Institutional Review Board
Information and Forms
Pregnancy Exclusion in Research Studies

                 Age

  1Non-Reproductive (45)     Reproductive (11-45)

       No Concern            Drug Fetotoxic

                             or Fetocidal

                             or unknown

                        No                     Yes

                    No Concern      

                            2Illness Terminal      Non-terminal Illness

                               No Concern       

                               3Immediate Treatment Required    Immediate Treatment Not Required

                                           4Information +

                                       6Single Pregnancy Test  

                                                      5Contraception Adequate   Contraception Not Adequate

                                                      4Information + Single      4Information +

                                                      6Pregnancy Test            6Single Pregnancy Test

                                                                                 or + 2 pregnancy tests,

                                                                                 15 days apart

____

¹No menstrual period in previous 6 months.

²Disease fatal within 12 months regardless of treatment.

³Less than 10 days from diagnosis.

⁴Protocol by protocol basis.

⁵Tubal ligation or vasectomy in monogamous relationship, or oral contraception,
or IUD Progesacert within one year with replacement or study completion prior
to anniversary, or copper IUD within ten years with replacement or study completion
prior to anniversary, or Depo-Provera 150mg every 3 months, or Norplant within five
years with replacement or study completion prior to anniversary.

⁶Within 10 days of last menstrual period.