RD Research Services, LLC | Compliance Expertise for IRBs & Institutions

Category: Regulatory

  • April 2025: RAC Digest

    April 2025: RAC Digest

    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, and Investigators! 200+ blog subscribers and counting!

    Welcome to the RAC Digest!

    RAC stands for “Research Administration and Compliance”.

    The RAC Digest will feature select publications from the previous month from journals related to research administration and research compliance.

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

    Let’s get started:

    Expanding Roles for Research Administration and Research Development Professionals: A Team Science Coaching Program

    • Addressing Interdisciplinary Challenges:
      • Interdisciplinary research teams often face issues like:
        • Misaligned goals,
        • Leadership struggles, and
        • Communication barriers.
      • The program aims to mitigate these challenges by introducing structured team coaching.
    • Training RA and RD Professionals as Coaches:
      • The initiative trained RA and RD staff to serve as team coaches, equipping them with skills to:
        • Support team formation,
        • Collaboration, and
        • The development of research outputs.
    • Utilization of Team Science Tools:
      • Coaches employed tools informed by the Science of Team Science (SciTS) to facilitate effective team dynamics and project progression.
    • Natural Extension of RA and RD Roles:
      • Many found the coaching role to be a seamless addition to their existing responsibilities, although interpretations varied among individuals.
    • Focus on Teamwork and Taskwork:
      • Coaches addressed both interpersonal dynamics (teamwork) and project-related tasks (taskwork), ensuring comprehensive support for research teams.
    • Support for Diverse and Virtual Teams:
      • The coaching model proved particularly beneficial for teams integrating diverse perspectives and collaborating virtually over extended periods.
    • Implications for Research Administration:
      • The program highlights the potential for RA and RD staff to play a more active role in facilitating interdisciplinary research.
      • This suggests shift towards more integrated support structures within research institutions.

    The Representative Studies Rubric: A Tool for Diversity in Clinical Trials

    • The Representative Studies Rubric (RSR) was created to promote diversity in clinical trials.
      • This 12-item questionnaire that assessed whether protocols included or excluded underrepresented groups such as:
        • People of all ages,
        • Women (cis and trans),
        • Gender nonbinary individuals,
        • People who inject drugs, and
        • Pregnant people.
      • It also evaluated the use of inclusive statistical practices, community engagement, and stigmatizing language.
    • Many current HIV trials still exclude underrepresented populationsโ€”often without justification.
      • The retrospective review of 47 NIH-funded HIV/AIDS trials showed frequent unjustified exclusions of:
        • Transgenders,
        • Gender nonbinary people, and
        • People who inject drugs.
    • Pregnant people are frequently excluded, limiting critical safety and efficacy data.
      • This occurred without clear scientific rationale of exclusion.
    • Only half of the studies included specific enrollment goals for diverse populations.
    • As a result, the NIH-funded HIV/AIDS Clinical Trials Networks mandated RSR use for future protocols to proactively promote diversity.

    If your institution can’t access the publication, you can download the article here: The Representative Studies Rubric: A Tool for Diversity in Clinical Trials

    “Dear Editor, may I speak with you?”

    • Many journals prohibit appeals and limit communication after manuscript rejection, preventing authors from understanding editorial decisions.
    • Factors such as an author’s prestige, institutional affiliation, or editorial board membership can unfairly influence publication decisions.
    • Restricting the number of peer-review rounds can prevent authors from fully addressing feedback and improving their work.
    • There is a call for advocacy for greater editor-author communication to foster fairness and mutual understanding in the review process.
    • Authors should investigate journal policies before submission, while editors should embrace transparent, responsive practices in the process.

    If your institution can’t access the publication, you can download the article here: “Dear editor, may I speak with you?”

