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Pregnant Women & Fetus

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There are additional protections and requirements for pregnant women and fetuses' participation in research that is federally funded. These protections are provided in 45 CFR 46 Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research.

CHOP's FWA requires that the IRB apply the Subpart B protections for all research involving pregnant women and the fetus that is federally funded. IRB SOP 502: Research Involving Pregnant Women, the Fetus and Neonates details the CHOP IRB's policies regarding research covered by Subpart B.

In addition, minors who become pregnant are no longer considered children in the State of Pennsylvania since they may consent for their own treatment.

Pennsylvania Law Related to Research involving the Fetus

Research taking place in Pennsylvania must adhere to the requirements imposed by PA Law which includes additional requirements for research involving the fetus under its Abortion statutes at 18 PCS §3216 - Fetal Experimentation. The eIRB application will include additional questions to ensure that the PA statute requirements are met. These requirements apply for all research, regardless of funding. PA law prohibits non-therapeutic research involving an “unborn child” which it defines as "an individual organism of the species homo sapiens from fertilization until live birth." Investigators will need to consult with CHOP legal counsel to determine whether or not the proposed research involves "non-therapeutic" research or whether or not the research involves "diagnostic" tests.

§ 3216. Fetal experimentation

(a) Unborn or live child.--Any person who knowingly performs any type of nontherapeutic experimentation or nontherapeutic medical procedure (except an abortion as defined in this chapter) upon any unborn child, or upon any child born alive during the course of an abortion, commits a felony of the third degree. "Nontherapeutic" means that which is not intended to preserve the life or health of the child upon whom it is performed.

(b) Dead child.--The following standards govern the procurement and use of any fetal tissue or organ which is used in animal or human transplantation, research or experimentation:

(1) No fetal tissue or organs may be procured or used without the written consent of the mother. No consideration of any kind for such consent may be offered or given. Further, if the tissue or organs are being derived from abortion, such consent shall be valid only if obtained after the decision to abort has been made.
(2) No person who provides the information required by section 3205 (relating to informed consent) shall employ the possibility of the use of aborted fetal tissue or organs as an inducement to a pregnant woman to undergo abortion except that payment for reasonable expenses occasioned by the actual retrieval, storage, preparation and transportation of the tissues is permitted.
(3) No remuneration, compensation or other consideration may be paid to any person or organization in connection with the procurement of fetal tissue or organs.
(4) All persons who participate in the procurement, use or transplantation of fetal tissue or organs, including the recipients of such tissue or organs, shall be informed as to whether the particular tissue or organ involved was procured as a result of either:
(i) stillbirth;
(ii) miscarriage;
(iii) ectopic pregnancy;
(iv) abortion; or
(v) any other means.
(5) No person who consents to the procurement or use of any fetal tissue or organ may designate the recipient of that tissue or organ, nor shall any other person or organization act to fulfill that designation.
(6) The department may assess a civil penalty upon any person who procures, sells or uses any fetal tissue or organs in violation of this section or the regulations issued thereunder. Such civil penalties may not exceed $5,000 for each separate violation. In assessing such penalties, the department shall give due consideration to the gravity of the violation, the good faith of the violator and the history of previous violations. Civil penalties due under this paragraph shall be paid to the department for deposit in the State Treasury and may be enforced by the department in the Commonwealth Court.

(c) Construction of section.--Nothing in this section shall be construed to condone or prohibit the performance of diagnostic tests while the unborn child is in utero or the performance of pathological examinations on an aborted child. Nor shall anything in this section be construed to condone or prohibit the performance of in vitro fertilization and accompanying embryo transfer.

Frequently Asked Questions

  1. Can a pregnant woman take part in a survey study involving questionnaires if the IRB hasn’t specifically approved participation of pregnant women?

    No. If the research is federally funded, pregnant women may take part in research only when the IRB has approved the research under Subpart B.

    However, if the research is not federally funded and if the risks are not greater than minimal, then under IRB SOP 502, approval under Subpart B is not required. The most frequent procedures where this applies include questionnaires, surveys and reviews of medical records of women who are pregnant.

  2. What if it isn't obvious that the woman is pregnant, do we still need to ask?

    Most studies that involve interventions or procedures will be required to include questions about possible pregnancy and/or pregnancy tests.

    However, if the study involves a simple questionnaire and it is not obvious that the prospective participant is pregnant, the IRB may, under these circumstances not require the investigator to add this question when it is not appropriate to the research in question.

  3. What do I need to do if a subject becomes pregnant during a study?

    There are issues that may require review. The IRB should be contacted as soon as possible to discuss these potential issues.

    1. Unless pregnancy is included as an anticipated event in the study protocol (e.g., a study about fertility); the pregnancy must be reported as an unanticipated problem to the IRB;
    2. If the IRB has not approved the participation of pregnant women, the study intervention should be stopped immediately unless continuing the study intervention would be in the woman's or the fetus's best interest;
    3. If there are no study interventions (an observational study), the investigator may amend the study and request that the study be approved under Subpart B;
    4. If there are any interventions or procedures which could negatively impact fetal development, the subject should be followed until delivery and possibly beyond to ensure that there are no serious adverse events that have been sustained, such as birth defects. For some interventional studies, this may also apply to the partner of a male subject. This plan must be included in the protocol and application.