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Your Safety and Protection

YOUR SAFETY AND PROTECTION
Are clinical trials safe?
How is the safety of the participant protected?
What is informed consent?
What is the role of the FDA?
What is good Clinical Practice?
What is the role of the IRB?
What is The Common Rule?
What are the alternatives to participating in a clinical trial?
Can I leave or drop out of the clinical trial after it has begun?

 

YOUR SAFETY AND PROTECTION

Are clinical trials safe?
Strict guidelines are followed and experts review the studies to ensure patients are never subjected to undue risk. However, studies may involve some degree of risk. Participant safety is the number one priority in any study. Top

Each participant is given a consent form to sign which describes the most common risks for the medication being studied, the potential benefits of participating in the study and expectations of persons participating. Participants will be able to discuss complete informed consent with the research clinic staff. They will help you fully understand the risks and potential benefits of participating in the study and your rights as a research participant. Your medical condition will be monitored throughout the study by experienced medical staff and physicians. Top

How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. All clinical research is federally regulated with built-in safeguards to protect the participants. Treatments have been thoroughly tested in laboratory trials before they are ever tested with groups of patients.  Medications must be FDA approved in phase 1 and 2 trials before they can be used in phase 3 and 4 trials. There are many other safeguards for patients taking part in trials including the following:

• The trial protocol is a study plan that details what researchers will do in the study. It is reviewed and must be approved by an external ethics review committee (Internal Review Board/IRB) before implementation.
• All aspects of the clinical trial are supervised for the duration of the trial. A data monitoring committee and researchers review and report research findings  during the course of the trial.
• Participant privacy is protected by HIPAA (Health Insurance Portability and Accountability Act of 1966) so individual participants’ names remain secret and are not mentioned in any reports.
• Participants are fully informed of the benefits and risks before they volunteer to take part. Top

What is informed consent?
The informed consent form includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained in this document. The participant then decides whether or not to participate and sign the document. The informed consent form must be signed by participants; prior to the initiation of any study procedures.  This is not a binding contract  and the participant may withdraw from the trial at any time.   

This process allows the participant to gain information about the clinical trial before deciding to volunteer participation. Patients must be provided with all known details about the trial when considering their consent to participate.  Top

What is the role of the FDA?
FDA
The Food and Drug Administration (FDA) ensures that medical treatments are safe and effective for people to use. The FDA requires that all medications are thoroughly tested for safety and effectiveness before they may be prescribed by a doctor. The FDA does not develop new therapies, or conduct the clinical trials. It functions strictly as a regulatory body. The FDA meets with researchers and performs inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data collected during a study. Top

What is Good Clinical Practice?
Good Clinical Practice (GCP) guidelines are standard which has been created for the design, conduct, monitoring, auditing, recording, analysis of results, and reporting of clinical trials. Both the FDA and IRBs adhere to GCP guidelines. These guidelines are applied in clinical research trials in order to provide assurance that the final results which are reported are accurate, credible, and that confidentiality and rights of trial participants are protected. Top

What is the role of the IRB?
An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. The purpose of these boards is to protect the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and the Department of Health and Human Services (specifically Office for Human Research Protections) have regulations that empower IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory. They ensure that participants involved in research projects are protected from undue risk. They also ensure that subjects voluntarily give informed consent and that their safety, rights, privileges, and privacy are protected. Top

What is the Common Rule?
According to the U.S. Department of Health and Human Services, the Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. These regulations governing Institutional Review Boards for oversight of human research came into effect in 1981 following the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A ("The Common Rule") is the baseline standard of ethics to which any government-funded research in the US is held. However, all academic institutions and researchers are held to these statements of rights regardless of funding sources. Top

What are the alternatives to participating in a clinical trial?
It is important to consider alternatives to clinical trials, such as treatment that is already deemed safe and approved by the FDA, or even treatments that do not involve medications. Top

Can I leave or drop out of the clinical trial after it has begun?
Yes. All qualified participants may leave a clinical trial, at any time. You should discuss your situation with the research team  regarding your decision and the reasons for leaving the study. Top