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Social-Behavioral-Educational (SBE) Basic

This course covers the core human subjects research topics for social-behavioral-educational researchers.


About this Course


The SBE Basic course provides an introduction to social-behavioral-educational research with a focus on the protection of human subjects. It offers historic and current information on regulatory and ethical issues important to the conduct of research involving human subjects. Case studies are used within the modules to present key concepts.

Language Availability: English, French, Khmer, Korean, Portuguese, Russian, Spanish, Tamil, Vietnamese

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


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)
$70

6 Credits
(12 CE certified modules)
$90

9 Credits
(18 CE certified modules)
$105

1 July 2016
30 June 2019

Psychologists

CE Credit/Hour

4 Credits
(8 CE certified modules)
$75

9 Credits
(18 CE certified modules)
$105

1 March 2015
28 February 2018
(Behavioral modules)

1 July 2016
30 June 2019
(Bio & SBE Combo Course)

Nurses

Contact Hour

4 Credits
(8 CE certified modules)
$70

18 January 2016
18 January 2018

Other Participants

Certificate of Participation

3 Credits
(6 CE certified modules)
$60

6 Credits
(12 CE certified modules)
$80

9 Credits
(18 CE certified modules)
$95

1 July 2016
30 June 2019


Course Content


Toggle Content History and Ethical Principles – SBE CME/CEU Badge

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), 16460 (Spanish), 15896 (Korean), 16299 (Russian), 16449 (French), 16377 (Tamil)
Author(s): Lisa Robinson Bailey, MA - Duke University

Toggle Content Defining Research with Human Subjects – SBE CME/CEU Badge

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), 16461 (Spanish), 15897 (Korean), 16294 (Russian), 16450 (French), 15548 (Khmer), 16111 (Vietnamese), 16378 (Tamil)
Author(s): Lorna Hicks, MS, CIP - Duke University

Toggle Content The Federal Regulations – SBE CME/CEU Badge

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), 16462 (Spanish), 15898 (Korean), 16298 (Russian), 16451 (French), 16379 (Tamil)
Author(s): Lorna Hicks, MS, CIP - Duke University

Toggle Content Assessing Risk - SBE CME/CEU Badge

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), 16463 (Spanish), 15899 (Korean), 16295 (Russian), 16452 (French), 16330 (Khmer), 16112 (Vietnamese), 16380 (Tamil)
Author(s): Tracy Arwood, MS - Clemson University; Sangeeta Panicker, PhD - American Psychological Association

Toggle Content Informed Consent - SBE CME/CEU Badge

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), 16464 (Spanish), 15900 (Korean), 16297 (Russian), 16453 (French), 16381 (Tamil)
Author(s): Lorna Hicks, MS, CIP - Duke University

Toggle Content Privacy and Confidentiality - SBE CME/CEU Badge

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), 16465 (Spanish), 15901 (Korean), 16296 (Russian), 16454 (French), 15545 (Khmer), 16113 (Vietnamese), 16382 (Tamil)
Author(s): Lorna Hicks, MS, CIP - Duke University

Toggle Content Research with Prisoners – SBE CME/CEU Badge

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

Toggle Content Research with Children – SBE CME/CEU Badge

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), 16466 (Spanish), 15903 (Korean), 16455 (French)
Author(s): Lorna Hicks, MS, CIP - Duke University

Toggle Content Research in Public Elementary and Secondary Schools – SBE CME/CEU Badge

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

Toggle Content International Research – SBE CME/CEU Badge

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), 16467 (Spanish), 15905 (Korean), 16456 (French)
Author(s): Lorna Hicks, MS, CIP - Duke University; Mary Simmerling, MA - University of Chicago

Toggle Content Internet-Based Research - SBE CME/CEU Badge

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), 16468 (Spanish), 15907 (Korean), 16457 (French), 16331 (Khmer), 16114 (Vietnamese)
Author(s): Alejandro Martinez, MPA - Duke University

Toggle Content Unanticipated Problems and Reporting Requirements in Social and Behavioral Research CME/CEU Badge

Defines unanticipated problems, describes the reporting requirements associated with unanticipated problems, and identifies the types of actions an Institutional Review Board (IRB) may take in response to an unanticipated problem.

