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  1. Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?Scott Burris & Corey Davis - 2009 - American Journal of Bioethics 9 (11):48-54.
    Assessing social risks has proven difficult for IRBs. We undertook a novel effort to empirically investigate social risks before an HIV prevention trial among drug users in Thailand and China. The assessment investigated whether law, policies and enforcement strategies would place research subjects at significantly elevated risk of arrest, incarceration, physical harm, breach of confidentiality, or loss of access to health care relative to drug users not participating in the research. The study validated the investigator's concern that drug users were (...)
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  • Human participants challenges in youth tobacco cessation research: Researchers' perspectives.Kathleen R. Diviak, Susan J. Curry, Sherry L. Emery & Robin J. Mermelstein - 2004 - Ethics and Behavior 14 (4):321 – 334.
    Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment (...)
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