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).
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 โRequest for Commentโ from the public for proposed rules. Essentially, they will be able to follow the APAโs exemption of public comment due to โgood causeโ when the agency finds that the procedures are โimpracticable, unnecessary, or contrary to the public interest.โ 5 U.S.C. 553(b)(B). Further, the APA exempts from these requirements โmatter(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
Letโs think about some of the agencies that fall under the HHS umbrella:
The Food and Drug Administration (FDA) which ensures that food is safe, pure, and wholesome; human and animal drugs, biological products, and medical devices are safe and effective; and electronic products that emit radiation are safe
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!
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 Researchers, Ethics Educators, and Investigators from around the globe!
I hope you are doing well! This has been one crazy year so far. To think we are already in March. I wanted to take the time to have a step back from these current events that have occurred. Though the previous posts have relevance to the research and compliance world…
I wanted to get back to the basics of this blog.
As the name suggests, the purpose of this blog is to promote scientific trust and research ethics education. In light of this, I also find it important to discuss how we should be teaching research ethics.
In today’s post, I want to describe how to make your training documents more accessible. If you have been following from the beginning, you may be thinking to yourself…
What a minute…didn’t Tasha already write a post like this?
Well, you’re right. I did write about a similar topic. However, I wanted to revamp this post to discuss what I have learned over the course of my careers.
You may not know this about me, but I didn’t always work in research and compliance. I’ve also been trained as an auditor and an analyst. This may explain why I am detail oriented.
Financial analysis and project management are tough topics. I remember being humbled my first semester of accounting. I thought to myself, if I can do calculus and differential equations, accounting should be a breeze. Boy, was I wrong! Though I had my tail between my legs, I still managed to rise to the occasion.
Even within these careers, I have always been fascinated with training and outreach. I thrive on understanding how people learn and if folks are engaged with what I’m attempting to teach. I also look for ways to make complex topics easier. I don’t like to over-complicate things. The simpler I can make something for someone, the better I feel I understand it.
They always say teaching something is the best way to become an expert at a topic. Even with this mindset, I prefer to “always be a student of my craft”. It’s natural to constantly be learning and evolving, as we all know life isn’t stagnant.
Therefore, I want to share top tips I’ve learned to make documents more inclusive. You won’t find the old post as it has been deleted (bye-bye, gone). 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 ready to learn!
What is accessibility?
When I look up what accessibility means, there are various definitions depending on the context. I really like how California State University Long Beach defines this term:
Accessibility is about providing a means for users with disabilities to access the same information and services that users without disabilities are able to access.
I like to think of accessibility as making training documents easy to comprehend and review for everyone. Accessibility makes it a level playing field. When it comes to folks with disabilities, the top ones to me are those with visual or hearing disabilities. Someone with color blindness or hard-of-hearing should be able to use the same training materials I create for someone who doesn’t have these disabilities.
Why is accessibility important?
Aside from the humanity aspect, it’s the law! Directly from the website itself, the Americans with Disabilities Act (ADA) protects people with disabilities from discrimination.
It is a Federal civil rights law that protects people with disabilities from discrimination in many areas of life.
Accessibility as a tenet of research ethics
Circling back to a statement I made earlier:
The purpose of this blog is to promote scientific trust and research ethics education.
In light of this, I feel we should understand how accessibility can be viewed as a tenet of research ethics. When I think of human subjects research ethics, I automatically think of the Belmont Report. If you’ve conducted research with human subjects or taken a bioethics course, you may be familiar with this report. The Belmont Report has three principles:
Respect for persons
Beneficence
Justice
With respect to accessibility, I’d like to discuss the Justice principle. Directly from the Belmont Report:
Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved”.
Justice can also be understood as:
Equals ought to be treated equally.
The formulations of Justice include:
To each person an equal share,
To each person according to individual need,
To each person according to individual effort,
To each person according to societal contribution, and
To each person according to merit
I really spent some time trying to find the perfect image to describe the Justice principle with respect to accessibility. I finally came up with the image below:
McMaster University’s representation of “equality”, “accommodation”, and “accessibility” (also known as “equity”).
