UAB Policy on Additional Safeguards for Pregnant Women and Fetuses and Neonates Involved in Research - IRB POL032

UAB Policy on Additional Safeguards for Pregnant Women and Fetuses and Neonates Involved in Research - IRB POL032

Abstract:
This policy describes the additional precautions used when research involves pregnant women, fetuses and neonates.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     POL032
Effective Date:   3/30/07
Revision Date:  -
Subject:  UAB Policy on Additional Safeguards for Pregnant Women and Fetuses and Neonates Involved in Research

POLICY STATEMENT

It is UAB policy that research will include additional safeguards to protect the rights and welfare of subjects when some or all of the subjects are pregnant women or fetuses or neonates. In addition to its other prescribed responsibilities, the IRB will review research involving pregnant women or human fetuses or neonates and approve only research which satisfies the applicable conditions as set out below. All research involving pregnant women, fetuses, or neonates, regardless of funding source will receive review and approval in accordance with 45 CFR Part 46 Subpart B, as applicable. This standard for review and approval also applies to research involving post-delivery placentas, dead fetuses, or fetal material. (See PRO132 Procedure for Review when Pregnant Women, Fetuses, and Neonates are Involved as Participants in Research.)

Pregnant women or fetuses may be involved in research if all of the conditions listed in 45 CFR §46.204 are satisfied. Pregnancy will encompass the period of time from implantation until delivery. A woman will be assumed pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. The term fetus refers to the product of conception from implantation to delivery. In addition, HHS-funded fetal research involving living fetuses will be conducted in accordance with federal law at 42 U.S.C. §289g. Neonates may be involved in research only if all the conditions of 45 CFR §46.205 are satisfied. The term neonate means newborn. A viable neonate means a newborn that is able to survive after delivery (with the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. A nonviable neonate is a newborn that, although living, is not viable.

Research involving, after delivery, the placenta; dead fetus; macerated fetal material; or cells, tissues, or organs excised from a dead fetus may be conducted if the conditions in 45 CFR §46.206, when applicable, are met regarding such activities. If information associated with any of the above human materials is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals will be research subjects and all relevant human subjects research protections will apply. Dead fetus refers to a fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord. Delivery refers to complete separation of the fetus from the woman by expulsion or extraction or any other means.

For HHS-funded research, if the IRB believes the research does not meet the review requirements or conditions of 45 CFR §46.204 or 45 CFR §46.205, but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, then the research will be referred to OHRP in accordance with 45 CFR §46.207. For non-HHS-funded research, the IRB may approve the research if it finds that the research will be conducted in accordance with sound ethical principles and informed consent will be obtained in accordance with the informed consent provisions of 45 CFR Part 46, including all applicable subparts.

Research on the transplantation of human fetal tissue will be conducted in accordance with FDA regulations, as applicable. When funded or conducted by HHS, such research will also be conducted in accordance with federal laws at 42 U.S.C. §§289g-1 and 289g-2, including obtaining informed consent from the donor and donee, as well as written statements from the attending physician and researcher. Human fetal tissue refers to tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion. The IRB will approve only research that meet the requirements of §§289g-1 and 289g-2, when applicable.


Approved on March 23, 2007, by:

Samuel J. Tilden, MD, JD, LLM
Deputy Provost for Human Subjects Research

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director