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Biomedical (Biomed) Refresher 1

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical researchers.


About this Course


This Refresher 1 course highlights important concepts from the Human Subjects Research – Biomedical (Biomed) basic course. It covers historical and current information on regulatory and ethical issues important to the conduct of research involving human subjects. It also explores topics with added depth to retrain learners on key points from the basic course.

It should be completed after learners complete the basic Human Subjects Research – Biomed 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, Korean

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 organizational subscription
Independent Learner Price: $110 per person


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

3 Credits
(6 CE certified modules)
$50

19 April 2016
18 April 2019

Psychologists

CE Credit/Hour

3 Credits
(6 CE certified modules)
$50

19 April 2016
18 April 2019

Other Participants

Certificate of Participation

3 Credits
(6 CE certified modules)
$40

19 April 2016
18 April 2019


Course Content


Toggle Content Biomed Refresher 1 – Instructions

Provides instructions for the Biomed Refresher 1 course.

Recommended Use: Required
ID (Language): 960 (English)

Toggle Content Biomed Refresher 1 – History and Ethical Principles CME/CEU Badge

Covers the Belmont Report’s ethical principles including respect for persons, beneficence, and justice as they relate to human subjects research. Based on History and Ethical Principles module.

Recommended Use: Required
ID (Language): 975 (English), 15953 (Korean)

Toggle Content Biomed Refresher 1 – Regulations and Process CME/CEU Badge

Defines “research” and “human subject,” identifies different types of exempt research, and discusses the process for expedited review. Also distinguishes populations where exempt review is not appropriate. Provides refresher training for the basic module Basic Institutional Review Board (IRB) Regulations and Review Process.

Recommended Use: Required
ID (Language): 981 (English), 15954 (Korean)
Author(s): Norma Epley, MS - The University of South Florida

Toggle Content Biomed Refresher 1 – Informed Consent CME/CEU Badge

Reviews key concepts from the basic module Informed Consent. Identifies the process of informed consent, describes the steps necessary to ensure human research subjects are provided the necessary information to make informed choices about their participation in research, and discusses the IRB’s role in reviewing informed consent process and documentation.

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

Recommended Use: Required
ID (Language): 980 (English), 15955 (Korean)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Toggle Content Biomed Refresher 1 – SBR Methodologies in Biomedical Research CME/CEU Badge

Highlights essential topics from the basic module Social and Behavioral Research (SBR) for Biomedical Researchers, including identifying the risks of harm to subjects associated with SBR and presenting some reasons why SBR may be perceived as low risk.

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

Recommended Use: Required
ID (Language): 982 (English), 15956 (Korean)
Author(s): Deborah Dickstein, MSPH - University of Washington; Celia Walker, BA, MA - Colorado State University (ret.)

Toggle Content Biomed Refresher 1 – Records-Based Research CME/CEU Badge

Identifies what levels of regulatory authority apply to research with records, describes the steps to ensure the protection of privacy and confidentiality when using existing records for research, and discusses the IRB’s role regarding informed consent (and waiver of consent) to collect data from existing records. Also discusses what makes records-based research exempt from federal regulations 45 CFR 46, as previously covered in basic module Records-Based Research.

Recommended Use: Required
ID (Language): 983 (English), 15957 (Korean)
Author(s): Judy Matuk, MS - Stony Brook University

Toggle Content Biomed Refresher 1 – Genetics Research CME/CEU Badge

Describes the difference between genetic privacy and confidentiality, lists the information that should be disclosed to subjects during the consent process associated with genetics research, and describes some of the risks of harm associated with genetic research. Expands on concepts covered in the basic module Genetic Research in Human Populations.

Recommended Use: Required
ID (Language): 984 (English), 15958 (Korean)
Author(s): Jeffrey R. Botkin, MD, MPH - University of Utah

Toggle Content Biomed Refresher 1 – Populations in Research Requiring Additional Considerations and/or Protections CME/CEU Badge

Discusses the types of vulnerability that may exist in research subjects and identifies aspects of study design that may make research subjects vulnerable. Summarizes key points from basic module Populations in Research Requiring Additional Considerations and/or Protections.

Recommended Use: Required
ID (Language): 985 (English), 15959 (Korean)
Author(s): David G. Forster, JD, MA, CIP - Western IRB

Toggle Content Biomed Refresher 1 – Research Involving Prisoners CME/CEU Badge

Describes why prisoners need special protections as subjects, identifies the types of research permitted with prisoners, and explains what to do if a subject becomes a prisoner during a research study. Highlights topics covered in 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): 973 (English), 15960 (Korean)
Author(s): Helen McGough, MA - University of Washington (ret.)

Toggle Content Biomed Refresher 1 – Research Involving Children CME/CEU Badge

Identifies the types of research with children permitted under 45 CFR 46, Subpart D and the requirements for consent and assent as covered in basic module Vulnerable Subjects – Children.

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

Recommended Use: Required
ID (Language): 974 (English), 15961 (Korean)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center

Toggle Content Biomed Refresher 1 – Research Involving Pregnant Women, Fetuses, and Neonates CME/CEU Badge

Provides refresher training for the basic module Vulnerable Subjects – Pregnant Women, Human Fetuses, and Neonates. Reviews when research involving pregnant women or fetuses is permitted, who may be involved in the decision to terminate a pregnancy, and when consent of the mother or the father is required in keeping with 45 CFR 46, Subpart B.

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

Recommended Use: Required
ID (Language): 986 (English), 15962 (Korean)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center; Ernie Prentice, PhD - University of Nebraska Medical Center

Toggle Content Biomed Refresher 1 – FDA-Regulated Research CME/CEU Badge

Explains the role of the FDA and when an investigational new drug (IND) application may be necessary. Defines what constitutes "off label" use of drugs, devices, and biologics and covers emergency use of an investigational biologic, drug, or device in human subject research. Provides in-depth review of topics covered in module FDA-Regulated Research.

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

Recommended Use: Required
ID (Language): 987 (English), 15963 (Korean)
Author(s): Susan Kornetsky, MPH - Children's Hospital Boston; David G. Forster, JD, MA, CIP - Western IRB; Gary L. Chadwick, PharmD, MPH, CIP - The University of Rochester / HRP Consulting Group, Inc.

Toggle Content Biomed Refresher 1 – Research and HIPAA Privacy Protections New/Updated Badge

Discusses the HIPAA requirements for research data related to security and explains data security goals of researchers and organizations in light of HIPAA and similar requirements. Summarizes key issues identified in basic module Research and HIPAA Privacy Protections.

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

Recommended Use: Required
ID (Language): 17261 (English)
Author(s): Reid Cushman, PhD - CITI Program

Toggle Content Biomed Refresher 1 – Conflicts of Interest in Human Subjects Research New/Updated Badge

Defines interests and relationships that may result in a COI, and distinguishes different types of COIs in research through examples.

Recommended Use: Required
ID (Language): 17544 (English)
Author(s): Julie Moore, JD, MS, PA, CIP - University of South Florida; Cristy McGoff, MA - Harvard University