    Perceptions of network-level ethics in an engineering research center: Analysis of ethical issues & practices reported by scientific & engineering participants

    • There were significant variations in how authorship was assigned e.g., some labs used structured discussions.
      • A major concern from participants was unequal contributions to the research.
    • Many engineers deferred ethical considerations to biomedical partners, viewing ethics as outside their domain.
    • Ethics and regulatory concerns (e.g., FDA requirements) were not deeply integrated into daily research decisions.
      • Some participants feared over-regulation could suppress innovation.
    • While collaboration was a central goal, early-stage efforts were often informal or idea-based.
    • Participants wanted clearer, network-wide policies on data sharing, authorship, and ethics training.
    • Many participants admitted limited understanding of ethics beyond lab-level compliance expressed desire for more training.

    If your institution can’t access the publication, you can download the article here: Perceptions of network-level ethics in an engineering research center: Analysis of ethical issues & practices reported by scientific & engineering participants

    SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials

    • SPIRIT 2025 is an updated guideline for writing protocols of randomized trials.
      • The revised checklist within the guidance integrated contemporary issues like open science, patient involvement, and transparency in reporting.
    • Several other items were revised for clarity and completeness such as:
      • Data sharing,
      • Conflicts of interest,
      • Blinding, and
      • Statistical methods.
    • SPIRIT 2025 incorporates elements from CONSORT Harms 2022, SPIRIT-Outcomes 2022, and the TIDieR checklist.

    If your institution can’t access the publication, you can download the article here: SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials

    Preserving Research Ethics Oversight Amid Decimation of the Research Enterprise

    • The following actions of the Trump administration has threatened the funding and functioning of IRBs:
      • Cutting grants,
      • Capping indirect costs, and
      • Reducing regulatory staff
        • All three of these components are essential for protecting research participants and maintaining public trust.
    • IRBs play a vital, legally mandated role in ensuring ethical conduct in human subjects research.
      • Their effectiveness depends on institutional support and federal guidance.
    • Massive cuts to OHRP and the termination of SACHRP weaken the federal governmentโ€™s ability to enforce ethical standards.

    If your institution can’t access the publication, you can download the article here: Preserving Research Ethics Oversight Amid Decimation of the Research Enterprise

    CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials

    • CONSORT 2025 introduces a 30-item checklist for reporting randomized trials. Some new changes included:
      • Reporting on data sharing,
      • Conflicts of interest, and
      • Patient/public involvement.
    • Items from related CONSORT extensions (e.g., on harms, outcomes, nonpharmacological treatments) and guidelines like TIDieR were incorporated.
    • Revisions to existing items emphasize transparency about protocol access and changes made after trial commencement.
    • The checklist aligns more closely with SPIRIT 2025 providing consistent guidance from protocol design to trial reporting.

    If your institution can’t access the publication, you can download the article here: CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials

    Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use

    • Only 56% of the 903 FDA-approved AI-enabled medical devices reported clinical performance studies at the time of approval, raising concerns about the depth of evaluation.
    • Fewer than one-third of clinical studies included sex-specific or age-specific data, limiting assessments of device performance across diverse patient populations.
    • Lastly, the study emphasized:
      • The need for continuous post-market monitoring,
      • Improved reporting standards, and
      • Stricter regulatory oversight to ensure safety, effectiveness, and generalizability of AI-enabled devices in real-world clinical settings.

    I hope you found this content useful!

  • Research Compliance Chronicle: April 2025 Edition

    Research Compliance Chronicle: April 2025 Edition

    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, and Investigators! 193 blog subscribers and 580 followers on LinkedIn!

    I hope everyone has been doing well! In lieu of the live regulatory reporting I was doing in the past, I have come up with the following newsletter concept:

    Research Compliance Chronicle:

    • At the beginning of each month, I will summarize key regulatory news related to research compliance from the previous month.
      • It can be easy to miss key information in today’s world – especially with the uncertainty in the research realm.
    • Consider this your one-stop shop for “ICYMI regulatory update”!

