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Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

23.3 Pregnant Women, Human Fetuses, and Neonates


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 24, 2006



23.3(a) Pregnant Women and Fetuses

23.3(a) Pregnant Women and Fetuses

Federal regulations (45 CFR 46, Subpart B) and University ethical standards require that principal investigators and the IRB shall be sensitive and apply special conceptual and regulatory protections to research involving pregnant women, human fetuses and neonates (newborn children). Key among these concepts is that investigators shall acknowledge and be sensitive to the vulnerability of subjects who are pregnant or newborn especially within the unique times of labor and delivery. Investigators shall also take into account that the health and wellbeing of the mother, the fetus and/or the newborn should take priority over the goals of any research study. Investigators shall ensure the highest possible standards in the conduct of research involving pregnant patients including cooperation from all involved in the labor and delivery processes.

Pursuant to special regulatory protections and in addition to the general requirements for IRB reviews (see earlier sections of these policies), the IRB shall require, in addition to all other requirements, that the following ten conditions be met and documented to approve the involvement of pregnant women or fetuses in research (c.f. 45 CFR 46.204). These required conditions are:

1)  Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses; AND

2)  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 that cannot be obtained by any other means; AND

3)  Any risk is the least possible for achieving the objectives of the research; AND

4)  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 consistent is obtained in accord with the informed consent provisions of these policies and procedures; AND

5)  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 in these policies and procedures, 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; AND

6)  Each individual providing consent under conditions (4) or (5) [above] is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; AND

7)  For children [as defined in these policies and procedures] who are pregnant, assent and permission are obtained in accordance with the provisions in these policies and procedures involving children; AND

8)  No inducements, monetary or otherwise, will be offered to terminate a pregnancy; AND

9)  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

10)Individuals engaged in the research will have no part in determining the viability of a neonate.

In conducting an IRB-approved research study involving pregnant women and fetuses, investigators should carefully and sensitively consider the process for obtaining informed consent. Whenever practical and feasible, information about the study should be made available prior to labor. If the patient must be approached during labor, permission should be sought first from the patient's obstetric care provider and the patient's primary nurse should be involved in discussions regarding the appropriateness of such an approach. If the obstetric care provider and/or the primary nurse believe that the patient may not comprehend a research protocol, the patient should not be approached for research participation. Investigators should also delay approaching patients for research participation if the patient's capacity for informed consent is impaired by medications.

Coincidental Pregnancy: There are circumstances in which pregnancy is coincidental to participant selection within a research study. This may occur, for example, when potential participants are recruited from a population that includes women of child bearing potential. In these circumstances, the IRB shall determine such matters as whether:

1)  Participants should be advised on the risks of participation in the study

2)  Participants should be advised to avoid pregnancy or nursing during or following participation in the study

3)  Participants should be advised to notify the principal investigator immediately should they become pregnant

4)  Participants should avoid causing a pregnancy during or following participation in the study and whether the participant should notify the principal investigator should the participant cause a pregnancy

5)  Pregnant women should specifically be excluded from the study or whether specified methods of contraception should be required during or following participation in the research



23.3(b) Placenta, Dead Fetus or Fetal Material

23.3(b) Placenta, Dead Fetus or Fetal Material

 

For studies involving, after delivery, any of the placenta, the dead fetus, macerated fetal material or cells, tissues or organs excised from a dead fetus, shall be conducted pursuant to federal regulations (45 CFR 46.206). The IRB may approve such research only if:

1)  The research is conducted only in accord with any applicable Federal, State or local laws and regulations regarding such activities; AND

2)  Information associated with the after delivery material described 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 written policies and procedures herein are applicable



23.3(c) Neonates

23.3(c) Neonates

As it pertains to these policies, "viable" means able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration.

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 these UM written policies and procedures that pertain to general IRB reviews and to reviews of research involving children (see below). An additional condition for approving any research involving viable neonates (defined as newborns) is that the IRB shall determine and document that:

1)  Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates; AND

2)  Each individual providing consent is fully informed regarding the reasonably f foreseeable impact of the research on the neonate; AND

3)  Individuals engaged in the research will have no part in determining the viability of a neonate. Rather, an independent examiner should determine such viability/nonviability

Neonates of Uncertain Viability: Until it has been determined whether or not a neonate is viable, the IRB may approve research involving these neonates of uncertain viability, only if it determines and documents (pursuant to 45 CFR 46.205) that:

1a)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

1b)The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means and there will be no added risk to the neonate resulting from the research; AND

2)  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 accord with the UM written policies and procedures (contained herein) on informed consent, 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: The IRB may approve studies involving post-delivery, nonviable neonates only if ALL of the following additional conditions of 45 CFR 46.206 are met and documented.

1)  Vital functions of the neonate will not be artificially maintained; AND

2)  The research will not terminate the heartbeat or respiration of the neonate; AND

3)  There will be no added risk to the neonate resulting from the research; AND

4)  The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; AND

5)  The legally effective informed consent of both parents of the neonate is obtained in accord with these UM written policies and procedures, 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 of a nonviable neonate will suffice to meet the requirements of this paragraph, 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 of this paragraph

Neonates of Uncertain Viability and Nonviable Neonates: The IRB may approve studies involving neonates of uncertain viability and nonviable neonates only if all of the following conditions are met and documented:

1)  Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates; AND

2)  Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate; AND

3)  Individuals engaged in the research will have no part in determining the viability of a neonate; rather, an independent examiner should determine such viability/nonviability; AND

4)  The requirements pertaining to neonates of uncertain viability and nonviable neonates that are contained in other sections of these policies and in 45 CFR 46.205 (b) and (c) have been met as applicable



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