Dr. Raper is particularly interested in informed consent, a legal contract between the physician and the patient. For the past several years he has been pursuing the process of bringing the Department of Surgery on line with procedure-specific consent forms and electronic consent allowing the forms to be completely done within the EPIC electronic medical record platform. Proper informed consent is both an event – the signature of the surgeon and patient (or surrogate) – and a process of communication of the necessary elements of a proposed operation between surgeon and patient. The electronic consent process he has spearheaded for the past few years enhances and improves both the event and the process. Looking ahead, he sees informed consent as one part of a health law curriculum that he hopes to introduce into legal and medical education as well as the performance of empiric studies on how to further improve the process.
The following scholarly papers are the most recent that he feels best describe my intense interest in writing and teaching about how to combine law and surgery:
- Raper SE, Joseph J, Seymour WG, Sullivan PG. Tipping the scales: educating surgeons about medical malpractice. J Surg Res. 2016 Nov;206(1):206-213. doi: 10.1016/j.jss.2016.08.002. This work arose from a course I taught surgery faculty on basic information about medical malpractice. The course had five parts: the basics of medical malpractice; the cost of malpractice insurance; current departmental claims experience; strategies for decreasing the risk of being named in a claim; and, an overview of malpractice reforms. An anonymous seven question survey was cast in a five point Likert scale format. A weighted average of 4.5 or above was considered satisfactory. Two free text questions asked about positive and negative aspects of the course.
- Raper SE, An Artless Tale: Challenges Faced in Clinical Research. Food and Drug Law J. 2016;71(1):59-104. I identified and provided ideas on how to face four foundational challenges associated with the design and conduct of novel research trials and specifically a gene transfer trial in which a subject died. First, regarding calculation of the risk to benefit ratio; we ultimately chose a group of relatively asymptomatic adults after first considering a seriously ill group of newborns. Second, communication with the agencies of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as well as local Institutional Review Boards (IRB); relevant aspects of 45 CFR 46 (the Common Rule) and FDA regulations with regard to conduct of clinical trials and difficulties in communication are highlighted. Third, issues of research consent. At the time, I considered research consent to be similar to standard clinical consent. But the two should be categorized differently. Lastly, the challenge of irreconcilable conflict of interest between investigator and subject in clinical research.
- Raper SE, Fleisher LA, Mayer DL, Ferman RV; Steele K, Hollway J Using root cause analysis to study prosecutorial error: a collaboration between the Montgomery County (Pennsylvania) District Attorney’s office and the Quattrone Center for the Fair Administration of Justice. 62 Villanova Law Review Tolle Lege 13-40. In a criminal investigation related to the alleged rape of an unconscious victim, members of the investigative team misread a laboratory report. The interpretive error was presented during a court proceeding. In order to learn from this error, and in furtherance of the prosecutor’s ethical obligations of (a) conviction integrity, (b) transparency and accountability, and (c) a culture of continuous self-improvement within the Office, the District Attorney partnered with the interdisciplinary Quattrone Center for the Fair Administration of Justice at the University of Pennsylvania Law School to conduct a Root Cause Analysis (RCA) of the error. The goal of the RCA was to identify specific activities, policies, procedures, and environmental factors that allowed the error to occur, and to implement changes that would prevent similar errors from occurring in the future.
- Raper SE, Rose D, Nepps ME, Drebin JA. Taking the Initiative: Risk-Reduction Strategies and Decreased Malpractice Costs. J Am Coll Surg. 2017 Nov;225(5):612-621. To heighten awareness of attending and resident surgeons regarding strategies for defense against malpractice claims, a series of risk reduction initiatives have been carried out in our Department of Surgery. We hypothesized that emphasis on certain aspects of risk might be associated with decreased malpractice costs. The relative impact of Department of Surgery initiatives was assessed when compared with malpractice experience for the rest of the Clinical Practices of the University of Pennsylvania (CPUP). Surgery and CPUP malpractice claims, indemnity, and expenses were obtained from the Office of General Counsel. Malpractice premium data were obtained from CPUP finance. The Department of Surgery was assessed in comparison with all other CPUP departments. Cost data (yearly indemnity and expenses), and malpractice premiums (total and per physician) were expressed as a percentage of the 5 year mean value preceding implementation of the initiative program. Surgery implemented 38 risk reduction initiatives. Faculty participated in 27 initiatives; house staff participated in 10 initiatives; and advanced practitioners in 1 initiative. Department of Surgery claims were significantly less than CPUP (74.07% vs 81.07%; p < 0.05). The mean yearly indemnity paid by the Department of Surgery was significantly less than that of the other CPUP departments (84.08% vs 122.14%; p < 0.05). Department of Surgery-paid expenses were also significantly less (83.17% vs 104.96%; p < 0.05), and surgical malpractice premiums declined from baseline, but remained significantly higher than CPUP premiums. The data suggest that educating surgeons on malpractice and risk reduction may play a role in decreasing malpractice costs. Additional extrinsic factors may also affect cost data. Emphasis on risk reduction appears to be cumulative and should be part of an ongoing program.
Dr. Raper's Law School experiences have also provided a further cross-disciplinary opportunity. As Vice-Chair for Quality and Risk Management for the Department of Surgery he has been involved in the various forms of medical error reduction in the wake of To Err is Human. He was fortunate to be directed to the Quattrone Center for the Fair Adminstration of Justice and the Center’s Executive Director John Hollway, by Law Professor Stephanos Bibas (now on the Federal Court of Appeals Third Circuit), yet another of his teachers, specifically in Criminal Procedure (from bail to jail). He has been able to help translate many of the principles of error reduction used in medicine into the law. As a result, he has been able to participate in several Quattrone-sponsored symposia and contribute a well-received lecture to Professor Hollway’s Convictions Integrity seminar. Dr. Raper aspires to get this course cross-listed next year with the Medical School. He has also lent his expertise to a Root Cause Analysis of a high profile case in Montgomery County as well as a similar analysis of the Lex Street massacre with the Philadelphia Police department. He is currently learning how to use the powerful social sciences coding software nVivo to code transcripts from Convictions Integrity Units across the country and to assist with the development of a statement on the Best Practices for such units. This work is directly analogous to similar concepts used in medicine; and think it will be useful in the simulation work done in communication skills.
Dr. Raper has no funded projects; the choice of study would be up to the resident. He would like for the residents to enroll in Penn’s Master in Law degree, specifically in the Health Law Track. Interested residents should contact him via email.