OsteoArthritis Resarch Studies: Participant Protections

Several agencies oversee the conduct of clinical research in every country involved in the studies. They include the local or central Ethics Committees, Institutional Review Boards and government regulators such as the FDA in the United States and the MHRA in the UK and AFSSAPS in France. Your safety in the study is very important. The following are some of the actions that have been taken to protect participant safety.

Ethics Committees (ECs) or Institutional Review Boards (IRBs) must review and approve each study and each study site. Their job is to help protect the rights and safety of research participants. These committees are made up of physicians, scientists, and non-medical members of the community. They have the authority to approve, modify, or stop any study at any time based on available information. Among other things, the ECs/IRBs review and approve the Informed Consent document.

Informed Consent Document is key for the protection of the rights and welfare of each research participant. It explains what you need to know about the study. You should read it carefully and ask as many questions as you need to fully understand what it says. The Informed Consent document will explain about the study drug, describe the procedures that are part of the study and explain any risks involved. It is your right to be informed about the research study before you give consent to participate.

Your Rights to Privacy and Data Protection
All countries participating in clinical research in volunteers have implemented laws that ensure that your privacy is protected. For example, the US government created the Privacy Rule to protect individuals’ personal health information from being used or shared without permission. You may have signed a HIPAA authorization at your doctor’s office. In the same way, you will be asked to sign a HIPAA authorization before you participate in this study. This form will explain what health information will be collected from you and how that information will be used. The research team will need to use your health information to manage your participation in this study.

WHAT IF I CHANGE MY MIND?
You are free to withdraw from the study at any time without having to give a reason. This will in no way affect your present or future medical treatment or other benefits to which you may be entitled.

WHAT WILL IT COST?
You will not be charged for study-related evaluations, tests, or procedures. The study sponsor will pay for these costs.

CONFIDENTIALITY
We make every effort to maintain your confidentiality and are compliant with laws and regulations that protect the privacy of your medical information. Your name will not be revealed in any publication that may result from this research. Your study physicians and nurses need to have access to your study-related medical records, as will the study sponsor and companies working on behalf of the study sponsor, the Institutional Review Board (IRB) and the Food and Drug Administration (FDA).



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		PARTICIPANT PROTECTIONS Several agencies oversee the conduct of clinical research in every country involved in the studies. They include the local or central Ethics Committees, Institutional Review Boards and government regulators such as the FDA in the United States and the MHRA in the UK and AFSSAPS in France. Your safety in the study is very important. The following are some of the actions that have been taken to protect participant safety. Ethics Committees (ECs) or Institutional Review Boards (IRBs) must review and approve each study and each study site. Their job is to help protect the rights and safety of research participants. These committees are made up of physicians, scientists, and non-medical members of the community. They have the authority to approve, modify, or stop any study at any time based on available information. Among other things, the ECs/IRBs review and approve the Informed Consent document. Informed Consent Document is key for the protection of the rights and welfare of each research participant. It explains what you need to know about the study. You should read it carefully and ask as many questions as you need to fully understand what it says. The Informed Consent document will explain about the study drug, describe the procedures that are part of the study and explain any risks involved. It is your right to be informed about the research study before you give consent to participate. Your Rights to Privacy and Data Protection All countries participating in clinical research in volunteers have implemented laws that ensure that your privacy is protected. For example, the US government created the Privacy Rule to protect individuals’ personal health information from being used or shared without permission. You may have signed a HIPAA authorization at your doctor’s office. In the same way, you will be asked to sign a HIPAA authorization before you participate in this study. This form will explain what health information will be collected from you and how that information will be used. The research team will need to use your health information to manage your participation in this study. WHAT IF I CHANGE MY MIND? You are free to withdraw from the study at any time without having to give a reason. This will in no way affect your present or future medical treatment or other benefits to which you may be entitled. WHAT WILL IT COST? You will not be charged for study-related evaluations, tests, or procedures. The study sponsor will pay for these costs. CONFIDENTIALITY We make every effort to maintain your confidentiality and are compliant with laws and regulations that protect the privacy of your medical information. Your name will not be revealed in any publication that may result from this research. Your study physicians and nurses need to have access to your study-related medical records, as will the study sponsor and companies working on behalf of the study sponsor, the Institutional Review Board (IRB) and the Food and Drug Administration (FDA).
Privacy Policy

PARTICIPANT PROTECTIONS