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Compliance In Focus
Posted by Shawn Kennedy on Wed, Jul 22, 2015

FDA Regulations - Title 21: 1981

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an FDA_Regulations_-_Title_21_1981eBook 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 might be surprised to learn that as recently as 1980 these regulations did not exist as they do today.  It was this year that 21 CFR Part 50 – Protection of Human Subjects was issued.  The following year, in 1981, 21 CFR Part 56 – Institutional Review Boards was issued.  This same year, 21 CFR Part 50 was also amended.  Since this time, these parts have seen continuous improvements through amendments over the years (most notably in 2001 when subpart D was added to 21 CFR Part 50 to provide additional protections for children involved in research).   These revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions.

Additional Parts of 21 CFR that are seminal in the conduct of clinical investigations in today’s research landscape include, all of which can be found transcribed across this silhouette of a book, with the number “21” on the cover:

  • 21 CFR Part 11 – Electronic Records
  • 21 CFR Part 54 – Financial Disclosures
  • 21 CFR Part 312 – Investigational New Drug Application
  • 21 CFR Part 812 – Investigational Device Exemptions

We encourage you to download our History of Clinical Research eBook to better understand key moments in the history of clinical research.

Image Credit: Nicolette Capuano

The History of Clinical Research

Topics: History of Clinical Research Timeline, FDA Regulations, Code of Federal Regulations (CFR) Title 21


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