Informed consent

Informed consent is the cornerstone of ethical clinical research conduct and provides the most responsible and reliable foundation from which robust research can be undertaken. Consent processes that ensure a participant’s decision to take part is well-informed and freely-chosen, and respect the agency and autonomy of participants. Information about a study should be provided in a calm, supportive, and culturally sensitive way, recognizing that pregnancy and the breastfeeding period can be an emotionally intense period for decision making. Respectful, transparent, and empathetic communication helps women feel valued and confident in contributing to research that benefits future mothers and babies.

For studies involving pregnant or lactating women, information about the study should be provided during the antenatal period to allow time for reflection and to help reduce stress during later decision-making.

During labour, any discussion about consent should be succinct, compassionate, and focused on comfort and safety, avoiding unnecessary stress, and discussions should only proceed when the woman feels capable and supported. Consent during labour should not be considered unethical and labour should not automatically disqualify a woman from participating in the trial. It is important to judge on a case-by-case basis. Use of a trusted third party may help to support assessment of capacity in labour.

In emergency scenarios, alternate pathways for consent exist and should be explored during trial set-up and approved for use by ethical review boards prior to implementation. An example of an alternate pathway is verbal consent at time of acute event, followed up with written consent later. When verbal consent is used in emergencies, reassure women as soon as possible that their wishes are understood and respected and ensure that their consent is documented. When follow-up consent is sought, ensure the discussion is done in a calm environment, respecting the woman’s physical and emotional recovery.

In women who are not pregnant at time of participation in a trial, consent forms should have the provision for re-consenting should she become pregnant during participation in the trial. When renewed consent is required, provide extra emotional support and counselling, as becoming pregnant during a trial can bring anxiety and uncertainty.

The use of template consent forms and standardized counselling protocols would aid consistency across studies. Information must be provided in plain, accessible language, using examples and visual tools whenever possible. Pictorial aids, simplified text, and comprehension‑checking methods should ideally be employed.

Forms must explicitly describe:

• for women of childbearing age, the possibility of women becoming pregnant during trial;
• for pregnant women, the risks and benefits to the woman, her potential baby and (if breastfeeding) the infant. If the risks are known, these need to be clearly explained. If they are not known, it is important to be clear about this and provide guidance through any data (if available) from non-pregnant populations;
• study procedures and any deviations from their routine antenatal, intrapartum and postpartum care;
• confidentiality, the woman’s right to withdraw, and her right to access results. Information for participants should clearly explain how their data and samples are stored, protected, and possibly shared. Participants should be reminded at intervals that they can withdraw from the study at any time without affecting their medical care or relationship with clinicians;
• the possibility of discovering genetic or maternal conditions incidentally; and
• the duration and methods of follow up of the woman and her potential baby postnatally.

Consent must always come directly from the pregnant or lactating woman. Women should be encouraged, however, to discuss enrolment with their partners and/or families.