Five Questions Paula Bistak, RN, MS, CIP, Executive Director, Human Subjects Protection Program, UMDNJ, talks about the importance of protecting the health and well-being of clinical trial participants. What are clinical trials? A clinical trial is a research study that evaluates the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. Clinical trials test experimental treatments, new combinations of drugs, surgical techniques or diagnostic tests and procedures. Clinical trials can be i interventional (where those participating are assigned a treatment or other intervention and the outcome is measured) or observational (in which individuals are observed and their outcomes measured). Once a research study involves human subjects, a broad spectrum of ethical and legal rules are imposed to protect the participants, including federal and state laws and regulations. At UMDNJ, where a wide range of human subject research is conducted, additional oversight includes University policies and even specific school or departmental requirements.

Q	What types of clinical trials are conducted at UMDNJ?

There are hundreds of clinical trials currently being offered throughout UMDNJ. Researchers from varied disciplines are studying diseases and health conditions as diverse as the population we serve.

Q	What is the Human Subjects Protection Program (HSPP)?

HSPP supports the University’s research enterprise by fostering the ethical conduct of research, ensuring compliance with all pertinent regulatory requirements and providing education and assistance to researchers.

HSPP consists of the campus Institutional Review Boards (IRBs), education for the research community, and a Quality Assurance/Quality Improvement (QA/QI) team. An information technology (IT) support staff manages the database and is developing an electronic submission system. In addition, the University has a contractual relationship with an outside organization, Western IRB (WIRB), for oversight of industry-sponsored protocols. WIRB has the same regulatory requirements as UMDNJ’s campus IRBs. HSPP works closely with them to ensure the same rigorous oversight of our campus-reviewed studies.

Q	What is the structure and role of the IRB?

There are 10 IRB committees throughout UMDNJ, each headed by an IRB chair. Mary Swigar, MD, oversees five for New Brunswick/Piscataway, Robert Fechtner, MD, oversees four for Newark, and Gintare Gecys, DO, oversees one for our Stratford/Camden campus. Committees are comprised of individuals from many disciplines with varied expertise: physicians, nurses, social and physical scientists, pharmacists, non-scientists, and community members. These volunteers review all human subject research submissions to assure the protection and welfare of subjects and the ethical conduct of research.

Being an IRB member takes dedication and a lot of work. Each member must
complete online training and attend educational offerings at IRB meetings and through additional topic-specific sessions. Besides attendance at meetings, members spend hours reviewing submissions and making specific regulatory determinations about the research. Many also interface with investigators offering assistance with projects.

Q	Who is responsible for ongoing oversight of clinical trials at the University?

Clinical trials are monitored throughout the entirety of the project, from initial recruitment through final data analysis. The IRB must re-review each study no less than once a year. In addition, the HSPP QA/QI team conducts audits of studies. HSPP analysts will conduct interviews with research staff, review records, count drug/device inventory, and even observe the subject consent process. Our QA/QI team also audits the IRB offices and committees, ensuring that they are following proper procedures and maintaining necessary documentation.