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Monday, February 21, 2011

MODEL OF an Informed Consent DOC for Egg Donors Provided by NY State

This is an abbreviated  model form by the  NYS DOH TASK FORCE ON HEALTH REGULATIONS after the Ads and before the actual donation takes place.
Here are some highlights of the items that are covered:
Program’s SART Name and Number
You are agreeing to undergo a cycle of egg donation at [program’s SART name].  Do
not sign this document if you have not received all of the information listed below or
have not met with your physician to discuss the information.  Do not allow the donation
cycle to begin until after you have given your consent by signing this document.

A DESCRIPTION of the PROCEDURES for egg donation.
The  RISKS of taking THE DRUGS ie OVARIAN HYPERSTIMULATION – AND information about the SYMPTOMS AND CONSEQUENCES of ovarian hyperstimulation
Your  CHANCES of developing ovarian hyperstimulation from taking drugs to induce ovulation
AND the NUMBER OF EGGS the program plans to produce by stimulating your ovaries with drugs.  
The process of REMOVING EGGS from your body AND any other problems that might  happen  including any potential  LONG-TERM PROBLEMS that might not occur until later in your life.
The AMOUNT OF TIME involved and the possible RESTRICTIONS on your work and activities How the donation process may affect your family or partner .The support and counseling resources available
How WELL-ESTABLISHED each procedure is in the field, including whether it
is generally accepted within the relevant medical community, how much EXPERIENCE [program’s SART name] has with each procedure, training of the professional staff
Your FINANCIAL OBLIGATIONS, WHAT COSTS ARE  and  ARE NOT COVERED  by  [program’s SARTname] and/or its INSURANCE, any  COSTS that you may be
RESPONSIBLE FOR, Who is responsible for the cost of MEDICAL COMPLICATIONS, including expenses related to any potential LONG-TERM PROBLEMS that might not occur until later in your life Whether you have any potential financial responsibility for certain medical problems that the resulting OFFSPRING might develop later in life Reporting your compensation as TAXABLE INCOME,COMPENSATION ,the amount of compensation, when will be paid, the  [Program’s SART name]’s policy on PARTIAL COMPENSATION or FULL PAYMENT.[Program’s SART name]’s policy on your  RIGHT TO WITHDRAW CONSENT, all the POSSIBLE USES of your eggs, information about the OUTCOMES of your egg donation, such as whether your donation resulted in a pregnancy or live birth. You should not assume that you will have any  PARENTAL RIGHTS AND RESPONSIBILITIES to any resulting offspring, although state laws on these issues remain unsettled.The risks involved with  MULTIPLE EGG DONATION, your CONFIDENTIALITY. Except as required  by law, your physician and  [program’s SART name] will not reveal any information about you or your egg donation without your consent, except that they may use  specific medical details in professional publications as long as personal information about you is not disclosed.  Statistics concerning your egg donation (without your name or personal information) will be included in information that  [program’s SART name] provides to the Society for Assisted Reproductive Technology and the federal Centers for Disease Control and Prevention.  Any other use of information about you or your egg donation would require your specific written consent.
I have read this entire consent form and have had the chance to ask any questions I might have about my egg donation.  My consent to egg donation is purely voluntary.  I understand that my consent applies to only  one cycle of egg donation and that I may withdraw my consent at any time before  eggs are removed from my body.  I have received a copy of this form.
Egg Donor:
     Date:  _______________________
(print name)
PHYSICIAN CERTIFICATION:  I hereby certify that before the cycle of egg donation
began, and before the egg donor signed this document,
(i)  I or the staff at this program have provided the egg donor with information
about the nature, purpose, benefits, risks of, and alternatives to, the proposed
cycle of egg donation; and
(ii)  I have met with the egg donor to discuss the information, have given the egg
donor an opportunity to ask any questions, and have fully answered such
I believe that the egg donor fully understands what I have explained and answered and
has consented to undergo the proposed cycle of egg donation.
Physician Responsible for the
Egg Donor’s Care:
     Date:  _______________________
(print name)

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