Human Subjects Research – IRB – Biomedical and Social-Behavioral-Educational Combined

Provides foundational training for IRB members involved in the review of both biomedical and social-behavioral-educational human subjects research.

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About this Course


This course is for IRB members who review biomedical and social-behavioral-educational research involving human subjects. 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 and social-behavioral-educational 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.

Learners select which modules are most relevant to their training needs and interests to complete this course (note that learners must complete a minimum of 16 modules of their choosing). It allows exploration of both biomedical and social-behavioral-educational focused topics.

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Note: This course is comprised of modules from our HSR Biomedical Basic and Social-Behavioral-Educational Basic courses.

Language Availability: English

Suggested Audiences: IRB members who review biomedical and social-behavioral-educational research

Organizational Subscription Price: For independent learners only
Independent Learner Price: $249 per person


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

History and Ethics of Human Subjects Research CME/CEU Badge

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

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: Elective
ID (Language): 491 (English), 15897 (Korean), 16450 (French), 16461 (Spanish)
Author(s): Lorna Hicks, MS, CIP - Duke University

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

Basic Institutional Review Board (IRB) Regulations and Review Process Updated Content

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

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

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

Informed Consent CME/CEU Badge

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

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: Elective
ID (Language): 505 (English), 15901 (Korean), 16454 (French), 16465 (Spanish)
Author(s): Lorna Hicks, MS, CIP - Duke University

Social and Behavioral Research (SBR) for Biomedical Researchers CME/CEU Badge

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: Elective
ID (Language): 4 (English), 15927 (Korean), 1718 (Spanish)
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 CME/CEU Badge

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: Elective
ID (Language): 5 (English), 15928 (Korean), 1490 (Spanish)
Author(s): Judy Matuk, MS - HRP Consulting Group, Inc.

Genetic Research in Human Populations CME/CEU Badge

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: Elective
ID (Language): 6 (English), 15929 (Korean), 1672 (Spanish)
Author(s): Jeffrey R. Botkin, MD, MPH - University of Utah

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

Research Involving Prisoners CME/CEU Badge

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

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

Research Involving Children CME/CEU Badge

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

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

Research Involving Pregnant Women, Fetuses, and Neonates CME/CEU Badge

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: Elective
ID (Language): 10 (English), 15933 (Korean), 1499 (Spanish)
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: Elective
ID (Language): 483 (English), 1720 (Spanish), 15944 (Korean)

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

Internet-Based Research - SBE

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: Elective
ID (Language): 510 (English), 16457 (French), 16468 (Spanish)
Author(s): Alejandro Martinez, MPA, CIP - Duke University

FDA-Regulated Research CME/CEU Badge

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

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

Hot Topics Updated Content

Designed to provide learners with current information on recent developments in human subjects research, including regulatory issues, new policies and hot topics. The module is revised throughout the year as needed.

Recommended Use: Elective
ID (Language): 487 (English), 15945 (Korean)
Author(s): Margaret Rankovic, MEd, CIP - CITI Program

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

Unanticipated Problems and Reporting Requirements in Social and Behavioral Research

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: Elective
ID (Language): 14928 (English), 16458 (French), 16469 (Spanish)
Author(s): Jeffrey M. Cohen, PhD, CIP - The HRP Consulting Group

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: Elective
ID (Language): 816 (English)
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

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: Elective
ID (Language): 14777 (English)
Author(s): Patricia A. MacCubbin, MS - Research Ethics Group

Avoiding Group Harms - U.S. Research Perspectives CME/CEU Badge

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: Elective
ID (Language): 14080 (English), 15934 (Korean), 1719 (Spanish)
Author(s): Helen McGough, MA - University of Washington (ret.)

Avoiding Group Harms – International Research Perspectives CME/CEU Badge

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

Recommended Use: Elective
ID (Language): 14081 (English), 15935 (Korean)
Author(s): Helen McGough, MA - University of Washington (ret.)

