Morocco’s First Biobank: Establishment, Ethical Issues, Biomedical Research Opportunities, and Challenges

Background. Biobanks are highly organized infrastructures that allow the storage of human biological specimens associated with donors’ personal and clinical data. These infrastructures play a key role in the development of translational medical research. In this context, we launched, in November 2015, the first biobank in Morocco (BRO Biobank) in order to promote biomedical research and provide opportunities to include Moroccan and North African ethnic groups in international biomedical studies. Here, we present the setup and the sample characteristics of BRO Biobank. Methods. Patients were recruited at several departments of two major health-care centers in the city of Oujda. Healthy donors were enrolled during blood donation campaigns all over Eastern Morocco. From each participant, personal, clinical, and biomedical data were collected, and several biospecimens were stored. Standard operating procedures have been established in accordance with international guidelines on human biobanks. Results. Between November 2015 and July 2020, 2446 participants were recruited into the BRO Biobank, of whom 2013 were healthy donors, and 433 were patients. For healthy donors, the median age was 35 years with a range between 18 and 65 years and the consanguinity rate was 28.96%. For patients, the median age was 11 years with a range between 1 day and 83 years. Among these patients, 55% had rare diseases (hemoglobinopathies, intellectual disabilities, disorders of sex differentiation, myopathies, etc.), 13% had lung cancer, 4% suffered from hematological neoplasms, 3% were from the kidney transplantation project, and 25% had unknown diagnoses. The BRO Biobank has collected 5092 biospecimens, including blood, white blood cells, plasma, serum, urine, frozen tissue, FFPE tissue, and nucleic acids. A sample quality control has been implemented and suggested that samples of the BRO Biobank are of high quality and therefore suitable for high-throughput nucleic acid analysis. Conclusions. The BRO Biobank is the largest sample collection in Morocco, and it is ready to provide samples to national and international research projects. Therefore, the BRO Biobank is a valuable resource for advancing translational medical research.

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Legal and ethical issues in integrating and sharing databases for translational medical research within the EU

2012 IEEE 12th International Conference on Bioinformatics & Bioengineering (BIBE) ◽

10.1109/bibe.2012.6399764 ◽

2012 ◽

Cited By ~ 1

Author(s):

Iheanyi Nwankwo ◽

Stefanie Hanold ◽

Nikolaus Forgo

Keyword(s):

Medical Research ◽

Ethical Issues ◽

Translational Medical Research ◽

Legal And Ethical Issues ◽

The Eu

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The Ethics of AI in Biomedical Research, Patient Care, and Public Health

The Oxford Handbook of Ethics of AI ◽

10.1093/oxfordhb/9780190067397.013.45 ◽

2020 ◽

pp. 702-718 ◽

Cited By ~ 1

Author(s):

Alessandro Blasimme ◽

Effy Vayena

Keyword(s):

Public Health ◽

Patient Care ◽

Biomedical Research ◽

Disease Surveillance ◽

Ethical Issues ◽

Ethical Review ◽

Ethical Challenges ◽

Healthcare Provision ◽

Social Scientists ◽

Ethical Frameworks

This chapter explores ethical issues raised by the use of artificial intelligence (AI) in the domain of biomedical research, healthcare provision, and public health. The litany of ethical challenges that AI in medicine raises cannot be addressed sufficiently by current regulatory and ethical frameworks. The chapter then advances the systemic oversight approach as a governance blueprint, which is based on six principles offering guidance as to the desirable features of oversight structures and processes in the domain of data-intense biomedicine: adaptivity, flexibility, inclusiveness, reflexivity, responsiveness, and monitoring (AFIRRM). In the research domain, ethical review committees will have to incorporate reflexive assessment of the scientific and social merits of AI-driven research and, as a consequence, will have to open their ranks to new professional figures such as social scientists. In the domain of patient care, clinical validation is a crucial issue. Hospitals could equip themselves with “clinical AI oversight bodies” charged with the task of advising clinical administrators. Meanwhile, in the public health sphere, the new level of granularity enabled by AI in disease surveillance or health promotion will have to be negotiated at the level of targeted communities.

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Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264618824921 ◽

2019 ◽

Vol 14 (2) ◽

pp. 107-116 ◽

Cited By ~ 3

Author(s):

Blessing Silaigwana ◽

Douglas Wassenaar

Keyword(s):

South Africa ◽

Research Ethics ◽

South African ◽

Biomedical Research ◽

Ethical Issues ◽

Ethics Committees ◽

Financial Contracts ◽

Scientific Validity ◽

Participant Selection ◽

Education And Awareness

In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting minutes for 180 protocols reviewed between 2009 and 2014 were coded and analyzed using a preexisting framework. Results showed that the most frequent queries involved informed consent, respect for participants, and scientific validity. Interestingly, administrative issues (non-ethical) such as missing researchers’ CVs and financial contracts emerged more frequently than ethical questions such as favorable risk/benefit ratio and fair participant selection. Although not generalizable to all RECs, our data provide insights into two South African RECs’ review concerns. More education and awareness of the actual ethical issues typically raised by such committees might help improve review outcomes and relationships between researchers and RECs.

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Race and Ethnicity in Medical Research: Requirements Meet Reality

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2006.00065.x ◽

2006 ◽

Vol 34 (3) ◽

pp. 520-525 ◽

Cited By ~ 21

Author(s):

Margaret A. Winker

Keyword(s):

Socioeconomic Status ◽

Medical Research ◽

Socioeconomic Factors ◽

Biomedical Research ◽

Race And Ethnicity ◽

Careful Consideration ◽

Biomedical Literature ◽

Genetics Research ◽

Race Ethnicity ◽

Policy And Procedure

Race and ethnicity are commonly reported variables in biomedical research, but how they were initially determined is often not described and the rationale for analyzing them is often not provided. JAMA improved the reporting of these factors by implementing a policy and procedure for doing so. However, still lacking are careful consideration of what is actually being measured when race/ethnicity is described, consistent terminology, hypothesis-driven justification for analyzing race/ethnicity, and a consistent and generalizable measurement of socioeconomic status. Furthermore, some studies continue to use race/ethnicity as a proxy for genetics. Research into appropriate measures of race/ethnicity and socioeconomic factors, as well as education of researchers regarding issues of race/ethnicity, is necessary to clarify the meaning of race/ethnicity in the biomedical literature.

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Should We Stop Collecting the Preoperative Autologous Blood before Bone Marrow Harvest?

Journal of Clinical Medicine ◽

10.3390/jcm10102134 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2134

Author(s):

Daniel Lysák ◽

Lenka Hejretová ◽

Marcela Hrabětová ◽

Pavel Jindra

Keyword(s):

Bone Marrow ◽

Blood Donation ◽

Autologous Blood ◽

Hemoglobin Level ◽

Time Interval ◽

Minimal Risk ◽

Preoperative Autologous Blood Donation ◽

Transfusion Threshold ◽

Healthy Donors ◽

Effective Use

Preoperative autologous blood donation (PAD) in bone marrow (BM) donors is performed to meet potential post-harvest transfusion needs and to avoid the risk of allogeneic transfusions. We reviewed retrospectively bone marrow harvests in 216 healthy donors during a ten-year period to determine the use of autologous blood. All donors except four had undergone PAD. The initial hemoglobin level of 153 g/L (male donors) and 135 g/L (female donors), respectively, decreased by about 8 g/L after preoperative blood donation and by 23 g/L after bone marrow harvest (medians). Autologous blood was administered to 70% of donors, 30% of the units remained unused. The evaluation of the risk of reaching transfusion threshold (<115 g/L males, <105 g/L females) revealed that donors with initial hemoglobin above 145 g/L and those weighing above 75 kg have minimal risk of requiring blood substitution (about 10%). A larger volume of bone marrow was obtained from male compared to female donors (1300 vs. 1100 mL) because of their higher body weight, which resulted in a higher number of procured nucleated cells (362 vs. 307 × 106/kg TNC, ns). The donor-recipient weight difference predicted the probability of sufficient collection. Only 1.5% of donors weighing ≥ 20 kg more than recipients failed to reach ≥3 × 108/kg TNC recipient. Our findings affirm previous data that PAD is unnecessary for healthy marrow donors and may be indicated individually after considering the pre-collection hemoglobin level, donor and recipient weight, and expected blood loss. Reasonable substitution cut-offs have to be set together with clinical symptom evaluation. The effective use of PAD also requires an adequate time interval between PAD and BM harvest.

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Human Physiology: A Very Short Introduction

10.1093/actrade/9780198869887.001.0001 ◽

2021 ◽

Author(s):

Jamie A. Davies

Keyword(s):

Human Physiology ◽

Medical Research ◽

Human Body ◽

Ethical Issues ◽

Physiological Mechanisms ◽

Short Introduction ◽

Process Information ◽

Internal Parameters ◽

The Creation

Human Physiology: A Very Short Introduction explores how the human body works, senses, reacts, and defends itself. Physiology is the science of life. It considers how human bodies are supplied with energy, how they maintain their internal parameters, the ways in which they gather and process information or take action, and the creation of new generations. This VSI examines the experiments undertaken to understand the interplay of the vast variety of physiological mechanisms and principles within us, and analyses the ethical issues involved. It also looks at how enhanced understandings of physiological knowledge can help inform medical research and care.

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