American Association for Cancer Research, Cancer Research, 24_Supplement(69), p. 6081-6081, 2009
DOI: 10.1158/0008-5472.sabcs-09-6081
Full text: Unavailable
Abstract Background: Accrual of biospecimens to biorepositories is a challenge and has been recognized as a critical barrier for translational research. HIPAA mandates that patients sign a separate Informed ConsentForm (ICF) for donating biospecimens for research. This poses a significant challenge to the medical staff and may negatively impact accrual to biorepositoriesMaterials and Methods: At NYU Cancer Institute, the ten page ICF was reformatted as a tri-fold brochure and one page ICF in 2005. The brochure is given to patients during the office visit or at time of registration and the triplicate one-page ICF on the day of surgery. The brochure contains information regarding biospecimen banking.The triplicate, one page consent is signed by the patient on the day of surgery.Results: In a 3-year period (2003-2005), the 10-page ICF was used to consent 433 patients from Breast, Gynecologic Oncology and GI Oncology, with an average of 2.77 patients per week. After the implementation of the novel brochure and single page ICF format, 1,426 patients were consented in the next 3- year period (2006-2008), with an average of 9.14 patients per week (10)Patients in the Breast Surgical Oncology Clinic at NYUCI were initially targeted. This was done in close cooperation with the breast surgical oncologists, nurses and operating room staff. The brochure/1-page ICF method doubled the accrual of patients from 141 to 304 patients in the first year (2005-6). However, the number of patients who consented did not increase in the next two years in spite of a significant increase in the total number of patients in the breast surgical oncology service.A root cause analysis was performed and it was determined that either the patients were not approached in the physician's office or the consenting process was not followed. It was concluded that a dedicated consenting professional was required to overcome these hurdles, who will primarily works in the operating room, where patients with diagnosis of cancer are targeted. This has yielded a significant increase in number of patients consenting for biospecimen donation. shows a significant increase in accrual since her recruitment in February 2009.Conclusions: A novel consenting mechanism with a brochure and one page consent has been successfully implemented at NYU Cancer Institute and has resulted in a significant increase in patients consenting for biospecimen donation. The process is being replicated institute wide for accrual to all biorepositories at NYULMC. This novel method can be widely employed to accrue specimens for clinical trials. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6081.