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Guidance for Application of the Human Subjects Protection Regulations to Actions Taken in Response to the COVID-19 Pandemic

The HHS Office for Human Research Protections (OHRP) issued guidance on COVID-19 for investigators, institutional review boards, and institutions conducting human subjects research during the coronavirus (COVID-19) pandemic.

OHRP recognizes that the COVID-19 pandemic is having an impact on research that is regulated by the Common Rule. For example, some research is conducted in healthcare settings, which may now require clinical screening for COVID-19. Investigators might now be required to report positive COVID-19 test results about research subjects. Some research projects will be amended, suspended, or terminated during the COVID-19 pandemic. OHRP is aware that investigators may have to deviate from approved protocols due to COVID-19.

This guidance highlights that the Common Rule should allow necessary actions to be taken to protect public health, while still appropriately protecting participants in research.

Among the scenarios discussed are:

  • Actions taken solely for public health or clinical purposes that do not require IRB review,
  • Public health surveillance activities that are deemed not to be research,
  • Compliance with legally mandated reporting of positive COVID-19 test about, and
  • Changes to research protocols as a result of the COVID-19 pandemic.

"The important thing to recognize is that our rules for protecting research subjects should not stop us from addressing this extraordinary public health crisis. We must be able to quickly move forward with ethical research studies that can lead to treatments for COVID-19," said Dr. Jerry Menikoff, Director of the Office for Human Research Protections. "OHRP remains ready and able to assist institutions and researchers in achieving those goals."

To read the OHRP Guidance on COVID-19, visit the Office for Human Research Protections website here.

OHRP, an office within the Office for the Assistant Secretary for Health at the U.S. Department of Health and Human Services, has the mission of protecting the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services.