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• The protocol should address what will happen if participants become pregnant during the course of the study.
  • For treatment studies:
    • Indicate in your protocol if pregnancy is an off-treatment criterion.
    • If the subject's partner becomes pregnant, and the intent is to continue to collect outcome data, the IRB must review and approve a consent form which allows the partner to provide consent to have pregnancy outcome data collected.  Another option is to indicate that you intend to collect outcome data and will enroll the partners on NIH Protocol 000268, NIH Intramural Research Program's Pregnancy Registry Protocol for Subjects and their Partners.  
  • For FDA regulated research, pregnancy outcome should be collected and reported.
• If the protocol indicates that the participant will remain on study, the protocol should include the following information:
  • While pregnant, neither research interventions nor research tests or procedures that are greater than minimal risk will occur (because per the regulations, research with pregnant women that is greater than minimal risk is not approvable unless there is potential for direct benefit to the pregnant woman or fetus).
  • Explain the justification in the protocol for why the biomedical knowledge to gained cannot be obtained from nonpregnant women.
  • If a participant becomes pregnant while on study and you intend the to keep the participant on-study, then an amendment a modification must be submitted to provide the justification for continued participation of the pregnant woman on the research.
  • Example:
    • In a natural history study of individuals with Lupus, the PI explains that the only way to learn about critical biological differences between pregnant and nonpregnant participants with this disease is to continue to follow pregnant women on study.
    • While pregnant, no research interventions, tests or procedures that are greater than minimal risk will be performed on the pregnant woman.
    • In this case, continued participation of a woman who becomes pregnant can be approved by the IRB under the regulations for the additional protections for pregnant women.

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• If a subject becomes incarcerated and the IRB and OHRP have not previously approved prisoner participation on your research protocol, you must notify IRBO as soon as possible by submitting a Reportable New Information form in the eIRB system.
• All research interactions, interventions with, and obtaining identifiable private information about the now-incarcerated prisoner-subject, must be halted until IRB and OHRP approval is obtained.
• If it is in the best interest of the subject to remain on study while incarcerated, you must promptly notify IRBO and obtain permission from the IRB Chair to continue activities needed to ensure the safety and welfare of the now prisoner-subject until IRB and OHRP approval is obtained.
  • Submit an amendment a modification in the NIH electronic IRB system for review by the convened IRB requesting permission for the prisoner-subject to remain on study and include any additional safeguards and changes to procedures (if any) needed for the now-prisoner-subject to remain on the research.
• No research activities involving the prisoner-subject may take place prior to IRB approval and receipt of a letter of authorization from OHRP, except for those necessary for the welfare or safety of the prisoner-subject.
• If the IRB disapproves continued participation of the prisoner-subject, the subject must be taken off study.
• For additional information, refer toOHRP Guidance–Prisoner Involvement in Research (May 23, 2003).

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• Children who are legally emancipated are considered adults and the requirements of NIH Policy 402, Research Involving Children do not apply.
• You MUST consult OHSRP who will discuss with contact OGC for guidance before considering a minor to be emancipated.

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• It is your responsibility to determine if it is scientifically and ethically appropriate to enroll children in your protocol, and this rationale much be documented in the protocol.
• When your research involves children, you must provide a plan in your protocol for obtaining parental permission as well as assent from the child, as applicable, or provide a justification for requesting a waiver of parental permission and/or assent.
• Do not initiate or conduct research involving children unless IRB approval has been obtained.
• Ensure that you will comply with the requirements for obtaining and documenting parental permission and assent as described in the protocol.
• No child may be enrolled, screened, or have research procedures initiated, unless parental permission and child assent are obtained consistent with the Common Rule and, as applicable, FDA regulations.

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• The research exemptions are complex, and not all exemptions can be applied to research involving children.
• Consult with the OHSRP Office of IRB Operations (IRBO) before submitting an exempt research protocol involving children in the electronic IRB system.
• Note that exempt category 3 for benign behavioral interventions that was added with the 2018 Common Rule revisions cannot involve children. Such interventions constitute non-exempt research and must be reviewed by the IRB accordingly.

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• • Identify and engage with the LAR, so the LAR can advocate on behalf of the subject.
  • Assess whether the loss of capacity is temporary or permanent.
    • When the loss of capacity is temporary (e.g., they are expected to regain capacity):
      • No amendment modification of the protocol needs to be submitted to the IRB.
      • Reconsent of the subject by the LAR is not needed for the subject's continued participation in the research.
    • When the loss of capacity is permanent:
      • Amend Modify the protocol and obtain IRB approval for the inclusion of subjects without capacity.
      • Note that the subject may remain on the research until the IRB has made the determination whether the protocol can include subjects without capacity on the research.
      • If the IRB determines that the subject without capacity can remain on the research, then reconsent by the LAR is required.
      • If the IRB determines that subjects without capacity may not be included on the research, then the subject must be withdrawn from the research study.

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