Biomedical (Biomed) Comprehensive

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

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

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

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

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

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

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

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

Recommended Use: Required
ID (Language): 4 (English), 15927 (Korean), 1718 (Spanish)
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 has its own risks, and researchers who propose to conduct such research must have an understanding of those risks and how to minimize them. Learners will be presented with an overview of the risks associated with and the types of review required for records-based research. They will also learn about privacy and confidentiality, certificates of confidentiality, and the federal privacy law.

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

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

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

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

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

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

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

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

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: Supplemental
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

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.)

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.)

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

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

Recommended Use: Required
ID (Language): 14777 (English), 15939 (Korean)
Author(s): Patricia A. MacCubbin, MS - Research Ethics Group

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

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

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

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

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

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

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

Provides learners with the Belmont Report.

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

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 A. Savini - HRP Consulting Group, Inc.; Judy Matuk, MS - HRP Consulting Group, Inc.; Diane Paul, MS, RN - Drug Development Associates, LLC

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)
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

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

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

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

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 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

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 Cashman, ScD, MS - 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

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 Bierer, MD - Brigham and Women's Hospital and Harvard Medical School Harvard Catalyst | The Harvard Clinical and Translational Science Center

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

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

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

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

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, CIP - Children's Hospital Los Angeles

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

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

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

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, MBA - Ethical and Independent Review Services, LLC

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: Supplemental
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

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

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

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

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

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, CIP - Children's Hospital Los Angeles; Jaime A. Arango, EdD, CIP - CITI Program

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

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

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

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 Block, PhD, MPP - Icahn School of Medicine at Mount Sinai

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

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

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 Block, PhD, MPP - Icahn School of Medicine at Mount Sinai Baruch College, City University of New York

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, MS, MA, PhD - Seattle University

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

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

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.

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

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

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.

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

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

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.

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

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

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.

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

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

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

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

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

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

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

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

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

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

Describes approaches to monitoring the emerging results of an ongoing study, the different types of study data that are monitored, and the role and operational procedures of independent monitoring groups and how they relate to other study oversight entities. It also explains regulatory requirements and other policies related to study monitoring and discusses similarities and differences between the Institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB). Reviews the basic elements of data safety monitoring plans and DSMBs.

Recommended Use: Supplemental
ID (Language): 17433 (English)
Author(s): Susan Ellenberg, PhD - University of Pennsylvania; Susan S. Fish, PharmD, MPH - Boston University; Stephen M. Davis, MPA, MSW - West Virginia University

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

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

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

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

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, JD, MA Bioethics - U.S. Department of Health and Human Services; Elizabeth Buchanan, PhD - University of Wisconsin-Stout

Provides researchers and Institutional Review Boards (IRBs) regulatory information about the use of mobile apps in research. Discusses ethical issues associated with mobile apps in research and gives practical advice. Covers IRB considerations for the review of mobile app-based research. Reviews key issues of applicability of FDA regulations for mobile medical apps in research.

Recommended Use: Supplemental
ID (Language): 19728 (English)
Author(s): Elizabeth Buchanan, PhD - University of Wisconsin - Stout; Michele Russell-Einhorn, JD - Advarra; Mitchell Parrish, JD, RAC, CIP - H Clinical; Kindra Cooper, JD, MPA, MA - Advarra

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

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

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