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.
Jennifer McClellan reintroduced the Relieving Economic Strain to Enhance American Resilience and Competitiveness in Higher Education and Research (RESEARCHER) Act.
A direct quote from the McClellan press release states, โThe RESEARCHER Act would support our young researchers, invest in their scientific and economic contributions, and build the STEM workforce of tomorrow. โ
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.
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.
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!190 blog subscribers!
I hope everyone has been doing well! I know it has been a while since I’ve published a post. I’ve been attempting to follow all the compliance news occurring. It seems as though something new happens every week, if not every day. There is certainly a lot of stress and uncertainty within the research and compliance world.
Which is why I feelthis post couldn’t be shared at a more appropriate time.
I would like to share top career hacks for compliance professionals. Not only can you apply these hacks to your career, but also in your life.
In these times of uncertainty, it is crucial to take a step back and reconnect with yourself.
As much as we talk about emotional intelligence and empathy towards others, self awareness is just as important. We should always take active steps to center ourselves.
As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
Let’s take a moment to reflect on these career and personal wellness hacks:
It’s okay to say “I don’t know”
Have you ever been asked a question during a presentation or meeting you weren’t sure how to answer?
Did the question seem out of left field? Was it about a topic that you didn’t account for? Maybe it was related to something that you deemed irrelevant?
As you imagine this scenario, I want you to try to remember how you felt. Did it make you feel incompetent? Were you caught off guard? How about your physical state? Were your palms sweaty? Did your jaw clench? Did you feel shortness of breath?
As someone with anxiety, I have certainly had these moments. Just sheer panic and fear of what someone would think of me. But you know what I’ve learned? It’s worse to pretend like you know the answer.
The best thing to say is, “I don’t have the answer right now. I can certainly look into this and get back to you.”
or
Another option I like is to say, “This is an excellent question and something I didn’t consider. Let me get back to you once I learn more information.”
By admitting you don’t know something, it shows integrity to your audience. It’s important to be candid. You should try not to focus on feeling incompetent. If anything, this is an opportunity for growth. You get to learn something new!
You can apply this in your personal life as well. You could be having a conversation with someone, and you have no clue what they’re saying. Again, in lieu of being embarrassed, take a leap and learn more about it! I always like to say that I am a “forever student”. I truly enjoy learning on my own, but even more so from others. Especially if they are passionate about the topic.
Build your network
Ever heard of the proverb, “it takes a village”?
Well, that’s because it does! You can read all the policies and procedure pertinent to your compliance area. You can watch all the videos you want from experts discussing a topic in depth. What you have to learn to accept is that you possibly couldn’t learn all of this on your own. And that’s okay. There’s a reason why we have different folks for various compliance areas. Sometimes, IRB professional needs to connect with a COI team for potential conflicts of interest related to an investigator’s research. Perhaps that same IRB professional needs to check in with Export Security for an investigator’s travel plans.
Recognizing that it takes a village is another positive step forward towards career growth. I urge you to build your network. Get to know folks from various fields in research administration/operations at your institution. Have lunch with them and ask them what it is they do. Ask them how does your area of expertise intersect with their daily tasks.
What about folks who were multiple compliance hats at their institution?
These folks should look at building their network outside of their institution. Of course, institutions have their own sets of policies and procedures. The key is to connect with folks who may have encountered the same or similar issue that you have. How did these folks handle the situation at their institution? Can you directly apply the resolution at your institution? If not, can you adapt certain aspects of the resolution?
When you have a group of folks you can ask questions and bounce ideas off of, this is called your network. Applying this concept to your personal life, we call this a support system. To compare, your support system is comprised of individuals that you can count on. These are the people you go to when you’re in a pickle and you don’t know what to do. These are the people you can also bounce ideas off of. This is why human connection is so important both at work and outside of the workplace.
Give yourself mental resets
Have you ever worked on a project where you just stared at your screen for hours? You wanted to make progress but felt stuck.
Perhaps you’re setting up decorations for your child’s birthday party. You have a vision of how the decorations should look, but you’re overwhelmed with frustration. Things aren’t turning out as you pictured in your mind.
If this has ever happened to you, you’re not alone. At moments like these when all seems lost, you need to step back. This is what we call a mental reset. By taking a break from the situation, you are allowing yourself that space to be gentle with yourself. Sometimes closing the laptop or stepping into another room away from the decorations can provide the clarity you need.
You can take mental resets by:
Simply stepping away from what is causing you frustration.
Going for a walk and getting fresh air.
Taking deep breaths to steady your mind.
Practicing meditation or prayer.
Doing something that brings you joy. Maybe a book you’ve been reading.
For anxiety, trying the grounding technique and stimulating your senses.
Washing your face with cold water to refresh yourself.
Whichever method you choose, I guarantee that you will feel much better at tackling your issue. These mental resets will help you figure out how to solve your problem. The beautiful thing is that there aren’t limits to the number of mental resets one can take. Take as many mental resets (i.e., breaks) as needed to center yourself and start again.
Celebrate your triumphs
Did you just receive an award at work for outstanding performance? Maybe you finally organized that storage closet that you never let your house guests see.
Whatever the achievement may be, no matter how big or small, should be celebrated! It doesn’t have to be an elaborate celebration with a lot of people and balloons. It can be something simple as buying that shirt you’ve had in your cart for months. Or maybe you take a day trip to enjoy nature. Celebrating your triumphs can promote your self-worth. As much as you remember the bad times, take the space to embrace the good times. Fill your heart and life with as much joy as you can. Life is too short not to be celebrated.
Group similar tasks together
In today’s world, it is so easy to be overwhelmed.
You can find yourself drowning in reviewing submissions, emails, meetings, and spontaneous tasks that fall in your lap. Days such as these are often unpredictable. It’s essential to take a step back and pause before you react.
At the start of your day, look at your calendar and compare this to any anticipated daily tasks.
Are there any daily tasks that coincide with a particular meeting you have scheduled that day?
If so, group those tasks together and prioritize completion based on when the meeting will start. If you’re unsure which tasks to complete first with respect to the meeting, review the meeting agenda (if available). Then, complete the tasks in the order of the meeting agenda.
If an agenda is unavailable, complete the tasks in a logical order that aligns with your compliance area’s process flow. When you present your task deliverables in this format, meeting attendees will be able to follow along with ease.
What if your free of meetings for the day and you have this daunting to-do list?
Again, review this list and see which tasks are similar to one another. Once you have grouped similar tasks together, consider how these tasks should be completed:
Are any of these task groups dependent on one another?
Can any of these task groups be completed quicker than other task groups?
Do any of these task groups depend on an action from a collaborator?
Can any of these task groups be streamlined via automation (e.g., creating a mail merge file)?
You can also apply this methodology in your personal life.
Again, let’s consider the following:
Are any of these task groups dependent on one another?
Can any of these task groups be completed quicker than other task groups?
Do any of these task groups depend on an action from another household member?
Can any of these task groups be streamlined (e.g., setting up automatic withdrawals on bill payments)?
By pausing to plan and group tasks together, you’ll find that your daunting, busy day won’t seem so grim. If something seems impossible:
Take a mental reset to acknowledge you are unsure how to proceed. Remember, it’s okay if you don’t know the answer.
Reach out to your network (i.e., support system) for guidance.
Work through your tasks at your own pace. I promise you there isn’t a time limit.
Give yourself a pat on the back for taking care of business. You made it! Celebrate it!
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.
