In 1981, the (U.S.) President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended that a “common rule” be established for all federally-funded research involving human subjects. In 1991, Title 45 of the Code of Federal Regulations (Public Welfare) Part 46, Subpart A – better known as The Common Rule – was published.
The Common Rule essentially converted the Belmont principles into regulations for federally-funded human research. Many institutions of higher learning (including the member institutions of the ACM) apply most or all of The Common Rule regulations to non-federally funded human subjects research, as well.
Summary of The Common
Does the research project meet the
four criteria below? If so, it is subject to review under The Common
Is the project
“research” as federally defined?
Is the human subjects research project supported by federal funds?
Does the research study
“human subjects” as federally defined?
Are the project results intended or suitable for dissemination to a scholarly or professional audience beyond the institution?
If the project does not meet the four criteria above, it is still subject to review under
The Common Rule if the institution has adopted The Common Rule criteria for all human subjects research, regardless of funding source.
Regardless of whether the project does or does not meet the criteria above, if it meets any of the following conditions below it is subject to review under
The Common Rule:
The subjects are prisoners.
The subjects are minors.
The subjects belong to other vulnerable or clandestine populations (eg, if any disclosure of responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation).
The research activities are not specified as “exempt” in
The Common Rule.
The following research activities are federally-designated as exempt from
The Common Rule:
Educational research in schools and colleges, the focus of which is on normal educational practices (e.g., research on special education instructional strategies, research on the effectiveness of instructional techniques)
Research involving the anonymized
collection of non-incriminating data
Research that uses publicly-available
or anonymized existing data
Research with public officials or
candidates (as long as it is not subject to other federal
Research on/about public programs*
(with the approval of the agency head)
Research involving safe foods
*For example, if a researcher is investigating a community organization and asks employees in the organization about its policies and sources of funding, the employees are not the subject of the investigation. But if the investigator asks the employees about their opinions of the organization’s policies or their experiences in fund-raising, then the employees are the subjects of the investigation and the project requires IRB/HSRB approval.
(modified by the Monmouth College HSRB from the Feb. 2012 ACM conference document,
Protecting Human Subjects in Student Inquiry Projects)