Search

Abstract Background Since the biological material that remains after diagnostic and therapeutic procedures plays crucial role in biobank research, this study aims to explore cancer patients’ views on the donation of biospecimens for research purposes. Methods 548 oncology patients from two hospitals with oncology treatment units in Poznan, Poland, completed an anonymous, self-administered pen-and-paper questionnaire. Results Although only 43.4% of patients had heard of biobanks, 93.1% declared themselves willing to donate. 71.1% of patients believed that doctors should ask patients to donate, and 60.9% that this should be done before the medical procedure. While 65% of patients were willing to donate any type of tissue that remained after a medical procedure, blood, saliva and hair were indicated most frequently. 40.5% of patients would donate their entire body after death and 21% would refuse. Patients’ support for biobanks was mainly driven by the desire to support science, help advance cancer research and altruism. Some respondents expected health information or medical treatment. The most common barriers for donation were physical distance, repeated examinations, concerns over the privacy and confidentiality of data and the commercial or unethical use of samples. Patients’ attitudes toward biobank donation seemed to be associated with age, education level, declared religiousness, a family history of genetically determined diseases and whether they were a blood donor. Conclusions Although cancer patients’ lack of biobank awareness had no effect on their affirmative attitudes towards biobank research, there is a need to further increase patients’ support and overcome possible barriers that might hinder their willingness to donate.

Introduction: The development of the scientific potential linked with biobanking and research on human biological material is highly dependent on the willingness of potential donors to cooperate with entities that collect the material. For this reason, it is crucial to identify the circumstances and factors that may encourage potential participants to donate their biological material. In particular, knowledge of the motivational factors that can be modified by the persons managing a biobank may prove notably important for shaping the organizational and communication policy of the biobank and other scientific institutions. Material and methods: The research was carried out on a group of 1,100 people over 18 years of age representing the adult population of Poland in 2021. Results: More than half of the respondents declared their willingness to donate a blood sample for research purposes to a biobank (57.8%). The most often indicated incentives among the factors supporting the donation of biological material were offers of: obtaining the results of genetic tests predicting the risk of diseases (77.1%), blood tests (71.3%), the possibility of obtaining a small remuneration (64.6%) and the carrying out of genetic ancestry tests (60.4%). Conclusion: Offering the possibility of performing additional diagnostic tests, especially genetic tests, may significantly increase the willingness of potential donors to cooperate with biobanks and other entities collecting human biological material for the purpose of scientific research. However, attention should also be paid to the challenges and risks linked with respecting the privacy and autonomy of research participants. [ABSTRACT FROM AUTHOR]

While biobanking is expanding globally, the empirical evidence concerning the impact of religion on future healthcare professionals' awareness and willingness to donate biospecimens for biobank research is lacking. To understand how medical students' religious beliefs can fuel their questions regarding how biospecimens would be stored, cared for, and used, we conducted a survey among 1500 medical students at Poznań University of Medical Sciences. Our findings suggest that, while both religious and nonreligious students supported the idea of biobanking of human biological material and were willing to donate for research purposes, nonreligious students felt more positive toward biobanking, supported the idea of establishing biobanks in Poland more often, and were more eager to donate most types of tissues and to participate in biobank research. Religious beliefs were also associated with medical students' perception of benefits and risks resulting from biobanking, perceived trust toward various biobank institutions, and preferred type of consent. [ABSTRACT FROM AUTHOR]

