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The IRB Coordinator’s Diary | The Raw Side of Research Ethics and Compliance.
Whether you’re a seasoned professional or an IRB novice, everyone can learn something from The IRB Coordinator’s Diary.
DISCLAIMER: Consider topics in this newsletter as food for thought. This is meant to be an educational resource only. This is NOT meant to provide legal advice or replace guidance provided by your institution. You should always consult your institution for specific practices related to research compliance or any legal subject matter presented in this newsletter.
Dear diary (and everyone else reading my diary),
Movies like M3GAN have shown us the dangers if AI was an entity that lived among us like other humans. But…what if we aren’t far from this becoming reality? What if AI entities and humans had to coexist? And if we were to coexist, what does this mean for the future of research within the regulatory landscape?
This article will explore a hypothetical nightmare for IRBs if AI entities lived among us. Specifically, we will explore the if AI was a:
Principal investigator conducting human subjects research,
Participant in a human subjects research study, or a
Reviewer of human subjects research.
Before we get started, I encourage you to please share this newsletter with your network and subscribe.
Table of Contents
AI as a Principal Investigator (PI)
Imagine an AI serving as a PI on a human subjects research study. At first glance, this might sound appealing. An AI PI (admit it, you laughed too) could theoretically:
Process vast amounts of literature in seconds,
Generate research protocols almost instantly, and
Never miss a deadline.
However, the regulatory landscape becomes considerably more complicated when the individual responsible for protecting human subjects is not actually human.
Current regulations place responsibility and accountability squarely on the shoulders of a human PI. When protocol deviations or adverse events occur, a human is held accountable. But what happens when the PI is not a human?
Can an AI PI truly exercise ethical judgment when unexpected situations arise?
Can an AI PI weigh competing interests, recognize subtle signs of participant distress, or make decisions that prioritize participant welfare over study outcomes?
Who bears responsibility when things go wrong: the institution, the developer of the AI PI, or the AI PI?
Perhaps the greatest challenge for IRBs would be determining whether an AI can satisfy the fundamental expectation that investigators respect and protect human subjects.
Regulations imply that PIs possess not only expertise but also a moral compass that guides them in conducting responsible human subjects research.
While AI may be capable of following rules, it remains unclear whether it can genuinely understand the ethical principles underlying them (let alone human emotions such as distress). The nightmare scenario for IRBs is not an AI that intentionally acts unethically. It is an AI that follows every instruction perfectly while missing the human element that ethical research demands.
Now consider the opposite scenario: an AI entity enrolled as a participant in a human subjects research study.
You would think the idea of AI serving as a research participant sounds like science fiction. Yet researchers are already encountering versions of this reality. In a 2024 qualitative research study, investigators unexpectedly discovered AI-generated responses within their dataset while conducting online research. The authors described the challenge of identifying “AI-as-participant” responses and raised concerns about how generative AI may blur the line between genuine human participation and artificial responses. As AI becomes increasingly capable of producing human-like narratives, researchers may find it difficult to determine whether they are collecting data from people, machines, or potentially both.
At the same time, some scholars are exploring whether AI can intentionally serve as a participant substitute. A recent study proposed using trained AI systems as experimental participants in behavioral and economic research, allowing investigators to create simulated participant groups that serve as rational, bias-free, or otherwise controlled comparison populations. It’s argued that AI participants could reduce recruitment costs, accelerate studies, and help researchers test hypotheses under conditions that would be difficult or impossible to create with human subjects alone.
For IRBs, this creates a fascinating regulatory dilemma.
If AI-generated responses are mixed with human data, what obligations do investigators have to disclose this to participants?
If researchers intentionally use AI participants, is the resulting activity still human subjects research?
The nightmare scenario is not necessarily an AI entity demanding informed consent or asserting legal rights.
It’s a future where human participants and artificial participants become blurred.
IRBs may find themselves reviewing protocols where the central question is no longer how to protect human subjects, but how to preserve the scientific validity, transparency, and integrity of research where participants may not always be human.
Anyone who has served on an IRB knows that committees routinely face increasing workloads, complex protocols, and pressure to provide timely reviews. An AI reviewer could instantly identify missing consent elements, compare protocols against institutional requirements, flag inconsistencies across submissions, and surface relevant regulations or precedent decisions. In an interview discussing the Chat-IRB concept, the author emphasized that properly designed systems could help standardize reviews, reduce administrative burden, and allow reviewers to focus their attention on the most challenging ethical questions rather than routine compliance checks.
But this is where the hypothetical nightmare begins.
Imagine a future in which an AI reviewer becomes so accurate and efficient that committees increasingly defer to it by default. Over time, reviewers may not introduce varying perspectives. The danger isn’t that the AI reviewer would ignore regulations.
The danger is that IRB review is not solely about regulatory compliance.
It requires judgment about fairness, community values, participant vulnerability, and whether a study respects the individuals it seeks to enroll. Ironically, the more reliable AI becomes, the easier it may be for humans to disengage from the very ethical deliberation that makes IRBs valuable. The future challenge for IRBs may not be deciding whether to coexist with these AI entities but determining how much ethical authority should ever be delegated to it.
HHS reversed its action of re-organization by removing the Assistant Secretary for Technology Policy and restoring with the Office of the National Coordinator for Health Information Technology (ONC)1,2.
The Office of Research Integrity (ORI) has announced co-sponsorship opportunities with non-federal institutions. The purpose of these events is to advance research integrity across the scientific research enterprise3.
In other news:
Advanced Research Projects Agency for Health (ARPA-H) announced STOMP: Systematic Targeting Of MicroPlastics, a nationwide $144 million program to create the definitive toolbox for measuring, researching, and affordably removing microplastics and nanoplastics (MNPs) in the human body4.
HHS and EPA announced landmark, coordinated actions to address microplastics contamination, one of the most urgent and growing public health challenges facing Americans5.
Administration for Children and Families (ACF) proposes to amend the Block Grants regulations, the Individual Development Account Reserve Funds Established Pursuant to Grants for Assets for Independence regulations, and the Emergency Community Services Homeless Grant Program regulations to eliminate unnecessary or obsolete regulations6.
Health Resources and Services Administration (HRSA) announced more than $135 million in new funding opportunities to expand nutrition services and strengthen the rural health workforce7.
HHS led a coordinated, cross-agency transition with the Federal Aviation Administration (FAA) and the Defense Finance and Accounting Service (DFAS) to move away from manual processes, overcoming limited documentation and decades-old logic to deliver a scalable, interoperable system8.
HHS Secretary Robert F. Kennedy, Jr. traveled to Arizona as part of his โTake Back Your Healthโ tour, meeting with leaders across health care, independent living, and recovery to drive a prevention-focused agenda9.
HHS announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them10.
HHS announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration11.
APRA-H announced the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative, which will collectively fund up to $139.4 million to help spur new, effective therapies for behavioral health12.
ORI found that Ariel Fernandez, PhD (Respondent), former Karl F. Hasselmann Chaired Professor of Engineering, Department of Bioengineering, Rice, engaged in research misconduct under 42 CFR Part 9313.
FDA is working towards clearer recommendations for Real-World Evidence (RWE). RWE is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of Real-World Data (RWD). FDA reported on 73 new examples growing use of RWD to validate device software functions, including artificial intelligence (AI)14,15.
The FDA reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov. According to an internal analysis, 29.6% of studies that are highly likely to fall under mandatory reporting requirements have no results information submitted to ClinicalTrials.gov. The FDA also may send Pre-Notices of Noncompliance and Notices of Noncompliance as part of risk-based compliance efforts related to ClinicalTrials.gov16.
The FDA shared promising progress towards a new indication of Testosterone Replacement Therapy (TRT). Sponsors are encouraged to contact the FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism (without a known cause). This would require demonstration of substantial evidence of effectiveness and that the benefits outweigh the risks for the intended population17,18.
