The informed consent process in whole blood donation

Informed consent in transfusion medicine has been an area lacking of significant research and it is unknown if donors fully comprehend the risks associated with whole blood donation.

To assess the adequacy of the informed consent process in whole blood donation.

A brief questionnaire was constructed and distributed to whole blood donors visiting various fixed and mobile donor sites of the Central Pennsylvania Blood Bank. Questions consisted of demographic information; donor opinions of information content, length, and comprehension; and a short quiz pertaining to donor risks and eligibility.

Analysis of 849 surveys demonstrated that donors comprehended a mean of 73.5% of the various donor eligibility and risks that were surveyed. Female and younger donors scored statistically higher on comprehension questions compared with male and older counterparts. Donors were most aware of (1) donor eligibility requirements related to acquired immunodeficiency syndrome comprehension, (2) the risk of dizziness postdonation, and (3) having lived in a certain country (93.7%-95.6% comprehension, respectively). Donors were least aware of (1) the risk of a possible referral to a physician for outstanding medical conditions or positive test results, (2) the risk of a positive test result, and (3) West Nile virus testing information (22.4%-49.3% comprehension, respectively).

Whole blood donors believed that they were giving informed consent, but a significant percentage of donors were unaware of several of the risks associated with blood donation, including participation in West Nile virus research testing. Our data suggest that donors do not fully comprehend the risks of whole blood donation and that repetition of information to the donor, and in multiple formats, strengthens the level of comprehension and thus the informed consent process.