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- Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research
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Biblio - KBL781 - 2011-01-25 18:14
- Research involving the vulnerable sick.
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Authors: Weijer, C
Publication Type: Journal Article
Secondary Title: Accountability in Research
Abstract: Discusses challenges associated with research involving the vulnerable sick, including deciding who among the ill count as vulnerable, and the need to include protections, including enrolling subjects in a study only with a strong j...
Year: 1999
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11657560
DOI: 10.1080/08989629908573940Biblio - KBL781 - 2010-04-29 13:36
- The limitations of "vulnerability" as a protection for human research participants.
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Authors: Eckenwiler, L ; Levine, C ; Sugarman, Jeremy ; Hammerschmidt, D ; Faden, Ruth R. ; Grady, C
Publication Type: Journal Article
Secondary Title: American Journal of Bioethics
Abstract: This article examines the concept of vulnerability in research ethics, and discusses how different regulations and policy documents have dealt with the concept of vulnerability, either as an inability to give informed consent or emp...
Year: 2004
DOI: 10.1080/15265160490497083Biblio - KBL781 - 2010-04-29 13:34
- Biomedical research involving prisoners: ethical values and legal regulation.
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Authors: Gostin, LO
Publication Type: Journal Article
Secondary Title: JAMA: Journal of the American Medical Association
Abstract: Discusses the history , ethics and regulatory issues involved when using prisoners in biomedical research. Suggests safeguards that should be put in place to promote responsible research and to reduce risks to participating prisoner...
Year: 2007
URL: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=976413Biblio - KBL781 - 2010-04-29 13:33
- Mentally disabled research subjects. The enduring policy issues.
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Authors: Dresser, R
Publication Type: Journal Article
Secondary Title: JAMA
Abstract: The author explores how U.S. regulatory policy falls to resolve many ethical issues inherent in research involving mentally disabled adults, and the many areas that must be addressed by investigators and institutional review boards ...
Year: 1996
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=8667543Biblio - KBL781 - 2010-04-29 13:32
- ETHICS: The Ethics of International Research with Abandoned Children
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Authors: Millum, Joseph ; Emanuel, Ezekiel J.
Publication Type: Journal Article
Secondary Title: Science
Abstract: The article discusses the ethical issues, such as standards of care, informed consent, and posttrial benefits, which are posed in the context of substantial healthcare inequalities. It cited the Bucharest Early Intervention Project ...
Year: 2007
DOI: 10.1126/science.1153822Biblio - KBL781 - 2010-06-15 11:52
- Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research
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Authors: Schmidt, Matthias H. ; Downie, Jocelyn
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: In this article,the authors focus on recent information about the physical risks of pediatric magnetic resonance imaging research and highlight information gaps, and the potential dangers posed to children participating in this kid...
Year: 2009
DOI: 10.1080/08989620902984106Biblio - KBL781 - 2010-09-20 16:36
- The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research
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Authors: Kenny, Nuala ; D'Arcy, Ryan ; Hadskis, Michael ; Downie, Jocelyn ; Schmidt, Matthias H.
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: Neuroimaging research has brought major advances to child health and well-being. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of p...
Year: 2008
DOI: 10.1080/08989620801946917Biblio - KBL781 - 2010-09-20 16:33
- Vulnerable Subjects and Canadian Research Governance
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Authors: Wilson, Mark
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article focuses on research ethics and regulatory climate in Canada. The legal validity of research involving persons unable to provide consent is addressed in the article. The rights and welfare of research subjects have been h...
Year: 2005Biblio - KBL781 - 2010-09-28 14:29
- The Issue of Consent in Research that Administers Drugs of Addiction to Addicted Persons
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Authors: Hall, Wayne ; Carter, Adrian
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. the authors review the case for doin...
Year: 2008
DOI: 10.1080/08989620802388689Biblio - KBL781 - 2010-09-20 16:32
- Can Underpowered Clinical Trials Be Justified?
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Authors: Rosoff, Philip M.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article discusses several issues related to clinical trials. The goal of human clinical trials is to identify safe and effective therapies. To justify exposing individuals to the risks of new interventions physicians often balan...
Year: 2004Biblio - KBL781 - 2010-09-28 14:25
- Knowledge of Regulations Governing Pediatric Research: A Pilot Study
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Authors: Stroustrup, Annemarie ; Kornetsky, Susan ; Joffe, Steven
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article discusses the study on knowledge of regulations governing pediatric research protocols in the U.S. The study evaluated self-reported preparedness for clinical research review, both in general and with respect to pediatri...
Year: 2008Biblio - KBL781 - 2010-09-28 14:27
- The Research and Family Liaison: Enhancing Informed Consent
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Authors: Salas, Halle Showalter ; Aziz, Zuraya ; Villareale, Nanci ; Diekema, Douglas S.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article focuses on the establishment of the Research and Family Liaison (RFL) position and its role in enhancing the informed consent process when children are participants in medical research. It states that main function of RF...
