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Protecting Human Subjects in the NIH's Intramural Research Program: A Draft Instrument to Evaluate Convened Meetings of its IRBs
| Title | Protecting Human Subjects in the NIH's Intramural Research Program: A Draft Instrument to Evaluate Convened Meetings of its IRBs |
| Publication Type | Journal Article |
| Year of Publication | 2006 |
| Authors | Wichman, Alison, Kalyan Dev N., Abbott Lura J., Wesley Robert, and Sandler Alan L. |
| Journal | IRB: Ethics & Human Research |
| Volume | 28 |
| Issue | 3 |
| Pagination | 7-10 |
| Type of Article | Article |
| Publication Language | eng |
| ISBN Number | 01937758 |
| Accession Number | 21160298 |
| Keywords | Government , Human , Institutional , National , PROCEDURE |
| 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 reviewing protocols at convened meetings. The authors outline a draft evaluation instrument that includes elements of IRB protocol review and meeting dynamics that promote implementation of the letter and intent of human subject protection regulations. |
| Notes | Wichman, Alison 1 Kalyan, Dev N. 2,3 Abbott, Lura J. 4 Wesley, Robert 5 Sandler, Alan L.; Affiliation: 1: Acting Director, Office of Human Subjects Research, Office of the Director, National Institutes of Health, Bethesda, MD 2: Columbia University Law School, New York, NY 3: Duke University School of Medicine, Durham, NC 4: Senior Health Science Administrator, Office of Human Subjects Research, Office of the Director, National Institutes of Health, Bethesda, MD 5: Staff Scientist at the Biostatistics Service, Clinical Center, Office of the Director, National Institutes of Health, Bethesda, MD; Source Info: May/Jun2006, Vol. 28 Issue 3, p7; Subject Term: INSTITUTIONAL review boards (Medicine); Subject Term: HUMAN experimentation in medicine -- Evaluation; Subject Term: PROCEDURE manuals; Subject Term: GOVERNMENT policy; Company/Entity: NATIONAL Institutes of Health (U.S.); Number of Pages: 4p; Document Type: Article |
