Advarra® is an independent institutional review board (IRB)/research ethics board (REB) that reviews clinical research involving human subjects. We help ensure subject rights and welfare are protected throughout the research process. As part of our mission to “apply the highest standards of ethics and research compliance for the advancement of human health,” we partner with stakeholders throughout the research community to help improve the way researchers safeguard participants.
Advarra staff members are available to answer any questions you may have about your rights as a research subject and/or concerns or complaints regarding the research study.
Ethical Research That Safeguards Participants
You, a friend, or a family member may have been asked to join a research study involving an investigational drug or other medical treatment. Medical research that involves people requires an IRB like Advarra to protect the rights of those study participants. IRBs ensure that a study is ethical; we review any study protocol with a participant’s safety in mind. We help ensure that participants understand the risks of a study, that participants know they are volunteers, and that the study will be conducted with respect toward the participant.
The Clinical Research Process
A clinical research study is a study that seeks to answer a specific scientific or health question. The study may test an unproven drug, an investigational medical device, a diagnostic tool, a food or drink, or an existing therapy used in a new way. The study also may involve an existing product used in a way that was previously found to be safe and effective in order to learn more about the product’s safety. Or the study may involve only the collection of health information in order to study a health issue in the general population.
People who volunteer to participate in a study may be called human subjects, research participants, or another term that identifies their role as volunteers in a clinical research study.
The doctor or health care professional who conducts the clinical research study may be called a clinical investigator, principal investigator, or study doctor.
It is important to remember that the role of a clinical investigator is very different from the role of a health care provider. Either one may be a medical practitioner or nurse, but your health care provider is responsible for making health care decisions for you based upon your medical condition. A clinical investigator is responsible for conducting a research study according to that study’s protocol.
In a research study, you are a participant, not a patient. This means that the clinical investigator must conduct the study in a way that minimizes risks to you and maximizes any benefits, but the requirements of the study might limit the treatment options the investigator can provide.
If you volunteer to participate in a research study, you also should maintain contact with your regular doctor and other specialists before, during, and after your participation in the study. You should have the best information available about your health care decisions.
The people who assist the clinical investigator are part of the research team or study staff and generally include other doctors, nurses, study coordinators, and other health care professionals.
Finally, studies involving a product are generally paid for and supported by the company that developed the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health, also act as sponsors in funding clinical research.
Need to contact us with a question or concern as a subject participating in a study? If you want to know more about your rights as a research participant, contact us: email@example.com
Advarra believes in the importance of providing study participants and advocacy groups with the best information available to help them decide if a clinical study is right for them or their group members. Advarra assists clients worldwide in helping participants understand clinical research to more securely access and share information.
For more information about clinical research trials and participation, visit the FAQs page.
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