PURPOSE

The cost and value of a tumor biobank is proportional to several factors including the participant accrual rate and the number, diversity and quality of the biospecimens banked in the program. Voluntary participation by patients is a central factor in the success of the biobanking program and also provides patients with opportunities to support research. To promote participation, tumor biobank personnel and associated and collaborating clinical professionals at participating institutions should work to ensure that appropriate patients are recruited.

SCOPE

This standard operating procedure (SOP) covers the overall processes for identifying, approaching and recruiting patients for the purpose of obtaining consent to participate in a tumor biobank program. The SOP is relevant to tumor biobank programs that collect biospecimens that are derived from standard medical procedures and that are not required for clinical diagnostic pathology requirements. Please refer to TJUHBB SOP 02.005.1 (Obtaining Informed Consent) for details of the procedure for obtaining informed consent. These processes may be adopted as is, or modified by specific TJUH biobanks at their collection sites to allow for the incorporation of site-specific details, conditions and requirements.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

TJUHBB POL 01.001 Quality Management Plan.
TJUHBB SOP 02.005.1 Obtaining Informed Consent

ROLES AND RESPONSIBILITIES

This SOP applies to all qualified tumor biobank personnel and clinical staff at the collection centers that are involved in recruiting patients and the acquisition of informed and voluntary consent. This may include the following personnel:

Tumor Biobank Personnel	Responsibility
Tumor Biobank Manager	Developing an appropriate recruitment plan in conjunction with physicians at the hospital or their designate. Obtaining and documenting informed consent and identifying patients for recruitment.

MATERIALS, EQUIPMENT AND FORMS

The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.

Materials & Equipment	Site Specific Materials
Informed Consent Form
Participant Recruitment Log	OpenSpecimen

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

Informed consent is obtained either before or after a medical procedure (e.g. surgery) that yields a potentially available biospecimen and can occur, through either pre or post-procedure IRB approved consent protocols.

Patients may be invited to participate in a research study and donate biospecimens where this involves undergoing procedures specifically conducted to obtain a research biospecimen. In some cases this procedure involves minimal risk (e.g. phlebotomy or buccal swab) and inclusion in the consent form of permission to obtain a blood sample is routine in many tumor biobank programs. However, all other instances that may involve other levels of risk (e.g. obtaining an additional biopsy core during a standard core biopsy procedure that would not have otherwise been taken for diagnosis) fall outside the scope of this SOP and require consultation and approval from an IRB for the specific research protocol. Often this increased level of risk needs to be weighed against the value of a specific research question.

Inclusion Criteria

To be suitable for participation in a Tumor Biobank Program that collects unused biospecimens after a medical procedure and diagnosis, the participant must meet the following general criteria:

As a general rule, must be able to give informed consent as outlined in the Informed Consent SOP 02.005 (Obtaining Informed Consent).
Must be scheduled to undergo a medical procedure such as surgery that yields a biospecimen as part of their cancer treatment. Healthy or at risk individuals scheduled to undergo procedures other than cancer surgery (such as breast reduction) may participate (e.g. to donate tissues for normal controls) and support cancer research.

Other Factors

The determination of availability and appropriateness of a biospecimen or portion thereof for the tumor biobank program is typically made by the attending surgeon, however, can be determined by an attending neuropathologist as well. This determination must be made at the time of potential harvesting from a fresh specimen after a medical procedure and also at the time of potential harvesting from an archival pathology block at any time in the future.

Phases of Consent Process

The process of obtaining consent by a tumor biobank can be usefully considered as involving three phases or steps:

Referral of potential patient (to secure permission to contact). As a research entity the tumor biobank program is not able to identify appropriate participants and is dependent on either relevant health professionals (typically a surgeon or their designate) introducing the program and making a referral (or self-referral by a knowledgeable patient). This may often occur during the office visit, at the same time as the clinical diagnosis is established and the decision to proceed to surgery is reached. The introduction of the tumor biobank program can be brief and establishes the permission of the patient to be contacted by the tumor biobank program to discuss further. This introduction may also provide an opportunity to the patient to consider a positive action as part of reacting to the challenge of the diagnosis.
Preliminary interview (to ascertain patient interest in the biobank and preference for the format of provision of full information). This step may occur in person or by telephone and can be used to describe the tumor biobank program in general terms, and most importantly to establish the preference of the patient for how to learn more about what is involved in participation (i.e. time and place to meet to discuss consent or medium to receive more information such as by email or mail).
* Informed Consent (interaction face to face or by phone to discuss in detail what is involved and to document the decision to decline or to provide informed consent by a signed consent form). The details of this step are covered in TJUHBB SOP 02.005 (Obtaining Informed Consent).

In practice these steps are often merged (e.g. referral and preliminary interview may be merged and conducted at the same time by a physician and informed consent obtained subsequently by the biobank, or all three steps accomplished by a physician). However, consideration of the process as a series of steps can be useful in designing deployment of pre- or post- procedure protocols in specific locations and situations. For example, the mechanism to obtain referrals is often instituted through establishing dedicated collaboration and participation with specific surgeons. Alternatively this mechanism may be expanded to involve the clinic staff to act as designates of the surgeons or oncologists to offer a clinic or unit or center wide invitation to patients to choose to provide permission to be contacted to consider participation in specified research.

Consent Protocols

Pre-procedure consent protocol. For many tumor biobank programs, such as those led by surgical investigators, it is more efficient and provides an opportunity to secure consent to obtain blood samples before and during procedures and to deploy specialized biospecimen handling protocols with patient consent. Disadvantages include the sometimes short pre-procedure consent period that can preclude consideration by the patient (e.g. patients requiring emergency surgery), high levels of stress experienced by some patients in the pre-procedure period, and the inefficiency for both patient and tumor biobank around taking time to discuss consent when the procedure that follows may not yield an appropriate biospecimen.
All specimens that are collected for the biorepository will be held in temporary storage as an identifiable specimen for six weeks. The identifiable biospecimen is held and no research may be conducted until the six week period has expired. This ensures that, upon clinician request, the tissue can be retrieved for diagnostic purposes only.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

Declaration of Helsinki
http://www.wma.net/en/30publications/10policies/b3/index.html
Tri-Council Policy Statement 2; Ethical Conduct for Research Involving Humans; Medical Research Council of Canada; Natural Sciences and Engineering Council of Canada; Social Sciences and Humanities Research Council of Canada, December 2010.
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, section 4.8.
http://www.ich.org/products/guidelines.html
Office for Protection from Research Risks, US Department of Health and Human Services, Tips on Informed Consent.
http://www.hhs.gov/ohrp/policy/ictips.html
Meslin, E. and Quaid, K. Ethical issues in the collection, storage, and research use of human biological materials. J Lab Clin Med. 2004; 144:229-34
Hoeyer K., Olofsson BO., Mjorndal T., Lynoe N. The ethics of research using biobanks: reason to question the importance attributed to informed consent. Arch Intern Med. 2005; 165(1): 97-100.
Patient Recruitment to Tumour Bank. OCRN Draft SOP: TB301.001 Feb. 2004.
Perun, H., Orr, M., Dimitriadis, F. Guide to the Ontario Personal Health Information Protection Act. 2Irwin Law Inc., 2005; p.650.
Hewitt R, Watson PH, Dhir R, Aamodt R, Thomas G, Mercola D, Grizzle WE, Morente MM Timing of consent for the research use of surgically removed tissue: is postoperative consenting acceptable? Cancer. 2009 Jan 1;115(1):4-9.