Funding Agency Stop Work Orders: Sample IRB Guidelines for Investigators. View Now
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Update – Clinical Decision Support Software Final Guidance

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A one page summary to clarify guidance on determining when CDS software is excluded from the definition of a “medical device” under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Only software functions that meet all four specified criteria qualify as “Non-Device CDS” and therefore are not subject to FDA device regulation. If any criterion is not met, the software may be regulated as a medical device.

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FDA Proposed Rule: Investigational New Drug Applications: Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement or Cosmetic

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The purpose of this overview is to explain a proposed U.S. Food and Drug Administration (FDA) rule that would create formal exemptions from investigational new drug (IND) requirements for certain clinical studies of products lawfully marketed as conventional foods, dietary supplements, or cosmetics.

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Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders

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HRP’s Commitment to the Research Community

HRP stands with our clients and the broader research community as we navigate the evolving political and economic landscape, including sudden grant funding cuts. We are just a few weeks into this journey, and we expect that as some actions are put on hold while litigated, other actions will be quickly taken to achieve the aims of reducing federal research funding and eliminating funding for certain research altogether.

Today we are providing sample IRB guidelines for investigators with research at risk for stop or pause work orders in the hope that this will be helpful as institutions develop their own instructions and guidelines. Please feel free to distribute to your colleagues. We hope to provide additional guidance and tools over the coming weeks.  If you have suggestions for other helpful resources, please let us know.

Sample IRB Guidance for Investigators

Federal Stop-Work Directives

These guidelines are intended to assist investigators who may or have received a directive from a federal funding agency to stop, pause, or otherwise prematurely end a human research study. 

1. What Should I Do If My Research Is at Risk for a Stop-Work Order?

  • Evaluate whether your research can be modified to reduce the risk of a stop-work directive while maintaining its objectives
  • Explore alternative funding options, including any options for bridge funding to support the safe wind down of research activities
    • [If available insert links to resources]
  • Identify studies where a sudden stop would put participants at risk (e.g., therapeutic studies)
    • Develop an action plan outlining steps that would be taken to safely wind down your research if necessary, considering factors such as:
      • The nature and severity of the risks to participants
      • Procedures that may be necessary for participants to safely stop (e.g., tapering meds, removing devices, labs and imaging, follow up assessments, referrals)
      • Alternative options for participants (e.g., making arrangements for therapeutic care outside of research)
      • Participant compensation obligations
  • Communication plans for:
    • Participants
    • Stakeholders (e.g., study personnel, collaborators, subcontractors)
    • Service providers (e.g., labs, imaging centers) and facilities where study activities take place (e.g., schools, clinics)
  • What will happen with study data and biospecimens (when applicable)
  • Develop action plans for studies where stopping would not put participants at risk, considering factors such as:
    • The current status of the research (e.g., open to enrollment, closed to enrollment but with active participants, follow up only, data analysis only)
    • Managing scheduled visits or tests
    • Participant compensation obligations
    • Communication plans for:
      • Participants
      • Stakeholders (e.g., study personnel, collaborators, subcontractors)
      • Service providers (e.g., labs, imaging centers) and facilities where study activities take place (e.g., schools, clinics)
    • What will happen with study data and biospecimens (when applicable)
  • [Include a link to any resources to help investigators plan]

2. What Do I Do If I Receive a Funding Agency Directive to Stop or Pause Research?

  • Contact [Insert name of grants office] 
    • [Insert contact information]
  • Contact the IRB (if the IRB of record is an external IRB, contact both the external IRB and the [Insert name of local IRB office]
    • [Insert contact information]
  • Implement your communication plans for Stakeholders, Service Providers, and Facilities.
    • Participant communication plans need to be approved by the IRB for non-exempt research
  • When applicable, take any actions necessary to mitigate immediate risks to participants and then report those actions to the IRB
  • Submit an amendment to the IRB with your action plan to safely wind down research activities (see prior section)

 

Understanding the Updated Final Rule on Research Misconduct: Key Changes and Institutional Impacts

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The research community is on the cusp of a significant change with the updated final rule on research misconduct set to take effect on January 1, 2025. This long-overdue revision, the first substantial update in decades, has been meticulously designed to address evolving research practices and enhance integrity within federally funded research projects. As John Baumann, a seasoned research compliance expert with over 25 years of experience, explains, this update not only clarifies procedural expectations but also imposes stricter documentation requirements, fundamentally reshaping how institutions manage allegations of misconduct.

