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Dictionary:

Clinical studies - step by step

Clinical studies - step by step
  • Page contents:

    Health and medical care or clinical research?

    Compare your idea with previous research

    Search for knowledge among systematic analyses

    Search for gaps in scientific knowledge

    Use data found in registers

    Formulate the problem

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    The design and method of the study are important

    A research plan is necessary for ethical review applications, and functions as a handbook

    Statistical analysis plan

    Information to study participants before consent

    Find out what insurance cover is available for the study participants

    Study budget for all the costs in the project

    Is a health economics evaluation of the study needed?

    Specific rules for clinical trials with medicines or medical devices

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Applying for an ethical review

    Applying for authorisation from a radiation protection committee

    Setting up a biobank or getting access to biobank samples

    Finding out what applies for handling of personal data

    Registering your study before the study begins

    Specific rules for clinical trials with medicines or medical devices

    SKL and LIF – agreements and templates for clinical studies

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Specific rules for clinical trials with medicines or medical devices

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Planning before the study begins determines how data is handled and analysed

    Studies with a confirmatory purpose

    Studies with an exploratory purpose

    Data handling when the study is concluded

    Analysis of study data

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Writing a scientific article

    Selecting the journal

    Publishing with open access

    Publishing the results in a public database

    Informing study participants of the study results

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Screening of personal data

    Specific rules for clinical studies using medicines

    Särskilda regler för läkemedel och medicinteknik

The Act concerning the Ethical Review of Research Involving Humans

The Act concerning the Ethical Review of Research Involving Humans (2006:460) came into force on 1 January 2004. The purpose of the Act is to protect the individual person and ensure respect for human dignity in research. The Act includes provisions with a requirement for ethical review of research involving living or deceased persons or biological material from humans.

An ethical review shall be based on:

  • respect for human dignity
  • human rights and fundamental freedoms
  • interest in the development of new knowledge through research
  • the well-being of humans shall be given priority ahead of the needs of society and science

Research may only be approved if the risks it may entail to the health, safety and personal integrity of study participants are outweighed by the scientific value. On the other hand, research cannot be approved if the expected results can be reached in another way that presents fewer risks to the health, safety and personal integrity of study participants. Handling of sensitive personal data and personal data on breaches of the law may only be approved if it is needed to carry out the research. Finally, research may only be approved if it is to be conducted by, or under the supervision of, a researcher who possesses the necessary scientific competence.

The Act also includes provisions on information to study participants, requiring information on the overall plan for the research, the purpose of the research, the methods that will be used, the consequences and risks that the research may entail, the identity of the research principal, and the facts that participation is voluntary and that participants can end their participation at any time. Special rules apply for study participants who are younger than 18 years.

The Act concerning the Ethical Review of Research Involving Humans does not cover activities carried out within health and medical care in order to develop and safeguard care quality systematically and continuously. Such activities do not constitute research in the meaning of the Act.

Link to the Act concerning the Ethical Review of Research Involving Humansexternal link, opens in new window


Skapad: 2017-11-07
Senast uppdaterad: 2017-11-07 

Contact

Office for Clinical Studies, Swedish Research Council

Östra Hamngatan 26
SE-411 09 Göteborg

 

Phone (Swedish Research Council, switchboard):
+46 (0)31 757 41 75

E-mail: kliniskastudier@vr.se

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Clinical Studies Sweden - a collaboration between The Swedish Research Council and the Swedish Association of Local Authorities and Regions.