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Legacy Biomedical (Biomed) Refresher

This legacy version (reflecting the pre-2018 requirements of the Common Rule) provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical researchers.

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About this Course


This legacy version of the Refresher course reviews key issues from the Human Subjects Research – Biomedical (Biomed) Basic course. It expands on topics covered in the basic course through summarizing the most important points from the foundational basic course. It also provides in-depth condensed retraining for human subjects protections.

It is generally recommended that organizations select refresher content requirements that reflect their selections for the basic course(s).

Note: This course does not reflect the 2018 requirements version of the Common Rule. 

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 organizational subscription
Independent Learner Price: $99 per person


Course Content


Legacy Biomed Refresher – History and Ethical Principles

Describes the ethical principles of respect for persons, beneficence, and justice from the Belmont Report. Presents a case study with a discussion identifying the roles of the ethical principles. Provides refresher training for the basic modules History and Ethics of Human Subjects Research and Basic Institutional Review Board (IRB) Regulations and Process.

Recommended Use: Required
ID (Language): 19232 (English)
Author(s): Elizabeth Bankert, MA - Dartmouth College; Jeffrey A. Cooper, MD - Huron Consulting Group, Inc.

Legacy Biomed Refresher – Regulations and Process

Summarizes the module Basic Institutional Review Board (IRB) Regulations and Review Process. Describes the regulatory definition of “research” as it applies to human subjects research and identifies the components of the definition “human subjects.”

Recommended Use: Required
ID (Language): 19233 (English)
Author(s): Ada Sue Selwitz, MA - University of Kentucky; Janelle R. Erickson, MPH - Seattle BioMedical Research Institute

Legacy Biomed Refresher – Informed Consent

Reviews the requirements for waiving or altering elements of informed consent and considerations for both IRBs and researchers to understand. Identifies the requirements for waiving the requirement for obtaining signed informed consent forms (documentation). Summarizes key points from Informed Consent.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 19234 (English)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Legacy Biomed Refresher – SBR Methodologies in Biomedical Research

Reviews the module Social and Behavioral Research for Biomedical Researchers. Identifies the risks from non-biomedical research methods and some of the ways these risks can be minimized.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 19235 (English)
Author(s): Deborah Dickstein, MSPH - University of Washington; Celia Walker, MA - Colorado State University (ret.)

Legacy Biomed Refresher – Records-Based Research

Takes another look at the key issues presented in the module Records-Based Research. Identifies types of review that apply to records-based research and note examples of records-based research that are appropriate for the different levels of review.

Recommended Use: Required
ID (Language): 19236 (English)
Author(s): Judy Matuk, MS - HRP Consulting Group, Inc.

Legacy Biomed Refresher – Genetics Research

Recommended Use: Required
ID (Language): 19237 (English)
Author(s): Jeffrey R. Botkin, MD, MPH - University of Utah

Legacy Biomed Refresher – Populations in Research Requiring Additional Considerations and/or Protections

Describes the elements of autonomy and its role in research. Discusses the relationship between autonomy and populations in research requiring additional considerations and/or protections. Reviews key concepts from the module Populations in Research Requiring Additional Considerations and/or Protections.

Recommended Use: Required
ID (Language): 19238 (English)
Author(s): David Forster, JD, MA, CIP - Western IRB

Legacy Biomed Refresher – Vulnerable Subjects – Prisoners

Defines “prisoner” pursuant to 45 CFR 46 and discusses why prisoners need additional protections in research based on the basic module Vulnerable Subjects – Prisoners.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 19239 (English)
Author(s): Helen McGough, MA - University of Washington (ret.)

Legacy Biomed Refresher – Vulnerable Subjects – Children

Describes the various parental permission requirements associated with the different types of permitted research with children under 45 CFR 46, Subpart D. Identifies when child assent is also required and when it may be waived. Condenses essential topics covered in Vulnerable Subjects – Children.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 19240 (English)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center

Legacy Biomed Refresher – Vulnerable Subjects – Pregnant Women, Human Fetuses, and Neonates

Reviews the requirements for conducting research with neonates of uncertain viability pursuant to 45 CFR 46, Subpart B. Abridged version of Vulnerable Subjects – Pregnant Women, Human Fetuses, and Neonates.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 19241 (English)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center; Ernie Prentice, PhD - University of Nebraska Medical Center