Problems with the consent process

[Guest guest]

Hello Everybody,

The IC presents some major challenges for study participants and research staff. Several papers have addressed problems with the current process some of which are as follows:

Subject's hesitation to ask detailed questions

Variable presentation of the content

Difficulty verifying the subject's comprehension.

Additionally, a survey of 1600 respondents performed by CenterWatch in 2002 found that 14% of participants did not read the consent before signing, and a high percentage of volunteers admitted to not fully understanding the risks and not knowing what questions to ask.

The concept of "therapeutic misconception" in research is another problem that has received much attention in both legal and bioethics literature. Generally, it is important that potential participants are aware that research is not the only therapeutic alternative for them.

Lack of participant understanding and comprehension is possibly compounded by the increasing regulations that govern the performance of study personnel and the cost pressures, meaning that there is ever-decreasing time available for study personnel to spend reviewing the consent with the subject.

Dr. Smita