The inclusion of pregnant women and/or fetuses as participants in research requires investigators to provide the additional protections described in 45 CFR 46 Subpart B. Approval from the Maternal-Fetal Welfare (MFW) Committee is also required in some (but not all) types of research involving pregnant women or women who may become pregnant.
The MFW Committee reviews protocols to assess research risks (e.g., from medications or physical tasks) that are unique to pregnant women and/or fetuses. The MFW Committee also advises investigators and the IRBs about effects that the pregnant state (e.g., changes in blood pressure or blood sugar, which are typically lower in pregnancy) might have on study outcomes or interventions. Evaluations include assessments of a study’s safety for the mother and fetus, appropriateness of including pregnant women in specific protocols, and recommended methods for excluding pregnant women from research that may pose unacceptable risks to mother and/or fetus.
Risks and/or study results may be affected by pregnancy’s changes on the following (this list is not all-inclusive):
- Endocrine system (blood glucose/insulin, thyroid)
- Cardiovascular system (blood pressure, pulse, cardiac output)
- Respiratory function
- Renal function.
Committee Review
For research involving pregnant women, MFW Committee approval is required when the study involves greater than minimal risk, or unknown but potentially serious risk(s), to the pregnant woman or fetus (e.g., phase I drug study). MFW Committee review should also be obtained whenever there are questions regarding the acceptability of including pregnant women in a study because of scientific concerns (e.g., antihypertensive drug study).
For studies that involve women who may become pregnant (when the research does not specifically exclude pregnant women), MFW Committee approval is required only when risks to the fetus are greater than minimal or unknown but potentially serious. MFW Committee review should also be obtained if the pregnant state (when not excluded) could have unintended effects on study outcomes or interventions.
Minimal risk research and studies in which the pregnant state does not present concerns about data validity do not require MFW Committee approval.
Review Determination
Use the following information to help determine when Maternal-Fetal Welfare Committee review is needed.
Pregnant Women
Yes, a review is needed
- Research involving greater than minimal risk or unknown but potentially serious risk (e.g., phase I drugs) to a pregnant woman or fetus
- Research involving physical activity beyond that required by activities of daily living
- Research of any risk level if pregnancy may affect study results
No, a review is not needed
- Minimal risk research involving surveys, interviews, or focus groups (Category 7)
- Minimal risk research involving medical records or other data review (Category 5)
- Minimal risk research involving specimens or other biological materials (Category 5)
- Blood draws that can be expedited under Category 2(b) (Category 2)
Women Who May Become Pregnant
Without Exclusion for Pregnancy
Yes, a review is needed
- Research involving risks to the fetus that are greater than minimal or unknown but potentially serious (e.g., phase I drugs)
- Research of any risk level if pregnancy may affect study results
No, a review is not needed
- Minimal risk research involving surveys, interviews, or focus groups (Category 7)
- Minimal risk research involving medical records or other data review (Category 5)
- Minimal risk research involving specimens or other biological materials (Category 5)
- Blood draws that can be expedited under Category 2(b) (Category 2)
Pregnant Women are Excluded
No, a review is not needed
- Research of any risk level that specifically excludes or by design does not involve pregnant women or women of child-bearing potential (e.g., studies involving post-menopausal women, prostate cancer, etc.)
Submission Instructions
Studies submitted for IRB review will be screened by the Office of Responsible Research Practices (ORRP) to determine if MFW Committee review is required. When submissions meet the criteria for Maternal Fetal Welfare Committee review, applicable sections of the submission and relevant materials (e.g., protocol, consent/assent forms) will be forwarded by ORRP staff to the MFW Committee prior to IRB review.
Notification of the outcome of MFW Committee review will be sent to the principal investigator and to ORRP and should be uploaded with the materials for IRB review. The IRBs may also independently request a review by the MFW Committee when questions arise during the review process.
Additional Information
Contact Kartik Venkatesh at Kartik.Venkatesh@osumc.edu for questions regarding Maternal-Fetal Welfare Committee review.