Initial roadmap for ethics, legal, data and organizational issues for cancer research in Armenia

ARICE developed an initial roadmap which is primarily concerned with institutional level for cancer research and requiring infrastructure and which will also serve at national and society levels to have a strategic impact on cancer research in Armenia. The roadmap which addresses the ethical, legal and organizational issues is dedicated for from the investigator to the society levels and which should be considered for a whole.

General concerns on ethical, legal, data and organizational issues
The ethical, legal, and social implications of cancer research are increasingly complex and of paramount concern in the genomic era. Protecting the rights and welfare of human research participants involves moral considerations as well as regulatory compliance. Currently, there are no legal regulations or laws in Armenia regulating the protection of human subjects, including human specimens, residual diagnostic specimens or medical information. Most usually, including in YSMU, the practice is based only of local Institutional Review Board (IRB) decisions. And best practices and policy options in many controversial areas are not regulaled, including:

- the collection, storage and research use of biological samples and genetic data,
- access to potentially identifiable information,
- appropriately developed and practiced consent and data sharing.

Addressing legal and ethical reports considers use of biospecimens to conduct genomic research, including considerations of informed consent, privacy and data sharing as well as ethical issues surrounding the return of incidental findings in research involving individuals’ biospecimens.

Genomic research has been largely incorporated in the cancer research for the last two decades. Meanwhile, sophisticated bioinformatics and biostatistics tools and expertise are required to support quality control, storage, data curation, integration, and final interpretation of genomic data to a biological context. There is an insufficient workforce and environment of bioinformatics and biostatistics requirement to support the genomic research in cancer in the whole Armenia, including the YSMU. However, to correspond to international standards with large scale of genomic research capabilities which in turn requireս not only organizational modernization of research policy but also adaptation of new codes or principles for ethical and legal activities. Therefore, ARICE considers in continuity and integrity legal, ethical and organizational issues for the realization of internationally recognized cutting-edge research and biobanking.

Ethical issues related to the collection and use of human specimens for research purposes should be a subject of considerable discussion. As there is no national regulation protecting human research subjects in Armenia, any research project is under the regulation of local IRB without known effective date. Application of regulatory standards to the research use of biological specimens and associated data, including of genomic data, is not regulated or could be complicated by a variety of organizational issues.

In the following, we describe the strategic steps and recommendations which the YSMU should meet for the creation of the biobank and development for cancer research infrastructure:

Strategic steps and recommendations
Cooperation with the government of Armenia and other national stakeholders:
  • to monitor and venture finances to launch and monitor strategically vital area of cancer research activities of the YSMU,
  • to align and make coherent the cancer research activities with the national cancer control program regulated by the Ministry of Health of Armenia.
Development of a principled and practical framework for responsible sharing of genetic and health-related data in Cancer Research including:
  • copyright policy with rights under national copyright law to adapt and utilize individual and institutional contributions, incorporate them into institutional, multi-center and international standards.
  • informed consent policy and related issues for genetic research, including for hereditary and sporadic cancer disorders and biobanking,
  • data privacy and security policy aiming the sharing of genomic and health-related data protecting confidentiality and integrity of data and privacy of individuals,
  • ethics review recognition policy supporting confidence in the adequacy of an ethics review from another legislative ethics review systems and enabling YSMU ethics committee to accept the review of another ethics committee.
Supporting development of national legal requirements applying to research that uses human bodily biomaterials and private information. Genomic and DNA data are described as private information. In this regard:
  • the research should comply with YSMU’s rules and the requirements of YSMU IRB as well as meet the national and international requirements in order to carry out cancer research,
  • the IRB at YSMU must have all necessary competences and rights to review and independently approve research if it involves human subjects to minimize risks, select subjects equitably, obtain informed consent when required and ensure privacy and confidentiality.
  • The YSMU IRB approval must precede initiation of any work involving human subjects, and this point should be considered as a prerequisite and compulsory, meaning that no national or international grant or contract can be awarded until receiving YSMU IRB approval.
  • promotion of a supportive policy environment for cancer research and biobanking should include development and implementation of a communications strategy to engage and inform policy makers about relationships between cancer reserach, biobanking and cancer control in Armenia.
Development and implementation of a special genomic data sharing policy. As next generation sequencing technologies are increasingly employed in cancer research, the accumulation of genomic data from individuals creates additional privacy risks. Therefore, to promote robust sharing of genomic data while simultaneously providing both transparency and appropriate protections to individuals whose data is collected, stored, and disseminated to researchers,
  • there is need to deliberate consent policy development, data access and security policies, best practices and opportunities for research in this challenging area,
  • YSMU should develop and implement a special genomic data sharing policy.
Organizational issues There are three main aspects of an organization for effective cancer research:
  • support and funding for research,
  • research infrastructure, and
  • a skilled workforce.
The most pressing issue that impacts on research infrastructure is involvement and training of researchers and young investigators through development of career paths for skilled staff, particularly for PhD students as foreseen in the ARICE. YSMU should identify priority skills needs to develop within the cancer research disciplines during and upon the end of the ARICE. Institute a working group to cooperate with the cancer registry system in Armenia including:
representatives from the YSMU, Ministry of Health of Armenia and international experts (including ARICE collaborators) to develop standard cancer registration procedures aligned with international IARC recommendations and enhance IT support to the registry.

Develop digitization systems like PACS (picture archiving and communication systems), LIS (laboratory information system), HIS (hospital information system), digital prescription etc. that will markedly improve biobanking and cancer research.

Upgrade the entire YSMU pathology and molecular diagnostics service to meet international standards (including infrastructure, human resources, education and training, specialization, quality management) while increasing numbers of specialists in histo-pathology, clinical laboratory genetics and bioanalytics.

Strategy in Human Resources
  • Increase number of faculty involved in both teaching and research thus providing more time for research and scholarship,
  • Attract new researchers involved in cancer research with application of the newest technology to advance knowledge
  • Create an incentive plan stimulating international grant submission,
  • Recruit graduate students and postdoctoral fellows as well as YSMU academic staff interested in training in cancer research,
  • Evaluate research productivity by developing principles for infrastructure needed to sustain present and future levels of cancer research and biobanking.
Strategy in the YSMU Technological Infrastructure
  • Purchase or obtain required cutting-edge equipment from institutional and other funding sources,
  • Establish research IT infrastructure with high-performance computing, research data storage, and networks.
Develop and maintain clear indicators of acquired excellence in cancer research which should involve:
  • indicators for scientific outputs
  • indicators for capability building
  • indicators for administrative management
  • general indicators of performance for the university.