|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |   |
|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
|        |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |        |
|   | *This staff working paper was discussed at the Council's             September 2003 meeting. It was prepared by staff solely to aid             discussion, and does not represent the official views of the Council             or of the United States Government.***U.S. Public Policy and the Biotechnologies               That Touch the Beginnings of Human Life:               Draft Recommendations**
 Over the past twenty months, the Council has devoted much time               and energy to examining the current governance of the uses of biotechnologies               that touch the beginnings of human life, practices arising at the               intersection of assisted reproduction, genetic screening, and human               embryo research. The Council has heard from various experts and               stakeholders, engaged its own comprehensive diagnosis of current               regulatory mechanisms and institutions, outlined the key findings               emerging from that diagnosis, and surveyed various general and specific               policy options. The Council now understands a great deal about the               current regulatory landscape and has identified concerns that suggest               the need for improved monitoring, oversight, and, perhaps, new forms               of governmental regulation. Yet we are very far from being able               to offer clear and well considered recommendations regarding major               institutional reforms. We do not know the precise costs and benefits               of overhauling existing regulatory institutions and practices or               of creating new regulatory authorities. We do not even know enough               about the incidence and severity of some of the possible risks and               harms we have identified as causes of concern to judge whether they               are serious enough to justify changing the present arrangements.               We do not accurately know, for example, how the technologies and               practices at the heart of our inquiry affect the health of those               whose lives are touched by them  —  most notably, the children               conceived with their aid. Similarly, we do not know how widely preimplantation               genetic diagnosis or preconception (and preimplantation) sex selection               will be practiced, and for which purposes. Without the answers to               such questions, it would be premature at best to recommend dramatic               legal or institutional changes. Further research and inquiry, and               additional consultations with all the relevant actors, are clearly               needed. 

Yet even as such inquiry and consultation proceeds, the Council               believes that some improvements can and should now be implemented               to address some of the concerns identified as a result of our present               inquiry. There are a number of measures, described in Sections I               and II below, that the Council believes the federal government and               the various relevant professional societies should adopt immediately.               Most of these suggestions are aimed precisely at the remaining empirical               questions described above. These include a call for comprehensive               information gathering, data collection, monitoring, and reporting               of the uses and effects of these technologies. They also address               the need for improving informed decision-making, consumer protection,               and enforcement of existing guidelines for practitioners of assisted               reproductive technologies (ART). In addition, in Section III, we               identify for Council discussion several aspects of the dignity of               human procreation that may warrant interim prudent legislative action,               especially in light of rapidly arriving innovations that signal               new departures in human reproduction. Familiar disquiet regarding               human cloning or commerce in human embryos and gametes is augmented               by recent reports of fusion of male and female embryos into one               chimerical organism, and of the derivation of gametes from embryonic               stem cells (in principle enabling embryos to become biological parents).               Accordingly, while policymakers monitor and gather information and               while deliberation continues in search of better and more permanent               monitoring and oversight arrangements, it may be necessary and desirable               to enact interim prophylactic limitations. Such limitations would               prevent individuals, acting on their own, from introducing major               innovations into human procreation in the absence of full public               discussion and deliberation about their ethical and social implications               and consequences. 

The recommendations we offer here are consensus recommendations               of the Council. Though we differ about certain fundamental ethical               questions in this field, and especially about the moral status of               the human embryo, we have nevertheless been able to agree on several               policy suggestions that we believe should command not only the respect               but also the assent of most people of common sense, good will, and               a public-spirited concern for human freedom and dignity. We have               sought to frame these recommendations with sufficient specificity               that they might be adopted by the relevant target audiences. 

**I. Federal Studies, Data Collection, Reporting, and Monitoring                             regarding the Uses and Effects of These Technologies**

***A. Undertake a federally funded longitudinal study               on the health and development impacts of ARTs on children born with               their aid.*** A most important unanswered question before               the Council concerns the precise effects of ART and adjunct technologies               on the health and normal development of children born with their               aid. There have been a few studies, mostly undertaken abroad, reaching               variable and sometimes contrary results. An effort has been undertaken,               by the Genetics and Public Policy Center in collaboration with the               American Academy of Pediatrics and the American Society for Reproductive               Medicine, to review all of the existing literature on this question.               This is a laudable start, capable of identifying harmful health               and development outcomes that should be monitored in the future.               The Council strongly believes that what is needed now is a prospective               longitudinal study that is national, comprehensive, and federally               funded, and which looks at both the short-term and long-term effects               of these technologies and practices on the health of children produced               with their assistance, including any cognitive, developmental, or               physical impairments. An ideal vehicle for this study is the National               Children's Study now being planned by a consortium of federal agencies               led by the National Institute of Child Health and Human Development               (NICHD), which, beginning in 2005, will track the health and development               of 100,000 children across the United States from before birth until               age 21.

