Volunteer Safety & Privacy

The US Congress passed The Health Insurance Portability and Accountability Act of 1996 (HIPPA) Privacy and Security Rules. This law protects your personal health information and requires that you give permission, in writing, for the use or transfer of that information. When you sign the Informed Consent at screening, you are also granting permission for your Protected Health Information to be collected and used inside and outside the United States for research at PRA.

You will not be identified (by name, street address, etc.) in any information used outside of the clinic unless required by law. While you are in the clinic, you will be identified by your initials and date of birth to protect your privacy. You may request your medical records from PRA at any time.

The safety of study volunteers is our top priority at PRA. Across the globe, clinical trial conduct is governed by the International Conference on Harmonization/Good Clinical Practice (ICH/GCP). The ICH mandate is to create “international harmonization, aimed at ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner.” Good Clinical Practice is outlined by the ICH and describes the ethical principles for medical research that must be observed to ensure volunteer safety. In the United States, the Food & Drug Administration (FDA) is the government agency that regulates clinical research. In addition to federal oversight, ICH/GCP also requires that all clinical research is overseen by a local Institutional Review Board (IRB) that includes both clinical experts and members of the community.

It is important to understand that there is a certain level of risk involved with clinical research studies. The safety and well-being of participants is always the number one priority at PRA. During the screening process, you are asked to provide information about your medical history. To minimize your risk as a study participant, it is important that you provide a thorough and accurate account of your past and present medical history. As a volunteer, you have the right to remove yourself from a study at any time, for any reason, with no penalty or loss of benefits to which you are entitled.