Workshops
Looking for valuable hands-on training?
PRIM&R training workshops deliver practical, applied education for professionals engaged in research oversight and administration across the research enterprise. Grounded in current regulations, policy guidance, and real-world practice, these workshops are designed to strengthen professional judgment, regulatory understanding, and day-to-day decision-making.
Why choose a PRIM&R workshop? PRIM&R workshops emphasize the rationale behind regulatory requirements rather than solely on procedural compliance, helping participants understand the why so they can carry out the how with greater efficiency, confidence, and consistency. Instruction is led by experienced faculty and informed by emerging issues.
Workshops are offered in two formats to meet learners at different stages of experience. Multi-day, foundational workshops are designed to build essential knowledge and skills for those new to a topic area or seeking a strong conceptual grounding. Single-day, advanced workshops are tailored for experienced professionals looking to deepen expertise and apply knowledge to complex and emerging challenges.
PRIM&R workshops are available as standalone 90-minute sessions or as interactive two-hour sessions delivered over three weeks, supporting sustained learning and real-world application. Together, these offerings provide flexible, high-quality professional development for individuals working in human subjects research, animal care and use, institutional compliance, and related oversight roles.
Single-Day Workshops
90-minute
- Advances in Non-Animal Testing Methods: The 3Rs and In-Vitro Innovations
- Maintaining Compliance at Any Size: How to Get the Most Bang for Your Buck
- The Assurance of Privacy and Confidentiality in Research: Is it Still Possible?
- Challenges to Maintaining Confidentiality in Clinical Research and its Impact on Public Trust
- AI-Driven Behavioral Analysis
- AI in Action: Institutional Innovations Supporting IRB Review
- iPSCs, Organoids, and IRB Panic Buttons: A Practical Guide to Stem Cell Research and SCRO Review
- Thorny Issues in Device Research: IVDs, HUDs, SaMD—and Their Cousins. You Can Do This.
- From Wearables to Data Ecosystems: Redefining Participant Protection in Digital Research
- Comparative Approaches to Post-Approval Monitoring (PAM) and Animal Care Compliance Across Biotech, Pharma, and Academia
- From Animal Models to Algorithms: Rethinking IRB Review in the Age of NAMs (New Approach Methodologies)
- Risk Assessment Reimagined: Evaluating Non-Traditional Risks in Digital and Behavioral Research
- When PAM Findings Trigger Action (and When They Shouldn't)
- When Is a Waiver Truly Impracticable? IRB Decision-Making for Consent Waivers
Multi-Day Workshops
3 Sessions | 120-minute | + 1 or 2 Learning Labs
- Exploring the Common Rule: A Guide for Beginners
- Exploring the IRB Administrator's Role in the Life of an IRB Submission
- Exploring IACUC Fundamentals
- Exploring IACUC Advanced Topics
- IRB Administrator: Key Administrative Skills
- IRB Administrator: Refining Key Skills
- FDA Regulations
- Training in Artificial Intelligence
Single-Day Workshops
Upcoming
August 12 | 1:00–2:30 PM ET
This workshop examines how post-approval monitoring (PAM) programs—while varying across institutions—support compliance, animal welfare, and continuous improvement. Participants will compare PAM practices in pharmaceutical/biotechnology and academic settings and explore how they intersect with IACUC inspections, veterinary oversight, and program reviews. Through real-world examples and discussion of emerging tools, including AI-enabled monitoring, attendees will identify best practices and opportunities for cross-institutional collaboration.
October 8 | 1:00–2:30 PM ET
When is a waiver of informed consent truly justified? One of the most challenging questions IRBs face is determining when research cannot practicably be conducted without a waiver or alteration of consent. This session explores the regulatory requirements, common areas of ambiguity, and real-world scenarios that test these decisions. Attendees will gain practical tools and review strategies to make more consistent, transparent, and well-supported waiver determinations.
Multi-Day Workshops
Upcoming
IRB Administrator Training: Key Administrative Skills
August 4, 11, 13, and 18, 2026 | 1:00–3:00 PM ET
Institutional Review Board(IRB) Administrator Core Training Courses are designed to provide you with a comprehensive understanding of the critical skills required for effective IRB administration, institutional policy development, recordkeeping, and applying regulations.
