IRB Member – Biomedical Focus

Provides foundational training for IRB members involved in the review of biomedical human subjects research.

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About this Course

This course is for IRB members who review biomedical research. It provides an overview of IRB responsibilities, tools, expectations, and review processes. It also offers historic and current information on regulatory and ethical issues important to the conduct of biomedical research involving human subjects. Case studies are used within the modules to present key concepts. This course has been updated to reflect the 2018 Requirements of the Common Rule.

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Note: This course is comprised of modules from our HSR Biomedical Comprehensive course.

Language Availability: English

Suggested Audiences: IRB members who review biomedical research

Organizational Subscription Price: For independent learners only
Independent Learner Price: $149 per person

Demo Instructions

Course Content

The IRB Member Module - "What Every New IRB Member Needs to Know”

Designed as an overview and resource for individuals joining an Institutional Review Board (IRB). It includes discussions on time commitment, liability, the role of the IRB chair, and the levels of review. An overview of IRB tools, including the content of new submissions as well as what is often seen during committee review provides a foundation for new IRB members and is complimented by a discussion of how an IRB member can review protocols. It concludes with information related to the IRB meeting, including the importance of quorum, the types of IRB decisions, and the review of meeting minutes. It is designed for new members, but may also be useful for any IRB member who continues to serve on an IRB.

Note: This module is meant as a supplement to the Human Subjects Research series, and should be used to enhance IRB member training by adding specific information intended for members.

Recommended Use: Required
ID (Language): 816 (English), 15946 (Korean)
Author(s): Cheryl A. Savini - HRP Consulting Group, Inc.; Judy Matuk, MS - HRP Consulting Group, Inc.; Allison Handler, BSN, CCRC - University of North Carolina at Chapel Hill; Lawrence B. Rosenfeld, PhD - University of North Carolina at Chapel Hill

External IRB Review

Reviews history and developments of external IRB review, the variety of relationships between institutions and IRBs, and the agreements and obligations involved in those relationships. Covers major arguments for and against institutional acceptance of an external IRB, defines several types of relationships between research institutions and external IRBs, describes operational differences, reviews different types of reliance agreements, and discusses factors that contribute to the increasing use of centralized IRB review.

Recommended Use: Required
ID (Language): 16711 (English)
Author(s): Erica Heath, CIP, MBA - Ethical and Independent Review Services, LLC

History and Ethics of Human Subjects Research

Discusses ethical principles for the conduct of research involving human subjects. It provides an overview of the historical events that influenced the development of the current regulatory requirements, a review of the Belmont Principles, and a discussion of the contemporary ethical standards that guide research today.

Recommended Use: Required
ID (Language): 498 (English), 15924 (Korean), 1478 (Spanish)
Author(s): Jeffrey M. Cohen, PhD, CIP - HRP Consulting Group, Inc.

Basic Institutional Review Board (IRB) Regulations and Review Process

Provides foundational information about the human subject protection regulations and IRBs, including the role, authority, and composition of the IRB. It discusses different types of IRB review processes, including an overview of the essential issues associated with exempt, expedited, and full (convened) IRB reviews.

The information presented is based on the Common Rule as codified by the U.S. Department of Health and Human Services at 45 CFR 46, Subpart A. It concludes with a discussion of additional regulations and requirements (including the U.S. Food and Drug Administration and the International Council for Harmonisation), as well as others (for example, the National Institutes of Health and the U.S. Department of Education) that require compliance based on certain types of research.

Recommended Use: Required
ID (Language): 2 (English), 15923 (Korean), 1479 (Spanish), 15884 (Vietnamese)
Author(s): Ada Sue Selwitz, MA - The University of Kentucky; Norma Epley, MS - East Carolina University; Janelle Erickson, MPH - Seattle BioMedical Research Institute

Informed Consent

Presents the framework for informed consent found within the Common Rule (45 CFR 46, Subpart A), including the process and documentation of informed consent. Some of the special challenges associated with informed consent in research are also discussed, including informed consent as it relates to vulnerable populations, the requirements for waiver of informed consent, as well as the differences between U.S. Food and Drug Administration and U.S. Department of Health and Human Services regulations.