***B. Undertake federally funded studies on the impacts               of ARTs on women.***Another area where better information               would be helpful regards the health and well-being of women who               use ARTs. One or more studies, either in conjunction with or separate               from the above-mentioned longitudinal study should be conducted               to discover the effects, if any, of the use of ARTs on women’s               health, including any short-term or long-term hormonal, emotional,               or physical impairments.

***C. Undertake federally funded comprehensive studies               on the uses and effects of reproductive genetic technologies.***               As noted above, assisted reproduction and genomic knowledge are               increasingly converging. Practices such as preimplantation genetic               diagnosis and gamete sorting represent the first fusion of these               disciplines. Before these practices become routine, it is necessary               for policymakers and the public to understand their present and               projected uses and effects. To this end, there should be a federally               funded comprehensive study, undertaken with the full participation               of the ART industry, on how and to what extent such practices are               currently and may soon be employed, and their health effects on               children born with their aid. Mechanisms need to be developed for               ongoing monitoring of the outcomes of these practices and others               to which they may lead.

***D. Strengthen and augment the Fertility Clinic Success               Rate and Certification Act.*** As currently written,               the FCSRCA is aimed at providing consumers with key information               about the pregnancy and live-birth success rates of assisted reproduction               clinics in the United States. We believe that the Act should be               augmented and strengthened, both to improve this original function               of consumer protection and to enable the federal government (through               the already existing Centers for Disease Control ART surveillance               program) to gather information and to monitor the development, uses,               and effects of all technologies and practices that touch the beginnings               of human life. Toward these ends, the Act should be improved and               strengthened in the following ways.

*1. Enhance Reporting Requirements.*

*(a) Efficacy: Provide more user-friendly reporting of data,                 including adding “patients” as an additional unit                 of measure.* Currently, data are reported only in terms of                 “cycles” of treatment (beginning when a woman starts                 ovarian stimulation or monitoring), rather than in terms of individual                 patients treated. Thus, it is impossible to know how many individuals                 undergo assisted reproduction procedures in a given year, how                 many patients achieve success in the first (or second or third)                 cycle, how many women fail to conceive, and the like. Presenting                 results in terms of numbers of individuals would be more meaningful                 to prospective patients and would yield more precise information                 for policymakers.*(b) Risks and Side Effects: Require reporting of all adverse                 health effects.*There is today no mechanism for reporting                 adverse health effects of assisted reproductive technologies,                 either for the adult patients or for the children produced. Such                 adverse effects are of paramount concern for prospective patients,                 policymakers, and the public at large. ART clinics should be asked                 to provide data on the incidence of adverse effects on women undergoing                 treatment, as well as on the health and development of children                 born using ART, at least through the first year of life. *(c) Costs: Require the reporting of the average costs of the                 procedures and successful pregnancy.*There is currently no                 comprehensive source of information regarding these costs. Not                 surprisingly, prospective patients are keenly interested in this                 information. Moreover, policymakers interested in questions regarding                 equality of access and related matters would greatly benefit from                 such information. It would shed light on the incentives currently                 at work that may induce patients and clinicians to engage in risky                 behavior, such as the transfer of multiple embryos in each cycle,                 in an effort to reduce costs.

*(d) Untransferred Embryos: Require reporting of creation,                 use, and disposition of embryos.*There is at present no means                 of reporting or monitoring the creation, use, and disposition                 of embryos produced in the context of assisted reproduction. By                 requiring such reporting, the federal government would signal                 a measure of respect for nascent human life and would allow prospective                 patients, policy makers, and the public to better understand the                 actual practice of assisted reproduction. Specifically, it would                 yield information regarding the number of embryos typically required                 to achieve a successful pregnancy, the ultimate disposition of                 untransferred embryos, and present and projected numbers of embryos                 in cryopreservation, as well as the rules and practices regarding                 the fate of the stored embryos. 

