Regulatory & Compliance Oversight
Back to the Basics: Reference Guides Every Research Admin Should Know
For research administrators, understanding the key reference guides, federal frameworks, and day-to-day responsibilities tied to these areas is non-negotiable. This list of resources brings you back to basics—not as a refresher, but as a toolbox for mastering compliance, supporting investigators, and fostering a culture of responsible conduct in research.
In the world of research administration, regulatory knowledge isn’t just helpful, it’s essential. Whether you're reviewing a new protocol or troubleshooting compliance gaps, your ability to navigate core oversight areas like Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), grants, and clinical trials can make or break the integrity of a research program. These domains, while distinct in scope, all share a common foundation: the ethical protection of human and animal subjects, institutional accountability, and regulatory precision. For research administrators, understanding the key reference guides, federal frameworks, and day-to-day responsibilities tied to these areas is non-negotiable. This article brings you the books that help you get back to basics—not as a refresher, but as a toolbox for mastering compliance, supporting investigators, and fostering a culture of responsible conduct in research.
Institutional Review Board: Management and Function
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This comprehensive guide offers a practical and ethical roadmap for managing IRBs in compliance with federal regulations and best practices. Developed in partnership with PRIM&R, the text serves as a foundational resource for IRB administrators, chairs, and members. It covers the full operational scope of IRBs—including protocol review, informed consent, continuing review, exempt determinations, and investigator compliance—with detailed discussions on the Common Rule (45 CFR 46), Federal Drug Administration (FDA) regulations, and international guidelines. Real-world case studies and sample SOPs support practical application. The book emphasizes the ethical principles outlined in the Belmont Report, while offering insight into policy development, staff training, audit preparedness, and board member education. Known for its clarity and authority, this text remains a go-to reference in human subjects research protection. |
The IACUC Handbook (3rd Edition)
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Widely regarded as the definitive reference for IACUCs, this third edition offers a comprehensive exploration of regulatory oversight and best practices in animal research administration. It updates federal policy interpretations and integrates the latest Guide for the Care and Use of Laboratory Animals, the 2013 American Veterinary Medical Association (AVMA) euthanasia guidelines, and Office of Laboratory Animal Welfare (OLAW) FAQs. Compiled by seasoned IACUC professionals, the text features real-world institutional surveys, operational benchmarks, and an international comparison. The 827-page volume covers the full spectrum of committee responsibilities—from protocol review, continuing review, and post-approval monitoring to facility inspections, animal welfare, personnel training, and ethical frameworks. True to its reputation, it's often called “the Bible” for IACUC members and administrators navigating the complexities of animal welfare, compliance, and institutional accountability. |
A Practical Guide to Managing Clinical Trials
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This volume provides step-by-step guidance tailored for professionals involved in research site operations. It covers the entire clinical trial process—from site selection and setup to subject recruitment, study visits, and close-out. Key topics include staff roles and responsibilities, training, budget and contract management, data and document handling, event reporting, research ethics, audits, informed consent processes, IRB and FDA regulations, and Good Clinical Practices (GCP). Each chapter concludes with a review of key points and knowledge application exercises. A unique feature of this edition is "A View from India," which provides a chapter-by-chapter comparison of clinical trial practices in India and the U.S., offering global context and operational insight into the challenges and opportunities in the emerging Indian clinical trials market. |
Grants Management Body of Knowledge (GMBoK) Guide
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This book is designed as a comprehensive resource to assist grants management professionals in navigating the complexities of the grant lifecycle and provides detailed insights into federal financial assistance governance, the phases of the grants management lifecycle, and the application of internal controls to mitigate fraud, waste, and abuse. It also outlines the roles and responsibilities of auditors and auditees, supporting grants management professionals across all sectors. The GMBoK Guide is updated regularly to reflect the latest federal standards and regulations, ensuring its relevance and utility in the ever-evolving field of grants management.
By providing authoritative federal standards, the Guide references key frameworks such as the Uniform Guidance (2 CFR Part 200), GAO’s Standards for Internal Control, OMB Circular A-123 on risk management, and the annual OMB Compliance Supplement. Its scope makes it an essential resource for grants management professionals across federal agencies, state and local governments, tribal entities, higher education institutions, nonprofits, and private sector organizations. The GMBoK Guide is distributed as a read-only digital publication to protect copyright and is regularly updated to reflect current compliance requirements and best practices.
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2025 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials
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The 2025 Comprehensive Clinical Research Desk Reference is a must-have for professionals involved in clinical trials for drugs and medical devices. Published by Clinical Research Resources, LLC, this robust, 750+ page reference consolidates essential regulatory documents, guidance, and policies from the FDA, Office for Human Research Protections (OHRP), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) into a single, easy-to-navigate resource.
Updated as of April 1, 2025, the guide includes critical sections of 21 CFR—such as Parts 11 (electronic records), 50 (informed consent), 56 (IRBs), 312 (Investigational New Drug), and 314 (New Drug Application)—alongside international standards like the ICH E6 GCP guidelines. It also features ethical frameworks such as the Belmont Report and the Declaration of Helsinki.
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References
Bankert, E. A., Gordon, B.G., Hurley, E. A. & Shriver, S. P. (Eds.). (2022). Institutional review board: Management and function (3rd ed.). Jones & Bartlett Learning.
Clinical Research Resources, LLC. (2025). Comprehensive clinical research desk reference for drug and medical device trials (2025 ed.). Clinical Research Resources.
National Grants Management Association. (2024). Grants Management Body of Knowledge (GMBoK) Guide. National Grants Management Association.
Pfeiffer, J., & Wells, C. (2017). A practical guide to managing clinical trials. CRC Press.
Silverman, J., Suckow, M. A., & Murthy, S. (Eds.). (2014). The IACUC handbook (3rd ed.). CRC Press/Taylor & Francis.