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Research with high-risk populations : balancing science, ethics, and law

Authors: Fisher, Celia B. ; Buchanan, David Ross ; Gable, Lance
Publication Type: Book
Abstract: This book offers social scientists regarding their ethical and legal responsibilities to respond appropriately to threats of harm that may arise during the course of data collection, especially when dealing with high-risk population...
Year: 2009

Biblio - KBL781 - 2010-07-14 13:36

Balancing Uncertain Risks and Benefits in Human Subjects Research

Authors: Barke, Richard
Publication Type: Journal Article
Secondary Title: Science, Technology & Human Values
Abstract: Composed of scientific and technical experts and lay members, thousands of research ethics committees—Institutional Review Boards (IRBs) in the United States—must identify and assess the potential risks to human research subjects, a...
Year: 2009
DOI: 10.1177/0162243908328760

Biblio - KBL781 - 2010-08-23 14:53

Data Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability

Authors: Tereskerz, Patricia M.
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: This article looks at some of the challenges facing data safety monitoring boards (DSMBs), especially with the increased risk of litigation surrounding human subject research. The author provides a legal and accountability analysis ...
Year: 2010
DOI: 10.1080/08989620903520313

Biblio - KBL781 - 2010-09-20 16:37

Incidental Findings: A Common Law Approach

Authors: Tovino, Stacey A.
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: This article discusses the current lack of federal regulations to address incidental neuroimaging findings of human research participants,and if researcher has an affirmative legal cuty to seek, detect, and report incidental finding...
Year: 2008
DOI: 10.1080/08989620802388705

Biblio - KBL781 - 2010-09-20 16:37

Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research

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: 10.1080/08989620902984106

Biblio - KBL781 - 2010-09-20 16:36

What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment

Authors: Pierce, Robin
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: Deception in human subject research is neither uncommon nor prohibited, though its use in the recruitment phase of clinical research has received relatively little attention. Using the example of prodromal psychosis, this article ex...
Year: 2008
DOI: 10.1080/08989620802388713

Biblio - KBL781 - 2010-09-20 16:35

Disclosure Issues in Neuroscience Research

Authors: Parker, Lisa S. ; Kienholz, Michelle L.
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: The authors discuss issues of disclosure arise in neuroscientific research, and how the possibility of disclosure of incidental findings and/or research results may raise informational expectations on the part of subjects and may al...
Year: 2008
DOI: 10.1080/08989620802388697

Biblio - KBL781 - 2010-09-20 16:35

Key Personnel and “Long Distance” Settings: Determining Who Must Report Financial Conflict of Interest

Authors: Lynch, John ; Lindsell, Christopher J.
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: This essay explores how individuals beyond scientists can have conflicts of interest involved in research that includes human subjects. This essay asks, for personnel who enroll subjects at a physical and organizational remove from ...
Year: 2010
DOI: 10.1080/08989621.2010.493096

Biblio - KBL781 - 2010-09-20 16:34

Offering Results to Research Subjects: U.S. Institutional Review Board Policy

Authors: Kozanczyn, Christa ; Collins, Katie ; Fernandez, Conrad V.
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: Background: This study aims to determine the nature of United States Institutional Review Board (IRB) policy in a broad spectrum of research settings regarding the return of results to study participants. The researchers found a mar...
Year: 2007
DOI: 10.1080/08989620701670179

Biblio - KBL781 - 2010-09-20 16:34

The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research

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: 10.1080/08989620801946917

Biblio - KBL781 - 2010-09-20 16:33

The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

Authors: Borenstein, Jason
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research ...
Year: 2008
DOI: 10.1080/08989620802201866

Biblio - KBL781 - 2010-09-20 16:32

Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs

Authors: Amin, Sanjiv B. ; McDermott, Michael P. ; Shamoo, Adil E.
Publication Type: Journal Article
Secondary Title: Accountability in Research: Policies & Quality Assurance
Abstract: The use of drugs for indications unapproved by the Food and Drug Administration, often called “off-label use,” is widespread in children and neonates, and presents ethical and safety challenges. Since the passage of the Best Pharmac...
Year: 2008
DOI: 10.1080/08989620802194392

Biblio - KBL781 - 2010-09-20 16:32

Untapped Potential: IRB Guidance for the Ethical Research Use of Stored Biological Materials

Authors: Wolf, Leslie E. ; Lo, Bernard
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: Focuses on the use of biological materials in various research in the U.S. Determination on the factors causing the increase of mortality rate in the country; Awareness on the causes of rheumatoid arthritis; Ways of improving the gu...
Year: 2004

