Biomedical (Biomed) Refresher 3

Provides instructions for the Biomed Refresher 3 course.

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

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

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)

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)

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)

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

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

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.)

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

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.)

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

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)

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

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