Research Involving Pregnant Women/Fetuses

Research Involving Pregnant Women/Fetuses

Attachment J

Research Involving Pregnant Women/Fetuses

COMIRB #: Approval Stamp here:

Principal Investigator:

Protocol Title:

Version date:

Studies in which pregnant women are NOT excluded, and studies in which pregnancy is likely to occur (no attempt is made to avoid/prevent pregnancy), require the submission of Attachment J if any research activity with pregnant women is planned (study categories A and B).

The submission of Attachment J is not required for studies that exclude pregnant women from enrolling and take measures to avoid pregnancy during the trial, even if research activities are planned for women who inadvertently become pregnant during the trial (study category C). Such studies should report pregnancy during the trial as an Unanticipated Problem and submit the required documents for review at the time of pregnancy if continued involvement (including follow-up) of the pregnant woman is desired. The Sponsor may request the study be reviewed for the inclusion of pregnant women at any time, however.

Please answer the following questions:

  1. What is the reason for including pregnant women?
  1. What procedures will pregnant women undergo in this study?

All study procedures as described in the protocol

Only certain procedures will/will not be done.

Describe which specific procedures will/will not be done:

  1. For research procedures indicated in #2, describe scientifically appropriate clinical and pre-clinical studies, including studies on pregnant and non-pregnant humans/animals, that provide data for assessing potential risks to pregnant women and fetuses (unless N/A):
  1. Do the interventions or procedures indicated in #2 hold out the prospect of direct benefit for the woman or the fetus? Yes No

If yes, explain:

  1. If there is no such prospect of benefit, the risk to the fetus from research procedures must not be greater than minimal and the purpose of the research must be the development of important biomedical knowledge that cannot be obtained by any other means.

Yes No N/A

If yes, justify minimal risk and justify what knowledge will be gained by including pregnant women:

  1. Is any risk from the procedures the least possible for achieving the research objectives?. Yes No

If no, explain:

If #4 or #5 are checked yes, then only the woman’s consent (must be competent to consent) need be obtained in accordance with the informed consent provisions of 45 CFR Part 46, Subpart A, unless alteration or waiver is approved by the IRB in accordance Section 46.116(c) or (d).

Do you plan to consent only the mother?

Yes No

If yes, only one signature line is required on the consent.

OR

Are you requesting an alteration or waiver of the consent? Yes No

If yes, complete Attachment M - Alteration or Waiver of Consent

  1. Does the research hold out the prospect of direct benefit solely to the fetus? Yes No

If yes, explain why:

If yes, you must consent both the mother and the father unless the father is unable to consent because of non-availability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest. Will you consent both parents?

Yes No If yes, two signature lines are required on the consent.

If no, explain why not:

  1. Will each individual providing consent be fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate?

Yes No

If no, explain why not (Note: an alteration of consent for deception may be required [Attchs M & N]:

  1. No inducements, monetary or otherwise, will be offered to terminate a pregnancy for the purposes of the research activity.

True False N/A

10. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.

True False N/A

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

True False N/A

12. Does the proposed research involve neonates?

Yes No If yes, complete Attachment I.

13. Does the proposed research involve, after delivery, the placenta, the dead fetus, or fetal material?

Yes No

a. If yes, describe how, after delivery, the placenta, the dead fetus, macerated fetal material, or cells, tissue, or organs from a dead fetus will be obtained:

b. Will any information associated with the above material be recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals? Yes No

  1. If yes, those individuals are research subjects. Describe how:

a. Consent will be obtained:

b. Privacy will be protected:

c. Confidentiality will be protected:

Attachment J: Research Involving Pregnant Women/Fetuses

CF-098, Effective 8/22/11Page 1 of 3

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