scholarly journals Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Elise Jacquier ◽  
Pierre Laurent-Puig ◽  
Cécile Badoual ◽  
Anita Burgun ◽  
Marie-France Mamzer
Keyword(s):  
Informed Consent ◽  
Translational Research ◽  
Biological Samples ◽  
Personal Data ◽  
Research Approach ◽  
Automatic Assessment ◽  
Digital Tool ◽  
Dynamic Information ◽  
Data Treatment ◽  
Treatment Context

Abstract Background In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants’ rights. Methods Informed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related to biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program “Flesch Score”. Results 29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs. Conclusions Our review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. “Old fashion written ICFs” should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested.

INFLUENCE OF OFFICE BLEACHING SYSTEMS ON THE RESISTANCE OF HARD TOOTH TISSUES

2020 ◽  
pp. 119-125
Author(s):  
Magsumova O.A. ◽  
Postnikov M.A. ◽  
Ryskina E.A. ◽  
Tkach T.M. ◽  
Polkanova V.A.
Keyword(s):  
Informed Consent ◽  
Oral Fluid ◽  
Personal Data ◽  
Acid Resistance ◽  
Non Invasive ◽  
Hard Tissues ◽  
Voluntary Informed Consent

One of the non-invasive methods for treating discoloration of hard tooth tissues is teeth whitening. The aim of this work is to assess the dynamics of changes in the acid resistance of enamel and hard tissues of teeth and the rate of its remineralization after the procedure of office teeth whitening. The study involved 123 patients aged 18 to 35 years with discoloration of various origins, with the color of hard tooth tissues on the Vita Classic A2 scale and darker. Before performing the office, teeth whitening procedure, all patients gave their written voluntary informed consent to participate in this study, as well as consent to the processing of personal data. Depending on the chosen method of office teeth whitening, patients were divided into 3 groups. The resistance of hard tooth tissues was judged based on the determination of TOER and CASRE tests. These indicators were determined at various times (5 days before the office teeth whitening procedure, 5 days after it, after 14, 30 days and 6 months). Regardless of the chosen whitening system, the office teeth whitening procedure is accompanied by a decrease in the enamel's resistance to acids and a decrease in the rate of its remineralization. The remineralizing function of oral fluid promotes the positive dynamics of the studied parameters after 14 days and after 30 days values increased due to the appointment of remineralizing therapy to all patients in 2 weeks after the teeth whitening procedure. After 6 months, all patients had high enamel resistance and the rate of its remineralization.

Biobanking for Neurodegenerative Diseases: Challenge for Translational Research and Data Privacy

2021 ◽  
pp. 107385842110366
Author(s):  
Emilia Giannella ◽  
Valentino Notarangelo ◽  
Caterina Motta ◽  
Giulia Sancesario
Keyword(s):  
Neurodegenerative Diseases ◽  
Translational Research ◽  
Data Protection ◽  
Biological Samples ◽  
Data Privacy ◽  
Neurological Diseases ◽  
Great Effort ◽  
General Data Protection Regulation ◽  
In Silico Studies

Biobanking has emerged as a strategic challenge to promote knowledge on neurological diseases, by the application of translational research. Due to the inaccessibility of the central nervous system, the advent of biobanks, as structure collecting biospecimens and associated data, are essential to turn experimental results into clinical practice. Findings from basic research, omics sciences, and in silico studies, definitely require validation in clinically well-defined cohorts of patients, even more valuable when longitudinal, or including preclinical and asymptomatic individuals. Finally, collecting biological samples requires a great effort to guarantee respect for transparency and protection of sensitive data of patients and donors. Since the European General Data Protection Regulation 2016/679 has been approved, concerns about the use of data in biomedical research have emerged. In this narrative review, we focus on the essential role of biobanking for translational research on neurodegenerative diseases. Moreover, we address considerations for biological samples and data collection, the importance of standardization in the preanalytical phase, data protection (ethical and legal) and the role of donors in improving research in this field.

DISORDERS OF PERIPHERAL CIRCULATION AMID CHRONIC OSTEOCHONDROSIS OF THE LUMBAR SPINE

Vestnik ◽  
2021 ◽  
pp. 24-28
Author(s):  
Р.С. Бегимбетова ◽  
Н.О. Бейсембинова ◽  
А.К. Кадырали ◽  
Г.М. Жолдасова ◽  
А. Бауржанкызы ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Informed Consent ◽  
Clinical Symptoms ◽  
Personal Data ◽  
Pain Syndrome ◽  
Peripheral Circulation ◽  
Research Protocol ◽  
Initial Visit ◽  
Continue Research ◽  
Inhibitory Reflex

