Basics - Deferment- Individuals - Tissues Regulated - Infections - Potential Impact - Global Policies - Safety - Recommendations 
*Click on Underlined Sections to Jump to the Topic*
**Topics not in bold are currently being researched and prepared for release**

Start Here (Basics):

Basics & Breakdown Overview

  • In 1994, the FDA implemented a new policy that rejected the tissue donations from queer men if they had been sexually active with another man in the past 5 years. 
  • This policy was expanded to include anonymous sperm donation in 2005, and upheld (with no changes) in 2007
  • The policy impacts tissues- smaller groups of cells than organs (which are regulated by Health & Human Services)
  • ​There is very little research on the topic, but Pride and Plasma is working to piece together what is available to provide evidence for a change in policy. 

FDA & CTGTAC

  • The US FDA is an federal government (executive branch) agency tasked with ensuring safety of drugs, food, cosmetics, and biological products. 
  • ​The FDA is made up of "centers", one of which- the Center for Biologics Evaluation and Research (CBER) creates policies and regulates biological products (vaccines, blood, tissue, & more)
  • One of CBER's advisory committees is the Cellular, Tissue, and Gene Therapies Advisory Committee reviews and creates recommendations for tissue policies. 
  • The CTGTAC meets 2-3x a year and are who we will direct our argument and evidence for a revision for the tissue donation eligibility criteria that turns away queer men. 

Organs Vs Tissues

  • Organs are groups of cells & tissues that perform a larger function, these include your heart, lungs, kidneys, liver, and more
  • Tissues are smaller groups of cells that perform a shared function. Examples include your skin, cornea, sclera, tendons, and more. 
  • Tissue transplants are regulated by the FDA, while organ transplants are regulated by the Department of Health and Human Services (HHS). The FDA has a 5-year deferment for tissue donations from queer men who have been sexually active. 
  • ​When you register to be an organ donor, you also register to be a tissue donor. The process is one and the same. 
  • If you are looking for the Department of Health and Human Services' 30-day policy for organ donations from queer men, learn more HERE. 

The 12 Tissues

The FDA's 2007 guidance: "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" regulates 12 tissues explicitly. These are:
  • Cornea, sclera, skin, heart valves, dura mater, bones, tendons, ligaments, cartilage, sperm, oocytes, and hematopoietic stem cells. 
  • These 12 tissues are the donations rejected from queer men due to the 5-year tissue ban. 
  • Click through these slides to view the tissue location and benefits from transplants. To learn more about each individual tissue, scroll down to "The Tissue Breakdown"​ below. 

The History

  • A 5-year ban on tissue donations from queer men has been around since at least 1994, but it wasn't always mandated by the FDA. 
  • In 1994 the Public Health Service and CDC released guidelines for organ and tissue donation that listed a 5-year deferral for MSM donors. This carried over into the 1997 Guidance for industry by the FDA. 
  • In 2004 a new policy- Eligibility Determination was released. It included anonymous sperm donation as a tissue subject to the ban and was reaffirmed when different policies were combined in a 2007 update. 

CBER 2023 Agenda

  • Every year the FDA's Center for Biologics Evaluation and Research publishes a list of policies they plan to update.
  • CBER houses Cellular, Tissue, and Genetic Therapies Advisory Committee. 
  • This list is not binding, and doesn't indicate what revisions may come. CBER can decide to not update the policies listed, or they can update policies outside of the list. 
  • In both 2022 (without an update published) and 2023, the Tissue Donation eligibility has been included, which means that CBER is at least considering a change in policy- even if it is something outside of the queer tissue ban- like mandating testing all donors for Hep A, B, & C instead of B & C as current. 

A Tale of 2 Donors

  • A Tale of 2 Donors is an activity we do to show how the policy is ineffective and discriminatory. 
  • Take a look at John: He has never been tested for STDs, has unprotected sex, and has had 4 new sexual partners (women) a month for the past 5 years. He is at a higher risk 
  • Take a look at Mark: Mark was tested for STIs after his last sexual contact (with a man), he only had safe sex, and he hasn't had any sexual activity in 4 years and 364 days. He is at very low risk. 
  • However, only John is eligible to donate tissues because of the ban. 
  • The policy is ineffective and discriminatory. 