Simply treating everyone as equals doesn’t fulfill the accessibility requirement. Referring to the picture, we can see the unfair distribution represented by “equality”. The Justice principle indicates that equals should be treated as equals. But what about those who are “unequal” to the “group of equals”? You can certainly provide accommodations, but accessibility is really about equity. Equity can be described as the formulations listed in the Justice principle.
Equity is about treating people fairly in accordance with their needs.
Top tips for training document accessibility
Tip #1: Ensure you have documents available as a PDF and a Microsoft Word document
I love this tip! This isn’t something I necessarily learned from a training session or workshop. Word documents are great because you can edit them and make notes.
I used to do this all the time when I was learning something new (especially in college). It would be helpful for me to make my own annotations directly into a handout.
Conversely, PDFs are great for distribution. If you just want a “clean copy” of a training handout, this is the best way to go. When you’re creating training handouts at your institution, you should strive to have both types of files available.
This is especially important if you embed objects in your files. This is when you link a file into your working file. The user will be able to click on the file and access it. If you only have a PDF version of your working file, the user will not be able to access the embedded object. This is why you should have a Word version and a PDF version.
Tip #2: Use Alt Text for images in your Microsoft Word document
What is Alt Text?
Short for alternative text, is a short description of an image in a training document. Typically, 1-2 sentences is the sweet spot for describing an image.
You may be wondering to yourself…
How is this different than adding a caption to your picture?
Though I’ll define captions below, alt text is specifically for individuals who have visual disabilities. Alt text is meant to quite literally describe the image in the handout.
Let’s review the picture used above from McMaster University. The text underneath is a caption adding a description of the image. An example of alt text of the image would be:
There are three whiteboards at varying lengths and with standing prop stools. At each whiteboard, there are two people standing and one personin a wheelchair.
As you can see, alt text literally describes the image itself. While a caption provides additional context or explanation about the image.
Tip #3: Always use the headers feature to separate topics (and to use the cross-reference feature)
The next three tips are related to formatting your training documents. Now, let me explain why I especially love this tip:
I like to think of this tip as a “two-for-one” combo!
Using headers in your training handouts is a great way to make different topics stand out. This helps folks visually see what you plan to discuss. Be sure to make your headers meaningful (i.e., the header should be concise and accurately describe the context beneath it).
Headers also work well if your training handout has a table of contents. When you use headers, you will be able to use the cross-reference feature. This essentially serves as a hyperlink. When you go to your training handout’s table of contents and click on the link, it will take you directly to that section in the handout!
Say goodbye to doom-scrolling! With the cross-reference, you can get to the desired section in seconds.
Tip #4: Use ordered (numbered) and/or unordered (bulleted) lists in lieu of long-winded paragraphs
Now if you’ve seen my profile picture on the About Us page, you may have noticed that I wear glasses. Interestingly enough, this does NOT fall under the Americans with Disabilities Act.
Even though I technicallydon’t have a visual disability, I do have ADHD!
Therefore, I strongly appreciate this tip! I hate reading through long-winded sentences and paragraphs. Lists just make life easier! Regardless if you have ADHD or not. I’d take lists over long paragraphs any day. With my attention span, lists are much better for me (and in general…for everyone who also suffers from short attention spans).
Tip #5: Use descriptive text when adding hyperlinks to your documents
Now, I’m totally guilty of this…
How many of you when writing an email or updated a website have written something along these lines?
“Click here for more information”.
That’s a HUGE NO NO! You should always use descriptive text when inserting a hyperlink to your training handouts. In lieu of the statement above, you could say:
“Click the following link for Tasha’s Insights“.
This way, the user of the file knows what the hyperlink is actually to!
BONUS TIP: Get feedback on your training document’s accessibility by those with individuals with disabilities
This is the ULTIMATE tip!
