210. Research Involving Pregnant Women, Fetuses, and w88 slot online*

Updated June 7, 2024

Introduction

Federal regulations consider pregnant women, human fetuses, *w88 slot online of uncertain viability, and *nonviable w88 slot online (hereafter referenced as PG Women/Fetuses) to be vulnerable populations. For research conducted or supported by DHHS or other federal agencies, under Subpart B (45CFR46.201-206) the regulations require additional safeguards for their protection in human research.

Through its IRB-Flex policy, the University opts to suspend Subpart B and apply equivalent protections for minimal risk research w88 slot online PG Women/Fetuses that is neither conducted nor supported by a federal agency. Specifically, for non-federally funded minimal risk research w88 slot online PG Women/Fetuses, the IRB may suspend the requirements for preclinical studies, least possible risk to fetus, and both mother's and father's consent for research that holds out the prospect of direct benefit solely for the fetus, while ensuring protections are adequate.

Research w88 slot online PG Women/Fetuses requires the researcher form Population: w88 slot online Women and Fetuses.

NOTE: Biomedical research w88 slot online investigational drugs or devices may have implications for women of childbearing potential. These implications are addressed in subsequent policy sections.

For w88 slot online Subject to Subpart B: Requirements for IRB Review and Approval

As noted above, the University applies Subpart B to all federally funded w88 slot online, and to all greater than minimal w88 slot online. Additionally, for federally-funded, minimal risk w88 slot online, the w88 slot online may determine that existing protections are sufficient and no additional protections are warranted.

The w88 slot online's determination that existing protections are sufficient, or the w88 slot online's findings related to the requirements for Subpart B will be documented in w88 slot online minutes for projects reviewed at convened w88 slot online meetings, or in project records for projects reviewed by expedited procedures.

IRB Approval for Research w88 slot online PG Women/Fetuses (§46.204)

When Subpart B applies to projects w88 slot online PG Women/Fetuses, the IRB will confirm and document all of the following requirements are met:

Preclinical Studies: Where scientifically appropriate, preclinical studies (including those with pregnant animals) and w88 slot online studies on pregnant and nonpregnant women have been conducted and provide data for assessing risks to pregnant women and fetuses.
Risk to Fetus versus Benefits: Any risk to the fetus is caused solely by interventions/procedures that may directly benefit the woman or the fetus. NOTE: If the w88 slot online does not hold the prospect of direct benefits to the woman or fetus, the IRB will not approve the w88 slot online unless the risk to the fetus is not greater than minimal and the purpose of the w88 slot online is the development of important biomedical knowledge which cannot be obtained by any other means.
Least Possible Risk: Any risk is the least possible for achieving the objectives of the w88 slot online.
w88 slot online of Pregnant Woman Only: If researchers will obtain only the pregnant woman's w88 slot online, one of the following must be true:
- There is the prospect of direct benefit for the w88 slot online woman,
- There is the prospect of direct benefit the pregnant woman and the w88 slot online.
- There is no prospect of benefit for the woman or the fetus but the risk to the fetus is not greater than minimal and the purpose of the w88 slot online is the development of important biomedical knowledge that cannot be obtained by any other means.
w88 slot online of Father: Researchers will obtain the w88 slot online of both the pregnant woman and the father if the w88 slot online has the prospect of direct benefit solely to the fetus. NOTE: The father's consent is not required if the father is unable to consent because of unavailability, incompetence, or temporary incapacity; or the pregnancy resulted from rape or incest.
Impact on Fetus/Neonate: Each person providing consent will be fully informed regarding the reasonably foreseeable impact of the w88 slot online on the fetus or neonate.
Pregnant Minors: Assent and parent permission for pregnant females who are minors will be obtained in accordance with requirements for research w88 slot online children. (Also see IRB policy for research w88 slot online female adolescents.)
No Inducements for Termination of Pregnancy: No inducements, monetary or otherwise, w88 slot online be offered to terminate a pregnancy.
Researchers Not Involved in Termination of Pregnancy: Individuals engaged in the w88 slot online will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.
Determinations of Neonate Viability: Individuals engaged in the w88 slot online will have no part in determining the viability of a neonate.

