Biobanking in obstetrics research: the opinions of project participants on the safety of donating biospecimens during pregnancy

Background and aims. In the context of the novelty of personalized medicine and biobanking in Romania, there is an acute need to analyze the degree of knowledge of the key actors in the domain. The present study sought to investigate the understanding of ‘biobanking’ and ‘personalized medicine’ in three categories of participants in the development of a biobank – health professionals (clinicians/diagnosticians), scientific researchers, and patients, in order to identify possible faults regarding the level of information. The secondary objective of this study was to identify key elements and relevant data that should be detailed in the clinical dataset that accompanies a biological sample. Methods. A total of 120 participants were included in this study that were divided into three categories that represent key actors in the development and management of a cancer biobank – clinicians (n=40), scientific researchers (n=40), and oncology patients (n=40). Results. The survey indicated that the terms ‘biobank’ and ’personalized medicine’ are unknown only in a proportion of patients, while for the other two groups, these terms are already known. The second questionnaire allowed the arrangement of a recommended clinical dataset to be filled when a biological sample is provided to be included in a cancer biobank. Conclusions. The trust of patients and healthcare professionals in building biobanks that adhere to ethical and operational standards in Romania is important, as the development of artificial intelligence and databases allows advanced knowledge and connection of findings from different databases and, therefore, brings the concept of personalized medicine closer to the clinical practice. The information included in this dataset will be integrated and constitutes a comprehensive biobank database. All these aspects are meant to increase the utility of the specimens in cancer research, as clearly annotated samples, along with prospective data, bring valuable knowledge that helps scientific researchers and clinicians make the clinical connection between the molecular alterations and the phenotype of particular patients or a disease.

We established a prospective birth cohort, the Westlake Precision Birth Cohort (WeBirth), based on 2000 pregnant women with gestational diabetes mellitus (GDM) in the second trimester and their offspring. The WeBirth provides a new framework for prospective birth cohort study with sophisticated integration of precision nutrition, wearable devices, and multiomics data collection among patients with GDM. [Image: see text]

Listening to and involving children and young people (CYP) in decision-making and services that affect them has become increasingly important. Since the 1990s, there has been a rise in participatory approaches and research with CYP. Both models of participatory research and practice in this area are being developed. This research aims to enhance developments in participatory research with CYP by learning from the experiences, perspectives and accounts of CYP who have experienced a participatory project.\nThe participatory research project that participants in this research experienced was The Verbatim Formula (TVF), a creative residential workshop for care-experienced young people, using applied art practices to investigate their experiences of care and plans for their futures.\nThis research used an Interpretative Phenomenological Analysis (IPA) approach to explore how the young people taking part in TVF, experienced the project. A sample of five young people, ranging from the age of 16 to 21 years old took part in face-to-face semi-structured interviews.\nThe findings of this research focused on three main themes: the young people made sense of their experiences of the project through participating; learning and interpersonal relationships. The richness and power of how young people experienced the project highlighted the possibilities of what can be gained by asking CYP about their experiences and how these could develop participatory research practices and thinking. There are also implications for educational psychology practice and the potential for future research with Educational Psychologists is outlined.

