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Category: Regulatory

  • ICYMI: HHS FY26 Budget Re-Org: Assistant Secretary for Enforcement (ASE)

    ICYMI: HHS FY26 Budget Re-Org: Assistant Secretary for Enforcement (ASE)

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

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    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Authored By: Tasha Mohseni

    Why does January always feel so long?

    If you saw my previous blog article, I covered select regulatory updates from HHS and its sub-agencies. There was so much to write about. It was difficult to determine which updates were the most important. So many things occur on a daily basis!

    crop chemist holding in hands molecule model

    It can be easy to miss the bigger picture. This inspired me for today’s topic.

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    Let’s dive right in!

    I’m going to cover the re-organization of the Department of Health and Human Services (HHS) and how how this impacts the Office of Human Research Protections (OHRP). Specifically, I’d like to highlight:

    • The current HHS structure with OHRP under the Office of the Assistant Secretary for Health (OASH)
    • Introduce the Assistant Secretary of Enforcement (ASE)
    • Close with how I envision OHRP under the new ASE

    As a general reminder, any legal information discussed within this post should be discussed with your institution.

    Table of Contents:

    What is OASH?

    The Office of the Assistant Secretary of Health (OASH) develops policy recommendations for public health across HHS and its agencies. OASH is tasked with improving the health and well-being of Americans by leading on policy, practices, and programs. OASH seeks to restore scientific integrity and transparency to rebuild public trust and advance the public good. Below is the current organizational structure:

    OHRP is one of these divisions that supports OASH.

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    What is OHRP?

    OHRP fulfills responsibilities set forth in the Public Health Service (PHS) Act including:

    • Providing leadership for human research subjects protections within HHS and for the U.S. Government in cooperation with other Federal Agencies
    • Developing and monitoring as well as exercising compliance oversight relative to HHS regulations for the protection of human subjects in research conducted or supported by any component of HHS
    • Promoting and coordinating appropriate HHS regulations, policies, and procedures both within HHS and in coordination with other Departments and Agencies in the Federal Government
    • Establishing criteria for approval of assurances of compliance for the protection of human subjects with both domestic and foreign institutions engaged in HHS-conducted or supported research involving human subjects
    • Conducting programs of clarification and guidance for both the Federal and non-Federal sectors with respect to the involvement of humans in research; and directing the development and implementation of educational and instructional programs and generating educational resource materials
    • Evaluating the effectiveness of HHS policies and programs for the protection of human subjects
    • Serving as the liaison to Presidential, Departmental, Congressional, interagency, non-governmental, and international commissions and boards to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues
    • Promoting the development of approaches to enhance and improve methods, particularly quality improvement at the institutional level, to avoid unwarranted risks to humans participating as subjects in research covered by applicable statutes

    OHRP is comprised of multiple subparts, including the formerly terminated Secretaryโ€™s Advisory Committee on Human Research Protections (SACHRP).

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    What is ASE?

    To quickly bring you up to speed:

    • In March 2025, HHS announced a new initiative, Make America Healthy Again, in response to Executive Order (EO) 14210 “Implementing the President’s โ€œDepartment of Government Efficiencyโ€ Workforce Optimization Initiative”
      • The EO was issued in February 2025
      • Within this initiative, the Assistant Secretary for Enforcement (ASE) is introduced: “HHS will create a new Assistant Secretary for Enforcement to oversee the Departmental Appeals Board (DAB), Office of Medicare Hearings and Appeals (OMHA), and Office for Civil Rights (OCR) to combat waste, fraud, and abuse in federal health programs.”
    • Then, in September 2025, the House Appropriations Committee approved the HHS FY26 budget (including the creation of ASE and re-organization within HHS)

    Now that we have some background information, let’s talk about ASE.

    Directly from the HHS FY26 budget justification, ASE will centralize executive oversight over several mission-critical offices:

    • Departmental Appeals Board (DAB)
    • Office for Civil Rights (OCR)
    • Office of Medicare Hearings and Appeals (OMHA)
    • Office for Human Research Protections (OHRP)

    This consolidation is designed to streamline oversight, improve enforcement and adjudication coordination, provide education and guidance on relevant legal authorities, and strengthen HHS’s ability to fulfill its legal obligations to the public. ASE will:

    • Ensure individuals and institutions attain resolution of complaints, disputes, and appeals
    • Encourage compliance through regulations, guidance, education, and technical assistance
    • Enforce legal compliance and adjudication under federal statutes and regulations

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    A Grim Future for OHRP Under ASE

    As someone with an accounting and program management background, I can appreciate cutting costs. Having said that…

    Cost reduction should NOT equal mission reduction.

    OHRP’s mission will take an even bigger blow.

    I was alarmed when I didn’t see OHRP mentioned in the HHS press release or fact sheet.

    In the press release, it was indicated that ASE would be comprised of DAB, OMHA, and OCR. Further, it was noted in the fact sheet that “A new Administration for a Healthy America (AHA) will consolidate the OASH, HRSA, SAMHSA, ATSDR, and NIOSH, so as to more efficiently coordinate chronic care and disease prevention programs and harmonize health resources to low-income Americans.” This made me wonder…where is OHRP in the midst of this?

    Reviewing OHRP’s approved budget is an even sadder story.

    I did feel some relief once I saw OHRP was mentioned within the HHS FY26 budget justification. However, it slowly disappeared as I read through the budget requests for each unit. HHS signaled where OHRP falls on the totem pole. Directly copied from the budget justification:

    “The Office for Human Research Protection also requests non-trust fund budget authority that will maintain minimal operations. This includes conducting a limited number of for-cause compliance assessments of human research protection programs or institutional review boards, processing approximately 800-1,000 incident reports, and approximately 400-600 complaints about research. Develop guidance, the fulfillment of the FWA and IRB registration missions, and the ability to develop educational tools and resources will be limited.”

