Many people think that human subjects research is primarily focused on studying medical conditions. However, there are many types of non-medical research that involve human participants, such as research that falls under the umbrella term “social, behavioral, and educational research” or SBER.
SBER studies strive to gain knowledge about human behavior, interactions and related social, economic, educational systems and groups. This includes the study of psychological factors (attitudes, beliefs, motivations, perceptions, and emotions) and social phenomena (interaction among individuals and among social groups and institutions such as families, communities and schools, work, neighborhoods, and other physical and policy environments).
SBER includes a range of scientific disciplines like psychology, sociology, anthropology, criminology, political science, linguistics, economics, and education. SBER researchers are also active in health research as social and behavioral factors are well-recognized as being important determinants of well-being and health care access and utilization.
SBER investigators often employ research methods that are different from those used in biomedical research, such as focus groups, surveys and interviews, behavioral manipulations, analyses of very large data sets, and observation of human behavior. SBER investigators are also more likely to make use of the internet to recruit and collect data, and of personal electronic devices such as smartphones.
Deception is occasionally used in some SBER studies when divulging the purpose of the research could influence subjects’ responses and negatively impact a study’s scientific validity. SBER studies that involve deception may include debriefing of participants after they complete the research to tell them about the deception.
Some SBER studies explore the impact of interventions on behavioral and social outcomes but the terminology and approaches are not equivalent to those used in biomedical clinical trials. For example, SBER intervention studies may use the term “non-active control” rather than placebo.
Human Subjects Regulations for SBER studies:
In terms of oversight of subjects in research, the regulations and related policies are the same for SBER and non-SBER human subjects research. However, applying the rules and policies to SBER studies reveals additional differences from biomedical research. Physical risks are less common for SBER studies but psychological distress and risks from inadvertent disclosure of sensitive information are more common, leading to the need for specific mitigation strategies for these kinds of risks. Many research institutions and organizations have separate Institutional Review Board (IRB) panels for reviewing SBER protocols to ensure that SBER expertise is represented on boards that review a mix of research.
To help SBER investigators understand their responsibilities for the protection of human research participants, Learn eCORE created a version of its Human Subjects Research Training online course specifically for those engaged in SBER research (HSRT SBER).HSRT SBER features SBER-related examples, terminology, and case studies to help learners understand how to apply ethical regulations and guidance in SBER studies.
Harvard Catalyst’s Regulatory Foundations, Ethics and Law ProgramSBER resources
National Institutes of Health (NIH) Office of Behavioral and Social Sciences