Starting October 1, 2026, postmarketing individual case safety reports (ICSRs) must be reported using the data standards adopted by FDA in the International Council for Harmonisation (ICH) guidance for industry entitled โE2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation GuideโData Elements and Message Specificationโ (ICH E2B(R3) Implementation Guidance), which incorporates by reference regional implementation guides (collectively ICH E2B(R3) data standards)19.
The FDA achieved its key first-year goals in the implementation of its April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies which included:
Releasing draft guidance on the reduction or elimination of nonhuman primate testing in monoclonal antibody development,
Updating guidance to support a transition from horseshoe crab-derived endotoxin testing, which could spare more than one million animals per year,
Working to reduce or eliminate animal used for FDA approval when drugs have demonstrated safety from their broad use in humans in other countries,
Releasing draft guidance expanding the use of weight-of-evidence approaches to support the use of NAMs and other human-relevant models to generate evidence across a wider array of safety endpoints,
Qualifying the first artificial intelligence-based drug development tool, and
Launching a searchable database clarifying where alternative methods are acceptable and established close collaboration with international regulators to align strategies20.ย
Learn directly from the FDAโs regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDAโs regulatory requirements, and also create awareness of current activities. This conferences also offers tracks for 1:1 opportunities for questions. Topics covered include:
Advanced Drug Manufacturing in CDER,
Use of AI to Advance Drug Development,
FDAโs Quality Management System Regulation (QMSR),
Small Business Determination Program Updates,
Use of Digital Health Technologies for Data Collection in Clinical Trials,
Benefit-Risk Framework and Analytical Methods to Inform Benefit-Risk, and
Revision to ICH Guidance on Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes43.
FDA approved Foundayo (orforglipron) making them the 5th approval under the Commissioner’s National Priority Voucher (CNPV) pilot program44.
Relatedly, FDA approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy marking this the 6th approval under the CNPV pilot program45,46.
FDA updated four of their CBER Biological Procedures (SOPPs)47,48,49,50.
FDA and CMS announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare57.
C3TI Compass is a knowledge repository that connects users to FDA guidance documents, case studies, and resources that support innovative approaches to clinical trial design and conduct. Compass centralizes completed activities, ongoing efforts, and practical tools to support engagement with CDER’s clinical trial innovation work and improve clinical trial efficiency58.
The FDA finally issued a Request for Information (RFI) regarding a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials59,60.
Basic Experimental Studies with Humans (BESH) will no longer be subject to NIH clinical trial requirements (e.g. registration and reporting in ClinicalTrials.gov). However, BESH must continue to follow all other applicable laws, regulations, and policies (e.g., human subjects protections and the Data Management and Sharing Policy). This applies to grant applications submitted for due dates on or after May 25, 202661. Other policy notices released were related to:
Update of NIH Late Application Submission Policy and End of Continuous Submission62,
Applicability of Transparency Act Subaward Reporting Requirements63,
Continuation of Modifications to Peer Review Practices64,
Announcement of Upcoming System Enforcement of Common Forms and End of NIHs Leniency Period71,
Update to Standard Language for Developer Terms of Access in the Terms and Conditions of Award72,
Notice to Rescind NOT-OD-23-075 “Office of Research Infrastructure Programs (ORIP) implementation of NIH Policy on Acceptance for Review of Applications Requesting $500,000 or More in Direct Costs in Any One Budget Year73, and
An RFI on Promoting Youth Participatory Action Research Approaches in Prevention Research74.
