Solved by verified expert:please reply ti theses discussion attached
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1.
While I do understand your position and wanting to help, I would also have to
disagree with proceeding on due to her medical condition. I’d want a family
member or a power of attorney of some sorts to give consent and be there for the
trial tests as well because there is a good possibility that Mrs. Franklin would
forget that she signed up for it. If she became hostile during treatment I think
a family member there would be able to calm her down more so than complete
strangers.
2.
In the case of an 81 year old woman or really any patient who has memory issues
and has consented to a clinical trial and post consent, doesn’t remember
anything about it, I would do several things and ask several questions first. 1)
Is the patient upset with what we are about to perform and are they violent? 2)
if answer to the first question is yes, than is this normal for patient when
having memory issues or what they perceive as change? If this is normal for the
patient then I would go to 3. If this is not normal then we would have to stop
and make sure no underlying medical condition exists that would change study or
merits of study. 3) If there is family or POA or MOA, they need to be contacted
to be safe. Explain what is happening and make sure all parties understand risks
and benefits of moving forward today. 4) If patient is willing, after you have
spoken to family, etc.. you can try to talk with patient about the new drug
again and see if that helps and will take without issue, if not when speaking
with family, could they help? Talk with nursing staff also to see how they
administer medicines if patient is refusing because they unfortunately deal with
this all the time. 5) Ultimately the patient when in a clear state of mind and
lucid, gave consent and I have no moral issues with administering the drug
because the problem we are trying to fix is the cause of the distress. I would
only try to administer in the safest and nicest way possible. I would also make
sure like I said that all family and POA’s for instance were in agreement and
had full understanding as to what was transpiring. I would compare to a violent
diabetic with low blood sugar, just because he is violent and refusing care
doesn’t mean we are not going to treat him and try to fix the problem even
though he might have other issues causing violence or attitude and refusing
care.�
3.
If I were in this position I would get a hold of one of Mrs. Franklin’s family
members, maybe her child, and bring them in to discuss the situation. I would
explain that I was present when Mrs. Franklin signed the consent form, but
because she doesn’t remember I would not feel comfortable starting the trial. I
would go through the whole process of explaining the testing again to both Mrs.
Franklin and her family member. I would not start the trial test until I
received consent from both parties. The reason I would go through with the
longer process is because I feel that if I didn’t Mrs. Franklin would be taken
advantage of. Just because she signed the consent form doesn’t mean she
shouldn’t know what is going to be happening to her. The reason I would bring in
a family member is so someone else has knowledge on what is going on with her. I
would feel better if one of her family members gave consent with her to start
the trial testing.�
4.
If I were in this position I would get a hold of one of Mrs. Franklin’s family
members, maybe her child, and bring them in to discuss the situation. I would
explain that I was present when Mrs. Franklin signed the consent form, but
because she doesn’t remember I would not feel comfortable starting the trial. I
would go through the whole process of explaining the testing again to both Mrs.
Franklin and her family member. I would not start the trial test until I
received consent from both parties. The reason I would go through with the
longer process is because I feel that if I didn’t Mrs. Franklin would be taken
advantage of. Just because she signed the consent form doesn’t mean she
shouldn’t know what is going to be happening to her. The reason I would bring in
a family member is so someone else has knowledge on what is going on with her. I
would feel better if one of her family members gave consent with her to start
the trial testing.�
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