The desire to contribute to our current understanding of drugs, disease and the human body is very noble. Along with this desire must be a commitment to become qualified to conduct clinical research properly. You can’t learn on the job When I began managing clinical research studies 25 years ago, a Clinical Investigator was a […]
Category Archives: en
en, Research Participants
The Soldier, the Good Samaritan and the Research Participant: A Discussion on Compensation for Research-Related Injuries.
17
Oct
Oct
Last month, five men in Nova Scotia risked their own lives to help a severely injured woman trapped in a burning vehicle that was wedged in some trees off the shoulder of the road. The car could have exploded at any time, but those men carried on and managed to move the woman out of […]
09
Sep
Sep
Do you know what Voltaire and Stan Lee, the co-creator of Spiderman, have in common? Both of them have been attributed the authorship of the quote “With great power comes great responsibility”. Many variations of this quote have been used in discussing ethical issues pertaining to genetic research. Pharmacogenomics and pharmacogenetics have led to novel […]
22
Aug
Aug
On July 30, 2014, Health Canada announced that the Office of Clinical Trials of the Therapeutic Products Directorate (TPD) will cease issuance of ‘Acknowledgement of Notification’ letters for Clinical Trial Application Notifications (CTA-Ns) on September 1, 2014. What does this mean for your clinical trial? First off, this change applies only to clinical trials involving […]
06
Aug
Aug
We all know how challenging drafting an effective informed consent form for research can be. As a researcher, you have the dual duty to disclose all the information considered to be legally and ethically necessary to make an informed decision in a manner that will be understandable to the prospective research participant. Many efforts have […]
17
Jul
Jul
When conducting clinical trials in Canada, a Sponsor must generally possess, for each clinical trial site, a Research Ethics Board Attestation (REBA), which provides administrative information regarding the research ethics board (REB) as well as a certification that its composition, operations and decisions are in compliance with Canadian regulations. A REBA must also be completed […]