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Society for immunotherapy of cancer (SITC) statement on the proposed changes to the common rule

Kaufman, HL and Butterfield, LH and Coulie, PG and Demaria, S and Ferris, RL and Galon, J and Khleif, SN and Mellman, I and Ohashi, PS and Overwijk, WW and Topalian, SL and Marincola, FM (2016) Society for immunotherapy of cancer (SITC) statement on the proposed changes to the common rule. Journal for ImmunoTherapy of Cancer, 4 (1).

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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.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Kaufman, HL
Butterfield, LHlhb3@pitt.eduLHB3
Coulie, PG
Demaria, S
Ferris, RLrlf1@pitt.eduRLF1
Galon, J
Khleif, SN
Mellman, I
Ohashi, PS
Overwijk, WW
Topalian, SL
Marincola, FM
Date: 21 June 2016
Date Type: Publication
Access Restriction: No restriction; Release the ETD for access worldwide immediately.
Journal or Publication Title: Journal for ImmunoTherapy of Cancer
Volume: 4
Number: 1
DOI or Unique Handle: 10.1186/s40425-016-0142-0
Institution: University of Pittsburgh
Schools and Programs: School of Medicine > Medicine
Refereed: Yes
Date Deposited: 25 Jul 2016 13:51
Last Modified: 30 Mar 2021 10:55


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