Recommended Use: Required
ID (Language): 3 (English), 15926 (Korean), 1480 (Spanish)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Social and Behavioral Research (SBR) for Biomedical Researchers

Discusses SBR techniques within the framework of biomedical research and the nature, risks, and benefits associated with these techniques. Included in this discussion are the types of biomedical studies that utilize SBR techniques, along with the kinds of data collected. It concludes with the risks and benefits that are unique to SBR

Recommended Use: Required
ID (Language): 4 (English), 15927 (Korean), 1718 (Spanish), 15886 (Vietnamese)
Author(s): Deborah Dickstein, MSPH - University of Washington; Celia Walker, MA - Colorado State University (ret.); Helen McGough, MA - University of Washington (ret.)

Records-Based Research

Records-based research has its own risks, and researchers who propose to conduct such research must have an understanding of those risks and how to minimize them. Learners will be presented with an overview of the risks associated with and the types of review required for records-based research. They will also learn about privacy and confidentiality, certificates of confidentiality, and the federal privacy law.

Recommended Use: Required
ID (Language): 5 (English), 15928 (Korean), 1490 (Spanish), 16242 (Vietnamese)
Author(s): Judy Matuk, MS - HRP Consulting Group, Inc.

FDA-Regulated Research

Addresses U.S. Food and Drug Administration-regulated clinical research and the responsibilities of researchers, IRBs, and sponsors when an FDA-regulated product is utilized in a study. In particular, it includes information on when an Investigational New Drug (IND) application is necessary and the requirements of Form FDA 1572. Medical devices research, including defining a medical device, classifying risk, and when an investigational device exemption (IDE) is needed are also presented. Lastly, it addresses FDA regulations about informed consent, emergency use, and 21 CFR Part 11 and electronic records and signatures.

Recommended Use: Required
ID (Language): 12 (English), 15936 (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

Populations in Research Requiring Additional Considerations and/or Protections

Provides an introduction to potentially vulnerable populations or those requiring additional protections and/or considerations in research. It describes different sources of vulnerability and distinguishes between populations in research who are specifically protected in the federal regulations and those who are not. It also includes the impact on autonomy, beneficence, and justice that may arise due to research on or with vulnerable individuals or groups.

Recommended Use: Required
ID (Language): 16680 (English), 15930 (Korean), 19566 (French), 19563 (Spanish)
Author(s): Jeremy Block, PhD, MPP - Icahn School of Medicine at Mount Sinai; Bruce Gordon, MD - The University of Nebraska Medical Center

Research Involving Prisoners

Describes the special requirements for conducting research with prisoners. The learner is provided with a review of why incarcerated individuals need special protection, as well as the regulatory definition of what constitutes a prisoner. It also includes a discussion of each of the permitted categories for research involving prisoners and the required IRB considerations and determinations pursuant to 45 CFR 46, Subpart C. It concludes with the topic of what happens if an enrolled subject becomes a prisoner.

Recommended Use: Required
ID (Language): 8 (English), 15931 (Korean), 1482 (Spanish)
Author(s): Helen McGough, M.A. - The University of Washington (ret.)

Research Involving Children

Describes the major historical events that influenced how research with children can be conducted today. Compares differences between U.S. Department of Health and Human Services regulations (45 CFR 46, Subpart D) and the U.S. Food and Drug Administration regulations (21 CFR 50, Subpart D) for the inclusion of children in research. Reviews the assent and informed consent requirements, and the current efforts by the FDA to ensure the inclusion of children in studies on the safety and efficacy of new drugs. An overview of the categories of research involving children pursuant to 45 CFR 46, Subpart D is provided, including examples.

Recommended Use: Required
ID (Language): 9 (English), 15932 (Korean), 1498 (Spanish), 16551 (Vietnamese)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center

Research Involving Pregnant Women, Fetuses, and Neonates

Discusses the historical exclusion of women of childbearing potential and the special requirements for conducting research involving pregnant women and fetuses. It includes a discussion of each of the permitted categories for research pursuant to 45 CFR 46, Subpart B, involving pregnant women, human fetuses, and neonates, as well as Institutional Review Board (IRB) review requirements and determinations. Informed consent requirements associated with the different categories of research permitted with pregnant women and human fetuses are also discussed.

