RD Research Services LLC

Category: Lessons Learned

  • National Advisory Committee on Human Research Protections (NACHRP): Interview with Julie Kaneshiro

    National Advisory Committee on Human Research Protections (NACHRP): Interview with Julie Kaneshiro

    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.

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Interview with Julie Kaneshiro

    Written by Tasha Mohseni

    Today, we are going to learn about National Advisory Committee on Human Research Protections (NACHRP).

    In this candid interview with Julie Kaneshiro, we will learn about her journey when she first started in federal human research oversight. Then, we will shift the discussion towards NACHRP and what we can expect from this new organization.

    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

    Advertisements

    Table of Contents:

    I see youโ€™ve worked in the federal government industry throughout your entire career, specifically with OHRP from 2002 until June this year. What initially drew you into human research oversight?

    Julie suspects that her childhood exposure to the National Institutes of Health (NIH) through her motherโ€™s role as a social worker in the NIH Clinical Center that led to her interest in human research protections. In the early 1990s, she became an NIH management intern at NIH. Through this internship program, she learned about the Office of Human Research Protections’ (OHRP) predecessor office, the Office for Protection from Research Risks (OPRR).  The typical career path for a management intern at the time was research administration.

    However, she was interested in public policy and bioethics.

    Once she learned about OPRRโ€™s mission to protect research participants, she knew this is where she wanted to be. She expressed gratitude towards the people at OPRR who became her mentors, including Gary Ellis, Joan Porter, Bill Dommel, and Tom Puglisi. Julie joined soon after the Common Rule was adopted. The OPRR staff gave her invaluable experiences and opportunities to learn about these regulations and ethical issues that were present.

    (Back to the Contents)

    Iโ€™d like to learn how you became engaged with SACHRP (The Secretaryโ€™s Advisory Committee for Human Research Protections, but first why donโ€™t you give us a brief overview of who SACHRP was and their mission?

    SACHRP was created in 2003. This organization advised the Secretary of HHS about issues related to human research protections. Unfortunately, SACHRP was terminated in March 2025. SACHRPโ€™s recommendations were of great value to HHS, and especially to OHRP over this 22-year period.  The members of SACHRP and its subcommittees were some of the most knowledgeable people working in human research protections. They provided valuable recommendations to OHRP and other entities within HHS that have a role in the participant protections. HHS agencies include the Food and Drug Administration (FDA), NIH and the Office for Civil Rights (OCR).  OHRP was responsible for the management and support of SACHRP. Specifically, OHRP staff were involved with identifying topics that institutions would benefit from SACHRP and their subcommitteesโ€™ experience and expertise. 

    (Back to the Contents)

    When SACHRP was terminated in March 2025, how did you feel about this? Was the termination a surprise to you?

    Naturally, Julie was disappointed to learn about SACHRPโ€™s termination, but was not surprised.  It is not unusual for advisory committees to undergo change or be eliminated with a change in administration.  Prior to the establishment of SACHRP, there was the National Human Research Protections Advisory Committee which existed from 2000-2003. Their mission was comparable to SACHRP.

    (Back to the Contents)

    What were the main consequences (intended or unintended) of dissolving SACHRP for the human research protections community?

    The loss of SACHRP was not just a loss for OHRP and HHS, but also to:

    • The other Common Rule department and agencies,
    • The broader human research protections community and
    • The public more generally. 

    Though SACHRP wasn’t the only entity engaged in these crucial discussions, its important voice gave OHRP and others valuable insights. It is key that SACHRP was a FACA committee.

    FACA committees conduct meetings and deliberations in public, with the opportunity for public input.

    All of SACHRPโ€™s recommendations are available to the public. These recommendations remain an important resource for the human research protections community.

    (Back to the Contents)

    Letโ€™s shift the discussion to NACHRP (The National Advisory Committee on Human Research Protections). What is NACHRP?

    NACHRP is a volunteer-driven organization that aims to continue the tradition of the U.S. Department of Health and Human Services, Secretaryโ€™s Advisory Committee on Human Research Protections (SACHRP). NACHRP will:

    • Provide expert advice and practical recommendations to the human research community based on established ethical principles, including the Belmont Report and the Declaration of Helsinki.
    • Promote consistent interpretation and application of federal regulations and guidance in coordination with Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs).
    • Respond to emerging challenges arising from advances in science, medicine, and technology, while anticipating future developments and supporting responsible innovation.
    • Commit to ethical vigilance and innovation in participant protections, and to honoring the trust placed in research with transparency, respect, and integrity.
    • Provide opportunities for community input and participation.