Background: Since the biological material that remains after diagnostic and therapeutic procedures plays crucial role in biobank research, this study aims to explore cancer patients' views on the donation of biospecimens for research purposes. Methods: 548 oncology patients from two hospitals with oncology treatment units in Poznan, Poland, completed an anonymous, self-administered pen-and-paper questionnaire. Results: Although only 43.4% of patients had heard of biobanks, 93.1% declared themselves willing to donate. 71.1% of patients believed that doctors should ask patients to donate, and 60.9% that this should be done before the medical procedure. While 65% of patients were willing to donate any type of tissue that remained after a medical procedure, blood, saliva and hair were indicated most frequently. 40.5% of patients would donate their entire body after death and 21% would refuse. Patients' support for biobanks was mainly driven by the desire to support science, help advance cancer research and altruism. Some respondents expected health information or medical treatment. The most common barriers for donation were physical distance, repeated examinations, concerns over the privacy and confidentiality of data and the commercial or unethical use of samples. Patients' attitudes toward biobank donation seemed to be associated with age, education level, declared religiousness, a family history of genetically determined diseases and whether they were a blood donor. Conclusions: Although cancer patients' lack of biobank awareness had no effect on their affirmative attitudes towards biobank research, there is a need to further increase patients' support and overcome possible barriers that might hinder their willingness to donate. [ABSTRACT FROM AUTHOR]

The South African National Health Research Ethics Council (NHREC) recently released a final draft revision of the standard material transfer agreement (MTA) that was promulgated into law in 2018. This new draft MTA raises pertinent questions about the NHREC's mandate, the way in which the draft MTA deals with data and with human biological material, and its avoidance of the concept of ownership. After South Africa's data protection legislation, the Protection of Personal Information Act (POPIA), became operational in mid 2021, the legal landscape changed and it is doubtful that the NHREC has a residual mandate to govern personal information in health research. Furthermore, data is dealt with in a superficial, throw-away fashion in the draft MTA. The position with human biological material is not substantially better, as the draft MTA fails to recognise that human biological material can contain pathogens, which has important legal and ethical ramifications that are not sufficiently addressed. A central problem with the draft MTA is its use of the term 'steward', and avoidance of the legal concept of 'ownership'. This is not only misaligned with the South African legal framework, but also fails to consider the ethical case for recognising ownership. Finally, a call to embrace decolonial thinking in health research underscores the importance of recognising ownership in order to foster the growth of the local bio-economy. Key recommendations to reshape the draft MTA include: Making use of the eventual revised MTA optional, and allowing it to evolve with input from scientific and legal communities; regulating the transfer of associated data in a separate data transfer agreement that can be incorporated by reference in the MTA; enhancing guidance on liability and risk management in respect of human biological material that contains pathogens; and, finally, adopting a decolonial approach in health research governance, which requires recognising the ownership rights of South African research institutions. [ABSTRACT FROM AUTHOR]

IntroductionThe development of the scientific potential linked with biobanking and research on human biological material is highly dependent on the willingness of potential donors to cooperate with entities that collect the material. For this reason, it is crucial to identify the circumstances and factors that may encourage potential participants to donate their biological material. In particular, knowledge of the motivational factors that can be modified by the persons managing a biobank may prove notably important for shaping the organizational and communication policy of the biobank and other scientific institutions.Material and methodsThe research was carried out on a group of 1,100 people over 18 years of age representing the adult population of Poland in 2021.ResultsMore than half of the respondents declared their willingness to donate a blood sample for research purposes to a biobank (57.8%). The most often indicated incentives among the factors supporting the donation of biological material were offers of: obtaining the results of genetic tests predicting the risk of diseases (77.1%), blood tests (71.3%), the possibility of obtaining a small remuneration (64.6%) and the carrying out of genetic ancestry tests (60.4%).ConclusionOffering the possibility of performing additional diagnostic tests, especially genetic tests, may significantly increase the willingness of potential donors to cooperate with biobanks and other entities collecting human biological material for the purpose of scientific research. However, attention should also be paid to the challenges and risks linked with respecting the privacy and autonomy of research participants.

The South African National Health Research Ethics Council (NHREC) recently released a final draft revision of the standard material transfer agreement (MTA) that was promulgated into law in 2018. This new draft MTA raises pertinent questions about the NHREC’s mandate, the way in which the draft MTA deals with data and with human biological material, and its avoidance of the concept of ownership. After South Africa’s data protection legislation, the Protection of Personal Information Act (POPIA), became operational in mid 2021, the legal landscape changed and it is doubtful that the NHREC has a residual mandate to govern personal information in health research. Furthermore, data is dealt with in a superficial, throw-away fashion in the draft MTA. The position with human biological material is not substantially better, as the draft MTA fails to recognise that human biological material can contain pathogens, which has important legal and ethical ramifications that are not sufficiently addressed. A central problem with the draft MTA is its use of the term ‘steward’, and avoidance of the legal concept of ‘ownership’. This is not only misaligned with the South African legal framework, but also fails to consider the ethical case for recognising ownership. Finally, a call to embrace decolonial thinking in health research underscores the importance of recognising ownership in order to foster the growth of the local bio-economy. Key recommendations to reshape the draft MTA include: Making use of the eventual revised MTA optional, and allowing it to evolve with input from scientific and legal communities; regulating the transfer of associated data in a separate data transfer agreement that can be incorporated by reference in the MTA; enhancing guidance on liability and risk management in respect of human biological material that contains pathogens; and, finally, adopting a decolonial approach in health research governance, which requires recognising the ownership rights of South African research institutions.

Consent, in the context of biomedical research, biotechnology and the use of human biological material and associated data, is examined here, and it is demonstrated that informed and broad consent do not constitute valid consent. Dynamic consent is introduced as a viable alternative. New science requires new models of consent and this Commentary introduces such a model so that consent may become future-flexible. [ABSTRACT FROM AUTHOR]

The prohibition of commercialisation of the human body and its parts is not applied consistently and suffers from many exceptions in the human biological material (HBM) market. Examples include the possibility of patenting certain HBM‐derived products and their commercial marketing or payments for blood donations. Thus, the current practice of marketing HBM‐derived products makes the altruistic donor most vulnerable to exploitation while being deprived of benefits. There seem to be two ways to improve this state of affairs. The first is to apply consistently the prohibition of commercialisation of the body and its parts to commercially marketed tissue and cell products as well. This would require limiting the possibility of financial gain associated with the processing, distribution and sale of HBM‐based products. Such a solution, however, does not seem to gain wide acceptance or have a chance of implementation in the near future. Therefore, introducing more transparent rules and greater donor empowerment seems more reasonable by exempting HBM from the ban on commercialisation under certain conditions and with clear limitations. [ABSTRACT FROM AUTHOR]

The willingness to donate human biological material for research purposes is shaped by socio-cultural factors; however, there is a lack of studies analysing the social perception of different human tissues, which may affect such willingness. This study aimed to distinguish different sociocultural categories of human tissues and types of potential donors based on their willingness to donate material. Quantitative research was conducted on a sample of 1,100 adult Poles representative in terms of sex, place of residence and education. According to the study, people were most willing to donate urine (73.9%), blood (69.7%), hair and tears (69.6%) and the least willing to donate post-mortem brain fragments (20%), sperm (males; 36.4%) and egg cells (females; 39.6%). A factor analysis revealed four sociocultural categories of donated tissues: irrelevant, redundant, ordinary and sensitive. Based on these sociocultural categories of tissues, four types of donors were identified: reluctant, highly cooperative, average cooperative and selectively cooperative. The willingness to donate human samples for research is shaped by the sociocultural perception of different body parts and tissues. The lower the sense of "personal relationship" with a specific type of tissue, organ or part of the body, the higher the motivation to donate such biological material for research purposes. Additionally, the willingness to donate is mostly shaped by social trust in physicians and scientists, and potential donors' engagement in charity activities. [ABSTRACT FROM AUTHOR]

