1) Neonates of uncertain viability - Saint Luke's Health ...



Pregnant Women, Human Fetuses, and Neonates GuidanceIntroduction: The IRB recognizes the additional protections required under Federal law for pregnant women, human fetuses and neonates who participate in research (45 CFR 46, Subpart B). Guidelines: A research protocol is considered to include pregnant women, human fetuses, and/or neonates when: Any of the above are the target population that will be recruited; or Pregnancy occurs during the course of a research study and information about the pregnancy, fetus and/or neonate will be obtained as part of the research study. Pregnant Women and FetusesIn order to approve the inclusion of pregnant women in a research protocol, the following conditions listed in 45 CFR 46.204, Subpart B must be met: Where scientifically appropriate, preclinical studies, including studies on pregnant animals and clinical studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses. The risk to the fetus: o is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, o if there is no 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. The research must either: o holds out the prospect of direct benefit to the pregnant woman, or the fetus; or both; or no greater than minimal risk to the pregnant woman or fetus, and have, as its purpose the development of important biomedical knowledge that cannot be obtained by any other means. The pregnant woman’s informed consent must be obtained in accord with the informed consent provisions of 45 CFR 46 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 must be obtained in accord with the informed provisions of 45 CFR 46 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. Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate. For children who are pregnant, assent must be obtained from the pregnant child and consent from her parent or legal guardian. No inducement, monetary or otherwise, will be offered to terminate a pregnancy. Individuals engaged in the research will have no part in determining the viability of the neonate. The research protocol must address how these conditions are met and provide sufficient justification for inclusion of pregnant women. NeonatesThe IRB may approve research that involves the following categories of neonates: neonates of uncertain viability, non-viable neonates, viable neonates, if all of the following are met (45 CFR 46.205, Subpart B), as well as additional criteria listed for each special population below: Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing the potential risk 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. 1) Neonates of uncertain viability A neonate whose viability has not yet been ascertained may only be involved in research if all of the following additional conditions are met: The research 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 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 the unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is obtained, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest. 2) Nonviable neonate After delivery, a neonate that is living but is not considered viable may be involved in research if 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. The legally effective informed consent of both parents of the neonate must be obtained. If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice to meet the requirements except that the consent of the father need not be obtained 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 will not suffice to meet the requirements. 3) Viable neonates A neonate determined to be able to survive to the point of independently maintaining heartbeat and respiration (“viable”) upon delivery may be included in research to the extent permitted by and in accordance with OHRP (including Subpart D) and FDA requirements. 4) Research use of dried blood spots obtained through newborn screening programs Any use of newborn dried blood spots collected clinically for Federally-funded research is considered “human subject research” regardless of whether the specimens are identifiable. This means that the research project must receive IRB review (expedited or full board) and approval prior to initiation. In addition, parental permission to use the dried blood clinical screening sample for research purposes must be obtained for Federally-funded research. Federal law no longer permits waiver of informed consent (parental permission) in these situations. Research activities involving the use of newborn dried blood spots that are not Federally-funded are not subject to this requirement. These projects may be submitted to the IRB prior to initiation and reviewed under the current OHRP human subject protection regulatory framework. These non-Federally funded research projects may qualify as “non human research” (NHR) or exempt research, or may require expedited or full Board review and approval. In addition, the IRB has the ability to waive or alter the requirements for parental permission pertaining to the non-federally funded research use of the dried newborn blood spots for the specific project. Inclusion of Participant who becomes Pregnant after Enrollment in the StudyIf a research protocol intends to allow participants who become pregnant during the course of the research study and/or collect pregnancy follow-up and outcome information