The Department of Health & Human Services is seeking comments on a plan to design a pilot study to establish “alternative donor deferral criteria” that would enable gay and bisexual men to donate blood.
In a notice published Tuesday in the Federal Register, HHS seeks information on putting together a study on different eligibility criteria for men who have sex with men, who are currently barred by regulation from donating blood or plasma. Responses to the notice are due at 4 p.m. on June 11 and can be submitted online.
“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,” the notice states.
Under current regulation, men who have had sex with other men since 1977 — even once — aren’t eligible to donate blood. The policy was set up administratively in 1985 at the height of the AIDS crisis, but could be overturned at any time without a change in law.
According to the notice, the ban was put in place because of “well-documented observations” of a higher prevalence of sexually transmitted diseases, such as HIV and Hepatitis, among gay and bisexual men. But the notice states the risk of infection from blood transfusion is now extremely low as a result of overlapping safeguards. In the case of HIV, less than one in one million blood transfusions results in infection.
The notice suggests that gay and bisexual men should go through additional screening so they can be allowed to donate. One possible strategy would be pre-donation testing in which they would have a blood sample drawn that would be tested prior to donating blood to ensure a lack of infection.
Another strategy would involve asking gay donors to return after their donation for additional testing after the window period expires for a recent infection to become apparent, but within the expiration period for the unit of blood. A combination of the two scenarios is also a possibility.
However, the notice states that both of these scenarios could be problematic because of the costs for this testing and the perception that putting these requirements in place would be discriminatory for gay and bisexual men.
In the notice, HHS emphasizes that the RFI is for planning purposes only and shouldn’t be construed as a solicitation or an obligation from the department. HHS won’t award a grant or contract to pay for any information that was submitted.
In June 2010, the Advisory Committee on Blood Safety & Availability for HHS voted to recommend that the ban not be changed and cited insufficient scientific data to support revision of the policy. However, the committee also recommended additional research to support a policy allowing low-risk gay and bisexual men to donate blood.
Last year, Sen. John Kerry (D-Mass.) and Rep. Mike Quigley (D-Ill.) were informed in a questionnaire response from HHS that the department is pursuing four areas of study to determine whether whether the gay blood ban can be lifted. It wasn’t immediately clear whether the notice published Monday was a component of this study or a separate initiative.