Protection for Clinical Trials Participants
Patients who join clinical trials are entitled to federally mandated protections of their rights, safety and welfare. Lehigh Valley Health Network (LVHN) is committed to providing the highest level of protection to our clinical trials participants. We have policies and standard operating procedures in place to ensure that protection.
LVHN entities responsible for protecting clinical trials participants include:
- Research investigators
- Administrative officials
- Research administration
- Research pharmacy
- Institutional Review Board (IRB), a group that reviews and monitors clinical trials and has the authority to approve, modify or disapprove research in accordance with FDA regulations
Our research participant protection office serves as the administrative body for the IRB. Health care professionals in the office review all research studies prior to IRB approval to ensure all studies are ethical, safe, and meet federal and institution requirements. Additionally, the progress and safety of all research studies are continually monitored.
The research participant protection office can be reached by calling 610-402-7544.
Additional information for potential volunteers is available from a new public outreach website – About Research Participation – from the Office for Human Research Protections (a division of the US Department of Health and Human Services). This newly developed website includes a series of short videos about participating in research and a printable list of questions potential volunteers can ask researchers; it can be accessed at https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/questions-to-ask/index.html.