Literature DB >> 26074215

Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study.

H Mansour1, N Zaki2, R Abdelhai3, N Sabry2, H Silverman4, S S El-Kamary5.   

Abstract

Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve their condition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized. Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception.

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Year:  2015        PMID: 26074215      PMCID: PMC5924596          DOI: 10.26719/2015.21.3.155

Source DB:  PubMed          Journal:  East Mediterr Health J        ISSN: 1020-3397            Impact factor:   1.628


  27 in total

1.  Trust and informed consent: insights from community members on the Kenyan coast.

Authors:  C S Molyneux; N Peshu; K Marsh
Journal:  Soc Sci Med       Date:  2005-02-12       Impact factor: 4.634

2.  The promise and pitfalls of clinical trials overseas.

Authors:  Dennis Normile
Journal:  Science       Date:  2008-10-10       Impact factor: 47.728

3.  Discrepancy between participants' understanding and desire to know in informed consent: are they informed about what they really want to know?

Authors:  Jiwon Koh; Eurah Goh; Kyung-Sang Yu; Belong Cho; Jeong Hee Yang
Journal:  J Med Ethics       Date:  2011-06-27       Impact factor: 2.903

4.  Quality of informed consent: a new measure of understanding among research subjects.

Authors:  S Joffe; E F Cook; P D Cleary; J W Clark; J C Weeks
Journal:  J Natl Cancer Inst       Date:  2001-01-17       Impact factor: 13.506

5.  The therapeutic misconception: informed consent in psychiatric research.

Authors:  P S Appelbaum; L H Roth; C Lidz
Journal:  Int J Law Psychiatry       Date:  1982

6.  Lay public's understanding of equipoise and randomisation in randomised controlled trials.

Authors:  E J Robinson; C E P Kerr; A J Stevens; R J Lilford; D A Braunholtz; S J Edwards; S R Beck; M G Rowley
Journal:  Health Technol Assess       Date:  2005-03       Impact factor: 4.014

7.  Benefits to research subjects in international trials: do they reduce exploitation or increase undue inducement?

Authors:  Angela Ballantyne
Journal:  Dev World Bioeth       Date:  2008-12       Impact factor: 2.294

8.  Why healthy subjects volunteer for phase I studies and how they perceive their participation?

Authors:  Luis Almeida; Benedita Azevedo; Teresa Nunes; Manuel Vaz-da-Silva; Patrício Soares-da-Silva
Journal:  Eur J Clin Pharmacol       Date:  2007-09-20       Impact factor: 2.953

9.  Evaluation of the ability of clinical research participants to comprehend informed consent form.

Authors:  S Bhansali; N Shafiq; S Malhotra; P Pandhi; Inderjeet Singh; S P Venkateshan; S Siddhu; Y P Sharma; K K Talwar
Journal:  Contemp Clin Trials       Date:  2009-03-31       Impact factor: 2.226

10.  Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting.

Authors:  Deon Minnies; Tony Hawkridge; Willem Hanekom; Rodney Ehrlich; Leslie London; Greg Hussey
Journal:  BMC Med Ethics       Date:  2008-09-30       Impact factor: 2.652

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  7 in total

1.  Motivators and barriers towards clinical research participation: A population-based survey from an Arab MENA country.

Authors:  Kamal M Al-Shami; Wesam S Ahmed; Karem H Alzoubi
Journal:  PLoS One       Date:  2022-06-24       Impact factor: 3.752

2.  Patients' attitudes and perceptions regarding research and their rights: a pilot survey study from the Middle East.

Authors:  Tamer Hifnawy; Samer Kobrosly; Hillary Edwards; Manal Anwar; Dalia Zahran; Henry Silverman
Journal:  East Mediterr Health J       Date:  2017-08-27       Impact factor: 1.628

3.  Perceptions and Attitudes of Cancer Patients and Caregivers Towards Enrollment in Clinical Trials in Lebanon.

Authors:  Rana Salem; Charbel Matar; Rita Assi; Raafat Alameddine; Sally Temraz; Ali Shamseddine; Deborah Mukherji
Journal:  J Cancer Educ       Date:  2019-04       Impact factor: 2.037

4.  Clinical features of Parkinson's disease patients are associated with therapeutic misconception and willingness to participate in clinical trials.

Authors:  Emmi Reijula; Anna-Maija Pietilä; Arja Halkoaho; Tuomas Selander; Kirsti Martikainen; Reetta Kälviäinen; Tapani Keränen
Journal:  Trials       Date:  2017-09-29       Impact factor: 2.279

5.  Sharing, reuse, and storage of biosamples among biomedical researchers in Jordan: Practice and concerns.

Authors:  Almuthanna K Alkaraki; Omar F Khabour; Karem H Alzoubi; Lina M K Al-Ebbini; Zaid Altaany
Journal:  PLoS One       Date:  2022-04-28       Impact factor: 3.240

6.  Perceptions and attitudes toward participation in clinical research in the Eastern Mediterranean Region: A systematic review.

Authors:  Mohamed Aabdien; Ibtihal Abdallah; Mohamed Iheb Bougmiza; Timo Siepmann; Ben Illigens
Journal:  Medicine (Baltimore)       Date:  2022-08-19       Impact factor: 1.817

7.  Why do participants drop-out: findings from a prospective pediatric cohort for fever surveillance established at Vellore, southern India.

Authors:  Kulandaipalayam Natarajan Sindhu; Manikandan Srinivasan; Sathyapriya Subramaniam; Anita Shirley David; Venkata Raghava Mohan; Jacob John; Gagandeep Kang
Journal:  BMC Med Res Methodol       Date:  2019-12-30       Impact factor: 4.615

  7 in total

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