How We Protect Patients
Patient safety is our top priority!
St. David’s has a strong human research protections program built around the St. David’s HealthCare Institutional Review Board (IRB), which is the entity responsible for overseeing all human research activities at St. David’s. The IRB operates in accordance with the Belmont principles of respect for persons, beneficence and justice. It follows the guidance published by the Office of Human Research Protections of the U.S. Department of Health and Human Services (OHRP) and the U.S Food and Drug Administration (FDA) for institutional review boards and clinical investigators.
Under the leadership of the Director of the Office of Research, the St. David’s IRB staff leads programs for the protection of the rights and welfare of human subjects involved in research activities.
The following is the Research Subject’s Bill of Rights:
- To be told what the study is trying to find out.
- To be told what will happen to you and whether any of the procedures, drugs, or devices are different from what would be used in regular practice.
- To be told about the frequent and/or important risks, side effects or discomforts of the things that will happen to you for research purposes.
- To be told if you can expect any benefit from participating, and, if so, what the benefit might be.
- To be told the other choices you have and how they may be better or worse than being in the study.
- To be allowed to ask questions about the study, both before agreeing to volunteer and during the study.
- To be told what kind of medical treatment is available if you have any problems.
- To refuse to participate in the study or to change your mind about participating after the study is started. This decision will not affect your right to receive the care you would receive if you were not in the study.
- To receive a copy of the consent form.
- To be free of pressure when deciding whether or not to participate in the study.