Abington Memorial Hospital Institutional Review Board
Vulnerable Populations:
PREGNANT WOMEN, HUMAN FETUSES, NEONATES OR
FETAL MATERIAL: Instructions
Submit this form to the IRB with the initial IRB application, the informed consent document(s), the
sponsor’s or Investigator’s protocol, the Investigator’s Brochure and any other supporting material.
Place a check next to the category that best describes your proposed research and
answer all questions related to that category.
§ 46.204 Research Involving Women or Fetuses.
1. Give a description of why this research is scientifically appropriate. Describe any animal
studies and previous human studies that were conducted on pregnant animals or humans
or non-pregnant animals and non-pregnant humans.
2. Describe the risks and rationale for any anticipated risk. Indicate if the risk is caused
solely by the research interventions or procedures.
3. Indicate how the risks are minimized and describe the impact of risks as they relate to
achieving the objectives of the research.
4. Place a check in the appropriate box to describe who will benefit and the importance of
benefits gained.
5. Indicate if there will be any inducements, monetary or otherwise, offered to terminate a
pregnancy.
6. Indicate if anyone engaged in research (performing the research procedures) has any
part in the timing, method or procedures used to terminate a pregnancy.
7. Indicate if anyone engaged in research will have any part in determining the viability of a
fetus.
§ 46.205 Research Involving Neonates. A neonate cannot be involved in research until it has
been ascertained as viable or not viable.
Neonates of Uncertain Viability and Nonviable Neonates.
1. Give a description of why this research is scientifically appropriate. Describe any animal
studies and previous human studies that were conducted that can provide data for
assessing potential risks to neonates.
2. Indicate if any individuals engaged in research will have any part in assessing viability.
Neonates of Uncertain Viability.
1. Indicate whether the research holds out the prospect of enhancing survival to the
point of viability and any risk is the least possible; or the information cannot be
obtained by any other method and there will be no added risk to the neonate.
2. Describe the procedures used for obtaining informed consent. Indicate if a legally
authorized representative will be used or if the consent process will require
signatures from both parents.
Nonviable Neonates.
1. Indicate if the vital functions of the neonate will be artificially maintained and describe
the procedure for maintaining vital functions.
2. Indicate if the research includes procedures to terminate the heartbeat or respiration
of the neonate.
3. Describe any added risks that may result to the neonate from this research.
4. Indicate if the sole purpose of the research is for the development of important
biomedical knowledge that cannot be obtained by any other means.
Vulnerable Population Use of Pregnant Women and Fetuses Instructions (Form #1116)
Form Revision Date: March 5, 2004
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5. Describe the procedures used for obtaining informed consent. Indicate if a legally
authorized representative will be used or if the consent process will require
signatures from both parents.
Viable Neonates. A neonate after delivery that has been determined to be viable may be
included in research if all of the requirements of Subparts A and D of 45 CFR 46 are met.
§ 46.206 Research Involving, After Delivery, the Placenta, the Dead Fetus, or Fetal Material.
1. Indicate from the table all that apply to the proposed research. The use of any of the
listed must be conducted in accordance with any applicable Federal, state, and local
laws, regulations, and institutional policies regarding such activities (See IRB Policy IX.C
for further details).
2. Indicate if any information associated with the material could be recorded for research
purposes in such a manner that living individuals can be identified. Describe the rationale
for the recording of identifiable information. If the information is identifiable, those
individuals are considered to be research subjects and all pertinent human subject
regulations are applicable to their participation.
§ 46.207 Research Not Otherwise Approvable Which Presents an Opportunity to
Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or Welfare of
Pregnant Women, Human Fetuses, or Neonates.
This requires review by the Secretary of the Department of Health and Human Services (DHHS)
and posting in the Federal Register for public comments and review.
Vulnerable Population Use of Pregnant Women and Fetuses Instructions (Form #1116)
Form Revision Date: March 5, 2004
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