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• Biobanks in Medical Care Act (2002:297), Ministry of Health and Social Affairs, May 23, 2002:

Scope

Section 3

“The Act applies to:

1. Biobanks that are established in Sweden as part of a care’s provider’s medical activities, irrespective of where the material in the biobank is stored, and
2. Tissue samples from a biobank as indicated in 1 that are released for storage and use on the premises of another care provider, an institution for research or diagnostics, a public research institution, a pharmaceutical company or other legal entity or other legal entity, and which after the release are traceable to the person or persons from whom they originate

Relevant parts of the Act shall apply for tissue samples taken and collected for transplant purposes in accordance with the Transplants Act (1995:831).

The Act does not apply to specimens that are routinely collected in the course of medical care for analysis, and which are solely intended to form the basis of a diagnosis and the ongoing care and treatment of the donor, and which are not stored for a long period.”

• The Act concerning the ethical review of research involving humans (2003:460), Ministry of Education and Cultural Affairs, June 5, 2003

Scope

Section 3

“This statute is applicable to research that involves dealing with

1. Sensitive personal data as defined by section 13 of the Personal Data Act (1998:204), or
2. personal data concerning offences against the law that include crimes, judgements in criminal cases, coercive penal procedural measures or administrative deprivation of liberty as defined in section  21 of the Personal Data Act. Law (2008:192)”

Section 4

“This statute is to be applicable to research that:

1. involves a physical intervention affecting a person who is participating in the research,
2. is conducted in accordance with a method intended to physically or mentally influence a person who is participating in the research,
3. concerns studies of biological material that has been taken from a living person and that can be traced back to that person,
4. involves a physical intervention upon a deceased person, or
5. concerns studies of biological material that has been taken for medical purposes from a deceased person and can be traced back to that person.”

Section 5

“This statute is applicable to research that is conducted in Sweden.”

• The Genetic Integrity Act, May 18, 2006

Scope

Section 2

“The Act applies to:

The use of genetics investigations and genetic information and gene therapy,

Genetic investigation in general medical screening,

Prenatal and preimplatation genetic diagnosis,

Measures for purposes of research or treatment using human eggs,

Insemination, and

Fertilisation outside the body.

The Act also contains provisions on criminal liability for trade in human biological material.”

 The Swedish rules to export

The editorial staff is writing this section...

The editorial staff is writing this section...