    OHRP already had limited staff and resources with great responsibility. How is OHRP supposed to act on their duties under the PHS Act when the budget request is so specific? I have so many questions about this budget request:

    1. What is considered a “limited number” of for-cause compliance assessments?
    2. How is OHRP supposed to prioritize which HRPPs and IRBs receive such assessments?
    3. What happens if there’s more complaints and/or incidents than originally projected?
    4. Why are resources (i.e., educational tools) and enforcement mechanisms (i.e., FWA) that uphold public trust in research on the back burner?

    OHRP is going to need support and expertise from research compliance professionals such as ourselves for education and guidance development. NACHRP and PRIM&R could potential lead such efforts.

    (Back to the Contents)

    I hope you found this article insightful!

  • Recent HHS Family of Agencies Developments: Key Regulatory Changes and Research Implications

    Recent HHS Family of Agencies Developments: Key Regulatory Changes and Research Implications

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Eager to skip ahead to today’s topic?

    Jump to the Table of Contents.

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Authored By: Tasha Mohseni

    Wow, what a busy start to the new year!

    I always think each new year should begin with pause and planning. Planning for personal and professional goals. Planning for family trips. Just planning in general. However, it already feels like I’m in the 2026 hamster wheel. You would think I’d be used to this by now, but I suppose not.

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    Let’s dive into today’s topic!

    I’m going to cover select recent developments within HHS and its agencies including:

    • Food and Drug Administration (FDA)
    • National Institutes of Health (NIH)
    • Office of Research Integrity (ORI)

    As a general reminder, any legal information discussed within this post should be discussed with your institution.

    Table of Contents:

    Public comment requested on the adoption and use of AI in clinical care

    The Department of Health and Human Services (HHS) issued a Request for Information (RFI) on accelerating the adoption and use of AI in clinical care. Public feedback will inform HHS-wide use of three different approaches: regulation, reimbursement, and research & development. Specifically, HHS seeks concrete, experience-based feedback from those building, buying, evaluating, using, and receiving care from AI tools that are part of clinical care as well as from those who wish to do so but face barriers. The RFI has a 60-day comment period from when the notice was first issued.

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    HTI-5 Proposed Rule announcement

    HHS, via the ASTP/ONC, released the HTI-5 Proposed Rule. A central component of the HTI-5 Proposed Rule is streamlining the ONC Health IT Certification Program. The HTI-5 Proposed Rule also includes updates to the information blocking regulations. Drawing from stakeholder feedback, the proposal edits definitions and adjusts several exceptions to reduce the potential for misuse and to strengthen HHSโ€™s ability to ensure patient access to electronic health information. The Proposed Rule will be open for public comment for 60 days upon publication in the Federal Register. 

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    HHS grand AI strategy

    HHS released a comprehensive AI strategy designed to transform how the agency operates, serves the public, and accelerates innovation across health, human services, and public health. This marks a significant milestone in HHSโ€™s efforts to harness AI responsibly and effectively to improve outcomes for all Americans. This framework that expands the responsible use of AI throughout the Department and aligns with broader federal directives to modernize government operations and innovation. Further, the strategy centers on a OneHHS approach uniting AI priorities and governance across all HHS agencies. The plan is built upon five main pillars:

    • Ensure governance and risk management for public trust
    • Design infrastructure and platforms for user needs
    • Promote workforce development and burden reduction for efficiency
    • Foster health research and reproducibility through gold standard science
    • Enable care and public health delivery modernization for better outcomes

    As part of this initiative, HHS published its AI Compliance Plan in late 2025. This plan implements the requirements of the Office of Management and Budgetโ€™s (OMB) Memoranda M-25-21 and M-25-22, which directs federal agencies to accelerate the safe, innovative, and trustworthy use of AI. The Compliance Plan focuses on three areas:

    • Encouraging public trust by promoting transparency and accountability in AI use
    • Driving innovation via removal of barriers and enabling efficient adoption of AI
    • Placing AI governance at the forefront by establishing policies, inventories, and oversight processes across HHS Divisions

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    Top FDA drug regulator Pazdur retires, Hรธeg takes his place in CDER

    The FDA continues to switch up the game with grand regulatory changes. STAT first reported Richard Pazdurโ€™s retirement from the FDAโ€™s Center for Drug Evaluation and Research (CDER) just weeks after acceptance. FDA Commissioner Dr. Marty Makary first appointed Pazdur mid-November calling him a true regulatory innovator. Though his departure appeared abrupt, itโ€™s not necessarily a shock. CNN reported that Pazdur initially turned down the CDER appointment primarily because of his strained relationship with Dr. Vinay Prasad.

    Years prior, Prasad openly criticized Pazdur in a blog post stating, โ€œFrankly Rick Pazdur has exerted his will over the FDA and has done a catastrophically bad job.โ€

    There was speculation as to whether Pazdurโ€™s retirement is connected to a leaked memo from Prasad. In this memo, Prasad claimed that the COVID-19 vaccine caused the death of 10 children. Further, within the memo, Prasad called for stricter vaccine regulation. A group of former FDA Commissioners gathered to express their deep concerns of this new framework in the New England Journal of Medicine. In a matter of days, the FDA moved quickly to appoint Dr. Tracy Beth Hรธeg as the CDER acting director.