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

    Time to rewind April 2025:

    Federal agencies

    FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

    • The FDA aims to reduce, refine, or potentially replace animal testing via AI-based computational models.
    • Software models will be used to simulate monoclonal antibodies throughout the human body to predict side effects and drug distribution.
    • Further, the use of lab-grown human โ€œorganoidsโ€ and organ-on-a-chip systems (i.e., mimic human organs) to test drug safety.
    • These techniques should help speed up the drug development process.

    NSF launches new sexual assault crisis helpline for research community

    • This is an anonymous and secure helpline available to:
      • NSF awardees, grantees, scientists, contractors and
      • those affiliated with supporting the mission of NSF,
      • including all those supporting NSFโ€™s mission throughout Antarctica and the Arctic.

    NIH to prioritize human-based research technologies

    • This aligns with the aforementioned FDA initiative to reduce the use of animals in research.
    • NIH intends to establish the Office of Research Innovation, Validation, and Application (ORIVA) within NIHโ€™s Office of the Director.
      • The new office will:
        • Coordinate NIH-wide efforts to develop, validate, and scale the use of non-animal approaches across the agencyโ€™s biomedical research portfolio and
        • Serve as a hub for interagency coordination and regulatory translation for public health protection.

    Presidential actions

    Transparency Regarding Foreign Influence At American Universities

    • The purpose of this policy is to:
      • End the secrecy surrounding foreign funds in American educational institutions,
      • Protect the marketplace of ideas from propaganda sponsored by foreign governments, and
      • Safeguard Americaโ€™s students and research from foreign exploitation.
    • The Secretary of Education shall require complete and timely disclosure by higher education institutions of foreign funding.
      • The Secretary of Education will work with the Attorney General and the heads of other executive departments, agencies, and offices as needed.

    Proposed bills

    H.R.3054 – To require the Director of the Office of Science and Technology Policy to develop a consistent set of policy guidelines for Federal research agencies to address financial instability of graduate researchers and postdoctoral researchers, and for other purposes.

    • Jennifer McClellan reintroduced the Relieving Economic Strain to Enhance American Resilience and Competitiveness in Higher Education and Research (RESEARCHER) Act.
    • The RESEARCHER Act was originally introduced in 2023.
    • A direct quote from the McClellan press release states, โ€œThe RESEARCHER Act would support our young researchers, invest in their scientific and economic contributions, and build the STEM workforce of tomorrow. โ€

    H.R.3043 – To prohibit the use of taxpayer dollars to support animal experimentation in the laboratories of adversarial nations.

    • Lisa McClain and Don Davis introduced the Accountability in Foreign Animal Research (AFAR) Act.
    • According to this press release, this act would prevent U.S. tax dollars from being used to conduct or support research on animals in China, Iran, North Korea, Russia, or other adversarial countries.
    • The bill text can be reviewed here: AFAR Act.

    H.R.2855 – Protecting Medical Research Funding Act

    • I was unable to locate a press release, but the bill was proposed by Timothy Kennedy.
    • The bill proposes to limit the impoundment, transfer, or reprogramming of Federal funds made available for the National Institutes of Health (NIH), and for other purposes.

    H.R.2821 – FDA Modernization Act 3.0

    • According to this press release, Earl โ€œBuddyโ€ Carter proposed a bill to direct the FDA to reduce unnecessary animal testing for drug development.
    • The bill can be reviewed here: FDA Modernization Act 3.0

    I hope you found this post insightful and worth sharing with your colleagues!

  • ICYMI: HHS Rescinds Public Participation in Rule Making

    ICYMI: HHS Rescinds Public Participation in Rule Making

    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, and Investigators! 184 blog subscribers!

    I would like to share my take on potential implications HHS rescinding public participation on rule making. As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

    Let’s get started!

    Revocation of Public Participation on Rule Making

    The following rule entitled “Policy on Adhering to the Text of the Administrative Procedure Act” was posted on March 3, 2025. Per the Federal Register (2025-03300 (90 FR 11029)):

    The Department of Health and Human Services’ Immediate Office of the Secretary is rescinding the policy on Public Participation in Rule Making (Richardson Waiver) and re-aligning the Department’s rule-making procedures with the Administrative Procedure Act (APA).

