Literature DB >> 17971467

The need for additional safeguards in the informed consent process in schizophrenia research.

K K Anderson1, S D Mukherjee.   

Abstract

The process of obtaining informed consent to participate in a clinical study presents many challenges for research conducted in a population of patients with schizophrenia. Morally valid, informed consent must include information sharing, decisional capacity, and capacity for voluntarism. This paper examines the unique features of schizophrenia that may threaten each of these elements of informed consent, and it proposes additional safeguards in the process of gaining informed consent from individuals with schizophrenia in order to maximise the decision-making potential of this patient population.

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Year:  2007        PMID： 17971467      PMCID： PMC2598106          DOI： 10.1136/jme.2006.017376

Source DB:  PubMed          Journal:  J Med Ethics        ISSN： 0306-6800            Impact factor:   2.903


  18 in total

Review 1.  Participatory research maximises community and lay involvement. North American Primary Care Research Group.

Authors:  A C Macaulay; L E Commanda; W L Freeman; N Gibson; M L McCabe; C M Robbins; P L Twohig
Journal:  BMJ       Date:  1999-09-18

2.  Informed consent, exploitation and whether it is possible to conduct human subjects research without either one.

Authors:  D Wendler
Journal:  Bioethics       Date:  2000-10       Impact factor: 1.898

Review 3.  Informed consent and the capacity for voluntarism.

Authors:  Laura Weiss Roberts
Journal:  Am J Psychiatry       Date:  2002-05       Impact factor: 18.112

4.  Ethical research with the mentally disordered.

Authors:  J Arboleda-Flórez; D N Weisstub
Journal:  Can J Psychiatry       Date:  1997-06       Impact factor: 4.356

5.  Decisional capacity for informed consent in schizophrenia research.

Authors:  W T Carpenter; J M Gold; A C Lahti; C A Queern; R R Conley; J J Bartko; J Kovnick; P S Appelbaum
Journal:  Arch Gen Psychiatry       Date:  2000-06

6.  Research and ethics: leaving exclusion behind.

Authors:  D P J Osborn
Journal:  Curr Opin Psychiatry       Date:  1999-09       Impact factor: 4.741

7.  Perspectives of patients with schizophrenia and psychiatrists regarding ethically important aspects of research participation.

Authors:  L W Roberts; T D Warner; J L Brody
Journal:  Am J Psychiatry       Date:  2000-01       Impact factor: 18.112

8.  Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders.

Authors:  Laura B Dunn; Laurie A Lindamer; Barton W Palmer; Shahrokh Golshan; Lawrence J Schneiderman; Dilip V Jeste
Journal:  Am J Geriatr Psychiatry       Date:  2002 Mar-Apr       Impact factor: 4.105

9.  Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions.

Authors:  Laura Weiss Roberts; Teddy D Warner; Janet L Brody; Brian Roberts; John Lauriello; Constantine Lyketsos
Journal:  Am J Psychiatry       Date:  2002-04       Impact factor: 18.112

10.  Informed consent: assessment of comprehension.

Authors:  D A Wirshing; W C Wirshing; S R Marder; R P Liberman; J Mintz
Journal:  Am J Psychiatry       Date:  1998-11       Impact factor: 18.112
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  8 in total

1.  Decisional capacity and consent for schizophrenia research.

Authors:  Allison R Kaup; Laura B Dunn; Elyn R Saks; Dilip V Jeste; Barton W Palmer
Journal:  IRB       Date:  2011 Jul-Aug

2.  Patient-Centered Outcomes Research (PCOR): How Can We Optimize Outcomes in CNS Research?

Authors:  Mitali Wadekar; Anil Sharma; Gina Battaglia
Journal:  Innov Clin Neurosci       Date:  2015 Mar-Apr

3.  Informed consent to research in persons with schizophrenia spectrum disorders.

Authors:  Lora Humphrey Beebe; Kathlene Smith
Journal:  Nurs Ethics       Date:  2010-07       Impact factor: 2.874

4.  Empirical evaluation of the need for 'on-going consent' in clinical research.

Authors:  William Smith; Christine Grady; Benjamin Krohmal; Jaime Lazovski; David Wendler
Journal:  AIDS       Date:  2011-01-02       Impact factor: 4.177

5.  Ethics, patient rights and staff attitudes in Shanghai's psychiatric hospitals.

Authors:  Liang Su; Jingjing Huang; Weimin Yang; Huafang Li; Yifeng Shen; Yifeng Xu
Journal:  BMC Med Ethics       Date:  2012-05-17       Impact factor: 2.652

6.  Knowledge & attitudes of mental health professionals regarding psychiatric research.

Authors:  N N Mishra; Triptish Bhatia; Nandini Kumar; Vishwajit L Nimgaonkar; Lisa S Parker; Smita N Deshpande
Journal:  Indian J Med Res       Date:  2014-02       Impact factor: 2.375

7.  Ethical considerations in placebo-controlled randomised clinical trials.

Authors:  Kenneth R Kaufman
Journal:  BJPsych Open       Date:  2015-06-30

Review 8.  Testing decision-making competency of schizophrenia participants in clinical trials. A meta-analysis and meta-regression.

Authors:  Sorin Hostiuc; Mugurel Constantin Rusu; Ionut Negoi; Eduard Drima
Journal:  BMC Psychiatry       Date:  2018-01-05       Impact factor: 3.630
  8 in total

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