Human Subjects in Research (1/23/17)

January 23, 2017

final rule has been issued to address regulations for the protection of human subjects in research studies. The rule was a cooperative effort by several departments and agencies including the Department of Health and Human Services (HHS) and the Environmental Protection Agency (EPA). It seeks to revise the original set of regulations referred to as the “Common Rule,” issued in 1991. The new rule aims to increase protection of human subjects involved in research and to modernize the current system of oversight.

Purpose of the Final Rule

Since the Common Rule was enacted, research involving human subjects has grown at speeds faster than regulatory oversight. The extent and diversification of research involving humans has expanded greatly in the past decades including:

  • Growth in the number and types of clinical trials
  • Development of various types of social and behavioral research
  • Use of progressive analytic techniques to study human biospecimens
  • Increased use of electronic health data and other digital records to analyze large datasets

The modernization of the Common Rule is meant to align oversight with shifts in the research landscape. These advancements include evolving technologies, such as computer software programs, growth in computing power, and the rise of mobile technology, advancements in biomedical science including the use of precision medicine, and the substantial increase in the volume of data available for analyzing and sharing among scientists.

Summary of Changes to the Common Rule

The final rule establishes new changes and requirements to simplify and enhance old provisions. Some of the major changes pertain to the following:

  • Consent Process: The final rule promotes a more informed consent process by requiring those conducting studies to provide more information about the study to potential subjects.
  • Broad Consent: The final rule allows broad consent, in which subjects can provide consent for a general scope of future research as long as it stays within certain parameters.
  • Exempt Research Categories: Some categories of research will be exempt based on their risk profiles. Exempt studies would be subject to limited review from the institutional review board (IRB) to ensure appropriate compliance with confidentiality.
  • Cooperative Research: Cooperative research studies conducted by U.S.-based institutions are required to use a single IRB for the components of the study that occur within the United States.
  • Discharged Review: Studies that undergo expedited review and studies that are in their secondary stage are not required conduct continuing review.

This final rule goes into effect on January 19, 2018.

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