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Are pregnant women vulnerable?

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  • pdiaz Dr P Diaz 31 May 2012

    Hello - this is an interesting point! I think it is very dependant on the individual setting (location, type of trial, local customs etc). I think one of the first things to consider is the meaning of 'vulnerable' in a trial context.

    Vulnerability usually relates to there being a possibility of the individual being potentially coerced into research, and/or not having a full understanding of what is involved in the trial (consent not being fully informed), or through the likelihood of health risks. There's an article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2975789/?tool=pubmed discussing how vulnerable populations can be identified and defined.

    Therefore, in my opinion there are ways in which pregnant women could be coerced into a trial in the same way that a new mother is vulnerable in trials, a good example being if free treatment is being offered in the trial which would not be available to the individual in other cases. Other issues include autonomy (obtaining the husband's consent, for example).

    Of course, pregnant women are further vulnerable because of potential harm that could be caused to the feotus but again this is dependant on the type of research and intervention (more information on that is here: http://www.rtjournalonline.com/10.08.1342.pdf if you're interested!)

    Most of these aspects will vary considerably depending on the location, type of research, usual standards of care for the setting, and so on - so each case would need to be considered individually, and this is something that the IRB/ERC will also address. I am really interested in others' views on this, so please let me know what you think!

    Pedro

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