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INTRODUCTION

Clinical research is becoming increasingly regulated and complex. With an ever-increasing number of regulations, guidance documents, and regulatory authorities, research professionals are figuratively driving between the ditches of compliance guidance and regulations. An additional layer of complexity exists because some regulations are written in broad language. Although this allows flexibility for the implementation of the regulations across diverse research sites, it can be challenging for investigators to turn the regulations into everyday research practice.

Let’s connect the dots between what research professionals are required and advised to do and what that can look like at the research site. This chapter demonstrates the connection between regulations and official guidance by using examples and tips taken from real-world site activities. We hope this will give you ideas for your site practices.

START BY LAYING A FIRM FOUNDATION

True understanding begins with mastery of the information in the regulations. The relationships between the different sources of the regulations and guidance can give the research professional insight into why and how they were created. The first task for all research professionals is to master the United States Food and Drug Administration (FDA) regulations for human subject protections. These regulations, along with the International Committee on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), are the gold standards, and investigators use this guidance as the foundation for their work on clinical research trials involving human studies. These fundamental regulations include:

  • 21 CFR part 50, Protection of Human Subjects (U.S. Department of Health and Human Services, 2013)

  • 21 CFR part 56, Institutional Review Boards (U.S. Department of Health and Human Services, 2013)

  • 21 CFR part 54, Financial Disclosure (U.S. Department of Health and Human Services, 2013)

If you are involved in clinical drug or device trials, you need to be aware of these regulations as well:

  • 21 CFR part 312, Investigational New Drug Application (U.S. Department of Health and Human Services, 2013)

  • 21 CFR part 812, Investigational Device Exemptions (U.S. Department of Health and Human Services, 2013)

The Common Rule refers to the standards required for government-funded research. These standards include the requirements for researcher professionals and the institutions where research is conducted. Although not all studies are government funded, the Common Rule standards for assuring compliance, obtaining and documenting informed consent, institutional review board (IRB) operations, and vulnerable subjects are generally applied for all clinical trials (U.S. Department of Health and Human Services, 2006).

Understanding the reporting and working relationships between regulatory authorities is one more way for research professionals to better understand their responsibilities. Regulations and guidance come from the United States government and international sources.

The mission of the United States Health and Human Services (HHS) department is to provide protection and essential services for all Americans (U.S. Department of Health and Human Services, n.d.-b). ...

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