The quality of consent form structure in biomedical research: a study from Jordan and Sudan.

BACKGROUND

Informed consent is one of the primary standards of ethical clinical research. This study assessed the quality of the informed consent forms (ICF) utilized in medical research conducted in Sudan and Jordan.

SUBJECTS AND METHODS

A total of 435 studies that were performed at health sciences schools in Jordan and Sudan were initially screened for the presence of ICF. Of these, 189 studies were reviewed for the major components of ICF using a standard checklist.

RESULTS

The majority of the reviewed ICFs did not achieve the full standards of the universal guidelines for the informed consent structure. The following elements were described in >50% of consent forms reviewed from both countries: study title, objectives, research investigators, description of study procedure, and confidentiality. Other essential elements such as duration of the subject's participation, risks/benefits, compensation, voluntary participation, and contact information were poorly described.

CONCLUSION

The major elements of ICFs were not adequately described in medical research studies from Jordan and Sudan. Improved understanding of major elements of ICF among researchers in the examined countries is necessary. Clear and informative consent template can be very valuable in this perspective.