For the extramural community, NIH issued many updates and blog posts related to:
Good Clinical Practice (GCP) Training Consistent with the International Conference on Harmonisation (ICH) E6 (R3) Meet the NIH Requirement75,
2026 Extramural Community Days: Securing NIH Controlled-Access Data76,
Feedback on Revised Clinical Trial Application Form to Reduce Burden and Enhance Review77,
An Update on Modernizing the NIH Grants and Funding Site: Helping the Research Community Quickly and Easily Understand NIH Funding Policies, Processes, and Activities79,
Current and Pending (Other) Support (CPOS) Common Form80,
NIH identified a novel, highly potent opioid that shows potential as a therapy for both pain and opioid use disorder. In a study published in Nature, the team observed the new drugโs effect in laboratory animals87.
An NIH clinical trial found that a scalable, team-based intervention strategy in federally qualified health centers (FQHCs) was able to significantly reduce systolic blood pressure for low-income participants88.
An NIH-funded research team has discovered an enhanced CRISPR gene-editing system that could enable targeted delivery inside the human body89.
Dr. Jonathan M. Green selected as CEO of the NIH Clinical Center90.
NIH researchers researchers developed a cancer assessment tool (scSurvival) that can identify high-risk patients and the tumor cells linked to that risk. The model uses a machine learning framework designed to analyze large-scale data at single-cell resolution91.
An NIH-supported clinical trial compared two commonly used treatments for pediatric patients treated for septic shock and found no difference in meaningful outcomes92.
Another NIH clinical study showed that a symptom-based treatment for babies withย neonatal opioid withdrawal syndrome (NOWS) could speed up their recovery93.
GAO listed three emerging technologies that may require congressional attention within the next 10 years:
Neural implants for human augmentation,
General purpose robots, and
Orbital debris removal technologies.
Though recommendations were not provided, GAO identified several policy considerations for the Congress and others to weigh as these technologies continue developing94.
GAO observed the pay and benefit trends for graduate students and postdoctoral researchers. They found that they were paid less than others with the same level of education and that the National Science Foundation (NSF) doesn’t collect enough data to fully analyze compensation for these researchers95.
Other reports include:
GAO identified trade-offs facing agencies as they acquire artificial intelligence (AI), and some associated challenges and benefits96.
GAO found that when recipients (e.g., universities and businesses) invented useful technologies, most chose to retain ownership rights, while about 21 percent declined to do so, from fiscal year 2020 through 2024 (see figure). The most common reason they declined was low commercial potential for the inventions (meaning they would not be likely to find a commercial partner to bring the invention to market, according to university representatives). This is in relation to the Bayh-Dole Act97.
GAO was asked to review recent initiatives to support agenciesโ ability to collaboratively address grants management challenges. This report describes: 1) the government-wide legal and administrative framework for federal grants management and 2) how member agencies communicate and collaborate through the Council on Federal Financial Assistance (COFFA)98.
GAO found about a quarter of the major rules issued from January 21, 2021, to January 20, 2025 (119 of 462 rules), agencies published effective dates inconsistent with the Congressional Review Actโs (CRA) 60-day waiting period. The waiting period begins when theย Federal Registerย has published the rule or the House and the Senate have received paper copies, whichever is later, and does not apply under certain exceptions, such as when agencies claim good cause99.
GAO found that 156 of the 258 appropriation accounts in their review of the Consolidated Appropriations Act, 2023 had budget authority available for obligation in fiscal year 2026 or later, as of September 30, 2025. These accounts had approximately $20.9 billion in unobligated budget authority, or about 1.97 percent of the approximately $1 trillion initially appropriated that had a period of availability of fiscal year 2026 or later100.ย
GAO expressed that space-based data centers would place data processing and storage systems for AI and other computing needs into satellites. This could reduce the land, electricity, and water needed for data centers on Earth101.
A rule was published which defined the membership and operating procedures of the Department of State’s Security Review Committee, an internal panel that reviews serious security incidents102.
National Science Foundation (NSF)
NSFโs National Science Board (NSB) received an e-mail from the Administration that their positions were terminated effective immediately103. The NSB has overseen the NSF and provided support for the American research enterprise that is central to the nationโs economic and geopolitical leadership, making this a cornerstone to NSF’s success104.
