How are participants protected from a research study?
Currently there are laws, guidelines and regulations that strict control and follow clinical research studies. At O-CINCO we work in compliance with Regulations; as well as international guidelines (Declaration of Helsinki, Good Clinical Practices, etc.) and along with independent Ethics Committees. All of us ensuring the Protection and well being of human subjects participating in clinical studies and also making certain site is obtaining and reporting reliable data that is useful to the community.
Process
The study is carried out following a document called Study protocol, which is writen and prepared by professional in compliance with national and international regulations.
This document specifies all the study activities, details and all study related information, including the participants protected information.
Protocol
All the Study protocols must be previously approved by an Ethics Committee (IEC) prior to its conduction.
IEC is a group of independent persons to O-CINCO who evaluate the study protocol and take care of the safety and well-being of the subjects, along with the MOH.
Incentive
O-CINCO offers free: medical assessment, and compensation for the time spent per site visits to all our volunteers once selected and willing to participate with us in the Clinical study Incentives must be previously approved by IEC.
What is an informed consent?
What do you need to volunteer?
It is the process by which a volunteer or patient confirms their desire to participate in a Clinical research study, after being informed of all study relevant aspects to make their decision in order to participate.
If you are willing to participate in a clinical research study at O-CINCO you will be granted with written study related information in which you could participate and you will be able to ask the questions that you consider necessary prior making the decision to participate.
This varies, it depends on the type of study you could be included. For studies requiring healthy subjects, generally you should be requested or meet the following items::
-
Copy of birth certificate (minors)
-
Copy of ID card
-
Know how to read and write (otherwise bring a witness who can read and write)
-
Do not do drugs.
-
Have disposition and time to participate in the study
If you suffer from a disease and you are interested in knowing if studies are being carried out for your treatment, you can contact us.
We invite you to participate in a clinical research study
We offer you without cost: Medical evaluation If you are interested in participating in research studies, please contact us.
Qualified staff will give you all the information and you will be free to ask all the questions you consider necessary before participating.