    If you’d like to read about the Administrative Procedure Act, I strongly urge you to read this post: Federal Guidance Repository: Offset to Trumpโ€™s EOs

    What is the Richardson Waiver?

    Per the Federal Register (36 FR 2532), the Richardson Waiver:

    A policy that waived the APA’s statutory exemption from procedural rulemaking requirements for rules and regulations relating to public property, loans, grants, benefits, or contracts

    This policy required HHS. to use the APA’s notice and comment rulemaking procedures for these types of matters. In plain English, this means that HHS no longer needs a โ€œRequest for Commentโ€ from the public for proposed rules. Essentially, they will be able to follow the APAโ€™s exemption of public comment due to โ€œgood causeโ€ when the agency finds that the procedures are โ€œimpracticable, unnecessary, or contrary to the public interest.โ€ 5 U.S.C. 553(b)(B). Further, the APA exempts from these requirements โ€œmatter(s) relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.โ€ 5 U.S.C. 553(a)(2).

    Potential Implications on HHS Recision

    Letโ€™s think about some of the agencies that fall under the HHS umbrella:

    These are two critical agencies that protect human participants in research (e.g., clinical trials). They release guidance documents on how investigators should conduct research with human participants as well as considerations for specific research areas. Without the public comment requirement, HHS is potentially losing out on insights from industry folks and academia that are directly on the field conducting this critical research. Further, HHS will be forgoing essential feedback from folks who review research with human participants such as research compliance. Lastly, HHS will be losing out on folks who support these research endeavors (such as clinical research coordinators). Though this may feel like a time of uncertainty, all we can do as a community is to be vocal in avenues that we can be. We have to band together for the sake of safe and ethical human research.

    I hope you found this post informative and useful!

  • Top Tips for Medical Writing vs. Scientific Writing

    Top Tips for Medical Writing vs. Scientific Writing

    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.

    Authored/ Reviewed by Tasha Mohseni

    Contribution by Adnan Shaikh

    Good morning, good afternoon, and good evening Compliance Rockstars, Clinical Researchers, Ethics Educators, and Investigators from around the globe!

    I hope you are doing well! I can’t believe we are already in February 2025. It feels like just yesterday I was celebrating New Years Eve with my loved ones.

    In this post, I plan to define medical writing versus scientific writing. Then, Adnan will end the post with helpful tips for both medical and scientific writing.

    I would like to thank Adnan Shaikh for his willingness to contribute to this post!

    Let’s get ready to learn! As a general reminder, these are our own interpretations. Any legal information discussed within this post should be discussed with your institution.

    What is medical writing?

    Medical writing can be defined as the process of creating scientific and clinical documents related to:

    • Healthcare,
    • Medicine, and
    • Life sciences

    This type of writing typically yields the following types of content:

    • Regulatory documentation,
    • Research publications,
    • Educational materials related to healthcare, medicine, and life sciences, and
    • Promotional content for healthcare professionals and patients

    To be a successful medical writer, it is recommended to acquire skills in:

    • Understanding of medical and scientific concepts
    • Strong writing and communication skills
    • Ability to interpret and summarize complex data
    • Knowledge of regulatory guidelines (e.g., FDA)
    • Proficiency in literature searching and referencing

    What is scientific writing?

    Scientific writing is the structured dissemination of research findings, theories, and technical information in a clear and objective manner. This type of writing is commonly used in the following fields:

    • Academia,
    • Medical field, and
    • Technical fields (e.g., engineering)

    When I think about scientific writing, not only do I think about research publications I also think about research documentation.

    What do I mean by “research documentation”?

