Featured Content
IRB Information for Participants and Patient Advocacy Groups
Advarra’s institutional review board (IRB) strives to protect participant rights and welfare throughout the research process.
Our Mission: Protect Research Participants
Advarra’s IRB reviews clinical research involving human participants. We help ensure participant rights and welfare are protected throughout the research process. As part of our mission to “advance clinical research — safer, smarter, and faster,” we partner with stakeholders throughout the research community to help improve the way researchers safeguard participants.
Advarra’s 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 to Safeguard Participants
- The Participant’s Role in Research
- The Clinical Research Process
Ethical Research to Safeguard 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. Clinical research that involves people requires an IRB like Advarra to protect the rights of those study participants. IRBs ensure a study is ethical; we review any study protocol with the participant’s safety in mind. We help make sure participants understand the risks of a study and know they are volunteers, and ensure that the study will be conducted with respect toward the participant.
The Participant’s Role in Research
In a research study, you are a participant, not a patient. This means the clinical investigator must conduct the study in a way that minimizes risks to you and maximizes any benefits, but the study requirements 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 Clinical Research Process
A clinical research study is a study seeking 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 identifying 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 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.
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.
Studies involving a product are generally paid for and supported by the company developing the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health (NIH), also act as sponsors in funding clinical research.
Participant FAQ
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.