Проведен анализ состояния периферического кровообращения у 28 мужчин, больных остеохондрозом поясничного отдела позвоночника, сопровождающегося люмбалгией с клинической симптоматикой нарушения периферического кровообращения нижних конечностей. Все больные, принимавшие участие в нашем исследовании, подписали информированное согласие на участие в программе и соглашение о неразглашении личных данных и протокола исследований. Критериями для анализа являлись изменения клинической симптоматики остеохондроза поясничного отдела позвоночника, обусловленной им люмбалгии и показателей оксиметрического исследования, которые были зафиксированы при первичном обращении и через 7 суток на фоне проводимого лечения и регрессии болевого синдрома. Таким образом, полученные результаты свидетельствовали о рефлекторном нарушении периферического кровообращения за счет развития патологического спинально-вазального тормозного рефлекса, обусловленного люмбалгией, которые восстанавливаются на фоне регрессии патологической импульсации в поясничном отделе позвоночника. Целесообразно продолжить исследования в этом направлении. The state of peripheral circulation in 28 men were analyzed, patients with osteochondrosis of the lumbar spine, accompanied by lumbodynia with clinical symptoms of impaired peripheral circulation of the lower extremities was carried out. All patients who took part in our study signed an informed consent to participate in the program and a non-disclosure agreement of personal data and research protocol. The criteria for the analysis were clinical symptoms of osteochondrosis of the lumbar spine caused by lumbodynia and indicators of oximetry studies, which were recorded during the initial visit and after 7 days amid treatment and regression of pain syndrome. Thus, the results indicated a reflex disorder of the peripheral circulation due to the development of a pathological spinal-vasal inhibitory reflex caused by lumbodynia, which is restored amid regression of pathological impulses in the lumbar spine. It is advisable to continue research in this direction.

scholarly journals Data Sharing Under the General Data Protection Regulation

Hypertension ◽  
2021 ◽  
Vol 77 (4) ◽  
pp. 1029-1035
Author(s):  
Antonia Vlahou ◽  
Dara Hallinan ◽  
Rolf Apweiler ◽  
Angel Argiles ◽  
Joachim Beige ◽  
...  
Keyword(s):  
European Union ◽  
Data Protection ◽  
Personal Data ◽  
Research Approach ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Personal Data Protection ◽  
Protection Legislation ◽  
General Data ◽  
Almost All

The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.

scholarly journals Communicating on the Worldwide Web – Dental Practice Websites

2015 ◽  
Vol 6 (2) ◽  
pp. 90-95
Author(s):  
Nigel Knott
Keyword(s):  
Informed Consent ◽  
News Media ◽  
Personal Data ◽  
The Internet ◽  
Dental Practice ◽  
Electronic Communications ◽  
Worldwide Web ◽  
Dental Practices

The news media are presently filled with headline stories concerning the security of electronic communications and the internet. The Financial Times’ weekend supplement FT Money devoted three pages under the title ‘Hack attack’ and asked whether companies are doing enough to protect data online. 1 Substitute dental practices for companies and we have an unhappy picture of the reasons why so much sensitive personal data is going missing or being accessed without properly informed consent.

scholarly journals Use of Existing Health Data in Epidemiologic Research–Issues of Informed Consent Under Normal Circumstances and at a Time of Health Crises

2020 ◽  
pp. 1-4
Author(s):  
Carsten Obel ◽  
Carsten Obel ◽  
Jørn Olsen ◽  
Uffe Juul Jensen
Keyword(s):  
Informed Consent ◽  
Personal Data ◽  
Health Data ◽  
Epidemiologic Research ◽  
Health Crisis ◽  
Research Issues ◽  
Data Analyses ◽  
Computer Scientists ◽  
Patient Groups ◽  
Access To Data

In epidemiologic research we study why we get sick and how we get better. To do this we frequently need large datasets on exposure, diagnoses, treatment and more. We need data often classified as sensitive and regulated by law stating a need for informed consent. We argue that modern epidemiologic research often can be done on existing data without having informed consent and without violating basic ethic principles. We also argue for a timely and fair access to data in approved project. Modern encryption technics and methods of data analyses can reduce the risk of disclosure of personal data to a level close to what we have for anonymous data. If we allow open use of administrative health data and existing research data, we will be able to produce much more information to advance disease prevention, health promotion and treatment. Epidemiologists should collaborate more with computer scientists and patient groups in developing/implementing principles for ‘modern methods of data analyses’. Under a severe health crisis data are in high demand to provide the information needed to prevent deaths and diseases and often time does not permit requiring ‘informed consent’. Such a situation in now plying out worldwide under the Covid-19 pandemic.

scholarly journals Informed consent to clinical research in India: A private law remedy

2020 ◽  
Vol 20 (3) ◽  
pp. 256-283
Author(s):  
Himani Bhakuni
Keyword(s):  
United States ◽  
Informed Consent ◽  
Clinical Research ◽  
Information Disclosure ◽  
Common Law ◽  
Case Law ◽  
The United States ◽  
Private Law ◽  
Patient Relationship ◽  
Treatment Context

There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.

Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

2020 ◽  
Vol 15 (2) ◽  
pp. 75-83
Author(s):  
Rachel S Purvis ◽  
Leah R Eisenberg ◽  
Christopher R Trudeau ◽  
Christopher R Long ◽  
Pearl A McElfish
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Diabetes Management ◽  
Community Based Participatory Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Approach ◽  
Community Based ◽  
Randomized Control ◽  
Participatory Research Approach

Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial. Results Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process. Conclusion Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

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