feel coerced • Communities are lied to

34. Some Red Flags in CBR • Background, Purpose, Objectives: Is research really justified?, Who benefits? How?, How was community involved or consulted in defining need?, Who came up with the objectives and how?, Are there concrete action outcomes? • Research Methodology: How will the community be involved? At what levels?, What training or capacity building will you build in?, Will the methods used be sensitive & appropriate to various communities (literacy issues, language barriers, cultural sensitivities, etc)?, How will you balance scientific rigor and accessibility? • Participants: Are you really talking to the ‘right’ people to get your questions answered appropriately (e.g. service providers, community members, leaders etc), How will you protect vulnerable groups?, Will the research process include or engage marginalized or disenfranchised folks? How?, Who speaks for community?, Is there a reason to exclude some people? Why?

35. Some Red Flags in CBR • Recruitment: Need to consider ‘power’ relationships (no coercion!), Make sure that ‘service providers’ & ‘researchers’ are different people, Assure participants that those who do not want to participate will still be assured service, Who approaches people about the study and how?, Make sure that you have culturally relevant & appropriate recruitment strategies & materials, Consider confidentiality. • Risks & benefits: What are risks for communities? For individuals?, Be honest about risks & consider how you will minimize them, Be clear about who will benefit and how? (How do you distribute the benefits most equitably?) • Privacy and confidentiality: How do you maintain boundaries between multiple roles?, What processes will you put in place to be inclusive about data analysis & yet maintain privacy, Where you store data? Who will have access to data? How? , What rules will you have for working with transcripts or surveys with identifying information?

36. Red Flags • Compensation: It is important to reimburse people for their time and honor their efforts – but honoraria are not ‘coercive’, Who is managing the budget? Which partners are getting what compensations?, Who is volunteering? How are those decisions being made? • Conflict of interest: What happens when your job or thesis depends on results?, What happens when you are the researcher and the friend, peer, service provider, educator, funder etc? • Informed Consent Process: What does this mean for ‘vulnerable’ populations (e.g. children, mentally ill, developmentally challenged)?, What does it mean to ‘inform’?, What does it mean to ‘consent’?, How do you do this in a culturally sensitive manner?, Whose permission do you need to talk to whom?

37. Summary of Key Ethical Issues • Individual versus community consent • Ownership of results • Academic versus community standards • Maximizing good versus minimizing harm • Emergence of community codes of ethics & review processes

38. The Future ? • Control • Capacity • Community Benefit

39. References • Dow, Greg. (2003). Governing the Firm: Workers’ Control in Theory and Practice. Cambridge: Cambridge University Press. • Green, L. (2004) Ethics and CBPR: Commentary on Minkler, Health Education and Behavior, 31 (6), 698‑701. • Israel, B. et al. (1998). Review of Community‑based Research. Ann Rev Public Health. 19, 173‑202. • Marshall, P. & Rotimi, C. (2001) Ethical Challenges in Community‑based Research. American Journal of the Medical Sciences, 322 (5), 241‑245. • Mergler, D. (1987). Worker participation in occupational health research: theory and practice. Int J Health Serv, 17, 151‑167. • Messing, K. & Mergler, D. (1995). "The rat couldn't speak, but we can": Inhumanity in occupational health research. In Re‑inventing biology (pp. 21‑49). Indianapolis: Indiana University Press.

40. References • Penslar, R. (1995). Research Ethics, Cases & Materials, Indiana University Press. • Smith, D. (2000). Consulted to death: How Canada's workplace health and safety system fails workers. Winnipeg: Arbeiter Ring. • Stern, D. (1997). Research Ethics, A reader, University press of New England. • Taylor, A. K. (1999). Organizing marginalized workers. Occup.Med, 14, 687‑695. • Tee, S. & Lathlean, J. (2004). The ethics of conducting a co‑operative inquiry with vulnerable people. Journal of Advanced Nursing, 47 (5), 536‑543. • Theobald, S. (1996). Employment and environmental hazard: women workers and strategies of resistance in northern Thailand. Gend.Dev., 4, 16‑21. • UBC Office of Research Services: http://www.orsil.ubc.ca/

41. Contact Information • Dr. Jim Frankish • Rm 425, Library Processing Centre2206 East Mall Vancouver BC V6T 1Z3 • 604-822-9205, 822-9228 • frankish@interchange.ubc.ca • jimfrankish.com