Informed Consent Form Challenges for Genetic Research in Jordan

Figures & data

Table 1 Categories/Minimal Essential Items for all Informed Consent Forms.

Category and ICF Essential Items	Percentage of Compliance
Purpose of the study and contact information
Rationale	84.1%
Study design	79.5%
Emergency contacts (questions/concerns)	9.1%
Need to re-contact	22.7%
Specimen management and study procedures
Study procedure(s)	47.7%
Specimen storage	4.5%
Specimen collection	86.4%
Participant extra expenses	25%
Research-related injury/compensation	2.3%
Potential benefits from participation
Participation benefits (individual/society)	22.7%
Potential risks from participation
Uncertainty of findings related to genetic risk for a given disease or trait.	0%
Physical risks, associated with collecting blood or other tissues samples.	15.9%
Participant confidentiality
De-identification of personal information	34.1%
Others access to participants health information records	31.8%
Health information sharing for research purpose participant privacy	15.9%
Participant privacy protection measures	36.4%
Participant rights and responsibilities
Participation is voluntary	56.8%
Ability to withdraw from the study at any time with no effects on standard care received	36.4%
Recall genetic specimen possibility after initiation of consent withdrawal	4.5%
Alternative procedures/arrangements available	2.3%
Overall compliance	38.9%

Note: Copyright ©2015 John Wiley and Sons. Adapted from Nair SC, Ibrahim H. Informed consent form challenges for geneticresearch in a developing Arab country with high risk for geneticdisease. J Genet Couns. 2015;24(2):294–299. doi:10.1007/s10897-014-9763-y.⁸

Figure 1 ICFs compliance scores out of 20 (X-axis) according to the International Conference on Harmonization—Good Clinical Practice with their frequencies (Y-axis), N=44.

Nair SC, Ibrahim H. Informed consent form challenges for genetic research in a developing Arab country with high risk for genetic disease. J Genet Couns. 2015;24(2):294–299. doi:10.1007/s10897-014-9763-y

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