Boston University
Charles River Campus IRB
Policies and Procedures

 

Title: Research Involving Pregnant Women

Date: November 7, 2014

Purpose

The purpose of this policy is to describe the additional responsibilities and procedures involved when reviewing research that involves pregnant women as subjects.

Defined Terms

Pregnancy: The period of time from implantation until delivery. A woman shall be 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

Policy

The Charles River Campus (CRCCharles River Campus) Institutional Review Board (IRB) applies additional protections for research involving pregnant women in accordance with the Department of Health and Human Services (DHHS) regulations for the protection of human subjects (45 CFR 46, Subpart B) which provides additional protections for research that that involves prisoners as subjects for all federally funded research.

This policy applies when pregnant women are the target population.

Equal protections are used when the research is not funded by the Department of Health and Human Services (DHHS). The CRC IRB will use Subpart B as a guide.

The CRC IRB does not review research involving fetuses, neonates of uncertain viability, and non-viable neonates.

Procedures

DHHS-funded studies:

Pregnant women may be involved in research if all of the following conditions are met:

  • Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses
  • Any risk is the least possible for achieving the objectives of the research and one of the following applies:
    • The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus
    • If there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of importan biomedical knowledge which cannot be obtained by any other means
  • The consent of the pregnant woman is obtained in any of the following circumstances:
    • The research holds out the prospect of direct benefit to the pregnant woman,
    • The research holds out the prospect of a direct benefit both to the pregnant woman and the fetus
    • The research offers no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means
  • The consent of both parents must be obtained for research that holds out the prospect of direct benefit solely to the fetus, with the following exceptions:
    • The father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity
    • The pregnancy resulted from rape or incest
  • Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate
  • For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part
  • No inducements, monetary or otherwise, will be offered to terminate a pregnancy
  • Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy
  • Individuals engaged in the research will have no part in determining the viability of a neonate

Studies not funded by DHHS

  • Where scientifically appropriate (e/g research involving investigational drugs or medical devices), preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses
  • Any risk is the least possible for achieving the objectives of the research and one of the following applies:
    • The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus
    • If there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important knowledge which cannot be obtained by any other means
  • The consent of the pregnant woman is obtained in any of the following circumstances:
    • The research holds out the prospect of direct benefit to the pregnant woman,
    • The research holds out the prospect of a direct benefit both to the pregnant woman and the fetus
    • The research offers no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important knowledge that cannot be obtained by any other means
  • The consent of both parents must be obtained for research that holds out the prospect of direct benefit solely to the fetus, with the following exceptions:
    • The father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity
    • The pregnancy resulted from rape or incest
  • Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate
  • For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part
  • No inducements, monetary or otherwise, will be offered to terminate a pregnancy
  • Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy
  • Individuals engaged in the research will have no part in determining the viability of a neonate

References

45 CFR 46.201 (Subpart B):http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#subpartb

Title: Research Involving Pregnant Women

Author: Cynthia Monahan

Effective Date: November 7, 2014

Last Review/Update Date:

Revision #:

Approved: Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance

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