PHRP Perspectives

Reliance Agreements and Collaborating with HRPPs

Join PHRP Perspectives as we explore the increasingly important world of reliance agreements in human subjects research. In this episode, Joe Smith and Vidhi Rami from the University of Maryland walk us through how these agreements reduce administrative burden, streamline IRB reviews, and ensure regulatory compliance in multi-site studies. In this episode of PHRP Perspectives, Advisory Board member Joe Smith sits down with Vidhi Rami (IRB Specialist, Reliance Agreements) to demystify reliance agreements and collaborating across HRPPs. They share how single-IRB review reduces duplicate work, what “reviewing” vs. “relying” institutions actually do, and why local context still matters. You’ll also hear real-world tips on organizing the process, setting expectations with partner IRBs, and using resources like SMART IRB and AAHRPP guidance to build a scalable program. Show Notes: Joe Smith and Vidhi Rami discuss the power and complexity of reliance agreements in human subjects research. Their key discussion points include: * What Are Reliance Agreements?: Reliance agreements allow one IRB to assume oversight for a multi-institution research project, significantly reducing duplicative review efforts and speeding up study launches. * Roles & Responsibilities Clarified: Reviewing IRBs handle approvals and monitoring, while relying institutions ensure their investigators are properly trained and resourced. Clear documentation of roles is essential. * Why Institutions Decline Agreements: Common reasons include lack of human subjects involvement or institutional policies requiring reliance only when federally mandated. Capacity and expertise also play a role. * Improving the Process Internally: Organizing communication, training administrative staff, and collecting data more efficiently (e.g., replacing Word docs with simple emails) can make a major impact. * Go-To Resources & Tools: SMART IRB and AAHRPP were cited as essential platforms and frameworks for best practices, standard operating procedures, and building institutional confidence in reliance agreements.  PHRP Online Training helps ensure ethical, safe research practices with human participants through accessible, up-to-date courses. Designed to meet HHS standards, the training includes realistic scenarios, exam-based certification, and two course options tailored to biomedical or social, behavioral, and educational (SBE) research. Individuals and institutions receive one-year access and a downloadable certificate upon completion. Institutional partners enjoy custom portals with branded URLs and messaging. Courses are offered in English, Spanish, and French, with CE credits available. Learn more at PHRPTraining.com. [https://bit.ly/4jrJEf8]

Non-Human Subjects Determinations

If you’ve ever struggled with deciding whether your project qualifies as human subjects research, you’re not alone. Compliance veterans Kim Dicciani (PHRP Online Training Board Member) and Christine Wallace break down the definitions, edge cases, and institutional policies that shape IRB determinations—and share practical guidance every researcher can use.    Show Notes:  Kim Dicciani and Christine Wallace break down key definitions, intent, and misconceptions on IRB review and non-human subjects determinations. Their key points include the following: * Understanding Intent is Critical: The intent behind your research—whether to contribute to generalizable knowledge or for internal use only—is a primary factor in determining if IRB oversight is required.  * Definitions Matter: A project qualifies as human subjects research if it involves a systematic investigation and either interaction/intervention with individuals or access to identifiable private data.  * Anonymous does not equal De-identified: Anonymous data cannot be traced back to individuals, while de-identified data can be linked if a key exists. Misunderstanding this distinction often leads to incorrect IRB submissions.  * Check User Agreements and Public Access: When using online tools such as applications, chat rooms accessed by logins may require IRB review and approval. Be sure to review restrictive user agreements as there could be language that may restrict the use of the site for research purposes.  * Early Communication with the IRB is Essential: Researchers should consult with their IRB early—especially for ambiguous or borderline projects—to avoid delays, ensure compliance, and meet journal requirements for documentation.  Read more about PHRP Online Training Advisory Board Member Kim Diccianni [https://bit.ly/4dGkx7j] PHRP Online Training helps ensure ethical, safe research practices with human participants through accessible, up-to-date courses. Designed to meet HHS standards, the training includes realistic scenarios, exam-based certification, and two course options tailored to biomedical or social, behavioral, and educational (SBE) research. Individuals and institutions receive one-year access and a downloadable certificate upon completion. Institutional partners enjoy custom portals with branded URLs and messaging. Courses are offered in English, Spanish, and French, with CE credits available. Learn more at PHRPTraining.com. [https://bit.ly/4jrJEf8]

