Final Report (all chapters)

iotech companies or university clinics, nor does it reach privately funded laboratories
conducting research on human development proper – i.e., on human embryos.
The statute defines success rate as the ratio between the number of achieved pregnancies and
“...the number of ovarian stimulation procedures attempted.” 2 ART treatments include only those
fertility treatments that involve the handling of both eggs and sperm. As a result, assisted (or
artificial) insemination (also known as intrauterine insemination, or IUI) and treatments that
consist only of ovarian stimulation (without egg retrieval) are not considered ART procedures.
The CDC, in cooperation with SART, now publishes success rates on a yearly basis. These
reports are intended both as a decision-making tool and as an educational resource for
prospective parents. 3
Measuring ART success rates is only one of two FCSRCA components. The other requires
the Department of Health and Human Services (HHS), through the CDC, to develop a model
program for the inspection and certification of embryo laboratories. The program, to be
implemented by the states, is voluntary. The delegation of the program’s implementation to the
states seems to reflect Congress’ desire to respect regional and cultural differences in this very
sensitive policy area. The CDC published the actual program requirements only in 1999, mainly
due to lack of funding. 4 To our knowledge, no state has yet implemented it.
The program is modeled after similar ones in other industrialized countries. Requirements
include developing standards and procedures to ensure consistency in performing ART
treatments, 5 standards for record-keeping of laboratory tests and ART treatments, 6 and standards
for maintaining written records about personnel and facilities. 7 An important element of the
model program is inspections, to be conducted periodically and unannounced by the states or by
accredited professional and trade organizations. The program includes specific criteria for an
organization to qualify as an accreditation organization. The performance of each accreditation
organization is reviewed on an annual basis. Inadequate performance can result in the withdrawal
of accreditation. The implementation of the model program can be in part or fully funded
through the user fees. 8
What role, if any, could FCSRCA play as a key component of a future regulatory system?
The short answer to this question is that it would be a modest one. At most, the FCSRCA could
provide a basic regulatory infrastructure on which additional statutory and regulatory
components could be built. For example, the reporting system designed to measure success rates
2
3
4
5
6
7
8
See 42 USC 263a-1 (b)(2).
All reports are available in electronic form at http://www.cdc.gov/reproductivehealth/ART/index.htm.
Department of Health and Human Services (Centers for Disease Control and Prevention), "Implementation of the
Fertility Clinic Success Rate and Certification Act of 1992 – a Model Program for the Certification of Embryo
Laboratories; Notice," Federal Register 64, no. 139 (1999).
See 42 USC 263a-2 (d)(1) and (d)(2).
See 42 USC 263a-2 (d)(3).
See 42 USC 263a-2 (d)(4).
See 42 USC 263a-6.
118