Regulatory Foundations, Ethics, and Law Program

Social, Behavioral, and Education Research

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

These case studies examine regulatory issues specific to various SBE research projects and provide suggestions for managing those issues.

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

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.

Additional Resources

Onsite SBER Training and Education
(Request Consultation: regulatory@catalyst.harvard.edu)
A customizable, case-based curriculum delivered and moderated by IRB experts.

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.

Contacts

For more information, please email regulatory@catalyst.harvard.edu.

To request any of the above documents be made accessible please email communications@catalyst.harvard.edu.