Presentation on theme: "ETHICS REVIEW – WHAT AND WHY? Briefing on the process of ethics review September 2013 Dept of Sociology, NUS."— Presentation transcript:
ETHICS REVIEW – WHAT AND WHY? Briefing on the process of ethics review September 2013 Dept of Sociology, NUS
What is the ethics review? The ethics review of your research proposal takes place only if you involve human subjects. The ethics review focuses on two main related principles: the protection of research subjects and informed consent.
How does the IRB define “Research”? IRB defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The intention to contribute to generalizable knowledge usually implies the publication of a paper from the study in a professional journal or a presentation of the research in an international conference.
Who needs to apply? Any research that may be published must go through DERC clearance. If it also involves vulnerable populations or possibility of risk to subjects, we will then advise you on your further application to IRB. [n.b.: All Masters/Ph.D. students should be expecting to publish]. If you are not intending to publish, you do not require IRB clearance, even if your research involves vulnerable populations or the possibility of risk to subjects. However, if your research does involve vulnerable popns or risk, you should take special care to discuss ethical aspects thoroughly with your supervisor, who will help you decide if the research is appropriate for Honours level or not. .
Honours students: Hons students not intending to publish do not need to go through DERC review. [To date, most HTs have not been published, but some have!] If you have any thought of publishing, please do apply to DERC, because publisher may ask to see proof that research went through ethical review – a problem if it didn’t! Either way, and especially if there is any possible risk to subjects, or vulnerable populations are involved, you should give serious consideration to the ethical aspects of your research, and discuss them thoroughly with your supervisor. Even if not publishing, DERC will be happy to offer further advice if you or yr supervisor have any concerns.
Background: Ethical review procedures have grown out of a concern to protect people in general, and vulnerable populations especially. In the past, some harmful and irresponsible medical experiments targeted such groups without telling them what the research was really about.
Read more about the history behind the need for ethical review: The Nuremberg Code 1949 (Directives for Human Experimentation) – a reaction to cruel and immoral medical experiments conducted by Nazi doctors like Joseph Mengele in concentration camps during WWII: http://ohsr.od.nih.gov/guidelines/nuremberg.html The Tuskegee Syphilis Experiment (Alabama, USA, 1932- 72) leading to The Belmont Report 1974; even worse US experiments w. prisoners, soldiers, and mental patients in Guatemala (1946-48), revealed only in 2010! ) http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment NUS article on ethics guidelines: http://www.cdtl/nus.edu.sg/link/Jul2002/sg1.htm
What is the NUS definition of ‘vulnerable populations’? Students, subordinate populations Medical patients People with limited citizenship protections (e.g. migrant workers) People engaged in illegal activities Pregnant women The educationally disadvantaged People with mental disabilities Children and youth (n.b. very strong reasons why sociological research with children is urgently needed, and it can be done ethically!)
If you are doing [publishable] research with a vulnerable population, you must have your research supervisor included as Co-PI (Principal Investigator). After DERC has reviewed your proposal, it will send it to IRB with a recommendation (either for ‘full review’, or ‘expedited review’). If research is low-risk, but on a vulnerable population, and you intend to publish, it would still go through IRB. DERC can approve research with low-risk, non-vulnerable populations without reference to IRB (at all levels including Masters and PhD research).
Protection of Research Subjects Does the study uphold the human subjects’ right to privacy and autonomy? What is the level of risk that subjects may face? How would the study benefit research subjects? How does the study contribute to knowledge in the social sciences?
Subjects’ right to privacy and autonomy: (1)Confidentiality of information collected from subjects needs to be guaranteed. HOW? (a)Omitting personal identification of research subjects or recording only personal identification that is absolutely necessary. (b)De-linking personal identifiers of each subject from your data on that subject and using code numbers or pseudonyms. (c)Destroying information on subjects’ identifiers as soon as possible (store safely meanwhile). (n.b. there may be instances where anonymity is less desirable/essential, or impossible to guarantee.)
Subjects’ right to privacy and autonomy: (2) AUTONOMY Respect for the subjects’ autonomy is a fundamental principle in research ethics and it is implemented by the principle of INFORMED CONSENT. HOW? Subjects must be given full information on what the research entails for them so that they can make an informed and autonomous decision on whether to participate or not to participate in your study. Use the Participant Information Sheet (PIS) and Consent Form (CF).
Subjects’ right to privacy and autonomy: (3) What if I want to do research online? This raises a whole lot of new and interesting questions! Private/public distinctions are not always clear; be aware that protecting confidentiality may be much trickier. Below are some links to discussions of internet ethics: http://www.nyu.edu/projects/nissenbaum/ethics_elg_full.html http://cfi.au.dk/en http://eresearch-ethics.org/position/internet-research-ethics-revisiting- the-relations-between-technologies-spaces-texts-and-people/ http://www.cc.gatech.edu/~asb/ethics/
What is the level of risk that subjects may face by participating in your study? Risk refers to the type and magnitude of harm that the study may inflict on human subjects. Defined as three levels: More than minimal risk Minimal risk Less than minimal risk
Examples of real or potential harm: Subjects are observed without their knowledge while involved in what they consider a personal and private activity Interviews include topics and questions that cause extreme anxiety and/or distress to subjects Subjects are asked questions on sensitive topics and their answers are recorded with their personal identifiers Subjects are promised confidentiality but they are asked to disclose their personal beliefs and opinions in a public setting, e.g. focus group discussion, third parties present.
How would the study benefit research subjects? Consider carefully the standard answer: “no benefit to subjects but benefit to ‘society’ or ‘the public’” Is this answer true in your case?
How does the study contribute to knowledge in the social sciences? From a knowledge perspective, a social science study is ethically justified if, while protecting subjects from harm, it contributes in some way to the welfare of humanity and/or to the advancement of knowledge in one or more of the social sciences. Requirements: Solid conceptual justification Appropriate and well- designed methodology
DERC Application Form The DERC Application Form is a tool designed to assist you, the researcher, to protect your intended research subjects from harm by designing your study systematically and appropriately. The DERC Application Form assists you by asking you relevant questions.
Step by step explanation of how to complete the forms The DERC Application Form The Participant Information Sheet (PIS) The Consent Form (CF) (Download them from the DERC website: http://www.fas.nus.edu.sg/soc/derc/homehttp://www.fas.nus.edu.sg/soc/derc/home )
For a general discussion of social research ethics, see: Earl Babbie (2001), The Practice of Social Research (9 th Edn). Ch. 18: The Ethics and Politics of Social Research. Pp. 468-88. (Belmont, CA: Wadsworth)
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