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    GAO calls for action in medical device recall oversight limitations

    The Government Accountability Office (GAO) recently published a report on the FDAโ€™s medical device recall process. The FDA monitors the safety of approximately 200,000 medical devices. From 2020 to 2024, the GAO reported that nearly 4,000 of these devices needed to be recalled. Using recalled medical devices can lead to serious injury, death, or other adverse effects.

    FDA’s oversight of the recall process includes reviewing manufacturers’ recall plans and verifying that recalls were carried out according to plan.

    Gaps in this oversight process not only magnify inefficiencies, but also places patients at risk. The ramifications of using recalled devices include the potential for serious injury or death. FDAโ€™s oversight of medical products, including devices, has been on GAOโ€™s high-risk list since 2009.

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    QSMR amended to align with revised ISO 13485:2016

    In February 2026, the FDA will begin enforcing the Quality Management System Regulation (QMSR). This replaces the Quality System Regulation (QSR) under 21 CFR 820 and is aligned with the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO) ISO 13485:2016. The December 2025 technical amendments are purely administrative revisions made by the FDA to align 21 CFR 820 with the QMSR framework.

    • The QMSR harmonizes key areas of a device manufacturerโ€™s Quality Management System (QMS) and more closely aligns the U.S. with many other regulatory authorities around the world.
    • Further, this action promotes consistency in the regulation of devices and provides a timelier introduction of safe, effective, high-quality devices for patients.

    Organizations can start communications early with key stakeholders to facilitate the understanding of shifting from QSR to QMSR. If your organization currently implements ISO 13485, they should review for any potential compliance gaps from the FDA QMSR (e.g., additional requirements or documentation). After gap analysis is performed, organizations can create training materials to educate staff. Further, any templates used to review for medical device studies should be updated for terminology changes from QSR to QMSR.

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    RFI on harmonizing NIH research participant data policies

    The NIH issued a RFI inviting public input on a significant proposal to harmonize and improve how human research participant data are protected and shared across NIH policies. This initiative reflects NIHโ€™s commitment to responsible data stewardship. Under NOT-OD-26-023, NIH proposes to:

    • A new NIH Controlled-Access Data Policy to support the research community in fulfilling NIH data sharing expectations
      • This policy specifies human participant data types required to be managed via controlled-access and provides criteria for assessing the need for controls for other data types
    • To revise the NIH Genomic Data Sharing (GDS) Policy to reduce duplicate policy requirements and improve overall performance with respect to human genomic data only

    NIH welcomes comments with respect to:

    • Whether the proposed data types requiring controlled access are appropriate
    • Suggested additions or modifications to definitions or criteria
    • Practical considerations for implementation
    • Views on the proposed scope of the revised GDS Policy

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    Recent statement from NIH Director Bhattacharya on engaging the public as clinical research partners

    The NIH director issued a statement titled โ€œRoadmap for Engaging the Public as Partners in Clinical Research,โ€ which signals a new era of participation, transparency, and shared ownership in the research. The roadmap reflects recommendations from the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) and its ENGAGE Working Group, which spent several years consulting experts and communities nationwide to identify ways to integrate public voices at every stage of clinical research. This includes:

    • Helping interpret and disseminate results in ways that matter to peopleโ€™s lives
    • Designing research questions that align with community priorities
    • Advising on recruitment strategies and study plans

    A cornerstone of this initiative is transparency about how clinical research data are used and shared. To support transparency, NIH is establishing agency-wide principles to foster, promote, and guide the responsible conduct of research using clinical data. The eight priniciples are as follows:

    • Leveraging existing infrastructure to promote access and improve efficiencies in cost and resources is a NIH-wide priority
    • Demonstrating respect for persons is a core NIH value when considering research uses of clinical data
    • Ensuring responsible stewardship of data is an essential component of demonstrating respect for persons
    • Recognizing the needs of the communities from which the data are collected and generated is imperative to respectful collaboration or partnerships on using clinical data for research
    • Fostering and maintaining public trust necessitates ongoing transparency regarding uses of clinical data for research and communication of the potential benefits and risks of such research
    • Promoting quality of EHR data that is beneficial for both clinical and research use should be accompanied by a recognition that data in the EHR was collected specifically for clinical use
    • Deciding to use clinical data for research purposes requires ongoing consideration of the risks and benefits, NIHโ€™s unifying principles, and the core principles captured in current laws, policies, and regulations
    • Ensuring that policies and decision-making processes regarding the use of clinical data for research purposes are designed to adapt to rapidly changing technical, social, ethical, and regulatory landscapes is essential

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    New NIH research security training requirement

    The NIH implemented research security training requirements as outlined in the CHIPS and Science Act of 2022. Several federal agencies including the NSF and DOE are implementing training requirements that address cybersecurity, international collaboration, foreign interference, and rules for proper use of funds, disclosure, conflict of commitment, and conflict of interest. This initiative safeguards U.S. scientific research. 

    The NSF, in partnership with the NIH, the DOE, and DOD, have created four online research security training (RST) modules as a resource for organizations to fulfill this requirement. The condensed RST module is designed to meet the government-wide RST requirement in the CHIPS and Science Act of 2022. To that end, NSF, NIH, DOE, DOD, and USDA all recognize completion of the condensed module as compliant with their respective RST requirements.

    Completion of this training as well as individual and institutional certifications will be effective for applications submitted for due dates on or after May 25, 2026. Organizations can ensure this requirement is communicated to investigators engaged in NIH-funded research. They can ensure covered individuals (those defined as senior/key personnel) listed on the grant certify completion of this training within 12 months of the date of application submission. Note that covered individuals may be defined differently depending on the specific federal agency.

