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).

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Language Availability: English

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

Organizational Subscription Price: Included with Human Subjects Research series, available as part of an organizational subscription package or for $1,000 as an add-on to current subscriptions.
Independent Learner Price: $129 per person

Demo Instructions


Course Content

Biomed Refresher 3 – Instructions

Provides instructions for the Biomed Refresher 3 course.

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

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

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)

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)

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)

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

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 Botkin, MD, MPH - University of Utah

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.)

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

Biomed Refresher 3 – Research Involving 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.)

Biomed Refresher 3 – Research Involving 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

Biomed Refresher 3 – Research Involving Pregnant Women, 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)

Biomed Refresher 3 - Research and HIPAA Privacy Protections

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

Biomed Refresher 3 – Conflicts of Interest in Human Subjects Research

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, CIP - Harvard University


CME/CEU Credits

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. Learn more about CE/CME Credits.

Physicians
AMA PRA Category 1 Credit
3 Credits
(5 CE certified modules)
$60

5 Credits
(8 CE certified modules)
$80
1 June 2021
31 May 2024
Psychologists
CEP Credit/Hour
3 Credits
(5 CE certified modules)
$60

5 Credits
(8 CE certified modules)
$80
1 June 2021
31 May 2024
Pharmacists
CPE Contact Hour
3 Credits
(5 CE certified modules)
$60

5 Credits
(8 CE certified modules)
$80
1 June 2021
31 May 2024
Dentists
ADA CERP Credit
3 Credits
(5 CE certified modules)
$60

5 Credits
(8 CE certified modules)
$80
1 May 2022
31 May 2024
Optometrists
COPE CE Credit
3 Credits
(5 CE certified modules)
$60

5 Credits
(8 CE certified modules)
$80
1 May 2022
31 May 2024
Nurses
Nursing Contact Hour
3 Credits
(5 CE certified modules)
$50

5 Credits
(8 CE certified modules)
$70
1 June 2021
31 May 2024
Dietitians
CDR CPEU
3 Credits
(5 CE certified modules)
$50

5 Credits
(8 CE certified modules)
$70
1 May 2022
31 May 2024
Social Workers
Ethics CE Credit
3 Credits
(5 CE certified modules)
$50

5 Credits
(8 CE certified modules)
$70
1 June 2021
31 May 2024
Athletic Trainers
Category A hour/CEU
3 Credits
(5 CE certified modules)
$50

5 Credits
(8 CE certified modules)
$70
1 May 2022
31 May 2024
Other Participants
Certificate of Participation
3 Credits
(5 CE certified modules)
$50

5 Credits
(8 CE certified modules)
$70
1 June 2021
31 May 2024


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