Who are vulnerable people? Why are they vulnerable in clinical trials? How are they protected in European law? Health research poses the old but constantly renewed dilemma of how to balance individual interests and integrity with the protection and promotion of public health. The case of vulnerable people will serve both as the subject of interest and as a heuristic tool. Why are older adults not a category of vulnerable participants? Why assimilate pregnant women to people unable to defend their interests? Why should patients suffering from orphan diseases be classified as a vulnerable category in clinical trials? How should participants from developing countries be classified? Vulnerability is dominantly approached through vulnerable categories as opposed to a proper definition. However, such an approach not only turns out to be stigmatizing, but also implies a one-size-fits-all protection rarely suitable to all. This work suggests to define vulnerability starting by distinguishing between the types of risk, to then only highlight the factors of vulnerability and, when appropriate, vulnerable categories. This thesis explores how the laws of the Council of Europe and of the European Union protect vulnerable people in clinical trials, with the underlying aim to analyse if and how this protection contributes to the construction of a concept of vulnerability. First, European law related to clinical trials seems to be mainly focused on individual vulnerability, more precisely on decisional vulnerability i.e. vulnerability to risks of violation of autonomy in the decision-making process of a (potential) trial participant. Vulnerable groups benefit from a solid protection when they cannot give valid consent, be it de jure like for instance minors and incapacitated adults, or de facto for instance persons who are unconscious or deprived of liberty. Nonetheless whenever the situation of vulnerability is more subtle and the potential participant only unable to defend his/her interests (e.g. suicidal or psychiatric patients, socially or economically disadvantaged groups, people in a situation of deference or dependency), European law is pretty much silent. This is all the more surprising because asymmetrical compared to the increasing implication of European law in specific safeguards for designated vulnerable groups. Second, European law does not openly describe a collective concept of health vulnerability dealing with negative consequences of underrepresentation of vulnerable groups in clinical trials on the safety and efficacy of medicinal products. Nonetheless, it does offer concrete although isolated solutions for paediatric and orphan medicines. It also provides for emerging processes which, although not comparable to the former palliative regimes, are also promoting research on specific health needs of older adults and of patients from developing countries. However, these provisions are scattered and, most importantly developed over political decisions lacking coherency as there are a lot more vulnerable groups who have similar needs, for instance pregnant women. This protection should rather stem from a generic approach grounded in European fundamental rights and public health ethics underlining the need for equitable access to health care and thus equitable representation of vulnerable groups in clinical trials.

Biological samples—such as tissues, blood and cells—are an increasingly important tool for research into human diseases and their genetic and physiological causes. To ease their storage and access, many of these samples are now stored in biobanks. The number of human biological samples in such collections amounted to several hundred million in 1999 in the USA alone—about one sample per US citizen (Eiseman, 2000; Azarow et al , 2003)—and is increasing rapidly. Three‐quarters of the clinical trials that drug companies submit to the US Food and Drug Administration (Rockville, MD, USA) for approval now include a provision for sampling and storing human tissue for future genetic analysis (Abbott, 2003). At the same time, there is a boom of population biobanks, as more and more countries establish new sample collections (Kaiser, 2002). Among the best known are: the Icelandic Health Sector Database; the Estonian Genome Project; the UK Biobank; the CARTaGENE Project in Quebec, Canada; the Banco Nacional de ADN in Spain; the International HapMap Project; and several US biobanks, such as the National Children's Study, the Marshfield Clinic's Personalized Medicine Research Project and the National Health and Nutrition Examinations Surveys. ![][1] This boom of biobanks has spawned a ‘boomlet’ of regulations and guidelines, which has created controversies, particularly about the importance and definition of informed consent. The consent of participants is usually required before biobank samples can be used in research, but the nature of this consent, and how it is obtained, vary widely. Many European guidelines take the view that general consent is acceptable to use samples for future, as yet unspecified, research projects; US and Canadian policy follows a more rigorous standard of consent. Until 2004, both Europe and the USA considered coded and linked anonymized samples—in which a code links the sample to its donor—as identifiable and therefore … [1]: /embed/graphic-1.gif