Biblio - KBL781 - 2010-09-28 14:29

Vulnerable Subjects and Canadian Research Governance

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: 2005

Biblio - KBL781 - 2010-09-28 14:29

IRB Policies Regarding Finder's Fees and Role Conflicts in Recruiting Research Participants

Authors: Wolf, Leslie E.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article reports on institutional review board (IRB) policies on finder's fees and role conflicts in recruiting research participants in the U.S. It focuses on financial conflicts which may arise in clinical research. Related top...
Year: 2009

Biblio - KBL781 - 2010-09-28 14:29

The Issue of Consent in Research that Administers Drugs of Addiction to Addicted Persons

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: 10.1080/08989620802388689

Biblio - KBL781 - 2010-09-20 16:32

Research on Stored Biological Samples: The Views of Ugandans

Authors: Emanuel, Ezekiel ; Wendler, David ; Maiso, Faustine ; Grady, Christine ; Talisuna, Ambrose O. ; Pace, Christine A.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article focuses on the scientific value of human biological samples obtained in the course of clinical research. The collection and storage of biological samples obtained from individuals in Africa is thought to be especially wo...
Year: 2005

Biblio - KBL781 - 2010-09-28 14:28

Protecting Human Subjects in the NIH's Intramural Research Program: A Draft Instrument to Evaluate Convened Meetings of its IRBs

Authors: Kalyan, Dev N. ; Sandler, Alan L. ; Wichman, Alison ; Abbott, Lura J. ; Wesley, Robert
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article presents a study of to develop a draft instrument for evaluating how the National Institutes of Health's Institutional Review Boards (IRB) apply ethical guidelines, regulatory requirements, and policies and procedures in...
Year: 2006

Biblio - KBL781 - 2010-09-28 14:29

Consent and Population Genomics: The Creation of Generic Tools

Authors: Wallace, Susan ; Lazor, Stephanie ; Knoppers, Bartha Maria
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article describes the work of the Public Population Project in Genomics (P3G) Consortium5 in creating aid in the harmonization of consent procedures across member organizations. It highlights that (P3<...
Year: 2009

Biblio - KBL781 - 2010-09-28 14:28

The Antidepressant Debate and Ethically Defensible Placebo-Controlled Trials

Authors: Waring, Duff R.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article discusses the ethical issue involved in the argument concerning the utilization of placebo in conducting randomized clinical trials for antidepressant drugs. It states that the debate centers on the effectiveness and rel...
Year: 2008

Biblio - KBL781 - 2010-09-28 14:28

Research Ethics Consultation at the Johns Hopkins Bloomberg School of Public Health

Authors: Taylor, Holly A. ; Kass, Nancy E.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article offers a description of the Research Ethics Consulting Service (RECS) launched at the Johns Hopkins Bloomberg School of Public Health (JHSPH) in the U.S. It highlights that RECS is a components of the JHSPH Office for th...
Year: 2009

Biblio - KBL781 - 2010-09-28 14:27

Respondent Burden in Clinical Research: When Are We Asking Too Much of Subjects?

Authors: Ulrich, Connie M. ; Wallen, Gwenyth R. ; Feister, Autumn ; Grady, Christine
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: Comments that the field of bioethics has not clearly identified or articulated the problem of respondent burden in clinical trials. Reluctance of health care providers to approach their patients for inclusion in clinical trials beca...
Year: 2005

Biblio - KBL781 - 2010-09-28 14:28

Protecting Third Parties in Human Subjects Research

Authors: Resnik, David B. ; Sharp, Richard R.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article focuses on how to protect third parties from potential risk in a human subject research. The third parties in a research are those who directly affected in the procedures of the research but they are neither the research...
Year: 2006

Biblio - KBL781 - 2010-09-28 14:25

Contraception in Research:A Policy Suggestion

Authors: Schonfeld, Toby L. ; Gordon, Bruce G.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: The article discusses the reasons for exclusion of women from participation in pharmacological research. There have been two prime concerns that have contributed to this exclusion, firstly, the difference in women's physiology intro...
Year: 2005

Biblio - KBL781 - 2010-09-28 14:26

Research with Victims of Disaster: Institutional Review Board Considerations

Authors: Collogan, Lauren K. ; Tuma, Farris K. ; Fleischman, Alan R.
Publication Type: Journal Article
Secondary Title: IRB: Ethics & Human Research
Abstract: Focuses on the research determining the effects of traumatism to several patients in the U.S. Assessment on the survival level of the victims; Description on the physical condition of the patients; Factors affecting the quality of l...
Year: 2004

Biblio - KBL781 - 2010-09-28 14:16