Legacy Biomedical (Biomed) Basic

This legacy version (reflecting the Common Rule’s pre-2018 requirements) of the Biomed Basic course provides an introduction to the protection of human subjects in biomedical research.


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About this Course

This course covers regulatory and ethical issues important to the conduct of research involving human subjects. It 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, Research Team Members, 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 Ethics of Human Subjects Research

Discusses ethical principles for the conduct of research involving human subjects. It provides an overview of the historical events that influenced the development of the current regulatory requirements, a review of the Belmont Principles, and a discussion of the contemporary ethical standards that guide research today.

Recommended Use: Required
ID (Language): 19222 (English)
Author(s): Jeffrey M. Cohen, PhD, CIP - HRP Consulting Group, Inc.

Legacy Basic Institutional Review Board (IRB) Regulations and Review Process

Provides foundational information about the human subject protection regulations and IRBs, including the role, authority, and composition of the IRB. It discusses different types of IRB review processes, including an overview of the essential issues associated with exempt, expedited, and full (convened) IRB reviews.

The information presented is based on the Common Rule as codified by the U.S. Department of Health and Human Services at 45 CFR 46, Subpart A. It concludes with a discussion of additional regulations and requirements (including the U.S. Food and Drug Administration and the International Council for Harmonisation), as well as others (for example, the National Institutes of Health and the U.S. Department of Education) that require compliance based on certain types of research.

Recommended Use: Required
ID (Language): 19223 (English)
Author(s): Ada Sue Selwitz, MA - The University of Kentucky; Norma Epley, MS - East Carolina University; Janelle Erickson, MPH - Seattle BioMedical Research Institute

Legacy Informed Consent

Presents the framework for informed consent found within the Common Rule (45 CFR 46, Subpart A), including the process and documentation of informed consent. Some of the special challenges associated with informed consent in research are also discussed, including informed consent as it relates to vulnerable populations, the requirements for waiver of informed consent, as well as the differences between U.S. Food and Drug Administration and U.S. Department of Health and Human Services regulations.

Recommended Use: Required
ID (Language): 19224 (English)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Legacy Social and Behavioral Research (SBR) for Biomedical Researchers

Discusses SBR techniques within the framework of biomedical research and the nature, risks, and benefits associated with these techniques. Included in this discussion are the types of biomedical studies that utilize SBR techniques, along with the kinds of data collected. It concludes with the risks and benefits that are unique to SBR

Recommended Use: Required
ID (Language): 19225 (English)
Author(s): Deborah Dickstein, MSPH - University of Washington; Celia Walker, MA - Colorado State University (ret.); Helen McGough, MA - University of Washington (ret.)

Legacy Records-Based Research

Records-based research has its own risks, and researchers who propose to conduct such research must have an understanding of those risks and how to minimize them. Learners will be presented with an overview of the risks associated with and the types of review required for records-based research. They will also learn about privacy and confidentiality, certificates of confidentiality, and the federal privacy law.

Recommended Use: Required
ID (Language): 19226 (English)
Author(s): Judy Matuk, MS - HRP Consulting Group, Inc.

Legacy Genetic Research in Human Populations

Although continued advancements in genetic research present exciting opportunities in biomedicine, they also present some of the most difficult challenges with respect to the protection of human subjects. This content begins with an introduction to the types and complexity of genetic research. Next it provides a review of ethical, legal, and regulatory issues associated with genetic research. Finally, it offers a discussion of the issues surrounding the use of stored biological samples.

Recommended Use: Required
ID (Language): 19227 (English)
Author(s): Jeffrey R. Botkin, MD, MPH - University of Utah

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 Block, PhD, MPP - Icahn School of Medicine at Mount Sinai; Bruce Gordon, MD - The University of Nebraska Medical Center

Legacy Research Involving Prisoners

Describes the special requirements for conducting research with prisoners. The learner is provided with a review of why incarcerated individuals need special protection, as well as the regulatory definition of what constitutes a prisoner. It also includes a discussion of each of the permitted categories for research involving prisoners and the required IRB considerations and determinations pursuant to 45 CFR 46, Subpart C. It concludes with the topic of what happens if an enrolled subject becomes a prisoner.

Recommended Use: Required
ID (Language): 19229 (English)
Author(s): Helen McGough, MA - The University of Washington (ret.)

Legacy Research Involving Children

Describes the major historical events that influenced how research with children can be conducted today. Compares differences between U.S. Department of Health and Human Services regulations (45 CFR 46, Subpart D) and the U.S. Food and Drug Administration regulations (21 CFR 50, Subpart D) for the inclusion of children in research. Reviews the assent and informed consent requirements, and the current efforts by the FDA to ensure the inclusion of children in studies on the safety and efficacy of new drugs. An overview of the categories of research involving children pursuant to 45 CFR 46, Subpart D is provided, including examples.

Recommended Use: Required
ID (Language): 19230 (English)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center

Legacy Vulnerable Subjects - Research Involving Pregnant Women, Fetuses, and Neonates

Discusses the historical exclusion of women of childbearing potential and the special requirements for conducting research involving pregnant women and fetuses. It includes a discussion of each of the permitted categories for research pursuant to 45 CFR 46, Subpart B, involving pregnant women, human fetuses, and neonates, as well as Institutional Review Board (IRB) review requirements and determinations. Informed consent requirements associated with the different categories of research permitted with pregnant women and human fetuses are also discussed.

Recommended Use: Required
ID (Language): 19231 (English)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center; Ernest Prentice, PhD - The University of Nebraska Medical Center


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).