A Timely Update to a Decades-Old Framework

The update stems from a growing need for clarity and modernization. As Dr. Baumann noted, the previous framework, largely unchanged since its inception, was increasingly inadequate in addressing modern research complexities such as multi-site investigations and collaborative studies. This gap prompted extensive community feedback during the drafting process, leading to a final rule that better aligns with current research practices while upholding federal funding accountability.

Notably, while the foundational processes of addressing misconduct—allegation, assessment, inquiry, investigation, and determination—remain unchanged, the updated rule introduces significant procedural refinements. These include expanded definitions of plagiarism, enhanced due process rights for accused individuals, and more explicit documentation requirements throughout every stage of the investigation.

Key Changes and Their Implications

  1. Enhanced Documentation Requirements: Institutions are now mandated to provide detailed reports at every stage, from initial allegations to final determinations. This includes transcripts of interviews, which must also be shared with both the interviewee and the accused, ensuring transparency and fairness.
  2. Addressing Collaborative and Multi-Site Research: The rule explicitly outlines responsibilities in collaborative research settings, recognizing the growing prevalence of multi-institutional projects. This change simplifies the inclusion of additional parties in investigations without restarting the process.
  3. Broader Definitions and Greater Clarity: The rule redefines key terms like “intentional” and “reckless” to guide institutions more effectively. While some subjectivity remains, these definitions aim to standardize interpretations across investigations.
  4. Increased Timeframes: The investigative window has been extended from 120 to 180 days, reflecting the complexities of modern research misconduct cases. However, institutions must still adhere to strict documentation and reporting standards to justify any delays.

Institutional Readiness and Challenges

Implementing these changes presents both opportunities and challenges for institutions. Dr. Baumann underscores the importance of robust electronic systems to manage documentation efficiently. Institutions may also need additional resources, including staff skilled in process management, to navigate the heightened requirements.

Furthermore, institutions are advised to proactively align their policies with the updated rule. Waiting for official templates and guidance, which may not arrive promptly, could leave organizations unprepared for new cases arising in early 2025.

Fostering a Culture of Integrity

The updated rule emphasizes protecting federal funds and ensuring the trustworthiness of research outcomes. This focus highlights the broader mission of promoting ethical research practices. Dr. Baumann’s experiences demonstrate that while these changes increase administrative burdens, they also empower institutions to address misconduct more comprehensively, reinforcing the credibility of academic and scientific pursuits.

Conclusion

The revised rule from ORI represents a pivotal step in strengthening the integrity of federally funded research. Institutions must adapt swiftly, leveraging clear documentation, community collaboration, and process innovation to meet the new standards. As these changes take effect, the collective commitment to ethical research will not only safeguard funding but also elevate the standards of scientific inquiry across the board.

To learn more contact Justin Osborne at osbornej@thehrpconsultinggroup.com.

The Role of AI in Clinical Research: Boosting Efficiency and Addressing Compliance Challenges

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The Role of AI in Clinical Research

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In the latest episode of the On Research with CITI Program podcast, host Justin Osborne speaks with Charlie Fremont, an EHR application analyst from Washington University, about the transformative potential and challenges of using AI in clinical research. Their conversation provides a balanced overview of how AI is currently being applied in the field, highlighting real-world use cases and addressing the legal and ethical considerations surrounding these tools.

Generative AI: Enhancing Productivity and Bridging Skills Gaps

Charlie distinguishes generative AI, like ChatGPT, as a technology designed to create new content, such as text or code, based on user prompts. He explains how generative AI can streamline routine tasks, such as building research billing calendars, by translating natural language into executable code. This approach has allowed Charlie to drastically increase his productivity, effectively doubling his output while maintaining accuracy.

A significant advantage of generative AI is its ability to bridge the communication gap between technical and non-technical staff. By serving as a “translator” between research needs and technical implementation, AI empowers non-programmers to create tailored solutions, facilitating collaboration and reducing reliance on traditional IT support.

Addressing Compliance Risks and Data Security

While the potential benefits of AI are substantial, the podcast highlights critical concerns related to data security and compliance. Charlie warns against using generative AI for handling sensitive information, such as personally identifiable or protected health data, as these models may inadvertently incorporate such data into their systems. To mitigate these risks, he suggests using local AI instances that run on secure, non-networked environments.

This cautious approach is crucial in regulated fields like healthcare and research, where compliance frameworks like HIPAA require stringent data protection measures. Charlie emphasizes that any AI adoption must be coupled with clear institutional guidelines and robust compliance checks.

Transformative Potential and Institutional Adoption

Despite the risks, AI adoption is accelerating. Charlie cites a Deloitte survey indicating that 75% of leading healthcare organizations are already using generative AI in some capacity. However, he notes that research-specific adoption has been slower due to the need for extensive legal and compliance reviews.

