Monica has been working at a large medical company that reviews lab procedures on blood samples shipped in weekly. On the first week on the job, her supervisor went over the procedure the company uses that give the institution permission to use blood samples for laboratory testing. One part of the procedure is to collect signed informed consent forms for each sample. Monica knows if a sample does not come with an informed consent sheet, the sample must be returned back to the supplier.
Almost a year after she started, Monica comes across an unsigned consent form fourteen pages long, with incredibly small font. Her initial reaction was to return it to the supplier to obtain the necessary signatures. However, reading through the first few sentences of the form, she wonders if the consent sheet is sufficient to inform a patient about the possible risks involved with consenting to their samples being used even if it were signed. It takes her about an hour to read through the entire form, and at the end of it she is certain no patient would take the same amount of time to read it. Furthermore, the text is complex to read due to all the technical vocabulary, and could put the organization at risk if challenged. She wonders how the draft of the consent form with the company could have been reviewed and approved by the institutional review board.
Monica has serious questions about the ethical basis of using this form, how it was approved and by whom. She wonders whether to bring it up to her boss, in order to see if there’s something she hasn’t understood. Her coworkers shrug it off, saying they have seen numerous consent forms similar to the one she found, and some that were even longer. Should Monica return the form back for a signature from the supplier without comments, or should she speak with her boss about the process used to accept the forms?
Nabilah Deen was a 2014-2015 Hackworth Fellow in Engineering Ethics at the Markkula Center for Applied Ethics at Santa Clara University.
August 2015