IRB Administrator Training: Refining Key Skills
September 22, 29, and October 6, 2026 | 1:00–3:00 PM ET | Learning labs: September 24 and October 1, 2026 | 1:00–2:00 PM ET
This advanced training is essential for IRB administrators looking to sharpen their skills in addressing the complex challenges of IRB management. Navigating noncompliance, unanticipated problems, and the nuances of single IRB processes are critical areas where administrators must be adept. With a focus on both foundational knowledge and practical application, this course provides the tools needed to manage these issues effectively and confidently.
Training on Artificial Intelligence
December 2026
Artificial intelligence is no longer a future concept—it is actively reshaping how research is conducted, overseen, and managed. For professionals in research compliance and administration, understanding how to effectively and ethically integrate AI into core processes is critical. This interactive workshop equips participants with the tools and confidence to do just that.
Designed for individuals working across academic institutions, healthcare organizations, private industry, and government agencies, this training focuses on real-world applications of generative AI within research oversight. Participants will explore how AI can streamline routine tasks, including document review, knowledge management, and data sourcing, while also gaining hands-on experience with tools for evaluating AI-generated outputs, training datasets, and data visualization.
Single-Day On Demand
Recorded
Post-Approval Monitoring (PAM) programs generate a steady stream of observations—but not every finding warrants corrective action, reporting, or escalation. Yet many IACUC programs struggle with inconsistent responses, overcorrection, or uncertainty about when a finding rises to the level of noncompliance or reportability. This 90-minute interactive workshop brings together real-world PAM scenarios, QA/QI strategies, and evolving reporting expectations to help attendees calibrate their responses.
Recorded
Traditional IRB risk assessment focuses on immediate harms to individual participants, but digital and behavioral research could now introduce diffuse, downstream, and group-level risks like algorithmic bias and stigmatization. Although 45 CFR 46.111(a)(2) tells us that risks involving the "possible long-range effects of applying knowledge gained in the research" are not in the IRB's purview for approval criteria, IRB professionals still encounter ethical questions about emerging forms of risk in data-intensive environments. In a world where content is posted with little expectation of privacy and companies consume large-scale personal data for business use, let's discuss ways that IRBs can think ethically about the new frontier of risk while remaining grounded in regulatory authority.
Recorded
As preclinical science shifts away from traditional animal models toward New Approach Methodologies (NAMs)—including AI-driven modeling, organoids, organ-on-chip systems, and human-based data—IRBs are increasingly asked to evaluate protocols supported by unfamiliar forms of evidence. This session examines how evolving FDA expectations and emerging scientific approaches are reshaping what counts as sufficient preclinical support and how IRBs should assess risk, uncertainty, and participant protections in this new landscape.
Thorny Issues in Device Research: IVDs, HUDs, SaMD-and Their Cousins. You Can Do This.
Recorded
Device research can be challenging, particularly when studies involve less familiar categories such as in vitro diagnostics (IVDs), humanitarian use devices (HUDs), and software as a medical device (SaMD). Uncertainty about regulatory pathways and ethical considerations can complicate IRB review and decision-making. This 90-minute online workshop clarifies commonly misunderstood types of device research and provides practical frameworks, real-world examples, and IRB review strategies that participants can apply immediately when reviewing complex or novel device protocols.
iPSCs, Organoids, and IRB Panic Buttons: A Practical Guide to Stem Cell Research and SCRO Review
REcorded
IRBs reviewing research involving iPSCs, hESCs, organoids, and embryo models often face uncertainty about when SCRO review is required and how to apply ISSCR Categories 1A and 1B. This session provides practical strategies, case-based examples, and decision tools to help IRBs integrate SCRO review into workflows and support consistent, efficient oversight.
From Wearables to Data Ecosystems: Redefining Participant Protection in Digital Research
Recorded
The growing use of consumer technologies—such as smartphones, wearables, and mobile applications—in human subjects research is reshaping the research landscape and raising new challenges for oversight and participant protection. As digital platforms generate large, interconnected datasets, traditional regulatory frameworks are increasingly strained. This session examines key ethical and regulatory tensions that arise when consumer devices become research tools, including blurred boundaries between everyday technology use and research activities, complex data flows that complicate informed consent, and ongoing uncertainty about distinctions between research-grade and consumer-grade devices.
AI in Action: Institutional Innovations Supporting IRB Review
REcorded
As institutions increasingly explore artificial intelligence (AI) to support research oversight functions, IRB professionals are navigating new opportunities and new responsibilities. This 90-minute workshop features a mix of brief tool demonstrations and governance-focused discussion, highlighting both institutions actively deploying AI-enabled tools and programs that are establishing guardrails before adopting any tool.
