We wanted to use the Quality of Informed consent questionnaire as part of a project I am working on, however, user testing has shown that it is time consuming for our participants to complete so we are looking for a validated alternative. Many thanks, Sinead
Hello Sinead
I can provide a solution for you.
The question of IC is quite a central one, in my sphere of action. And central to what I do, at very different levels. Which means that I have developed a series of activities that I have followed, to provide exhaustive, in depth replies to the scientific community. I understand that you need a questionnaire that is given to the subject who has previously given consent, to verify what was understood. This was used extensively by a project, and I believe the answer for you is that the questionnaire has to be designed specifically for each subject but the questions should cover certain asppects that provide information essential to inform the subject. This work has been done and the results can be consulted.
FP7Framework Health Programme project - CONTRACT( that you can find at the site below)t has been quite exhaustive on the subject of informed consent. Furthermore, they developed an extremely interesting electronic tool, the same site identifying the company that manages this tool for the project. This tool is in fact quite a short but adequately informative information sheet. This is a questionnaire that is usually used by many of the european researchers, as it is drafted by a group of legal experts and clinical paediatricians and doctors of other specialities. Even more interesting, it is a consent form that was developed also by data protection specialists, and is currently being archived (and adapted) by a company that provides data protection services to the research community. I don't know what are the conditions of this service (that is for the data protection management part, that is), but the use of the tool is not paid.
I hope that this reply is useful. It is important not to duplicate efforts, and this could save a lot of heartburn.
http://www.contract-fp7.eu/site/
Good luck
JN
I find Joana's claim that " . . . you need a questionnaire that is given to the subject who has previously given consent, to verify what was understood" will require a bit of bootstrapping. Will a different quesionnaire be required to validate the "previously geiven consent"?
Hello William
Yes, it is a different one, a short questionnaire, and really asks the person what they consented to in their words. Unfortunately it is a chore, but rewarding. The thorough application of this method teaches one how to "save effort" safely, because the type of information the person is capable of retaining and devolving depends on lots of factors, cultural, mostly, but the situation in which the consent is sought is very basic, too, so the inquirer can soon pick his "more probable" routines. Simplification is a "learning curve". But taking this trouble ultimately pays off. Because you get less withdrawals, refusals, "disappearances, and negative reactions, which create a lot of useless and dangerous effects.
Most study subjects only react angrily if they suspect they are treated carelessly. And the regulators are getting very severe, as lawsuits and negative effects are starting to take a toll.
- Badges
- Science topic
- Similar topics
- Geoscience
- Asia
- India