Year: 2008Biblio - KBL781 - 2010-09-28 14:26
- SACHRP Recommendations for Review of Children's Research Requiring DHHS Secretary's Approval
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Authors: Fisher, Celia B. ; Kornetsky, Susan Z.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article focuses on the recommendations for the review of children's research requiring the United States Department of Health and Human Services (DHHS) Secretary's approval. If an Institutional Review Board (IRB) determines that...
Year: 2005Biblio - KBL781 - 2010-09-28 14:18
- Reformed Consent: Adapting to New Media and Research Participant Preferences
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Authors: Henry, James ; Palmer, Barton W. ; Palinkas, Lawrence ; Glorioso, Danielle Kukene ; Caligiuri, Michael P. ; Jeste, Dilip V.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article offers a description of the reaction and preference of a layperson who underwent a multimedia-aided consent process for a hypothetical clinical trial. It informs that the trial involved several participants who have seve...
Year: 2009Biblio - KBL781 - 2010-09-28 14:19
- Marginalized Populations and Drug Addiction Research: Realism, Mistrust, and Misconception
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Authors: Fisher, Celia B. ; Oransky, Matthew ; Mahadevan, Meena ; Singer, Merrill ; Mirhej, Greg ; Hodge, Derrick
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article examines the understanding of clinical trial information and expectations about randomized controlled trials in a population of active and recent drug users to participate in addiction research. It focuses on the commitm...
Year: 2008Biblio - KBL781 - 2010-09-28 14:18
- Québec Physicians' Knowledge and Opinions Regarding Substitute Consent for Decisionally Incapacitated Older Adults
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Authors: Bravo, Gina ; Dubois, Marie-France ; Pâquet, Mariane ; Langlois, Fabienne ; Bernier, Jean-Pierre
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: Focuses on the study determining the knowledge of the physicians regarding substitute consent for incapacitated adults in Quebec. Treatment of the patients suffering from cognitive diseases; Provisions of medical care; Lack of decis...
Year: 2004Biblio - KBL781 - 2010-09-28 14:15
- Informed Consent for Dementia Research: The Study Enrollment Encounter
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Authors: Kass, Nancy E. ; Black, Betty S. ; Rabins, Peter V. ; Fogarty, Linda A.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article reports on the increase in number of elders who are affected by dementia, a mental deterioration of organic or functional origin, in the U.S. This increase implies that there is a need for the development of treatment es...
Year: 2007Biblio - KBL781 - 2010-09-28 14:15
- The Conduct of Canadian Researchers and Institutional Review Boards Regarding Substituted Consent for Research
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Authors: Bravo, Gina ; Dubois, Marie-France ; Paquet, Mariane
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: Focuses on the growth in the number of individuals suffer from diseases that impair the decision-making capacity. Efforts of researchers to identify the causes of the diseases; Recognition of ethical dilemma that arises in conductin...
Year: 2004Biblio - KBL781 - 2010-09-28 14:15
- Confidentiality: More than a linkage file and a locked drawer
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Authors: Henderson, Gail E. ; Davis, Arlene M. ; Easter, Michele M.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article examines how researchers keep their promise of confidentiality and how that promise is sometimes challenged during primary data collection. It is noted that researchers promise confidentiality because their purpose is to...
Year: 2004Biblio - KBL781 - 2010-09-28 14:17
- Bipolar Mania and Capacity to Consent: Recommendations for Investigators and IRBs
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Authors: Misra, Sahana ; Rosenstein, Donald ; Socherman, Robert ; Ganzini, Linda
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article presents a review of research on the decisional capacity of patients with mental health disorders, discusses how mania characteristics may affect research participation and provides recommendations for investigators and ...
Year: 2010Biblio - KBL781 - 2010-09-28 14:23
- Are the New EPA Regulations Concerning Intentional Exposure Studies Involving Children Overprotective?
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Authors: Resnik, David B.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The author focuses on the U.S. Environmental Protection Agency (EPA) towards its new regulations regarding research using human subjects in the U.S. He sights several problems regarding the new regulations and concerns towards child...
Year: 2007Biblio - KBL781 - 2010-09-28 14:25
- Does Size Matter?: Salience of Follow-Up Payments in Drug Abuse Research
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Authors: Rosenwasser, Beth J. ; Marlowe, Douglas B. ; Dugosh, Karen L. ; Festinger, David S. ; Croft, Jason R.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article reports on the payment incentives to compensate participants for their time and effort in a drug abuse research in the U.S. It is stated that the scheme has increased their participation in the research by encouraging th...
Year: 2007Biblio - KBL781 - 2010-09-28 14:16
- Complex Considerations
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Publication Type: Case Study
Abstract: This case discusses issues related to the testing of pharmacologic agents in children specifically problems associated with inadequate studies in children and concerns with designing trials involving the pediatric population....
Year: 1999
URL: http://www.onlineethics.org/Resources/Cases/complexcon.aspxBiblio - KBL781 - 2010-10-22 11:42
- Ethical Issues in Research with Children
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Publication Type: Case Study
Abstract: Case that discusses issues of researcher obligations, the role of informed consent, developmental factors; and options of action available to researchers who discover that minors may be in jeopardy....
Year: 1999
URL: http://www.onlineethics.org/Resources/Cases/children.aspxBiblio - KBL781 - 2010-10-22 11:43
