caa a22 4500 477139957 CHVBK 20180405111729.0 cr unu---uuuuu 170330e19970901xx s 000 0 eng 10.1007/BF01105559 doi (NATIONALLICENCE)springer-10.1007/BF01105559 Ethical considerations in neuroclinical trials [Elektronische Daten] [Stephen Macciocchi, Wayne Alves] Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. Ethical concepts applicable to Neuroctinical Trials (NCT) are reviewed. The discussion is directed towards ethical concerns that investigators must consider and justify prior to Institutional Review Board (IRB) submission. Risk-benefit analysis, methodology (randomization; placebo; design) and consent (informed; deferred; waived) are reviewed and Office for Protection from Research Risk (OPRR) guidelines are described. Our confusions: Investigators proposing NCT face increasing ethical scrutiny by IRBs. Attention to ethical issues early in trial planning process is recommended. Walter de Gruyter & Co., 1997 Clinical trials nationallicence informed consent nationallicence risk-benefit analysis nationallicence Macciocchi Stephen Department of Physical Medicine and Rehabilitation, University of Virginia Medical School, Charlottesville, Virginia, USA aut Alves Wayne Department of Neurosurgery, University of Virginia Medical School, Charlottesville, Virginia, USA aut Neurosurgical Review Springer-Verlag 20/3(1997-09-01), 161-170 0344-5607 20:3<161 1997 20 10143 https://doi.org/10.1007/BF01105559 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF01105559 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Macciocchi Stephen Department of Physical Medicine and Rehabilitation, University of Virginia Medical School, Charlottesville, Virginia, USA aut NATIONALLICENCE 700 1- Alves Wayne Department of Neurosurgery, University of Virginia Medical School, Charlottesville, Virginia, USA aut NATIONALLICENCE 773 0- Neurosurgical Review Springer-Verlag 20/3(1997-09-01), 161-170 0344-5607 20:3<161 1997 20 10143 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer