Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.
The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.
The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.
The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies.
Thematic content analysis; Ethical views of scientists; Application to ethics committee; Informed consent; Recruitment
Considerable variation has been demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.K., and European nations. With the rise of international research collaborations, RECs in developing countries apply a variety of international regulations. We conducted a qualitative descriptive pilot study with members of the national REC in Malawi to determine criteria they use to review research, and their views on international collaborations. Qualitative content analysis demonstrated that international guidelines are interpreted in light of local African conditions such that emphasis is placed on examining benefit to the community and ensuring the informed consent process translates concepts in locally-meaningful ways. Members suggest that RECs often must comply with regulations that do not fit local conditions. Recommendations are provided for improving such international collaborations.
Research ethics; ethics review; REC; Africa
Since the first successful transplantation of umbilical cord blood in 1988, cord blood has become an important source of hematopoietic stem and progenitor cells for the treatment of blood and genetic disorders. Significant progress has been accompanied by challenges for scientists, ethicists, and health policy makers. With the recent recognition of the need for a national system for the collection, banking, distribution, and use of cord blood and the increasing focus on cord blood as an alternative to embryos as a source of tissue for regenerative medicine, cord blood has garnered significant attention. We review the development of cord blood banking and transplantation and then discuss the scientific and ethical issues influencing both established and investigational practices surrounding cord blood collection, banking, and use.
Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most important steps which thus far have been taken in Belgium are examined. Secondly, recent opinion by the Belgian Advisory Committee on Bioethics with regard to ethics committees is presented and the activities of Belgian ethics committees are discussed. Finally, the option to bring research ethics and clinical ethics under the roof of just one committee is criticised using a pragmatic and a methodological argument. Concomitantly, the authors build an argument in favour of the further development of ethics consultation.
Research ethics have become universal in their principles through international agreements. The standardization of regulations facilitates the internationalization of research concerning drugs. However, in so-called observational studies (i.e. from data collected retrospectively or prospectively, obtained without any additional therapy or monitoring procedure), the modalities used for applying the main principles vary from one country to the other. This situation may entail problems for the conduct of multi-centric international studies, as well as for the publication of results if the authors and editors come from countries governed by different regulations. In particular, several French observational studies were rejected or retracted by United States peer reviewed journals, because their protocols have not been submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC).
national legislation case analysis
In accordance with European regulation, French observational studies from data obtained without any additional therapy or monitoring procedure, do not need the approval of an IRB/IEC. Nevertheless, these researches are neither exempt from scientific opinion nor from ethical and legal authorization.
We wish to demonstrate through the study of this example that different bodies of law can provide equivalent levels of protection that respect the same ethical principles. Our purpose in writing this paper was to encourage public bodies, scientific journals, and researchers to gain a better understanding of the various sets of specific national regulations and to speak a common language.
Biomedical Research; legislation & jurisprudence; Ethics Committees, Research; Ethics, Research; France; Helsinki Declaration; Humans; International Cooperation; Legislation, Drug; Multicenter Studies as Topic; ethics; legislation & jurisprudence
In northeastern Italy, according to Italian legislation, authorized public facilities can accept the donation and preservation of cord blood stem cells (CB-SC). Attitudes and knowledge in pregnant women differs between the local and immigrant (non-European Union [EU]) population. In this study we assessed the choices that pregnant women have with respect to the public and private harvesting system and the main reasons driving their decisions. We examined the ethnic origin of the families and compared tests for syphilis screening and leukocyte (WBC) counts in the CB-SC bags that are required for validation of the collection.
Out of a population of 3450 pregnant patients at the Institute for Maternal and Child Health of Trieste, northeast Italy, 772 women agreed to cord blood harvesting and the associated lab tests. Of these, 221 women (28.6%) were from immigrant families of non-EU countries. Their ethnic affiliation was recorded, and tests were performed for syphilis screening and for nucleated red blood cell (NRBC) interference with the WBC count in CB-SC bags to assess cellularity and to determine if storage was appropriate.
Of the 772 pregnant women, 648 (84.0%) accessed the public collection system, which is free of charge, and 124 (15.0%) accessed the private fee-based system. One woman from the non-EU group opted for the private fee-based system. Of the 3450 pregnant women screened for syphilis at the Institute for Maternal and Child Health, the Treponema pallidum hemagglutination (TPHA) and Venereal Disease Research Laboratory (VDRL) tests were the main tests performed (66.0% of total cases) because many gynecologists in the public harvesting system apply the Italian regulations of the 1988 Decree, while the private system requires tests on syphilis and leaves the option to the lab physicians to select the best determination method. We found that the chemiluminescence method was more specific (97.0%) than the TPHA (83.0%) and nontreponemal rapid plasma reagin VDRL (75.0%) tests (P < 0.05, χ2 test). The specificity link between the two automatic methods versus microscopes for WBC dosing and NRBC interference was r2 = 0.08 (ADVIA 120) and r2 = 0.94 (XE-2100). The public system does not include human T-cell lymphotropic virus testing; this is reserved for the population from endemic zones.
In northeastern Italy current legislation prevents the establishment of private fee-based banks for storage of CB-SC. The cryopreservation, for future autologous personal or family use, is possible only by sending to foreign private banks, with a further fee of €300. These regulations confirm that Italian legislation tries to increase the anonymous allogenic donations and the number of CB-CS bags stored in the free-cost public system, that are available to anyone with therapeutic needs. Private banking is used almost exclusively by the wealthier local population. In the public system, many physicians continue to use older Italian laws regarding syphilis diagnosis, and NRBC interference on WBC count may have an impact on cord blood harvesting. Our findings suggest that in the EU there is no consensus policy on donor management. The value of storage for potential use within the family is useful only with collaboration between the public and the private systems.
cord blood collection; public system; private system; pregnant women’s choice
An international ethics review committee, founded seven years ago, has several unusual features: it selects its own members, who are independent of the drug industry; it includes members with no medical or paramedical background, such as lay people and lawyers; and it reviews protocols together with the study's sponsor. Membership of 31 from nine European countries enables frequent meetings and there is a full meeting of the committee every year to review progress and consider policy. Of the first 294 protocols for phase I, II, or III trials reviewed, 37 were admitted outright, 243 were amended (usually during the discussion of the protocol), and 14 were rejected. It is suggested that, to overcome the problem of ethics review in smaller institutions, regional health authorities in Britain might consider establishing similar committees.
The International Committee of Medical Journal Editors expects authors to report if their studies were carried out in accordance with the International Ethical Guidelines and Declaration of Helsinki; and inform readers regarding the same.
To determine the proportion of International Indexed Dental Journals reporting on ethical clearance for human and animal research, obtaining of informed consent and / or assent, and the conduction of research in accordance with the Declaration of Helsinki and International Medical Research, 2006.
Settings and Design:
A cross-sectional survey of ‘instructions for authors,’ for analysis of editorial policy on ethical processes, was done.
Materials and Methods:
One hundred and twenty-six dental journals (which included 50 general and 76 specialties) were reviewed for reporting, with regard to the Ethical Committee Approval for human and animal researches, obtaining of informed consent / assent from the research participants, and research in accordance with the Declaration of Helsinki as well as International Medical Research 2006 were analyzed.
Statistical Analysis Used:
Descriptive statistics was used and results were expressed in percentages.
Of the 126 dental journals, 57 (45.23%) reported having obtained approval from the Ethics Committee, 33 (26.19%) were instructed about the Animal Ethics Committee approval, and 38 (30.15%) insisted on obtaining and reporting informed consent / assent. 41 (32.53%) journals expected authors to mention the research being conducted according to Declaration of Helsinki and and 3 (2.38%) journals required researches to be conducted in accordance with International Medical Research, 2006.
A significant proportion of international indexed dental journals did not provide instructions to authors to report on the ethical approval, informed consent and / assent, and research conduction according to the Declaration of Helsinki as well as the International Medical Research, 2006.
Authors; ethics; publication; research
The Friuli Venezia Giulia (FVG), a region of North Eastern Italy, has passed legislation (Decree No 2324/2010) to regulate the banking of umbilical cord blood samples for personal, autologous, or family-directed use, and to implement the Agreement of the State-Regions Permanent Conference (Decree No 62/CSR/2010). This paper aims to identify the formalities and the reasons why families collect and bank their cord blood in foreign banks for both personal and private use.
To this end, at the Institute for Maternal and Child Health of Trieste (the regional capital city of the FVG), Italy, which assists about 1800 pregnant women a year, 129 questionnaires, drafted from January 2010 to December 2011 and concerning the granting of authorization to export samples, were examined.
The collected data showed that 75% of involved families had resorted to anonymous public collection, which is available to anyone with therapeutic needs, and provided compatibility and hematologic protocols recognized by the scientific and international community (main indications: leukemia, hemoglobinopaties, and inherited hematologic and immunologic disorders). Conversely, 25.0% requested private storage at a foreign bank for personal or family-dedicated use. The principal motivation by disease was for treatment for diabetes (22.4%) and celiac disease (19.7%) (a multiorgan disease for which the FVG region has provided safeguards by approving a specific law granting support to families; Decree No 561/2007). For these two types of disease we found that information was received from the internet and not from general medical physicians, with a significant difference found using the χ2 test (P < 0.01).
The indication of treating these diseases with cord blood stem cell transplantation appears to be well grounded and encouraging, and has recently been corroborated by the international literature; however, the economic and social motivations promoting cord blood storage, for a fee, in the event of diseases that are still under study, require accurate information through general medical physicians on the actual possibilities of treatment.
autologous cord blood harvesting; North Eastern Italy; emerging hopes of therapy
Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan.
This study consisted of four national surveys sent twice over a period of eight years to two separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses.
Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees.
Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees.
Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs.
To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: (1) Do existing procedures promote representation of women and gender expertise in the committee? (2) How are sex and gender issues dealt with in protocol evaluation?
Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents (regulations, guidelines and review tools in use in 2003).
All countries have rules (mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender‐specific risk–benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools.
The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs.
This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.
bioethics; biological specimen banks; cord-blood stem cell transplantation; ethics; informed consent; legislation
Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs).
Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.
Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.
Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.
Background to the debate: Umbilical cord blood—the blood that remains in the placenta after birth—can be collected and stored frozen for years. A well-accepted use of cord blood is as an alternative to bone marrow as a source of hematopoietic stem cells for allogeneic transplantation to siblings or to unrelated recipients; women can donate cord blood for unrelated recipients to public banks. However, private banks are now open that offer expectant parents the option to pay a fee for the chance to store cord blood for possible future use by that same child (autologous transplantation.)
Private banks offer expectant parents the option to pay a fee for the chance to store cord blood for possible future use by the child. The practice is controversial, for scientific and ethical reasons
Background and objectives
Umbilical cord blood (CB) banking and therapeutic use raise several ethical issues: medical indications, legal framework, public versus private biobanks, autologous versus allogeneic use, ownership, commercialisation, quality assurance and many others. Surrogate informed consent is one of the most notable controversial ethical issues. The aim of this study was to analyse and compare informed consent forms for CB collection, storage and use in the 18 accredited biobanks of the Italian Network.
Material and methods
The first part of the article gives a brief overview of the scientific framework, the comparison of allogeneic and autologous use and Italian regulations. In the second part the contents of the consent forms from the 18 Italian biobanks are compared with the “NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration”.
Most of the Italian consent forms differ significantly from the NetCord-FACT Standards, with regards both to formal and substantial aspects.
Italian forms for CB collection, storage and use need standardisation to meet international criteria.
cord blood; informed consent; biological specimens banks; transplantation
The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively) in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.
With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA) was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee), the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP) Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.
