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Informed Consent Form Challenges for Genetic Research in Jordan.
Alkaraki, Almuthanna K; Khabour, Omar F; Alzoubi, Karem H; Al-Ebbini, Lina M K; Altaany, Zaid.
Afiliación
  • Alkaraki AK; Department of Biological Sciences, Faculty of Science, Yarmouk University, Irbid 21163, Jordan.
  • Khabour OF; Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid 22110, Jordan.
  • Alzoubi KH; Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid 22110, Jordan.
  • Al-Ebbini LMK; Department of Biomedical Systems and Informatics Engineering, Hijjawi for Engineering Technology, Yarmouk University, Irbid 21163, Jordan.
  • Altaany Z; Department of Basic Medical Sciences, Faculty of Medicine, Yarmouk University, Irbid 21163, Jordan.
J Multidiscip Healthc ; 13: 235-239, 2020.
Article en En | MEDLINE | ID: mdl-32184613
BACKGROUND: Informed consent is an obligatory requirement for research engaging human subjects. Informed consent form (ICF) should be provided for human subjects to confirm their willingness for voluntary participation in a study. Ethical and legal obligations necessitate the presence of informed consent essential items to be built into the ICF. OBJECTIVE: To evaluate the content of ICFs obtained from different genetic studies accomplished in Jordan and their adherence to ethical guidelines proposed by the International Conference on Harmonization-Good Clinical Practice (ICHGCP). METHODS AND MEASURES: A total of 44 ICFs obtained from master theses and grant proposals at two major universities in Jordan were analyzed according to the good clinical practice criteria proposed by ICHGCP. ICFs were scored for the presence or absence of ICF main items/categories. RESULTS: Results show inadequate information present in the examined ICFs. The highest information score was 17 out of 20, while the lowest score was one out of 20. The average score for all studied ICFs was 6.18±3.65. Among essential items/categories that were absent from the majority of studied ICFs were a statement about voluntary participation, confidentiality of data, compensation to study participants, risk/benefits of the study, and researchers' contact information. CONCLUSION: The ICFs were missing a number of required items. This could reflect inadequate knowledge about minimal informed consent requirements among Jordanian investigators highlighting the need for research ethical training in the country.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Guideline Aspecto: Ethics Idioma: En Revista: J Multidiscip Healthc Año: 2020 Tipo del documento: Article País de afiliación: Jordania Pais de publicación: Nueva Zelanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Guideline Aspecto: Ethics Idioma: En Revista: J Multidiscip Healthc Año: 2020 Tipo del documento: Article País de afiliación: Jordania Pais de publicación: Nueva Zelanda