Informed Consent Form Challenges for Genetic Research in Jordan

Area of Science:

• Bioethics
• Genetic Research
• Clinical Trials

Background:

• Informed consent is mandatory for human subject research.
• Informed consent forms (ICFs) document voluntary participation.
• Ethical and legal standards require specific essential items within ICFs.

Purpose of the Study:

• To assess the content of ICFs from Jordanian genetic studies.
• To evaluate adherence to International Conference on Harmonization-Good Clinical Practice (ICHGCP) guidelines.

Main Methods:

• Analysis of 44 ICFs from master theses and grant proposals in Jordan.
• Scoring ICFs based on the presence or absence of ICHGCP criteria.

Main Results:

• ICFs demonstrated inadequate information, with scores ranging from 1 to 17 (average 6.18).
• Key missing elements included statements on voluntary participation, data confidentiality, compensation, risks/benefits, and researcher contact details.

Conclusions:

• Many ICFs lacked required information, indicating potential gaps in investigator knowledge.
• There is a clear need for improved research ethics education for investigators in Jordan.