Legacy Social-Behavioral-Educational (SBE) Basic

This legacy version (reflecting the Common Rule's pre-2018 requirements of the Common Rule) of the SBE Basic course covers the core human subjects research topics for SBE researchers.


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About this Course

This course covers regulatory and ethical issues important to the conduct of research involving human subjects. This course does not reflect the 2018 requirements version of the Common Rule. Case studies are used within the modules to present key concepts.

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Language Availability: English

Suggested Audiences: Researchers, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Chairs, IRB Administrators and Staff, Human Subject Protection Staff, Students

Organizational Subscription Price: Included in base subscription
Independent Learner Price: Not available for individual learners

Course Content

Legacy History and Ethical Principles - SBE

Discusses the evolution of the ethical principles in the U.S. that guide research design as well as the development of the federal regulations that govern the conduct of research relevant to researchers in the social and behavioral sciences. It reviews why ethics are necessary when conducting research involving human subjects including major historical events that have influenced how human subjects’ research is conducted.

It also describes problems with past studies that have violated ethical standards or have raised ethical concerns that have contributed to the national dialog related to the protection of human subjects. The Belmont Report principles are discussed as the basis for the ethical standards for research that guide us today.

Recommended Use: Required
ID (Language): 19242 (English)
Author(s): Lisa Robinson Bailey, MA - Duke University

Legacy Defining Research with Human Subjects - SBE

Defines the terms “human subject” and “research” with an emphasis on the interpretation for human subjects research in the social and behavioral sciences. Also included is a discussion as to the differences between private and public information and behavior, a critical aspect of many types of social and behavioral research.

Recommended Use: Required
ID (Language): 19243 (English)
Author(s): Lorna Hicks, MS, CIP - Duke University

Legacy The Federal Regulations - SBE

Describes the federal regulations and their basic provisions for human subjects research. It provides specific examples of the ways in which the federal regulations are particularly pertinent to social and behavioral science researchers and methodologies.

It also discusses the criteria for exemption from the federal regulations, describes criteria for the use of expedited review procedures and institutional review board (IRB) review, summarizes the authority and scope of an IRB, and describes the kinds of additional IRB review that approved research may need. In addition, it reviews regulatory information pertinent to social and behavioral research including the criteria for expedited and full board review and the authority of the IRB.

Recommended Use: Required
ID (Language): 19244 (English)
Author(s): Lorna Hicks, MS, CIP - Duke University

Legacy Assessing Risk - SBE

Presents the challenges in identifying and evaluating risks associated with participation in social and behavioral sciences research. Unlike biomedical clinical trials, risks associated with social and behavioral science research are often elusive and less predictable. Topics include assessing risks, balancing risks and potential benefits, minimizing and managing risks, certificates of confidentiality, and ways to address risks in the informed consent document and process.

Recommended Use: Required
ID (Language): 19245 (English)
Author(s): Tracy Arwood, MS - Clemson University; Sangeeta Panicker, PhD - American Psychological Association

Legacy Informed Consent - SBE

Discusses the process and documentation of informed consent, including informed consent guidelines as well as the required and additional elements of informed consent as described by the federal regulations 45 CFR 46. There is also a discussion of the circumstances under which an Institutional Review Board (IRB) may waive the requirements for informed consent with examples of how this is commonly applied in social and behavioral sciences research. Includes information related to recruitment, ensuring consent comprehension, timing of consent, documentation of consent, safeguards for vulnerable subjects during consent, and exculpatory language.

Recommended Use: Required
ID (Language): 19246 (English)
Author(s): Lorna Hicks, MS, CIP - Duke University

Legacy Privacy and Confidentiality - SBE

Distinguishes between privacy and confidentiality and identifies privacy risks associated with social behavioral study designs. Includes a discussion on protecting privacy in research and guidelines for designing confidentiality procedures. Topics include private versus public behavior, controlling access to private information, privacy and exempt research, privacy and research methods, confidentiality, privacy and reporting laws, and certificates of confidentiality. The discussion focuses on how these concepts apply to social and behavioral science research.

Recommended Use: Required
ID (Language): 19247 (English)
Author(s): Lorna Hicks, MS, CIP - Duke University

Legacy Research with Prisoners - SBE

Examines the regulatory definition of “prisoner” and describes the requirements for conducting research with prisoners pursuant to 45 CFR 46 Subpart C. Reviews the permitted categories of research involving prisoners and Institutional Review Board (IRB) review considerations. Importantly, it contains a discussion on essential elements related to designing prisoner research, including consent issues, free choice, use of incentives, limits to confidentiality, when an enrolled subject becomes a prisoner, and the assessment of risk. It concludes with information related to accessing prisoner populations.

Recommended Use: Required
ID (Language): 19249 (English)
Author(s): Stephan Kiefer, PhD - Copernicus Group IRB; Glenn C. Veit, JD, CIP - Copernicus Group IRB

Legacy Research with Children - SBE

Identifies regulations that apply to research with children. Defines “children” and discusses examples of research that meet the criteria of exempt research and expedited review and issues involved in obtaining and documenting parental permission and child assent. Discusses the four risk level categories according to 45 CFR 46 Subpart D. Included in the discussion is a review of the criteria for waiver of parental permission and/or child assent.

Recommended Use: Required
ID (Language): 19250 (English)
Author(s): Lorna Hicks, MS, CIP - Duke University

Legacy Research in Public Elementary and Secondary Schools - SBE

Recommended Use: Required
ID (Language): 19251 (English)
Author(s): Lorna Hicks, MS, CIP - Duke University

Legacy Populations in Research Requiring Additional Considerations and/or Protections

Provides an introduction to potentially vulnerable populations or those requiring additional protections and/or considerations in research. It describes different sources of vulnerability and distinguishes between populations in research who are specifically protected in the federal regulations and those who are not. It also includes the impact on autonomy, beneficence, and justice that may arise due to research on or with vulnerable individuals or groups.

Recommended Use: Required
ID (Language): 19228 (English)
Author(s): Jeremy N. Block, PhD, MPP - Icahn School of Medicine at Mount Sinai; Bruce Gordon, MD - The University of Nebraska Medical Center

Legacy International Research - SBE

Social and behavioral scientists conduct research around the globe. It includes a discussion of applicable regulations and guidelines and the importance of the local research context. Because international research may also include collaborating institutions, it provides information related to “engagement” in research. Additional topics include determining where research should be reviewed, exempt research, and informed consent considerations.

Recommended Use: Required
ID (Language): 19252 (English)
Author(s): Lorna Hicks, MS, CIP - Duke University; Mary Simmerling, MA - University of Chicago


Are these modules updated to reflect the revised Common Rule?

No, these modules reflect the pre-2018 requirements of the Common Rule. 

Does CITI Program offer modules that reflect the revised Common Rule?

Yes. We updated current CITI Program modules to reflect the revised Common Rule (2018 Requirements) on 20 January 2019.

How do I know if the module I completed reflects the revised Common Rule or the pre-2018 requirements version?

Each module that reflects the pre-2018 requirements includes the term "legacy" in the module title. Also, an alert message will be at the top of every legacy module stating that the module reflects the pre-2018 requirements, not the revised Common Rule (2018 Requirements).