Kowalski C.J, Hewett J.L.
Article Type: Brief article
Subject: Medical research (Safety and security measures)
Medicine, Experimental (Safety and security measures)
Medical protocols (Evaluation)
Informed consent (Medical law) (Laws, regulations and rules)
Patients (Care and treatment)
Patients (Safety and security measures)
Data security (Laws, regulations and rules)
Pub Date: 05/01/2010
Publication: Name: IRB: Ethics & Human Research Publisher: Hastings Center Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2010 Hastings Center ISSN: 0193-7758
Issue: Date: May-June, 2010 Source Volume: 32 Source Issue: 3
Topic: Event Code: 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime; 260 General services Advertising Code: 94 Legal/Government Regulation Computer Subject: Government regulation; Data security issue
Product: Product Code: 8000200 Medical Research; 9105220 Health Research Programs; 8000240 Epilepsy & Muscle Disease R&D; 9916270 Data Processing Security NAICS Code: 54171 Research and Development in the Physical, Engineering, and Life Sciences; 92312 Administration of Public Health Programs
Accession Number: 239462731
Full Text: Kowalski CJ, Hewett JL. Data and safety monitoring boards: Some enduring questions. Journal of Law, Medicine, and Ethics 2009:37(3)496-506. * Kowalski and Hewett criticize the increasing use, role, and power of Data Safety and Monitoring Boards (DSMBs), in particular the exclusion of investigators from membership on such boards and the withholding of incremental data pertaining to the efficacy and safety of treatments from participants and physicians responsible for the treatment of these individuals. They suggest that more, not less, communication between researchers and subjects is best for protecting human subjects and helping to preserve trust between all parties involved in research. Although they acknowledge that DSMBs will not disappear, they insist that IRBs explicitly detail the existence and function of DSMBs in informed consent procedures and that principal investigators be involved in the formulation and preservation of appropriate study protocols.
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