    (Back to the Contents)

    NACHRP is just beginning its work and is eager for input about what topics would be useful to address.

    NACHRPโ€™s first Town Hall meeting will be on Monday, December 8th from 10:00-11:30 PT (1:00-2:30 ET) on The Importance of โ€œUnchecking the Boxโ€:  A Primer on the Power of Regulatory Flexibility.

    This Town Hall will be hosted by the organization, Public Responsibility in Medicine and Research: Event Link

    • NACHRP appreciates and acknowledges the incredible breadth of subject matter expertise, creativity, and skill among those in the human research community.
    • If folks are interested in volunteering, NACHRP will issue periodic calls for those with specific, topical subject matter expertise to also help develop guidance.
    • Folks are welcome to submit their CV and top two specific areas of expertise at any time.

    (Back to the Contents)

    I hope you enjoyed this interview with Julie Kaneshiro!

  • DOJ Bulk Data Transfer Rule Brief

    DOJ Bulk Data Transfer Rule Brief

    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.

    Eager to skip ahead to today’s content?

    Jump to the Table of Contents.

    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

    Can’t believe we are already through November! As much as this year has gone slow for me, it also feels unbelievably fast…

    As I’ve mentioned in numerous posts, we have endured MANY changes this CY25 that have impacted FY26. Ideally, a central repository would be best to review all regulatory updates (at least in my opinion).

    brown wooden ruler and colored pencils on papers

    For now though, I will do my best to keep up with these changes in this evolving landscape! It truly lifts my spirits to spread knowledge to the research compliance community.

    Did anyone attend CITI Program’s webinar that discussed the DOJ Bulk Data Transfer Rule last month?

    I thought the presentation was fabulous! The speaker was informative and had great slides to explain this rule. If you weren’t able to attend, I’m really glad you’re here! For today’s post let’s learn about DOJ’s Bulk Data Transfer Rule. Specifically, I’d like to touch on:

    • What is this rule?
    • When is the rule effective?
    • Why is this rule necessary?
    • What resources are available to better understand this rule?

    Please note that I will NOT be sharing presentation slides or describing the presentation verbatim. Though it gave me background on this topic, I have spent quite some time researching this rule myself. I always want to provide my readers a comprehensive overview of any topic I write about!

    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

    Advertisements

    Table of Contents:

    1. DOJ Rule Matrix
    2. DOJ Rule Timeline
      1. EO 14117: Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
      2. CISA Publication: Security Requirements for Restricted Transactions
      3. Key Dates and Actions
    3. DOJ Rule Applicability
      1. Data Types Defined Under the DOJ Rule
        1. Biometric Identifiers
        2. Covered Personal Identifiers
        3. Goverment-related Data
        4. Human Biospecimens
        5. Human’omic Data
        6. Personal Financial Data
        7. Personal Health Data
        8. Precise Geolocation Data
      2. Data Transactions Defined Under the DOJ Rule
        1. Transaction
        2. Exempt Transactions
        3. Prohibited Transactions
        4. Restricted Transactions
      3. Other Important Definitions Under the DOJ Rule
        1. Bulk U.S. Sensitive Personal Data
        2. Covered Data Transaction
          1. Access
          2. Countries of Concern
          3. Covered Person
          4. Data Brokerage
          5. Vendor Agreement
          6. Employee Agreement
          7. Investment Agreement
      4. Piecing it Together: Applying the DOJ Rule

    DOJ Rule Matrix

    The DOJ Rule Matrix provides key highlights of the final rule.

    DOJ Bulk Data Transfer RuleDownload
    • In general, this rule prohibits and restricts certain sensitive health, genomic, and personal data transactions with certain countries or persons.
    • This rule heavily relies on understanding definitions to determine appropriate applicability and compliance.
    • The rule was finalized in January 2025 with two effective dates (which will be discussed in the subsequent sections).
    • Each resource listed within the matrix will also be described in the subsequent sections.

    (Back to Contents)

    DOJ Rule Timeline

    The timeline for rule creation and implementation stemmed from EO 14117 in February 2024.

