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The Code of Federal Regulations (CFR), Title 21, Part 640.3, Suitability of Donor, reads in part that eligibility of a
prospective donor will be determined "on the day of collection by means of a medical history".
The goal of the PRE-REGISTRATION TEST PROGRAM is twofold: First, to gather sufficient data to determine, whether or not
presenting repeat donors with the donor eligibility questions on the Internet prior to the day of donation is as
safe as asking the donors the identical questions on the day of donation. And second, whether or not first-time
donors presented with the questions in a manner identical to that presented to repeat donors will yield blood
products which are as safe as measured by the infectious disease rates in the two groups.
If the results indicate that asking both categories of donors the eligibility questions in advance of the donation date
are as safe as asking the questions on the day of donation, the blood center will ask for a variance from Part
640.3 allowing donors meeting certain criteria to answer the questions prior to the day of donation.
There is no reason to believe that administration of the medical history questions over the Internet using modern
technologies will be any less secure and private than asking the same questions on-site the day of a blood donation.
With proper security precautions in place it is reasonable to propose that asking the eligibility questions online
may be more secure and more private than on-site registration. Nor is there any reason to presume that
administering the questions prior to the date of the blood drive will encourage donors to misrepresent their medical
histories.
During the study period all applicable FDA rules and regulations will be followed. Eligible donors willing to
participate in the study will have access to the medical history questions on the internet up to 120 hours (5 days)
prior to their donation and will also have them administered on the day of donation.
From the time the study begins, all blood donors will be compared to determine safety and eligibility. Only willing
donors may participate in the pre-registration part of the study. Donors with a current deferral for any reason
will be unable to participate. This includes donors with positive test results, previous deferrals for high risk
behavior, etc. Donors who are within an interval between donations may not participate until the interval has been
completed. |
To continue with the Pre-Registration process, please click
here. |
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