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: Elective
ID (Language): 15166 (English)
Author(s): Roderick K. 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

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

This content is designed to introduce and onboard new Institutional Review Board (IRB) community members (also referred to as “unaffiliated members”). Provides basic information and tools related to IRBs, including an overview of regulatory definitions and requirements, and discusses strategies on how 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 new 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) that are generally charged with evaluating research protocols according to local ethical standards and regulations.

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


Additional Modules of Interest


Belmont Report and Its Principles CME/CEU Badge

Provides learners with the Belmont Report.

Recommended Use: Supplemental
ID (Language): 1127 (English)

Human Subjects Considerations and Big Data Research

Examines the ethical issues of using large datasets (big data) in human subjects research, including informed consent, risk of harm, anonymity, data security, privacy, and confidentiality. The module helps IRB members, administrators, and researchers identify how best to protect human subjects when reviewing or conducting big data research studies that create or use large datasets, with a focus on maintaining the value of the data while complying with federal regulations.

Recommended Use: Supplemental
ID (Language): 19126 (English)
Author(s): Laura Odwazny, MA, JD - U.S. Department of Health and Human Services; Elizabeth Buchanan, PhD - University of Wisconsin-Stout

Ethical and Appropriate Uses of Administrative Data for Research and Evaluation

This module discusses the benefits and limitations of utilizing administrative data for research, evaluation, and analytic purposes, including an overview of ethical use; privacy and security; legal considerations; study design, analysis, and reporting; and data management.

Recommended Use: Supplemental
ID (Language): 19826 (English)
Author(s): Amy Hawn Nelson, PhD - University of Pennsylvania; Dennis Culhane, PhD - University of Pennsylvania

Are You Thinking About Being in a Research Study? Updated Content

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

Humanitarian Use Devices (HUDs)

Provides a basic overview of the U.S. Food and Drug (FDA) regulations and responsibilities regarding HUDs. It describes the HUD program and Humanitarian Device Exemption (HDE) regulatory process, and explains the applicable requirements and differences between 1) a “clinical use” of a HUD to treat or diagnose patients or 2) a “HUD investigation.” It also categorizes the FDA regulations and IRB review requirements for HUD investigations within and outside of the HDE approved indications, and identifies additional federal rules or institutional requirements that may apply to the clinical use of a HUD or HUD investigations.

Recommended Use: Supplemental
ID (Language): 16306 (English)
Author(s): Belinda Smith, MS, RD, CCRC - University of Kentucky; Kevin L. Nellis, MS, CIP - Maimonides Medical Center; Ada Sue Selwitz, MA - University of Kentucky

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), 15940 (Korean), 1481 (Spanish)
Author(s): E. Dawn Fitzgibbons, MPH; Wenjin Li, M.D., Ph.D. - Fred Hutchinson Cancer Research Center

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

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

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

Consent and Cultural Competence

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

Informed Consent and Incidental Findings in Research with Human Subjects

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

Consent and Subject Recruitment Challenges: Remuneration

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 - Advarra

Consent and Subject Recruitment Challenges: Therapeutic Misconception

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

Consent in the 21st Century

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

Consent Tools Used by Researchers

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

Consent with Subjects Who Do Not Speak English

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

Consent and Biobanks and Associated Databases

Describes different consent approaches used for biobanks and associated databases, with reference to pertinent legal and ethical documents and regulatory requirements. Additionally, learners will review examples of key consent clauses (for example, linkage, return of research results and incidental findings, storage for future use, and access by researchers). Reviews the diversity, nature, and characteristics of biobanks and associated databases.

Recommended Use: Supplemental
ID (Language): 17254 (English)
Author(s): Bartha Maria Knoppers, PhD
 - McGill University; Ma’n H. Zawati, LLM
 - McGill University

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

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

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

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

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

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

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

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

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

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

Students in Research CME/CEU Badge

This module addresses students as researchers and when students are involved in research as participants. It reviews the history and status of key research regulations, the Institutional Review Board (IRB) review process, and general best practices when conducting human subjects research. It provides best practices in creating an accurate, robust submission for IRB review and conducting responsible, ethical research.

