|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Foundations, Ethics, and Law Program|
Social, behavioral, and education research (SBER) encompasses a range of methodologies and tackles questions that seek to improve our understanding of human behavior, attitudes, beliefs, and interactions as well as social and economic systems, organizations, and institutions.
The primary focus of SBER is on the actions of diverse groups including individuals and families, and regional populations and nations. Often SBE research utilizes methods such as interviews, surveys, focus groups, observation, and/or behavioral manipulations. Census and employment data as well as records from education, social service, or healthcare programs may also be incorporated.
Knowledge gained from SBE research informs the development of prevention and intervention programs and facilitates strategies in policy and practice.
Issues to Consider When Conducting SBE Research
Researchers and IRBs must understand:
A series of case studies examining regulatory issues specific to various SBE research projects and suggestions for managing them.
The case studies can be used in a variety of ways, which include:
Download the complete Harvard Catalyst SBER Case Study Library or select from the individual topics below:
Case studies follow a standard format that includes:
A Microfinance Study
Economic researchers seek to test the decision-making impact of microfinance with an underserved population.
"Mystery Shopper" Dealing with Companies and Government Offices
Researchers are studying publically available data about the implementation of loan modification programs after the 2007 financial crisis, evaluating government interventions in markets during times of stress.
Critical Incident Stress Debriefing and Incidence of PTSD in Firefighters
A study to identify risk factors related to developing and coping with PTSD in firefighters following a critical incident. Phone and internet-based screenings and data gathering occurs before and after the critical incidents.
Assessing Adherence to a Hybrid Tai-Chi/Yoga Regimen in Anxiety Disorder Research
A psychiatry practice is partnering with a fitness club to treat a specific kind of anxiety disorder. Subjects are given a regimen of self-directed workouts and a yoga mat with a hidden chip. To avoid influencing behavior subjects will not be told about the chip or usage tracking.
Oral History, Journalism, or Research?
A PhD candidate and a journalism student work with a counseling group for victims of the Boston Marathon bombings to collect oral history of the event and test how connected the victims now feel to their city or town.
The Effectiveness of Middle School "Grit" Training as Mediated by Traumatic Life Experiences
Researchers study a middle school training on how to exhibit "grit." Researchers propose interviewing students before, during, and after the training to determine students' history of traumatic life experience and their psychological profile. Findings from the psychological tests will be reported to the parent/guardian.
The Effect of Shared Experiences on Mood
Clinical psychologists believe they can detect changes in mood of college students based on whether their college's football team wins or loses games. Changes in mood will be measured by analyzing changes in the proportion of positive vs. negative emails sent by students through their university email accounts.
Adolescents and Young Adults Coping with Cancer
Researchers evaluate cancer experience, comparing the psychological distress of adolescents and young adults with psychological distress in an older cohort. Potential participants are cancer patients with a prognosis of less than a year to live.
Using Focus Groups to Perform a Needs Assessment with Caregivers of Persons with Psychotic Disorders
A needs assessment is performed with caregivers and of families of people with psychotic disorders. The researcher is interested in learning about needs of the families who provide support to patients with mental illness.
Looking at Gang Participation and Perceptions of Neighborhood Safety
A study involving audio-recorded interviews on gang participation and perceptions of neighborhood safety. Study staff will approach known gang members and non-gang members at public venues and give them recruitment flyers.
Conducting an HIV Health Initiative Needs Assessment in Boston and Surrounding Communities
The Department of Public Health is funding a citywide wellness needs assessment to help plan future HIV services. Focus groups of eligible HIV-positive individuals will solicit insight on HIV-related community programming in the Boston area.
The Effect of Peer Pressure on Risk-Taking Behaviors Among Youth
A sociologist looks at peer pressure effect on risk-taking behaviors (shoplifting and recreational drug use among youth). Focus groups, group therapy sessions, and participants log risk-taking activities via an app on a device provided by the research team.
Recruiting Employees for an fMRI Study Assessing the Effects of Alcohol and Drug Use
Screening for a study involving a new, FDA-approved fMRI imaging method includes an extensive pre-screening and mental health examination. The study has low enrollment; the researcher requests opening recruitment to employees of the healthcare center where the study is conducted.
Conducting NIH-Funded Research in U.S. State Prisons
An NIH-funded study on U.S. state prisons to assess health status and the perceived need for health services among inmates.
Enrolling Students into a Research Study on Adjusting to College Life
A faculty member in the Psychology Department is conducting a study on how students adjust to college life. Enrolled subjects will be asked to complete questionnaires and weekly diary entries.
Assessing Factors that Influence a Refugee Population's Associations with Terrorist Groups
A study to determine what factors influence long-term social and psychological outcomes of refugee resettlement in the U.S. Enrolled subjects recount traumatic encounters and tell their refugee stories.
Complete Harvard Catalyst SBER Case Study Library, bookmarked in one PDF
If you have feedback on an existing case study, a suggestion for a new case study topic, or would be interested in collaborating on case study development, please contact us.
Members of the Harvard Catalyst SBER Subcommittee bring to the table their expertise in research policy, review, and compliance, as well as the development of educational initiatives and engagement with community members. Subcommittee members are professionals from within and beyond the Harvard community who share experiences in the review of SBE research, discuss emerging issues in this field, and develop common resources and guidance for investigators and institutions. Learn more on our How We Work page.
SBER Subcommittee Co-Chair
SBER Subcommittee Co-Chair
Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations