Category: Regulatory

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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

It feels so good to be writing, reporting, and sharing my insights with you all again!

I have a fun fact to share that you may not have known about me. When I was in high school I always thought I would be a journalist. I *almost* wish I pursued that, but I’m glad I didn’t. I only pictured myself as the type of journalist that would be present during a high-stakes car chase. Or maybe even being at the front lines of a natural disaster. Another fun fact about me is that I always wanted to be a blogger. But…I never knew what I would write about. I just knew I wanted to write something meaningful…and useful.

I had no idea that I could report the type of regulatory updates I do now. Without having gone through what I’ve gone through, I never would have ended up in research compliance. And without this journey, I never would have created this meaning AND useful blog for professionals in our field.

Speaking of our field, can you think of a recent human research ethics violation? If you know of a recent event, please leave a comment and share a link to promote discussion!

I tried to think about this some time ago (I want to say last month). Of course I am familiar with the cases that led to the Belmont Report. And I certainly recall some after the Belmont report (e.g., Jesse Gelsinger). Fast forward to last Wednesday. I was browsing Regulations.gov, which is still in operation despite the government shutdown. You can imagine my surprise when I came across the following docket:

When I read this, I thought "WHOA!" I couldn't believe my eyes. This sounds to me like a recent human research ethics violation case. Which leads me to today's topic. Today, I'm going to cover this request for an FDA investigation. Specifically, I will:

• Introduce the case prompting investigation
• Share my thoughts on which ethical tenets were violated based on the intial petition
• Review the remaining documents associated with this docket
• Close the article with my concluding thoughts

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:

1. Citizen Petition from Kimberly C. Tanner
2. Initial Ethical Analysis
   1. Nuremberg Code
   2. Belmont Report
   3. ICH GCP E6(R3)
   4. Declaration of Helsinki
3. Review of Remaining Documentation within the FDA Docket
   1. The "Good Science" Article
   2. The Legal Dagger
   3. The Coup De Gras
4. Closing Thoughts

Citizen Petition from Kimberly C. Tanner

This can be reviewed under FDA-2025-P-5514-0001.

In summary, the petition states:

• The FDA to complete the following actions:
  • Initiate an investigation and oversight review into alleged non-consensual human experimentation and Electroconvulsive Shock Torture (ECST) conducted through the misuse of electrophysiological and neuromodulation technologies
  • Issue a Federal Register notice clarifying that the non-therapeutic use of electroconvulsive shock and electromagnetic neuromodulation devices outside approved research or clinical contexts constitutes a violation of human-subject protections under the Common Rule(45 CFR 46) and FDA device regulations (21 CFR Parts 50 and 56)
  • Review and revoke, where appropriate, device clearances or research exemptions that enable non-consensual human application of electrophysiological stimulation
• The petition is then backed by the following claims:
  • Alleged ongoing use of electrophysiological stimulation and electromagnetic exposure causing pain, seizure-like events, and neurological harm amounting to Electroconvulsive Shock Torture (ECST)
    • The petitioner has journal records indicating this and is conssistent with electrophysiological stimulation under UN Convention Against Torture and the Istanbul Protocol (2022)
  • ECST is distinct from Electroconvulsive Therapy (ECT) which is a regulated medical treatment
  • Citing federal regulations mentioned above and that human experimentation cannot be performed without consent

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Initial Ethical Analysis

I immediately thought of four ethical frameworks once I read the petition.

I'd like to walk through each of these frameworks and share my analysis as it relates to the case.

Nuremberg Code

How does this NOT violate every entry in the Nuremburg Code?

Though there isn't a reason to walk through each statement one by one, I feel we should. Each statement has its own impact to the case:

• "The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion, and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
  
  The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity."
  • This one is self explanatory as this is one of the claims against the alleged party
• "The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature."
  • You will see my rationale behind this as I explore the other documents within the investigation. I can assure you this was not based on "good science".
• "The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment."
  • This doesn't sound applicable based off the files within the docket.
• "The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury."
  • I believe the name of this petition explains enough as to why this statement is in direct violation.
• "No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects."
  • Again, the docket's title is plenty of explanation for this statement's violation.
• "The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment."
  • Self explanatory...
• "Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury disability or death."
  • This relates to the "good sciences" article.
• "The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment."
  • A blend of being "self explanatory" and "good science".
• "During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible."
  • Given that consent was acquired, it's safe to assume that the participant wasn't given any liberties.
• "During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required by him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject."
  • Again, a blend of being "self explanatory" and "good science".

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Belmont Report

This can be reviewed here: Belmont Report.

I immediately saw that this was in direct violation of two out of the three tenets:

• Respect for Persons
  • Violating informed consent is in direct violation of this principle.
  • Specifically, violating the fact that folks are autonomous agents and that consent must be voluntarily given to be valid.
• Beneficence
  • Though it is unclear what any benefits would be from this study, potential harms were not minimized.
  • This also ties into violation of the Hippocratic Oath, which is foundational to medical ethics.

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ICH GCP E6(R3)

This can be reviewed here: ICH GCP E6(R3).