Title 21- Code of Federal Regulations (CFR)

  • The CFR is a compilation that specifically of regulations for executive agencies in the federal government. Title 21 covers Food and Drugs, Chapter 1 includes the FDA, and part 1271 under subchapter L covers HCT/Ps- (tissues)
  • ​The CFR establishes the FDA's ability to set best practices, eligibility requirements, and other procedures to prevent transmission of infection. 

The Deferral Policy

Donor Screening

  • The FDA's Tissue Donation Eligibility Policy is implemented in two ways, the first of which is the screening questionnaire. 
  • The questionnaire is asked to a deceased donor's family, loved ones, and other close individuals.
  • Deferment criteria include questions about sexual activity, family medical history, and geographical criteria
  • The first question is the MSM deferral- or the "queer tissue ban"- where the question is asked if any male donors have had sex with another man in the past 5 years. 

Donor Assessment

  • The FDA's Tissue Donation Eligibility Policy is implemented in two ways, the second of which is the physical assessment.
  • Donors are assessed to look for physical evidence related to the deferral criteria. 
  • For queer men, the employee performs a rectal exam to look for "evidence of anal intercourse" 
  • This practice is not effective at identifying all donors at increased risk of HIV and Hepatitis B, and it is dehumanizing and disrespectful to the donor

The Individuals

Liam Dee & Canada

  • Liam Dee was a Registered Nurse in Nova Scotia, Canada. When diagnosed with cancer, his dying wish was to continue the life of others through tissue donation. 
  • Liam's tissue bank applied the USA's 5-year deferral policy for tissue donors, making him ineligible, despite living in a completely different country.  
  • Because of the FDA's inaction on ending this outdated, unscientific, and discriminatory policy- not only are American queer men having their tissues rejected, Canadian queer men are as well. 
  • Liam's husband Jacob and mother Cindy have partnered with Christopher Karas to file a complaint with the Canadian Human Rights Commission. You can stay up to date with #justiceforliamdee on socials and reading coverage here:

AJ Betts & The Impact of the Ban

  • AJ Betts was a 16-year old boy from suburban Des Moines, Iowa. He was active in his school's performing arts and always had a smile and a laugh. On July 27th, 2013 he took his own life. He was a registered organ and tissue donor. 
  • Under the FDA's 5-year queer ban, his tissues were rejected, despite wanting them to go to those in need. 
  • AJ's mother Sheryl Moore began to fight the FDA's discriminatory blood, tissue, and organ policies after the loss of her son and learning of the regulations. Her awareness and mobilization was critical in gaining congressional pressure on the FDA to revise and reduce the blood ban. 

TreVaughn Roach-Carter

  • TreVaughn Roach-Carter is a Black YA Author in NYC who in 2019, was denied the chance to donate at a sperm bank because he was gay. 
  • ​Only 2% of all sperm donors in the USA are Black, and diversity in the donor pool is critical that those pursuing donor assisted reproduction. 
  • TreVaughn found it important to donate as a gay man, since he would likely have to utilize donor assisted processes to have children of his own.
  • Sperm donation is one of the 12 tissues explicitly listed in the FDA's tissue donation eligibility policy. However, direct donation (where the donor and recipient know each other) is not subject to the 5-year ban on queer men. 

Tissues Impacted by the Ban

Cornea Donation

  • Corneas are the clear tissue over the front of the eye covering the iris and pupil, and they allow light to enter the eye. 
  • Conditions that require corneal transplant for treatment include Keratoconus, Fuch's dystrophy, thinning/tearing/ swelling of the cornea, or corneal ulcers.
  • Transplants can restore vision, decrease pain, and improve the external appearance of the eye 
  • Cornea donors are tested for HIV, Hep B & C, TSE, and Syphilis. Additionally corneas will not be transplanted if they are scarred (risk of vaccinial keratitis)
  • Corneas have universal matching- any donor can give to any recipient regardless of blood type, eye color, or glasses prescription
  • There are 12 million corneal blind individuals across the world- a severe need for donations. 

