Who’s Responsible for What — And Why Patients Get Confused
- maryrburrell
- 7 hours ago
- 2 min read
This is the fifth and final post in our series explaining the new global guidelines (ICH E6(R3)) through real patient experience, not complicated policy terms.
In clinical research, there are a lot of people involved: Doctors, study coordinators, sponsors, and research staff. Each person has a role, and each role has responsibilities. On paper, this is supposed to be clear.
The Reality of the “Shuffled” Patient
For patients, it often isn’t that clear. They’re told, “Call us if you have questions.”
But then they wonder:
Who is "us"?
Who do I call after hours?
Who handles my side effects vs. my test results?
Who do I talk to if something just feels "off"?
When roles aren’t clear, patients don’t know where to turn. That uncertainty adds stress when you’re already dealing with one or more health conditions.
Clear Roles = Stronger Trust
The new ICH E6(R3) guidelines push for clear accountability. This means research teams should not only know who is responsible for what but must communicate that to the patient.
When roles are clear:
Questions get answered faster.
Patients don't feel like they are "bothering" the wrong person.
Trust is built because the "safety net" is visible.
The Burden of the "Self-Coordinator"
When responsibility isn’t clear, patients often end up carrying it themselves. They track everything, follow up again and again, and worry about being seen as a “difficult” patient. Over time, that kind of pressure wears people down and leads them to pull back.
At HeartBridge Collective (HBC), we help patients prepare their questions and understand the different "players" in a study.
We help you ask:
"Who should I contact if X happens?"
"Is this a study question or a medical care question?"
Patients aren’t trying to run the study. They just want to know who’s in charge. That kind of clarity builds trust — and trust keeps people engaged.
❤️🩹 HeartBridge Collective ~Bridging the gap between clinical research and the patient experience.
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