    DOJ Rule TimelineDownload

    (Back to Contents)

    CISA Publication: Security Requirements for Restricted Transactions

    • As directed by EO 14117, CISA developed security requirements to apply to classes of restricted transactions identified in the DOJ regulation.
    • The security requirements require that U.S. persons engaging in restricted transactions comply with organizational-, system-, and data-level requirements to prevent covered persons and countries of concern from accessing covered data that is linkable, identifiable, unencrypted, or decryptable using commonly available technology.

    (Back to Contents)

    Key Dates and Actions

    (Back to Contents)

    Now, we have a better background as to why this rule was created. Further, we’ve reviewed supporting publications prior to the issuance of the DOJ rule. In the final section, we will dive into:

    • Key terms that will help us understand when the rule applies
    • Rule applicability

    (Back to Contents)

    Advertisements

    DOJ Rule Applicability

    There are many terms we need to work through prior to applying this rule.

    Data Types Defined Under the DOJ Rule

    DOJ Rule DataDownload

    Note that “Sensitive Personal Data” will be described in the next section as it is based off many terms.

    Biometric Identifiers

    • Measurable physical characteristics or behaviors used to recognize or verify the identity of an individual, including facial images, voice prints and patterns, retina and iris scans, palm prints and fingerprints, gait, and keyboard usage patterns that are enrolled in a biometric system and the templates created by the system

    Covered Personal Identifiers

    • Any listed identifier:
      • In combination with any other listed identifier; or
      • In combination with other data that is disclosed by a transacting party pursuant to the transaction such that the listed identifier is linked or linkable to other listed identifiers or to other sensitive personal data.
    • There are also several exclusions and examples listed within this term within the rule

    Goverment-related Data

    • Any precise geolocation data, regardless of volume, for any location within any area enumerated on the Government-Related Location Data List in ยงโ€‰202.1401 which the Attorney General has determined poses a heightened risk of being exploited by a country of concern to reveal insights about locations controlled by the Federal Government, including insights about facilities, activities, or populations in those locations, to the detriment of national security, because of the nature of those locations or the personnel who work there; and
    • Any sensitive personal data, regardless of volume, that a transacting party markets as linked or linkable to current or recent former employees or contractors, or former senior officials, of the United States Government, including the military and Intelligence Community

    Human Biospecimens

    • Means a quantity of tissue, blood, urine, or other human-derived material, including such material classified under any of the following 10-digit Harmonized System-based Schedule B numbers

    Human’omic Data

    • Represents the following human data types:
      • Genomic data
      • Epigenomic data
      • Proteomic data
      • Transcriptomic data
    • Excludes pathogen-specific data embedded in human `omic data sets

    Personal Financial Data

    • Data about an individual’s credit, charge, or debit card, or bank account, including purchases and payment history; data in a bank, credit, or other financial statement, including assets, liabilities, debts, or trades in a securities portfolio; or data in a credit report or in a โ€œconsumer report”

    Personal Health Data

    • Health information that indicates, reveals, or describes the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual.

    Precise Geolocation Data

    • Includes data, whether real-time or historical, that identifies the physical location of an individual or a device with a precision of within 1,000 meters

    (Back to Contents)

    Data Transactions Defined Under the DOJ Rule

    Note that “Covered Data Transaction” will be described in the next section as it is based off many terms.

    DOJ Rule Data TransactionsDownload

    Transaction

    • Any acquisition, holding, use, transfer, transportation, exportation of, or dealing in any property in which a foreign country or national thereof has an interest.

    Exempt Transactions

    • A data transaction that is subject to one or more exemptions described in subpart E of this part.
    • This will be described in the last section.

    Prohibited Transactions

    • A data transaction that is subject to one or more exemptions described in subpart C of this part.
    • This will be described in the last section.

    Restricted Transactions

    • A data transaction that is subject to one or more exemptions described in subpart D of this part.
    • This will be described in the last section.

