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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?

 

 

Strict guidelines are followed and experts review the studies to ensure participants are never subjected to undue risk. However, studies may involve some degree of risk. Participant safety is the number one priority of any study.

 

Each participant is given a consent form to sign that describes the most common risks for the medication being studied, the potential benefits of participating in the study and expectations of persons participating. You will be able to discuss the 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.

 

 

 

 

Are Clinical Trials Safe

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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 participants. Then, 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 participants 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 before implementation.

 

  • As the clinical trial progresses it is supervised. A data monitoring committee and researchers review and report the ongoing results of the trial during the course of the trial.

 

  • Your privacy is protected by HIPPA so the individual participants’ names will remain secret and will not be mentioned in these reports.

 

  • You are fully informed of benefits and risks before you agree to take part.

 

 

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The Informed Consent Process allows you to learn the key facts about a clinical trial before deciding whether or not to participate. Participants must be provided with all facts about a study before giving consent to participate, including treatment details and possible risks and benefits.

 

The informed consent form or document includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained in the informed consent 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 participation. However, this is not a binding contract. The participant may withdraw from the trial at any time.

 

 

 

 

 

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The Food and Drug Administration (FDA) makes sure 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. However, the FDA does not develop new therapies, or conduct the clinical trials. 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.

 

 

 

 

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

 

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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 with the aim to protect the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and 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 give informed consent and that their safety, rights, privileges, and privacy are protected.

 

 

What is the role of the IRB?

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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, nearly all academic institutions hold their researchers to these statements of rights regardless of funding sources.

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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.

 

 

 

What are the alternatives to participating in a clinical trial?

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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.

 

 

 

 

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Can I leave or drop out of the clinical trial after it has begun?