Course Handbook

WEEK 1: OVERVIEW OF BIOSPECIMEN RESEARCH

STARTING A BIOBANK

Starting a Biobank: An overview of all the various components that can be involved with starting a biobank

MATERIAL TRANSFER AGREEMENT

• Governs the transfer of biospecimens (and associated clinical data, as relevant) between two organizations, when the recipient intends to use it for research purposes

• Defines the rights and obligations of the biobank and the researcher with respect to the biospecimens

• Addresses the future distribution of modifications and derivatives made by the recipient

• May document the process for determining each party's interest in the modifications or derivatives

• Addresses confidential information or data transferred to the recipient along with the biological material

APPLYING TO A BIOBANK

WEEK 2 - BIOSPECIMEN COLLECTION AND PROCESSING

BEFORE YOU COLLECT YOUR BIOSPECIMENS

• Collection and storage of biospecimens has been approved by appropriate ethics review boards or committees

• Governance policies are in place to guide the accrual, management and release of biospecimens.

• Decisions have been made as to the type of biospecimen(s) to be collected, its preservation format, and processing

• Appropriate laboratory equipment and infrastructure are in place for the type of biospecimens being collected, processed and stored.

• Data management systems are in place to document the collection, processing and storage of specimens.

• Established biospecimen collection procedures are in place to minimize pre-analytical variables and minimize biospecimen desiccation, degradation, risk of cross-contamination (Betsou et al., 2010, Lehmann S et al., 2012).

• All standard operating procedures (SOPs) for handling of biospecimens are consistent with biosafety regulations.

• All personnel have received training on relevant SOPs for handling biospecimens.

• All personnel are trained in proper laboratory safety procedures and are aware that all biospecimens should be considered high risk and therefore handled with precaution (CTRNet ROP, 2012)

TISSUE BIOSPECIMEN COLLECTION PROCESS MAP

DOCUMENTATION AND MANAGEMENT OF BIOSPECIMEN PHOTOGRAPHS

• Include a label with code, date, and scale in all photos where possible or the sentinel photograph in a set

• Import/upload images into an appropriate data storage location

• Name folders by categories and assign a category for each biospecimen image

• Create a folder using the unique biospecimen ID

• Rename each image with a consistent naming convention that will be indicative of tissue type.

HOW TO USE STANDARD PREANALYTICAL CODE (SPREC)

The pre-analytic variables are defined as those procedures that take place between specimen collection and experimental analysis. This code, or adaptations of the code, might be considered for integration into barcode labeling and data management systems to facilitate categorization and scoring of the main pre-analytical factors of fluid and solid biospecimens.

Each biospecimen will be assigned a seven-element-long code that corresponds to seven pre-analytical variables and contains a string of 11 (for fluids) or 13 (for solid tissues) letters in a defined order, separated by six hyphens.

The SPREC elements related to solid tissue include sample type, collection type, warm ischemia time, cold ischemia time, fixation type, fixation time, and storage condition.

COLLECTING AND PROCESSING FLUID BIOSPECIMENS

• Select the processing format for fluid biospecimens that is suitable for the research that will be carried out on the biospecimens

• Consider storage and facility requirements of the biobank when selecting a preservation format

• Follow quality control and quality assurance policies as outlined in the biobank's quality management system to ensure preservation of the integrity of the sample and its components

BLOOD COLLECTION PROCESS MAP

WEEK 3 - BIOSPECIMEN STORAGE AND DISTRIBUTION

LABELING BIOSPECIMENS

The best practices for biospecimen labeling are that labels should integrate or be associated withe following properties:

• Computer-printed or clearly hand written

• Confirmed to remain tightly adhered to the container under all projected storage conditions (e.g. frozen versus room temperature or storage vials versus paraffin blocks)

• Confirmed to be resistant to all common laboratory solvents (e.g. ethanol)

• Identify exactly what is stored in the container

• Placed in a location on the container that allows for label legibility when placed in a wide variety of boxes or storage units

• Based on barcodes if available

• Comply with applicable laws and institutional policies

• Designed in a way that Protects privacy and confidentiality of participants (e.g. no patient names or initials)

