section 1 of this Act contains provisions on the ethical review of
research involving humans and biological material from
humans. It also contains provisions on consent to
such research.
The purpose of the Act is to protect the individual and
respect for human dignity in research.
Definitions
2 for the purposes of this Act, section
scientific research: experimental or theoretical work
in order to acquire new knowledge and development of
scientific basis, however, no such work carried out within the
the framework for higher education at the basic level or advanced
level,
Research principal: a State authority or a person or
legal person in whose activities the research is carried out,
Research: a living person as the research relates,
and
the processing of personal data: the processing referred to in paragraph 3 of the
personal data Act (1998:204). Law (2008:192).
Scope of application
Research covered by the Act
section 3 of this Act shall apply to research involving
the treatment of
1. sensitive personal data pursuant to article 13 of the personal data Act
(1998:204), or
2. personal data relating to offences involving criminal offences;
judgments in criminal cases, pre-trial supervision measures, or
administrative detention under section 21
the personal data Act. Law (2008:192).
4 § in addition to what follows from section 3 of the Act shall apply to
Research
1. does a physical intervention on a research person,
2. is carried out in accordance with a method that seeks to influence
research the person physically or mentally, or involving a
the obvious risk of harming the person physically or
mentally,
3. refer to studies of biological material taken from a
living person and can be traced back to this man,
4. does a physical intervention on a deceased person, or
5. refer to studies of biological material taken
medicinal purpose from a deceased person and can be derived
to this man. Law (2008:192).
Geographical scope
section 5 of this Act shall apply to the research to be carried out in
Sweden.
Approval
section 6 of the Research referred to in paragraphs 3 to 5 must be carried out only if it has
approved by an ethical review. The approval may be subject to
terms and conditions. An approval must relate to a specific project or a
part of a project or in any similar manner decided
research. The research may include the processing of such
personal data referred to in paragraph 3 only if the treatment has
approved by the ethics trial.
An authorisation ceases to be valid, unless the research has
started to be carried out within two years of the decision to
approval became final.
An approval under this Act does not mean that the research
may be carried out, if it violates any other statutes.
Starting points for ethics trial
7 § Research may be approved only if it can be performed with respect
for human dignity.
section 8 of the human rights and fundamental freedoms,
always be taken into account in the ethical examination while taking into account
be taken of the interest of that new knowledge can be developed through
research. People's welfare is to be given precedence over
the needs of society and science.
9 § Research may only be approved if the risks it can
result of research people's health, security and personal
Privacy is outweighed by its scientific value.
10 § Research may not be authorised, if the expected results
can be achieved in another way, which means less risk for
Research individuals ' health, safety and personal integrity.
The processing of personal data referred to in paragraph 3 may be accepted
only if it is necessary for the research will be
be carried out.
section 11 of the Research may be approved only if it is to be carried out by or
under the supervision of a researcher who has the scientific
skills needed.
11 a §/expires U: 2016-01-01/
On the ethical review of clinical examination of people of
a pharmaceutical properties (clinical trials)
In addition to what is provided for by this law, the provisions of the 13E and
(f) § § the medicines Act (1992:859) applies. Act (2004:198).
11 a §/entry into force: 01/01/2016
On the ethical review of clinical study on humans of a drug's properties (clinical trials), in addition to what is provided for by this law, Chapter 7. 6 and 7 of the medicines Act (2015:315) applied. Law (2015:320).
Disclosure of personal information
section 12 of the personal data may be disclosed for use in
research, subject to rules of confidentiality
and professional secrecy.
Information and consent
paragraph 13 of the research referred to in paragraph 4 of the 1-3, the provisions of
16-22 sections on information and consent shall apply. For research
referred to in paragraph 4 of 3, however, in some cases, specific
provisions of section 15. If in any other statutes, see
specific provisions on information and consent by
Research referred to in paragraph 4 of the 1-3, the regulations apply in
rather than the provisions of this Act.
At the research referred to in paragraph 4 of the 4 and 5, the provisions of
information and consent in the Act (1995:831) If transplantation
accommodation and Act (1995:832) of autopsy etc. are applied in
rather than the provisions of this Act.
Special conditions for approval
section 14 of the Research referred to in paragraph 4 may be approved only if it can
assumed that the relevant provisions on information and
consent will be followed or if the conditions for
research without consent in paragraphs 20-22 are met.