I absolutely love getting feedback from folks. Especially if it’s a product I developed for them. You should also do this at your institution, especially from folks with disabilities. This way, if they find the document readable…or should I say accessible, then you know you’re on the right track.
I hope you found this content useful in developing your training materials!
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:
Once you’ve reviewed my work, take a look to see how I applied my top tips for scientific writing:
The Do’s
The “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.
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.
Reviewed by Tasha Mohseni
Authored by Neeba Wilson
Good morning, good afternoon, and good evening Compliance Rockstars, Clinical Researchers, Ethics Educators, and Investigators from around the globe!
In this post, Neeba Wilson will help us understand good laboratory practices (GLP). She has a master’s degree in biotechnology and graduate certification in clinical research. She possesses over a decade of experience in research, pharmaceuticals, and life sciences. Her expertise encompasses:
Good Clinical Practice (GCP),
Good Laboratory Practice (GLP),
Good Manufacturing Practice (GMP), as well as
Robust skills in project management, quality control (QC), and quality assurance (QA)
I would like to thank Neeba for her willingness to share her expertise with us and author this post!
As a general reminder, these are her own interpretations. Any legal information discussed within this post should be discussed with your institution.
What are Good Laboratory Practices (GLP)?
GLP provides a structure for overseeing lab operations and guarantee the reliability and quality of data produced during research. Both regulatory compliance and the establishment of trust in scientific findings depend on these activities.
The essential principles of GLP are outlined by the Organization for Economic Co-operation and Development (OECD).
Key Principles of GLP
Organization and Personnel
A well-structured laboratory is crucial for effective operations. This includes having:
Clearly defined roles and responsibilities for all personnel involved in the research process
The training and qualifications of staff must be documented to ensure that everyone is competent in their respective roles
Regular training sessions can help maintain high standards and keep staff updated on the latest practices and technologies.
Quality Assurance (QA)
Implementing a robust quality assurance system is vital for monitoring compliance with GLP standards. This involves:
Regular audits and inspections to ensure that all laboratory activities adhere to established protocols
A dedicated quality assurance unit is responsible for:
Evaluating the effectiveness of GLP implementation,
Identifying areas for improvement, and
Ensuring that corrective actions are taken promptly
QA programs should include a statement listing:
The types of inspections conducted,
Dates when inspections occurred, and
Confirmation that the final report accurately reflects the raw data collected
Standard Operating Procedures (SOPs)
SOPs are essential for maintaining consistency in laboratory operations. These documents outline the specific procedures to be followed for various tasks, ensuring that all personnel perform their duties uniformly.
Regular reviews and updates of SOPs are essential.
These activities incorporate new findings and technologies, thereby enhancing the overall quality of laboratory work.
Documentation and Record Keeping
Accurate and thorough documentation is a cornerstone of GLP.
All laboratory activities, including experimental designs, results, and deviations from protocols, must be recorded meticulously. This not only facilitates transparency but also allows for reproducibility of results, which is critical in scientific research. The final report should include a description of materials and methods, results, and storage locations for study documentation and samples.
Equipment and Facilities
The laboratory environment must be conducive to high-quality research. This includes:
Maintaining equipment in good working order,
Ensuring that facilities are clean and organized, and
That safety protocols are followed
Regular maintenance and calibration of equipment are essential to prevent errors and ensure reliable results. Test facility management plays a crucial role in this aspect which involves:
Documented approval of study plans by the Study Director,
Maintaining a master schedule, and
Ensuring that test and reference items are appropriately characterized
Test and Control Substances
Proper handling and characterization of test and control substances are crucial for the validity of research findings. This includes ensuring that all substances are properly labeled, stored, and disposed of according to regulatory guidelines. Comprehensive records of all substances used in experiments should be maintained to facilitate traceability.