• Use unique biospecimen identifiers

The biospecimen identifier (ID) will have the following properties:

• Human readable format and barcode format (if available) to minimize errors

• Include information that represents each individual aliquot of the biospecimen

• Not contain personal health information about the participant or the biospecimen storage location (as locations may change over time)

• Include a link to all data associated with the biospecimen for tracking purposes

CHECKLIST FOR RETRIEVING FROZEN BIOSPECIMENS FROM STORAGE

• Use efficient and well established procedures to minimize delays

• Involve two or more individuals to carry out the retrieval process if possible

• If the retrieval process is conducted manually, involve a second individual to verify and confirm the identity of all retrieved biospecimens

• Throughout the retrieval process, try to maintain biospecimens at, or as close to, the storage temperature as possible (e.g. biospecimens stored at -80°C or below should be placed directly onto dry ice during the retrieval process)

• Use barcode labels and readers to minimize errors in biospecimen retrieval

SHIPPING BIOSPECIMENS

• Test shipping procedures to ensure shipments are delivered within the time expected, to the proper locations and have maintained their proper temperature

• Packaging and shipping regulations for all jurisdictions (country of origin, country of transit, country of destination) involved in the transport of the biospecimens are met

• Air shipments conform to International Air Transport Association (IATA) standards

• Ground shipments conform to applicable federal standards

• Personnel involved in shipping biological materials are trained properly around protocols for both air and ground shipments and hold any necessary training certificates

• Shipping contains any necessary preservatives or materials to maintain the biospecimen in its desired state

• Courier has assigned a tracking number to the shipment

• Follow up with the recipient to confirm the shipment was successful

DOCUMENTING RECEIPT OF BIOSPECIMENS

Upon receipt of biospecimens, the following will be documented:

• Name of personnel who received the shipment

• Study name or number that will utilize the biospecimens

• Date and time the shipment was received

• Sample type(s) and quantity

• Tracking number assigned by the courier service

• Result of inspection of package and container for visible signs of damage

• Confirmation of the condition of the coolant used during specimen transport

• Confirmation that specimens received match those listed on the manifest

• Documentation of any problems or discrepancies

DISASTER RECOVERY/INCIDENT RESPONSE PLAN ● Is consistent with institutional policy and reviewed and tested at least annually to ensure that all

personnel are trained and that the plan meets the anticipated needs ● Include a backup strategy for both biospecimens and data (such as alternate storage space) and may

include a business continuity plan ● Is distributed to all applicable staff ● Identify key individuals who will be "on call" and be able to respond to an emergency at the biobank ● Provides emergency contact numbers that are posted in prominent locations in the biobank and carried

by "on-call" staff members at all times ● Has a checklist of activities for "on call" staff to follow during an emergency. "On call" staff will be

familiar with the location and operation of key equipment and controls

WEEK 4 - DATA SYSTEMS AND RECORDS MANAGEMENT

COMMON DATA SETS AND ELEMENTS

Typical data set for a small biobank

The table below shows examples of complex data sets and the associated data elements from a large biobank. Biobanks will usually have the capacity and expect to support complex research study requirements and can collect patient-related data sets such as patient care events, patient outcomes, patient history and risk factors, and treatment and medical history.

Complex data set collection for a biobank

KEEPING DATA SECURE

• All electronic records are password protected

• All data that also contain sensitive information is additionally encrypted

• All identifiable electronic data are fully contained within, and protected by, the institutional network and firewall, or held on equivalently protected non-networked computers

• Access levels to databases are set as minimally as operationally required

• Access levels are consistent with user roles within the biobank, as described in user job descriptions

• Computers have automatic timeout mechanisms that lock access

• Use of data management system with audit trail capability

WEEK 5 - ETHICS, PRIVACY AND CONSENT

INFORMED CONSENT DISCUSSION

The consent process aims to provide potential participants with information about:

• The purpose of the biobank and/or research project that involves biobanking (objectives, inclusion/exclusion criteria, potential uses for the biospecimen)

• The type and approximate amount of biospecimen material to be taken

• Potential risks and benefits if any to the potential participant and how these will be minimized

• How the participant's privacy and confidentiality will be protected