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Blood DROPS - Frequently Asked Questions

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Blood DROPS

1.    What is the “Blood DROPS” project?
A: Researchers will conduct focus groups and surveys to gather more in-depth information on opinions and perspectives about the current U.S. blood donation policy for men who have had sex with men (MSM). The focus groups will also provide information on the best methods to recruit MSM for an online survey that will explore motivations of MSM who donate blood despite the existing blood donation deferral policy.

2.    Who is conducting this survey?
A: Four US blood centers are collaborating with researchers at Blood Systems Research Institute and the University of California San Francisco, Center for AIDS Prevention Studies to conduct these studies.  The four participating blood centers are: BloodCenter of Wisconsin (WI); Institute for Transfusion Medicine (Pittsburgh); American Red Cross Blood Services (CT Region); and Blood Centers of the Pacific (CA).

3.    Who is funding this survey?
A: The U.S. Food and Drug Administration (FDA) and the National Heart, Lung, and Blood Institute (NHLBI, part of the National Institutes of Health), are funding this survey. The project is part of the NHLBI Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program. (For more information on REDS-III, visit https://reds-iii.rti.org/).

4.    What is the current policy for blood donation regarding men who have sex with men?
A: FDA’s current policy is to defer men who have had sex with men (MSM) even one time since 1977 from donating blood.  Deferral of all MSM from donation of blood and tissues is based on well-documented observations of a much higher prevalence (current infection) and incidence (newly acquired infection) of transmissible agents, including HIV, among some MSM than in the non-MSM general population.

5.    How did this policy come to be?
A: FDA’s policies on donor deferral for history of male sex with males date back to 1983, when the risk of AIDS/HIV from transfusion was first recognized.  FDA’s deferral policy is based on the documented increased risk of certain transfusion transmissible infections, such as HIV, in men who report male-to-male sex and is not based on any judgment concerning the donor’s sexual orientation.

6.    Are there other groups that may be temporarily or indefinitely deferred when seeking to donate blood?
A: FDA has policies in place to defer other persons from donating blood who have  high risks for exposure to transfusion transmissible infections, whether through behavior (e.g., injecting drug users, commercial sex workers), medical conditions (e.g., history of hepatitis after age 11), or geographical exposures (e.g., people who have traveled to or resided in areas with high levels of malaria or risk for exposure to Mad Cow Disease).

7.    Why is this survey being conducted now?
A: The government is gathering information to determine whether the FDA should revise its existing blood donation policy in regards to men who have had sex with men. The United Kingdom recently updated its own blood donation policy regarding men who have had sex with men in September 2011. If a man has not had sex with another man during the preceding 12 months, then he is now eligible to donate blood in the United Kingdom.

8.    Is other research planned about blood donation policies affecting men who have sex with men?
A: Yes.  The US Department of Health and Humans Services (HHS) Blood, Organ, and Tissue Safety Working Group recommended collection of scientific data in four areas.  In addition to the Blood DROPS survey, two other research studies are currently funded:

    • Epidemiology of Transfusion-Transmissible Infections in US Blood Donors – Funded by the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health

    • Evaluation of the current blood Donor History Questionnaire (DHQ) – Funded by the Centers for Disease Control and Prevention (CDC)

A fourth data collection (an operational pilot program) is under consideration and was the subject of a Request for Information (announced in the Federal Register 3/13/2012, http://www.gpo.gov/fdsys/pkg/FR-2012-03-13/pdf/2012-6091.pdf).

9.    How might the results of this survey affect the current policy?
A: The results of the survey will be considered along with other information gathered from the related scientific studies recommended by the HHS Blood, Organ, and Tissue Safety Working Group about this topic to help determine whether the policy should be updated.

10. Who establishes and updates policies regarding blood donation?
A: The Food and Drug Administration is responsible for determining policies designed to help ensure the safety of the Nation's blood supply. (For more information on the FDA and blood donation policies, visit http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/default.htm)

11. Where can I get information about participating in this survey?
A: Study enrollment has ended and data analysis is underway.

12. Can I make suggestions on what should be included in the survey?  If so, how can I submit that information?
A: The public comment period ended on May 23, 2012 (Link to Federal Register Comment Request Information: http://www.gpo.gov/fdsys/pkg/FR-2012-02-23/html/2012-4211.htm). The study design and survey content have been finalized, so there is no further opportunity to make suggestions on the content of the survey.

13. Will the results of this survey be posted?  When will they be available?
A: The results of this survey will be published in scientific peer-reviewed journals and may be presented at scientific conferences and HHS advisory committee meetings.


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