Version
1.1
Date Updated
Sunday, March 11, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  193                     
AAHRPP Elements:  II.4. A., II. 4.B, III.1.C, III.1.F


POLICY


  1. Pregnant women represent a vulnerable population when involved in human subjects research and require additional safeguards from the investigator and IRB, because of women’s additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The IRB must apply additional federal and state regulations and laws.
  2. To safeguard their interests and protect them from harm, additional regulatory protections exist for research involving pregnant women, human fetuses and neonates. The UIC IRBs approve research involving these vulnerable groups only if the research complies with the safeguards described in this policy and 45 CFR 46 Subpart B regardless of funding.
  3. The UIC IRBs review and consider research involving pregnant women, human fetuses, and neonates of uncertain viability or nonviable neonates in accordance with the federal regulations at 45 CFR 46 Subpart B, UIC HSPP policies and procedures, and other applicable federal, state and local laws regardless of funding.
  4. Research involving pregnant women as subjects may be exempt from the requirements of subpart B when the research meets the exemption criteria at 45 CFR 46.101(b).
  5. The UIC IRBs also consider the need for additional safeguards when reviewing research in which women of childbearing potential are possible subjects as the potential exists for these women to become pregnant during the course of the research.
  6. Definitions. The following definitions are taken from 45 CFR 46.202.
    1. DEAD FETUS: a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
    2. DELIVERY: complete separation of the fetus from the woman by expulsion or extraction or any other means.
    3. FETUS: the product of conception from implantation until delivery.
    4. NEONATE: a newborn.
    5. NONVIABLE NEONATE: a neonate after delivery that, although living, is not viable.
    6. PREGNANCY: the period of time from implantation until delivery. A woman is assumed to be 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.
    7. VIABLE: as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
  7. The Illinois Consent by Minors to Medical Procedures Act (410 ILCS 210/1) permits a pregnant minor to provide her own informed consent to the performance of a medical or surgical procedure performed by: (i) a physician licensed to practice medicine and surgery, (ii) an advanced practice nurse who has a written collaborative agreement with a collaborating physician that authorizes provision of services for minors, or (iii) a physician assistant who has been delegated authority to provide services for minors. The UIC IRB extends the provisions of the Minors Medical Treatment Act to research. Specifically, under the circumstances or for the conditions stipulated in the Act, the UIC IRB views the minor to have the same legal capacity to act and as having the same powers and obligations as a person of legal age to consent for research involving such medical or surgical procedures. The minor is not deemed to be able to provide consent for research involving conditions not stipulated by the Act or involving medical or surgical procedures not covered by the Act. In these instances, assent from the pregnant minor and permission from the parent or guardian must be obtained as described in the UIC HSPP policy and procedure Research Involving Children.
  8. Additional VA Requirements. In addition to the requirements provided in 45 CFR 46 Subpart B and those conveyed in this policy, the following VA regulations from Handbook 1200.05, Paragraphs 45.c.(1) and (2) and 46 are followed for research to be conducted at JBVAMC.
    1. Research in which the subject is a fetus, in-utero or ex-utero (including human fetal tissue), must not be conducted by VA investigators while on official duty, or at VA facilities, or at approved off-site facilities.
    2. Research related to in vitro fertilization must not be conducted by VA investigators while on official duty, or at VA facilities, or at approved off-site facilities.
    3. Women of childbearing potential:
      1. may be entered into studies,  including studies whose interventions include FDA’s Categories for Drug Use in Pregnancy’s Category C drugs;
      2. may not be entered into studies involving use of FDA Categories for Drug Use in Pregnancy’s Category D or X drugs unless a waiver is obtained from the CRADO
    4. For research involving the participation of pregnant women as research subjects, the IRB must find and document that the criteria at 45 CFR 46.204 are met in the meeting minutes or, when review occurs under expedited conditions, review guides.
  9. Department of Defense (DoD)

    The DoD applies subpart B with some modifications.  Please refer to UIC HSPP Policy Research Involving Department of Defense Components for more detail.