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 Informed Consent and 10 Questions to Ask the Principal Investigator when enrolling in Clinical Trials

Informed consent, is the process of granting full knowledge to the clinical trial participant about the trial and all it’s risks and benefits, his rights, the cost and everything related to the trial he/s interested to participate in. Informed consent form is the document used to document his willingness to participate and that he received all the information needed to make an informed decision and was given the chance to ask questions.

Questions that you could ask the study team could include:

  1. What is the aim of the study?
  2. What are the anticipated benefits?
  3. What are the side effects and risks?
  4. How many visits should I attend?
  5. Does the study require hospitalization? If yes, for how long?
  6. What are the procedures I will go through?
  7. Does my participation in this clinical trial affect my daily life or my existing medical plan?
  8. How can I contact the study team during and after the study?
  9. Is there any cost for my participation?
  10. Is there any compensation?
 Clinical Trials Participants Rights and the Role of IRB
  1. You have the right to have enough time to make a decision to participate without being pressured by the study team.
  2. You have the right to communicate with the ethics committee (or Institutional Review Board) directly without permission from the study team.
  3. You have the right to refuse to participate in the trial or withdraw your consent without any effect to you’re the medical care given to you.
  4. You have the right to know the aim of the study and what’s your role in it and what are the procedures you’re required to go through.
  5. You have the right to know the potential risks and side effects.
  6. You have the right to know the potential benefits.
  7. You have the right to know if there are any costs for your participation and if you will receive any compensation.
  8. You have the right to know who will have access to your information and how will it be stored.
  9. You have the right to know who to contact to answer your questions anytime.
  10. You have the right to know if there are available alternative treatment for your condition that does not requires participating in clinical trials.

 

What is the role of the Medical Research Ethics Committee?

The role of this important committee is focused on human research, to ensure its safety and to minimize the side effects of treatment.

This committee supervises the overall course of study and the extent to which the research team applies the pre-approved study program and is held accountable in cases of non-application of study controls. This committee also imposes adequate explanation of the study participant by the research team.

And ensuring that the consent of the participant is taken part in the participation, the committee also guarantees the confidentiality of the participant’s information in the study and does not cause any harm to the participant.