NSF also issued an RFI to invite feedback a comprehensive review of the Presidential Awards for Excellence in Mathematics and Science Teaching (PAEMST) program and the Presidential Awards for Excellence in Science, Mathematics, and Engineering Mentoring (PAESMEM) program105.
S. 3971, the โSmall Business Innovation and Economic Security Actโ, is authorized through FY2031. S. 3971 amends the Small Business Innovation Research (SBIR) program, Small Business Technology Transfer program (STTR), and related pilot programs106.
Trump signed an executive order (EO) that will accelerate access to treatments for patients with serious mental illness. The EO directs the FDA Commissioner to provide National Priority Vouchers to appropriate psychedelic drugs that have received Breakthrough Therapy designations for treating serious mental illnesses. The FDA must work with the DEA to establish a pathway for eligible patients to access investigational psychedelic drugs. Further, the order requires the HHS and the FDA to collaborate with the Department of Veterans Affairs and the private sector to increase clinical trial participation and evidence generation surrounding experimental psychedelic therapies107,108,109,110,111.
The Council on Environmental Quality (CEQ), in collaboration with NASAโs Center of Excellence for Collaborative Innovation opened its “Permitting Innovators Call for Solutions” inviting technology companies, startups, researchers, and non-profits to help modernize federal permitting for the 21st century. The Call for Solutions is now open through June 2, 2026, at 6:00 p.m. ET112.
The Investigations and Oversight House Subcommittee (of the House Committee on Science, Space, and Technology) held a hearing which examined the current state of scientific publishing, including open access policies, the current state of peer review, conflict of interest policies, data access and reproducibility, emergence of predatory journals, paper mills, and โpublish or perishโ systems that prioritize publication quantity over quality. Emerging technologies (e.g., artificial intelligence (AI)) were also evaluated to assess its influence on the quality of science, scientific integrity, scientific misconduct, and the advancement of gold-standard science113.
The Senate Committee on Health, Education, Labor, & Pensions (HELP) held a hearing to discuss the FY2027 HHS Budget. Per Robert F. Kennedy, Jr.โs testimony, the emerging priorities of the HHS Budget include:
House Science, Space, and Technology Committee Chairman Brian Babin issued a statement in recognition of the Artemis II crewโs safe return home following a successful splashdown, concluding a landmark mission116.
House Science, Space, and Technology Committee Chairman Brian Babin, along with Investigations and Oversight Subcommittee, sent a letter to Dr. Marcia McNutt, President of the National Academies of Sciences, Engineering, and Medicine (NASEM), requesting information related to NASEMโs report on Anthropogenic Greenhouse Gases and U.S. Climate: Evidence and Impacts117.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!
340+ 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:
Updates Since Last Week’s Edition
This section contains updates that became available AFTER the prior week’s edition was published:
Finally, CDER issued a warning letter to Dr. Cole for his role as s clinical investigator. The investigator didn’t adhere to the protocol.,The deviation related to incorrect dosing for four out of four participants during various site visits. These significant dosing errors led to adverse events, including nausea, vomiting, stomach pain, fatigue, dizziness, pyrosis (heartburn), and injection-site reactions.
Curious about the differences between the two document versions? You can read my brief analysis on LinkedIn.
The FDA is aware that Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers that all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring and TRUE METRIX PRO Professional Monitoring Blood Glucose Systems have updated use instructions. This early alert details the specific affected devices as well as next steps.
CDRH issued the following notice in the Federal Register:
The FDA and the University of Texas Medical Branch are launching an in-person and virtual Non-Clinical Course. This four and one-half day training program is offered annually utilizing expert faculty from the not only the FDA, but also other government agencies, academia, and business and industry. In-person attendees participate in laboratory activities conducted in mock Biosafety Level (BSL) 2, 3, and 4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.