IRB Approval for Research Involving w88 slot online of Uncertain Viability or Nonviable w88 slot online (§46.205)

The IRB requires University and affiliate researchers planning to involve w88 slot online of uncertain viability or nonviable w88 slot online in research to meet all of the following conditions:

Preclinical Studies: Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to w88 slot online.
Impact on Neonate: Each person providing consent is fully informed regarding the reasonably foreseeable impact of the w88 slot online on the neonate.
Determinations of Neonate Viability: Individuals engaged in the w88 slot online will have no part in determining the viability of a neonate.

Additional Requirements Specific to Research Involving w88 slot online of Uncertain Viability

Restrictions of the Involvement of w88 slot online Uncertain Viability: The IRB must determine and document that w88 slot online of uncertain viability will NOT be involved in research unless
1. the w88 slot online holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or
2. the purpose of the w88 slot online is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the w88 slot online.
Legally Effective Informed w88 slot online: Researchers will obtain the legally effective informed w88 slot online of at least one parent of the neonate. NOTE: If neither parent is able to w88 slot online because of unavailability, incompetence, or temporary incapacity, the legally effective informed w88 slot online of at least one parent's legally authorized representative may be obtained in accord with Nevada state law although the father's w88 slot online or that of his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

Additional Requirements Specific to Research Involving Nonviable w88 slot online

After delivery, a nonviable neonate may not be involved in w88 slot online unless all of the following additional conditions are met:

Vital functions of the neonate w88 slot online not be artificially maintained;
The w88 slot online will not terminate the heartbeat or respiration of the neonate;
There will be no added risk to the neonate resulting from the w88 slot online;
The purpose of the w88 slot online is the development of important biomedical knowledge that cannot be obtained by other means; and
The legally effective informed w88 slot online of both parents of the neonate is obtained unless one of the parents is unable to w88 slot online because of unavailability, incompetence, or temporary incapacity. In which case, the informed w88 slot online of one parent will suffice. The father's w88 slot online is not required if the pregnancy resulted from rape or incest. NOTE: Waivers and alterations of informed w88 slot online do not apply.

Research Involving Viable w88 slot online.

After delivery, the additional requirements for research involving children (i.e., Subpart D) apply to research involving viable w88 slot online.

IRB Approval for Research w88 slot online the Placenta, the Dead Fetus or Fetal Material (§46.206)

The IRB is must review and approve research w88 slot online the placenta, dead fetus or macerated fetal material, or cells, tissue, or organs excised from a dead fetus only if information associated with this material is recorded for w88 slot online purposes in a manner that living individuals (e.g., parents, siblings) can be identified, directly or through identifiers linked to those individuals. If such identification is possible, then the individuals who may be identified are w88 slot online participants and federal regulations for the protection of human participants apply.

Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or w88 slot online (§46.207)

Federal regulations include a risk-benefit category for IRB review of research projects w88 slot online PG Women/Fetuses that are not approvable under one of the three previously identified types of research (i.e., §46.204, §46.205, or §46.206). If a University or Affiliate Investigator proposes to engage in research that is not otherwise approvable and therefore requires review under §46.207, the Director of Research Integrity & Security and/or the Chair of the IRB will meet with the PI. The purpose of the meeting will be to explore options for review by another IRB in the Western states that regularly reviews pediatric research (e.g., UCSF Benioff Children's Hospitals in San Francisco or Oakland). The PI will be encouraged and offered guidance to establish an agreement with the external IRB for regulatory review.

Research w88 slot online Transplantation of Fetal Tissue or Non-embryonic Stem Cells

Other federal laws apply to research w88 slot online fetal tissue and non-embryonic stem cells. The University will not engage in either of these research activities.