Ethical Aspects of Human Placental Perfusion: Interview of the Mothers Donating Placenta

Abstract

Within the EU project “NewGeneris” human placental perfusion has been used for assessing in utero fetal exposure to food carcinogens. Within the work package of ethical aspects of the research, we were interested in the way mothers who donated placentas for perfusion perceived their participation in the study. Thematic interviews were conducted with 25 mothers who had donated the placenta for placental perfusion studies. The main themes covered during the interviews were recruitment for placental perfusion studies, informed consent, risks and benefits, handling and confidentiality of personal information and societal meaning of the placental perfusion studies. Data were analysed qualitatively using thematic content analysis. Mothers, when rightly informed about the purpose of the placental perfusion study were very interested in the study and supported the use of the placenta for such purpose. Overall, this study revealed several points of particular interest in placental perfusion studies. First, the recruiters’ involvement with and commitment to the research project and its ethical conduct were of utmost importance for handling the informed consent procedure correctly. Second, the timing of the recruitment was important since it considerably affected the understanding of the given information, women in labour being obviously less receptive to such information. Third, the trust of participants depended on the multidisciplinary collaboration between the researchers and hospital personnel and this trust was enhanced by a thorough, objective and fair informed consent procedure.

Introduction

Research on ethics of studies involving pregnant women is sparse. Most studies target clinical trials in pregnant women where potential physical harm for both the mother and baby is the main objective [1], [2], [3]. However, while other types of research not directly related to medical side-effects or harm are still meagre, in any type of research pregnant women have been considered as a vulnerable group. According to the Declaration of Helsinki [4] and e.g., in the Finnish law [5] this fact has to be taken into consideration. Current research on informed consent deals mainly with women’s decisions on the mode of delivery [6], [7], [8], [9] genetic testing [10], [11], [12] or serum screening for a variety of diseases, such as HIV [13].

The participation in any study requires that the participants are fully competent to give consent for their participation. The consent must be a voluntary choice, and as a basis of this choice the participants need information presented to them in a manner they can comprehend. Thereafter, the putative participant can make his or her own choice to participate and thus authorise the research staff to act according to the plan [14]. Both autonomy and informed consent are also emphasised in the Finnish Act on the Status and Rights of Patients (785/1992) [5]. In different types of research informed consent may have a different meaning for the participant. For instance, it has been discussed whether the use of human tissue samples given anonymously or archived pathology samples requires specific informed consent [15]. Although a number of studies on healthy volunteers exist [16], [17] the number of perception studies is much less abundant [18].

Use of human placenta in biomedical research has increased in the past few years [19], [20], [21], [22]. The placenta and cord blood are known to be an important resource for stem cell research [23] and some research has already been conducted on ethical aspects of cord blood banking [24], [25]. According to the literature, mothers were willing to donate cord blood to be stored in a biobank with associated relevant information [24], [25]. Major future challenges are the consent for future biobank storage and unforeseen future research [26] as well as tissue exportation from the developing countries to the developed world [27].

Within an EU project NewGeneris (Contract no. FOOD-CT-2005–0163202) we have carried out human placental perfusions to study transplacental transfer and placental effects on placental metabolism of food carcinogens [28], [29]. During these studies, the term placenta was collected after the delivery of healthy women and the tissue remained anonymous. For the present study on ethical aspects of recruitment, mothers who previously agreed to participate in the placental perfusion research were interviewed.

The ethical aspects of human placental perfusion have been almost an unstudied field. In the literature, only one study could be identified using search terms “human placental perfusion” and “ethics” [18]. However, such data may contribute to both improving ethical conduct of recruitment and increasing participation in environmental health studies.