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Biomedical (Biomed) Refresher 3

This course 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 Refresher 3 course summarizes the essential points from the Human Subjects Research – Biomedical (Biomed) basic course that are most important to the conduct of research involving human subjects. Short, condensed content focuses on practical issues in human subjects protection for the experienced learner.

It should be completed after learners complete the second refresher course in this series, Human Subjects Research – Biomedical (Biomed) Refresher 2 course.  It is generally recommended that organizations select refresher content requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle at an interval specified by your organization (for example, Refresher Stage 1: 3 years after completion of basic course; Refresher Stage 2: 6 years after completion of basic course).

Language Availability: English

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


CE Credits and Units


To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first.

Physicians

AMA PRA Category 1 Credit

1 Credit
(3 CE certified modules)
$20

2 Credits
(6 CE certified modules)
$40

1 November 2016
31 October 2019

Psychologists

CE Credit/Hour

2 Credits
(3 CE certified modules)
$40

1 November 2016
31 October 2019

Other Participants

Certificate of Participation

1 Credit
(3 CE certified modules)
$15

2 Credits
(6 CE certified modules)
$30

1 November 2016
31 October 2019


Course Content


Toggle Content Biomed Refresher 3 – Instructions

Provides instructions for the Biomed Refresher 3 course.

Recommended Use: Required
ID (Language): 12631 (English)

Toggle Content Biomed Refresher 3 – History and Ethical Principles – Research vs. Practice CME/CEU Badge

Reviews the basic modules History and Ethics of Human Subjects Research and Basic Institutional Review Board (IRB) Regulations and Process. Distinguishes between the regulatory definitions of “research” and “practice,” by providing examples applicable to human subjects research.

Recommended Use: Required
ID (Language): 993 (English)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center

Toggle Content Biomed Refresher 3 – History and Ethical Principles – Belmont Principles CME/CEU Badge

Provides a review of the key themes from the basic modules History and Ethics of Human Subjects Research and Basic Institutional Review Board (IRB) Regulations and Process. Defines how "Respect for Persons", "Beneficence", and "Justice" are used in the Belmont Report and how each applies to research involving human subjects.

Recommended Use: Required
ID (Language): 12640 (English)

Toggle Content Biomed Refresher 3 – Regulations and Process – IRB Authority and Composition CME/CEU Badge

Summarizes what the IRBs are authorized to do by federal regulations and describes the required composition of an IRB. Based on module Basic Institutional Review Board (IRB) Regulations and Process.

Recommended Use: Required
ID (Language): 12644 (English)

Toggle Content Biomed Refresher 3 – Regulations and Process – IRB Responsibilities CME/CEU Badge

Considers key concepts of regulatory responsibilities of the IRB related to the requirements for approval of research involving human subjects from the basic modules History and Ethics of Human Subjects Research and Basic Institutional Review Board (IRB) Regulations and Process. Identifies the Belmont Report principles as reflected in the IRB’s responsibilities.

Recommended Use: Required
ID (Language): 12645 (English)

Toggle Content Biomed Refresher 3 – Informed Consent CME/CEU Badge

Reviews the basic and additional elements of informed consent as presented in the basic module Informed Consent.

Recommended Use: Required
ID (Language): 1003 (English)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Toggle Content Biomed Refresher 3 – Genetics Research CME/CEU Badge

Reviews the risks and regulatory issues relevant to research using stored biospecimens as covered in the basic module Genetic Research in Human Populations.

Recommended Use: Required
ID (Language): 12633 (English)
Author(s): Jeffrey R. Botkin, MD, MPH - University of Utah

Toggle Content Biomed Refresher 3 – SBR Methodologies in Biomedical Research CME/CEU Badge

Summarizes various SBR data collection methods used by biomedical researchers SBR data collection methods often used by biomedical researchers from the basic module Social and Behavioral Research for Biomedical Researchers.

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

Recommended Use: Required
ID (Language): 1004 (English)
Author(s): Helen McGough, MA - University of Washington (ret.)

Toggle Content Biomed Refresher 3 - Populations in Research Requiring Additional Considerations and/or Protections CME/CEU Badge

Reviews key concepts of vulnerability from the basic module Biomed Refresher 3 - Populations in Research Requiring Additional Considerations and/or Protections. Identifies the meaning of social, institutional, and deferential vulnerabilities. Describes safeguards that may be used to address the vulnerabilities.

Recommended Use: Required
ID (Language): 12643 (English)
Author(s): David Forster, JD, MA, CIP - Western IRB

Toggle Content Biomed Refresher 3 – Vulnerable Subjects - Prisoners CME/CEU Badge

Provides another look at research involving prisoners by identifying important considerations. Reviews definition of “prisoner” and describes research allowed under the regulations as outlined in basic module Vulnerable Subjects - Research Involving Prisoners.

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

Recommended Use: Required
ID (Language): 12647 (English)
Author(s): Helen McGough, MA - University of Washington (ret.)

Toggle Content Biomed Refresher 3 – Vulnerable Subjects - Children CME/CEU Badge

Lists the conditions under which the requirement for parental permission may be waived. Basic module Vulnerable Subjects - Research Involving Children serves as the foundation for this module.

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

Recommended Use: Required
ID (Language): 12648 (English)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center

Toggle Content Biomed Refresher 3 – Vulnerable Subjects – Pregnant Women, Human Fetuses, and Neonates CME/CEU Badge

Reviews the requirements of 45 CFR 46, Subpart B, for research involving pregnant women, human fetuses, and neonates. Includes IRB considerations and outlines who provides consent. The basic module Vulnerable Subjects – Pregnant Women, Human Fetuses, Neonates serves as the basis of this module.

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

Recommended Use: Required
ID (Language): 12649 (English)

Toggle Content Biomed Refresher 3 - Research and HIPAA Privacy Protections New/Updated Badge

Summarizes HIPAA’s protections for health data that are used for human subjects research, such as privacy notices, authorizations, accountings of disclosures, and minimum necessary usage.

Recommended Use: Required
ID (Language): 17265 (English)
Author(s): Reid Cushman, PhD
 - CITI Program

Toggle Content Biomed Refresher 3 – Conflicts of Interest in Human Subjects Research New/Updated Badge

Reviews management strategies for individual and institutional COIs in research and describes management controls that can be included in the study design or put into place by a COI management plan.

Recommended Use: Required
ID (Language): 17546 (English)
Author(s): Julie Moore, JD, MS, PA, CIP - Julie Moore, JD, MS, PA, CIP; Cristy McGoff, MA - Harvard University