scholarly journals Informed Consent for Research Using Biospecimens, Genetic Information and Other Personal Data

2017 ◽  
Author(s):  
Kathleen Liddell ◽  
Jeffrey M. Skopek
Keyword(s):  
Informed Consent ◽  
Genetic Information ◽  
Personal Data

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.

Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data

2021 ◽  
pp. 019394592110292
Author(s):  
Elizabeth E. Umberfield ◽  
Sharon L. R. Kardia ◽  
Yun Jiang ◽  
Andrea K. Thomer ◽  
Marcelline R. Harris
Keyword(s):  
Informed Consent ◽  
Scoping Review ◽  
Real World ◽  
Genetic Information ◽  
Final Analysis ◽  
Health Data ◽  
Federal Regulations ◽  
Secondary Research ◽  
Domain Experts ◽  
Key Issues

Nurse scientists are increasingly interested in conducting secondary research using real world collections of biospecimens and health data. The purposes of this scoping review are to (a) identify federal regulations and norms that bear authority or give guidance over reuse of residual clinical biospecimens and health data, (b) summarize domain experts’ interpretations of permissions of such reuse, and (c) summarize key issues for interpreting regulations and norms. Final analysis included 25 manuscripts and 23 regulations and norms. This review illustrates contextual complexity for reusing residual clinical biospecimens and health data, and explores issues such as privacy, confidentiality, and deriving genetic information from biospecimens. Inconsistencies make it difficult to interpret, which regulations or norms apply, or if applicable regulations or norms are congruent. Tools are necessary to support consistent, expert-informed consent processes and downstream reuse of residual clinical biospecimens and health data by nurse scientists.

The protection of genetic information

2010 ◽  
pp. 91-113
Author(s):  
Juri Monducci
Keyword(s):  
Genetic Information ◽  
Personal Data ◽  
Genetic Data ◽  
Case Law ◽  
Genetic Determinism ◽  
Genetic Identity ◽  
Statutory Protection ◽  
Right Not To Know ◽  
Genetic Makeup ◽  
The Right

The law pertaining to personal data has developed in Italy over a thirty-year span that took us from recognition of such data in the case law, in 1975, to its statutory protection, in 2003. This evolution would subsequently come to the point of specifically regulating the processing of genetic data as data revealing an individual's genetic makeup, thereby also revealing the biological future of individuals and their offspring: this information describes an individual at a core level where the deepest, most unchangeable traits are found and can therefore nurture what is nowadays referred to as genetic determinism, which reduces the person to a complex of genetic data and so ignores the whole layer of characteristics that make each of us unique. There is, then, a discriminatory risk inherent in the processing of genetic data, and equally clear are the psychological implications of such processing, so much so that the need has arisen to have rules in place aimed at regulating the biotechnologies and genetics in particular. These rules have given birth to the so-called fourthgeneration rights, inclusive of the right to ones genetic identity and the right not to know ones genetics (although this is something that had been discussed earlier, too), and it is to a discussion of these rights that this essay is devoted.

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 Role of Legal Principles in Eliminating and Minimizing the Risks of Genomic Technologies

Lex Russica ◽  
2019 ◽  
pp. 121-128 ◽  
Author(s):  
M. N. Maleina
Keyword(s):  
Genetic Information ◽  
Personal Data ◽  
Negative Consequences ◽  
Genetic Characteristics ◽  
Legal Principles ◽  
Genomic Technologies ◽  
Preventive Actions ◽  
The Individual ◽  
Modern Genomic

The use of modern genomic technologies, along with the benefits to the man and society, can lead to negative consequences. Such risks exist both in the process and after the production, isolation, modification, storage of DNA. Prior to detailed legislative regulation of relations regarding the use of genomic technologies for medicinal purposes and not for medical reasons, legal principles become vital.The paper formulates the following basic legal principles of genomic technologies application: the principle of preventive actions of the state to protect citizens from the risks of using genomic technologies; the principle of preserving the human genome as a special species; the principle of guaranteeing the inviolability of the individual of every citizen when using genomic technologies; the principle of priority of life and health of citizens over the interests of science and society; the principle of equality of citizens regardless of genetic characteristics; the principle of protection of genetic information of every citizen as part of personal data; the principle of guaranteeing access to the citizen’s own genetic information. Legal principles can be used to resolve a dispute by analogy of law.

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.

Issues of Ethics in Prenatal Diagnostics

2011 ◽  
Vol 24 (4) ◽  
pp. 470-476
Author(s):  
Vera I. Saburova
Keyword(s):  
Informed Consent ◽  
Preventive Medicine ◽  
Genetic Information ◽  
Current Practice ◽  
Good Practice ◽  
State Regulation ◽  
Prenatal Diagnostics ◽  
Patient Confidentiality ◽  
Ethical Concerns ◽  
Parental Informed Consent

Aspects of the current practice of prenatal diagnostics in Russia are surveyed. In the light of this, various ethical concerns are highlighted: (1) the requirement of parental informed consent to testing is not always sufficiently respected either in state regulation or in the practice of physicians; (2) not all Russian physicians are aware of international guidelines or standards of good practice in areas such as non-directive counselling, patient confidentiality with respect to genetic information and the patient’s right to maintain control over his or her information; (3) abortion is viewed increasingly as an aspect of preventive medicine.

scholarly journals Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road

2021 ◽  
Author(s):  
Eugenijus Gefenas ◽  
J. Lekstutiene ◽  
V. Lukaseviciene ◽  
M. Hartlev ◽  
M. Mourby ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Personal Data ◽  
Data Informed
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