    (Back to Contents)

    Advertisements

    Other Important Definitions Under the DOJ Rule

    Bulk U.S. Sensitive Personal Data

    Bulk US SP DataDownload
    • As notated in the rule, “bulk” is equivalent to a sensitive personal data threshold.
      • There are seven thresholds:
        • Human `omic data
        • Biometric identifiers
        • Precise geolocation data
        • Personal health data
        • Personal financial data
        • Covered personal identifiers
        • Combination of all data types above

    Covered Data Transaction

    Covered Data TransactionDownload

    Note that the following terms have been defined:

    • Transaction,
    • Government-related data, and
    • Bulk U.S. sensitive personal data
    Access
    • Logical or physical access, including the ability to obtain, read, copy, decrypt, edit, divert, release, affect, alter the state of, or otherwise view or receive, in any form, including through information systems, information technology systems, cloud-computing platforms, networks, security systems, equipment, or software
      • For purposes of determining whether a transaction is a covered data transaction, access is determined without regard for the application or effect of any security requirements
    Countries of Concern
    • Cuba, Venezuela, Russia, North Korea, China, and Iran are countries of concern
    • From the rule, these are any foreign government that, as determined by the Attorney General with the concurrence of the Secretary of State and the Secretary of Commerce:
      • Has engaged in a long-term pattern or serious instances of conduct significantly adverse to the national security of the United States or security and safety of United States persons; and
      • Poses a significant risk of exploiting government-related data or bulk U.S. sensitive personal data to the detriment of the national security of the United States or security and safety of U.S. persons
    Covered Person
    • There are five types listed within this definition along with their associated examples within the rule
    • From the webinar, a covered person can be anyone who is from any of the countries of concern (resident, national, official) and also could mean a corporate person/entity from these countries
      • Considering this person’s affiliation is crucial
    Data Brokerage
    • The sale of data, licensing of access to data, or similar commercial transactions, excluding an employment agreement, investment agreement, or a vendor agreement, involving the transfer of data from any person (the provider) to any other person (the recipient), where the recipient did not collect or process the data directly from the individuals linked or linkable to the collected or processed data.
    Vendor Agreement
    • Any agreement or arrangement, other than an employment agreement, in which any person provides goods or services to another person, including cloud-computing services, in exchange for payment or other consideration.
    Employee Agreement
    • Any agreement or arrangement in which an individual, other than as an independent contractor, performs work or performs job functions directly for a person in exchange for payment or other consideration, including employment on a board or committee, executive-level arrangements or services, and employment services at an operational level.
    Investment Agreement
    • An agreement or arrangement in which any person, in exchange for payment or other consideration, obtains direct or indirect ownership interests in or rights in relation to:
      • Real estate located in the United States; or
      • A U.S. legal entity.

    (Back to Contents)

    Piecing it Together: Applying the DOJ Rule

    Though this was shared earlier in this post, the following resource is recommended to review to ensure compliance and understanding of this rule: Data Security Program: Compliance Guide

    • In general, you should complete an inventory of your data
      • You should review the type of data in question and where it is being transferred to, so rule applicability can be assessed
    • Subparts C-E are critical in understanding data transactions as some of these data transactions are exempt from this rule
    • The guide and rule itself should be reviewed for specific reporting, record keeping, and auditing requirements

    (Back to Contents)

    I hope this article helped you better understand the DOJ’s Bulk Data Transfer Rule! If you did attend the CITI Program webinar, then this post should have been a nice resource to complement what you learned.

  • Subscriber Spotlight: Confessions of a Research Compliance Professional

    Subscriber Spotlight: Confessions of a Research Compliance Professional

    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.

    Eager to skip ahead to today’s content?

    Jump to the Table of Contents.

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Written by Kelsey Miller

    Reviewed by Tasha Mohseni

    We’ve made it to November folks! I bet you’re ready for a much needed holiday break at the end of the month (aka Thanksgiving).

    I always love using that week/weekend for family time and connecting with loved ones. However, it’s just as important to recharge your OWN batteries. I can’t stress enough how important it is to practice self care. Life in itself can be difficult. Even if life is going smoothly, our profession can be burdensome. Whether you’re in IRB, IACUC, or any other compliance area, you might feel that we have a heavy burden. And by burden, I don’t mean feeling weighed down. I mean our burden (and responsibility) to protect those who choose to participate in research.

    a woman wearing a sleep mask

    If you feel overwhelmed or unsure your daily tasks, this article is for you: Top Career Hacks for Compliance Professionals.

    For today, first, I’d like to welcome you back to the Subscriber Spotlight blog series!

