Rights and Safety of Clinical Trial Participants

All clinical trial organizers consider the safety of trial participants as a top priority. Therefore, each phase of the trial follows strict scientific standards.

Scientific Supervision of Clinical Studies

Rights and Safety of Clinical Trial

Institutional Review Board (IRB)

IRBs are committees designated to review and monitor clinical trials involving human subjects. An IRB has the authority to approve the methods and techniques for conducting a clinical trial, require changes to a trial protocol, or disapprove any trial that poses risk to participants. Every clinical study in the United States must be approved by an Institutional Review Board.

The primary goal of an IRB is to protect the rights and safety of clinical trial participants.

Data Safety Monitoring Board (DSMB)

A Data Safety Monitoring Board is a group of experts who are not involved in the trial. They are independent of the trial organizers.

DSMBs provide data analysis of clinical trial data and inform the sponsor about the safety of participants, hidden risks, and scientific validity of the trial. Almost every Phase III clinical trial has a Data Safety Monitoring Board. This board is comprised of a panel of research and study topic experts.

Food and Drug Administration (FDA)

The Food and Drug Administration regulates research that involves new drugs and medical devices. The FDA also reviews applications for new medicines before any testing on humans is done. It requires that informed consent be obtained from all subjects of clinical trials. The FDA provides supervision and guidance during different phases of a clinical trial.

Rights of a Clinical Trial Participant

Informed Consent

Informed consent includes detailed information about the purpose and course of a clinical trial. Potential trial participants should be given adequate time to make a decision and sign an informed consent. There is a list of set questions to ask the study coordinator and make sure that the participant is properly and correctly informed.● Purpose of the trial.

Who is sponsoring this clinical trial?
What is the investigational drug?
What are the responsibilities of a trial participant?
What kinds of procedures and tests are involved?
What are the risks of taking part in the study?
Potential benefits of participating in the study.
How long will the clinical trial last?
Will the study sponsors arrange the reimbursement of clinical travel costs and other expenses?
Will hospitalization be required?
Is there compensation for participants who suffer harm from trial participation?

Potential participants can take the informed consent and consult with their doctor about the pros and cons of participation in the study.

Patients Rights

Right to independently decide on participation in the trial (informed, voluntary consent).
Right to privacy and confidentiality of personal data.
Right to receive new information that may influence the decision to participate in the trial.
Right to withdraw from the trial at any time by your own decision and without explanation.
Right to receive copies of medical assessments and analyses of the conducted surveys.
Right to ask any questions to the research doctor.
Right to inform your primary physician about your participation in the trial.
Right to receive medical care as usual.