The main purpose of birth tissue donation is to provide tissue-based products for wound coverings, diabetic ulcers, sports medicine, ophthalmology, spine, or dental procedures. Donated tissue is also utilized in the development of new clinical products or general research studies. Your participation is entirely voluntary.

A mother qualifies to donate if she does not have any diseases that could be passed on to a patient who receives transplant products made from the birth tissues.

To donate, you will be asked to:

• Read, understand, and sign a consent form.
• Complete a medical and social history questionnaire.
• Allow blood to be drawn and tested.
• Permit BTR to review, make copies, and retain portions of your medical record.

The consent, history questionnaire, medical records, and blood specimens are used to ensure the safety of tissue for use. You will complete a questionnaire similar to one used for blood donation. The questionnaire will be completed during a brief, private interview.

In most cases, blood is drawn at the same time as the hospital draw so a second stick can be avoided. Your blood will be tested for several infections that could transmit disease through use of products made from birth tissue. Infectious disease testing is mandated by law whenever human tissue is used for transplantation. If necessary, we will report the results of these tests to your physician within 3-4 weeks. Your physician will discuss with you the meaning of these results.

The review of your medical record is strictly confidential. Information and documents are accessed only by trained, authorized personnel working in a secure environment.

There are no significant risks related to donating your birth tissues.

• The amount of blood drawn from you is small and not enough to affect your health.
• Taking blood from you has a small risk of slight pain and bruising, lightheadedness, possible fainting and, rarely, infection.
• Some of the questions that we will ask you are of a personal nature and may cause you to feel embarrassed.
• The placenta is not needed after delivery.
• If your doctor decides that the placenta should be evaluated after your baby is born, then it will be used for that purpose.

Human amniotic membrane is a versatile, effective wound treatment, and in some cases has effectively treated wounds otherwise unresponsive to usual therapeutic measures.

Birth Tissue Recovery staff will attach a unique identification code to the donated tissue and the records related to your donation.

To protect your privacy, we keep all information that contains your personal identifiers confidential and in a secure location, with access allowed only to authorized personnel.

We will not identify you or your baby in any publications. Our processes are HIPAA compliant.

Birth tissues are normally thrown away after delivery.

There will be no cost to you.

We are prohibited by law from providing or offering monetary compensation or other valuable consideration to donors.

Participation is your choice.

Birth Tissue Recovery LLC is a for-profit entity and is paid for its services. Hospitals are paid for drawing blood, computer use, and printing. There is no cost to you.