Recommended Use: Required
ID (Language): 14928 (English), 16469 (Spanish), 15906 (Korean), 16300 (Russian), 16458 (French), 16383 (Tamil)
Author(s): Jeffrey M. Cohen, PhD, CIP - The HRP Consulting Group

Toggle Content Vulnerable Subjects - Research Involving Workers/Employees CME/CEU Badge

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), 1720 (Spanish), 15944 (Korean)

Toggle Content Populations in Research Requiring Additional Considerations and/or Protections CME/CEU Badge

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), 1483 (Spanish), 15930 (Korean), 16447 (French), 16258 (Khmer), 15888 (Vietnamese)
Author(s): Jeremy N. Block, PhD, MPP - Icahn School of Medicine at Mount Sinai; Bruce Gordon, MD - The University of Nebraska Medical Center

Toggle Content Conflicts of Interest in Human Subjects Research New/Updated Badge

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. (A previous version of this module is available in Spanish, Korean, Russian, Khmer, Vietnamese, and Tamil.)

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


Additional Modules of Interest


Toggle Content Research and HIPAA Privacy Protections CME/CEU Badge

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: Supplemental
ID (Language): 14 (English), 15942 (Korean), 1725 (Vietnamese)
Author(s): Reid Cushman, PhD - CITI Program

Toggle Content Are You Thinking About Being in a Research Study? New/Updated Badge

Aims to help subjects (and their family members) learn more about participating in research. It also defines research and common terms, provides questions to think about, and reviews the overall steps of a research study from the perspective of a subject. It is written in lay language and designed to be used by subjects and their family members.

Recommended Use: Supplemental
ID (Language): 14562 (English)
Author(s): Cheryl Savini, CIP - HRP Consulting Group, Inc.; Judy Matuk, MS - State University of New York at Stony Brook; Diane Paul, MS, RN - Drug Development Associates, LLC

Toggle Content Cultural Competence in Research CME/CEU Badge

Provides an overview of the essentials of cultural competence in research. It reviews the definition of cultural competence and the importance of understanding the demographics, historical contexts, communication styles, customs, values, and beliefs of study populations involved in research. It also identifies challenges faced by researchers when working with culturally diverse populations and describes ways to enhance the engagement of diverse populations and communities in research. In addition, it includes a discussion of how IRBs and researchers can operate to support cultural competence in research.

Recommended Use: Supplemental
ID (Language): 15166 (English), 16304 (Russian), 16385 (Tamil)
Author(s): Roderick King, MD, MPH - Harvard Medical School; Julian Jane Atim, MBChB, MPH - Uganda Health Marketing Group (UHMG); Stephanie Cantu - Harvard Medical School; Jonelle Wright, PhD, RN - University of Miami

Toggle Content Hot Topics

Designed to provide learners with current information on recent developments in human subjects research, including regulatory issues, new policies and hot topics. It is updated frequently, with previous content archived and accessible to learners.

Recommended Use: Supplemental
ID (Language): 487 (English), 15945 (Korean), 16261 (Khmer), 16109 (Vietnamese)
Author(s): Margaret Rankovic, M.Ed. - CITI Program

Toggle Content International Studies CME/CEU Badge

Identifies information for U.S. researchers and collaborating international researchers who receive funding from the U.S. federal government sources and who plan to conduct human subject research outside the United States. Focuses on international research ethical issues that may affect planning research outside the U.S. and specific ethical issues that have been raised in international research through the use of case studies. Reviews published international research guidelines, U.S. guidelines, and U.S. federal regulations for ethical review of international projects. Includes resources researchers and their staff members to help identify ethical requirements of their global research partners.

Recommended Use: Supplemental
ID (Language): 971 (English), 1481 (Spanish), 1510 (Portuguese), 15940 (Korean), 16302 (Russian), 16376 (Tamil)
Author(s): E. Dawn Fitzgibbons, MPH; Wenjin Li, M.D., Ph.D. - Fred Hutchinson Cancer Research Center

Toggle Content Introduction To Community-Engaged Research (CEnR)

Discusses the meaning of the term "community," the disciplines and social movements that contributed to the development of CEnR, and the principles that guide CEnR. It also identifies the main differences between a traditional research approach and the CEnR approach.