    For these posts, you can expect to read:

    • An introduction of the valued subscriber,
    • How long the individual has been a subscriber,
    • Relevant social media and/or publications, and
    • A brief description of today’s topic.
    Advertisements

    Who is Kelsey Miller?

    Kelsey Miller is compliance program manager with a focus on collaborative approaches to enhance the research enterprise who has been a CREST subscriber since.

    • She has experience working in the laboratory research industry in a cross functional research management and compliance role.
    • She’s highly skilled in areas of human subjects research, animal research, committee coordination, internal and external communication, and protocol development.
    • She’s adept in team leadership, facilitation, project management, training, and presentation of scientific concepts.
    • Lastly, Kelsey’s passionate about human health and research-driven solutions.

    Kelsey will share her perspective as a research compliance professional and the importance of building community in this space.

    Without further ado, let’s get started! As a general reminder, any legal information discussed within this post should be discussed with your institution. The views in this post are of the authors alone and not their employers.

    Table of Contents:

    Research compliance found me

    I hear this kind of sentiment regularly around the field. Most of us arrive in our first IRB, IACUC, or other compliance role without having known it existed previously. This field isnโ€™t on a list of careers in high school or college. It isn’t something typically โ€œfallen intoโ€ based on interest in research or general administrative ability. What Iโ€™ve found in my first decade in this field is a profession that deserves to be defined.

    This is community that I could not be more proud to count myself among.

    We have an opportunity, perhaps a responsibility, to continue the growth of this community by:

    • Defining our professional identity and core skill sets,
    • Supporting the continued development and standardization of best practices, and
    • Finding our communal voice as a cohesive field.

    (Back to the Contents)

    Our professional identity is difficult to define

    Sometimes we are defined by the term โ€œcomplianceโ€ as playing the hall monitor or security guard role, catching bad behavior.

    Letโ€™s all agree here, catching bad behavior is NOT why we came to this field!

    If youโ€™re like me, you connect most with the vision of finding the best way to harmonize the requirements, research, and reality (aka constraints) with the larger mission of helping humankind through ethical scientific discovery! Our shared identity may then be better defined by:

    • The communities we bring together,
    • The regulatory complexities we navigate, and
    • The ethical values we are charged to prioritize within our roles.

    (Back to the Contents)

    The ability to bridge

    The foundational competency of a successful Research Compliance Professional, I believe, is best defined as the ability to bridge.

    Bridging the gap between science and the realities of people impacted, between the complexity of the requirements and the chaos of the research environment, between whatโ€™s most ethical and whatโ€™s actually possible, between what the researcher wants to do and what they actually wrote in a protocol๐Ÿ˜‰. This competency is much more than simply memorizing regulations, it is rooted in an understanding of both people and language, blossoming through collaborative facilitation of interconnected yet fragmented systems. I believe our professionโ€™s defining characteristic is as complexity navigators!

    Our certifications, professional communities, and career development focus should therefore reflect this foundation as a collection of many more skills and abilities than regulatory knowledge. Todayโ€™s drivers of change are many (e.g., AI, regulatory uncertainty, changes to research systems, etc), but the research compliance profession is founded in this ability to navigate complex perspectives and fragmented systems. By supporting these professionals more holistically, our untapped capacity to navigate and connect systems can drive the research environment of the future.

    (Back to the Contents)

    We must prioritize connection and collaboration

    As the field takes this defining next step in recreating our professional identity, we must prioritize creating spaces for connection and sharing.

    Communities are a necessity to establish innovative best practices designed to take on our future challenges. I have had the privilege of talking with many in this community, and each individual voice brings a different experience. From the small institution where a weary one-person office juggles five compliance roles to the manager of two dozen staff focused only on the huge workload of a human subjects research program.

    Our shared knowledge has the potential to create significant advances and define the next generation of our professional identity, but we must bring these voices together.

    In celebrating the diverse experiences of our field and the complex skillset we develop, it should not be lost that sharing and cocreation requires many different forums. By supporting networking and information sharing both within and across regional groups and regulatory areas, our communal identity can begin to shape the development of the field as a whole. The complexity of these fragmented systems necessitates wider connections between institutions for standardization and specialization as needed in organizations both large and small, health-centered and academic, for-profit and public, etc. 

    (Back to the Contents)

    Share your voice with the community

    If thereโ€™s one message I hope to convey, it is to encourage readers to add their voice as well as learn from the wider community.

