5.3.2 Description of how privacy and confidentiality of medical information/biological specimens will be maximized Initially the samples of each patient will be barcoded. At no time will patient’s names be used on the blood and tissue samples. Sometimes, because a group collaboration or journal policy requires it, a subject’s genetic data will be deposited in a database such as dbGaP. Although there is controlled access to such a database, such a submission carries theoretical risks of revealing the identity of the subject. This is discussed in the consent. 5.3.3 Management of Results Subjects will be contacted if a clinically actionable gene variant is discovered. Clinically actionable findings for the purpose of this study are defined as disorders appearing in the American College of Medical Genetics and Genomics recommendations for the return of incidental findings that is current at the time of primary analysis. (A list of current guidelines is maintained on the CCR intranet: https://ccrod.cancer.gov/confluence/display/CCRCRO/Incidental+Findings+Lists). Subjects will be contacted at this time with a request to provide a blood sample to be sent to a CLIA certified laboratory. If the research findings are verified in the CLIA certified lab, the subject will be offered the opportunity to come to NIH (at our expense) to have genetic education and counseling to explain this result. If the subject does not want to come to NIH, a referral to a local genetic healthcare provider will be provided (at their expense). This is the only time during the course of the study that incidental findings will be returned. No interrogations regarding clinically actionable findings will be made after the primary analysis. 5.3.4 Genetic counseling The costs of CLIA testing will be paid for by the Principal Investigator. If the health history, family history, or tumor diagnosis suggests that the participant might benefit from genetic testing, we will discuss this with him/her. 6 DATA COLLECTION AND EVALUATION 6.1 DATA COLLECTION The PI will be responsible for overseeing entry of data into a 21 CFR Part 11-compliant data capture system provided by the NCI CCR and ensuring data accuracy, consistency and timeliness. The principal investigator, associate investigators/research nurses and/or a contracted 50 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022 data manager will assist with the data management efforts. All data obtained during the conduct of the protocol will be kept in secure network drives or in approved alternative sites that comply with NIH security standards.