Recommended Use: Supplemental
ID (Language): 16994 (English)
Author(s): Mary Anne McDonald, DrPH, MA - Duke University; Claude-Alix Jacob, MPH - Cambridge Health Alliance; Barbara E. Bierer, MD - Brigham and Women's Hospital and Harvard Medical School Harvard Catalyst | The Harvard Clinical and Translational Science Center; Jennifer Opp - Brigham and Women's Hospital; Sabune Winkler, JD - Harvard Catalyst | The Harvard Clinical and Translational Science Center

Toggle Content Introduction to Community-Based Participatory Research (CBPR)

Reviews historical context for CBPR’s framework and philosophical foundation, strategies for effectively using CBPR, and the ways a CBPR approach benefits and otherwise impacts communities, as well as academic researchers and their organizations. It also identifies the ways CBPR differs from traditional approaches to research.  Describes the benefits and challenges of a CBPR approach and strategies for engaging community partners in the research process.

Recommended Use: Supplemental
ID (Language): 16995 (English)
Author(s): Suzanne B. Cashman, ScD - University of Massachusetts Medical School; Jennifer Opp - Brigham and Women's Hospital; Alex Pirie, BA - Immigrant Services Providers Group for Health; Karen Hacker, MD, MPH - Allegheny County Health Department

Toggle Content Ethical and Practical Considerations in Community-Engaged Research (CEnR)

Identifies the ethical and practical considerations particular to the design, review, and conduct of CEnR. It also demonstrates how to apply ethical risk-benefit assessments for CEnR, the varying impacts that risks and benefits may have on individual research participants as well as on communities and groups, and strategies for training and educating community members on a research team.

Recommended Use: Supplemental
ID (Language): 16996 (English)
Author(s): Julie Kaberry, MPH, CIP (Co-Lead Author) - Harvard T.H. Chan School of Public Health; Sabune Winkler, JD (Co-Lead Author) - Harvard Catalyst | The Harvard Clinical and Translational Science Center; Nandini Sengupta, MD - The Dimock Center; Hila Bernstein, MS - Harvard Catalyst | The Harvard Clinical and Translational Science Center; Doug Brugge, PhD, MS - Tufts University School of Medicine; Barbara E. Bierer, MD - Brigham and Women's Hospital and Harvard Medical School Harvard Catalyst | The Harvard Clinical and Translational Science Center

Toggle Content Consent and Cultural Competence New/Updated Badge

Focuses on cultural competence, as it applies to developing consent processes, obtaining consent, and evaluating the appropriateness of the consent processes. Describes strategies for enhancing understanding of research among diverse populations and communities during the consent process.

Recommended Use: Supplemental
ID (Language): 17263 (English)
Author(s): Renee Holt, RN, JD, MPH - PATH; Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group

Toggle Content Informed Consent and Incidental Findings in Research with Human Subjects New/Updated Badge

Defines incidental findings (IFs) in human subjects research and covers how IFs should be managed in the informed consent process. Provides an overview of Institutional Review Board (IRB) and researcher responsibilities, as well as strategies for managing IFs in the consent process, including review of the research plan, IF management plan, and consent form language.

Recommended Use: Supplemental
ID (Language): 17342 (English)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Toggle Content Consent and Subject Recruitment Challenges: Remuneration New/Updated Badge

Explores remuneration in research, regulatory requirements regarding remuneration to research subjects, how to distinguish between remuneration and reimbursement, and strategies to reduce the potential for undue influence. Also identifies ways of disclosing remuneration plans in consent and advertising materials.

Recommended Use: Supplemental
ID (Language): 16881 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Quorum Review IRB

Toggle Content Consent and Subject Recruitment Challenges: Therapeutic Misconception New/Updated Badge

Describes therapeutic misconception and identifies potential strategies researchers and institutional review board (IRB) members can use for reducing therapeutic misconception in the consent process. Identifies groups of people at risk for therapeutic misconception and their vulnerabilities. Also discussed are the related phenomena of therapeutic misestimation and therapeutic optimism.

Recommended Use: Supplemental
ID (Language): 17259 (English)
Author(s): Moore Rhys, BA, CIP - Children's Hospital Los Angeles

Toggle Content Consent in the 21st Century New/Updated Badge

Explores how technology has impacted the informed consent process in the 21st Century, especially electronic informed consent (eIC). It covers technology and tools used in the recruitment and consent process, describes alternatives to paper-based informed consent forms, and explores confidentiality issues. It also reviews federal guidance concerning multimedia tools and eIC.

