Literature DB >> 18388256

Patients' perception of the informed consent process for neurooncology clinical trials.

Eva Knifed1, Nir Lipsman, Warren Mason, Mark Bernstein.   

Abstract

The informed consent process is a cornerstone of modern medical research. This study was conducted to explore the process in the context of neurooncology clinical trials. Qualitative methodology and analysis were used on open-ended, face-to-face interviews conducted with 21 patients. Six comprehensive themes emerged: (1) general understanding of the objectives and purpose of clinical trials was good, (2) recall of risks was low, (3) patients did not believe that their care would be compromised by forgoing the clinical trial, (4) patients felt participation was voluntary and free of coercion, (5) patients would not have withdrawn from the trial in the event of complications, and (6) patients were satisfied with the informed consent process. Informed consent is a dynamic process; when appropriately executed, it can be a powerful safeguard protecting patient autonomy. If sufficient time is allowed to deliberate participation and ample opportunity is provided for information sharing and disclosure, researchers can be confident that participants are knowledgeable about the trial and aware of their rights.

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Mesh:

Year:  2008        PMID: 18388256      PMCID: PMC2563057          DOI: 10.1215/15228517-2008-007

Source DB:  PubMed          Journal:  Neuro Oncol        ISSN: 1522-8517            Impact factor:   12.300


  21 in total

1.  Communication and miscommunication in informed consent to research.

Authors:  Pamela Sankar
Journal:  Med Anthropol Q       Date:  2004-12

2.  Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis.

Authors:  J Kimmelman; N Palmour
Journal:  J Med Ethics       Date:  2005-04       Impact factor: 2.903

3.  Fully informed consent is impossible in surgical clinical trials.

Authors:  Mark Bernstein
Journal:  Can J Surg       Date:  2005-08       Impact factor: 2.089

4.  Randomised clinical trials with clinician-preferred treatment.

Authors:  E L Korn; S Baumrind
Journal:  Lancet       Date:  1991-01-19       Impact factor: 79.321

5.  Patient-centered informed consent in surgical practice.

Authors:  James L Bernat; Lynn M Peterson
Journal:  Arch Surg       Date:  2006-01

6.  Informed consent in surgical trials.

Authors:  H A Dudley
Journal:  Br Med J (Clin Res Ed)       Date:  1984-10-13

7.  Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective.

Authors:  C K Daugherty
Journal:  J Clin Oncol       Date:  1999-05       Impact factor: 44.544

8.  Participating in a trial in a critical situation: a qualitative study in pregnancy.

Authors:  S Kenyon; M Dixon-Woods; C J Jackson; K Windridge; E Pitchforth
Journal:  Qual Saf Health Care       Date:  2006-04

Review 9.  The parameters of informed consent.

Authors:  Edward L Raab
Journal:  Trans Am Ophthalmol Soc       Date:  2004

10.  Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial.

Authors:  K Featherstone; J L Donovan
Journal:  BMJ       Date:  1998-10-31
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  8 in total

Review 1.  The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries.

Authors:  Amulya Mandava; Christine Pace; Benjamin Campbell; Ezekiel Emanuel; Christine Grady
Journal:  J Med Ethics       Date:  2012-02-07       Impact factor: 2.903

2.  Using digital multimedia to improve parents' and children's understanding of clinical trials.

Authors:  Alan R Tait; Terri Voepel-Lewis; Robert Levine
Journal:  Arch Dis Child       Date:  2015-03-31       Impact factor: 3.791

3.  Assessing research participants' perceptions of their clinical research experiences.

Authors:  Rhonda G Kost; Laura M Lee; Jennifer Yessis; Barry S Coller; David K Henderson
Journal:  Clin Transl Sci       Date:  2011-11-07       Impact factor: 4.689

4.  Neuro-oncology: Under-recognized mental incapacity in brain tumour patients.

Authors:  Mark Bernstein
Journal:  Nat Rev Neurol       Date:  2014-08-12       Impact factor: 42.937

5.  Racial/Ethnic Differences in Comprehension of Biospecimen Collection: a Nationwide University of Rochester Cancer Center NCI Community Oncology Research Program Study.

Authors:  Matthew Asare; Charles E Heckler; Eva Culakova; Charles S Kamen; Amber S Kleckner; Lori M Minasian; David S Wendler; Michelle Feige; Carol J Weil; Joan Long; Sharon K Cole; Adedayo A Onitilo; Luke J Peppone; Gary R Morrow; Michelle C Janelsins
Journal:  J Cancer Educ       Date:  2020-04       Impact factor: 2.037

Review 6.  Strengths and weaknesses of guideline approaches to safeguard voluntary informed consent of patients within a dependent relationship.

Authors:  Sara A S Dekking; Rieke van der Graaf; Johannes J M van Delden
Journal:  BMC Med       Date:  2014-03-24       Impact factor: 8.775

Review 7.  Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis.

Authors:  Nguyen Thanh Tam; Nguyen Tien Huy; Le Thi Bich Thoa; Nguyen Phuoc Long; Nguyen Thi Huyen Trang; Kenji Hirayama; Juntra Karbwang
Journal:  Bull World Health Organ       Date:  2015-01-22       Impact factor: 9.408

8.  Psychometric Development of the Research and Knowledge Scale.

Authors:  Lauren R Powell; Elizabeth Ojukwu; Sharina D Person; Jeroan Allison; Milagros C Rosal; Stephenie C Lemon
Journal:  Med Care       Date:  2017-02       Impact factor: 2.983

  8 in total

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