Background: Over the past few years, several biobanks have been organized in the Republic of Kazakhstan (RoK). As research biobanks are becoming an increasingly important tool for precision medicine, they require competent biobankers who will help disseminate the idea of biobanking throughout the society and support donation for research purposes. This study aimed to assess the support for research biobanks among medical students (MSs) in Kazakhstan. Methods: This research includes data from an anonymous, self-administered online questionnaire regarding MSs' support for research biobanks in the RoK. Results: Only 212 (31.3%) MSs have heard of biobanks and 466 (68.7%) have not. Students who were biobank-aware held more positive views regarding biobanks, were more likely to support the idea of establishing a research biobank in Kazakhstan, and expressed a greater willingness to donate their biological material for research purposes. Students' awareness of biobanks was also associated with the respondents' motivations to donate. Students who were familiar with biobanks tended to be motivated by altruistic reasons more often, and those unfamiliar with biobanks tended to indicate selfish motives. Students' attitudes toward donation to various types of research and biobanks were influenced by their awareness of biobanks, any family history of genetic disease, experience of chronic disease, declared religiousness, hospitalization history, blood donor status, and year of study. Conclusion: Since MSs' awareness of research biobanks is low, there is an urgent need for biobank education in Kazakhstan.

The willingness to donate human biological material for research purposes is shaped by socio-cultural factors; however, there is a lack of studies analysing the social perception of different human tissues, which may affect such willingness. This study aimed to distinguish different sociocultural categories of human tissues and types of potential donors based on their willingness to donate material. Quantitative research was conducted on a sample of 1,100 adult Poles representative in terms of sex, place of residence and education. According to the study, people were most willing to donate urine (73.9%), blood (69.7%), hair and tears (69.6%) and the least willing to donate post-mortem brain fragments (20%), sperm (males; 36.4%) and egg cells (females; 39.6%). A factor analysis revealed four sociocultural categories of donated tissues: irrelevant, redundant, ordinary and sensitive. Based on these sociocultural categories of tissues, four types of donors were identified: reluctant, highly cooperative, average cooperative and selectively cooperative. The willingness to donate human samples for research is shaped by the sociocultural perception of different body parts and tissues. The lower the sense of “personal relationship” with a specific type of tissue, organ or part of the body, the higher the motivation to donate such biological material for research purposes. Additionally, the willingness to donate is mostly shaped by social trust in physicians and scientists, and potential donors’ engagement in charity activities.

Abstract Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.

The text covers the issue of the admissibility of conducting research using human biological material derived from human corpses and removed (amputated) parts of the human body or material obtained during medical procedures carried out for other purposes. The author analyzes the issue of the admissibility of conducting research and the necessary consent of the entity from which the material originates, as well as the nature of legal opposition to the ex mortuo collection of cells, tissues and organs. The test is a double voice and includes considerations based on Polish legal solutions, which are complemented by an ethical perspective that is an immanent part of the study. [ABSTRACT FROM AUTHOR]

The text is devoted to consideration on the morally desirable way of clarifying the ambiguities identified in a previous part of the double voice. So it contains deliberations on meaning and authority of biological material donor informed consent. Considering research on human corpses the author focus on two questions: why deceased patient's premortem preferences should be taken into account at all and whether "an advance research directives" of that kind should take a form opt-in or opt-out arrangements? Whereas when it comes to research on biological samples the most important question is what type of actual - not presumed - consent meet ethical standards. [ABSTRACT FROM AUTHOR]

The use, collection and modification of human biological material/ the human body is a difficult, controversial and challenging subject demanding deep analyses of all the ethical, social and legal aspects. Use of the human body for experimental purposes for or without the reward is often criticized. It is clear, however, that not all researches on new medicinal products, medical devices or cosmetics can be carried out on animals only. Contribution of a human being in experiments and clinical trials (including organs, tissues or cells) is the only way to verify safety and efficacy of a tested method or substance. Storage of human biological material intended for tests demands meeting conditions provided by legal standards and showing respect for the human body and human dignity; that is why biological material must be, as a rule, stored in cell and tissue banks (biobank). Any entity that wants to operate a biobank must meet a number of complex requirements before entering this narrow, difficult and demanding market. This is the result of legislative chaos and fragmentation of laws at the national and EU level, but also social, ethical or religious prejudice. However, biobanks are an indispensable research tool for understanding genetic or environmental grounds of many diseases, e.g. hereditary ones. Biobanks can undoubtedly revolutionize the health market and contribute to the further development of personalized medicine. However, the entity willing to establish a cell and tissue bank must meet and take into account several criteria. Any entity considering the foundation of a biobank wonders whether this activity will be profitable and whether it can be included in the chain of clinical trials. [ABSTRACT FROM AUTHOR]

