Results 11 to 20 of about 317,032 (210)

The National Ethics Committee: a truly valuable asset for clinical trials? [PDF]

, 2017
Advances in biomedicine, increased patient autonomy, and higher average life expectancy, have contributed to raising a multitude of questions relating to Clinical Ethics.
Campanozzi, Laura Leontina, Pirillo, Isabel, Ricci, Giovanna   +2 more
core   +1 more source

On-site monitoring of clinical trials by an Ethics Committee in India: a road less travelled

Research Ethics Review, 2021
Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees
Nusrat Shafiq, Savita Kumari, Vivek Kumar, Vinita Suri, Muralidharan Jayashree, Ajay Duseja, Arun Bansal, Samir Malhotra   +7 more
doaj   +1 more source

Human neural stem cell transplantation in ALS: initial results from a phase I trial [PDF]

, 2015
We report the initial results from a phase I clinical trial for ALS. We transplanted GMP-grade, fetal human neural stem cells from natural in utero death (hNSCs) into the anterior horns of the spinal cord to test for the safety of both cells and ...
Bernardini, Laura, Bersano, Enrica, Binda, Elena, Boulis, Nicholas M, Cantello, Roberto, Carletti, Sandro, Carriero, Alessandro, Cerino, Annalisa, Cima, Valentina, Cisari, Carlo, Domenico, Frondizi, Ferrari, Daniela, Gaiani, Alessandra, Gelati, Maurizio, Giorgi, Cesare, Glass, Jonathan, Maglione, Annamaria, Masiero, Stefano, Massara, Maurilio, Mazzini, Letizia, Muzi, Gianmarco, Nasuelli, Nicola, Novelli, Antonio, Petruzzelli, Francesco, Prandi, Paolo, Profico, Daniela Celeste, Projetti Pensi, Massimo, Querin, Giorgia, Ricciolini, Claudia, Rota Nodari, Laura, Sarnelli, Maria Francesca, Servo, Serena, Sgaravizzi, Giada, Soraru', Gianni, Spera, Cristina, Stecco, Alessandro, Torres, Barbara, Trombetta, Domenico, Vescovi, Angelo L., Visioli, Alberto, Zalfa, Cristina   +40 more
core   +2 more sources

Exempting low-risk health and medical research from ethics reviews: Comparing Australia, the United Kingdom, the United States and the Netherlands [PDF]

, 2020
Background: Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and ...
Glasziou, Paul, Hammatt, Zoë, Kolstoe, Simon, Ploem, M. C.(corrette), Scott, Anna Mae   +4 more
core   +2 more sources

Research ethics committees: agents of research policy?

Health Research Policy and Systems, 2005
The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials.
Hemminki Elina
doaj   +1 more source

Prevalence, characteristics, and publication of discontinued randomized trials. [PDF]

, 2014
IMPORTANCE: The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear.
Akl, E.A., Amstutz, A., Bassler, D., Bengough, T., Blümle, A., Briel, M., Bucher, H.C., Burnand, B., Busse, J.W., Carrasco-Labra, A., Ebrahim, S., Faulhaber, M., Ferreira-González, I., Gloy, V., Guyatt, G.H., Hemkens, L.G., Johnston, B.C., Kasenda, B., Lamontagne, F., Meerpohl, J.J., Mertz, D., Moja, L., Mulla, S.M., Neumann, I., Nordmann, A., Raatz, H., Rosenthal, R., Saccilotto, R., Schandelmaier, S., Schwenkglenks, M., Stegert, M., Tikkinen, K.A., Tomonaga, Y., Vandvik, P.O., von Elm, E., Walter, M.A., Xin, S., You, J.   +37 more
core   +3 more sources

Developing clinical ethics committees [PDF]

Clinical Medicine, 2004
Formal clinical ethics review first developed in the USA and most hospitals there have structures in place. This is often a clinical ethics committee. Developments have been slower in the UK, where there has been uncertainty and variability about the role of clinical ethics committees. Even in the USA, their exact role is uncertain.
openaire   +2 more sources

Study protocol for a prospective, non-controlled, multicentre clinical study to evaluate the diagnostic accuracy of a stepwise two-photon excited melanin fluorescence in pigmented lesions suspicious for melanoma (FLIMMA study) [PDF]

, 2016
Introduction: Non-invasive, nanosecond, stepwise two-photon laser excitation of skin tissue was shown to induce melanin fluorescence spectra that allow for the differentiation of melanocytic nevi from cutaneous melanoma.
Fink, Christine, Forschner, Andrea, Garbe, Claus, Haenssle, Holger A., Hofmann, Maja, Jagoda, Agata, Leupold, Dieter, Lomberg, Diana, Spaenkuch, Iris, Tampouri, Ioanna   +9 more
core   +1 more source

Core competencies for clinical ethics committees [PDF]

Clinical Medicine, 2010
Clinical ethics committees (CECs) are increasing in number in the UK and have mostly developed in response to local interest, as opposed to being mandated as in the USA. However, there is no regulatory framework for UK CECs with no defined educational requirements or specification of core competencies for their members.
Victor, Larcher, Anne-Marie, Slowther, Alan R, Watson   +2 more
openaire   +2 more sources

Should Research Ethics Encourage the Production of Cost-Effective Interventions? [PDF]

, 2016
This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness.
A Briggs, A Fleischman, A Rid, AD Paltiel, AJ London, AJ London, AM Garber, AS Kesselheim, C Grady, CC Denny, D Barnbaum, D Mortimer, D Wendler, DA Hyman, DB Resnik, DJ Torgerson, DM Dimichele, DR Buchanan, E Frank, ED Prentice, EE Roughead, EJ Emanuel, EJ Emanuel, EJ Emanuel, EJ Emanuel, EJ Emanuel, F Baylis, FA Lederle, G Yamey, GA Cohen, GR Wilensky, H Grabowski, HF Lynch, HG Frankfurt, HJ Curzer, I Rudan, J Cohen, J Dowie, J Harris, J McMahan, JA Tobert, JC Lindsey, JW Berg, L Bojke, LP Garrison Jr, M Angell, M Limb, MF Drummond, MJ Mehlman, MS Mano, N Daniels, NMP King, NMP King, PA Ubel, PJ Neumann, PJ Neumann, PR Orszag, PR Orszag, PT Menzel, PT Menzel, PT Menzel, R Dresser, RA Epstein, RA Rettig, RA Spinello, RK Lie, RL Fleurence, S Batt, S Joffe, S Palmer, S Thomson, S Woods, SE Weinberger, SK Shah, T Fojo, T Hurka, T Schrecker, TJ Zywicki, U Schüklenk, WC Black, Z Kmietowicz   +80 more
core   +1 more source