Tag: participant

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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!

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Without further ado, let’s dive into today’s topic!

For today, I am going to follow up with my original post regarding the open FDA investigation on alleged non-consensual human experimentation.

• Here is the original post ICYMI: Why Ethics Matters: Open FDA Investigation on Alleged Non-Consensual Human Experimentation

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. A comment from a subscriber
2. Let’s review the petition again
3. A very important lesson is to be learned here
4. Distinguishing between research and practice
5. Final Thoughts

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A comment from a subscriber

A special thank you to Erica Heath for your commentary!

I’ll say it again for the people in the back, I LOVE receiving feedback from CREST subscribers. When Erica reached out to me, she made a very interesting point:

"This is very strange. All I see is the petition which, in one page, says nothing and the one page journal entry which is about bad treatment but not research.  Is there a study?  In your analysis, none of these apply if there is no research. There is a significant difference between experimentation and research."

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Let’s review the petition again

This can be reviewed here: FDA-2025-P-5514-0003: Citizen’s Petition Documentation to be attached to Procedural Citizen’s Petition to FDA – Redacted

As a recap, the petition states:

• Alleged ongoing use of electrophysiological stimulation and electromagnetic exposure causing pain, seizure-like events, and neurological harm amounting to Electroconvulsive Shock Torture (ECST)
• 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

In greater detail, the petitioner states the following methods are being used against her:

• Electroconvulsive Shock Torture (ECST):
  • Non-consensual, abusive use intended to inflict pain, seizures, cognitive disruption, and trauma
  • Conducted at voltages higher than those used in Electroconvulsive Therapy (ECT), without safegaurds
• Electromagnetic torture:
  • Pressure, pain, and disruption of neurological processes, including simulated seizures and cardiovascular distress
• Human-to-Human interface and psychological torment:
  • Harassment, defamation, ridicule, and interference with personal relationships
  • Continuous verbal torment designed to destabilize her socially and psychologically

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A very important lesson is to be learned here

So, no study ID was mentioned. We just verified this. Now, what does this mean?

When I first saw this petition, I automatically assumed this was human subjects research. I saw “non-consensual”, took it, and ran with it. I saw “FDA investigation” and thought I hit the jackpot. I thought I found a recent research ethics violation case. And maybe I still did. But without that study ID, I can’t assume this is human subjects research.

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Distinguishing between research and practice

Let’s revisit the Belmont Report.

When I traditionally think of the Belmont Report, I think of only Parts B and C. These parts are where the principles are introduced as well as application of these principles. However, there is another very important part, Part A. In Part A of the Belmont Report, the distinction between research and practice is noted.

"It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research."

Let’s define these terms:

• Practice
  • Refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.
  • The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals.
• Research
  • An activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).
  • Usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

I’d like to pull another important quote from the Belmont Report:

"When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is 'experimental', in the sense of new, untested or different, does not automatically place it in the category of research."

The report continues with stating that new procedures of this description should be considered formal research at an early stage to determine whether they are safe and effective. Further, it is the responsibility of medical practice committees to insist that a major innovation be classified as research. Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.

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Final Thoughts

Unless we know for certain that we are investigating human subjects research, then these research ethic tenets wouldn’t be applicable to this docket.

If I see another docket of this nature, you bet your bottom dollar that will be the first thing I do. I will see if there is an ethics board and/or study ID mentioned. I also wanted to share some relevant links I found during my research if you’d like to further dive into the topic:

• Office of Research Integrity’s Basic Research Concepts Course
• FDA In Brief: FDA takes action to ensure regulation of electroconvulsive therapy devices better protects patients, reflects current understanding of safety and effectiveness
  • Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses
• “Shock tactics”, ethics, and fear. An academic and personal perspective on the case against ECT

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I hope you enjoyed my follow-up post to this open FDA investigation!