IRB Member – Social-Behavioral-Educational Focus

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

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

Discusses the evolution of the ethical principles in the U.S. that guide research design as well as the development of the federal regulations that govern the conduct of research relevant to researchers in the social and behavioral sciences. It reviews why ethics are necessary when conducting research involving human subjects including major historical events that have influenced how human subjects’ research is conducted.

It also describes problems with past studies that have violated ethical standards or have raised ethical concerns that have contributed to the national dialog related to the protection of human subjects. The Belmont Report principles are discussed as the basis for the ethical standards for research that guide us today.

Recommended Use: Required
ID (Language): 490 (English), 15896 (Korean), 16449 (French), 16460 (Spanish)
Author(s): Lisa Robinson Bailey, MA - Duke University

Defines the terms “human subject” and “research” with an emphasis on the interpretation for human subjects research in the social and behavioral sciences. Also included is a discussion as to the differences between private and public information and behavior, a critical aspect of many types of social and behavioral research.

Recommended Use: Required
ID (Language): 491 (English), 15897 (Korean), 16450 (French), 16461 (Spanish), 16111 (Vietnamese)
Author(s): Lorna Hicks, MS, CIP - Duke University

Describes the federal regulations and their basic provisions for human subjects research. It provides specific examples of the ways in which the federal regulations are particularly pertinent to social and behavioral science researchers and methodologies.

It also discusses the criteria for exemption from the federal regulations, describes criteria for the use of expedited review procedures and institutional review board (IRB) review, summarizes the authority and scope of an IRB, and describes the kinds of additional IRB review that approved research may need. In addition, it reviews regulatory information pertinent to social and behavioral research including the criteria for expedited and full board review and the authority of the IRB.

Recommended Use: Required
ID (Language): 502 (English), 15898 (Korean), 16451 (French), 16462 (Spanish)
Author(s): Lorna Hicks, MS, CIP - Duke University

Presents the challenges in identifying and evaluating risks associated with participation in social and behavioral sciences research. Unlike biomedical clinical trials, risks associated with social and behavioral science research are often elusive and less predictable. Topics include assessing risks, balancing risks and potential benefits, minimizing and managing risks, certificates of confidentiality, and ways to address risks in the informed consent document and process.

Recommended Use: Required
ID (Language): 503 (English), 15899 (Korean), 16452 (French), 16463 (Spanish), 16112 (Vietnamese)
Author(s): Tracy Arwood, MS - Clemson University; Sangeeta Panicker, PhD - American Psychological Association

Discusses the process and documentation of informed consent, including informed consent guidelines as well as the required and additional elements of informed consent as described by the federal regulations 45 CFR 46. There is also a discussion of the circumstances under which an Institutional Review Board (IRB) may waive the requirements for informed consent with examples of how this is commonly applied in social and behavioral sciences research. Includes information related to recruitment, ensuring consent comprehension, timing of consent, documentation of consent, safeguards for vulnerable subjects during consent, and exculpatory language.

Recommended Use: Required
ID (Language): 504 (English), 15900 (Korean), 16453 (French), 16464 (Spanish)
Author(s): Lorna Hicks, MS, CIP - Duke University

Distinguishes between privacy and confidentiality and identifies privacy risks associated with social behavioral study designs. Includes a discussion on protecting privacy in research and guidelines for designing confidentiality procedures. Topics include private versus public behavior, controlling access to private information, privacy and exempt research, privacy and research methods, confidentiality, privacy and reporting laws, and certificates of confidentiality. The discussion focuses on how these concepts apply to social and behavioral science research.

Recommended Use: Required
ID (Language): 505 (English), 15901 (Korean), 16454 (French), 16465 (Spanish), 16113 (Vietnamese)
Author(s): Lorna Hicks, MS, CIP - Duke University

Examines the regulatory definition of “prisoner” and describes the requirements for conducting research with prisoners pursuant to 45 CFR 46 Subpart C. Reviews the permitted categories of research involving prisoners and Institutional Review Board (IRB) review considerations. Importantly, it contains a discussion on essential elements related to designing prisoner research, including consent issues, free choice, use of incentives, limits to confidentiality, when an enrolled subject becomes a prisoner, and the assessment of risk. It concludes with information related to accessing prisoner populations.

Recommended Use: Supplemental
ID (Language): 506 (English), 15902 (Korean)
Author(s): Stephan Kiefer, PhD - Copernicus Group IRB; Glenn C. Veit, JD, CIP - Copernicus Group IRB

Identifies regulations that apply to research with children. Defines “children” and discusses examples of research that meet the criteria of exempt research and expedited review and issues involved in obtaining and documenting parental permission and child assent. Discusses the four risk level categories according to 45 CFR 46 Subpart D. Included in the discussion is a review of the criteria for waiver of parental permission and/or child assent.

Recommended Use: Supplemental
ID (Language): 507 (English), 15903 (Korean), 16455 (French), 16466 (Spanish)
Author(s): Lorna Hicks, MS, CIP - Duke University

Provides an overview of the types of public school research and the regulations that apply to research in these settings. Individual sections discuss the Family Educational Rights and Privacy Act (FERPA), the Protection of Pupil Rights Amendment (PPRA), and at 45 CFR 46 Subpart D (Additional Safeguards for Children). Examples of activities that may qualify for exemption are discussed. It concludes with a discussion of parental permission and child assent issues, as well as research-related harms to children and requirements for reporting observed child abuse and neglect.

Recommended Use: Supplemental
ID (Language): 508 (English), 15904 (Korean)
Author(s): Lorna Hicks, MS, CIP - Duke University

Social and behavioral scientists conduct research around the globe. It includes a discussion of applicable regulations and guidelines and the importance of the local research context. Because international research may also include collaborating institutions, it provides information related to “engagement” in research. Additional topics include determining where research should be reviewed, exempt research, and informed consent considerations.

Recommended Use: Supplemental
ID (Language): 509 (English), 15905 (Korean), 16456 (French), 16467 (Spanish)
Author(s): Lorna Hicks, MS, CIP - Duke University; Mary Simmerling, MA - University of Chicago

Identifies some of the ways in which social, behavioral, and educational researchers are using new Internet technologies. Discusses application of the federal definition of research with human subjects to Internet-based research and how ethical principles can be applied in the design, conduct, and review of Internet-based research. Presents issues associated with obtaining consent online and explains why privacy and confidentiality may be of particular concern for Internet-based research. Reviews challenges with assessing risks of harm in Internet-based research and issues that must be addressed.

Recommended Use: Supplemental
ID (Language): 510 (English), 15907 (Korean), 16457 (French), 16114 (Vietnamese)
Author(s): Alejandro Martinez, MPA, CIP - Duke University

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

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

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

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

Discusses issues around student data and privacy from the perspective of IRBs that are reviewing research on human subjects in various educational settings (public secondary and elementary schools, and postsecondary institutions). Provides education to IRB administrators and members on the role of IRBs as they relate to FERPA, potential FERPA issues during IRB review of a research plan (including consent, data requests, and compliance with the Protection of Pupil Rights Amendment [PPRA]), and strategies for researchers to collect, handle, and analyze student records in compliance with FERPA.

Note: This module is part of the CITI Program’s Information Privacy and Security (IPS) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Information Privacy and Security (IPS) to your organization’s subscription.

Recommended Use: Supplemental
ID (Language): 17411 (English)
Author(s): Thomas Gold, PhD - Acceleration Group, Inc.

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

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

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

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

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