“The Secretary of Health and Human Services should work with HHS funding agencies to ensure that key information on the agencies’ risk reviews of extramural research and intramural projects involving pathogens are publicly shared with researchers, Congress, and the public, as appropriate. Such information should be regularly updated and include the outcomes of risk reviews, steps HHS funding agencies and researchers took to mitigate risk, and the total number of research projects involving higher-risk pathogen research that agencies support.”
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!
340+ subscribers and counting!
Authored By: Tasha Mohseni
It can be difficult to keep up with it all policy changes that occurred in calendar year (CY) 2025.
Therefore, in this three-part blog series, I will cover significant policy changes from the following agencies:
Department of Human and Health Services (HHS) and select agencies including:
Office of Research Integrity (ORI)
Food and Drug Administration (FDA)
National Institutes of Health (NIH)
National Science Foundation (NSF)
Department of Energy (DOE)
Department of Defense (DoD) (or Department of War (DOW))
Department of Education (ED)
Office of Science and Technology Policy (OSTP)
Office of Management and Budget (OMB)
Executive Orders from the White House
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.
RESCINDED – NIH Implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP): NOT-OD-25-061
NIH Implementation of Uniform Administrative Requirements for Federal Financial Assistance: NOT-OD-25-059
RESCINDED – Notice of Civil Rights Term and Condition of Award: NOT-OD-25-090
Reminder: Application Requirements for Projects Involving Activities Outside of the United States or Partnerships with International Collaborators: NOT-OD-25-098
Revision: Notice of Updated Effective Date for the 2024 NIH Public Access Policy: NOT-OD-25-101
Updated NIH Policy on Foreign Subawards: NOT-OD-25-104
Updated NIH Processes for No-Cost Extensions: NOT-OD-25-110
Implementation Update: Improving the Safety and Security of Biological Research: NOT-OD-25-112
Request for Information on Responsibly Developing and Sharing Generative Artificial Intelligence Tools Using NIH Controlled Access Data: NOT-OD-25-118
Notice of Rescission of Civil Rights Term and Condition of Award: NOT-OD-25-124
Implementation Update: Terminating or Suspending Dangerous Gain-of-Function Research in Accordance with the Executive Order on Improving the Safety and Security of Biological Research: NOT-OD-25-127
Guidance on Enforcement of Closeout Requirements During the Appeals Process: NOT-OD-25-128
NIH Announces a New Policy Requirement to Train Senior/Key Personnel on Other Support Disclosure Requirements: NOT-OD-25-133
Supporting Fairness and Originality in NIH Research Applications: NOT-OD-25-132
Flexibilities for Registration and Results Reporting of Prospective Basic Experimental Studies with Human Participants: NOT-OD-25-134
Revision: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research: NOT-OD-25-131
Updated Implementation Guidance of NIH Policy on Foreign Subawards for Active Projects: NOT-OD-25-130
Request for Information on Maximizing Research Funds by Limiting Allowable Publishing Costs: NOT-OD-25-139
Update: No-Cost Extension Functionality in eRA: NOT-OD-25-142
NIH Will Stop Posting Notices of Funding Opportunities in the NIH Guide for Grants and Contracts in FY2026: NOT-OD-25-143
Review of the Accuracy of Grants Information for Fiscal Year 2025: NOT-OD-25-151
Preview of NIH Common Forms for Biographical Sketch and Current and Pending (Other) Support Coming Soon to SciENcv: NOT-OD-25-152
RESCINDED – Implementation of NIH Research Security Policies: NOT-OD-25-154
New Application Structure for NIH-Funded International Collaborations: NOT-OD-25-155
NIH Disposition of Biospecimens Collected from Tribal Populations: NOT-OD-25-153
Required Security and Operational Standards for NIH Controlled-Access Data Repositories: NOT-OD-25-159
NIH Policy on Enhancing Security Measures for Human Biospecimens: NOT-OD-25-160
Updated NIH Policy on Allowable Costs for Animals: NOT-OD-25-163
Update: Recission Notice re: Implementation of NIH Research Security Policies: NOT-OD-25-161
Reminder of Compliance Requirements for NIH Extramural Recipients Related to Renegotiated Aims, Objectives, Titles, and Abstracts: NOT-OD-26-007
Updated Terms and Conditions of Award Termination and Compliance with Court Orders: NOT-OD-26-009
Research Security Training Requirements for NIH: NOT-OD-26-017
NIHs Implementation of Common Forms for Biographical Sketch and Current and Pending (Other) Support for Due Dates on or after January 25, 2026: NOT-OD-26-018
Updated Application Policies: NIH Administrative Burden Reduction Effort Removal of Requirements for Letters of Intent and Unsolicited Applications Requesting $500,000 or More in Direct Costs: NOT-OD-26-019
Request for Information on Draft NIH Controlled-Access Data Policy and Proposed Revisions to NIH Genomic Data Sharing Policy: NOT-OD-26-023
Reminder: NIH Applications Must Be Complete and Compliant with NIH Policy and Application Instructions at Time of Submission: NOT-OD-26-025
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!
