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Consenting Vulnerable Population

By Cherlynn Basignani posted 09-10-2013 05:18 PM

  
Dear Colleagues,
I have a clinical trial that I need to consent Alzheimer's patients. I would appreciate insight on how other centers consent this vulnerable population. I have a day care center that is allowing me  to screen their AZ population but then I have an issue with consenting them  using the current regulation  process. I can use family  member /LAR but they are not present during normal operations of the day care. They actually drop their family member off at the Day care to go to work so it is difficult for my research team to meet face to face with the LAR /Care taker and the client at the sametime. I can design a letter and send it out the the family and client and explain the trial, the consenting  process and the one day of testing ( which is a smell test ( scratch and sniff)  and picture test which will take 1 hour) and they have completed the trial events. Have our research information on the letter if they have any questions about the trial they can call me but if they do not they can sign the consnet form and return it to the center and then my reserach team will meet with the client have a vebal conversation with the client and get a verbal assent to particpatein the 1 hour testing. The research nurse will document this  process sign the consent  form and then give a copy of the consent form back to the Director to give back to the family/ LAR. The clients are able to follow directions but they normally do not sign forms for themselves. They no longer drive nor cook for themselves. They play games at the day care , listen to music and have a variety of OT  therapy at the Center. They are a perfect choice for our study I just need to figure a way to get them consented  so I am comfortable with the ethics of the consenting process and it is not a burden for the family/LAR and client  to meet the SOP requirements for consenting patients.
I am open to anyone's ideas and suggestions.
Regards,
Cheri
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Comments

Jayalakshmi Ramanna
09-23-2013 03:24 PM

All guidelines insist on VOLUNTARY participation of the subjects AFTER being explained about ALL the trial related aspects.
But, in this case as the subjects are vulnerable, the best idea is to always have LAR's consent also in place. We can think of an alternative for your logistic issue.
You can make use of video clips, pictures to explain about the study to the best possible understanding of the subject, as the guidelines mandate on making the subjects understand about the study to the best level possible. Please see: http://www.egms.de/static/en/journals/gms/2013-11/000171.shtml. This article explains about the different types of communications that could be used in vulnerable cases.
It would be easier if you try to know the next visit date/ track if you already know when the patient would revisit. (I guess that the patient visits on everyday basis here, right?.) Inform the day care representative to schedule an appointment for a subject's representative who plays the role of LAR according to his/her convenient time. This would be an ideal way to consent patient and LAR at once.
Try to obtain patient's signature or name at signature section as much as possible as you say that they are able to follow and don’t sign. If they are not able to sign it with their complete name, it is acceptable in these cases. You can always document saying that the patient has consented , however he /she is not able to sign as expected due to his illness. Anyways, you have LARs signature also in addition ,which would suffice the requirement.
Hope this helps!
Jaya*