Governance
Research Ethics & Data Integrity
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Research Ethics & Data Integrity
Working from research ethics and scientific integrity, we manage research, laboratory and medical data properly and keep that data sound.
Contents
01
Research ethics
03
Conflicts of interest
02
Data integrity
04
Whistleblowing and reporting
Contents
01
Research Ethics
02
Data integrity
03
Conflicts of interest
04
Whistleblowing and reporting
Research Ethics
Research involving human participants is conducted under the laws, ethical guidelines and study protocol that apply to it, and only after the ethical review, consent and other procedures it requires. We respect the rights, safety and dignity of those who take part, and hold to what is scientifically and ethically sound.
Data Integrity
Data from research and testing is managed across its whole life — as it is generated, recorded, changed, stored and accessed — with attention to its completeness, consistency, traceability and reliability.
GMP records and quality management in pharmaceutical manufacturing are handled under the quality systems of each party concerned, NOVARK BIO included. Data management in clinical development follows each study protocol and the applicable laws and regulations.
ALCOA+ PRINCIPLES
Principles for records
We work to ALCOA+: records should be attributable, legible, contemporaneous, original and accurate, and also complete, consistent, enduring and available.
AUDIT TRAIL
Traceability of changes
For electronic records, the history of changes is recorded and checked as the system and the work require, so that the data remains traceable.
ACCESS CONTROL
Permissions and access
Access to information and systems is granted and managed according to what the work requires, guarding against improper viewing, alteration or deletion.
ALCOA+ PRINCIPLES
記録の原則
帰属性（Attributable）、判読性（Legible）、同時性（Contemporaneous）、原本性（Original）、正確性（Accurate）に加え、完全性、一貫性、永続性、利用可能性等を含む ALCOA+ の考え方を重視します。
AUDIT TRAIL
監査証跡
電子記録等について、システムや業務の特性に応じて変更履歴等を記録・確認し、データの追跡可能性を確保します。
ACCESS CONTROL
アクセス権限管理
情報・システムへのアクセスについて、業務上必要な範囲に応じて権限を設定・管理し、不適切な閲覧、変更、削除等の防止に努めます。
Conflict of Interest (COI)
Conflicts of interest that may arise in research, joint research, business partnerships, donations and funds, and other activities are identified, managed and, where necessary, disclosed. We act under the relevant rules and procedures so that the impartiality of scientific and medical judgement is not compromised.
Conflicts of interest within the Certified Special Committee for Regenerative Medicine, and the independence of its reviews, are managed under the Committee’s own rules and practice.
Whistleblowing & Reporting
We maintain a channel through which breaches of the law, misconduct and other compliance concerns can be reported or raised. Reports are treated in confidence, and the channel is operated under the applicable laws and our internal rules, including the protection of those who report from detrimental treatment.
Scientific Integrity
In assessing and publishing research findings, we distinguish between what has been established, how it is interpreted, and what remains hypothesis, and we state the limits and the uncertainties. We avoid selective use of data and overgeneralisation of results, and deal honestly with each piece of data.
What is covered elsewhere
For governance as a whole — quality management, the Certified Special Committee for Regenerative Medicine and legal compliance among them — see Quality, Ethics & Governance. This page deals with research ethics, data integrity, conflicts of interest, and whistleblowing and reporting.
GMP and pharmaceutical quality management at NOVARK BIO
Quality management and ISO/IEC 17025 at the Shin-Yokohama Facility
Clinical development and data management
QUALITY & GOVERNANCE
Enquiries about research ethics and data integrity
We welcome enquiries about research ethics, data management, conflicts of interest and research governance generally.