Ethics review of pediatric multi-center drug trials

AC Needham, MZ Kapadia, M Offringa - Pediatric Drugs, 2015 - Springer
The assessment of safety and efficacy of therapeutics for children and adolescents requires
the use of multi-centered designs. However, the need to obtain ethical approval from …

Moving toward evidence-based human participant protection

M McDonald, S Cox - Journal of Academic Ethics, 2009 - Springer
There is near universal recognition that human participant protection is both morally and
practically essential for all forms of research involving humans. Yet most of the discourse …

[HTML][HTML] Navigating investigator-initiated clinical trials: A call for guidelines & monitoring frameworks from an Indian context

G Kumar, JJ Cherian, R Mathur… - The Indian Journal of …, 2024 - pmc.ncbi.nlm.nih.gov
Investigator-initiated clinical trials–also known as non-regulatory or academic clinical trials,
are conducted by investigators from academia or research organizations. They usually aim …

The Ontario cancer research ethics board: a central REB that works

MR Chaddah - Current Oncology, 2008 - pmc.ncbi.nlm.nih.gov
The Ontario Cancer Research Ethics Board (ocreb) has made its mark within Ontario as a
successful, centralized, oncology-specific research ethics board. As such, ocreb has proven …

Canadian research ethics boards and multisite research: experiences from two minimal-risk studies

E Racine, E Bell, C Deslauriers - IRB: Ethics & Human Research, 2010 - JSTOR
umerous studies have identified the chal lenges researchers face when attempting to obtain
ethics approval for multisite studies. For instance, Greene and Geiger have identified delays …

Considerations for ethics in multisite research in paediatric palliative care

S Cadell, G Ho, L Jacques, K Wilson… - Palliative …, 2009 - search.proquest.com
Sir—In the January 2008 issue of Palliative Medicine, we were interested to read the letter to
the editor calling for international multisite research. As paediatric palliative care …

Ontario Cancer Research Ethics Board: lessons learned from develo** a multicenter regional institutional review board

R Saginur, SF Dent, L Schwartz… - Journal of Clinical …, 2008 - ascopubs.org
Purpose We describe issues and outcomes in the development of a specialized, central
institutional review board (IRB) for multicenter oncology protocols. Numerous authoritative …

Ethics application protocols for multicentre clinical studies in Canada: a paediatric rheumatology experience

LA Matheson, AM Huber, A Warner… - Paediatrics & child …, 2012 - academic.oup.com
INTRODUCTION: Individual institutions govern research ethics applications and each must
administer and regulate their own protocols. Variations in ethics review procedures and …

Multisite research ethics review: Problems and potential solutions

A Ferguson, Z Master - BioéthiqueOnline, 2016 - erudit.org
Large scale, multisite clinical research trials have been increasing in frequency. As it stands
currently, a research project performed at multiple institutions requires ethics review at each …

Hospital ethics approval for a population-based case–control study of very preterm birth

LF Watson, JA Rayner, JM Lumley - Australian Health Review, 2007 - CSIRO Publishing
Aim: To describe the process involved in obtaining ethics approval for a study aiming to
recruit women from all maternity hospitals in Victoria, Australia. Design: Observational data …