If a person is in a research related to
Research principal or a scientist, or if
the subject is likely to have particular difficulties
to be their right, the questions concerning information and consent
Special attention at the ethics trial.
section 15 About research relating to studies on biological material
previously have been taken from a living person, it shall, at a
approval to be determined which requirements shall apply in respect of
information and consent for the use of the materials.
Information
section 16 of the subject must be informed of the
-the overall plan for the research,
-the aim of the research,
-the methods that will be used;
-the consequences and risks involved in the research,
-who is research principal,
-participation in research is voluntary, and
-research the person's right to terminate their
participation.
If the subject has not reached the age of 18 applies to what is being said
in section 18.
Consent
section 17 of the Research may be carried out only if the subject has
consented to the research that relates to him or her. A
the consent is valid only if the subject has been previously
a information about the research under section 16. Consent shall
be voluntary, explicit and clarified to some
research. Consent shall be documented.
If the subject has not reached the age of 18 applies to what is being said
in section 18.
Research people under 18 years of age
section 18 If the subject has reached the age of 15 years but not the age of 18 and
realize what the research means for his or her part, shall
He or she must be informed of, and consent to research
as indicated in paragraphs 16 and 17.
In other cases when the subject has not reached the age of 18,
the guardians are informed of and agree to the research on
as indicated in paragraphs 16 and 17. Research the person himself
However, as far as possible be informed about the research. Despite
the consent must not be performed if the research a
Research person who is under 15 years of age understand what it means for
his or her part and object to it is carried out.
In the case of a married person who applied research is what
provided for those who have reached the age of 18.
Withdrawal of consent
19 § consent may be withdrawn at any time with immediate
effect. The data that was collected in prior to that, however, may
be used in the research.
Research without consent
section 20 of the Research may be carried out without consent, if the illness, mental
disturbance, weakened health or any other similar
relationship with the subject precludes his or
her opinion should be sought. The research may be carried out only under the
the conditions set out in paragraphs 21 and 22.
21 § Research regarding a research person as stated in section 20,
be performed on the
1. the research is expected to deliver a knowledge that is not possible
to get through research with the consent, and
2. the research can be expected to lead to the direct benefit of
research the person.
Even if the condition in the first subparagraph of paragraph 2 are not fulfilled,
the research carried out on
1. the purpose is to contribute to the results that may be
benefits for research the person or anyone else suffering from
the same or a similar disease or disorder, and
2. the research poses a minor risk of injury and a
slight discomfort to the subject.
section 22 of the person mentioned in section 20 shall as far as possible
be informed personally about the research. Consultation shall take place with
research the person's next of kin. Consultations shall be also
with the trustee or custodian under Chapter 11. the parental code, if
the issue is part of his mission. The research must not be performed if the
the subject in any form is an expression of not wanting to
participate or if any of those objects has been consulted
to the performance.
Application
section 23 application for ethical review of research shall be made by
Research principal.
Regional committees
Data
section 24 there should be regional committees with the task of examining
applications referred to in section 23.
The boards are responsible also to examine some issues in
associated with establishing biobanks pursuant to lagen (2002:297) om
biobanks in health care, etc.
Departments
section 25 of a regional Committee shall be divided into two or more
departments. A Chamber shall hear cases within certain
research areas.
A Department shall consist of a Chairman and fifteen other
members. Ten of the other members shall have scientific
skills and five represent public interests. It may be appointed
replacements for the members. The Chairman and stand-in for
the President shall be or have been regular judges.
All of the members and alternates shall be appointed by the Government for a
certain time.
Quorum
section 26 a Department of a regional board is quorate when
the Chairperson and at least eight other members are present. By
the other members, at least five have scientific competence
and at least two represent the public interests. Members with
scientific skills will always be in range, when a
the case is decided.
section 27 a Department is deemed quorate with the President alone at
-preparatory action,
-correction of typos and the like,
-other decisions do not constitute a final determination by a
case, and
-examination of the case of rejection or cancellation of ticket.
The President may hand over the data referred to in the first
paragraph to a Rapporteur at the Committee.
A Department must hand over to the President or any other
Member to after substance determine a particular case or
cases are such that the previous guiding decisions can
applied or which otherwise are such that they do not
need to be determined by the Department.