IRB Considerations for Treatment Use Protocols in Investigational Products

What role do IRBs play when investigational drugs are used for treatment? PHRP Advisory Board Member and longtime FDA and HHS leader Richard Klein and Lisa Kearns, Senior Research Associate in the division of Medical Ethics at NYU's Grossman School of Medicine, provide clarity on the ethical and regulatory frameworks behind expanded access, Right to Try laws, and the pivotal function of informed consent.   Show Notes:  Richard and Lisa explore IRB considerations for compassionate use and treatment under expanded access programs. Their key takeaways include: Expanded Access Explained: Expanded access, or compassionate use, allows seriously ill patients to access investigational drugs outside clinical trials when no satisfactory alternatives exist. The IRB’s Role: Even though expanded access is for treatment, IRB oversight is required due to the investigational nature of the drugs, ensuring proper informed consent and ethical safeguards. Informed Consent Challenges: Patients pursuing expanded access may be in vulnerable states, making it crucial for IRBs to ensure they understand the risks, benefits, and experimental nature of treatments. Regulatory Nuances: Single-patient expanded access can proceed with IRB chair approval rather than full board review, streamlining the process for critically ill individuals. Expanded Access vs. Right to Try: Right to Try laws are distinct from expanded access. They bypass FDA and IRB oversight, but have seen minimal uptake due to ethical concerns and sponsor hesitation. Learn more about PHRP Advisory Board Member Richard Klein [https://bit.ly/4jrJEf8] Resources: FDA Guidance: Expanded Access | Information for Institutional Review Boards (IRBs) [https://urldefense.com/v3/__https:/www.fda.gov/news-events/expanded-access/expanded-access-information-institutional-review-boards-irbs__;!!MXfaZl3l!a9Y5AJ0Q1Neln2zjzg845gX5s9Fr1LVg-czDZq3IO-rHq3XjArbdApcs4WIDPi9W6O4YIfDVmr70HzN-2AY63okYNhySWQ$] FDA Guidance: Expanded Access to Investigational Drugs for Treatment Use Questions and Answers Guidance for Industry [https://urldefense.com/v3/__https:/www.fda.gov/media/162793/download__;!!MXfaZl3l!a9Y5AJ0Q1Neln2zjzg845gX5s9Fr1LVg-czDZq3IO-rHq3XjArbdApcs4WIDPi9W6O4YIfDVmr70HzN-2AY63okl_GK4qg$] FDA's Expanded Access Regulations – 21 CFR 312 Subpart I [https://urldefense.com/v3/__https:/www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I__;!!MXfaZl3l!a9Y5AJ0Q1Neln2zjzg845gX5s9Fr1LVg-czDZq3IO-rHq3XjArbdApcs4WIDPi9W6O4YIfDVmr70HzN-2AY63ol-hr62Eg$] FDA's Informed Consent of Human Subjects Regulations – 21 CFR Part 50 [https://urldefense.com/v3/__https:/www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50/subpart-B__;!!MXfaZl3l!a9Y5AJ0Q1Neln2zjzg845gX5s9Fr1LVg-czDZq3IO-rHq3XjArbdApcs4WIDPi9W6O4YIfDVmr70HzN-2AY63okXar0-yQ$], Subpart B [https://urldefense.com/v3/__https:/www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50/subpart-B__;!!MXfaZl3l!a9Y5AJ0Q1Neln2zjzg845gX5s9Fr1LVg-czDZq3IO-rHq3XjArbdApcs4WIDPi9W6O4YIfDVmr70HzN-2AY63okXar0-yQ$]  See more r [https://phrptraining.com/news/considerations-treatment-use] PHRP Online Training helps ensure ethical, safe research practices with human participants through accessible, up-to-date courses. Designed to meet HHS standards, the training includes realistic scenarios, exam-based certification, and two course options tailored to biomedical or social, behavioral, and educational (SBE) research. Individuals and institutions receive one-year access and a downloadable certificate upon completion. Institutional partners enjoy custom portals with branded URLs and messaging. Courses are offered in English, Spanish, and French, with CE credits available. Learn more at PHRPTraining.com. [https://bit.ly/4jrJEf8]

