Ethical Issues in Social Science Research

1. Ethical Issues in Social Science Research Cristina E. Torres, Ph.D. Social Science Professor FERCAP Coordinator

2. Presentation Outline • Definitions • Research methodologies • Ethical issues in social research • Levels of risks/ benefits to participants • Vulnerable participants • Types of ethical review required • Addressing ethical issues in social research • Case study • Technical rigor • Ethical soundness

3. Useful Definitions • “Research means a systematic investigation to include research development, testing and evaluation, designed to develop or contribute some information or generalizable knowledge.” • “Human subject is a living individual about whom an investigator (professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

4. Useful Definitions • Minimal risk – probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or during the performance of routine physical or psychological examinations or tests

5. Useful Definitions • Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place. • Information provided for specific purposes by which the individual can reasonably expect that it will not be made public (like a medical record).

6. Types of Research Methodologies in Social Science • Types • Quantitative – results in generalizable knowledge • Qualitative – in depth study about an individual, social group, community, etc. (case study, observation studies, ethnography; • Research on human behavior based on the reality construction paradigm or on its interpretation (hermeneutics, phenomenology, ethnography, constructivism, and constructionism) can only be guided by values, as the researcher is part of the researched issue,

7. Common Data Gathering Methods • Observation • Interview • Focus group discussion • Survey (use quantitative techniques and analysis)

8. Ethical issues in social research

9. Unethical research? • Milgram study – study about obedience • Recruited subjects who were told that they will be monitors in a grammar exercise. • Brought to a room and made to believe that they could administer electric shock to examinees in another room every time they gave a wrong answer. They received prompts from the investigator and could decide to follow the command or not. • Concluded that majority of the participants obeyed commands to hurt other people.

10. Unethical research? • Tea room trade study – study of homosexual sex in public toilets - 1960 • Arrests for homosexual conduct resulted from sex in public toilets • Behavior stigmatized and illegal • Sociologist Laud Humphrey decided to observe men who engaged in this type of sex by pretending to be the watcher for the police for these men. • He made detailed description of 50 sex encounters.

11. Types of Risks in Social Research Potential Risks • Physical risks • Bodily harm • Simple inconvenience • Psychological risks • Emotional suffering • Breach of confidentiality • Social risks • Employment or social discrimination • Economic risks • Financial costs related to participation

12. Definition of Risk • The term risk refers both to the probability of a harm resulting from an activity and to its magnitude. • `Risk' often stands for the combined probabilities and magnitude of several potential harms.

13. Types of Benefits in Social Research Potential Benefits • Physical benefits • Alleviation or comfort from suffering • Psychological benefits • Feeling of helping others • Empowerment • Economic benefits • Financial benefits related to research participation • Benefit to science/society • Generalizable knowledge • Effective interventions • Community improvement/ empowerment

14. Definition of Benefit • A benefit refers to any sort of favorable outcome of the research to society or to the individual • In practice, 'benefit' often stands for the combined probabilities and magnitudes of several possible favorable outcomes

15. Type of Research Based on Risk • Negligible risk research • no foreseeable risk or foreseeable risk no more than inconvenience • Low risk research • only foreseeable risk is one of discomfort • Greater than “low risk” Not all social science research is low or negligible risk!

16. Levels of Harm • Harm • physical: injury, illness or pain • psychological: worthlessness, distress, guilt, anger or fear, devaluation of worth • social, economic or legal • Discomfort • minor side effects • measuring blood pressure • anxiety induced by interview • Inconvenience • completing questionnaires • giving time to participate www.monash.edu

17. Levels of Reviewwww.monash.edu

18. Exempt from review • Negligible risk research • Involves the use of existing collection of data or records that contain only non-identifiable data • Anonymous databases • Opinion surveys • Interview and questionnaire research about general (not private) behavior • Observation of public behavior (no identifiers) • Data collected from elected officials

19. Research on Vulnerable Populations • Persons who are absolutely or relatively incapable of protecting their interests • Insufficient power, intelligence, resources, strength or other needed attributes to protect their own interests through informed consent • Each person when measured against the highest standards of capability is relatively vulnerable • Robert Levine, The Ethics and Regulation of Clinical Research, 1986

20. Inclusion of vulnerable groups • Research should be protective? …or inclusive of vulnerable groups? • Vulnerable groups need extra protection from potential harms of research • It is important to be especially careful to include at least some of these groups in research so they can benefit from the knowledge gained

21. Need to determine type of review (expedited vs. full board) Research that involves more than low risk are those that involve: • – Pregnant women and fetus • – Children and younger people • – People in dependent or unequal relationships • – People highly dependent on medical care and may be unable to give consent • – People with cognitive impairments, intellectual disability, or mental illness • – Aboriginal groups • – And some research with people who may be involved in illegal activities www.monash.edu

22. Determination of significant risk • Sensitive nature of the topic • May cause stigmatization – loss of reputation • Type of social interaction • Intervention may cause psychological stress or harm – Milgram study • Financial implications • Loss of job or profession • Legal implications • Drug addiction, prostitution, abortion as criminal activities

23. Addressing ethical issues in social research

24. Case Study: Survey of Tsunami Victims in Thailand Methodology • Study design: Cross sectional study (survey sample representative of study population) • Subject selection: Study populations in tsunami area • Study area: Ranong province • Community approach: asking permission from the community leader • Sampling method: Simple random sampling shelter, random household • Subjects: Knowledgeable person in the house or household head, housewife Orapin C. Laosee, 2005 FERCAP Conference