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    New ORI Final Rule Guidance Documents Released

    The Office of Research Integrity (ORI) released a new set of guidance documents to support institutions preparing for the implementation of the 2024 Final Rule on Public Health Service (PHS) Policies on Research Misconduct. These resources are designed to help institutions better understand and comply with the updated regulations, which became effective January 1, 2026. New topic-specific guidance documents released include:

    • Institutional Records (pdf): This document is designed to assist institutions in producing a complete institutional record including reports, interviews, research records, and other documents and information compiled during a research misconduct proceeding.
    • Research Records (pdf): This document describes the wide range of research records and other evidence that may be needed to complete a research misconduct proceeding.
    • Multiple Institutions (pdf): This guidance document is intended to help institutions navigate research misconduct proceedings involving multiple institutions.

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    I hope this post brought you up to speed on some recent actions from the HHS and its agencies!

  • Top 2026 Research Administration and Compliance Conferences

    Top 2026 Research Administration and Compliance Conferences

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Jump to the Table of Contents.

    Eager to skip ahead to today’s content?

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Authored By: Tasha Mohseni

    Happy New Year and welcome to the first CREST blog post in 2026!

    It feels good to get back on the saddle and write to you all. I hope you all enjoyed the holidays with your family and loved ones.

    I wish that 2026 brings you all success, good health, and whatever you were working towards last year that will be worthwhile.

    people lighting sparklers

    For today’s article, I’d like to highlight top research administration and compliance conferences. These are events you don’t want to miss to develop professionally!

    IMPORTANT: Events within this article were included only if they were a “conference” or “annual meeting” (i.e., no other event types such as workshops or webinars).

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    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

    Table of Contents:

    Research Administration and Compliance 2026 Conferences Summary

    OrganizationAnnual Conference(s)Information Available?
    WCGMAGIYes, 2026 information is available.
    Public Responsibility in Medicine and Research (PRIM&R)PRIM&RYes, 2026 information is available as well as a call for session proposals.
    Northwest Association for Biomedical Research (NWABR)1. IRB, IBC, & IACUC Conference

    2. Clinical Research Professional Conference

    3. CyberBIO    		Only a call for 2026 session proposals for each conference (as of 1/3/26).
    Association of Clinical Research Professionals (ACRP)ACRPYes, 2026 information is available.
    Society of Clinical Research Associates (SOCRA)1. Clinical Research Project/Program Management Conference

    2. Quality Management Conference

    3. FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference

    4. Pediatric Clinical Trials Conference    		No information at this time (as of 1/3/26).
    National Council of University Research Administrators (NCURA)1. Annual Meeting of the Membership

    2. Financial Research Administration Conference

    3. Pre-Award Research Administration Conference    		For two conferences, 2026 information is available (as of 1/3/26).
    SCOPESCOPE 2026Yes, 2026 information is available.
    Society of Research Administrators (SRAI)1. Annual Meeting

    2. Financial Management

    3. Research Administration Conference    		Yes, 2026 information is available..

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    WCG’s MAGI Conference

    MAGI is a WCG event that connects clinical research professionals who are committed to ensuring the quality, compliance, and efficiency.

    Per the website, WCG is a partner to research sponsors, CROs, sites and participants in navigating the clinical research journey. WCG showcases their solutions in exhibit booths at various conferences. Further, they offer informative webinars (especially if you’re new to clinical research. You can view the following links below for educational materials:

    Upon review of the MAGI 2025 conference…

    • Five education tracks were offered including:
      • Budgets: learning the nuances of ensuring your site is optimized for conducting clinical trials
      • Contracts: exploring field-tested, easily implemented negotiation tools and techniques that can help maintain control, improve turnaround times, and reduce last-minute scrambles
      • Billing compliance: strengthening research billing compliance development and program oversight
      • Quality and regulatory: ensuring adherence to the regulations on research participant protections
      • Clinical operations: mastering approaches to maintaining trial quality and effective tactics for protecting participant safety and data integrity
    • You can review the 2025 agenda to view workshops within these educational tracks

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    PRIM&R Annual Conference

    The PRIM&R Conference educates those involved in research and research oversight to support and achieve the advancement of ethical, responsible, and high-quality research.

    PRIM&R is a nonprofit,โ€ฏfounded in 1974 that works to ensure the highest ethical standards in research by:

    • Providing education,
    • Membership, and
    • Other professional resources to the research and research oversight community, including those who work with:
      • Human research protections programs (HRPPs),
      • Institutional review boards (IRBs),
      • Animal care and use programs,โ€ฏand
      • Institutional animal care and use committeesโ€ฏ(IACUCs).

    Those who attend these conferences can use the session materials in preparation for the following certifications:

    Upon review of the 2025 PRIM&R Annual Conference…

    This also includes the PRIM&R Social Behavioral Educational Research Conference (SBER25). Attendees have the choice to either:

    • Attend PRIM&R 2025 only
    • Attend SBER 2025 only
    • Attend PRIM&R 2025 and SBER25

    Educational tracks range from program administration, regulation-specific topics, quality control, post approval monitoring, emerging challenges, and many more!

    You can also submit proposals to speak at PRIMR26!

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    NWABR Annual Conferences

    NWABR offers three annual conferences and is currently accepting 2026 submissions.

    NWABR is dedicated to promoting the public’s trust in ethically conducted biomedical research. You can read more about this organization here: About Us.

    IRB, IBC & IACUC Conference Series

    This conference is PERFECT if you wear multiple compliance hats or in a small HRPP.

    You can review the 2025 program to see the various topics within these compliance areas.

    Clinical Research Professional Conference Series

    This conference is for clinical research professionals who ensure the ongoing integrity of research within their institutions.

