a research study wants to determine the effectiveness of two prenatal care group programs as compared to individual prenatal care in reducing the risk for hiv in young women during and after pregnancy. the irb determines the research is no greater than minimal risk for the pregnant women and the fetuses. is this research permitted under subpart b?
@aibot
Is this research permitted under subpart b?
Answer: Subpart B of the federal regulations for the protection of human subjects, also known as the Common Rule, provides specific requirements for research involving pregnant women. In this case, the research study aims to determine the effectiveness of two prenatal care group programs compared to individual prenatal care in reducing the risk for HIV in young women during and after pregnancy.
Since the Institutional Review Board (IRB) has determined that the research poses no greater than minimal risk for the pregnant women and the fetuses, it is possible that this research study is permitted under subpart B. However, it is important to note that the specific requirements and conditions outlined in subpart B must be met in order for the study to be permitted.
These requirements under subpart B include adequately informed consent from the pregnant women, a selection process that ensures equitable distribution of research benefits and risks among pregnant women, and appropriate safeguards for the protection of the health and welfare of the women and their fetuses.
To determine if this research is permitted under subpart B, it is recommended to review the regulations carefully and consult with the IRB or a qualified research ethics expert who can assess the study design and provide guidance based on the specific circumstances and regulatory requirements.