Risks
The researcher of PRA International satisfies all required standards. The guidelines for Good Clinical Practice (GCP) protect the well-being of participants and the quality of the research data.
Most clinical research studies in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible .
An IRB is a group of individuals from the community responsible for the review and approval of research proposed to be conducted in human subjects.
Compensation and Medical Treatment in the Event of Injury
If you are injured as a result of participating in this study, the Sponsor will provide for medical treatment to the extent that the injuries resulted from:
- The drug being studied in the trial, so long as it was administered according to the study procedures, or
- Procedures the study doctor performed as part of the study, so long as they were performed according to the study procedures. The cost of treatment will be paid by the Sponsor to the extent they are not covered by your health insurance. No further compensation for research-related injury is available.
It is important to understand that there is a certain level of risk involved with research studies. The safety and well being of participants are always the number one priority with the qualified clinical staff here at PRA International. During the screening process you will be asked to provide information about your medical history. To minimize risk to you as a study participant, it is important that you provide a thorough and accurate account of your past and present medical history.
We have been successfully conducting clinical trials for more than 17 years and have an excellent safety record. Clinical trial protocols are developed to ensure that subjects are not put at undue risk. These protocols are carefully reviewed by a committee of experts and lay persons, called an Institutional Review Board, before testing can begin.
As a volunteer, you have the right to remove yourself from the study at any time, for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