AI’s role, according to Charlie, should be viewed not as a job replacement but as an augmentation tool—an “extra set of arms” that expands human capabilities by automating repetitive tasks, freeing researchers to focus on more demanding “deep work” (higher-level work). For organizations that effectively integrate these tools, the productivity gains could be transformative.

Finding the Right Balance: Efficiency and Safety

The episode concludes with a call for a balanced approach to AI adoption. Charlie believes that AI’s benefits can outweigh its risks if institutions implement strong safeguards and educate staff on responsible use. In the long term, the institutions that will lead in AI adoption are those that manage to leverage these tools while maintaining compliance and ethical standards.

By highlighting both the potential and pitfalls of generative AI, this podcast episode provides a valuable roadmap for research professionals looking to integrate AI technologies into their workflows responsibly.

Listen to the entire conversation on the Practical Uses of AI In Research here

Want to learn more about the role of AI in clinical research? Contact Us.

    Exception Process for Revised Common Rule Single IRB RequirementComparison of Common Rule_FDA_Revised FDA_May 2024Exception Process for Revised Common Rule Single IRB Requirement

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    The FDA Regulations cited in this table are primarily from 21 CFR 50 and 56 as these regulations refer to human subject protection and institutional review boards (IRBs). The proposed FDA changes cited in this table are from FDA proposed rules Protection of Human Subjects and Institutional Review Boards and Institutional Review Boards; Cooperative Research. The proposals, if finalized would harmonize certain sections of FDA’s regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). This table does not attempt to comprehensively address all FDA requirements nor to capture every minor change or nuance in the proposed amendments to the regulations. Comparison of Common Rule_FDA_Revised FDA_May 2024

    Navigating the Complexities of Exception from Informed Consent (EFIC) in Research

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    A growing area of research involves exception from informed consent, also known as planned emergency research. Under certain conditions, in an emergency setting, participants can be enrolled in a trial without their consent. This article summarizes the podcast hosted by CITI Program with guest Michael Linke, PhD from the University of Cincinnati and the host Justin Osborne from The HRP Consulting Group where they discussed the regulations and ethical considerations around this important area of research.

    In the dynamic landscape of medical research, certain situations arise where obtaining informed consent from participants becomes impractical. In these instances, researchers may turn to a mechanism known as Exception from Informed Consent (EFIC) to conduct studies aimed at addressing urgent medical needs. A recent discussion sheds light on the intricacies of EFIC and its role in advancing medical knowledge.

    EFICinvolves conducting research without obtaining prospective informed consent from participants. The regulations governing EFIC, outlined in 50.24 CFR 40, set strict criteria for its approval. Central to EFIC is the need for studies to address life-threatening conditions with no acceptable treatments, offering potential benefits to participants. Additionally, there must be a limited timeframe to find a legally authorized representative (LAR) for surrogate consent.

    One of the key elements of EFIC studies is community consultation and public disclosure. Before initiating a study, investigators engage with the local community to inform them about the research, address concerns, and seek feedback. This process ensures transparency and community involvement in research activities, although challenges exist in effectively implementing it, particularly in diverse and dynamic communities.

    Despite the regulatory framework established in 1986, recent discussions have highlighted the need for continued review and potential updates to EFIC guidelines. A meeting hosted by the National Institutes of Health (NIH) brought together stakeholders to discuss current practices, challenges, and potential improvements in EFIC implementation.

    One notable topic of discussion was the distinction between EFIC studies and waivers of informed consent, with EFIC presenting a higher threshold due to its stringent criteria and community engagement requirements. The meeting also addressed the evolving definition of “minimal risk” and the scope of conditions eligible for EFIC studies.

    While no immediate regulatory changes are anticipated, ongoing dialogue and collaboration among researchers, regulatory agencies, and institutional review boards (IRBs) are essential to ensure the ethical conduct of EFIC studies. Additionally, advancements in technology, such as remote community engagement through social media, offer new avenues for conducting community consultation activities.

    The ultimate goal of EFIC research remains unchanged: to advance medical knowledge and improve patient outcomes in emergency situations where traditional consent procedures are not feasible. With careful consideration of ethical principles, rigorous oversight, and ongoing dialogue, EFIC studies can continue to contribute meaningfully to medical research while upholding participant welfare and community engagement.

    Listen to the podcast here: On Research Podcast on Exception from Informed Consent (citiprogram.org)

    Interested in learning more about Exception from Informed Consent?  Set up a conversation with one of our consultants info@thehrpconsultinggroup.com.