Compliance In Focus

The Poly Implant Prothese (PIP) Breast Implant Scandal is one of the most significant patient protection failures in the history of clinical research.

As traumatic as it was for the patients involved, it has also been credited in part for triggering significant regulatory changes in the European Union—including the new EU MDR requirements. 

Here's a look back at what happened and how the regulatory landscape in Europe has changed as a result. 

The National Research Act of 1974 set the stage for several important systems of checks and balances in clinical research.

It led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, as well as the Belmont Report and Institutional Review Boards (IRBs). 

Here's a closer look at this important milestone in the history of clinical research.

For research professionals involved in clinical trials, there is an immense responsibility of protecting human subjects, but history has taught us, unethical practice and disregard for the well-being of human subjects has occurred and will continue to occur.

Ensuring accurate and credible data from clinical trials and protection of human subjects is the role of every individual on the research team. The price for compromise is high; history provides an array of haunting reminders of our failure to uphold our obligation to ethical excellence in our work.

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 years.

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 years.

In today’s day and age, it is a widely accepted and understood requirement that conducting clinical research for investigational new drugs and devices in the United States means that you will be responsible for following the FDA regulations.  The terms, “according to the regulations, “or “according to the regs,” are used commonly, as we all have grown accustomed to these seemingly intuitive laws that govern the practice of clinical research.  However, not too long ago, the regulations we freely refer to now did not exist.  It wasn’t until after the 1979 Belmont Report, that FDA and the Department of Health and Human Services formally revised regulations for human subject protections by creating Title 21 - Food and Drugs. 

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.