For Patients & Volunteers
SIH created the Office of Clinical Research to support investigators and, therefore, to better protect research volunteers. The decision to participate in research is very important and personal. You should ask many questions and take as much time as needed to decide before volunteering.
What is a Clinical Research Study?
A clinical research study involves research using human volunteers that is intended to answer a question and add to medical knowledge. Studies may be either observational or interventional. In an observational study, the investigator assesses health outcomes. Volunteers may receive interventions but are not assigned to specific interventions.
Interventional studies are also called clinical trials. A clinical trial is a controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions. Volunteers are assigned to a specific intervention, then outcomes of all volunteers are measured and compared.
What is Informed Consent?
Informed consent is the process of fully informing potential research volunteers of the nature of the study including:
- Volunteer rights and responsibilities
- Potential risks and benefits of participation
- Study procedures and costs to volunteers
Inherent in the informed consent process is fully explaining the study and providing potential volunteers with the opportunity to ask questions and take time to consider participating.
What are the Rights of Research Volunteers?
As a potential research volunteer, you have the right to:
- Refuse to participate in a research study without affecting the care you receive
- Ask questions and have your questions answered
- Receive a copy of the informed consent document
As a research volunteer, you have the right to:
- Withdraw from the research at any time
- Receive information about any new findings related to the study that may change your willingness to continue participating