Are we keeping research participants safe enough?

PC Hébert, DA Fergusson - CMAJ, 2010 - Can Med Assoc
There is no question that research participants need protection. But regulations have grown
so burdensome that they are overwhelming the very things they are meant to support and …

[HTML][HTML] Protecting patients in ongoing clinical trials

M Shuchman - 2010 - Can Med Assoc
Canada's largest clinical research firms, alleging he'd been injured after participating in a
clinical trial three years earlier. Dennis, of Drummondville, Quebec, ingested a trial drug as …

Enhancing the scientific integrity and safety of clinical trials: Recommendations for data monitoring committees

RJ Lewis, KA Calis, DL DeMets - JAMA, 2016 - jamanetwork.com
The risks of participatinginaclinicaltrialcannotbepre-dicted with certainty at the time of trial
design, especially when evaluating novel therapies. Accordingly, once the trial is initiated …

[HTML][HTML] Dances with the pharmaceutical industry

E Gibson, F Baylis, S Lewis - Cmaj, 2002 - Can Med Assoc
CMAJ• FEB. 19, 2002; 166 (4) 449 ing Director of the Joint Centre for Bioethics at the
University of Toronto, and Bartha Knoppers, an expert in health law and policy from …

Toward protecting the safety of participants in clinical trials

RM Califf, MA Morse, J Wittes, SN Goodman… - Controlled clinical …, 2003 - Elsevier
It is a widely held belief that the current system of oversight of clinical research, particularly
the means of assessing risks and minimizing harms to participants in clinical trials, could be …

How should adverse events be reported in US clinical trials?: ethical considerations

AE Shamoo, LI Katzel - Clinical Pharmacology & Therapeutics, 2008 - Wiley Online Library
Research with human subjects, including clinical trials, forms the cornerstone of the
development of knowledge on the safety and efficacy of potential drugs and devices. During …

Appraising harm in phase I trials: healthy volunteers' accounts of adverse events

L McManus, A Davis, RL Forcier… - The Journal of Law …, 2019 - journals.sagepub.com
While risk of harm is an important focus for whether clinical research on humans can and
should proceed, there is uncertainty about what constitutes harm to a trial participant. In …

[HTML][HTML] Canada's new ethical guidelines for research with humans: a critique and comparison with the United States

J Millum - CMAJ, 2012 - Can Med Assoc
© 2012 Canadian Medical Association or its licensors CMAJ, April 3, 2012, 184 (6) 657
government or regulatory approval of new drugs and devices is sought. Again, this differs …

Ensuring respect for human research participants: institutional review boards and sharing results from research

SN Doernberg, D Wendler - JAMA, 2016 - jamanetwork.com
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that
investigators report summary results of eligible clinical trials to ClinicalTrials. gov within 1 …

[HTML][HTML] Nav Persaud

P Doshi - CMAJ - bioseek.eu
Regulatory agencies such as Health Canada and the US Food and Drug Administration
(FDA) have to date treated submissions of clinical trial data as confidential business …