Sclera Donation

  • The sclera is the white layer of the eye covering the eye. It supports the shape of the eye and protects from injury. 
  • Sclera transplants are used to treat glaucoma, orbit reconstruction, and eyelid reconstruction.
  • Effects of transplants include restored vision, improved ocular function, restoration of traditional appearance, and more. 
  • Donors are tested for HIV, Hep B & C, TSE, and syphilis when screened. 

Skin Donation

  • The skin is the body's external barrier and contains 3 layers. It regulates temperature. It protects from infection and water loss, and injury. 
  • Skin transplants or "grafts" are often taken from a different body part of the recipient- termed "autologous". These are not impacted by the queer tissue ban
  • Skin grafts are used in burns, injuries, infection, cancer removal, pressure injuries, large/slow-healing wounds, and are used for cosmetic and reconstruction treatments. 
  • Grafts improve healing of large wounds/burns, improve appearance, and reconstruct skin
  • Donors are tested for HIV, Hep B & C, TSE, and syphilis. Either individual donor grafts or an entire donor will not be used if there are signs of smallpox vaccination, Kaposi's sarcoma, west nile virus, jaundice, tattoos or piercings, rashes, or lesions. 

Heart Valve Donation

  • Heart valves are located between the atria and ventricles and regulate the flow of blood between the chambers. 
  • There are 4 sets- tricuspid, bicuspid, pulmonary, and atrial. 
  • Heart valves are transplanted for valvular stenosis (reduced flow), valvular regurgitation (back flow of blood), and infective carditis (bacteria growth on the valve). Transplant ensures that the blood is flowing as it should.
  • Types of heart valve transplants include autografts (self), allografts (a human donor), xenograft (animal valve), and mechanical (carbon and metal).
  • Donors are screened for HIV, Hep B & C, TSE, & syphilis. 
  • There are 200,000 heart valve transplants a year, with a projected growth of 850,000/year by 2050. 

Dura Mater Donation

  • The Dura Mater is the outermost lining of the brain and provides protection to the brain, nerves, and neurons
  • ​Synthetic, allograft (human), or xenograft alternatives (animals- pericardium) can be used for dural replacement and repair. Dura transplants are used for defects, repair after surgery, and damage. They prevent CSF leakage, fistula formation, protrusion, hemorrhage, and more. 
  • One risk of dura transplants is prion disease, commonly Creutzfeldt-Jakob Disease, which leads to central nervous system degeneration. 
  • In addition to testing for HIV, Hep B & C, TSE, and Syphilis, dura have increased deferment criteria: degeneration of the brain, relatives with CJD, or geographical criteria (living in certain parts of Europe from the 1980s-1990s. 
  • 30% of cranial surgeries may need a dura repair, and while not every repair requires an allograft, the option of human tissue for surgeons is vastly important. 

Bone Donation

  • Bones provide structural support and protection for internal organs. Transplanted bones can be from the recipient (autografts), from another human donor (allografts), or synthetic replacements. 
  • ​Bone transplants are used to treat fractures or bone loss. This helps to promote healing and ensure that bone growth is facilitated. 
  • Donors of bone grafts are tested for HIV, Hep B, TSE, and Syphilis, the same as other tissues. 
  • There are 2.2 million orthopedic procedures that utilize bone grafts around the world every year. This number is expected to rise every year. 
  • Although not every procedure that can use bone grafts does, the option of use is critically important for patients and health care providers. 

Tendon Donation

  • Tendons are the tissues that connect your muscles to bones and ensure that your body moves when your muscles contract. They also prevent injury by absorbing impact. 
  • ​Tendon transplants are used to treat tendon injury and may be used in additional procedures (like genitourinary prolapse). 
  • Tendon surgery can utilize autografts (recipient tissue), allografts (human donor tissue), or synthetic products. 
  • Tendon grafts help to stabilize anatomy, restore function, and protect against additional injury. 
  • Like other tissues, tendon donors are tested for HIV, Hepatitis B & C, TSE, and Syphilis. 
  • Not all procedures that can use cadaveric allografts (donors who are deceased), but the option for their usage is critical. 

