Lactation and breastfeeding research studies: who should provide consent for the neonate?

Area of Science:

• Bioethics
• Human Lactation Research
• Pediatric Research Ethics

Background:

• Current research ethics guidelines offer inadequate direction for studies involving breastfeeding and human lactation.
• Ethical considerations for pediatric research, particularly concerning vulnerable populations like infants, require specific attention.

Purpose of the Study:

• To delineate the principles of informed consent applicable to research involving human lactation and breastfeeding.
• To explore and establish rationales for determining appropriate consent providers for infants participating in lactation and breastfeeding research.

Main Methods:

• Review of existing research ethics frameworks and guidelines.
• Analysis of ethical principles related to consent, assent, and proxy decision-making for pediatric research subjects.
• Discussion of specific challenges in obtaining consent for research involving breastfeeding dyads.

Main Results:

• Identified gaps in current ethical guidelines concerning breastfeeding and lactation research.
• Presented a framework for understanding consent principles in this specialized research area.
• Provided rationales for designating specific individuals (e.g., mothers, legal guardians) as appropriate consent providers for infants.

Conclusions:

• There is a critical need for updated and specific ethical guidelines for breastfeeding and human lactation research.
• Clearer protocols for informed consent are essential to protect the rights and welfare of infant participants.
• Establishing who can provide consent for infants is crucial for the ethical progression of lactation and breastfeeding studies.