Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: <scp>B</scp>razilian Regulation

Marodin, Gilmar Arduíno Bettio; França, Paulo Henrique Condeixa de; Salgueiro, Jennifer Braathen; Motta, Márcia Luz da; Tannous, Gysélle Saddi; Lopes, Anibal Gil

doi:10.1111/dewb.12012

Cited by 3 publications

(2 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Nonetheless, the Brazilian position is to guarantee to the participants the option to be re-contacted, or not, about the research results and/or incidental findings, with or without genetic counseling, funded by the researcher. 26 The Ministry of Health and CONEP defend the "duty to rescue" principle, which involves unexpected relevant results as well as incidental findings. 27 However, it is possible to adopt in the Brazilian biobanking context the most recommended position of securing the participant's access only to the information and incidental findings that are relevant to their health and at the same time that does not hinder the development of the biobank research.…”

Section: Dallari Castellaro and Guerrieromentioning

confidence: 99%

Biobanking and Privacy Law in Brazil

Dallari

Castellaro²,

Guerriero

2015

J. Law. Med. Ethics

View full text Add to dashboard Cite

Recent scientific and technological developments have promoted the emergence of biobanks on a population scale. Although the storage of human biological material has taken place for a long time, it is only recently that biobanks have acquired a broader scientific significance, especially for genomic research. The increase in biobanks creates many ethical dilemmas, such as the protection of privacy, and creates the need for a new regulatory framework, which must enable the sustainable development of biobanks while also protecting the rights of research subjects and biobank participants.

show abstract

Section: Dallari Castellaro and Guerrieromentioning

confidence: 99%

Biobanking and Privacy Law in Brazil

Dallari

Castellaro²,

Guerriero

2015

J. Law. Med. Ethics

View full text Add to dashboard Cite

show abstract

“…Brazil favors a consent form with two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, the informed consent form for Bio-repositories must be exclusive and related to specific research [16].…”

Section: Introductionmentioning

confidence: 99%

Ethical Issues of Consent for Genetic Research in Latin American Bio-banks

2015

J Clinic Res Bioeth

View full text Add to dashboard Cite

This article reviews ethical issues of consent for genetic research in relation to Latin American bio-banking practices and collaborative research projects with developed countries. There is need for ethical legal safeguards for informed consent procedures so that Bio-banks, bio-specimens and data will be used in accordance with Latin American cultural needs. The issue of national regulations for bio-banking in Latin America may help to clarify what can be done in the field of international and national research respecting subject donations.

show abstract

Comparative analysis of regulatory framework on biobanking to inform policymakers in Central America and the Dominican Republic

Canario¹

2021

Wellcome Open Res

View full text Add to dashboard Cite

Background. The clinical and scientific importance of biobanks has been highlighted. Ethical governance and regulatory oversight for biobanks should be in place to preserve and promote ethical and responsible conduct of research. Methods. This is an analytical documentary study of the regulatory scope concerning biobanks in Central America and the Dominican Republic. From the International Compilation of Human Research Standards 2020 edition of the Office of Human Research Protection Department of Health and Human Services of the United States of America identified the existing guidelines applicable to human research in each of the eight SICA member countries. Regulatory aspects searched for and the analysis was based on the recommendations set forth in Guideline 11 on the collection, storage, and use of biological materials and related data in the International Ethical Guidelines for Research Related to Human Health. Results. There is a lack of specific guidelines for the collection, use, and storage of human biological materials for research purposes, and the creation of biobanks in the countries been studied. No country in Central America and the Dominican Republic region has specific regulations for the creation of biobanks for research purposes. The term "biobank" was not found in the revised regulations. However, there are good examples of ethical governance of research in general in the region been Costa Rica, Panamá, and Guatemala examples of advances towards this direction. Conclusions. There is a need to move forward the governance and regulatory framework of biobanks in Central America and the Dominican which can be seen as an opportunity for international cooperation and regulatory collaborative agenda within this region.

show abstract

Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation

Cited by 3 publications

References 7 publications

Biobanking and Privacy Law in Brazil

Biobanking and Privacy Law in Brazil

Ethical Issues of Consent for Genetic Research in Latin American Bio-banks

Comparative analysis of regulatory framework on biobanking to inform policymakers in Central America and the Dominican Republic

Contact Info

Product

Resources

About