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natsu's picture

Human subjects and informed consent

It seems like people have already brought up a lot of interesting questions and topics in the forum, and I’d like to comment on the issues concerning informed consent that have been mentioned by several people above.

I’m not sure how many of us are currently doing research with human subjects, but the significance of obtaining consent for participation, is something that I’ve personally had a lot of opportunities to think about during my project working with elderly patients who have Alzheimer’s. Like with any research, we have to obtain consent from all of our subjects- we give them a form and they sign it (if they still have the ability to write their name; otherwise this step is done verbally and we also obtain written consent from their caregiver). However, to be honest I am quite sure that some of our subjects who are in the severe stages of AD do not have any idea that they are in a study even though we have been working with some of them for over three months, and sometimes this makes me feel uncomfortable. Perhaps the thing that I dislike the most about research is that sometimes I feel like I am forcing people to do things. Most of our subjects seem to enjoy working with us and our computer exercises, but it is not at all rare for subjects to express feeling tired, bored or unhappy about what we are doing. Of course, most treatments have some unpleasant component to it; if we didn’t continue to stick to treatment just because it is a mildly unpleasant, we would probably not get to experience the positive effects. So I know that we can’t let people drop out simply because they complained about some part of the treatment being a little bit unpleasant- after all, people complain all the time and one of our most important roles as experimenters is actually to encourage people to continue and push people when they are in a complaining mood. While I understand this, I find this hard to justify sometimes, because I don’t feel as if I have obtained full consent from the subjects themselves in the first place.

While I do think that research on the possible use of psychedelic drugs is very important, I also think that conducting research on these drugs would be challenging because it could be difficult to monitor the side effects and participant consent. When we are testing substances that could potentially be so dangerous, it will probably be important to stop the administration of the drug whenever physicians see even the slight signs of adverse effects. Granted, most of the effects of the drugs aren’t supposed to be too bad (as Professor Grobstein noted in class) there also have been self-reports from people who have suffered severe dangerous effects after taking these drugs. But if we stopped people in this way, will we really be able to see the full positive effects? Also, what if an experimenter noticed signs of some negative effects and wanted to stop the administration of the drug, but the patient wanted to continue because he didn’t want to go back to suffering from the original disorder (like PTSD)? The informed consent must be composed REALLY carefully, because if the person had perceived that volunteering for the study means getting treatment in return, the subject would probably feel very unhappy that he did not get the full treatment that was promised to him. As Liz mentioned in class, in the end it really is about cost vs. gain. There may be some risks, but if the original condition is so debilitating you might want to take a risk, even if that might mean suffering from some negative effects. The assumption seems to be that these drugs will be used for people who are suffering from really severe forms of depression, fear and anxiety, but can we really depend on such individuals to make judgments about what psychological changes the drugs are promoting and make accurate cost vs. gain judgments? I know that the studies are performed under careful monitoring by professional experimenters, but who gets to choose whether the benefits are outweighing the costs during treatment, the subject or the experimenter?

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