Of course, this is under the assumption that this was a clinical trial:

• "Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and applicable regulatory requirement(s). Clinical trials should be designed and conducted in ways that ensure the rights, safety and well-being of participants."
  • I won't dive further into this since I already mentioned the Declaration of Helsinki.
• "Informed consent is an integral feature of the ethical conduct of a trial. Clinical trial participation should be voluntary and based on a consent process that ensures participants (or their legally acceptable representatives, where applicable) are well-informed."
  • Again, one of the most compelling elements of this case.
• "Clinical trials should be subject to an independent review by an IRB/IEC."
  • This ties into the "good science" article.
• For principles 4-11:
  • See bullet point above.

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Declaration of Helsinki

This can be reviewed here: Declaration of Helsinki.

Not that I want to take shortcuts here, but in case you didn't know there are 30+ tenets! It's safe to say that there is a lot of overlap with these ethical principles. For the sake of not being repetitive, we can assume this case violated the Helsinki tenets. I can only imagine if we walked through each principle how long this post would be!

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Review of Remaining Documentation within the FDA Docket

I'm curious of how spot on my analysis is now that we are going to review other critical documents.

Let's deep dive into the other elements of the case.

The "Good Science" Article

Here is the article: Bad Science Used to Support Torture and Human Experimentation.

In short, this relates to FDA-2025-P-5514-0004: Exhibit E-9 — Misuse of Science in Torture Justifications. Upon review:

• Exhibit E-9 discusses why Bad Science Used to Support Torture and Human Experimentation article is not "good science".
• The "good science" articles details how the Office of Medical Services (OMS) and affiliated behavioral scientists falsely claimed scientific validation by referencing internal field reports and memoranda as though they were controlled studies.
  • The science used to justify torture was bad because it repeatedly failed to assess important long-term physical and mental health outcomes.
  • To avoid this from happening again, recommendations with respect to the following topics were provided:
    • Independence and accountability
    • Peer review and monitoring
    • Training and education
    • Government accountability
• Further, per Exhibit E-9:
  • This misuse of empirical language gave policy-makers a pseudo-scientific justification to continue torture while claiming medical supervision.
  • The OMS’s interpretation of physiological data ignored established neurobiological evidence showing that severe stress, hypoxia, and sleep deprivation cause long-term neurocognitive and psychological injury.
  • By reclassifying human suffering as “data,” medical personnel violated:
    • The Nuremberg Code (1947),
    • The Declaration of Helsinki, and
    • The U.S. Common Rule (45 CFR 46)
  • The authors emphasize that no circumstance—national security, emergency, or war—permits deviation from these ethical standards.

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The Legal Dagger

Here, I reviewed the following documents:

• FDA-2025-P-5514-0003: Citizen's Petition Documentation to be attached to Procedural Citizen's Petition to FDA - Redacted
• FDA-2025-P-5514-0005: Appendix C-B — Federal Human Subject and Device Oversight Regulations

The first document complements FDA-2025-P-5514-0001 within the docket (associated with the original petition). Nature of violations described in greater detail (see image below):

Initial legal and ethical frameworks were also introduced (see image below):

For the second document:

• This describes the complete legal framework for the case (i.e., regulations that are relevant to the docket).
• Details can be reviewed within the file, to summarize:
  • The alleged experiments and interventions(electroconvulsive shock, electromagnetic fields, human-to-human neural interfacing) clearly fall under “research involving devices or procedures not clinically approved.”
  • Due to no informed consent, IRB review, device labeling, or IDE authorization, actions described here directly violate 45 CFR 46 and 21 CFR 812.
  • These violations are compounded when the procedures are used as instruments of torture (i.e., they violate both human-rights and regulatory law).

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The Coup De Gras

This reviews FDA-2025-P-5514-0007: Torture Journal Entry by Kimberly C. Tanner 10-17-25.

In essence, this incredibly vivid journal entry describes the torture Kimberly C. Tanner went through during these experiments. I'd like to use these next couple of bullet points solely to highlight direct quotes from the journal entry. In my opinion, these horrific statements speak to the importance of this FDA investigation and the magnitude of the situation.

• "Fearmongering is a factor, but real fear is at play since I have no idea how many years this will take off my life, how much damage is being done to my brain and the rest of my body including other organs of my body since no part of my body is off limits to Operator #1, who also has no conscience and behaves maliciously most of the time."
• "I’d like to also add that non-consensual human-human interfacing is molestation in and of itself."

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Closing Thoughts

This song played in my head as soon as I formatted this section:

"Closing time, you don't have to go home but you can't stay here"

I'm thinking this must have been a FDA-regulated study (given the device regulations that were cited. However, I also wonder if this was DOD-sponsored research. One of the ethical/legal frameworks that was mentioned within the case was specific to DOD. I wonder if it is safe to assume that this isn't a clinical trial (given ICH GCP E6(R3) guidelines weren't mentioned). I know that I'm not a lawyer. However, I did have fun analyzing this case. It's amazing that these ethical principles that were applied to human rights violations in the 1940s still hold true today.

Just as the image says, human rights are not optional. Participant protections are not optional. This is why myself (and other professionals within our field) hold these ethical tenets so close to heart.

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I hope you found this post thought-provoking and insightful!

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