Recommended Use: Required
ID (Language): 10 (English), 15933 (Korean), 1499 (Spanish), 16552 (Vietnamese)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center; Ernest D. Prentice, PhD - The University of Nebraska Medical Center

Vulnerable Subjects - Research Involving Workers/Employees

Describes why workers/employees may be a vulnerable population when they participate in research, and the potential risks and benefits associated with research involving workers/employees. It also discusses protections that need to be afforded to workers/employees. It proposes that while workers/employess may serve as study subjects for political as well as scientific reasons, adequacy of the science and adherence to the Common Rule (45 CFR 46, Subpart A), are paramount.

Excerpted from: The Department of Energy Guidebook Creating an Ethical Framework for Studies that Involve the Worker Community and "Workers as Research Subjects: A Vulnerable Population", Susan L. Rose, PhD and Charles E. Pietri, BA from J. Occup Environ Med. 2002;44:801-805. Used with permission.

Recommended Use: Required
ID (Language): 483 (English), 15944 (Korean), 1720 (Spanish)
Author(s): Susan L. Rose - University of Southern California (retired); Charles E. Pietri - Department of Energy

Avoiding Group Harms - U.S. Research Perspectives

Describes some distinct groups or communities of people who are vulnerable to group harms and is intended for individuals conducting research in the U.S. In addition, learners are presented with examples of research that has caused group harms. This module concludes with strategies that researchers can take to reduce the risk of group harms.

Recommended Use: Required
ID (Language): 14080 (English), 15934 (Korean), 1719 (Spanish), 16118 (Vietnamese)
Author(s): Helen McGough, MA - University of Washington (ret.)

Genetic Research in Human Populations

Although continued advancements in genetic research present exciting opportunities in biomedicine, they also present some of the most difficult challenges with respect to the protection of human subjects. This content begins with an introduction to the types and complexity of genetic research. Next it provides a review of ethical, legal, and regulatory issues associated with genetic research. Finally, it offers a discussion of the issues surrounding the use of stored biological samples.

Recommended Use: Required
ID (Language): 6 (English), 15929 (Korean), 1672 (Spanish), 15887 (Vietnamese)
Author(s): Jeffrey Botkin, MD, MPH - University of Utah

Conflicts of Interest in Human Subjects Research

Provides an overview of COIs in human subjects research by identifying when an interest or relationship may result in a COI, differentiating types of COIs and when they should be reported, and discussing challenges and strategies to manage both individual and institutional COIs.  This module also reviews federal regulations that govern disclosure and management of individual COIs.

Recommended Use: Required
ID (Language): 17464 (English)
Author(s): Julie Moore, JD, MS, PA, CIP - University of South Florida; Cristy McGoff, MA, CIP - Harvard University

Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research

The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services human subject protection regulations require institutions to have policies and procedures to ensure prompt reporting of unanticipated problems (UPs) involving risk to subjects or others to the IRB, regulatory agencies, and appropriate institutional officials. In addition, FDA regulations require researchers to promptly report to the IRB all UPs involving risk to subjects or others and unanticipated adverse device effects. This content is intended to provide guidance to researchers on complying with reporting requirements by providing an overview of UPs, unanticipated adverse device effects, and the relationship between adverse events and UPs involving risk to subjects or others. It includes a discussion on how to detect UPs and how to report them.

Recommended Use: Required
ID (Language): 14777 (English), 16555 (Vietnamese)
Author(s): Patricia A. MacCubbin, MS - Research Ethics Group

Research and HIPAA Privacy Protections

Discusses the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and how they supplement the U.S. Department of Health and Human Services (HHS) and U.S. FDA requirements. It also describes situations where full HIPAA privacy protections are required and those that can qualify for waivers, alterations or exemptions with more limited requirements. In addition, it reviews the responsibilities of researchers and institutions for meeting HIPAA privacy requirements and for appropriate data security protections that are necessary to protect privacy.