This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to some extent to the differing and/or unclear requirements of the individual ethics committees on the content and comprehension of the submission documents. However, applicants also need to pay more attention to the completeness and validity of the submission documents. The majority of content-related objections apply to the patient information and consent documents and study protocols submitted. Applicants on average acted upon only 3 out of 4 objections, for various reasons: the relevant information was already given in the submitted documents, but had not been taken into consideration by the ethics committees; objections were not applicable; objections lacked a legal basis. In such cases the applicants made reference to the specific information already submitted or gave reasons for not acting on the objection. This course of action was accepted by the ethics committees, with few exceptions. The survey sheds light on the existing inconsistencies in the evaluations of applications by the various ethics committees and suggests ways in which the existing constructive dialogue between applicants and ethics committees may provide a basis to further harmonize both the requirements regarding form and content of application documents, and the criteria for evaluation of applications by ethics committees within the legal framework.
ethics committees; application procedure; formal and content-related objections; clinical trials
Objectives: To summarise the types of case brought to the Clinical Ethics Committee of the National Hospital of Norway from 1996 to 2002 and to describe and discuss to what extent issues of information/communication have been involved in the ethical problems.
Design: Systematic review of case reports.
Findings: Of the 31 case discussions, (20 prospective, 11 retrospective), 19 cases concerned treatment of children. Twenty cases concerned ethical problems related to withholding/withdrawing of treatment. In 25 cases aspects of information/communication were involved in the ethical problem, either explicitly (n = 3) or implicitly (n = 22).
Conclusion: Problems related to information/communication may underlie a classic ethical problem. Identification of these "hidden" problems may be important for the analysis, and hence, the solution to the ethical dilemma.
OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from all 36 chairmen contacted: four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines. CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees.
Umbilical cord banks are a central component, as umbilical cord tissue providers, in both medical treatment and scientific research with stem cells. But, whereas the creation of umbilical cord banks is seen as successful practice, it is perceived as a risky style of play by others. This article examines and discusses the ethical, medical and legal considerations that arise from the operation of umbilical cord banks in Mexico.
A number of experts have stated that the use of umbilical cord goes beyond the mere utilization of human tissues for the purpose of treatment. This tissue is also used in research studies: genetic studies, studies to evaluate the effectiveness of new antibiotics, studies to identify new proteins, etc. Meanwhile, others claim that the law and other norms for the functioning of cord banks are not consistent and are poorly defined. Some of these critics point out that the confidentiality of donor information is handled differently in different places. The fact that private cord banks offer their services as "biological insurance" in order to obtain informed consent by promising the parents that the tissue that will be stored insures the health of their child in the future raises the issue of whether the consent is freely given or given under coercion. Another consideration that must be made in relation to privately owned cord banks has to do with the ownership of the stored umbilical cord.
Conflicts between moral principles and economic interests (non-moral principles) cause dilemmas in the clinical practice of umbilical cord blood storage and use especially in privately owned banks. This article presents a reflection and some of the guidelines that must be followed by umbilical cord banks in order to deal with these conflicts. This reflection is based on the fundamental notions of ethics and public health and seeks to be a contribution towards the improvement of umbilical cord banks' performance.
Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region.
We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data.
We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support.
While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.
The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated.
The high variability of “centre-specific” documentation required by Independent Ethics Committee (IEC) plays a role in the time required for activation of participating centres of multicentre clinical trials. This study (a) provides a picture of the different activities, structural requirements and resources dedicated to the operation of the local IEC in Italy; (b) defines a detailed list of “centre-specific” documents considered as essential by the IEC for issuing its opinion and (c) suggests a “single document” to reduce the variability of the “centre-specific” documents required by the IEC.
Two surveys were conducted through the portal of National Monitoring Centre of Clinical Trials (https://oss-sper-clin.agenziafarmaco.it/). The first survey focused on the local IEC resources and on the “centre-specific” documentation that local IEC required from the Sponsor and local Principal Investigator (PI). The second focused on “single document” required in the form of statements from the Sponsor and the PI. Answers were discussed and extended during regular scheduled teleconferences and plenary meeting.
From 22/07/2009 to 15/12/2009, and from 19/04/2010 to 14/05/2010, 131 and 125 IECs responded to the first and the second surveys, respectively. 67% and 51% of IECs consider the structural requirements and the staff dedicated to the activity of the IECs as sufficient, respectively. Most of the IECs consider the “centre-specific” documentation as necessary for issuing the opinion, and a high percentage of IECs consider the proposed documentation as acceptable in substitution to any other “centre-specific” documentation already in use.
