Appendix D Interview Instrument for RAND Evaluation of Selected Existing Tissue Resources A. GENERAL Can you give us some history/background about your repository? What was the main purpose for developing the repository? Do you belong to a professional organization that deals with specimen collection? B. BIOSPECIMEN COLLECTION, PROCESSING, AND STORAGE Biospecimen Collection The following questions cover your tissue collection techniques and standards: Who are the sources of the tissues (e.g., patients, volunteers)? How were donors recruited? Do you collect samples from minority populations? From the aged? From children? From donors outside the United States? Do the proportions of samples contained in your repository reflect the ethnic diversity in the general U.S. population? Why were the tissue samples originally collected (e.g., diagnostic purposes, research)? Who is responsible for collecting the samples for the repository (surgeons, pathologists, researchers, trained repository personnel)? How many people do you employ to collect, store, process and distribute tissue? Where are the samples collected (community hospitals, academic medical centers)? How do the samples get transferred to the repository? Or are they stored locally? What kind of quality control (QC), auditing, and/or standardization is performed during the collection of tissues? How are these standards ensured at the participating institutions that contribute tissue? Are certain standards required of the institutions you agree to participate by contributing tissue? Are they dismissed if they do not adhere to these standards? Biospecimen Storage Can you share with us the storage techniques and standards you use for tissues in your repository? How many and what types of tissues do you have in storage (e.g., tissues from cancer patients, tissues from patients with rare diseases, etc.)? Are tissues collected from normal controls? What types of tissues are collected, stored, available along with samples of diseased tissue (healthy adjacent tissue, blood, serum)? How are tissues stored? In liquid nitrogen freezers, mechanical freezers, or both? What maintenance and backup procedures do you have for the freezers? What are your procedures/standards for storage of biospecimens in mechanical freezers (-80º C) and in liquid nitrogen? In what form are tissues stored (e.g., fresh frozen, paraffin block)? For how long? Do you attempt to keep your stock of tissues at a certain level, either numerically or as a distribution of various types of samples? If so, what techniques are used to maintain these levels (e.g., recruitment of additional medical facilities)? What kind of QC, auditing, and/or standardization is performed during the storage of tissues? Biospecimen Processing and Annotation Can you share with us the processing and annotation techniques and standards you use for tissues stored in your repository? Is there a basic set of tests conducted on each sample to characterize the tissues? Gene arrays, DNA/RNA studies, immunohistochemistry (histopathology), other? What kind of data are available about each sample? Clinical, longitudinal, pathology report, diagnostic, demographic (gender, ethnicity), medical history, family history, genetic profile, environmental exposure, treatment outcomes data, recurrence, survival, etc.? If you collect longitudinal data, how is this information tracked? What kind of QC, auditing, and/or standardization is performed during the processing and annotation of tissues? C. CONSUMER/USER NEEDS Can you tell us about your tissue distribution policies? How do you review and prioritize requests for tissue? How do you prioritize the distribution of rare/precious tissues? How many tissues do you distribute and to whom? Who are your consumers/users? From what types of institutions are your consumers/users? Academic? Industry? Government? What is the relative proportion of types of users (e.g., 60- percent academic; 40-percent industry)? Do researchers from certain institutions or researchers conducting certain types of research receive priority? Are any of your samples distributed internationally? For what purposes have the stored tissues been used (e.g., cancer research, gene mapping, genomics/proteomics)? Do you believe there are unmet users' needs that are beyond your control to meet? If yes, what are they? What kind of QC, auditing, and/or standardization is performed during the distribution of tissues? D. BIOINFORMATICS AND DATA MANAGEMENT The following questions concern your data storage, distribution, and analysis techniques and standards: For what do you use your bioinformatics system (e.g., tracking of collection, processing, distribution and analysis of samples, histopathological datasets, clinical/outcome information, results of research)? Does your bioinformatics system contain any genomics/proteomics data? What kind of QC, auditing, and/or standardization is performed on data entered into your data repository/bioinformatics system? Standardized data reporting and data entry? Is the data repository (bioinformatics system) aggregated? Searchable? For example, can a researcher query the database to determine whether you have X numbers of samples for a particular disease? Is your data repository set up so that automated extraction of information (data mining) is possible (i.e., is the data repository [bioinformatics system] “minable”)? (NOTE: Data mining is part of a larger process called knowledge discovery; specifically, the step in which advanced statistical analysis and modeling techniques are applied to the data to find useful patterns and relationships.) Does the extent of the access to the data in the repository differ for these different groups of people (physicians, researchers, employees, insurers, employers), and if so, what are the differences? Are any of the data from your repository about the tissue publicly available? Are these data available on the World Wide Web? Who has access to the data (e.g., physicians, researchers, insurers, employers)? Do any of the data from research performed on the tissues feed back into the repository data system (e.g., reentry of relevant outcomes or research results)? If so, how do you validate the results that come back into the database? What kinds of network security do you employ (e.g., encryption algorithms, firewalls, intrusion detection, etc.)