The Office for Human Research Protections (OHRP) recently published new draft guidance to clarify the difference between human research that might require IRB review and public health surveillance that is not defined as research.
The OHRP recommendation is that activities supported by the U.S. Department of Health and Human Services (HHS) and initiated on or after Jan. 21, 2019, comply with the revised Common Rule. There are additional categories of nonresearch activities under 45CFR 46.102. (The guidance can be found at: http://bit.ly/2AyK1RX.)
The research definition remains the same: “A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
HHS recognizes that the requirements of 45 CFR part 46 should not impede a public health authority’s ability to accomplish its mandated mission to protect and maintain the health and welfare of the populations for which it is responsible, which is why this type of investigation is excluded from the definition of human research, according to Julia G. Gorey, JD.
“While the 2018 requirements retain the pre-2018 research definition as ‘a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge,’ public health surveillance activities is one of the categories of activities that have been explicitly deemed not to be research, to clarify that they do not fall within the scope of the regulations,” adds Gorey, public health analyst in OHRP’s division of policy and assurances and executive director of the Secretary’s Advisory Committee on Human Research Protections.
The new draft guidance is intended to resolve uncertainties that existed in the regulated community concerning whether such activities were considered research, she says.
The guidance spells out four categories of activities that are deemed explicitly to not be research, providing clarity over what might have been ambiguous before the Common Rule changes:
• Public health surveillance activities. These include the collection and testing of information or biospecimens when conducted or authorized by a public health authority. This might be necessary for monitoring, identifying, assessing, or investigating disease outbreaks, public health trends, risk factors, disease patterns, and other conditions important to public health. These activities might be associated with a public health crisis following a natural or manmade disaster.
• Scholarly and journalistic activities. These include oral history, journalism, biography, literary criticism, legal research, and historical scholarship.
OHRP guidance, effective July 19, 2018, states that scholarly and journalistic activities often are conducted in fields that focus on the specific individuals about whom the information is collected and not to draw generalizations about other individuals or groups. (This guidance can be found at: http://bit.ly/2P964DK.)
• Collection and analysis of biospecimens, records for criminal justice activities. Activities involving the collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order, solely for criminal justice or criminal investigative purposes, are not defined as research.
• Intelligence operations. Authorized operational activities, determined by each agency, in support of intelligence, homeland security, defense, or other national security missions are not defined as research. (More information is available at: http://bit.ly/2RoONIS.)