Background: Iodine deficiency (ID) during pregnancy has been recognized as a major cause of hypothyroidism and adverse health consequences in both mothers and children. Although urinary iodine concentration (UIC) in school-aged children is recommended as an indicator to assess ID in the general population, it may not be a good surrogate for directly assessing iodine status in pregnant women. Iodine supplementation of mildly iodine-deficient pregnant women has been recommended worldwide; however, long-term benefit and safety of iodine supplementation in this group is uncertain. Finally, pre-pregnancy body mass index (BMI) and gestational weight gain (GWG) may negatively affect thyroid function and pregnancy outcomes. Objectives: 1) to measure UIC in pairs of pregnant women and their school-aged children living in the same household; 2) to investigate the effects of iodine supplementation on maternal thyroid function, pregnancy and birth outcomes, and newborn development; 3) to evaluate the association between pre-pregnancy BMI and GWG with thyroid function and pregnancy outcomes. Methods: 1) In a cross-sectional pilot study, UIC was measured in spot urine samples from pairs (n=302) of healthy pregnant mothers and their school-aged children in Bangkok; 2) Arandomized controlled trial was conducted with 200 µg iodine per day or placebo given to mildly ID pregnant Thai women from <14 weeks to term. Anthropometrics, maternal thyroid function, UIC and thyroid volume were measured at baseline, 2ndand 3rdtrimester, at delivery and 6-week postpartum. Birth outcomes were collected from hospital records. Neonatal thyroid function, UIC and thyroid volume were measured at delivery and 6 weeks after birth. The Neonatal Behavioral Assessment Scales (NBAS) was used to assess newborn development. Results: 1) In the pilot study, median UIC in the pregnant women was 108 (11–558) µg/L and was lower than UIC in their school-aged children [200 (25–835) µg/L] (P<0.001); 2) In the RCT, medianUIC increased significantly from baseline in both groups, and the increase was higher in the iodine group (p<0.001). At 30 weeks of gestation, only 2% of the women in the placebo group and 7% in the iodine group reported a median UIC >500 µg/L. Maternal thyroid function, thyroid volume and the prevalence of all thyroid dysfunction subtypes did not differ significantly between treatment groups during the study (p>0.05). At 6-week postpartum, the prevalence of postpartum thyroiditis (hyperthyroidism) was significantly lower in the iodine group (3%) as compared to the placebo group (9%) (OR: 95%CI, 0.17: 0.04-0.70). There were no significant differences between newborn groups in thyroid function, thyroid volume, birth characteristics, UIC and NBAS score (p>0.05); 3) Pre-pregnancy BMI was a negative predictor of free thyroxine (fT4) (β=-0.20, P<0.001) in early gestation (<14 weeks). Compared to normal weight women, the prevalence ratio (95% CI) of a low fT4 in overweight women was 3.64 (2.08–6.37) (P<0.01). In addition, secondary data analysis showed that overweight women had an 11-fold higher risk of delivering a large for gestational age infant compared to normal weight women, while women who had excessive GWG were 5.6 times more likely to deliver a macrosomic infant compared to women with normal GWG. Conclusion: 1) UIC in school-aged children should not be used as a surrogate for monitoring iodine status in pregnancy; 2) iodine supplementation (200 µg/d) in mildly iodine-deficient pregnant Thai women was effective in increasing iodine intakes into the adequate range but had no benefit on antenatal maternal thyroid function or newborn outcomes out to 6 weeks; however, it significantly reduced the risk of maternal postpartum thyroid dysfunction; 3) excess maternal body weight both before and during pregnancy may have adverse impacts on maternal thyroid function as well as birth weight. Therefore, maintaining normal body weight before and throughout pregnancy should be recommended.

Role orientation and community pharmacists' participation in a project to improve patient care

Introduction: In biobanks, participants’ biological samples are stored for future research. The application of artificial intelligence (AI) involves the analysis of data and the prediction of any pathological outcomes. In AI, models are used to diagnose diseases as well as classify and predict disease risks. Our research analyzed AI’s role in the development of biobanks in the healthcare industry, systematically. Methods: The literature search was conducted using three digital reference databases, namely PubMed, CINAHL, and WoS. Guidelines for preferred reporting elements for systematic reviews and meta-analyses (PRISMA)-2020 in conducting the systematic review were followed. The search terms included “biobanks”, “AI”, “machine learning”, and “deep learning”, as well as combinations such as “biobanks with AI”, “deep learning in the biobanking field”, and “recent advances in biobanking”. Only English-language papers were included in the study, and to assess the quality of selected works, the Newcastle–Ottawa scale (NOS) was used. The good quality range (NOS ≥ 7) is only considered for further review. Results: A literature analysis of the above entries resulted in 239 studies. Based on their relevance to the study’s goal, research characteristics, and NOS criteria, we included 18 articles for reviewing. In the last decade, biobanks and artificial intelligence have had a relatively large impact on the medical system. Interestingly, UK biobanks account for the highest percentage of high-quality works, followed by Qatar, South Korea, Singapore, Japan, and Denmark. Conclusions: Translational bioinformatics probably represent a future leader in precision medicine. AI and machine learning applications to biobanking research may contribute to the development of biobanks for the utility of health services and citizens.