AI-Driven Behavioral Analysis
Recorded
This workshop explores the integration of artificial intelligence (AI) in preclinical research, focusing on how AI-driven behavioral monitoring of mice and rats enhances data accuracy, reduces variability, and improves animal welfare. Having an electronic system flag potential animal behaviors and alert staff that veterinary treatments may need to be initiated saves time, reduces animal welfare incidents, and ensures animal welfare issues are caught early. In this session, speakers and attendees will examine real-world applications, ethical considerations, and the impact of AI on study outcomes in biotech and pharmaceutical research.
Recorded
With the commercial marketplace for large data sets, the increasing ease of re-identification, the frequency of data breaches, and the accelerating capabilities of artificial intelligence, the long-standing regulatory promises of privacy and confidentiality in human subjects research are under mounting pressure.
Recorded
The conduct of clinical research often challenges our ability to keep information about research participants confidential and our ability to enhance trust from participants and the public. Extensive information may be included in medical record systems that allow a wide range of individuals ready access to confidential research information not only during a study, but long after the study is completed. Rarely are there clear standards as to what information is necessary to be included, and what should be maintained outside of the medical record in more confidential research records.
Recorded
Not all HRPP programs have equal resources or the same compliance needs, yet every HRPP—regardless of size—must ensure adherence to the Common Rule (45 CFR 46), FDA human subjects regulations (21 CFR Parts 50 and 56), and the ethical principles that guide research oversight. Programs must structure their processes so they fulfill required regulatory functions such as review, continuing oversight, reporting, and documentation, while maintaining flexibility to adapt to institutional constraints and changing operational environments. In this workshop, speakers will discuss how their HRPPs interpret and implement key regulatory requirements within different resource models.
Recorded
Ensuring compliance with ClinicalTrials.gov requirements is a key institutional responsibility that intersects with IRB review and regulatory oversight. This session provides a detailed examination of federal requirements governing clinical trial registration and results reporting under FDAAA 801, the Common Rule, and NIH policy. ClinicalTrials.gov staff will clarify how these regulations apply to human subjects research oversight, including when registration is required, how Applicable Clinical Trials (ACTs) are identified, and how institutions and IRBs support accurate reporting and documentation.
REcorded
This session explores recent advancements in non-animal testing methods and new approach methodologies (NAMs), focusing on the principles of the 3Rs (Replacement, Reduction, and Refinement). We will examine innovative in-vitro models, including organ-on-a-chip, 3D cell cultures, and computational approaches, and their impact on drug development and regulatory acceptance in the pharmaceutical and biotech industries.
Multi-Day Workshops On Demand
Exploring IACUC Fundamentals
REcorded
Navigating the complex and evolving regulations governing the use of animals in research can feel overwhelming, but you don’t have to do it alone. This interactive workshop is designed to help new IACUC administrators build the essential knowledge and practical skills needed to oversee animal research compliance with confidence.
Recorded
Designed for professionals with a foundational understanding of IACUC programs and regulations who seek to deepen their expertise in animal research oversight. The workshop focuses on post-approval activities, through real-world case studies and discussion of common challenges. Led by experienced professionals, the program offers practical strategies, peer engagement, and actionable insights to support effective decision-making and continued growth in IACUC administration.
REcorded
This workshop is designed for both new IRB administrators as well as a refresher for those with more experience. The workshop examines the roles and responsibilities of an IRB administrator from the receipt of a new protocol to study close out.
Exploring the Common Rule: A Guide for Beginners
Recorded
New to IRB administration? Does the Common Rule seem daunting? If so, this workshop is for you! Gain a comprehensive understanding of the regulations that guide human protections provides a foundation to efficiently review research, effectively communicate with researchers, and ensure that research conducted at your institution is in compliance with the regulations.
FDA-Regulated Research
Recorded
This introductory workshop is an essential resource for professionals involved in the conduct, review, or oversight of FDA-regulated research on drugs, biologics, and medical devices. Designed to build foundational knowledge, the program is ideal for individuals working at academic medical centers, research hospitals, contract research organizations, pharmaceutical or biotechnology companies, and federal agencies—as well as those serving on or supporting institutional review boards (IRBs), quality assurance units, or regulatory affairs offices.