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What’s the difference between Canada and US: CTA versus IND

WEBThe approval process is different in Canada. Once a CTA has been submitted and reviewed, Health Canada notifies the Sponsor within 30 calendar days if the application …

Actived: 7 days ago

URL: https://researchethicssimplified.com/whats-the-difference-between-canada-and-us-cta-versus-ind-2/

Release of Veritas IRB’s Investigator’s Manual: An Essential …

WEBCanada’s second National Health Ethics Week is being held from March 2 to March 8, 2015. This event is being coordinated by the Canadian Bioethics Society …

Category:  Health Go Health

What is ‘consent’ and ‘assent’ for research

WEBThe ‘assent form’ allows them to say ‘yes’ or ‘no’ to the research, even if they don’t understand everything about it. For example, if a research study is about people …

Category:  Health Go Health

Is research without consent legally or ethically possible

WEBIt is legally and ethically possible to conduct research without consent. Under US and Canadian normative frameworks governing research with humans, it is …

Category:  Health Go Health

What should a research consent form tell you

WEBThe things the researchers tell you about the research study are usually written in the ‘informed consent form’, too. Some of the details that should be in the …

Category:  Health Go Health

Hey Canada! Should you care about the U.S. modernization of the …

WEBThe U.S. Department of Health and Human Services (hereinafter HHS), as well as fifteen other Federal Departments, have announced proposed revisions to their …

Category:  Health Go Health

How to obtain a Health Canada Research Ethics Board Attestation …

WEBAs part of its commitment to keeping studies on TRACKTM and to reduce the record-keeping burden on Sponsors/CROs and Sites, Veritas IRB has incorporated the …

Category:  Health Go Health

How to write a confidentiality clause in a research consent form

WEBIt is best practice to explain clearly which security measures are being put in place to ensure the confidentiality of the collected information. These security measures …

Category:  Health Go Health

Lost in Translation

WEBthis posting is the second of a six-part series that will explore various examples of terminologies that carry different meaning when conducting transnational …

Category:  Health Go Health

Beyond Quick Turnaround Times: IRB Delegated/Expedited Review …

WEBDelegated IRB review is an exception to the general requirement of a review by a full panel of the IRB. Some research applications may be delegated to a single …

Category:  Health Go Health

A Tribute to Ellen Roche – Research ethics simplified™

WEBEllen Roche was an employee at the Johns Hopkins Asthma and Allergy Center. She enrolled in a research study whose objective was to analyze the reflexes …

Category:  Health Go Health

Will Health Canada still acknowledge clinical trial notifications

WEBHealth Canada has stated that there’s no regulatory requirement for the Office of Clinical Trials to issue ‘Acknowledgement of Notification’ letters for Clinical Trial …

Category:  Health Go Health

Am I IRB Forum Shopping

WEBIRB Forum Shopping is an under-researched yet highly-relevant ethical issue in the context of the North American governance of clinical research. Essentially, it …

Category:  Health Go Health

Veritas IRB Approved in Saskatchewan as a Research Ethics …

WEBMontreal, QC – August 8, 2017 – Veritas IRB is proud to announce that it has been approved by the Ministry of Health in Saskatchewan to perform research ethics review …

Category:  Health Go Health

Les études comparatives d’efficacité sont-elles réellement uniques

WEBCommentaires sur deux articles récemment parus dans le New England Journal of Medicine Lors de notre dernier blogue, nous faisions référence à un article …

Category:  Medicine Go Health

Quelle est la différence entre le Canada et les États-Unis: DEC …

WEBSi vous êtes un promoteur ou un ORC et que vous gérez un essai clinique impliquant des sites de recherches situés au Canada et aux États-Unis, sachez qu’il y a …

Category:  Health Go Health

Voltaire, l’Homme araignée et la divulgation des risques en …

WEBLa pharmacogénomique et la pharmacogénétique nous ont menés à de nouvelles approches dans la découverte des médicaments en identifiant de nouvelles …

Category:  Health Go Health

et « assentiment » à la recherche

WEBLe consentement est « éclairé » lorsque vous êtes capable de bien comprendre les conséquences de votre participation vous permettant ainsi de prendre …

Category:  Health Go Health

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