In their original article on the subject of research using human biological material, Mahomed, Nöthling-Slabbert and Pepper advanced the notion that the law regarding ownership of human biological material is uncertain, and proposed that our country’s healthcare policy of altruism be changed to mandatory profit-sharing by research participants. In my critique article, I took issue with the notion that the relevant law is uncertain, and suggested that Mahomed et al. failed to present a convincing argument in support of the proposed policy change from altruism to profit-sharing. In their response to my critique article, Mahomed et al. persist with the notion that the relevant law is uncertain; I suggest that this notion is erroneous, as our common law in this regard is well established, and as the authors base their argument exclusively on foreign case law. The authors further fail to make use of the opportunity to augment their argument in support of their proposed policy change from altruism to profit-sharing – in fact, they contradict themselves by disavowing their proposed policy change.

Total reflection X-ray fluorescence (TXRF) analysis was applied in determination of low concentration of lead in samples of human biological materials. The determination of lead in human serum and hair samples is presented as an example. In serum samples, lead concentration was in the range from 0.013 to 0.051 μg/g (median 0.024 μg/g). The reference ranges of lead content in hair are from 1.41 to 4.08 μg/g for men and from 1.18 to 3.29 μg/g for women groups, respectively. Because of Pb concentration range close to the detection limit of the TXRF method, the measurement needed evaluation of the best analytical conditions. This paper presents the results of this evaluation, namely internal standard selection, measurement conditions, and quantitative calibration of the spectrometer. Finally, as a result of evaluation, the detection limit was found on the level 0.001 μg/g (water solution) and about 0.005 μg/g for human hair samples and 0.007 μg/g for serum samples. The obtained values reach nearly the physiological lead level. The presented results are of practical importance for lead concentration studies in human biological materials using the TXRF method. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The right to withdraw one's consent after having agreed to participate in research is a fundamental principle in contemporary research ethics. However, it has been questioned whether this right should apply to research conducted on donated biological samples, including stem cells and tissues from which stem cells can be derived. In this article we present some of the concerns that have been expressed related to this question. We then identify five areas that one needs to pay greater attention to before any conclusions can be drawn as to whether donors should be given the right to withdraw, or under what circumstances withdrawal should be allowed. [ABSTRACT FROM AUTHOR]

Commonly used techniques for trace-element analysis in human biological material are flame atomic absorption spectrometry (FAAS), graphite furnace atomic absorption spectrometry (GFAAS), inductively coupled plasma atomic emission spectrometry (ICP-AES) and inductively coupled plasma mass spectrometry (ICP-MS). Elements that form volatile hydrides, first of all mercury, are analysed by hydride generation techniques. In the absorption techniques the samples are vaporized into free, neutral atoms and illuminated by a light source that emits the atomic spectrum of the element under analysis. The absorbance gives a quantitative measure of the concentration of the element. ICP-AES and ICP-MS are multi-element techniques. In ICP-AES the atoms of the sample are excited by, for example, argon plasma at very high temperatures. The emitted light is directed to a detector, and the optical signals are processed to values for the concentrations of the elements. In ICP-MS a mass spectrometer separates and detects ions produced by the ICP, according to their mass-to-charge ratio. Dilution of biological fluids is commonly needed to reduce the effect of the matrix. Digestion using acids and microwave energy in closed vessels at elevated pressure is often used. Matrix and spectral interferences may cause problems. Precautions should be taken against trace-element contamination during collection, storage and processing of samples. For clinical problems requiring the analysis of only one or a few elements, the use of FAAS may be sufficient, unless the higher sensitivity of GFAAS is required. For screening of multiple elements, however, the ICP techniques are preferable. [ABSTRACT FROM AUTHOR]