    There are so many opportunities to engage! For the last three years, Iโ€™ve had the honor of facilitating a group of professionals from small human subject programs, the Small HRPP Community. In this community we:

    • Focus on keeping up-to-date on regulatory changes (thanks for your help CREST!) and
    • Open discussion of local challenges within our programs.

    We are able to focus on solutions that are specific to small programs with 1 or 2 staff members, provide support for particular challenges we face in lack of resources or historical precedent, and come together to share innovations and best practices. This year, Iโ€™ve begun a new initiative to create a similar community for animal research programs. If you havenโ€™t found the community that fits your needs, start one! The more opportunities we take to share, the stronger our identity grows.

    (Back to the Contents)

    Final thoughts

    We are in a foundational moment as our profession matures, and our regulatory and research environments change.

    Our strength is in our diverse experience and shared knowledge, our ability to bridge across complexities and perspectives. By supporting each other through community, we have the opportunity to emerge as a unified voice for reasonable, ethical research practices in an environment desperate for complexity navigators!

    (Back to the Contents)

    I hope you enjoyed reading this post from Kelsey Miller!

  • Followup: Open FDA Investigation on Alleged Non-Consensual Human Experimentation

    Followup: Open FDA Investigation on Alleged Non-Consensual Human Experimentation

    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.

    Eager to skip ahead to today’s content?

    Jump to the Table of Contents.

    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’s not often that I post twice in one week.

    But when I do…it’s for a good reason! This is also the first time I am following up on a topic that I have recently written about. I’m unsure how many of you all are also writers, but I love revisiting my old articles. There are several reasons why I enjoy doing this:

    clear light bulb placed on chalkboard
    1. You get to see how your writing style has evolved.
      • You get to see if your writing has improved (or may need improvement). You might even pick up on mistakes you’ve made to correct for next time.
      • Better yet, maybe you will come across something you felt you wrote really well. Maybe you liked how you communicated a certain topic and you want to follow that writing style again.
    2. You get to see how the design of your website has changed.
      • I’m still finalizing my “blog template”, so to speak. In other words, I review my old articles to see how I can optimize my blog layout for my readers.
        • I’m always open to suggestions, so please feel free to reach out!
    3. You can learn a lot by reviewing your old content.
      • Sometimes you can think of new content to generate from old content.
      • Other times, you may challenge your old content. Maybe what you originally wrote is either:
        • Incorrect or
        • You should have thought about it differently

    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.

    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

    Advertisements

    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

    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."

    This was my exact expression…it was as if my mind blew up on itself! It didn’t even dawn on me that there wasn’t a study number referenced. I thought to myself,

    Hmmm…it’s not like me to miss something like that.

    First, I checked to see if there were new documents in the docket. There were none. Then, I thoroughly went through the files within the docket again. No study ID found.

    (Back to the Contents)

    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

    (Back to the Contents)

    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.

    (Back to the Contents)

    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.

    (Back to the Contents)

    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:

    (Back to the Contents)

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

  • Why Ethics Matters: Open FDA Investigation on Alleged Non-Consensual Human Experimentation

    Why Ethics Matters: Open FDA Investigation on Alleged Non-Consensual Human Experimentation

    See: Followup: Open FDA Investigation on Alleged Non-Consensual Human Experimentation

    RD Research Services Current Way of Thinking as of 10/30/25

    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.

    Eager to skip ahead to today’s content?

    Jump to the Table of Contents.

    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.

    a woman reporting beside the van

    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!

    Leave a Reply

    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:

    Screenshot from Regulations.gov RE: FDA nonrulemaking 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.

    Advertisements

    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

    (Back to Contents)

    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".

    (Back to Contents)

    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.

    (Back to Contents)

    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.

    (Back to Contents)

    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!

    (Back to Contents)

    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 โ€” 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 OMSโ€™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 โ€œdata,โ€ 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 circumstanceโ€”national security, emergency, or warโ€”permits deviation from these ethical standards.

    (Back to Contents)

    Here, I reviewed the following documents:

    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 โ€œresearch involving devices or procedures not clinically approved.โ€
      • 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).

    (Back to Contents)

    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."
    • "Iโ€™d like to also add that non-consensual human-human interfacing is molestation in and of itself."

    (Back to Contents)

    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"

    handwritten message on brown background

    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.

    (Back to Contents)

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