The harmonization of IECs practice in Italy is the first step to facilitate multicentre clinical trials. Similar efforts should be directed to reduce the total number of IECs and to standardize clinical trials approval procedures, focusing on administrative procedures as well.
Umbilical cord blood banking efforts have increased dramatically in the past two decades in response to increasing demand for alternative sources of blood stem cells to support patients requiring hematopoietic stem cell transplantation. Transplant centres have accumulated increasing expertise in their understanding of umbilical cord blood characteristics that are associated with improved outcome following transplantation. These characteristics and factors can assist transplant centres in selecting cord blood units from the worldwide inventory of banked units. Umbilical cord blood banks, therefore, need to remain agile in adjusting the inventory of the banks to address shifts or changes in the needs of transplant centres. Public umbilical cord blood banks face the challenge of building inventory while managing limited resources and are faced with decisions regarding which units can be stored and which units that have been collected should be discarded or used for other endeavours such as research. To this end, we sought to review parameters influencing the decision to bank a collected cord blood unit. In this paper, we will address parameters associated with graft potency and address other factors that guide the decision to bank collected units.
There are no published studies on stem cells from equine cord blood although commercial storage of equine cord blood for future autologous stem cell transplantations is available. Mesenchymal stem cells (MSC) have been isolated from fresh umbilical cord blood of humans collected non-invasively at the time of birth and from sheep cord blood collected invasively by a surgical intrauterine approach. Mesenchymal stem cells isolation percentage from frozen-thawed human cord blood is low and the future isolation percentage of MSCs from cryopreserved equine cord blood is therefore expectedly low. The hypothesis of this study was that equine MSCs could be isolated from fresh whole equine cord blood.
Cord blood was collected from 7 foals immediately after foaling. The mononuclear cell fraction was isolated by Ficoll density centrifugation and cultured in a DMEM low glucose based media at 38.5°C in humidified atmosphere containing 5% CO2. In 4 out of 7 samples colonies with MSC morphology were observed. Cellular morphology varied between monolayers of elongated spindle-shaped cells to layered cell clusters of cuboidal cells with shorter cytoplasmic extensions. Positive Alizarin Red and von Kossa staining as well as significant calcium deposition and alkaline phosphatase activity confirmed osteogenesis. Histology and positive Safranin O staining of matrix glycosaminoglycans illustrated chondrogenesis. Oil Red O staining of lipid droplets confirmed adipogenesis.
We here report, for the first time, the isolation of mesenchymal-like stem cells from fresh equine cord blood and their differentiation into osteocytes, chondrocytes and adipocytes. This novel isolation of equine cord blood MSCs and their preliminary in vitro differentiation positions the horse as the ideal pre-clinical animal model for proof-of-principle studies of cord blood derived MSCs.
BACKGROUND: There is relatively little research concerning the processes whereby Local Research Ethics Committees discharge their responsibilities towards society, potential participants and investigators. OBJECTIVES: To examine the criteria used by LRECs in arriving at their decisions concerning approval of research protocols through an analysis of letters sent to investigators. DESIGN: Four LRECs each provided copies of 50 letters sent to investigators after their submitted proposals had been considered by the committees. These letters were subjected to a content analysis, in which specific comments and requests for additional information and changes in the protocols were recorded and compared. FINDINGS: Overall 24% of proposals were approved without request for changes or clarifications, but this varied by committee: one committee approved only 6% of proposals without change or clarification while the others ranged from 26% to 32%. The content analyses of responses indicated that they could be placed into four categories: (i) further information for the committee to aid in their deliberations; (ii) requests for changes to the design or justification for the design used; (iii) changes to the information sheets provided to potential participants; and (iv) changes to consent procedures. Of these, alterations to information sheets were the most common type of request. These four types of response could be seen as safeguarding the wellbeing of potential participants (the principle of non-maleficence), of promoting the scientific validity of the research (the principle of beneficence), and of enhancing the rights of potential participants (the principle of autonomy). CONCLUSIONS: The committees were consistent in the types of requests they made of investigators, which can be seen as attempts to protect participants' rights and ensure the scientific validity of studies. Without an analysis of the proposals sent to the committees, however, it is difficult to account for the variation in the requirements set by the committees before approval was given.