In a previous blog post, revisions to the Common Rule were to be implemented January 19, 2018; however, due to a Notice of Proposed Rulemaking (NPRM), the compliance date was delayed until January 21, 2019.
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
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In a previous blog post, revisions to the Common Rule were to be implemented January 19, 2018; however, due to a Notice of Proposed Rulemaking (NPRM), the compliance date was delayed until January 21, 2019.
My motivations for going to professional conferences usually revolve around staying abreast of new information relevant to my field, networking with others, and earning CEUs. I’ve never gone to a professional conference expecting to be emotionally moved in a giant way, but that’s exactly what happened at an ACRP meeting about 10 years ago when I attended the keynote address given by Eva Mozes Kor, one of the “Mengele Twins” on whom horrific medical experiments were conducted at the Aushwitz concentration camp during WWII. I vividly recall Kor’s strength as she marched us all through her experiences which started when she was only 10 years old. Only 10 years old. Let that sink in.
Topics: History of Clinical Research, Eva Mozes Kor, Mengele Twins
The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death.
It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of these events occurred decades ago, medical devices still have the potential to cause harm.
These issues are documented in the FDA’s annual list of medical device recalls and (in some rare cases) even make headlines. Here are two examples of more recent medical devices that have hurt patients.
Topics: History of Clinical Research
The history of clinical research is both fascinating and troubling. It’s a series of trial and error, followed by regulations that put patient safety ahead of profits.
In fact, it’s the reason IMARC Research exists—and why we're proud to be a partner in compliance for so many medical device companies.
Topics: History of Clinical Research
Imagine being enrolled in a clinical trial without fully understanding the scope or the risks.
The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection.
In this post, we’ll discuss the key principles of the report, and in particular, how it clarified our understanding of informed consent.
Topics: History of Clinical Research
For clinical research professionals, the protection of human subjects has always been of paramount importance. Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team. Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.
Topics: History of Clinical Research, eBook, IMARC Research
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive
Back in the early 1960’s, public perception of clinical research began to take a turn as talks and frightful images of the Thalidomide tragedy gained national news. In this case, Congress managed to pass new legislation to attempt to mitigate the issue (the Kefauver-Harris Amendment, respectively), but who couldn’t be left wondering “What’s the next terrible course of events that will happen?”
Topics: Good Clinical Practice, World Health Organization, History of Clinical Research, IMARC Research, International Conference on Harmonization
For clinical research professionals, the protection of human subjects has always been of paramount importance. Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team. Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.
Topics: Sandra Maddock, History of Clinical Research, IMARC Research
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.
Topics: History of Clinical Research, Kefauver-Harris Amendment, IMARC Research, FDA
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.
Topics: History of Clinical Research, Guatemala Syphilis Experiment, John Charles Cutler, IMARC Research
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.
Topics: History of Clinical Research, Human Radiation Experiments, Department of Defense
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.
Topics: History of Clinical Research, Nazi Human Experimentation, Human Experimentation, IMARC Research
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive
Topics: History of Clinical Research, Elixir Sulfanilamide, FDA
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.
Topics: History of Clinical Research, James Lind, IMARC Research
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.
Topics: History of Clinical Research, IMARC Research, Clinical Research
You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.
Topics: History of Clinical Research, The Hippocratic Oath, IMARC Research
For clinical research professionals, the protection of human subjects has always been of paramount importance. Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team. Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.
Topics: Sandra Maddock, History of Clinical Research, Clinical Research Timeline, eBook, IMARC Research