Consider this paradox: if a physician reads a case report abouta novel method of ventilation for critically ill patients andwants to try it in the next several patients with respiratoryfailure he or she treats, the physician may do so provided thepatients have given general consent for treatment. On the otherhand, if a physician is interested in performing a randomized,controlled trial to determine rigorously which of two widelyused antibiotics is more effective at treating bronchitis, heor she must prepare a formal protocol, obtain approval fromthe institutional review board, and seek written informed . . . [Full Text of this Article]
Address reprint requests to Dr. Truog at the MICU, Children's Hospital FA-108, Boston, MA 02115.
Buchanan, D., Sifunda, S., Naidoo, N., James, S., Reddy, P.
(2008). Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight. Public Health Ethics
0: phn027v1-phn027
[Abstract][Full Text]
Byrne, M. M., Thompson, P.
(2006). Collective equipoise, disappointment, and the therapeutic misconception: on the consequences of selection for clinical research.. Med Decis Making
26: 467-479
[Abstract]
Morley, C J, Lau, R, Davis, P G, Morse, C
(2005). What do parents think about enrolling their premature babies in several research studies?. Arch. Dis. Child. Fetal Neonatal Ed.
90: F225-f228
[Abstract][Full Text]
(2004). The Ethical Conduct of Clinical Research Involving Critically Ill Patients in the United States and Canada: Principles and Recommendations. Am. J. Respir. Crit. Care Med.
170: 1375-1384
[Full Text]
Gammelgaard, A, Mortensen, O S, Rossel, P
(2004). Patients' perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial. Heart
90: 1124-1128
[Abstract][Full Text]
Kodish, E., Eder, M., Noll, R. B., Ruccione, K., Lange, B., Angiolillo, A., Pentz, R., Zyzanski, S., Siminoff, L. A., Drotar, D.
(2004). Communication of Randomization in Childhood Leukemia Trials. JAMA
291: 470-475
[Abstract][Full Text]
Lo, B., Groman, M.
(2003). Oversight of Quality Improvement: Focusing on Benefits and Risks. Arch Intern Med
163: 1481-1486
[Abstract][Full Text]
Foëx, B A
(2001). The problem of informed consent in emergency medicine research. Emerg. Med. J.
18: 198-204
[Abstract][Full Text]
Emanuel, E. J., Wendler, D., Grady, C.
(2000). What Makes Clinical Research Ethical?. JAMA
283: 2701-2711
[Abstract][Full Text]
Casarett, D., Karlawish, J. H. T., Sugarman, J.
(2000). Determining When Quality Improvement Initiatives Should Be Considered Research: Proposed Criteria and Potential Implications. JAMA
283: 2275-2280
[Abstract][Full Text]
Kagarise, M. J., Sheldon, G. F.
(2000). Translational Ethics: A Perspective for the New Millennium. Arch Surg
135: 39-45
[Abstract][Full Text]
Woodward, B.
(1999). Challenges to Human Subject Protections in US Medical Research. JAMA
282: 1947-1952
[Abstract][Full Text]
Carome, M. A., Grodin, M. A., Dresser, R., Johnson, J. R., Silverman, H., King, N. M.P., Churchill, L. R., Tenery, R. M., Truog, R. D., Robinson, W., Morris, A. H.
(1999). Is Informed Consent Always Necessary for Randomized, Controlled Trials?. NEJM
341: 448-450
[Full Text]