CloudLIMS Publishes a Complimentary eBook on Informed Consent in Clinical Research

Home CloudLIMS Publishes a Complimentary eBook on Informed Consent in Clinical Research

Wilmington, Delaware – July 05, 2023, CloudLIMS, a leading provider of lab informatics, today published a free, open-access eBook titled “Demystifying Informed Consent: Ethics, Regulations, and Key Elements.” 

Clinical research bears an ethical duty to safeguard the well-being, rights, and safety of its participants. Informed consent plays a crucial role in fulfilling this responsibility. It entails providing comprehensive information to potential participants about the nature of the clinical research, including its potential risks and benefits, as well as participants’ rights and responsibilities. 

This eBook underscores the importance of informed consent in clinical research and its impact on patient care, ethical principles, and legal frameworks. It explores the historical development and progression of informed consent, along with its present implementation and potential future directions. Additionally, it delves into the complexities and ethical dilemmas researchers encounter when seeking informed consent and provides practical approaches to obtain informed consent effectively.

What is included in the eBook:

  • History and evolution of informed consent
  • What makes clinical research ethical?
  • Five principles of ethics in clinical research
  • Risks associated with lack of ethics in clinical research
  • What is informed consent and how it came into being?
  • Why is informed consent important?
  • What are the basic elements of informed consent?
  • Writing language for informed consent and key terms
  • A cheat sheet for writing informed consent
  • Important regulations for informed consent
  • Protection of children’s rights and welfare in informed consent
  • What are the exemptions for informed consent?
  • What are the key issues and barriers to informed consent?
  • How does laboratory software for clinical research support informed consent management?
  • Future considerations for informed consent in clinical research

“Informed consent is fundamental to safeguarding the rights, welfare, and safety of participants in clinical research. This free resource provides a comprehensive overview of informed consent and its fundamental elements to researchers, and gives tips to effectively craft informed consent documents,” said Arun Apte, CEO at CloudLIMS. “We hope this eBook will contribute to a better understanding of informed consent in clinical research while advocating for ethical and conscientious conduct within the field. By doing so, we aim to contribute to advancing responsible practices and promoting integrity in research endeavors.”

About CloudLIMS offers a secure, in-the-cloud, SaaS LIMS purpose-built for clinical research labs. CloudLIMS offers a range of complimentary services, including technical support and training, instrument integration, reporting templates, product upgrades, legacy data migration, and automatic backups. CloudLIMS helps labs maintain user access for PHI control, manage clinical data, automate workflows, and meet compliance such as US FDA, EMEA, CAP, EU GDPR, ICH-GCP, HIPAA, and 21 CFR Part 11. is a SOC 2 Type 2 compliant and ISO 9001:2015 certified informatics company.


Mrinal Kanti Chatterjee