Penn State Intercom......October 3 , 2002
Paperless processing adopted
for research subject protection
By Barbara Hale
Public Information 
Penn State is one of only three major U.S. research universities using and developing a new computer-based, automated, paperless approach to processing the documents that safeguard the public and the human and animal subjects used in scientific, agricultural and medical investigations.
Phase one of the new system, the business processing side, went online in March. Now, the developers have received a $150,000 grant from the National Institutes of Health to enhance the system and extend the paperless approach to individual University researchers.
Candice Yekel is director of the Office of Research Protections, currently the prime user of the new system which is called the Protocol Review and Approval Management System or PRAMS.
"PRAMS is a national model and software being developed here for the system can be readily adapted to other universities and research facilities," she said.
Kenneth Forstmeier is director of the Office of Research Information Systems (ORIS) and manages PRAMS and the group that developed the new system. The development team includes Christopher Lose, assistant director of ORIS; Emily Broking, lead database administrator and designer; and Richard Gabel, programmer. "The primary beneficiaries of Version 1.0 of PRAMS are the human and animal subjects and the public because the system helps the Office of Research Protections by automatically applying business rules and issuing reminders for follow-up," said Forstmeier. "PRAMS also decreases the likelihood that adverse research events can be overlooked because it helps staff members identify and track trends early on that could signify problems."
Forstmeier also said that PRAMS streamlines ORP operations by reducing duplicative data entry and will save about $10,000 a year on photocopying.
The next version of PRAMS will extend paperless processing to researchers and relieve them from some of their reporting burden. Researchers currently have to complete numerous paper forms to report their plans for experiments, called protocols. For example, today, a research project that uses human subjects, chickens and radioisotopes would require that the researcher complete three separate sets of forms, one set each for the human subjects, animal subjects and radioisotopes. Each set would go to a different review board.
When Version 1.1 of PRAMS is complete, researchers will use an online protocol Wizard instead of paper forms. The researcher will fill in the electronic forms by responding to prompts from the Wizard, which will adjust the questions so that the only ones that appear are relevant to the researcher's study. The Wizard then will automatically collect, store and/or distribute the data as appropriate.
"The customization possible through PRAMS will not only benefit the researchers but it will ensure that the appropriate information gets to the appropriate review boards and committees as well," Yekel said.
Besides adapting to PRAMS, Yekel adds that her office has been undergoing other changes, signified by its new name. Formerly the Office for Regulatory Compliance, the Office for Research Protections now focuses on education as well as regulations. Yekel is adding a new staff member to serve as a research protections educator. This new staff member will offer training and assistance in coping with human subject and animal care and use regulations; conflict of interest; research ethics; and intellectual property and technology transfer guidance.
"We want to take a national position and be the leader in education in these areas. Federal agencies are requiring education. We want to be ahead of the curve," Yekel said.