Recommended Use: Supplemental
ID (Language): 17060 (English)
Author(s): Jennifer Kucera, MS, CIP - University of Nebraska Medical Center; Sue Logsdon, MS, CIP - University of Nebraska Medical Center

Toggle Content Consent Tools Used by Researchers New/Updated Badge

Provides an overview of the potential barriers to informed consent and discusses strategies and tools that may be used to enhance and ensure research subjects’ understanding of study information, including subject capacity assessments, the teach-back approach, tools for child assent, use of framing and graphics, and video and multimedia presentations. Discusses ways to present research information to subjects in several simple, practical, and inexpensive ways.

Recommended Use: Supplemental
ID (Language): 16944 (English)
Author(s): Alan R. Tait, PhD - University of Michigan Health System

Toggle Content Consent with Subjects Who Do Not Speak English New/Updated Badge

Focuses on the role that language plays in developing consent processes and obtaining consent in study populations that do not speak English. It identifies challenges and strategies that researchers can use in the consent process when they are not fluent in the potential subject’s language, including the role of interpreters and the use of translations in obtaining consent and during the conduct of the study, and short form consent. It concludes with a discussion of the federal regulations and guidance covering recruitment and consent for subjects who do not speak English with particular attention to the role of the IRB and the responsibilities of researchers.

Recommended Use: Supplemental
ID (Language): 17260 (English)
Author(s): Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group; Lisa Morris, MSTD - University of Massachusetts Medical School

Toggle Content 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: Supplemental
ID (Language): 16711 (English)
Author(s): Erica Heath, CIP - Ethical and Independent Review Services, LLC

Toggle Content I Have Agreed to be an IRB Community Member. Now What? CME/CEU Badge

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

Toggle Content 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

Toggle Content The IRB Member Module - "What Every New IRB Member Needs to Know” CME/CEU Badge

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.

Recommended Use: Supplemental
ID (Language): 816 (English), 15946 (Korean)
Author(s): Cheryl Savini, CIP - HRP Consulting Group, Inc.; Judy Matuk, M.S. - Stony Brook University, State University of New York; Allison Handler, B.S.N., CCRC - University of North Carolina at Chapel Hill; Lawrence B. Rosenfeld, Ph.D. - University of North Carolina at Chapel Hill

Toggle Content Gender and Sexuality Diversity (GSD) in Human Research

Provides a starting point to develop cultural competency for human subject researchers and research team members, who will come in contact with subjects or prospective subjects of a variety of sexuality and/or gender identities. It is also meant to be a resource for institutional review board (IRB) members and administrative staff. It begins with a short overview of the constituent parts of the GSD community from a broad perspective, continues with a summary of the legal and social/cultural vulnerabilities faced by members of these groups and describes research considerations for members of these communities, and concludes with a discussion on what IRBs and researchers should do with respect to these populations.

Recommended Use: Supplemental
ID (Language): 16556 (English)
Author(s): M. Isabel Fernandez, PhD - Nova Southeastern University; Moore Rhys, BA, CIP - Children's Hospital Los Angeles; Jaime A. Arango, EdD, CIP - CITI Program

Toggle Content Illegal Activities or Undocumented Status in Human Research

Provides training and insight to researchers, administrators, and institutional review boards (IRBs) regarding added risks and challenges of conducting research with individuals who are engaged in illegal activities or who have undocumented status. Presents examples of vulnerable groups and identifies ethical considerations when including them in research. Also describes research design issues, recruitment methods, informed consent issues, and additional safeguards specific to research with groups of individuals involved in illegal activities or who have undocumented status.

Recommended Use: Supplemental
ID (Language): 16656 (English)
Author(s): Rebecca Dahl, RN, PhD - Children's Hospital Los Angeles; George Gasparis, CIP - The PEER Consulting Group

Toggle Content Research Involving Subjects at the End-of-Life

Persons at the end of life may be vulnerable for numerous reasons, including cognitive and physical impairments, which may progress as death approaches. It describes the ethical challenges of research with subjects at the end of life, including voluntariness and withdrawal from research. It also explains how cognitive impairment may impact vulnerability in end of life research and identifies strategies to overcome this challenge. Barriers to subject recruitment and special challenges for researchers and institutional review boards (IRBs) in assessing risk of harm and potential benefits in end of life research are also examined.