Key Components of GLP
Test Facility Management
For GLP to be implemented successfully, test facilities must be managed effectively. Important duties include:
Study Plan Approval:
The study director is responsible for:
Recording the approval of study plans,
Making sure that every facet of the research is clear, and
Complies with GLP guidelines
Maintenance of the Master Schedule:
Maintaining a master schedule facilitates the planning and coordination of several research and guarantees the effective use of available resources
Test item characterization:
To preserve the study’s integrity, it is essential to make sure that test and reference items are suitably defined
Computer System Validation:
Protocols must be in place to guarantee that the laboratory’s computer systems are appropriate, verified, and maintained in compliance with GLP guidelines
This involves making certain that staff members are competent and aware of their responsibilities.
Quality Assurance (QA)
QA Unit:
A dedicated QA unit is essential for monitoring compliance with GLP standards
This unit conducts regular audits and inspections of laboratory practices, ensuring that all activities are documented and that deviations from protocols are addressed promptly
Documentation of Inspections:
The QA unit should maintain records of all inspections, including the types of inspections conducted and their outcomes
This documentation is crucial for demonstrating compliance during regulatory reviews.
Content of Final Reports
The final report is a critical document that summarizes the study’s findings.
It must include the following:
Identification of Study:
This section includes:
The title, nature, and purpose of the study,
along with a description of the test and reference items
Information Concerning Sponsor and Test Facility:
Details about the sponsor, test facilities, test sites, and key personnel involved in the study must be documented
Dates:
The report should specify the start and completion dates of the study, providing a timeline for the research conducted
Results and Discussion:
A comprehensive analysis of the results obtained during the study, including any statistical evaluations and interpretations, should be included
This section should also discuss the implications of the findings in the context of existing knowledge
Conclusions:
The final report should conclude with a summary of the study’s findings and their relevance to the field,
along with any recommendations for future research or regulatory considerations
Data Management
Raw Data:
All raw data generated during the study must be retained and organized systematically
This includes laboratory notebooks, electronic data, and any other documentation that supports the findings of the study.
Data Integrity:
Ensuring the integrity of data is paramount
This involves implementing measures to prevent data manipulation and ensuring that all changes to data are documented and justified
Training and Competence
Personnel Training:
Continuous training programs should be established to ensure that all personnel are familiar with GLP principles and the specific procedures relevant to their roles
This includes training on equipment use, safety protocols, and data management practices.
Competence Assessment:
Regular assessments of personnel competence should be conducted to ensure that staff members can perform their duties effectively and in compliance with GLP standards
Equipment and Facility Maintenance
Calibration and Maintenance:
All laboratory equipment must be regularly calibrated and maintained to ensure accurate and reliable results
Records of maintenance and calibration activities should be kept as part of the laboratory’s documentation
Facility Conditions:
The laboratory environment must be controlled to prevent contamination and ensure the safety of personnel
This includes maintaining appropriate temperature, humidity, and cleanliness standard
The Importance of Compliance Monitoring
A crucial component of upholding GLP is compliance monitoring.
It requires a careful evaluation of laboratory procedures to guarantee compliance with GLP guidelines. This may consist of:
Frequent Audits:
Performing planned audits to evaluate adherence to GLP guidelines and identify areas in need of development
Education and Training:
Ensuring that laboratory staff receive regular training, so they are knowledgeable about GLP regulations and best practices
Feedback Mechanisms:
Creating opportunities for employees to voice concerns or recommend enhancements to promote a continuous improvement in culture.
Closing Thoughts
The integrity and dependability of non-clinical research depend on GLP.
Labs can improve the caliber of their work, meet regulatory standards, and foster confidence by following the OECD’s guidelines.
A good GLP framework must have strong quality assurance systems, efficient test facility management, and rigorous documentation procedures. Consult the official materials of the OECD for more information on GLP (provided below), including compliance monitoring and comprehensive guidelines. By adhering to these guidelines, labs likely can guarantee top-notch research and promote scientific progress.
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:
The US noticed its withdrawal from the World Health Organization (WHO) in 2020 due to:
The organizationโs 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 worldโs 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):
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!
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 countryโs 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 – specified
Special programs and collaborative agreements
Outbreak and crisis response
Special 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:
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:
Reduction in collaboration with global researchers (impacting current projects and future work)