Ligament Breakdown

  • Ligaments are tissues that connect  bones and keep them together. They ensure stability when movement occurs. 
  • Ligament transplants can either be autografts (recipient tissue), allografts (human donor), or synthetic. 
  • ​Ligament transplants are used in the case of ligament rupture and injury- they repair or replace damaged ligaments. These procedures can result in increased stability, improved acceleration, improved strength, and a potential return to pre-injury level of activity. 
  • Like donors of other tissues, ligament donors are tested for HIV, Hep B & C, TSE, and Syphilis.
  • Not all procedures that can use cadaveric allografts (donors who are deceased), but the option for their usage is critical. 

Cartilage Donation

  • Cartilage helps protect the spots where your bones meet, preventing friction and breakdown, as well as providing structure in areas like your trachea, ears, and nose. 
  • ​Cartilage transplants are used in various locations, frequently when there is damage or defects in joints. Benefits of a cartilage transplant are reduced pain, promotion of function and range of motion, and removal of symptoms. 
  • Like donors of other tissues, cartilage donors are tested for HIV, Hep B & C, TSE, and Syphilis. 
  • ​Millions of patients have cartilage and joint issues, some of which can be treated with a transplant. Use of allografts may enable promotions in symptoms without reduction in mobility at the site of removal. 

Oocyte (Egg) Donation

  • Although not impacted by the 5-year queer tissue ban, female tissue donors are subject to a 12-month deferral if they have had sex with a queer man
  • Oocytes (eggs) are the female reproductive cell that contain DNA and combine with sperm to form an embryo
  • Oocyte donations occur in 2 ways: Anonymous or Direct
  • Anonymous​: The donor and the recipient do not know each other. This can be handled through an intermediary organization, like a egg bank. This is impacted by the 12-month deferral. 
  • Direct: the donor and recipient do know each other. The 12-month deferral is not applied.
  • ​Sperm donors are tested for the same tests as other tissue donors: HIV, Hep B & C, TSE, and Syphilis. Oocyte donors are additionally tested for Chlamydia trachomatis and Neisseria gonorrhea. 

Sperm Donation

  • Sperm is the male reproductive cell that contains DNA and combines with an oocyte (egg) to form an embryo.
  •  Sperm donations occur in 2 ways: Anonymous or Direct
  • Anonymous: The donor and the recipient do not know each other. This can be handled through an intermediary organization, like a sperm bank. Queer men cannot donate sperm unless they have not had sex with another man in the past 5 years. 
  • Direct: direct donations (the donor and recipient know each other and agree to a donation) are not subject to the 5-year ban.
  • ​Sperm donors are tested for the same tests as other tissue donors: HIV, Hep B & C, TSE, and Syphilis. Additionally leukocyte-rich tissue donors are tested for Human T-lymphotropic virus and cytomegalovirus. Sperm donors are additionally tested for Chlamydia trachomatis and Neisseria gonorrhea. 

Hematopoietic Stem Cell Donation

  • Hematopoietic Stem Cells are found in 3 locations: peripheral blood (circulation), bone marrow, and umbilical cord blood. They have the potential to develop into all types of blood cells. 
  • There are two types of transplants: autologous (from the recipient), and allogenic (from a human donor). These transplants are used frequently in the treatment of blood disorders and can elicit remission and prolong life. 
  • HSC donors are tested for HIV, Hepatitis B & C, TSEs, and Syphilis like all other tissue donors. Additionally, as leukocyte-rich tissue, donors are tested for Human T-Lymphotropic virus and cytomegalovirus. 

