**4.1 Strategic risks**

Strategic risks are those that arise from fundamental decisions that managers/ directors take concerning organization's objectives.

Strategic risks are often risks that organizations may have to take in order to expand and to continue in the long term. The following section describes some strategic risks of a biobank.

*4.1.1 Unpredictable change of the strategic focus of the funding organization*

#### **Possible reasons**


#### **Possible consequences**


**4. Implementation of a risk management plan**

*SWOT analysis—example of one of the partners (HigherKos Project—CONEKT).*

Opportunities Threats

• Collection opportunity potential • **International collaboration**

• **Collection of private institution**

generation)

**Table 1.**

**80**

• Interdisciplinary collaboration potential • Academic research potential (young

• **European (international and private funding**

Strengths Weaknesses

• **Limitation of health care system**

• No separate budget for pathology • **Lack of experience in biobanking**

management

concentration

• Lack of space

• **Economic risks** • Low health care budget

• **Sustainability** • Brain drain

(culture)

• **Legal & ethical changes**

• No health insurance system

samples

equipment is difficult

• No informed consent data

board boxes & wooden racks) • Suboptimal safety conditions at pathology

• Idea of academic career • No dedicated personnel • Lack of technical staff • Undertrained technical staff • Uncoordinated ethic landscape

**(motivation, low salaries of all personnel)** • HIS status: limited access to local clinical data • LIS status: new computer program since 05/ 2013, but no general access—only NIPH • No standardized biobank databank for sample

• **No QM system & SOPs for sample collection and handling (e.g., unsteady formalin concentration of tissue samples** • For tissue samples: no standardized formalin

• Restricted research possibilities due to sample treatment (formalin vs. fresh frozen tissue) • Infrastructure service: Maintenance of

• Sample circulation to private labs & loss of

• Separate sample collections at departments UCCK, Forensic medicine & NIPHK

• Pencil-marked blocks & slides; storage in card-

• Weak coordination of responsible authorities • No motivation of research and development

• **Access to focused patient collective**

*Risk Management and Assessment*

• Support by opinion leaders/key players: minister of health, chairman of the local ethical committee board, dean of medical faculty • **Unique epidemiology profile (e.g., TBC, Crimean-Congo hemorrhagic fever,**

• Already some experience with grants and interdisciplinary collaboration • Provided services: diagnostic, research,

• Access to public • Access to students

**brucellosis)**

consulting

• **Already existing sample collections (blood, liquid body fluids, tissue, microbial cultures, DNA): disease and population based**

As mentioned before in the planning of biobank infrastructure and processes, a specific focus should be on risk management in the case of disasters and unexpected occurrences. In the future, risk management has to be a core competency of every biobank. In order to provide structure for a risk management plan, risks need to be categorized. On the one hand, managers/directors have to ensure that there is an effective management of both, few risks that are fundamental to the organizations and many risks that impact on day-to-day activities and have a shorter time frame

*DOI: http://dx.doi.org/10.5772/intechopen.91463*

*Risk Management in Biobanks*

documentation of near-accident)

• Expiration of the cooperation contract

• No access to data of the partner organization

• Better contractual protection and control

**Possible reasons**

**Possible consequences**

**Possible coping strategy**

*4.1.4 Inadequate common profile*

**Possible consequences**

**Possible coping strategies**

**Possible reasons**

funding

**Possible reasons**

**83**

• For each cooperation an individual collection strategy will be developed, which

• Specification of risks, including infrastructure, equipment and personnel (e.g.

will be defined together with the cooperation partners.

*4.1.3 Databases from partner organizations are no longer available*

• Unclear contract situation with partner organizations

• Lack of personnel—not enough time for PR activities

• Higher prioritization of PR activities and lobbying

*4.1.5 A bad strategy for public relation activities for the donors*

• Inadequate information transfer to donors

• A hardly comprehensible informed consent

• More budget for PR activities and presentations at congresses

• Less projects—less project requests ! risk of interruption of third-party

• Inadequate trained medical personnel for the informed consent procedure

• Intensive cooperation with the areas of research of the organization.

**Figure 6.** *Overview: risks in biobanking.*