    Well, I mean your research protocol! To be a strong scientific writer, it is essential to:

    • Explain complex ideas in a concise format
    • Avoid technical jargon (i.e., write in a way that anyone who is not in your field would understand)
    • Use credible references to support your hypothesis
    • Let graphics and tables enhance the “research story” you’re trying to tell

    Is there truly a difference between these writing styles?

    To be honest here, I would say that I am well versed in scientific writing. I had to do some research and learn about what is considered medical writing. Even though I explained the differences here, if you’re scratching your head right now you maybe wondering…

    Tasha, there’s so much overlap. Aren’t these pretty much the same thing?

    I was feeling the same way! Even when I was doing my research on what constitutes medical writing, scientific writing would often appear! Therefore, I decided to go to my old friend, ChatGPT. First, I prompted ChatGPT to create a Venn diagram of medical writing versus scientific writing.

    For those who may not know, a Venn diagram is an illustration of two overlapping circles comparing two topics. In the area where the circles intersect, these are similarities between the two topics. Outside of the circle overlap, are the differences between the two topics.

    Below is the result from ChatGPT:

    Venn diagram comparing medical writing to scientific writing created by ChatGPT

    Though I technically haven’t done medical writing, I can see the significant overlap with scientific writing! It makes sense to me now why when I was researching medical writing, scientific writing often popped up.

    Next, I prompted ChatGPT to put this into a table for comparison:

    Tabular comparison of medical writing versus scientific writing created by ChatGPT

    What I love about this table even more than the Venn diagram is how ChatGPT defined these writing styles based on:

    • Content
    • Sentence structure
    • Audience

    I feel these components are so important! I almost wished I started out knowing this comparison.

    I wouldn’t have driven myself bonkers trying to figure it out for myself!

    Now that we have a better understanding of this, let’s see what top tips Adnan has to offer us!

    Top tips for medical writing

    Hello researchers, I am glad to be here once again. I’m excited to share my top tips for successful medical writing!

    Remember to rely on the following organizations below : 

    These associations provide many informational resources for professionals or novice learners, such as books and webinars. These materials will guide you on your journey to improve your medical writing skills. They will also help in understanding novel approaches in this field. 

    Other essential key skills for medical writing are:

    • Proficiency in the English language,
    • Ability to simplify medical and scientific terminologies,
    • Knowledge of clinical research, regulatory bodies, and ICH GCP Guidelines,
    • Proofreading of the content,
    • Ability to interpret complex research content, and
    • Knowledge of statistics

    I recommend writing in a daily gratitude journal and to connect with other seasoned medical writers. With knowledge sharing and daily practice, you will be on your way to mastering this skill!

    One bonus tip I’d like to offer is to complete an internship or get training by the organizations mentioned above. Whether you’re experienced or new to the field, these top tips will mold you to become a better medical writer.

    Top tips for scientific writing

    Scientific writing is completed by researchers from various backgrounds. Completing an academic project within my PharmD program provided the exposure I needed to grow in this area. You can review my publications here as a sample of scientific writing:

    1. Pemphigus Vulgaris: An Overview
    2. An Observational Prospective Study on Drugs Utilization Pattern in Cardiovascular Diseases at a Tertiary Care Hospital

    Once you’ve reviewed my work, take a look to see how I applied my top tips for scientific writing:

    The Do’sThe “Don’t”s
    1. Find gaps in published literature that could lead to your research question.
    2. Prepare content simultaneously. While conducting your literature search, use this time to also list your references.
    3. Use active and passive appropriately.
    4. Define abbreviations and acronyms when first introducing them in your paper.
    5. Always read the journal authors’ instructions in depth. This is to ensure your work is suitable for the journal of interest.    		1. Avoid filler words such as “like” or “you know”.
    2. Avoid using the same word repetitively; this often happens with transition words.
    3. Avoid directly copying and pasting as this leads to plagiarism. Further, if Artificial Intelligence (AI) tools were used to generate your content, you must credit this tool in your paper.
    4. Avoid errors by ALWAYS proofreading your content before submitting to the journal for review.

