Question

A local pharmaceutical company has received clearance from your community health center to test a new Zika virus vaccine. The Internal Review Board (IRB) for your hospital system has given approval to the study and the study is now being conducted at your health center. Study participants are being recruited by members of the research team who are onsite. At the end of the day, you are escorting one of your patients to the lab. The elderly patient does not understand English very well, nor does the patient have her family member present at this visit. You are aware that the family member always accompanies the patient and interprets for her. You also know that within this patient’s culture, the patient often consults with the family member for guidance and decision making. The patient is asking several questions that you cannot interpret. The lab studies are drawn and a family member arrives. The patient relates to their family member that she was asked several questions about a needle that would help prevent her from getting sick; she said yes, but did not quite understand what the shot was for. She thought it would help her. She then signed a paper and received an injection in her arm.

What is your initial reaction to this scenario?

What ethical standards are being violated?

How often do you think this happens?

What would you do if you were the one escorting the patient?

Answer 1

The informed consent is the most basic need for any clinical trials . In this scenario it appears that subject informed consent was not taken as she could not understand about injection and said yes on pretext of it being useful as told by those conducting trial.

I think ethical standards have been compromised. Ethics does not rely on legality , i.e. she has signed so one should conduct trial rather than it relies on inherent goodness of any act. In this act , those conducting trial knew it the she is not understanding anything but then also they ignored this fact and injected her. Risk associated with it must have been told to her through sign languages or trial should have been conducted only after family members were told.

I think this happens many times where uninformed citizenry are used for private gain of pharmaceuticals. But with technology and awareness penetration , people have become more aware and avoid many such incidents. But still enough cases of such violation of ethical standards occur.

If I were escorting the patient , I would have found somebody who can talk to her or called her family members and asked her to discuss with her. I should have also asked those conducting trial to follow the ethical standards and standard operating procedure enumerated by IRB to conduct trial only if informed consent is given.