Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.

"Declarations Ethics approval and consent to participateThis study was approved by the Protocol Review and Monitoring Committee and Institutional Review Board at Emory University Winship Cancer Institute (Study IDs: IRB00112187 for Windows and IRB00114961 for FIH). All methods were performed in accordance with the relevant guidelines and regulations for research with human subjects, including the Declaration of Helsinki. Following the instructions of our IRB, each patient was given an information sheet, which was also explained in detail. As approved by the Emory University IRB, consent was documented by the completion of the interview. This is in accord with United States regulations under the U.S. Department of Health and Human Services regulation 45 CFR 46. All personal information was de-identified. This study was only conducted in the United States. Consent for publicationNot applicable. Competing interestsThe authors declare that they have no competing interests. Competing interests The authors declare that they have no competing interests."

"Funding Research reported in this publication was supported by the National Cancer Institute’s National Institutes of Health under Award Number P50CA217691-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This research is also supported by the Winship and Davidson Impact Fellowship, and Winship Cancer Institute of Emory University and NIH/NCI under award number P30CA138292."