Referral
section 28 if the Board finds that the research gives rise to ethical
questions by new and principled character, should the Board acquire
the opinions of the Medical Research Council and other relevant authorities.
Surrender
section 29 if the Board is divided on the outcome of the ethics trial, shall
Board leave the matter for the decision of the Central Committee
referred to in section 31. However, this applies only if at least three members
calls for handover to take place. If only nine members
participating in the trial, however, must surrender shall take place if at least two
Members request it.
When the Board hands over a case shall include a private
opinion.
Decision
30 § a regional Board decisions effective immediately, if not
the Board decides otherwise.
Central Board
Data
section 31 there shall be a central Committee for ethical review of
research.
The Central Board shall hear cases as a regional board
has provided over pursuant to section 29 and appeals under section 36 of the
Regional Board decisions. The Board's task is also to
examine certain questions in connection with the creation of biobanks in accordance with
Lagen (2002:297) om biobanks in health care, etc.
The Board shall also exercise supervision in accordance with paragraphs 34 and 35.
Composition
32 § the Central Board shall consist of a Chairman and six
the other members. Four of the other members shall have
scientific competence and two represent the public interests.
It may be appointed deputies for the members. The Chairman and the
replacement of the Chairman shall be or have been regular
judge.
All of the members and alternates shall be appointed by the Government for a
certain time.
Quorum
33 § the Central Board is quorate when the Chairman and
at least three members with scientific expertise and at least one
representatives of public interests are present. Members
with scientific skills will always be in range, when a
the case is decided.
The Board is a quorum with the President alone at
-preparatory action,
-correction of typos and the like,
-other decisions do not constitute a final determination by a
case, and
-examination of the case of rejection or cancellation of a
case.
The President may hand over the data referred to in the second
paragraph to a Rapporteur at the Committee.
Supervision
section 34 the Central Committee has oversight over compliance with
This Act and the regulations issued pursuant to the Act.
However, this does not apply to the extent the supervision falls within any
other regulatory responsibilities.
The Central Committee may determine that a supervisory decision shall
apply immediately.
35 § the Central Board has the right to request the
information and documents needed for supervision and
access to the rooms used by the research.
Research the principal shall, on request, give the Board all the assistance
needed for supervision to be carried out.
The Board must notify the injunctions and prohibitions as needed
to this Act and the regulations issued pursuant to
of the law shall be followed. The Board may issue subpoenas also
When information or documents not submitted or when
access or assistance is refused. An injunction or prohibition
may be subject to a penalty. Such an injunction or prohibition may
be directed also against the State as research principal.
The Board is required to make a notification of charges, if there are
reasonable suspicion of an offence referred to in section 38.
Appeal
36 § a regional Committee's decision in a case concerning the ethical review may
be appealed to the Central Board of research principal;
If the Regional Council has settled the case and the decision has
been the principal received. Other decisions by a regional Board of
cases where ethical review may not be appealed.
37 § the Central Committee's decision in the cases concerning the ethical review may
not subject to appeal.
The Central Committee's decision on the injunction or prohibition
According to § 35 may be appealed to the administrative court.
Other decisions of the Board in supervisory matters may not be appealed.
Leave to appeal is required for an appeal to the administrative court.
Penalty
38 § Whoever willfully violates section 6, first paragraph, or
against a criterion that has been issued pursuant to section 6 of the first
subparagraph shall be sentenced to a fine or imprisonment of up to six
months. In minor cases are judged not to liability.
Liability under the first subparagraph shall be liable if the Act is not
subject to penalty under the provision of any other enactment.
Those who have violated a penalty notice under section 35 may
not be liable for an offence covered by the
the injunction.
Appropriations
39 § Government or authority the Government determines
may provide for fees for ethics review under
This law.
section 40 of the Government or the authority, as the Government determines
may provide for exceptions from the requirement for approval at
Ethics Review for research or treatment of
personal data, where it is clear that research does not
pose any significant risk to the individual's health or
safety of persons or to infringement of the individual's privacy.
Disclosure of the details
41 § Government announces details relating to the regional
Councils and the Central Committee.
The Government or the authority, as the Government determines
Announcing details of the ethical review.
Transitional provisions
2003:460
This law shall enter into force on 1 January 2004. The law, however,
not apply to research prior to the entry into force has
etikgranskats by a State authority or whose execution has
started.
