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How to obtain informed consent for research

Sara Manti, Amelia Licari
Breathe 2018 14: 145-152; DOI: 10.1183/20734735.001918
Sara Manti
1University of Messina, “G. Martino” Hospital, Messina, Italy
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Amelia Licari
2University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
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Figures

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  • Figure 1
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    Figure 1

    Flow chart of parental permission requirements.

  • Figure 2
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    Figure 2

    Flow chart of child assent requirements.

Tables

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  • Table 1

    Conditions to be met in emergency clinical study

    • Subjects affected by a life-threatening condition
    • The treatment is experimental
    • The clinical research allows verification of both the effectiveness and safety of the treatment
    • It is impracticable to obtain consent
    • The waiver of informed consent is needed for the clinical trial
    • The researcher will contact the legally authorised representative
    • The family members can decline the patient’s participation in the study
  • Table 2

    Conditions to be met in research studies involving pregnant women and fetuses

    • In vivo studies have also been conducted on pregnant animals
    • Clinical studies have been conducted on nonpregnant women
    • Clinical findings assessing potential harms to pregnant women and fetuses are available
    • The risk to the fetus is minimal and caused exclusively by the procedure/intervention
    • The study will achieve crucial knowledge not obtainable by any other means
    • The researchers will have no part in any decision influencing fetal viability or pregnancy
    • No incentive will be provided to influence the course of pregnancy
  • Table 3

    Consent signature requirements for pregnant women and children

    For pregnant women
     Direct benefit to motherMother#
     Direct benefit to mother and fetusMother#
     Direct benefit to fetusMother and father#
    For children
     Direct benefit to individual subjectsOne parent or guardian#
     No direct benefit to individual subjectsBoth parents#
     No direct benefit to the subject or societal (indirect) benefitBoth parents#
     Medical care related to pregnancyParental consent is not needed
     Medical care related to mental health treatment, or the diagnosis or treatment of infectious, contagious or communicable diseasesParental consent is not needed
     Self-sufficient minorsParental consent is not needed
      Aged ≥15 years
      Living alone
      Managing their own financial affairs
     Emancipated minorsParental consent is not needed
      Married or divorced
      On active duty in the US armed forces
      By a court
      Having the legal right to consent on their own behalf to medical, dental or mental health treatment

    #: consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.

    • Table 4

      Studies that may involve prisoners

      • Studies on the possible causes, processes and effects of incarceration
      • Studies on prisons as institutional structures or on prisoners as incarcerated persons
      • Studies on special conditions affecting prisoners
      • Studies on practices of improving the health or well-being of the prisoners
      • Epidemiological studies
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    How to obtain informed consent for research
    Sara Manti, Amelia Licari
    Breathe Jun 2018, 14 (2) 145-152; DOI: 10.1183/20734735.001918

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    How to obtain informed consent for research
    Sara Manti, Amelia Licari
    Breathe Jun 2018, 14 (2) 145-152; DOI: 10.1183/20734735.001918
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