Recommended Use: Supplemental
ID (Language): 16658 (English)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center

Toggle Content Research with Critically Ill Subjects

Discusses ethical considerations and additional safeguards for critically ill subjects participating in research. Describes the reasons why critically ill persons may be considered "vulnerable" and how this vulnerability arises, why informed consent may be difficult to obtain in this vulnerable population, and ethical implications, the benefits, and the limitations of obtaining proxy consent. Identifies additional safeguards for protecting critically ill subjects participating in research.

Recommended Use: Supplemental
ID (Language): 16592 (English)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center

Toggle Content Research with Decisionally Impaired Subjects

Provides an overview of the nature and sources of decisional impairment. Discusses the obligations imposed on institutional review boards (IRBs) and researchers to ensure that appropriate protections are in place when research involves adult subjects who are or may be decisionally impaired and may have impaired consent capacity. Reviews additional safeguards, discusses assessment of consent capacity, and defines who can provide consent on behalf of an adult subject who lacks consent capacity.

Recommended Use: Supplemental
ID (Language): 16610 (English)
Author(s): Susan J. Delano, CIP - Research Foundation for Mental Hygiene, Inc.; Jeremy N. Block, PhD, MPP - Icahn School of Medicine at Mount Sinai

Toggle Content Research with Older Adults

Provides education and training regarding the conduct of research with older adults. It discusses information for both researchers and IRBs in order to begin the process of addressing underrepresentation of older adults in research, while at the same time providing critical information to consider when conducting research with this group. It also covers the demographic and social issues concerning the exclusion of older adults in research, barriers to inclusion, and research design considerations to enhance inclusion and protect this potentially vulnerable population.

Recommended Use: Supplemental
ID (Language): 16502 (English)
Author(s): Moira A. Keane, MA, CIP
 - Human Research Protections Consultant

Toggle Content Research with Persons who are Socially or Economically Disadvantaged

Discusses subject’s social and economic disadvantage as a potential vulnerability in research. Describes barriers to participation, the ethical and regulatory mandates for the inclusion of these populations in research, as well as the additional protections that may be used to minimize risk. It also explains considerations for IRBs and researchers when planning, reviewing, or conducting research with socially or economically disadvantaged persons.

Recommended Use: Supplemental
ID (Language): 16539 (English)
Author(s): Moira A. Keane, MA, CIP
 - Human Research Protections Consultant

Toggle Content Research with Subjects with Physical Disabilities & Impairments

Provides an overview of physical disabilities and impairments, and the obligations imposed on IRBs and researchers to ensure that appropriate research protections are in place when research involves subjects who are physically disabled and may require additional tailored protections. Additional barriers, vulnerabilities, and challenges that individuals with physical disabilities face when participating in research are identified. It also discusses safeguards and additional protections that IRBs and researchers can implement to protect this potentially vulnerable population, as well as ways to make research studies more accessible to individuals with physical disabilities.

Recommended Use: Supplemental
ID (Language): 16657 (English)
Author(s): Jeremy N. Block PhD, MPP - Icahn School of Medicine at Mount Sinai Baruch College, City University of New York

Toggle Content Students in Research CME/CEU Badge

Designed as a "one-stop shop" for students who may be involved in human subjects research as a researcher and/or a subject. Degree requirements in undergraduate, masters, or doctoral degree programs often require students to conduct or assist in research projects that include human subjects. In addition, students may be asked or be "required" to participate as subjects in research projects. A review of the history and principles of ethics for research involving human subjects (including a definition of research and categories of review), the role and operations of IRBs, and the issues related to students as subjects are provided, as well as a resource section.

Recommended Use: Supplemental
ID (Language): 1321 (English), 15948 (Spanish)
Author(s): Jackie Galvez - University of Southern California; Susan L. Rose, Ph.D. - University of Southern California; Jennifer Hagemann, MS - University of Southern California; Monica Aburto - University of Southern California

Toggle Content Disaster and Conflict Research, Part 1: PI Responsibilities New/Updated Badge

Defines disasters, emergencies, and conflicts and discusses contemporary disaster management terminology and the unique features of disasters and conflict situations that affect research initiatives. Defines the challenges for disaster research in natural and man-made disasters (including conflict). Identifies the public health and medical concerns in disasters that affect disaster research initiatives and discusses the frameworks for disaster management utilized by public health and medical providers.