25. Had Sai Kao Beach # 2 Field Work

26. Scientific validity:Sampling methods Define area 6 provinces in Thailand Province Sample random sampling Shelters Sample random sampling Households Knowledgeable household member Respondents

27. Summary of study procedures Defining study area Developing protocol & tool Training data collectors Obtaining IRB review Coordinating with health staffs Asking permission from community leader Field work

28. Critique of application of international guidelines in qualitative research • “We have studied the application and the concept of research found in international and in the Brazilian guidelines. We have noticed that they adopt a positivist conception of research, which establishes 1) the hypothesis test, 2) that all procedures are previously defined by the researcher; 3) neutrality of the researcher and of the knowledge produced.”

29. Sound Qualitative Research Methodology • Nature of Qualitative research • Emphasize particular context and settings • Not necessary to be able to generalize • Its rigor cannot be judged based on sample size • Should provide sufficient detailed account or analysis to enable others to determine the application of the findings to other circumstances • Should be assessed by quality and credibility of data collection and analysis and not by validity and reliability Australian National Statement on Ethical Conduct in Human Research (Sec.3.1.4 -3.1.8)

30. Ethical Components of Qualitative Research • Respect for persons: Accuracy or completeness of interview transcript should be verified by relevant participant before completing analysis (Sec. 3.1.15) • Consent process (oral or written) depends on type of research, level of sensitivity, cultural context and participant vulnerability. (Sec. 3.1.16) • Consent may be implied by participation (answering a questionnaire, etc.) (Sec. 3.1.17)

31. Ethical Components of Qualitative Research • Justice: Inclusion/exclusion criteria should be stated clearly and should be justified. (Sec. 3.1.9) • Beneficence: When sensitive information is given, care should be taken to protect the identity of participants in information dissemination or material storage, unless they agree to be identified. (Sec. 3.1.10)

32. Ethical Components of Qualitative Research • Participants should be informed about any potential to be identified in the research results. (Sec. 3.1.11) • Sensitive topics may involve emotional and other risks and require clear protocols on how distress will be managed. (Sec. 3.1.12) • Researchers should have training on what topics could cause distress and how to address them. (Sec. 3.1.13)

33. Ethical Components of Qualitative Research • Qualitative research may involve development of personal relationships to collect data and researchers should describe in the proposal any anticipated impact of this nature. (Sec. 3.1.14)

34. Research involving illegal activities • Establish that risks are justified by the benefits of research. • Use of pseudonyms or removal of links between names and data should be explained in the protocol. • Explain how the researcher will keep confidential any illegal activity. • Explain who has access to confidential information and the threats to confidentiality.

35. Research about aboriginal groups or tribes • Relevance of topic to community concerns • Research methods should be respectful of the local cultures. • Evidence of support from relevant cultural communities. • Identify potential negative consequences of the research. • Agreement with local groups about appropriate recruitment techniques, suitable information about the research and appropriate reporting of results.

36. Confidentiality Protection • Recognize confidentiality issues in • Initial study design • Identification, recruitment and consent processes for the study population • Security, analysis and final disposition of data • Publication or dissemination of data and results

37. Data Confidentiality • Avoid disclosing identifiable data • Use of surrogate subjects • Adequate physical structures • Protecting confidentiality of data – key element in minimizing risk

38. Data protection plan in the protocol • Minimize need to collect identifiable data • IRB review • Describe appropriate level of confidentiality based on potential magnitude of risk from disclosure. • Physical security of data – lock and key, data disposal • Social measures – people in the know • Confidentiality training for research team

39. Not all research require confidentiality • Observation of behavior in public places where there is no interaction with the researcher • Anonymous information • Consent agreement makes clear that research subjects do not seek or want confidentiality • Protocol makes clear to reviewers the nature of the consent form

40. Ethical Consent Process Recruitment Issues • How does a researcher gain access to a database of probable research participants? • What recruitment methods are used? • Personal contact • Recruiters • Power relationships between researcher and participants • Inducement to participate

41. Consent process in social science research • Full disclosure of confidentiality risks • Identifying who has access to database • Disclosure of psycho-social and economic risks • Identification of potential psychological stress • Disclosure of use of data and reporting methods (anonymize names of persons, places, organizations in the final report) • Withholding information • Debriefing

42. Need for second order consent • Second order consent Sample “You should be aware that to complete this study, the investigator cannot inform you of all its details. For this reason, certain details have been left out of the description of the study. However, the investigator will be happy to explain these details to you at the end of the study. You are free to choose not to participate and your refusal will not be held against you.” (Wendler, 1996)

43. Consent from secondary subjects • Secondary subjects are persons about whom information is derived from primary subjects • Consent has to be obtained from secondary subjects

44. Community research Examine community involvement and impact • Community participation • Local involvement • Local capability building • Benefit to local communities • Availability of study results

45. Publication: Privacy and Confidentiality Issues • Identifying information should not be published (written descriptions, photographs, and pedigrees unless • Essential for scientific purposes • Patient (or parent or guardian) gives written informed consent for publication. • Patient who is identifiable should be shown the manuscript to be published. • If informed consent has been obtained it should be indicated in the published article.

46. Social research requires technical rigor and ethical soundness.