*(e) Innovative Techniques: Include information on novel and                 experimental procedures.*A key area of concern for the Council                 is the ease and speed with which experimental technologies and                 procedures (such as intracytoplasmic sperm injection [ICSI] or                 preimplantation genetic diagnosis [PGD]) move into clinical practice,                 even in the absence of careful clinical trials regarding the efficacy                 and long-term consequences. It would be useful for consumers and                 policymakers to understand more fully how each clinic manages                 this process and what safeguards are in place. Such information                 would include human subjects protections, the extent to which                 technologies are tested in animals, the standards that must be                 satisfied before a given procedure is deemed fit for clinical                 use, and the measures taken to evaluate safety and efficacy.

(*f) Adjunct Technologies: Require more specific reporting                 on the frequency of, and reasons for, uses of specialized techniques                 (such as ICSI), genetic diagnosis, sperm sorting for sex-selection,                 etc.*Little is understood about the frequency and uses of                 the various adjunct technologies and practices complementing standard                 IVF. While the current version of the Act provides some raw data                 on the number of cycles in which certain techniques are used,                 this information is inadequate for policymakers and the public                 to understand fully the contours of present practice. For example,                 the present system of reporting sheds no light on why patients                 chose ICSI as their preferred method of fertilization. The CDC                 reported that in 2000, ICSI was used in 46 percent of all IVF                 cycles, yet in nearly 40 percent of these instances the prospective                 patients did not suffer from male factor infertility. Also, because                 results are reported in terms of cycles rather than patients (as                 discussed above), it is impossible to know how many individuals                 used ICSI in 2000. Other techniques, particularly those fusing                 reproductive technology and genomic knowledge, are not reported                 at all under the present version of the Act. For example, there                 is no requirement to report the number of cycles using PGD, much                 less the reasons for using PGD. For example, how many patients                 using PGD are infertile? How many have family histories of genetic                 disorders? What sort of screening is being done? For aneuploidy                 and single-gene mutations? For donor siblings? For non-medical                 traits? There is also no reporting of any practices in which sex                 selection occurs, and the reasons for undertaking them. Consumer                 protection and public policy would be enhanced if this information                 were included. Consumers would benefit from knowing how much experience                 a given clinic has in performing such procedures. Policymakers                 and the public would benefit from knowing how, why, and to what                 extent genomic knowledge is being used to enhance control over                 procreation. 

*2. Enhance Patient Protections.*

*(a) Improved Measures of Reporting: De-emphasize per cycle                 “success rates” as chief benchmark.*By narrowly                 focusing on pregnancy and birth rates per cycle, the Act may unintentionally                 be creating incentives for clinicians and patients to adopt practices                 that carry extra risks to health and safety. For example, it might                 encourage the transfer of an increased number of embryos, leading                 to more multiple gestations that threaten both mother and children,                 or it might encourage additional use of ICSI to increase the success                 rate, even in the absence of male-factor infertility. Also, the                 present emphasis on a clinic’s success rate might induce                 clinicians to reject patients whose chance of pregnancy is low.                 1 Finally, success rates are                 highly manipulable. For example, clinicians can reclassify unsuccessful                 cycles in an effort to improve their overall statistics. For example,                 such clinics might classify their most difficult cases as “research”                 rather than as cycles of treatment that must be reported to the                 CDC.*(b) Informed decision-making: Provide model decision-making                 form.*The present Act would be greatly improved by providing                 for the promulgation of an easy-to-read model consent form that                 includes information on the possible health risks to mother and                 child, the novelty of the various procedures used, the number                 of procedures performed to date, the outcomes, and the various                 safeguards in place to ensure that such procedures are safe and                 effective.                3. Improve Implementation.                (a) Enforcement: Provide stronger penalties to enhance compliance.                 Under the Act as currently written the only penalty for noncompliance                 is publication of the names of non-reporting clinics. This is                 insufficient, given the importance of clinic compliance to ART                 customers and the greater public. The penalties should reflect                 the magnitude of harms to be avoided. We leave to legislators                 the question of what precisely these should be.

