title: Society for immunotherapy of cancer (SITC) statement on the proposed changes to the common rule.
abstract: The Common Rule is a set of ethical principles that provide guidance on the management of human subjects taking part in biomedical and behavioral research in the United States. The elements of the Common Rule were initially developed in 1981 following a revision of the Declaration of Helsinki in 1975. Most academic facilities follow the Common Rule in the regulation of clinical trials research. Recently, the government has suggested a revision of the Common Rule to include more contemporary and streamlined oversight of clinical research. In this commentary, the leadership of the Society for Immunotherapy of Cancer (SITC) provides their opinion on this plan. While the Society recognizes the considerable contribution of clinical research in supporting progress in tumor immunotherapy and supports the need for revisions to the Common Rule, there is also some concern over certain elements which may restrict access to biospecimens and clinical data at a time when high throughput technologies, computational biology and assay standardization is allowing major advances in understanding cancer biology and providing potential predictive biomarkers of immunotherapy response. The Society values its professional commitment to patients for improving clinical outcomes with tumor immunotherapy and supports continued discussion with all stakeholders before implementing changes to the Common Rule in order to ensure maximal patient protections while promoting continued clinical research at this historic time in cancer research.
authors.affiliation: Rutgers Cancer Institute of New Jersey, 195 Little Albany Street, Room 2004, New Brunswick, NJ 08901 USA.
authors.forename: Howard L
authors.initials: HL
authors.lastname: Kaufman
authors.affiliation: University of Pittsburgh, Pittsburgh, PA USA.
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Butterfield
authors.affiliation: De Duve Institute, Universite Catholique De Louvain, Brussels, Belgium.
authors.forename: Pierre G
authors.initials: PG
authors.lastname: Coulie
authors.affiliation: Weill Cornell Medicine, New York, NY USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Demaria
authors.affiliation: University of Pittsburgh, Pittsburgh, PA USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Ferris
authors.affiliation: Cordeliers Research Center, INSERMFrench National Institute of Health and Medical Research, Paris, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Galon
authors.affiliation: Georgia Regents University Cancer Center, Augusta, GA France.
authors.forename: Samir N
authors.initials: SN
authors.lastname: Khleif
authors.affiliation: Genentech, Inc., San Francisco, CA USA.
authors.forename: Ira
authors.initials: I
authors.lastname: Mellman
authors.affiliation: Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Ohashi
authors.affiliation: MD Anderson Cancer Center, University of Texas, Houston, TX USA.
authors.forename: Willem W
authors.initials: WW
authors.lastname: Overwijk
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD USA.
authors.forename: Suzanne L
authors.initials: SL
authors.lastname: Topalian
authors.affiliation: Sidra Medical Center, Doha, Qatar.
authors.forename: Francesco M
authors.initials: FM
authors.lastname: Marincola