Accessibility disclaimer: To obtain information contained in document files on this page in an accessible format please contact the Human Subjects Office at (317) 274-8289. Or email the IU Institutional Review Board at email@example.com
HRPP Policy - Pregnant women, fetuses, and neonates
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
This policy applies to the conduct of non-exempt human subjects research involving pregnant women, fetuses, and/or neonates under the oversight of the IU IRBs.
This policy does not apply to the conduct of research with viable neonates. A neonate, after delivery, that has been determined to be viable falls under the IU HRPP Policy on Children in Research.
Pregnant minors cannot, by virtue of their pregnant status alone, consent on their own behalf to participate in research; as such, research involving children who are pregnant must comply with both this policy and IU HRPP Policy on Children in Research.Back to top
Research involving women who are or may become pregnant requires special consideration from the IRB to ensure ongoing safety of subjects during pregnancy, avoid unnecessary risk to the fetus, and ensure informed consent is obtained from the appropriate persons.
Pregnant women or human fetuses may be involved in research if all of the following conditions are met:
- 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 generalizable knowledge that 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 generalizable knowledge that cannot be obtained by any other means, her consent is obtained or informed consent is waived in accordance with the IU HRPP Policy on Informed Consent
- 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 or waived in accordance with the IU HRPP Policy on Informed Consent, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity, or if 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
- 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
- Individuals engaged in the research will have no part in determining the viability of a neonate
Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
- Where scientifically appropriate, preclinical and clinical studies have been conducted and provide 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 for neonates of uncertain viability or nonviable neonates listed below have been met, as applicable
Neonates of Uncertain Viability
Until it has been ascertained whether a neonate is viable, a neonate may not be involved in research unless the following additional conditions have been met:
- IRB determines that: (a) 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 (b) the purpose of the research is the development of important generalizable 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 (LAR) is obtained, except that the consent of the father or his LAR need not be obtained if the pregnancy resulted from rape or incest
After delivery, a nonviable neonate may not be involved in research 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 generalizable knowledge that cannot be obtained by other means
- The informed consent of both parents of the neonate is obtained in accordance with the IU HRPP Policy on Informed Consent
- Waiver or alteration of the consent process is not available for research involving nonviable neonates
- 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
- The consent of the father need not be obtained if the pregnancy resulted from rape or incest
- The IRB cannot approve the consent of an LAR for a nonviable neonate
The IRB may approve research which does not meet the requirements described in 2.1 or 2.2 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.
For federally-funded research which meets this criteria, the DHHS Secretary or his/her designee, after consultation with a panel of experts in pertinent disciplines (e.g., science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, must determine either:
- that the research in fact satisfies the conditions of 2.1 above; or
- 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; 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 46 CFR 46 and subpart A.Content
For studies proposing to enroll pregnant women, fetuses, and/or neonates, the study team completes the IRB application and provides protocol-specific information related to research with these populations. The IRB considers the information in the IRB application and documents its determinations as appropriate.
When a human subject involved in ongoing research becomes pregnant during the course of the study, and the relevant research study was not previously approved by the IRB for the inclusion of pregnant women, fetuses, or neonates:
- All research procedures with the pregnant subject, including interactions and interventions and collection identifiable private information, must immediately cease.
- If research personnel wish to have the pregnant subject continue to participate in the research, the study team must submit an amendment to the IRB requesting inclusion of pregnant women, and the IRB must approve the inclusion in accordance with this policy. The pregnant woman may continue to participate in research procedures once the amendment is approved.
- If research personnel believe it is in the best interest of the pregnant woman to continue to receive research procedures before such an amendment can be reviewed, the IRB Chair may determine that the pregnant woman may continue to participate in the research until the above requirements are met if the potential benefits of continued treatment for the woman outweigh the risks of ongoing fetal exposure to the investigational drug, of discontinuing maternal therapy, and/or of exposing the fetus to additional drugs if placed on an alternative therapy.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
IU HRPP Guidance
Related Guidance Documents
drug As regulated by the FDA, A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and B) rticles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
federally-funded Supported, either directly or indirectly, by funds provided by the federal government. This includes federal pass-through funding (i.e., received as a subrecipient through subcontracts). Use of administrative services funded by a federal grant, alone, is not sufficient to consider research federally-funded.
fetus The product of conception from implantation until delivery.
generalizable knowledge Information that expands the knowledge base of a scientific discipline or other scholarly field of study.
identifiable private information Private information for which the identity of the subject is or may readily be ascertained by the research personnel or associated with the information.
informed consent An ongoing process by which a subject (or his/her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.
interaction Includes communication or interpersonal contact between research personnel and the subject.
intervention Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
investigational biologic, drug, device, or test article A drug or device that is the object of a clinical investigation.
legally authorized representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to the participant’s participation in the procedure(s) involved in the research. For definition of LAR in Indiana, see the IU HRPP Policy on Adult Individuals Lacking Consent Capacity.
neonate A newborn child less than four weeks old. A Bold-nonviable neonate-Bold is an expelled or delivered fetus who, although living, cannot sustain life independently, even with medical intervention.
parent A child's biological or adoptive parent.
private information Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., medical records).
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
research personnel (See also investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), Student, Fellow, Resident PI, site-specific PI) Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.
viable As it pertains to the neonate, being able to survive post-delivery (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.Back to top