    You can review the 2025 program to see this year’s focus: quality initiatives and artificial intelligence (AI)

    CyberBIO Conference Series

    This conference includes experts across government, industry, and academia to discuss issues at the intersection of biomedical sciences and cybersecurity.

    You can review the 2025 program once it is available (as of 9/23/25).

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    ACRP Annual Conference

    ACRP is a registered charitable organization whose mission is to promote excellence in clinical research.

    Their vision ensures that clinical research is performed ethically, responsibly, and professionally everywhere in the world. 

    The ACRP 2026 website is available!

    Educational tracks for this year’s conference include:

    • Clinical operations
    • Study and site management
    • Regulatory/quality
    • Innovation and change management
    • Workforce and professional development

    Those who attend these conferences can use the session materials in preparation for certification:

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    SOCRA Annual Conferences

    SOCRA is a non-profit, charitable and educational membership organization incorporated in 1991 committed to providing:

    • Education,
    • Certification, and
    • Networking opportunities to all persons involved in clinical research activities.

    Those who attend these conferences can use the session materials in preparation for the following SOCRA certification:

    Clinical Research Project/Program Management Conference

    This conference is designed to introduce, affirm, or elevate your understanding of project management in the field of clinical research.

    The program will broaden the participantsโ€™ knowledge of the regulatory framework, project management, planning and accounting, and achieving successful clinical trials. For more details, you can review:

    Quality Management Conference

    This conference provides insights, practical tools, and real-life examples to navigate quality planning, control, assurance, and improvement in clinical research. 

    The event delivers vital information on developing and implementing effective quality management systems in line with FDA Regulations and ICH guidance. For more details, you can review:

    FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference

    This conference is designed to aid in the understanding of the FDA’s mission, responsibilities and authority and to facilitate interaction with FDA representatives.

    The conference will focus on:

    • FDA Clinical Research Requirements,
    • Enhancing Success through Communication, and
    • Financial Incentives, and Assuring Confidence in Clinical Research

    For more details, you can review the program’s learning objectives and 2025 agenda.

    Pediatric Clinical Trials Conference

    This conference will improve professional skills and understanding of the responsibilities of conducting clinical research in the pediatric population. 

    This program is designed to elevate attendees’ understanding and application across the:

    • Regulatory environment,
    • Informed consent and assent,
    • Recruitment and retention,
    • Feasibility,
    • Budgeting,
    • Contracting, and
    • Financial management

    For more details, you can review the program’s learning objectives and 2025 agenda.

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    NCURA Annual Conferences

    NCURA offers three annual conferences!

    NCURA is a non-profit professional society dedicated to advancing the profession of research administration through:

    • Education and professional development programs, the
    • Sharing of knowledge and experiences, and the
    • Fostering of a diverse, collegial, and respected global community. 

    Annual Meeting of the Membership

    This conference is held each year in August in Washington DC with workshops prior to the main event!

    Various tracks and sessions relate to:

    • Pre-Award,
    • Post-Award,
    • Compliance,
    • Departmental,
    • Global,
    • Predominantly Undergraduate Institutions,
    • Clinical Trials/Research, and
    • Career-Skills

    You can review the 2025 program schedule for specifics related to the conference sessions.

    Financial Research Administration Conference

    This conference is for those who work in the financial administration of research, specifically to discuss post-award issues.

    Various tracks relate to:

    • Accounting, Finance & Costing
    • Clinical/Medical
    • Financial Compliance/Audit
    • PUI
    • AI/Data/ERA/Systems
    • Departmental
    • Global
    • Workforce, Wellness & Resilience
    • Career Development
    • Federal
    • Pre-Award for Finance

    You can review the 2026 program information here.

    Pre-Award Research Administration Conference

    This conference complements the conference mentioned above; however, pre-award issues are discussed.

    Various tracks relate to:

    • Clinical/Medical/Industry
    • Departmental
    • Professional Development
    • Sponsors: Federal & Non-profits
    • AI/Data/ERA/Systems
    • Finance for Pre-Award
    • Proposal/Research Development
    • Compliance
    • Global
    • PUI

    You can review 2026 program information here.

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    SCOPE Annual Conference

    The SCOPE 2026 website is available and proposals are being accepted!

    Though an official schedule isn’t posted, the event brochure highlights the following educational tracks:

    • Trial design and protocol development
    • Feasibility and site selection
    • Recruitment and engagement

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    SRAI Annual Conferences

    SRAI provides research administrators globally with the knowledge, resources, and community they need to excel, collaborate, and drive impactful research.

    Directly from the website, this organization is the only research management society in the world whose membership spans the entire spectrum of research institutions, including:

    • For-profit entities involved in research and development
    • Public and private colleges and universities
    • Research hospitals and institutes
    • Charitable and research-focused nonprofits
    • Federal, state, and local government bodies engaged in research

    Annual Meeting

    Folks who attend the SRAI 2026 conference will gain fresh perspectives on timely topics from the world’s leading research administration experts.

    Educational tracks include:

    • Financial and Post-Award Administration
    • Management and Operations
    • Professional Development
    • Research Impact and Communications
    • Research Ethics and Compliance
    • Research Law and Regulations
    • Sponsors and Agencies
    • Sponsored Programs Planning, Development and Deliveries
    • Technology Solutions in Research Administration

    Financial Management Conference

    The Financial Management Conference is a virtual professional development event focused on financial and post-award management in research administration.

    This year’s tracks include:

    • Grant accounting
    • Departmental administration finance
    • Non-financial post-award
    • Financial leadership
    • Advance finance topics

    Research Administration Conference

    The Research Administration Conference offers one yearโ€™s worth of online training in three days, with the flexibility to create your own schedule.

