Hi b_jim, Limejuice, LaPoisse, GLC, and everyone,
Everybody would like to know more precisely what happens, and have more details, for sure. But we do not have those information, and we will not be given answers to our questions, because the process of a complaint is confidential.
I think complainant surely had signed a document about potential risks. But that does not take away the power to make a complaint ( that would against ethical research), and one of this participant did use this power, and the IRB had to follow the rules, to receive and consider the complaint, and make an inquiry according to their own protocol. Why ten months ? What was the reason for the complaint? Why this... ? When that...?, And so on... We don't know, we have not been told anything more than what we have shared with you. We only have been told at the end the the complaint had been deemed unfounded.
From there, we have to turn toward the new study, and learn from this, and work toward a better screening of participants, meaning: having less "psychological vulnerability", being more willing to accept that a research protocol implies RISKS. I think for now, it is important to make it clear, that the POIS sufferers that will choose to take part in the future study will have to accept the risks that comes with this choice. We all agree that life with POIS is not easy, We don't know why, sometime, our POIS gets more severe, or less severe. We don't know much, so, how this complainant could have thought that it is the study that made him worst? This worsening could have happened anyway, that's something to consider. Only the anxiety link to being part of the study could explain this! We have to be clear, POIS is something quite severe and abnormal, and may have a complex relation with other illnesses, be they psychological comorbidities, or else, so we have to accept this. If you can't, and cannot accept that, even if POIS really manifest in the physical body, that at least a part of POIS may be of psychological origin,well, at least, accept that it can be the case in other POIS sufferers, and the study is for every POIS sufferers, not only for you, and must be aware of this. And this includes the possibility that many members are really hard case of psychological disturbance, apart from having POIS. I, for one, like I have already mentioned often, had psychological issues like severe anxiety and emotional instability before POIS and apart from POIS. I do not beleive that is is "All In our Heads", no, but a part of it, and surely some aggravating factors, can.
So, those who will accept to participate in the future study, in my own opinion, will need to have a clear sense of commitment to the POIS community, a sense that they do not go there just for themselves, they do care that the study goes through, whatever they have to personally accept as effects or apparent worsening of their POIS. They should be aware of their own situation, health-wise, in particular on the psychological level and about resistance to stress. On top of that, any one choosing to enter the study should make it clear that it is an experimental study, and refrain from having ANY expectations about results ! If you enter the study because you find life unbearable with POIS and think this is your last chance to get better, don't enter the study ! Do the POIS community a favor and stay home, and let those who are more stable and have a more realistic perspective enter the study.
I think it is more important to make this clear than to make guesses at the details of how the Rutgers study fiasco happened.
