You are hereBiblio / Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial
Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial
| Title | Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial |
| Publication Type | Journal Article |
| Year of Publication | 2005 |
| Authors | Sabik, Lindsay, Pace Christine A., Forster-Gertner Heidi P., Wendler David, Bebchuk Judith D., Tavel Jorge A., McNay Laura A., Killen Jack, Emanuel Ezekiel J., and Grady Christine |
| Journal | IRB: Ethics & Human Research |
| Volume | 27 |
| Issue | 5 |
| Pagination | 13-18 |
| Type of Article | Article |
| Publication Language | eng |
| ISSN Number | 01937758 |
| Accession Number | 18484465 |
| Keywords | Clinical , Human , Informed , INTERLEUKINS , MEDICINE , SURVEYS |
| Abstract | The article focuses on a survey of multinational sample of investigators, which determines how much time they dedicate to the consent process, what aspects of the clinical trials they emphasize during the consent process, and what they think about the effectiveness of that process. Although nearly 90% said they would have included the rare risk of death from Interleukin-2 in the written consent materials, only 46% reported discussing the risk of death with potential subjects. Investigators may have found talking about death and other serious side effects to be stressful or uncomfortable because enrollees had to be relatively healthy, and most were asymptomatic. |
| Notes | Sabik, Lindsay 1 Pace, Christine A. Forster-Gertner, Heidi P. Wendler, David 2 Bebchuk, Judith D. 3 Tavel, Jorge A. 4 McNay, Laura A. 5 Killen, Jack 6 Emanuel, Ezekiel J. 7 Grady, Christine 8; Affiliation: 1: Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 2: Head, Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD. 3: Research Associate, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN. 4: Deputy Clinical Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. 5: Chief, Regulatory Compliance and Human Subjects Protection Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. 6: Director, Office of International Health Research in the National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, MD. 7: Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD. 8: Head, Section on Human Subjects Research, Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD.; Source Info: Sep/Oct2005, Vol. 27 Issue 5, p13; Subject Term: INFORMED consent (Medical law); Subject Term: SURVEYS; Subject Term: MEDICINE -- Research; Subject Term: CLINICAL trials; Subject Term: INTERLEUKINS; Subject Term: HUMAN experimentation in medicine; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 6p; Document Type: Article |