    This year’s tracks include:

    • Professional development
    • Pre-award
    • Contract and law
    • Compliance and ethics
    • Financial and cost accounting

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    I hope you found this article informative!

  • National Advisory Committee on Human Research Protections (NACHRP): Interview with Julie Kaneshiro

    National Advisory Committee on Human Research Protections (NACHRP): Interview with Julie Kaneshiro

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Interview with Julie Kaneshiro

    Written by Tasha Mohseni

    Today, we are going to learn about National Advisory Committee on Human Research Protections (NACHRP).

    In this candid interview with Julie Kaneshiro, we will learn about her journey when she first started in federal human research oversight. Then, we will shift the discussion towards NACHRP and what we can expect from this new organization.

    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

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    Table of Contents:

    I see youโ€™ve worked in the federal government industry throughout your entire career, specifically with OHRP from 2002 until June this year. What initially drew you into human research oversight?

    Julie suspects that her childhood exposure to the National Institutes of Health (NIH) through her motherโ€™s role as a social worker in the NIH Clinical Center that led to her interest in human research protections. In the early 1990s, she became an NIH management intern at NIH. Through this internship program, she learned about the Office of Human Research Protections’ (OHRP) predecessor office, the Office for Protection from Research Risks (OPRR).  The typical career path for a management intern at the time was research administration.

    However, she was interested in public policy and bioethics.

    Once she learned about OPRRโ€™s mission to protect research participants, she knew this is where she wanted to be. She expressed gratitude towards the people at OPRR who became her mentors, including Gary Ellis, Joan Porter, Bill Dommel, and Tom Puglisi. Julie joined soon after the Common Rule was adopted. The OPRR staff gave her invaluable experiences and opportunities to learn about these regulations and ethical issues that were present.

    (Back to the Contents)

    Iโ€™d like to learn how you became engaged with SACHRP (The Secretaryโ€™s Advisory Committee for Human Research Protections, but first why donโ€™t you give us a brief overview of who SACHRP was and their mission?

    SACHRP was created in 2003. This organization advised the Secretary of HHS about issues related to human research protections. Unfortunately, SACHRP was terminated in March 2025. SACHRPโ€™s recommendations were of great value to HHS, and especially to OHRP over this 22-year period.  The members of SACHRP and its subcommittees were some of the most knowledgeable people working in human research protections. They provided valuable recommendations to OHRP and other entities within HHS that have a role in the participant protections. HHS agencies include the Food and Drug Administration (FDA), NIH and the Office for Civil Rights (OCR).  OHRP was responsible for the management and support of SACHRP. Specifically, OHRP staff were involved with identifying topics that institutions would benefit from SACHRP and their subcommitteesโ€™ experience and expertise. 

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    When SACHRP was terminated in March 2025, how did you feel about this? Was the termination a surprise to you?

    Naturally, Julie was disappointed to learn about SACHRPโ€™s termination, but was not surprised.  It is not unusual for advisory committees to undergo change or be eliminated with a change in administration.  Prior to the establishment of SACHRP, there was the National Human Research Protections Advisory Committee which existed from 2000-2003. Their mission was comparable to SACHRP.

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    What were the main consequences (intended or unintended) of dissolving SACHRP for the human research protections community?

    The loss of SACHRP was not just a loss for OHRP and HHS, but also to:

    • The other Common Rule department and agencies,
    • The broader human research protections community and
    • The public more generally. 

    Though SACHRP wasn’t the only entity engaged in these crucial discussions, its important voice gave OHRP and others valuable insights. It is key that SACHRP was a FACA committee.

    FACA committees conduct meetings and deliberations in public, with the opportunity for public input.

    All of SACHRPโ€™s recommendations are available to the public. These recommendations remain an important resource for the human research protections community.

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    Letโ€™s shift the discussion to NACHRP (The National Advisory Committee on Human Research Protections). What is NACHRP?

    NACHRP is a volunteer-driven organization that aims to continue the tradition of the U.S. Department of Health and Human Services, Secretaryโ€™s Advisory Committee on Human Research Protections (SACHRP). NACHRP will:

    • Provide expert advice and practical recommendations to the human research community based on established ethical principles, including the Belmont Report and the Declaration of Helsinki.
    • Promote consistent interpretation and application of federal regulations and guidance in coordination with Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs).
    • Respond to emerging challenges arising from advances in science, medicine, and technology, while anticipating future developments and supporting responsible innovation.
    • Commit to ethical vigilance and innovation in participant protections, and to honoring the trust placed in research with transparency, respect, and integrity.
    • Provide opportunities for community input and participation.

    (Back to the Contents)

    NACHRP is just beginning its work and is eager for input about what topics would be useful to address.

    NACHRPโ€™s first Town Hall meeting will be on Monday, December 8th from 10:00-11:30 PT (1:00-2:30 ET) on The Importance of โ€œUnchecking the Boxโ€:  A Primer on the Power of Regulatory Flexibility.

    This Town Hall will be hosted by the organization, Public Responsibility in Medicine and Research: Event Link

    • NACHRP appreciates and acknowledges the incredible breadth of subject matter expertise, creativity, and skill among those in the human research community.
    • If folks are interested in volunteering, NACHRP will issue periodic calls for those with specific, topical subject matter expertise to also help develop guidance.
    • Folks are welcome to submit their CV and top two specific areas of expertise at any time.

    (Back to the Contents)

    I hope you enjoyed this interview with Julie Kaneshiro!

  • Critical Clinical Trial Documents under ICH GCP E6(R3)

    Critical Clinical Trial Documents under ICH GCP E6(R3)

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Eager to skip ahead to today’s topic?