from the participant who has become pregnant, the provisions as they pertain to the protection of pregnant women as outlined under OHRP and FDA regulations, including 45 CFR 46 Subpart B, are applicable and criteria for inclusion must be met. The protocol and consent form must address the following: whether research procedures will be continued; if research procedures will be discontinued, how this will be done to ensure participant safety; what clinical information will be collected about the pregnant women and how long will the information be collected; what clinical information will be collected about the fetus/newborn and how long the information will be collected. If the IRB did not previously make a determination regarding the inclusion of pregnant women in the currently approved research protocol, then an amendment to allow the inclusion must be reviewed and approved prior to inclusion. Inclusion of Pregnant PartnersWhen the Pregnant Subject is an Adult If a research protocol proposes to collect information from the pregnant partner of a research subject, the pregnant partner becomes a “research subject” and the provisions as they pertain to the protection of pregnant women as outlined under OHRP and FDA regulations, including 45 CFR 46 Subpart B, are applicable. This includes obtaining informed consent from the pregnant partner for participation. See section C. Inclusion of Participant Who Becomes Pregnant after Enrollment in the Study.When the Pregnant Subject is a Minor In addition to the regulations outlined by OHRP and FDA, including 45 CFR 46 Subpart B, if the pregnant subject is also a minor, there are additional considerations that must be accounted for under 45 CFR 46 Subpart D, Additional Protections for Children Involved as Research Subjects. According to Missouri statute, a minor may consent to treatment “in case of pregnancy, but excluding abortion; venereal disease, drug and substance abuse. Separate statutes define HIV testing and reporting. Testing information from a minor-requested test may not be released without the minor’s consent if the test result is negative. However, breech of confidentiality does not apply if the healthcare provider decides to inform a parent/legal guardian of positive test results. This decision is a difficult one and is up to the individual health care professional. When making such decisions, it is important to keep in mind that doctor-patient trust and rapport may be affected by this decision. The decision must be in the best interest of the minor.When a minor receives medical treatment as allowed for pregnancy, VD or drug and substance abuse, “the parent, parents, or conservator shall not be liable for payment for such care unless the parent, parents, or conservator has expressly agreed to pay for such care. Although an un-emancipated minor patient may not provide legally required consent, the minor should be involved to the extent appropriate given the patient’s age, understanding and treatment contemplated. This is considered assent. According to Missouri State Law (Chapter 431, Section 431.061, pregnant minors and/or mothers who retain custody of their child (ren) are consisted legally capable of providing consent. Contraceptives and Minors Missouri law does not specifically require healthcare professionals to obtain parental consent before a minor receives family planning services or contraceptives, so healthcare professionals can and do provide these services to minor patients without parental consent. Federally funded Title X (ten) family planning clinics must provide confidential services to minors and may not require parental consent for minors to receive the services. For a complete listing of Title X family planning clinics in Missouri.In an emergency situation, consent to healthcare is implied, even if the minor objects or in the absence of consent of a parent or guardian. An emergency situation is one in which it is imminently necessary to provide medical care, and any delay caused by an attempt to obtain consent would jeopardize the life, health, or limb of the minor patient.left0Under state law, Missouri minors are able to consent without parental consent for:? VD/STD/STI diagnosis and treatment? Pregnancy diagnosis and treatment? Substance abuse diagnosis and treatment (only outpatient unless emancipated)Most Missouri minors are NOT able to consent for:? Abortions? Routine medical carePLEASE NOTE: This publication is intended as a guide and does not provide individual legal assistance. 00Under state law, Missouri minors are able to consent without parental consent for:? VD/STD/STI diagnosis and treatment? Pregnancy diagnosis and treatment? Substance abuse diagnosis and treatment (only outpatient unless emancipated)Most Missouri minors are NOT able to consent for:? Abortions? Routine medical carePLEASE NOTE: This publication is intended as a guide and does not provide individual legal assistance. Definitions: Pregnancy: includes 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 (45 CFR 46.202, Subpart B).Fetus: means the product of conception from implantation until delivery. (45 CFR 46.202, Subpart B). Neonate: means a newborn. (45 CFR 46.202, Subpart B). The accepted medical definition of neonate refers to the period between birth and 28 days of life ................
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