    Always remember that practice makes perfect! I’d like to express gratitude to Tasha for providing me this space to showcase my ideas and thought with you.

    We hope you found this post insightful!

  • Trump’s WHO Withdrawal EO | Impact on HSR

    Trump’s WHO Withdrawal EO | Impact on HSR

    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.

    Authored by Tasha Mohseni

    Good morning, good afternoon, and good evening Compliance Rockstars, Clinical Researchers, Ethics Educators, and Investigators from around the globe!

    Without further ado, let’s dive in! Remember, these are NOT my opinions. I am simply reporting what I see and accessing potential impact.

    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution. I am not a lawyer; these are solely my views of how this could be interpreted.

    Trump’s Executive Order (EO)

    On January 20th, 2025, Trump signed the following EO:

    Withdrawing the United States From The World Health Organization

    In summary, the EO states:

    • The US noticed its withdrawal from the World Health Organization (WHO) in 2020 due to:
      • The organizationโ€™s mishandling of the COVID-19 pandemic that arose out of Wuhan, China,
      • Other global health crises,
      • Its failure to adopt urgently needed reforms, and
      • Its inability to demonstrate independence from the inappropriate political influence of WHO member states
    • In addition:
      • The WHO continues to demand unfairly onerous (i.e.., burdensome) payments from the US, far out of proportion with other countriesโ€™ assessed payments
      • China, with a population of 1.4 billion, has 300 percent of the population of the United States, yet contributes nearly 90 percent less to the WHO

    Other significant points directly from the EO include:

    • The Secretary of State and the Director of the Office of Management and Budget (OMB) shall take appropriate measures, with all practicable speed, to:
      • Pause the future transfer of any US Government funds, support, or resources to the WHO,
      • Recall and reassign US Government personnel or contractors working in any capacity with the WHO, and
      • Identify credible and transparent US and international partners to assume necessary activities previously undertaken by the WHO

    Analysis of the EO and the World Health Organization (WHO)

    Naturally, I have some preliminary questions...but let’s first define…

    Who is the WHO?

    The WHO leads global efforts to expand universal health coverage. They direct and coordinate the worldโ€™s response to health emergencies. They also promote healthier lives โ€“ from pregnancy care through old age. You can read more about the WHO here: About WHO

    They’ve also published the following guides for conducting human subjects research (HSR):

    Okay, back to my questions and analysis

    As we have seen with many of these EOs, they are coming in hot. I feel each time I review the presidential actions, there’s a new EO that I’m unaware of. To say the least, Trump has been extremely busy in only a matter of 10 days. As mentioned in prior posts, if I’m given a definition (or a fact), I want an examples. As I’ve said, examples help solidify the concept and the point a person is trying to make.

    I would love to understand more of how Trump feels COVID-19 was mishandled.

    I hate to rely on news outlets due to misinformation and bias. Even if I were to see footage of why he feels this way, I’m unsure it would be reliable. It’s so easy to edit footage nowadays. I know I’m just one person, but I wish I could understand what he meant by this.

    How has the WHO failed to adopt to urgently needed reforms?

    Which reforms are we referring to here? Again, this is ambiguous. A statement like this could be interpreted in so many ways. I know I’m not here to solve this enigma. It simply would have been to nice to see within the EO what he was referring to. Were these reforms related to the protection of human participants? Were these reforms related to established updating ethical guidelines in conducting human subjects research? It’s difficult to not go down a rabbit hole because again, this is undefined.

    My last question relates to burdensome payments. Not necessarily why these payments were burdensome. The statement that stood out to me was:

    “The WHO continues to demand unfairly onerous payments from the US, far out of proportion with other countriesโ€™ assessed payments“

    This is where my accounting skills might come in handy!

    Let’s review the WHO’s 2023 audited financial statement

    Figure 1: Top 10 contributors to the WHO’s revenue

    As we can see in Figure 1, the US only contributed 15% to the WHO’s revenue. The primary contributor being “Others”. Unfortunately, I couldn’t see where “Others” was defined in terms of revenue. I only saw this for expenses.

    I believe Trump was referring to the following graphic with respect to the EO:

    Figure 2: Top donors to the WHO’s budget

    As you can see, the US is the primary donor contributing to the budget, while China comes in 7th place. Another quote from the EO stood out to me in reviewing this graph:

    “China, with a population of 1.4 billion, has 300 percent of the population of the United States, yet contributes nearly 90 percent less to the WHO“

    To confirm that this is factual, we need to understand a couple definitions first from the WHO website:

    • Assessed contributions (AC) are a percentage of a countryโ€™s gross domestic product
      • This percentage is agreed by the United Nations General Assembly
      • Member States approve them every two years at the World Health Assembly. They cover less than 20% of the total budget
    • Voluntary contributions (VC) are largely from:
      • Member States,
      • Other United Nations organizations,
      • Intergovernmental organizations,
      • Philanthropic foundations,
      • The private sector, and
      • Other sources

    Comparing China’s VC to the US’s VC, the US is in fact contributing 90% more than China. Again, I don’t have an opinion here, I’m simply reporting what I assess from the financial statements.

    Notice that this says “Voluntary Contribution – Specified”.

    Again, I tried to look up how this was defined in the financial statements, but I was unsuccessful. I did find the following from this website:

    • Specified voluntary contributions are tightly earmarked to specific programmatic areas and must be spent within a specified timeframe

    According to this WHO report (published in May 2024), these specified voluntary contributions fall into a “voluntary funds” bucket. This bucket is apart of a “general funds” bucket (from my understanding). This “general funds” bucket is comprised of:

    • Core voluntary contributions account
    • Voluntary contributions – core
    • Voluntary contributions – specified
    • Special programs and collaborative agreements
    • Outbreak and crisis response
    • Contingency fund for emergencies
    • Special program of research, development, and research training in human production
    • Special program for research and training in tropical diseases

    In the table below, I have highlighted the US voluntary contributions to the WHO’s general fund:

    Voluntary contributions – specifiedSpecial programs and collaborative agreementsOutbreak and crisis responseSpecial program of research, development, and research training in human production
    $150,789,734$100,330,732$116,485,026$50,000

    The financial flow of how the US’s donations contributed to global health

    The WHO has a nifty dashboard where we can review this information by contributor:

    US contribution to WHO budgetDownload

    As you can see, the US donations span over seven country regions. Though you can look at the contribution distribution yourself, I have summarized a list below:

    • Improved access to quality essential health services irrespective of gender, age, or disability
    • Acute health emergencies rapidly responded to, leveraging relevant national and international capacities
    • Polio eradication and transition plan implemented in partnership with the Global Polio Eradication Initiative
    • Epidemics and pandemics prevention
    • Health emergencies rapidly detected and responded to
    • Countries prepared for health emergencies
    • Strengthened country capacity
    • Improved access to essential medicines, vaccines, diagnostics, and devices for primary health care
    • Proven prevention strategies for priority pandemic-/epidemic-prone diseases implemented at scale
    • Countries operationally ready to assess and manage identified risks and vulnerabilities
    • Safe and equitable societies through addressing health determinants
    • Financial, human, and administrative resources managed in an efficient, effective, results-oriented, and transparent manner
    • Supportive and empowering society through addressing health risk factors
    • Strengthened leadership, governance, and advocacy for health
    • Special Program for Research and Training in Tropical Diseases
    • Special Program of Research, Development and research Training Human Reproduction
    • Healthy environments to promote health and sustainable societies
    • Reduced number of people suffering financial hardship

    How Does This Impact Human Subjects Research (HSR)?

    I believe the list above likely provides a clear description of how all human participants will be affected. In addition to that, I believe the following HSR implications could also occur:

    I hope you found this post thought-provoking!

    What do you think of my analysis? I want to know!