    Jump to the Table of Contents.

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Authored By: Tasha Mohseni

    I’d like to dedicate today’s article to those who have served our country!

    Your sacrifices for our freedom can never be repaid.

    If any of my subscribers are veterans, please know that I recognize your patriotism, courage, and contributions. Regardless of the branch of military you serve, we see you. We may be honoring you today, but we keep you in our hearts forever. I know I always keep those family members of mine who have served in my heart daily.

    american flag on brown grass field
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    For today’s post, we are going to do further exploration on an ethical guideline.

    We will explore which documents are critical for clinical trials:

    • I will use ChatGPT to see what is considered a clinical trial document.
    • I will compare the ICH GCP E6(R3) document with ChatGPT’s analysis.

    As a general reminder, any legal information discussed within this post should be discussed with your institution.

    Table of Contents:

    Learning about critical clinical trial documents from ChatGPT

    As you may recall, I have a personal ChatGPT-4 account that I have used for various posts.

    Via the iterative prompting process, I’m going to share how I learned about critical documents in a clinical trial.

    Prompt 1: “What are critical documents in clinical trials?”

    ChatGPT provided the following response below:

    Critical documents in clinical trials are essential records required to ensure that a trial is conducted in compliance with Good Clinical Practice (GCP) and applicable regulatory requirements. These documents enable the evaluation of the conduct of the trial and the quality of the data produced. According to ICH E6(R2) GCP guidelines, critical documents should be maintained throughout the trial life cycle and are grouped into three categories:

    • Before the Clinical Trial Begins
    • During the Clinical Trial
    • After Completion or Termination
    ChatGPT has broken down the ICH GCP E6(R2) critical clinical trial documents into three phases: before, during, and after a clinical trial (or termination of a clinical trial). Each phase has a description of the type of documents present as well as a list of these documents.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    The purpose of these critical documents is to:

    • Ensure participant safety
    • Verify data integrity
    • Provide a trail for regulatory inspections
    • Support reproducibility and transparency

    Though this sounds like great information, I noticed one critical component.

    The above response is in accordance with ICH GCP E6(R2) guidelines.

    There are new guidelines that were adopted in January 2025: ICH GCP E6(R3).

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    Prompt 2: “What about in the ICH E6(R3) guidelines?“

    ChatGPT provided the following response below:

    Great question. The upcoming ICH E6(R3) Good Clinical Practice (GCP) guideline builds on the principles of ICH E6(R2) but takes a more flexible, risk-based, and modern approach to clinical trial documentation and conduct. While the core concept of critical documents remains, ICH E6(R3) shifts focus toward quality by design, fit-for-purpose documentation, and proportionality in managing trial records.

    What Are “Critical Documents” in ICH E6(R3)?
    ICH E6(R3) does not list a fixed inventory of critical documents (like R2 did with its Essential Documents list in Section 8). Instead, it emphasizes, Fit-for-purpose documentation:

    • Documentation should be proportional to the risk and complexity of the trial.
    • Only documents necessary to reconstruct and evaluate the trial are considered critical.
    • Sponsors and investigators are expected to identify which documents are critical for data reliability and participant protection.

    Key Shifts in R3 Regarding Documentation:

    There are three key shifts with respect to clinical trial documentation per the ICH GCP E6(R3): principle-based approach, quality management integration, and technology considerations. Each shift is described within this image.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    Instead of a fixed list, the types of documents likely to be considered critical still include:

    These examples of ICH GCP E6(R3) critical clinical trial documents fall under six categories: trial design, oversight & approval, participant safety, data integrity, accountability, and closure.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    Summary of Differences: ICH E6(R2) vs. R3 Table:

    AspectE6(R2)E6(R3)
    Document listFixed list of essential documents (Section 8)No fixed list; context-dependent
    FlexibilityLess flexibleMore flexible, risk-based
    EmphasisComplianceQuality-by-design
    TechnologyLimitedEmbraces digital systems, decentralized trials
    As stated within the table’s title, this table compares various aspects of documentation with respect to ICH GCP E6(R2) and ICH GCP E6(R3).

    Though I felt like I was getting closer to what I was looking for, I wasn’t quite there yet.

    (Back to the Contents)

    Prompt 3: “For Examples of Critical Documents under ICH E6(R3) can you define these in a bulleted list?”

    ChatGPT provided the following response below:

    Absolutely! Here’s a bulleted list of examples of critical documents under ICH E6(R3), grouped by functional area. These reflect the risk-based, flexible approach of R3 while aligning with essential GCP principles:

    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to trial design and planning. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to oversight and ethical approval. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to participant safety and rights. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to data collection and integrity. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to investigational product management. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to trial oversight and conduct. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to trial closure and reporting. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    (Back to the Contents)

    Reviewing the ICH GCP E6(R3) guidelines

    Now that I have a list to refer to from ChatGPT, it’s time to review the guidelines themselves!

    What is Good Clinical Practice (GCP)?

    “Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the
    conduct of trials that involve human participants.”

    The above is a direct quote from the ICH GCP E6(R3) guidelines. A few other bullet points worth mentioning are listed below:

    • The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
    • This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies which includes:
      • Fostering a quality culture and proactively designing quality into clinical trials and drug development planning,
      • Identifying factors critical to trial quality, engaging interested parties, as appropriate, and
      • Using a proportionate risk-based approach

    Please note that it is not within the scope of this blog to discuss the guidelines in its entirety.

    (Back to the Contents)

    Jumping to Appendix C within the ICH GCP E6(R3) guidelines

    Appendix C includes essential records for the conduct of a clinical trial.