(b) ?Funding: Increase funding for CDC’s ART surveillance                 project. CDC’s budget should be augmented sufficiently to                 enable it to undertake the additional measures suggested above.                 We leave to legislators the question of how much additional funding                 would be required.

**II. Increased Oversight by Professional Societies and Industry**

 Professional oversight has traditionally been the principal mechanism               of regulation for the practice of medicine. While there is a well               developed body of professional guidelines and standards for the               clinical practice of assisted reproduction, the Council has identified               the following substantive areas that require attention and improvement:

***A. Improve informed decision-making.***               Clinicians and their professional societies should make efforts               to improve the current system of informed decision-making to conform               to the concerns and suggestions described above. ASRM and SART (Society               for Assisted Reproductive Technology) should pay attention not only               to helping devise an improved and standardized consent form, but               also to recommending procedures to their members for discussing               it properly with patients and securing their meaningful consent.               For this purpose, they should consider making training sessions               on this subject a requirement of membership. 

***B. Treat children-to-be as patients.***               ART clinicians should take measures to ensure the health and safety               of all participants in the ART process, including the children who               are born as a result. To this end, ART clinicians should collaborate               with pediatricians in making decisions that might affect the health               and safety of these children. Moreover, they should not view their               responsibility as ending once a pregnancy has been initiated. Clinicians               and professional societies should also cooperate fully and vigorously               with any efforts (such as the studies described in part I above)               to study the effects of ART and related practices on the health               and development of such children. As a substantive matter, clinicians               and professional societies should take concrete steps to reduce               the incidence of multiple embryo transfers and resulting multiple               births. ***C. Improve enforcement of existing guidelines.***There               are today a host of meaningful guidelines in place for clinicians               and practitioners engaged in ART. However, the relevant professional               societies need to take stronger steps to ensure that these guidelines               are followed. For example, one such society “actively discourages”               the use of PGD for sex selection for non-medical purpose, yet several               prominent members of the society openly advertise the practice.               Professional societies must clarify the contours of appropriate               conduct and adopt reasonable mechanisms of enforcement. 

***D. Improve procedures for movement of experimental               procedures into practice.*** Professional societies and               clinicians should develop a more systematic mechanism for reviewing               experimental procedures before they become part of standard clinical               practice. Such a system might include requirements for animal studies,               IRB oversight, and formal discussion of the significance and results               of novel procedures.

***E. Create and enforce minimum, uniform standards for               human subjects protection.*** At present there is no               systematic, mandatory mechanism for protecting human subjects who               are engaged in experimental ART protocols not affiliated with institutions               receiving federal funds. This problem is compounded by the fact               that there is not a clear distinction between research and innovative               clinical practice in the context of ART. Investigational interventions               that could affect the health and well-being of a future child should               be subjected to at least as much ethical scrutiny and regulatory               oversight as investigational interventions affecting humans after               birth. A higher degree of scrutiny and oversight is justified in               this context, because those affected by the interventions cannot               protect their interests and prospective parents may have interests               that conflict with those of the future child. Clinicians and their               professional societies should adopt measures (such as IRB-like oversight)               to provide safeguards to protect the health and well-being of human               subjects.

***F. Develop self-imposed ethical boundaries.***Clinicians               and professional societies would be well advised to establish for               themselves clear boundaries defining what is and what is not ethically               appropriate conduct, in the context of both research and clinical               practice. Recent events have shown that without such guidance rogue               clinicians and scientists may engage in practices that will, fairly               or unfairly, bring opprobrium on the discipline as a whole. Practices               such as the fusion of male and female embryos, use of gametes harvested               from fetuses (or produced from stem cells) to create embryos, and               transfer of embryos to non-human uteri for purposes of research               fall squarely into this category. The relevant professional societies               should preemptively take a firm stand against such practices and               back it up with meaningful enforcement.

**III. Possible Targeted Measures to Defend the Dignity of               Human Procreation**

Several particular practices and techniques (some present, some               likely forthcoming) that touch the beginnings of human life raise               new and distinctive challenges to the special character and dignity               of human procreation. For that reason they require special attention,               not only from professional societies but also from the people’s               representatives. Especially because technological innovations are               coming quickly and because there are today no other institutions               capable of setting appropriate limits, we believe the Congress should               consider some targeted measures that might give expression to and               provide protection for the dignity of human procreation, by limiting               the practice of a number of carefully defined activities. These               measures would remain operative at least until policy makers and               the public can discuss the possible impact and human significance               of these new possibilities and deliberate about how they should               be governed or regulated.

