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Legal Compensation for Referring Doctors in Clinical 
Trials 
As we all know, the best way for clinical research sites to recruit patients is through 
patient referrals. These referrals usually come either from the PI (principal 
investigator) or more often from other referring physicians.  
 
Physicians who refer patients to your site can work independently or work as your 
sub-investigators. Now, when these physicians are your sub-Is you’ll have to find 
the proper way to compensate them. Many sites experience challenges related to 
sub-I compensation for referrals.  
 
 
The way in which you choose to compensate these sub-investigators for referring 
patients to you should be legal and it shouldn’t interfere with “Anti-Kickback 
Statute” or the IRB.  
 
 
So, how can clinical research sites do this? How do we compensate sub-Is in a legal 
way? We’re here to tell you that there are actually many ways in which this can be 
done. Below, we’ll give you the best solutions to this common problem.  
 
 
 
 
 
How to legally pay sub-Is for referring patients to your site?  
 
1. Sub-investigators are supposed to do more than just referring patients 
Theoretically speaking, sub-investigators are listed on the 1572. This means that 
their job is mainly to back up the PI and to help with the protocol and procedures. 
Sub-Is are supposed to be trained in the protocol as well as some (or better - all) of 
the procedures. This means that they should be doing some of these things as well, 
together with patient referrals. In this way, you will be able to compensate them for 
referral as well.  
 
 
    2.  Consulting fee vs. Bonus 
Sub-investigators can work as independent contractors for your site or be 
employed. If they work as independent contractors, you’ll pay them a consulting fee 
(notice that we do NOT say a referral fee). On the other hand, if they’re employed at 
your site you can pay them their normal salary, plus a bonus fee (which will actually 
be the referral fee). In both cases, the sub-investigator will have to do also other 
site activities so that you’re able to legally pay them for referring patients to your 
site.  
 
 
    3.  Have the sub-I fill out pre-screening forms 
In order to be able to legally pay sub-Is for patient referrals and recruitment, have 
them fill out a pre-screening form for every patient they refer. In this way, the 
process will be documented and authorities can actually see the activities that the 
sub-Is did. These forms contain the patient’s general information, contact info, 
medical history, full physical exam, known allergies, existing conditions, current 
medications, surgical history, etc. By filling out these forms, you’ll be able to legally 
pay them “for pre-screening” the amount that you agreed on as compensation for 
referrals. Everything that the sub-I does regarding recruitment has to be backed-up 
with the proper documentation.  
 
 
    4.  Have the sub-I do procedures on the patients he/she referred 
Another way to compensate sub-investigators, while at the same time giving them 
the motivation to refer more patients, is to have them do procedures on the 
patients that they referred. In this way, you will only pay them for the procedures 
that they do and you won’t even need a referral fee. This method serves as an 
incentive for a sub-I to start referring more and more patients to your site since the 
more he refers - the more money he gets out of it. If your sub-I is well-trained and 
able to do these necessary procedures, then this is one of the best ways to settle 
the issue of referral compensation.  
 
 
    5.  Attorneys will always say ‘no’ to everything 
Even though consulting an attorney for legal help during a clinical trial research is 
of crucial importance, when it comes to this topic attorneys will always say ‘no’. 
According to them, everything will be dangerous and illegal. As a disclaimer, the tips 
we gave you above come from personal experience, not a background in law. 
However, common sense tells you that there are many ways in which you can 
legally pay a sub-I for referring clinical trial participants. The only thing you’ll have to 
do is figure out the best way to do this. We’re not providing any legal advice, so of 
course propose multiple ways to your legal counsel and see which route they 
advise. 
 
    6.  Be careful how you present this issue to the IRB 
The IRB (institutional review board) sees referral fees as something that’s frowned 
upon. This is why we’ve told you that the sub-I should also do other activities, in 
order for the compensation to not be strictly for patient referrals. You are allowed 
to pay your sub-I for pre-screening activities, and recruitment, but only as a part of 
all the other stuff that he or she is doing at your site. Another important thing to 
know is regarding documentation. Everything that your sub-I is doing related to 
recruitment has to be well-documented. An example for this is filling out the 
pre-screening form that we mentioned above. This will justify your actions and 
costs in front of the IRB.  
 
 
To sum up, there are many ways in which you can legally pay referring doctors. One 
of the most important things that every clinical research site should remember is: 
 
A sub-I should do much more than just refer patients! They’re supposed to be 
trained in the protocol and procedures and serve as a back-up to the PI! 
 
This means that if the referring doctor works as a sub-I on your site, he should be 
able to do all the procedures and know everything about the protocol. If he’s not 
doing this and he’s only referring patients, then he isn’t a sub-I but just another 
referring physician in your list. However, if he is a sub-I that performs also other 
activities on-site, then there are many ways in which he can be compensated for 
referrals and recruitment. As a final note, the important thing is that you find real 
work for your sub-Is to do! After you’ve done this, then everything else can be 
settled in an easy and legal way.  
 
 
Make the sub-I do many other activities, amongst which - patient referral and 
recruitment.  
 
 
 
 
Visit ​https://trialjoin.com/research-resources/​ for more articles
Or Call
(415) 873-9709 
 

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