Recommended Use: Supplemental
ID (Language): 17384 (English)
Author(s): Susan Briggs, MD, MPH - Harvard University

Toggle Content Disaster and Conflict Research, Part 2: Best Practices and Recommendations New/Updated Badge

Identifies the research tools and methods in disaster management utilized by public health and medical providers to enhance communication between research teams and disaster responders. Discusses practical challenges and strategies for human subjects research in natural and man-made disasters (including conflicts). Defines key disaster research priorities for disasters and/or conflicts. Provides guidelines for conducting disaster and conflict research.

Recommended Use: Supplemental
ID (Language): 17385 (English)
Author(s): Susan Briggs, MD, MPH - Harvard University

Toggle Content Single Institutional Review Board (sIRB) Use and Administration: When Relying on a sIRB New/Updated Badge

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 - Quorum Review IRB; Raffaella Hart, MSHS, CIP - BRANY IRB

Toggle Content Single Institutional Review Board (sIRB) Use and Administration: When Serving as a sIRB of Record New/Updated Badge

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 - Quorum Review IRB; Raffaella Hart, MSHS, CIP - BRANY IRB

Toggle Content Single Institutional Review Board (sIRB) Use and Administration: Authorization Agreements New/Updated Badge

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): Cynthia Gates, RN, JD, CIP - University of California, Davis

Toggle Content FERPA: An Introduction New/Updated Badge

Provides a brief history of FERPA, and covers the law’s different requirements and how it protects student educational records. It discusses how FERPA categorizes protected information, how FERPA is applied in various educational settings (public secondary and elementary schools, state and local school districts, and postsecondary institutions), and emerging issues with FERPA.

Recommended Use: Supplemental
ID (Language): 17407 (English)
Author(s): Thomas W. Gold, PhD - Network for Teaching Entrepreneurship

Toggle Content FERPA for Researchers New/Updated Badge

Covers compliance with FERPA for researchers. It identifies the level of risk in using different types of student data for research, how to employ safe methods in the collection and analysis of student data, proper ways to present student data without disclosing private information, and ways to remain compliant with FERPA in human subjects research.

Recommended Use: Supplemental
ID (Language): 17410 (English)
Author(s): Thomas W. Gold, PhD - Network for Teaching Entrepreneurship

Toggle Content FERPA for Institutional Review Boards (IRBs) New/Updated Badge

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.

Recommended Use: Supplemental
ID (Language): 17411 (English)
Author(s): Thomas W. Gold, PhD - Network for Teaching Entrepreneurship

Toggle Content Introduction to Public Health Research New/Updated Badge

Describes the roles, responsibilities, and activities of public health systems, as relevant to research. Discusses characteristics of international public health systems and identifies public health services and their interrelationships with core public health functions.

Recommended Use: Supplemental
ID (Language): 17637 (English)
Author(s): Charles Hennekens, MD, DrPH - Florida Atlantic University; Joanna Drowos, DO, MPH, MBA - Florida Atlantic University

Toggle Content Public Health Research and Public Health Practice New/Updated Badge

Examines the difference between public health practice and public health research. By discussing different types of public health activities, this module explores how and when human subjects research regulations may apply.

Recommended Use: Supplemental
ID (Language): 17638 (English)
Author(s): Charles Hennekens, MD, DrPH - Florida Atlantic University; Joanna Drowos, DO, MPH, MBA - Florida Atlantic University

Toggle Content Informed Consent and Confidentiality in Public Health Research New/Updated Badge

Reviews regulatory requirements for obtaining informed consent in public health research. Identifies challenges and best practices for obtaining consent. Discusses the importance of protecting subject privacy and confidentiality of data, and the implications for population-based surveillance datasets.

Recommended Use: Supplemental
ID (Language): 17639 (English)
Author(s): Charles Hennekens, MD, DrPH - Florida Atlantic University; Joanna Drowos, DO, MPH, MBA - Florida Atlantic University

Toggle Content Ethical Issues in Public Health Research New/Updated Badge

Summarizes the application of ethical principles to public health research, identifies additional ethical challenges unique to public health research, and provides a six-step framework for application to public health problems.

Recommended Use: Supplemental
ID (Language): 17640 (English)
Author(s): Charles Hennekens, MD, DrPH - Florida Atlantic University; Joanna Drowos, DO, MPH, MBA - Florida Atlantic University