Recommended Use: Required
ID (Language): 14 (English), 15942 (Korean)
Author(s): Reid Cushman, PhD - CITI Program

Additional Modules of Interest

I Have Agreed to be an IRB Community Member. Now What?

This content is designed for new Institutional Review Board (IRB) community members, but may be useful to anyone involved with human subjects research. Provides basic information and tools related to IRBs, including an overview of definitions and the regulations, and strategies for a community member to become a well-informed IRB member. Offers an overview of various aspects of the IRB review processes as they relate to specific types of protocols. 

It was prepared for U.S. IRB community members; however, it serves as a resource for community/unaffiliated/lay members of other review bodies (such as Independent Ethics Committees). Bodies of review vary by country, but are generally charged with evaluating research protocols according to local ethical standards and regulations.

Recommended Use: Supplemental
ID (Language): 13018 (English), 15947 (Korean)
Author(s): Jackie Galvez - University of Southern California; Susan L. Rose, PhD - University of Southern California; Jennifer Hagemann, MS - University of Southern California; Monica Aburto - University of Southern California

Single Institutional Review Board (sIRB) Use and Administration: When Relying on a sIRB

Explores key considerations when implementing sIRB relationships and what a participating site needs to do in preparation for relying on an external sIRB.

Recommended Use: Supplemental
ID (Language): 17387 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Raffaella Hart, MSHS, CIP - BRANY IRB

Single Institutional Review Board (sIRB) Use and Administration: When Serving as a sIRB of Record

Discusses key elements and considerations for setting up an IRB to serve as a sIRB.

Recommended Use: Supplemental
ID (Language): 17388 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Raffaella Hart, MSHS, CIP - BRANY IRB

Single Institutional Review Board (sIRB) Use and Administration: Authorization Agreements

Introduces best practices for drafting, reviewing, and implementing authorization agreements between the sIRB and participating sites in multi-site research.

Recommended Use: Supplemental
ID (Language): 17392 (English)
Author(s): Cindy Gates, JD, RN, CIP - University of Miami

The IRB Administrator’s Responsibilities

Provides the foundation for the IRB administrators’/directors’ responsibilities including communication, interpretation and implementation of regulations, training and professional development, managing grants and contracts, preparing reports, and interacting with the media. Reviews basic policies and procedures that institutions should have with regard to the human subjects protection program, including the IRB.

Recommended Use: Supplemental
ID (Language): 13813 (English), 15949 (Korean)
Author(s): Norma Epley, M.S. - East Carolina University; Christy Stephens - Moffitt Cancer Center

IRB Risk Assessment of Technologies in Human Subjects Research

The use of technologies, such as mobile apps, wearable devices, artificial or augmented intelligence (AI), machine learning, and nanotechnology, will soon be standard in biomedical and social-behavioral-educational human subjects research. The use of such technologies enables researchers to electronically capture research data that could help to control data reliability, ensure data integrity, perform remote monitoring, and comply with the requirements for regulatory documentation. These technologies also present new privacy, confidentiality, safety, and social challenges.

This module provides IRB members and administrators with a framework for assessing the risks of technologies, whether the technology is helping conduct the research or is itself the subject of the research. It also identifies strategies to mitigate such risks. For researchers, this module provides context for how the IRB will review their work on and/or involving technology. It identifies ethical and regulatory dimensions of novel technology and considers ways to assess the risk of technology in research. The case studies in this module illustrate examples of using a risk assessment framework for both social-behavioral-educational and biomedical research.

Recommended Use: Supplemental
ID (Language): 20480 (English)
Author(s): Kimberley Serpico, EdD, CIP - Harvard T.H. Chan School of Public Health; Barbara Bierer, MD - Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), Vivli, Inc., Harvard Medical School; Joseph Zurba, CISSP, CISA - Harvard Medical School; Tonya Ferraro, MEd - Boston Children’s Hospital; Aaron Kirby, MSc - Harvard Medical School; Anna Suojanen, MPH - Harvard University

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