Comprehensive CIP Course for Advanced Learners

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: Elective
ID (Language): 12 (English), 1493 (Spanish), 15889 (Vietnamese)
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: Elective
ID (Language): 14777 (English), 16555 (Vietnamese)
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: Elective
ID (Language): 14 (English), 15942 (Korean)
Author(s): Reid Cushman, PhD - CITI Program

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

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), 16114 (Vietnamese)
Author(s): Alejandro Martinez, MPA, CIP - Duke University

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

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: Elective
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

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: Elective
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

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

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: Elective
ID (Language): 13813 (English)
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: 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

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

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: Elective
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: Elective
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: Elective
ID (Language): 16556 (English)
Author(s): M. Isabel Fernandez, PhD - Nova Southeastern University; Moore Rhys, CIP - University of California, 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: Elective
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: Elective
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: Elective
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: Elective
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: Elective
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: Elective
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: Elective
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: Elective
ID (Language): 1321 (English) , 1671 (Spanish)
Author(s): Andrea Rossing McDowell MS, MA, PhD - Seattle University

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)
Author(s): Susan L. Rose - University of Southern California (retired); Charles E. Pietri - Department of Energy

Introduces the nature and characteristics of common types of stem cells and their derivation. It reviews the requirements of the federal regulations associated with stem cell research and the role of both state and local requirements. It discusses the contentious historical and ethical issues surrounding stem cell research. It also considers future clinical applications of stem cells in medicine.

Recommended Use: Elective
ID (Language): 13882 (English)
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, as well as national and international guidelines. It provides an overview of the National Academy of Sciences (NAS), National Institutes of Health (NIH), and the International Society for Stem Cell Research (ISSCR) guidelines related to human embryonic stem cell research. It examines revisions to the ISSCR voluntary guidelines in response to changing scientific research. 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. The module also provides detailed information on the procurement, banking, and use of human stem cell lines.

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

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: Elective
ID (Language): 17407 (English)
Author(s): Thomas Gold, PhD - Acceleration Group, Inc.

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

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