I agree with Graham that the primary concern is lack of information. But there was another point that was discussed in class, and that was the notion that they aren’t getting any medication at all. So, why should it matter if they are given placebos and not informed? These sugar pills will have no affects on the subjects, so there is no risk of harm. Therefore, the fact that they are given placebos has no physical implications. I think that this study could go forward if the researchers put a disclaimer in their paperwork that the pregnant women sign. It should say two things:
1) There is a possibility of the subject receiving a placebo.
2) Those who are given the placebo will have no risks associated with taking that placebo.
This information discloses all of the relevant information that directly relates to the subjects.
The other issue that our group had with this proposal was about the “risks” that were told to the subjects. Yes, we agreed that the knowledge of a potential risk during a pregnancy (which is already a stressful experience for the mother) could increase the stress levels of the participants. Even though the women would be giving their consent to participate in the study, there could be complications that arise after the subject has started participating in the study. If the effects of this placebo could have a psychologically beneficial outcome, couldn’t the thought of the risks have a reversed psychological effect on the subject? The mind is a powerful thing, and we can get ourselves to believe something if we really put our minds to it. Since we thought that this was such an important aspect of the study, maybe the researchers could put some psychological testing into the pre-screening to ensure that the women are prepared to deal with the associated “risks”.
There was one other aspect of this study I want to address… Since I am concerned with the lack of information given to the subjects, I am wondering why this wouldn’t apply to the controls as well? They are told that they have a genetic marker that makes them ineligible for the study, when in fact the researchers of this study are using the data collected form those individuals as the control data. It might be a little tricky to tell the women that they are actually controls for a study that has no medication administered, so maybe that is why they are told about the genetic marker (I am not sure how a medical researcher would approach this situation). But it seems that if we want to inform the participants as much as possible, we should be concerned that the control subjects are informed as much as the participating subjects.