Additional Tissues Not Listed in the 2007 Policy

  • Although the 2007 Tissue Donation Eligibility Policy explicitly lists 12 different tissues, these aren't the only donations subject to the queer tissue ban
  • We reviewed all FDA tissue guidances since 2007, and the following tissues were also listed at least once- amniotic membrane, fascia, pericardium, vasculature, adipose, lymph nodes, parathyroid glands, peripheral nerves, pancreatic tissue

The Infections

Human Immunodeficiency Virus

  • HIV is one of the two transmittable infections used for rationale of the 5-year MSM deferral for tissue donations. 
  • HIV attacks an individual's immune system and impacts their ability to fight infections
  • It is spread through sex, sharing needles, pregnancy/birth, breastfeeding, and contact through infected blood. It is NOT spread through saliva, sweat, air, or sharing food/drinks. 
  • ​Preventing HIV infection can be achieved through knowing your status, using barrier methods of contraception, and for at-risk individuals, taking medications like PrEP and PEP. (it is important to note that for PrEP prescriptions, U=U only applies to sexual activity, not blood transfusion or tissue donation​)
  • ​All tissue donors must be tested for HIV-1 and HIV-2.

Hepatitis B

  • Hepatitis B is one of the two transmittable infections used for rationale of the 5-year MSM deferral for tissue donations.
  • Hepatitis B is a virus that causes inflammation and damages the liver. Hep B is the most common form of hepatitis. 
  • Hep B can be spread through sexual contact, sharing needles, pregnancy/birth, sharing toothbrushes/razors, and contact with infected blood or sores. It can NOT be spread through kissing, sneezing/coughing/hugs, sweat, air, or sharing foods/drinks. 
  • The acute infection is usually within the 6 months after infection. Chronic infections lead to further symptoms and damage. Not all acute infections lead to chronic infections. 
  • There is a vaccine for Hep B, which is critical, since there is no cure.

Testing of All Donors

  • All donors are tested for HIV (types 1 & 2), Hep B & C, Human Transmissible Spongiform Encephalopathy, and Syphilis
  • ​Hepatitis C is a viral infection that causes inflammation and damage to the liver. It is spread through infected blood, sex, birth, and transfusion/transplantation.
  • TSEs are infections that degenerate the brain and lead to CNS deficiencies. They're assessed by viewing a brain after death.
  •  Syphilis is a common STI which progresses through 4 stages and is fatal if untreated. It is tested for by serum testing.

Testing of Reproductive Tissues

  • Reproductive tissues (sperm and oocytes) are also tested for Chlamydia and gonorrhea. 
  • Chlamydia trachomatis is a common STI that is spread through sexual activity and birth. It is tested for by swabs or urine testing in living individuals
  • Neisseria gonorrhea is a common STI. It is spread through sexual activity and birth. It is tested for by swabs or urine testing in living individuals. ​

Testing of Leukocyte-Rich Tissues

  • Leukocyte-rich cells (sperm and hematopoietic stem cells) are tested for Human T-lymphotropic virus (types 1 & 2) and cytomegalovirus​
  • HTLV (types 1 & 2) are tested via serum testing. It is a group of viruses that cause immunosuppression and inflammation, as well as potential tumor growth. It is spread through sex, breastfeeding, and blood transfusions. 
  • ​Cytomegalovirus (CMV) is a mild illness during reactivation and symptoms include fever, sore throat, swollen glands. It can progress to mononucleosis or hepatitis in severe cases. It is spread through bodily fluids, sex, transplants and transfusion, but does't usually require medical treatment. 

Other Relevant Infections

  • The FDA's tissue donation eligibility includes 3 infections that are relevant to donation, and should be assessed in donors. 
  • West Nile Virus is an infection that is primarily spread through mosquito bites. Not all donors are symptomatic, but blood and spinal fluid can be tested. 
  • Sepsis is an extreme response to an infection that leads to tissue damage, organ failure, and potentially death. Sepsis itself is not contagious but the causative infection may be. 
  • The vaccinia virus is used in smallpox vaccination. Individuals who have been recently vaccinated may be able to spread an infection to other individuals. Donors are assessed based on risk, a scab from vaccination, and potential contact. 

Global Policies

United Kingdom

  • In September 2023, the United Kingdom announced that following a working group on the applicability of blood donation policies for tissue donation, the blanket MSM ban would be replaced with an individual risk assessment
  • We believe this to be the first transition of its kind, and the recommendations released by the working group were directly in line with our own that were submitted to the FDA. 
  • Given the FDA's policy of following in the footsteps of other nations, we hope that an IRA for American tissue donors is coming sooner than later.