| Title | Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions |
| Publication Type | Journal Article |
| Year of Publication | 2006 |
| Authors | Nowak, KS, Bankert, EA, Nelson, RM |
| Journal | Accountability in Research: Policies & Quality Assurance |
| Volume | 13 |
| Issue | 1 |
| Pagination | 11-24 |
| Type of Article | Article |
| Publication Language | eng |
| ISSN Number | 08989621 |
| Accession Number | 20491241 |
| Keywords | Clinical , ethics , Institutional , Medical , MEDICINE , multi-site , Pharmaceutical , professional , regional , research , VALUES |
| Abstract | The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. To remedy this, the authors of this article consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet™, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. |
| Notes | NOWAK, KRISTIN S. 1; BANKERT, ELIZABETH A. 1; NELSON, ROBERT M. 2; Email Address: nelsonro@email.chop.edu; Affiliations: 1: Dartmouth College, Hanover, New Hampshire, USA; 2: Department of Anesthesiology and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, USA, and Center for Research Integrity, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; Issue Info: Jan2006, Vol. 13 Issue 1, p11; Thesaurus Term: RESEARCH; Thesaurus Term: PROFESSIONAL ethics; Subject Term: CLINICAL trials; Subject Term: MEDICINE; Subject Term: MEDICAL ethics; Subject Term: ETHICS; Subject Term: VALUES; Author-Supplied Keyword: clinical research; Author-Supplied Keyword: Institutional Review Board; Author-Supplied Keyword: multi-site; Author-Supplied Keyword: multi-site research; Author-Supplied Keyword: pharmaceutical research; Author-Supplied Keyword: regional ethics organization; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 14p; Document Type: Article |
| DOI | 10.1080/08989620600588845 |
| Short Title | Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions |
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