340+ 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:
Updates Since Last Week’s Edition
This section contains updates that became available AFTER the prior week’s edition was published:
CDER issued a warning letter to Dr. Mark S. Dacey for failing to obtain informed consent from a study participant prior to specimen collection. CDER empathized that failure to obtain informed consent before conducting study procedures jeopardizes the rights, safety, and welfare of participants. This denies participants the opportunity to fully assess the risks and benefits of their participation in the clinical investigation. As I reflect upon an article I wrote, I wonder if:
Did Dr. Dacey receive adequate human subjects research ethics training? If so, was it adequate?
Even if training was received and adequate, did Dr. Dacey understand the significance of completing this training?
I wrote a post on LinkedIn about this incident. This is why research ethics education is so important. Not only to take the training, but to understand how to apply the principles you’ve learned from the training.
FDA announced an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. This voluntary program is for CDER-regulated drug products manufacturers to gain more experience with the assessment tool and process.
CDER has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT). According to this press release, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the โboxed warning,โ the agencyโs most prominent safety-related warning.
The FDA has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. According to this press release:
Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen
TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue
The results showed that the addition of TTFields to standard of care chemotherapies gemcitabine and nab-paclitaxel (GnP) improved Overall Survival by approximately two months compared to GnP alone
The FDA granted Breakthrough Device designation for the Optune Pax device in December 2024
Finally, CDRH announced the availability of the most recent Medical Device User Fee Amendments 2028 (MDUFA VI) meeting minutes:
CBER’s “Refusal to File” letter to Moderna received a lot of attention both on LinkedIn and various news media outlets. Moderna released the letter to promote transparency in the scientific community.
I made a post about this update on LinkedIn as I had questions about it for those who work in the field
CBER announced its forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The meeting will be held on March 12, 2026, from 9 a.m. to 3:30 p.m. Eastern Time.
From the Office of Research Integrity (ORI), an HHS agency, released Dr. Daniel Andrade’s case summary involving research misconduct. Within the summary, ORI by a preponderance of the evidence found:
Dr. Andrade intentionally and knowingly falsified and/or fabricated data included in two grant applications submitted for PHS funds
He was engaged in research misconduct by intentionally and knowingly falsifying and/or fabricating for data under his DP2 and R21 grants
ORI proposed a three-year period of supervision under 42 CFR 93.407(a)(7) and a three-year period of prohibition from PHS advisory service under 42 CFR 93.407(a)(9).
The Centers for Medicare & Medicaid Services (CMS), another HHS agency, proposes a new rule to improve implementation of the Patient Protection and Affordable Care Act. Under the CMS proposed rule:
Improvements to payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs are included
2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs) are included
Other notable provisions are listed within the Federal Register
HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trumpโs, Secretary Kennedyโs, and Deputy Secretary OโNeillโs directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nationโs strategic advantages in technology, AI, and healthcare infrastructure. This press release highlights the top eight accomplishments for the first year under the Trump administration.
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