? How does the medical informatics system located at the collection site (i.e., hospital, laboratory) interface with the tissue bank’s bioinformatics system? Who develops your informatics systems? How many people do you employ in bioinformatics? E. BUSINESS PLAN AND OPERATIONS With whom or how were the arrangements made between the institutions that provide the tissues and the repositories? Was this arranged through the medical facility's administration or through individual doctors? Can you share with us any lessons learned from setting up the medical institution/repository relationships? The donor/repository relationships? Are you primarily involved in tissue banking, or do you collect tissues prospectively for distribution to particular researchers or for specific studies? Is the tissue repository centralized, decentralized, or a centralized resource deployed through a virtual network of geographically dispersed tissue centers? How is your repository funded? Privately? Publicly? Some combination of the two? How much does it cost your organization to collect, process, store, and distribute tissue? Per sample? Yearly? How much does it cost a researcher to obtain tissues from your repository? Do you regularly evaluate whether the resource is used effectively, and if so, how do you measure this? What procedures are in place for improving specimen collection, storage, annotation, and distribution based on the development of new technologies? How do you plan for new technology? Have you had to deal with any institutional barriers to collecting, storing, distributing, or using these tissues for research purposes? If so, how did you overcome these? Can you share with us any “best practices” and standard operating procedures that are in place for your repository, including those that address sample and data handling; ethical, legal, and social issues; and intellectual property issues? Can you identify procedures within your existing operating structure that you would change? For example, if you were starting over what would you do differently (e.g., eliminate procedures, add procedures, etc.)? Do you have a reporting mechanism to track the use of your specimens, including the number of specimens that are distributed each year? Do researchers who use specimens from your repository cite/acknowledge the use of repository specimens in a standardized manner? F. PRIVACY, ETHICAL CONCERNS, AND CONSENT ISSUES Privacy Issues What kind of personal/identifying information about the patient/donor is stored with the tissues? Are tissues in the repository: Unidentified – i.e., identifiable information was not collected or, if collected, was not maintained and cannot be retrieved by the repository? Identified – i.e., the tissues are linked to personal information in such a way that the person from whom the material was obtained could be identified by name, patient number, or clear family relationship? When tissues are distributed to researchers, what kind of personal information is sent with them? Are the samples given to the researchers: Unidentified samples – i.e., samples and data are supplied by repositories to researchers from a collection of unidentified tissues (sometimes called “anonymous”)? Unlinked samples – i.e., samples and data lack identifiers or codes that can link particular samples to an identified specimen or a particular human being (sometimes called “anonymized”)? Coded samples – i.e., samples and data are supplied by repositories to researchers from identified tissues with a code rather than with personally identifying information such as a name or Social Security number (sometimes called “linked” or “identifiable”)? Identified samples – i.e., samples and data are supplied by repositories from identified tissues with a personal identifier (such as a name or patient number) that would allow the researcher to link the biological information derived from the research directly to the individual from whom the material was obtained? What policies and procedures do you use to ensure that patient/donor privacy is protected? How do you ensure confidentiality of patient information? How have repository processes changed as a result of the new Health Insurance Portablity and Accountability Act (HIPAA) regulations? What impact do state privacy laws have on your repository? Consent Issues What type of informed consent is obtained from each patient/donor? General consent for any type of research versus explicit/specific consent for an individual research project? Does consent for tissue donation occur with or separate from consent for the treatment/surgical procedure? Do you use a consent interview? If so, what type of individual conducts the interview? For whom does this individual work? The hospital? The repository? Can you share with us a copy of your informed consent form and policies and procedures? Institutional Review Boards Does your repository have an institutional review board (IRB) or have IRB approval? From whom? What kind of IRB approval is needed for researchers to use the samples? G. INTELLECTUAL PROPERTY AND OTHER LEGAL ISSUES What kinds of policies do you (the repository) have in place regarding intellectual property rights? What rights do the submitting institution/researcher have to the tissue once it is given to the repository? What rights do the individuals donating the tissue have once it is given to the repository? Do they have access to their own tissue once it is donated (e.g., for medical purposes, for research purposes)? Do you (the repository) retain any rights to the tissue once it has been transferred to the user? Do researchers have to sign an agreement/contract to obtain samples? Do you use a materials transfer agreement (MTA)? If so, can you share with us a copy of your MTA? Are donors compensated in any way for their tissue? What kinds of policies, if any, are in place regarding publication review and approval, proper acknowledgement of the resource, and reporting of publications (i.e., to help the repository measure the impact of what has come out of the resource)? How do you address liability issues associated with collection, distribution, and use of samples in your repository (e.g., insurance, researchers sign a release, etc.)? Has there ever been an incident or legal action involving the collection, distribution, and/or use of samples in the repository? If so, how this was resolved? What kind of security do you use to ensure that the persons requesting tissues are legitimate? H. PUBLIC RELATIONS, MARKETING, AND EDUCATION How do you market your tissue resource to researchers (e.g., booths at scientific meetings, advertising in journals word of mouth)? What kind of postresearch communications do you have with patients who donated their tissues, if any? Future discoveries and therapeutic advances Results of research with their samples – general results of research versus individual patient results Patient education Contributions to patient care Do you release any information back to the donors of the tissues?

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