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Compliance In Focus
Posted by Kelly Schindelholz on Tue, Apr 16, 2019

How The National Research Act of 1974 Enhanced Trial Safety

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

National-Research-Act

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.

 

The History of the National Research Act

In 1974, President Richard Nixon signed the National Research Act into law.  This created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This came after several egregious abuses of human subjects in research, including Nazi Party experiments on prisoners of concentration camps during World War II (which led to the creation of the Nuremberg Code) and the Tuskegee Syphilis study, in which black men with syphilis were denied life-saving treatment. 

The main purpose of the National Research Act was for the newly established commission to identify basic ethical principles to be followed when conducting biomedical and behavioral  research on human subjects.  Additionally, the commission was tasked with developing guidelines that would help the medical community conduct research in accordance with the principles they set forth.  Some concepts the commission considered included: 

  • Differences between biomedical and behavioral research and standard medical practice
  • How risk-benefit analysis should be done when deciding whether research involving human subjects is appropriate
  • Developing guidelines for how to properly select human subjects for participation
  • Defining how informed consent should be sought in various research settings

Want to learn more about the history of clinical research? Take a minute to watch the video and explore our History of Clinical Research timeline for more detail.

 

The National Research Act And The Belmont Report

The result of the commission’s work was summarized in what is now known as the Belmont Report.  The Belmont Report gets its name from the location where the commission held its initial four-day summit in February 1976 to discuss the ethical concepts, which took place at the Smithsonian Institute’s Belmont Conference Center. The commission met numerous times after the initial summit to expand and revise their ideas, until the final Belmont Report was ultimately released in 1979.  The end result was a new set of three underlying ethical principles that were to guide biomedical and behavioral research conducted on human subjects:

  • Respect for persons - All individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection
  • Beneficence - Researchers should maximize possible benefits and minimize possible harm
  • Justice - All persons should be treated equally, and the selection of research subjects should be scrutinized so that no one is systematically selected on the basis of race, ethnicity, class or other factors

The Belmont Report remains a primary ethical framework for researchers today.

The Creation Of Institutional Review Boards (IRBs)

Another important provision that came out of the National Research Act was the requirement that all human subjects’ research must be reviewed and approved by an Institutional Review Board (IRB).  IRBs remain a critical component of the clinical research process, as they work to ensure that each study involving human subjects has scientific merit, is ethically sound, and follows regulatory requirements.  When deliberating whether or not to approve a clinical research protocol, IRBs take into consideration the three tenets of the Belmont Report, among other factors.  The image associated with the National Research Act is meant to symbolize a magnifying glass through which IRB’s careful review research protocols. 

The selection, scope and operational requirements of IRBs are outlined in CFR 21 Part 56

According to the regulations, an Institutional Review Board must consider the following in its review of a clinical research plan:

  • Are procedures in place to minimize risks to human subjects?
  • Are the risks to subjects reasonable in relation to anticipated benefits?
  • Is the selection of subjects equitable?
  • Will each subject be able to give informed consent to participating?
  • Will informed consent be documented appropriately? 
  • Does the research plan make adequate provisions for monitoring the data collected to ensure the safety of subjects?
  • Are adequate provisions in place to protect the privacy of subjects and maintain the confidentiality of data?
  • Are there appropriate protections for vulnerable populations, such as children, prisoners and pregnant women?
  • Does the research plan comply with CFR 21, Part 50, subpart D?

To this day, the National Research Act remains an important milestone in the history of Clinical Research and a foundation for Good Clinical Practice. To learn more about other key milestones and share them with your colleagues, download a printable version of our timeline. 

The History of Clinical Research

Topics: History of Clinical Research Timeline

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