CIP Course for Advanced Learners – Biomedical and FDA Research Topics

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

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

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

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

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

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

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