Welcome to The Office of Human Subject Recruitment and Protection (OHSRP)
The Office of Human Subject Recruitment and Protection (OHSRP) provides consultation and guidance to the Penn research community on all issues related to adult and pediatric human subjects being seen through the CTRC facilities, including recruitment and protection.
The role of the OHSRP is to champion the mission of the feasible, safe and ethical conduct of human subject research within the CTRC. The original Research Subject Advocate (RSA) was a position mandated by the National Center for Research Resources under the NIH and was defined in order to ensure that research was being conducted in ways that did not increase the risk associated with conducting studies.
In April 2008, the CTSA Consortium Steering Committee approved and endorsed best practices, which serve to define the mission, scope, and model for research advocacy within the CTSA consortium. The OHSRP has advanced the role of the Research Subject Advocate (RSA) by adopting the 2008 best practices defined by the CTSA Consortium.
- The OHSRP operations are complementary to and integrative with existing entities at the institution to promote and facilitate safe and ethical conduct of human research. The OHSRA complements the University of Pennsylvania Office of Human Research (OHR) and Institutional Review Board (IRB) in support of ensuring the safety of individuals participating in health research.
- The OHSRP serves as a resource to the research community and to participants; has a voice in policy regarding research ethics, participants’ rights, and research safety; and plays a role in the protection of human subjects and responsible conduct of research educational programs of the institution.
- The OHSRP has direct access to, an authority that can temporarily suspend a research activity based on ethical and safety concerns so that problems can be explored or resolved through proper procedures. This capacity enables preliminary intervention into problems that might not necessarily invoke an institutional review board (IRB) suspension.
- The OHSRP has a reporting pathway to institutional officials of appropriate authority and is free of conflict of interest.
Additionally, OHSRP staff can work closely with CTRC investigators in study design, approval, and oversight. Our staff consists of Recruitment and Protection Specialists (RPS). We have expertise on both the pediatric and adult sides. We can provide training and education for research participants, parents, investigators and co-investigators, study coordinators, and CTRC staff members.
Specifically we can;
- Meet with individual investigators to evaluate the feasibility of potential CTRC projects to evaluate any potential human subject protection concerns as well as recruitment and retention concerns. For example, we can review inclusion and exclusion criteria for subject safety and feasibility.
- Assist investigators with an over all recruitment strategy.
- Assist study coordinators with recruitment strategies.
- We provide 24 hour a-day coverage to any human subjects research concerns.
- Liaise between CTRC personnel and the research study team to preempt any human subject protection concerns.
- Provide additional education to CTRC study coordinators on the nuances of conducting human subjects’ research within the CTRC environment.
- Help investigators develop Data and Safety Monitoring Plans (DSMPs).
- Meet with individual study participants and or their families to address concerns.
- Assist investigators with adverse event and protocol deviation reporting.
- Serve as an impartial witness to the informed consent process.
Investigators should feel free to contact the OHSRP for advice before a protocol is submitted to the CTRC and IRB, as well as for any human subject issues occurring at any time after a protocol commences.
Penn Data Store
The Penn Data Store (PDS) is a virtual warehouse containing years of highly detailed patient data currently from 12 major information systems throughout UPHS, including the outpatient electronic medical record and a number of inpatient databases. It currently contains over a billion rows of information, with about 400,000 more added every day.
Jennifer Morrissey, MSN, MBE, CRNP
Director, Subject Recruitment, Retention and Protection
Carl Shaw, M.Ed.
Recruitment and Protection Specialist
Sharon A. Carbonara, BSN, RN
Recruitment and Protection Specialist