Pregnant Women, Fetuses or Neonates

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Mother Frances Hospital Tyler Institutional Review Board [email protected]

/ (903) 606-2472

Initial Review Supplement Pregnant Women, Fetuses or Neonates

Principal Investigator: Protocol Title: Date: Name of person completing this form: Handwritten, copied or scanned versions of this form are not accepted. To prevent errors and delays due to legibility problems, submit the original to [email protected]

. All questions must be answered. Indicate NA for questions that are not applicable. Research involving pregnant women and fetuses 1.

2.

3.

Minimal risk: “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Does this research pose a greater than minimal risk to the: Yes No Pregnant woman? If yes, explain: Fetus? If yes, explain: Explain why the level of risk is the least possible for achieving the objectives of the research and provide justification for your explanation. Does the research hold out the prospect of direct benefit to the: Yes No Pregnant woman? Fetus? If no, explain how the research will develop important biomedical knowledge which cannot be obtained by any other means: If the research holds out the prospect of direct benefit solely to the fetus, then consent of both the pregnant woman and the father of the fetus must be obtained. If the father of the fetus is unable to consent because of unavailability, incompetence, or temporary incapacity, or if the pregnancy resulted from rape or incest, the father's consent need not be obtained. 4.

Where scientifically appropriate, have preclinical studies (including studies on pregnant animals), and clinical studies (including studies on non-pregnant women), been conducted to provide data for assessing potential risks to pregnant women and fetuses? Yes No Explain: Initial Review Supplement Pregnant Women, Fetuses or Neonates Last revised 07/21/2014 Page 1 of 3

5.

6.

Describe how you will ensure that individuals providing consent are fully informed regarding the reasonably foreseeable impact of the research on the fetus. Yes No Will inducements, monetary or otherwise, be offered to terminate a pregnancy? Will individuals engaged in conducting the research have a part in any decisions as to the timing, method, or procedures used to terminate a pregnancy? Will individuals engaged in conducting the research have a part in determining the viability of a neonate? Research involving neonates Newborns are only considered neonates until they are determined to be viable. Once they are determined to be viable, they are considered children. Initial Review Supplement – Children should be completed for viable newborns. 1.

Complete this section when neonates of uncertain viability and nonviable neonates will be involved in research. Yes No Will there be any added risk to the neonate resulting from the research? Explain: Will individuals engaged in the research have a part in determining the viability of a neonate? Where scientifically appropriate, have preclinical and clinical studies been conducted to provide data for assessing potential risks to neonates? Explain: Does the research hold out the prospect of enhancing the probability of survival of the neonate to the point of viability, and is any risk the least possible for achieving that objective? Explain: Is the purpose of the research the development of important biomedical knowledge that cannot be obtained by other means, and will there be no added risk to the neonate as a result of the research? Explain: In the case of nonviable neonates, will vital functions of the neonate be artificially maintained? Explain: In the case on nonviable neonates, will the research terminate the heartbeat or respiration of the neonate? Explain: Initial Review Supplement Pregnant Women, Fetuses or Neonates Last revised 07/21/2014 Page 2 of 3

2.

Will legally effective informed consent from both parents* be obtained in the case of: Yes No A neonate of uncertain viability? A nonviable neonate? *The legally effective informed consent of either parent may be waived because of unavailability, incompetence, or temporary incapacity. In these cases, the legally effective informed consent of either parent's legally authorized representative is obtained (45CFR46, subpart a). If the pregnancy resulted from rape or incest, consent need not be obtained from the father of the neonate or his legally authorized representative. Initial Review Supplement Pregnant Women, Fetuses or Neonates Last revised 07/21/2014 Page 3 of 3

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