Background: Physical activity reduces psychosocial stress in pregnant women. Stress levels might be self-reported (psychosocial) or measured with biomarkers, one of which is hair cortisol concentration (HCC). Additionally, personality has been associated with stress and physical activity. Methods: The first aim of our study was to explore the differences in self-reported stress assessed by the Perceived Stress Scale (PSS) and in HCC with regard to physical activity level in pregnant (N = 29) and non-pregnant (N = 21) women. The second aim was to analyze the correlations among perceived stress, HCC, frequency of exercise and personality in the two groups separately. Results: There was a significant difference in frequency of exercise and self-reported stress between the two groups, with a lower level in pregnant women, but no differences in HCC and in personality were found. In the group of pregnant women, there was a significant negative correlation between HCC and frequency of exercise sessions, with the latter correlating positively with openness to experience. In the group of non-pregnant women, perceived stress negatively correlated with extraversion, agreeableness and emotional stability. HCC correlated negatively with conscientiousness. Conclusions: Our findings indicate the importance of physical activity programs dedicated to pregnant women for their life quality.

This is a shortened version of the background briefing and discussion paper commissioned by the Wellcome Trust in November 1999. The original paper was called 'The Use of Biological Sample Collections and Personal medical Information in Human Genetics Research-Issues for Social Science Research and Public Policy'. This paper provides a description of some of the current research using biological samples and the new developments in this field. It also provides an overview of the legal, social and policy issues that surround the use of biological samples and personal medical information in human genetics research within the UK.

Effectiveness of a two-stage strategy using the 16-item Prodromal Questionnaire (PQ16/fPQ16) and the Comprehensive Assessment of At Risk Mental States (CAARMS) in the early detection of Ultra High Risk (UHR) patients in Lebanon: a cross-sectional pilot study

How Can Biobanks Help You in Your Research Projects?

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi.

The concept of fear of childbirth includes various types of anxiety and fears related to pregnancy and delivery. This fear can have a significant impact on women's health. Therefore, a study was conducted to analyze the regression model of fear of childbirth among pregnant women. This pilot cross-sectional study was conducted from August to November 2023 with 152 pregnant women in Bojnurd, Iran, using a multi-stage sampling method. Data were collected from tools including a personal and obstetric information form, a childbirth attitude questionnaire, social support assessments, and a childbirth self-efficacy scale. Data analysis was performed using SPSS version 24, utilizing descriptive statistics, t-tests, and multiple linear regression. The results of multiple linear regression indicate that the variables of age (B = 0.257), women's education(B = 2.54), spouse's education (B = 3.87), and preferred delivery(B = 7.097) can significantly predict the variance in fear of childbirth. The results of this study can help healthcare providers identify and screen women at risk of experiencing fear of childbirth. By doing so, they can take proactive measures to reduce this fear and its negative effects, thereby easing the delivery process. This can be achieved through counseling sessions and by improving the quality of prenatal care for at-risk women.

Worldwide research in down syndrome have shown that advanced maternal age (˃30 years) at conception, lower folate status and/or impaired folate metabolism, maternal weight gain during pregnancy, low socioeconomic conditions, radiation exposure, use of contraceptive pills, and taking tobacco/smoking are major maternal risk factors for giving birth child with DS. However, the occurrence of those factors in pregnant women at advanced age has not yet been investigated in Bangladesh. Therefore, a large scale study was needed to explore the overall scenario in Bangladesh. This pilot cross sectional study was aimed to determine the serum folate and homocysteine status at advanced age pregnant women. We measured serum folate and homocysteine concentrations using the Enzyme-Linked Immunosorbent Assay (ELISA). Out of 70 pregnant women, serumfolate level was low (&lt;5 ng/ml) in 13 (18.57%), intermediate (5-6.9 ng/ml) in 8 (11.43%) and normal in 49 (70%) whereas homocysteine concentrations were found low (&lt;5 ng/ml) in all participants. Finally, questionnaire data indicates, low socioeconomic status, overweight during pregnancy, taking contraceptive pills and taking tobacco/smoking was higher percentage in folate-deficient pregnant women than normal serum folate level women. Additionally, women (n=13) with low folate level belongs to low socioeconomic status, overweight, taking contraceptive pills and tobacco/smoking did not give birth child with DS phenotypes. Together, our preliminary findings give an overview of DS associated risk factors in Bangladeshi pregnant women. Large scale study is going on. In next study, we might able to investigate DS risk factors, their associations with serum folate and homocysteine levels and finally with DS phenotypes in child throughout the country. Keywords: Down syndrome; risk factors; folic acid; homocysteine; pregnant women; Bangladesh.