Administrative Services > IRB & Human Subjects

Human Subjects Traning And Certification Instructions for PSC Researchers (PDF)
For additional information about human subjects, and IRB contact information and forms, go to the Human Subjects, Bioethics & IRB Resources page

This is the area of the Administrative Core with the greatest growth in demand for services during the current grant period (IRB and human subjects), and the one in which we still expect great growth. IRBs and human subjects rules are evolving, so far in the direction of increase in complexity. Smith was a faculty-leader of a University-wide effort (also involving Pauly, Watkins, Soldo, and Jaeger) to draft rules for human subjects research in the social and behavioral sciences. In the long-term, this is expected to rationalize some of the process of obtaining research compliance with University and federal standards, since it brings rules more closely into conformity with the issues facing social and behavioral, as opposed to biological and medical, scientists. However: (1) a keystone of the new policy is that social and behavioral scientists be able to understand what technically is and is not human subjects research, especially with respect to de-identified public use data, so that they might legitimately absent themselves from the jaws of the IRB in instances in which quotidian social science meets anodyne data sets; and many PSC program scientists are (2) obtaining biomarkers and similar biomedical data, (3) do complex record linkages on sensitive data, including biomarkers, and are (4) operating in international research environments where controlling IRB authority is uncertain. Issues (2) through (4) are sufficiently recurrent and vexing that we have opted to make a silk purse out of a sow’s ear: the proposed Best Practices core is a “pull out” of these issues from standard Administrative Core (and CITID) services. Issue (1) is resolved by a training course designed in part by Soldo and Jaeger; seeing that all PSC program scientists are certified and compliant in this and any other relevant IRB training is a responsibility of the Administrative Core. Jaeger works with researchers to develop proposals that meet the federal requirements for the protection of subjects and withstand IRB review. She is the PSC Administrative Core resource for the identification of IRB issues during project development, communicates changes in the regulatory environment both internal and external to Penn, and works with faculty to prepare for compliance audits in addition to handling routine questions regarding the IRB process for review and approval of protocols. Jaeger has developed the PSC research website, has developed a research ethics curriculum and led several University-sponsored workshops at PENN on Scientific Integrity, including a day long seminar that will take place this fall sponsored by the School of Nursing. She is also a valuable resource for graduate students, many of whose research builds on funded projects at the PSC. As a former IRB administrator at Penn, a current member of the social sciences IRB (she absents herself from applications involving PSC members), a Registered Nurse with a masters in Bioethics from Penn’s SoM, and a Ph.D. in Sociology who did ethnographies of IRBs for her dissertation, she is unparalleled in her combination of intellectual, institutional, administrative, and practical knowledge of IRBs and human subjects research.