To provide written guidelines regarding additional protections for pregnant women and fetuses as subjects of a research protocol.
The Cottage Health System Institutional Review Board (CHS IRB) supports a policy of providing pregnant women the same opportunities as non-pregnant women to participate in research unless the individual meets legitimate exclusionary criteria or the study poses more than minimal risk to the fetus. Research inclusive of pregnant women increases the likelihood that the knowledge gained can be extended judiciously to this population in society. Federal Regulations require that Institutional Review Boards (IRBs) give special consideration to protecting the welfare of pregnant women and fetuses.
This policy currently reflects:
• 21 CFR 56 – IRB Functions and Operations
• 45 CFR 46, Subpart B – Protection of Human Subjects
• Health and Human Services Institutional Review Board Guidebook, Chapter VI - Special Classes of Subjects
DEFINITIONS: (from 45 CFR 46.106, Subpart B):
- Dead fetus: A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
- Delivery: Complete separation of the fetus from the woman by expulsion or extraction or any other means.
- Fetus: The product of conception from implantation until delivery.
- Neonate: A newborn
- Nonviable neonate: A neonate after delivery that, although living, is not viable.
- 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.
- Viable: Being able, after delivery, to survive (given the benefit of available medical therapy) to the point
- of independently maintaining heartbeat and respiration.
It is the policy of the CHS IRB to review and approve all research involving pregnant women, human fetuses, and all neonates including those of uncertain viability or nonviable neonates based on the Federal regulations at 45 CFR 46, Subpart B – Additional Protection for Pregnant Women, Human Fetuses and Neonates Involved in Research, and in addition to those imposed under other IRB policies, procedures, and other applicable Federal, State, and local laws.
Research involving women who are or may become pregnant should receive special attention from the IRB because of women's additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus. Further, in the case of a pregnant woman, the IRB must determine when informed consent of the father is required for research. Special attention is justified because of the involvement of a third party (the fetus) who may be affected but cannot give consent and because of the need to prevent harm or injury to future members of society. Procedural protections beyond the basic requirements for protecting human participants are prescribed in the Federal regulations for research involving pregnant women.
Pregnant women or fetuses may be involved in research if all of the following conditions are met (from 45 CFR 46.204, Subpart B):
- 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;
- 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; or, 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 biomedical knowledge which cannot be obtained by any other means;
- Any risk is the least possible for achieving the objectives of the research;
- If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or 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, her consent is obtained in accord with the informed consent provisions of 45CFR46 Subpart A;
- If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of 45CFR46 Subpart A, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
- 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; and
- Individuals engaged in the research will have no part in determining the viability of a neonate.
Research Involving Neonates (from 45 CFR 46.205, Subpart B)
Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
- Scientifically appropriate, preclinical and clinical studies have been conducted and provided data for assessing potential risks to neonates.
- Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate.
- Individuals engaged in the research will have no part in determining the viability of a neonate.
- The requirements of the following sections, "Neonates of Uncertain Viability" and "Nonviable Neonates," have been met as applicable.
Neonates of Uncertain Viability (from 45 CFR 46.205, Subpart B)
Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the following additional conditions have been met:
- The IRB determines that
- The research offers 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
- The purpose of the research 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 research; and
- The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative is obtained in accordance with 45 CFR 46 subpart A, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
Nonviable Neonates (from 45 CFR 46.205, Subpart B)
After delivery nonviable neonates may not be involved in research covered by this subpart unless all of the following additional conditions are met:
- Vital functions of the neonate will not be artificially maintained;
- The research will not terminate the heartbeat or respiration of the neonate;
- There will be no added risk to the neonate resulting from the research;
- The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
- The legally effective informed consent of both parents of the neonate is obtained in accord with subpart A, except that the waiver and alteration provisions of 45 CFR 46.116(c) and (d) do not apply. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent will suffice.
Note: The consent of the father need not be obtained for research involving a nonviable neonate if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate is not adequate.
Viable Neonates (from 45 CFR 46.205, Subpart B)
A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of 45 CFR 46 Subpart A and Subpart D.
Research Involving, After Delivery, the Placenta, the Dead Fetus or Fetal Material
(from 45 CFR 46.206, Subpart B)
- Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
- If information associated with material described in paragraph (a) above is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of 45 CFR 46 are applicable.
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 Neonates (from 45 CFR 46.207, Subpart B)
The Secretary of the Department of Health and Human Services (HHS) will allow the conduct or funding of research that the IRB does not believe meets the requirements of 45 CFR 46.204 or 45 CFR 46.205 (as outlined in this document) only if:
- The IRB 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; and
- The HHS Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either that the research in fact satisfies the conditions of 45 CFR 46.204, as applicable; or the following
- 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;
- The research will be conducted in accord with sound ethical principles; and
- Informed consent will be obtained in accord with the informed consent provisions of Subpart A and other applicable subparts of 45 CFR 46.
Consent Signature Requirements
See Appendix A.
Note: Research using cord blood does not necessarily fall under this policy and the aforementioned federal regulations. Research pertaining to cord blood will be reviewed on a case by case basis.
COTTAGE HEALTH SYSTEM POLICY
|ORIGINAL POLICY EFFECTIVE DATE: