Comprehensive Head and Neck Database policies are established by the Executive Steering Committee. Adherence to policies is required by CHND staff members and investigators using CHND materials.
The Biorepository complies with federal regulations regarding the use of human subjects and human tissues (45 CFR 46). Research activities conducted by the Biorepository are approved through the University Hospitals Case Medical Center Institutional Review Board under protocol CASE4513. Informed consent is required and is obtained from patients before the collection of materials.
UHCMC IRB
University Hospitals, Lakeside 1400
11100 Euclid Avenue
Cleveland, OH 44106
Phone: (216) 844-1529
Fax: (216) 844-1547
FWA Number: 00003937
Research subjects, from whom materials are collected, are recruited from the patient bases of collaborating sites. There are no gender, age, or race restrictions placed on subject eligibility. Researchers using materials from CHND may have no contact with subjects.
CHND may collect infectious agent biospecimens from subjects, including HIV and HPV. Such materials will not be released without specific request.
The confidentiality of those individuals from whom CHND materials are collected is strictly maintained. Data and samples are coded with unique database identification numbers and access to identifying patient information is limited to specific CHND personnel. All materials released from CHND to researchers are de-identified.
Standard data included with CHND materials:
- Demographics: age, gender, race
- Biospecimen type and weight
- Clinical diagnoses related to requested biospecimens
- Pathology confirmation
Additional clinical data (e.g. dates of treatment) may be available upon request through the use of a Data Use Agreement and/or additional IRB approval.
Data and samples can be picked up at the Biorepository's location on the third floor of the ÐÇ¿Õ´«Ã½ School of Dental Medicine.
The Comprehensive Head and Neck Database maintains strict confidentiality of information collected from patient sources and information disclosed within Material Use Applications. Confidential material may not be released unless otherwise specified in writing by patients or applicants. Members of the CHND will not engage in research or other intellectual property discoveries with patient or applicant information unless otherwise authorized to do so.
Projects using CHND data and samples should cite "Comprehensive Head and Neck Database, University Hospitals Cleveland Medical Center" in any publications and presentations.