Tag: human-subjects-research

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

Welcome to This Week Inside HHS, FDA, and the NIH!

Updates from the prior week from agencies that impact research and public health.

As a general reminder, any questions you may have about legal information within this article should be discussed with your attorney or legal counsel at your institution.

Table of Contents:

Inside FDA

The FDA began accepting requests to participate in the FDA PreCheck pilot program.

• FDA PreCheck is designed to:
  • Strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and
  • Streamline aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application

• Phase I of the program will select participants who are developing new pharmaceutical manufacturing facilities based on alignment to program priorities
• Interested companies can review eligibility criteria, selection criteria, submission details, and what to expect through program participation

The Quality Management System Regulation (QMSR) became effective on February 2, 2026. Under QSMR:

• The device current good manufacturing practice (CGMP) requirements of 21 CFR Part 820 was amended
• Incorporated by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes

This action harmonizes the FDA’s CGMP regulatory framework with that used by other regulatory authorities. You can read more about this update in a previous blog post: Recent HHS Family of Agencies Developments: Key Regulatory Changes and Research Implications.

The FDA created the Rare Disease Innovation Hub with the goal of ultimately improving outcomes for patients. This is a collaboration between Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).

The U.S. Government Accountability Office (GAO) was absolutely obsessed with the FDA this week. In this Q&A blog post, GAO uncovers challenges for the FDA including becoming responsible for overseeing new types of products, including regulating all products containing nicotine (not just tobacco), as well as over-the-counter hearing aids. Next, the GAO issued the following reports:

• FDA: Oversight Responsibilities and Funding from Fiscal Years 2008 through 2024
• Rare Diseases: Funding for Rare Neurodegenerative Disease Research and Access to ALS Investigational Drugs

The FDA also released the following guidance documents:

• Computer Software Assurance for Production and Quality Management System Software (Final)
• Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (Final)
  • This has been reissued to align with FDA’s QMSR (1).
• E22 General Considerations for Patient Preference Studies (Draft)
  • Available for public comment via Federal Register (2).

Lastly, the FDA issued a rule and notice via the Federal Register:

• New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address (Rule)
• Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments (Notice)

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Inside HHS

Per the Office of Management and Budget’s (OMB) memo on January 30th, HHS was affected by the shutdown. Luckily, only five days later OMB issued another memo that all agencies can resume operations on February 4th. Appropriations are available for the fiscal year ending September 30, 2026.

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Inside NIH

Due to lapse in Federal funding, NIH announced that staff may not be available to provide oversight and administrative services. NIH hasn’t published a policy notice regarding resumption of operations. However, they did issue the following notice:

• NOT-OD-26-033: Adjusted Timeline for NIHs Implementation of Common Forms

Finally, the NIH launched a new central resource to support replication and reproducibility. This centralized hub will highlight NIH’s ongoing efforts to promote rigorous, transparent, and reliable science. he new resource: 

• Outlines NIH’s current activities and future directions to support replication studies,
• Incentivizes reproducible research practices, and 
• Embeds these principles more fully across the biomedical research ecosystem. 

(Back to the Contents)

I hope you found this bite-size weekly update helpful!

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.

• LinkedIn
• Mail
• Bluesky
• Facebook

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

Welcome to This Week Inside HHS, FDA, and the NIH!

Updates from the prior week from agencies that impact research and public health.

As a general reminder, any questions you may have about legal information within this article should be discussed with your attorney or legal counsel at your institution.

Table of Contents:

Inside HHS

HHS issued a notice rescinding several Office for Civil Rights (OCR) Documents Under Executive Order 14192. Further details can be reviewed for each of the documents that were rescinded below:

• OCR Letter to University of Vermont Medical Center
• 3 Letters Concerning 45 CFR 75.300, RFRA, and Foster Care
• Guidance on Equitable Administration of COVID Vaccines
• Letter Rescinding a Notice of Violation Letter Concerning California’s Violation of the Weldon Amendment Conscience Protection

HHS issued another notice by the OCR rescinded “Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Nondiscriminatory Access to Health Care at Pharmacies,” issued on September 29, 2023 (2023 Guidance) as revised guidance to “Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services,” originally issued on July 13, 2022 (2022 Guidance). You can read for further details on guidance rescission.