Recommended Use: Supplemental
ID (Language): 1321 (English)
Author(s): Andrea Rossing McDowell - Seattle University

Disaster and Conflict Research, Part 1: PI Responsibilities

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

Disaster and Conflict Research, Part 2: Best Practices and Recommendations

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

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): Cynthia Gates, RN, JD, CIP - University of Miami

FERPA: An Introduction

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 - Acceleration Group, Inc.

FERPA for Researchers

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 - Acceleration Group, Inc.

FERPA for Institutional Review Boards (IRBs)

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 - Acceleration Group, Inc.

Phase I Research: Understanding Phase I Research

Defines phase I research as it relates to non-clinical and other phases of research. Identifies routine study designs used to develop the initial safety profile and achieve study objectives in phase I research. Reviews the importance of phase I research on drug development.

Recommended Use: Supplemental
ID (Language): 16873 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research

Phase I Research: Protecting Phase I Subjects

Reviews U.S. Food and Drug Administration (FDA) requirements for initiation of phase I research studies following non-clinical studies. Describes IRB considerations for review of phase I research. Identifies ways in which researchers and staff involved in phase I research can apply the necessary safeguards to protect subjects including selecting a safe starting dose, safeguards for standard dosing regimens, selecting appropriate subjects, facility safeguards, and the role of informed consent.

Recommended Use: Supplemental
ID (Language): 16874 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research

Overview of the Clinical Trial Agreement (CTA)

Discusses the general purpose of a CTA, roles and responsibilities of parties to the CTA, and how the CTA fits into the research enterprise. It also compares and contrasts clinical trials involving drugs, biologics, and devices from a CTA perspective.

Recommended Use: Supplemental
ID (Language): 17356 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Understanding the Terms of the Clinical Trial Agreement (CTA)

Provides an overview of the context behind certain CTA terms and sections, types of language used for CTA sections, and some key elements of each section. It also outlines what should be addressed in the key sections of the CTA and the aim for each section.

Recommended Use: Supplemental
ID (Language): 17357 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Role of the Researcher and Site in Managing the Clinical Trial Agreement (CTA)

Discusses key roles of the researcher and site in managing the CTA, including initial assessment, review, and implementation. It also describes how the CTA is linked to site policies, the protocol, and the informed consent form, and identifies key sections of the CTA that could present risk to the site.

Recommended Use: Supplemental
ID (Language): 17358 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Clinical Trial Agreement (CTA) Negotiation for Researchers and Sites

Addresses strategies and preparation for CTA and study budget negotiations. It also identifies terminology and alternative wording options to ensure a fair and balanced CTA.

Recommended Use: Supplemental
ID (Language): 17359 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Stem Cell Research Oversight (Part I) CME/CEU Badge

Introduces the nature and characteristics of both adult and embryonic stem cells. It reviews the requirements of the federal regulations associated with stem cell research and the role of both state and local requirements. It also discusses the contentious historical and ethical issues surrounding stem cell research and the clinical application of stem cells.

Recommended Use: Supplemental
ID (Language): 13882 (English), 15937 (Korean)
Author(s): David A. Crouse, PhD - University of Nebraska Medical Center (ret.); Ruth L. Fischbach, PhD, MPE - Columbia University; Gwenn S.F. Oki, MPH, CIP - Van Andel Institute

Stem Cell Research Oversight (Part II) CME/CEU Badge

Builds on the content presented in Part 1 and provides a framework for institutional review of stem cell research, national guidelines as well as current federal law and policy. It provides an overview of the National Academy of Sciences (NAS), International Society for Stem Cell Research (ISSCR), and National Institutes of Health (NIH) guidelines related to human stem cell research and research involving human subjects. Consideration is given to U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulatory requirements, Stem Cell Research Oversight (SCRO) committee composition and responsibilities, categories of research, and a comprehensive definition of provenance as it applies to human stem cell research. A detailed overview of the recommendations of the NAS, ISSCR, and NIH Guidelines as well as information related to the procurement, banking, and use of human stem cell lines are provided via the hyperlinks at the end.

Recommended Use: Supplemental
ID (Language): 14584 (English), 15938 (Korean)
Author(s): Ruth Fischbach, PhD, MPE - Columbia University; Gwenn Oki, MPH, CIP - Van Andel Institute