    Though this is not an exhaustive list, I wanted to make note of the following with Appendix C:

    • The essential records permit and contribute to the evaluation of the conduct of a trial in relation to the compliance of the investigator and sponsor with Good Clinical Practice (GCP) and applicable regulatory requirements and the reliability of the results produced
    • These records are used by the sponsorโ€™s independent audit function and during inspections by regulatory authority(ies) to assess the trial conduct and the reliability of the trial results
    • Certain essential records may also be reviewed by the institutional review board/independent ethics committee (IRB/IEC) in accordance with applicable regulatory requirements
    • These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their respective records
    • Certain essential records may not be specific to a trial but may be related to the investigational product, facilities or processes and systems, including computerized systems, involved in running multiple trials and retained outside the trial-specific repositories such as:
      • Investigatorโ€™s Brochure
      • Master services agreements
      • Standard operating procedures
      • Validation records

    “The assessment of whether a record is essential and has to be retained should take into account the criteria below.”

    As stated within the guidelines, an essential record:

    • Is a document that is submitted to or issued by the regulatory authority or IRB/IEC, including related correspondence and those documenting regulatory decisions or approvals/favorable opinions;
    • Is a trial-specific procedure or plan;
    • Is relevant correspondence or documentation of meetings related to important discussions and/or trial-related decisions that have been made related to the conduct of the trial and the processes being used;
    • Documents the conduct of relevant trial procedures (e.g., database lock checklist produced from following data management standard operating procedures (SOPs));
    • Documents the arrangements between parties and insurance/indemnity arrangements;
    • Documents the compliance with the requirements and any conditions of approval from the regulatory authority or the favorable opinion of the IRB/IEC;
    • Documents the composition and, where appropriate, the functions, correspondence and decisions of any committees involved in the trial approval or its conduct;
    • Demonstrates that a trial-specific computerized system is validated and that non-trial-specific systems (e.g., clinical practice computerized systems) have been assessed as fit for purpose for their intended use in the trial;
    • Is a document that has been authorized/signed by the sponsor and/or investigator to confirm review or approval;
    • Is, where necessary, documentation that demonstrates signatures/initials of staff undertaking significant trial-related activities; for example, completing data acquisition tools;
    • Documents what information was provided to potential trial participants and that participantsโ€™ informed consent was appropriately obtained and maintained;
    • Documents that sponsor personnel involved in the trial conduct and individuals performing significant trial-related activities on their behalf are qualified by education, training and experience to undertake their activities;
    • Documents that the investigator and those individuals delegated significant trial-related activities by the investigator are qualified by education, training and experience to undertake their activities, particularly where the activities are not part of their normal role;
    • Contains the data as well as relevant metadata that would be needed to allow the appropriate evaluation of the conduct of the trial;
    • Is a document related to the sponsor or investigator oversight of trial participant safety during the trial, including compliance with safety reporting requirements between sponsors and investigators, regulatory authorities and IRBs/IECs and informing trial participants of safety information as necessary;
    • Documents that service providers are suitably qualified for conducting their delegated or transferred activities;
    • Documents that laboratory activities and other tests used in the trial are fit for purpose;
    • Documents sponsor oversight of investigator site selection and monitoring and audit of the trial, where appropriate, and provides information on arising issues/noncompliance and deviations detected and implementation of corrective and preventative actions;
    • Documents the compliance with the protocol and/or procedures for management and statistical analysis of the data and production of any interim report and the final report;
    • Documents the collection, chain of custody, processing, analysis and retention or destruction of biological samples;
    • Provides relevant information on the investigational product and its labeling;
    • Provides information about the shipment, storage, packaging, dispensing, randomization and blinding of the investigational product;
    • Provides, where appropriate, traceability and accountability information about the investigational product from release from the manufacturer to dispensation, administration to trial participants, return and destruction or alternative disposition;
    • Provides information on the identity and quality of the investigational product used in the trial;
    • Documents processes and activities relating to unblinding;
    • Documents the recruitment, pre-trial screening and consenting process of trial participants and their identity and chronological enrollment as appropriate;
    • Documents the existence of the trial participants and substantiates the integrity of trial data collected. Includes source records related to the trial and medical treatments and history of the trial participants;
    • Defines processes/practices in place in the event of a security breach in order to protect participantsโ€™ rights, safety and well-being and the integrity of the data

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    Comparing essential ICH GCP E6(R3) records to ChatGPT critical clinical trial documents

    For ease of comparison, let’s review the essential records table from ICH GCP E6(R3) to ChatGPT’s critical clinical trial documents!

    I decided that a Google spreadsheet would be the best way to do this comparison. You can view and download the spreadsheet here: CT Document Table Comparison.

    Upon review:

    • ChatGPT only stated 26 clinical trial documents while the ICH guidelines stated 55 essential documents.
      • Please note that though there are 59 rows within the spreadsheet, three of the rows are grouped (rows 18-21).
    • In yellow, I highlighted documents that ChatGPT mentioned which appeared to be a direct match to the ICH guidelines.
      • 12 clinical trial documents were highlighted.
    • In orange, I highlighted documents that ChatGPT mentioned which appeared to be a partial match to the ICH guidelines.
      • Six clinical trial documents were highlighted.
    • Eight documents remained white (i.e., no color highlight) from the ChatGPT column.
      • These documents didn’t appear to match any of the essential records from the ICH guidelines column.

    Though ChatGPT gave me a starting point, I wouldn’t solely rely on this for learning purposes.

    You really need that specialized expertise to help get you started.

    (Back to the Contents)

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    I hope you found this post educational and useful!