In a recent press release, HHS announced new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients in a manner that’s low risk under the federal anti-kickback statute, so long as key safeguards are met. The guidance by the HHS Office of Inspector General (OIG), supports efforts to make medically necessary drugs more affordable while protecting patients and federal health care programs from fraud and abuse. To further support this effort, HHS OIG issued a RFI to gather public input on creating a formal regulatory safe harbor on matters related to direct-to-consumer drug sales.

HHS issued a RFI on a proposed rule, “Diagnostic Imaging Interoperability Standards and Certification.” Input from the public is requested on the potential adoption of diagnostic imaging technical standards and certification criteria for health information technology under the ONC Health IT Certification Program to better enable the access, exchange, and use of diagnostic images by health care providers and patients.

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Inside FDA

The FDA, Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada announced a collaborative symposium titled “Regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice”. The symposium will be held June 2-4 2026, where participants will learn:

• Strategies for implementing quality by design to support proactive trial management and cultivate a quality culture that values critical thinking and transparency
• Key updates and practical application of ICH E6(R3)
• Approaches for balancing quality expectations with operational efficiency
• Regulatory expectations for incorporating decentralized and pragmatic elements into clinical trials
• Strategies to ensure participant safety and data reliability enabling reliable decision-making throughout the clinical trial lifecycle
• Clinical and bioanalytical challenges in bioequivalence studies
• Updates on regulatory collaborations, inspections and remote assessment practices
• Updates on regulation, guidance, policies and initiatives from each agency
• Pharmacovigilance inspection metrics, common inspection findings and harmonization efforts

The FDA issued a warning letter issued to the Center For Immunology Science, LLC‘s role as a sponsor for the clinical investigation of the investigational drug, heat-killed Mycobacteria smegmatis:

• The sponsor failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].
• During FDA’s inspection, the heat-killed Mycobacteria smegmatis was intended for use as a drug, not as a dietary supplement, for the clinical investigation conducted under Protocol CISMX-001.
• Therefore, the Center for Immunology Science was required to submit an IND before initiating and conducting the clinical investigation.

This week also marks the 120th anniversary of the FDA. In honor of this occasion, the FDA recently unveiled an official agency seal, its first ever. FDA at a Glance was also published by the FDA’s Office of Economics and Analysis (OEA). OEA’s mission is to provide public health, economic, and strategic analysis and evaluation to inform FDA’s policy and rulemaking decisions. You can also review Center for Devices and Radiological Health (CDRH)’s 2025 annual report highlighting the center’s performance last year.

Lastly, the FDA re-issued their Clinical Decision Support Software guidance published earlier this month.

• This guidance clarifies FDA’s thinking on the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act (“Non-Device CDS criteria”).
• Further clarity of FDA’s existing digital health policies were included with respect to software functions that meet the definition of a device.
• The FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software functions.

The FDA issued a RFI for a future public workshop series entitled “Rare disease Innovation, Science, and Exploration (RISE) Workshop.”

• The purpose of the public workshops is to focus on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions.
• The workshops will primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the FDA.

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Inside NIH

The NIH is removing AIDS application due dates from the application process. This policy change is effective for applications submitted for January 2027 and later Advisory Council Reviews. HIV/AIDS applications must be identified, segregated, and their status validated in manual processes outside of the normal referral stream. With this shift, HIV/AIDS applications being submitted on the standard receipt dates will continue to have three receipt dates per year, four months apart from one another, as they had with the previous AIDS receipt dates. The change will also lift the administrative burden on recipients of trying to determine if their application met current NIH guidelines for “AIDS research”. This corresponding press release explains the policy change and concludes with Q&A for extramural researchers.

The Government Accountability Office (GAO) reissued the NIH: Assessing Efforts to Improve Animal Research Could Lead to Greater Human Health Benefits report. Originally published in December 2024, GAO reissued this report to reflect corrected information of NIH’s spending on animal research.

Next, NIH implemented another major policy shift. Basic Experimental Studies Involving Humans (BESH) will no longer be subject to the requirements under the NIH Clinical Trial Definition.

• The BESH definition from 2014 stemmed from broader stewardship initiatives to ensure all NIH-supported research involving human participants are subject to rigorous standards.
• Because policies related to results dissemination have changed since 2014, and as part of ongoing efforts to reduce administrative burden, effective for applications submitted to due dates on or after May 25, 2026, the NIH will no longer characterize BESH as clinical trials. 

