The US Department of Health and Human Services recently announced that it is seeking information for a pilot study that would be designed to test alternative blood donor deferral criteria for men who have sex with men (MSM). All men who have had sex with another man since 1977 have been barred for life from donating blood or plasma in the United States, a policy enacted at the height of the AIDS crisis in 1985.
“The concept is to conduct a pilot operational study, in which MSM who meet specified criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients during the course of the study,” says the March 13th Federal Register notice.
The study would seek to establish whether blood safety could be maintained or enhanced under revised screening criteria that would permit donation by some MSM. The agency's request for information reflects the difficulty of designing a study to evaluate feasibility, design and logistics. HHS said the request is for planning purposes only - it does not intend to award a grant or contract for the feedback or its use.
In June 2010, the HHS Advisory Committee on Blood Safety and Availability voted to recommend the lifetime MSM ban continue unchanged, citing inadequate data to support revision. However, it also recommended additional research to assess a policy that could allow some MSM to become donors.
The deadline for responses is June 11, 4 p.m. EDT.
For more information, visit: https://www.federalregister.gov/articles/2012/03/13/2012-6091/request-for-information-rfi-on-design-of-a-pilot-operational-study-to-assess-alternative-blood-donor.
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