A concern for the integrity and dignity of human procreation might               give rise to a fairly wide range of specific provisions, and the               Congress should consider these in their full array. But the concerns               we have taken up in this report, and which emerge from our findings,               suggest to us a few that are especially crucial, and also especially               likely to command fairly broad assent. They may be usefully grouped               around the following four principles and desiderata:

1. Respect for the *humanity* of human procreation, preserving                 a clear boundary between the human and the non-human (or, between                 the human and the animal).                2. Respect for *women* and *human pregnancy*, protecting                 them against certain exploitative and degrading practices.                3. Respect for*children* born with assisted reproductive                 technologies, securing for them the same rights and human attachments                 naturally available to children conceived in vivo.                4. Respect for *early stages of nascent human life,* setting                 some agreed upon boundaries on why embryos may be made and how                 they may be used and treated.

The following suggestions indicate the kinds of specific measures               that could give concrete expression to these goals and that might               serve as safe interim boundaries, as public deliberation tries to               catch up with rapidly changing technologies. 

For instance, in an effort to guard the*humanity* of human               procreation, Congress might consider a ban (or moratorium) on the               production of human-animal chimeras, produced either by combining               a human gamete with a gamete from any non-human species or by combining               blastomeres from human and non-human embryos to produce a hybrid               human-animal embryo. Legislators might also proscribe the transfer,               for any purpose, of any human embryo into the body of any member               of a non-human species. 

To guard the dignity of women and of human pregnancy, legislators               might institute measures to carefully limit the purposes for which               a pregnancy may be initiated artificially. Congress might, for instance,               prohibit the initiation of a human pregnancy (using embryos produced               ex vivo) for purposes of research, for purposes of securing fetal               tissues or organs for transplant, or for any purpose other than               to attempt to produce a live-born child. It might also consider               restrictions on so-called “surrogate pregnancy,” at               least for pay. 

To guarantee that all children conceived through assisted reproduction               techniques receive a full and equal share in our common human origins,               legislators might act to make certain that no child conceived by               means of artificial reproductive technologies be denied two (adult,               not fetal or embryonic) human biological parents. This, for instance,               might lead to a prohibition on attempts to conceive a child using               gametes from more than two or less than two human parents, or by               any means other than the union of egg and sperm obtained directly               from such parents. It might also lead to specific prohibitions on               creating a human embryo from the fusion of blastomeres from two               or more other embryos, or by fertilization using gametes obtained               from a human fetus or derived from human embryonic stem cells.

In addition, some measures may be taken to show a decent respect               for the early stages of nascent human life, and therefore set some               general boundaries on how human embryos may be used and treated.               This subject can of course arouse great controversy, but we believe               some measures may be agreeable to all parties to the significant               ongoing dispute over the moral status of the embryo, whether as               modest steps toward the protection of nascent life, or as demonstrations               of a limited but nonetheless genuine respect for the human embryo.               These may include a prohibition on the use in research, or the preservation               for the purpose of conducting research, of any human embryo past               the tenth day of development (not counting any time during which               it is stored in a frozen state); and a prohibition on the buying               and selling of any human organism, at any stage of development.               They may also include a moratorium on creating human embryos solely               for the purpose of research.

Moreover, these concerns, combined with a certain ambiguity in               the patent laws, also suggest the need for a provision instructing               the United States Patent and Trademark Office not to issue patents               on claims directed to or encompassing a human organism at any stage               of development; and amending Title 35, United States Code, section               271(g) (which extends patent protections to products resulting from               a patented process) to exclude any product which is a human organism               at any stage of development. Such a law should, however, be quite               careful to clarify that human genes, human stem cell lines, and               processes that result in human organisms will still be eligible               for patents. 

Of course, these are by no means the only possible legislative               measures Congress might take to limit practices that put at risk               the dignity of human procreation. We believe, however, that some               provisions along these lines are at present among the most needful               and most likely to win agreement. 

_______________ 
Endnotes
1. There are, of course,               defensible reasons to reject such patients, and it is arguably unethical               to encourage hopes in couples whose chances of pregnancy are extremely               low, or to take their money for a service that is unlikely to do               them any good. |        |