Finally, NIH will continue to update their Strengthening Replication and Reproducibility of NIH-funded Research site, to keep the scientific community informed of their initiatives including:

• Driving effective NIH replication and reproducibility
• Incentivizing replication and reproducibility sciences across the research enterprise
• Institutionalizing replication and reproducibility as a scientific discipline

(Back to the Contents)

I hope you found this bite-size weekly update helpful!

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.

• LinkedIn
• Mail
• Bluesky
• Facebook

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

Welcome to This Week Inside HHS, FDA, and the NIH!

Updates from the prior week from agencies that impact research and public health.

As a general reminder, any questions you may have about legal information within this article should be discussed with your attorney or legal counsel at your institution.

Table of Contents:

Inside HHS

Secretary Robert F. Kennedy, Jr. launched the nationwide “Take Back Your Health” Tour in Pennsylvania. At the State Capitol in Harrisburg, Secretary Kennedy joined more than a dozen Pennsylvania legislators to highlight the Trump administration’s first-year public health accomplishments of the President’s second term, including unveiling a new food pyramid, cutting waste, fraud, and abuse in Medicaid, and securing Most Favored Nation agreements that lower prescription drug costs for Americans.

(Back to the Contents)

Inside FDA

FDA’s Health Information Technology Advisory Committee (HITAC) announced their meeting schedule for 2026. All meetings are open to the public. They also announced the availability of the following guidance documents:

• M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
• Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval
• Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation

Next, the FDA ImportShield Program (FISP) has dramatically enhanced their ability to stop dangerous imports at U.S. borders. Specifically, they reported increased processing speed by 66%, boosted monthly volume capacity by 33%, and reduced staff hours by 20%, saving approximately 3,388 hours each month. This is only after four months of data collection.

• FISP streamlines the FDA’s import review process by combining five separate regional teams into one centralized operation.
• By leveraging time-zone coverage and focused commodity expertise under unified management, the program improves efficiency, consistency, and accountability in import decision-making. 

Finally, the FDA announced it will begin accepting applications on February 1, 2026, for the PreCheck  Pilot Program. Though more details will be released after Feburary 1st, the PreCheck  Pilot  Program will select an initial cohort of new pharmaceutical manufacturing facilities. These facilities will be selected based on overall alignment with national priorities such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. 

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Inside NIH

The NIH issued a notice regarding an Update to Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals. The PHS policy had six major revisions to provide clarity to reporting requirements, including:

• Clarification on how reporting requirements apply based on the scope of the institution’s Animal Welfare Assurance. This can be found in the sentence underneath the first paragraph in the section discussing examples of reportable situations.
• Clarification on situations that may impact activities subject to the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy). This is the final bullet in the section discussing examples of situations where reporting is required.
• Addition of examples to the list of situations that normally are not required to be reported to OLAW. These are the final three bulleted items in the section on examples of situations where reporting is not normally required.
• Updates to the guidance for inclusion of award numbers and funding sources in reports to OLAW. These updates can be found in the second and third bullets in the section regarding information to be reported.
• Clarification on how reporting requirements apply when federal entities have a memorandum of understanding (MOU) with OLAW that applies the PHS Policy to activities they conduct or fund involving live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes (PHS Policy section III). This is introduced in the background and is clarified in the section on information to be reported.
• Clarification that the signature of the Institutional Official (IO) on the final report to OLAW provides verification of compliance with PHS Policy section IV.F.3. This can be found in the section on information to be reported.

Next, NIH issued another notice with respect to eRA Commons. NIH will require that all prior approval requests be submitted in eRA Commons Prior Approval Module for all grant and cooperative agreement awards. This requirement is effective 30 days from the date of when the notice was issued.

Another major policy update was issued with respect to human fetal tissue (HFT). Effective on date of issuance, NIH funds will not be permitted for research using HFT from elective abortions. HFT obtained from miscarriage or stillbirth for research may use NIH funds in accordance with NOT-OD-15-143 and NOT-OD-16-033. NIH Director, Dr. Bhattacharya released a statement on the rationale of this decision. Given that HFT research projects have decreased more than 50% between 2019 and 2024, Bhattacharya emphasized the that they will continue to assess other research areas ripe for modernization. NIH will engage the community in identifying emerging areas in which additional investments could bolstered alternative, validated models. As reaffirmed in the press release, NIH will soon seek public comment on emerging biotechnologies to reduce or potentially replace reliance on human embryonic stem cells to drive modernization.

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I hope you found this bite-size weekly update helpful!