Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Social, Behavioral, and Education Research (SBER)

Overview

Case Study Library | Additional Resources for Investigators and IRBs | SBER Subcommittee | Contacts

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:

  • The nature of the risks, harms, and impacts associated with the research
  • Factors likely to contribute to increased risk in otherwise relatively low-risk research
  • How to design research with sufficient protections in place to minimize the risk of negative impacts
  • How risks may change as the nature of the research changes or moves forward in a different direction

SBER Case Study Library

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:

  1. As an education tool for training individuals in human subjects research
  2. As a basis for developing reviewer checklists/worksheets
  3. As a tool in designing research projects

Complete Harvard Catalyst SBER Case Study Library, bookmarked in one PDF

Download a PDF

Download the complete Harvard Catalyst SBER Case Study Library [PDF] or select from the individual topics below:

Regulatory_SBER_3-Case-Study-Fan-Image

Overview

Case studies follow a standard format that includes:

  1. Scenario/fact pattern
  2. Regulatory, Cultural, and Ethical Issues to be considered
  3. Resolutions & Discussions:
    • Risk/Benefit Analysis
    • Mitigation/Management Options of Risks
    • Alternate Details and Other Events
Regulatory_SBER_3-Case-Study-Fan-Image

Behavioral
Economics Research

A Microfinance Study

Economic researchers seek to test the decision-making impact of microfinance with an underserved population.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Business Research

"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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Crisis Research

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Deception in
Research

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Edges of Research

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Education Research

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Electronic Media
Research

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

End of Life Issues

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Focus Groups

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Gang Violence

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

HIV

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Illegal Behaviors

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Recruitment of
Employees

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Research in Prisons

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Social Anthropology
Study

An Ethnographic Study of the Organizational Structure of Occupy Boston

A graduate student proposes an ethnographic research study on organizational structure and response to the legal and cultural challenges of Occupy Boston. The study includes reviewing online for in-person interviews, and photographing and videotaping activists' activities.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Students in
Research

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Terrorism Research

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.

Download a PDF

Regulatory_SBER_3-Case-Study-Fan-Image

Text Messages in Human Research

Infectious Diseases (ID) practitioners propose a research study in order to try to improve adherence to appointment scheduling among non-English-speaking patients infected with Hepatitis C virus. Participants will be randomized to either a standard clinical scheduling arm or an enhanced communication arm. The enhanced communication arm will consist of standard scheduling procedures plus 3 text message appointment reminders in the participants' preferred language.

Download a 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.

Return to top

Additional Resources

For Investigators
  • SBER 101 [PDF]
    An overview of social, behavioral, and education research including issues to consider when planning and conducting projects.
  • SBER 201 (coming soon)
    The Common Rule and IRB review of social, behavioral, and education research.
  • SBER 301 [PDF]
    IRB assessment of risks associated with social, behavioral, and educational research.
  • Onsite SBER Training and Education (Request Consultation)
    A customizable, case-based curriculum delivered and moderated by IRB experts.
  • SBER Risk Assessment Annotated Bibliography [PDF]
    Guidance for investigators, research teams, and IRBs of current curated literatures on how to evaluate the risks associated with SBE research.
  • Materials to share with participants
  • Additional Resources
    • E-Source Behavioral and Social Science Research
      A digital anthology of key methods for developing and implementing behavioral and social science research created by the Office of Behavioral and Social Sciences Research (OBSSR) at the NIH.
    • Survey Core
      Provides comprehensive, high-quality survey data collection and management services that support research conducted by investigators and staff at the Dana-Farber/Harvard Cancer Center and the Harvard medical and research community.
For IRBs
  • SBER 101 [PDF]
    An overview of social, behavioral, and education research including issues to consider when reviewing projects.
  • SBER 201 (coming soon)
    The Common Rule and IRB review of social, behavioral, and education research.
  • SBER 301 [PDF]
    IRB assessment of risks associated with social, behavioral, and educational research
  • Onsite SBER Training and Education (Request Consultation)
    A customizable, case-based curriculum delivered and moderated by IRB experts.
  • SBER Risk Assessment Annotated Bibliography [PDF]
    Guidance for investigators, research teams, and IRBs of current curated literatures on how to evaluate the risks associated with SBE research.
  • Additional Resources
    • E-Source Behavioral and Social Science Research
      A digital anthology of key methods for developing and implementing behavioral and social science research created by the Office of Behavioral and Social Sciences Research (OBSSR) at the NIH.
    • Oversight of Social and Behavioral Research [PDF] (from OHRP)
      This guidance for IRBs provides an overview of regulations applicable to social and behavioral research. The document covers assessment of social and psychological risks and impacts, and the application of the Common Rule in SBE research.
    • FAQs and Vignettes (from the National Science Foundation)
      Guidance from the National Science Foundation (NSF) to aid IRBs in interpreting the Common Rule for the protection of human subjects in social and behavioral research.
    • Anthropological Research and "the Common Rule" (from the American Anthropological Association (AAA))
      Case studies exploring complex ethical issues in anthropological research.

Harvard Catalyst Social Behavioral Education Research (SBER) Subcommittee

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.

Contacts

Cynthia Monahan
SBER Subcommittee Co-Chair
Email

Matt Stafford
SBER Subcommittee Co-Chair
Email

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Email

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Email

Return to top