We are committed to protecting the people who take part in our clinical trials, and to upholding the highest ethical standards as we seek safe and effective ways to prevent or treat diseases.

All clinical trials have potential benefits and risks. We hope that by understanding more about how the safety, confidentiality, and privacy of participants are addressed in a clinical trial, you can make the best choice for you.

 

Understanding clinical trial safeguards

The important role of informed consent

Informed consent is one of the first and most important tools to help you understand how your rights, safety, and well-being will be addressed throughout the clinical trial. During informed consent, you will be given all details about the study you are considering. This will include potential benefits and risks of the study. The information will help you decide whether you would like to participate.

A member of the study team will walk you through the informed consent document and answer any questions you may have before you agree to participate and sign it. You can take as much time as you need to review it.

While you are participating, the study team will tell you in a timely manner if new information is learned that could change your mind about continuing in the study. You can stop being in the study at any time. Your decision will not affect your regular medical care or any benefits to which you are entitled.

Oversight of clinical trials

Researchers are required to follow clinical trial regulatory requirements and guidelines to protect your safety and rights, such as Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical trials. In addition, there are many entities that provide oversight of clinical research studies. Some of these include:

Regulatory agencies or health authorities such as the U.S. Food and Drug Administration (FDA).

The FDA is responsible for reviewing clinical trials before they begin.

Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs).

An IRB or IEC is an independent group that includes scientists, doctors, and lay people. This group reviews a clinical trials design and any updates to it, as well as any information provided to participants, to ensure that participants rights, safety, and well-being are protected. IRBs and IECs have the authority to approve, ask for changes, or disapprove clinical research.

Data and Safety Monitoring Boards (DSMBs).

DSMBs are typically made up of a group of external, independent experts who monitor any potential safety concerns that may develop during a clinical trial.

Protecting your personal information

All clinical trials must comply with and operate under relevant laws, including privacy laws. In the U.S., the main federal privacy law is known as the Health Insurance Portability and Accountability Act or HIPAA.

Your personal information will be protected in compliance with relevant laws such as HIPAA, and in the manner explained in the informed consent document.

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