Improving IRB Community Outreach Methods

How can IRBs and research investigators improve outreach within their institutions and with the broader community? Joe Smith, PHRP Advisory Board Member and Director of the Human Research Protection Program at University of Maryland College Park and Samantha Martocci, IRB Specialist in Education and Improvement with the University of Maryland, discuss how to better connect, communicate, and collaborate to build stronger internal and external engagement.    Show Notes:  Joe Smith and Sam Martocci offer many tips to improve community outreach – from engaging researchers on campus to connecting with local communities.  * Internal and External Outreach Require Distinct Strategies: Internal outreach focuses on researchers, IRB members, and institutional stakeholders via surveys, listservs, websites, and presentations. External outreach targets current and potential research participants and the surrounding community using clinics, partnerships, and educational materials. * Partnerships Enhance Reach and Relevance: Collaborating with offices like community engagement or research administration brings broader perspectives and deeper connections, often opening access to specialized populations and established communication channels. * Trust and Relationship-Building Are Essential: Effective outreach isn’t just about information—it's about trust. Establishing rapport with researchers encourages collaboration, transparency, and compliance. Outreach should be personal, approachable, and consistent. * Surveys and Feedback Drive Improvement: Regular feedback from investigators and community members reveals gaps in communication and areas for resource development. Listening fosters improvement and validates stakeholders' perspectives. * Resource Sharing and Institutional Knowledge Matter: Many tools already exist within an institution. By auditing current resources, reaching out to peer organizations, and learning from others, IRBs can build stronger foundations without reinventing the wheel. Learn more about PHRP Advisory Board Member Joe Smith [https://bit.ly/4dCGggt] PHRP Online Training helps ensure ethical, safe research practices with human participants through accessible, up-to-date courses. Designed to meet HHS standards, the training includes realistic scenarios, exam-based certification, and two course options tailored to biomedical or social, behavioral, and educational (SBE) research. Individuals and institutions receive one-year access and a downloadable certificate upon completion. Institutional partners enjoy custom portals with branded URLs and messaging. Courses are offered in English, Spanish, and French, with CE credits available. Learn more at PHRPTraining.com. [https://bit.ly/4jrJEf8]

PHRP Perspectives - Podcast Trailer

New Podcast Launch: PHRP Perspectives:  Ethics, Research & Compliance We're excited to introduce PHRP Perspectives — your new go-to podcast for ethics, compliance, and best practices in human subjects research. Featuring leading voices in the field, our first season dives into: - Informed consent and expanded access - Community outreach and IRB reliance agreements - Human subject research determinations and compliance tools Join PHRP Advisory Board Members Richard Klein, Joe Smith, and Kim Diccianni, and their expert guests as they explore practical strategies and evolving standards that affect your work every day. 🎧 Available on YouTube, Apple Podcasts, Spotify — and at PHRPtraining.com [https://phrptraining.com/]  Show Notes: Expert-Driven Insights: PHRP Perspectives features guidance and stories from industry leaders in human research protection, including advisory board members with decades of experience in biomedical, clinical, and social-behavioral research. Timely and Relevant Topics: Upcoming episodes will address expanded access, reliance agreements, community outreach, and human subjects research determinations — all aimed at helping professionals stay current with evolving regulations and best practices. Real-World Challenges and Solutions: Guests explore the complexities of compliance, including navigating gray areas in IRB determinations and improving outreach across diverse research settings. Support for Professionals at All Levels: Whether you're a new investigator or a seasoned IRB administrator, the podcast provides practical tools, policy tips, and shared experiences to help strengthen human subject protection programs. A Collaborative Approach to Compliance: The series emphasizes the value of community, shared learning, and building strong relationships between researchers and IRBs to enhance ethical research and protect participants. PHRP Online Training helps ensure ethical, safe research practices with human participants through accessible, up-to-date courses. Designed to meet HHS standards, the training includes realistic scenarios, exam-based certification, and two course options tailored to biomedical or social, behavioral, and educational (SBE) research. Individuals and institutions receive one-year access and a downloadable certificate upon completion. Institutional partners enjoy custom portals with branded URLs and messaging. Courses are offered in English, Spanish, and French, with CE credits available. Learn more at PHRPTraining.com. [https://bit.ly/4jrJEf8]