| Original language | English (US) |
|---|---|
| Pages (from-to) | 1204-1209 |
| Number of pages | 6 |
| Journal | Journal of the American College of Surgeons |
| Volume | 206 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 2008 |
ASJC Scopus subject areas
- Medicine(all)
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In: Journal of the American College of Surgeons, Vol. 206, No. 6, 06.2008, p. 1204-1209.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Responsible Development and Application of Surgical Innovations
T2 - A Position Statement of the Society of University Surgeons
AU - Biffl, Walter L.
AU - Spain, David A.
AU - Reitsma, Angelique M.
AU - Minter, Rebecca M.
AU - Upperman, Jeffrey
AU - Wilson, Mark
AU - Adams, Reid
AU - Goldman, Edward B.
AU - Angelos, Peter
AU - Krummel, Thomas
AU - Greenfield, Lazar J.
N1 - Funding Information: In August 2004, the director of the Association of American Medical Colleges (AAMC) Council of Academic Societies Affairs sent a memo to the presidents of five major surgery societies, suggesting that leaders of the surgical community should provide guidance on this issue. The memo urged the leaders to convene a consensus conference or some other process to accomplish this, and it encouraged application for funding of such a venture through the AAMC's program with the Office of Research Integrity (ORI), the AAMC-ORI Responsible Conduct of Research (RCR) Program for Academic Societies. The Society of University Surgeons chose to pursue this initiative. The objectives of this project were to clarify the distinction between “variations” (minor modifications not requiring specific disclosure), “innovations” (modifications of potential significance to the patient, requiring disclosure), and “research” (systematic investigations designed to develop or contribute to generalizable knowledge); and suggest guidelines to surgeons and hospitals for appropriate implementation and oversight of surgical innovations. The Society of University Surgeons Surgical Innovations Project team was able to draw from earlier work completed by the University of Virginia Center for Biomedical Ethics, led by Angelique M Reitsma, MD and Jonathan D Moreno, PhD, including the proposed criteria used to identify innovations that require formal review ( Table 1 ). 7,10,29 The ultimate deliberations and recommendations of the Project team were presented and discussed in an open forum at the Second Annual Academic Surgical Congress in Phoenix, AZ in February 2007. Based on discussion and feedback from attendees, these guidelines were subsequently revised, and the final consensus recommendations are presented here.
PY - 2008/6
Y1 - 2008/6
UR - http://www.scopus.com/inward/record.url?scp=43849088958&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=43849088958&partnerID=8YFLogxK
U2 - 10.1016/j.jamcollsurg.2008.02.011
DO - 10.1016/j.jamcollsurg.2008.02.011
M3 - Article
C2 - 18501819
AN - SCOPUS:43849088958
SN - 1072-7515
VL - 206
SP - 1204
EP - 1209
JO - Journal of the American College of Surgeons
JF - Journal of the American College of Surgeons
IS - 6
ER -