Informed consent (IC) is a fundamental aspect of ethical clinical research, safeguarding the rights and well-being of participants. It empowers participants with comprehensive information about the research, enabling them to make voluntary and informed decisions about their participation in the research after understanding all risks and benefits associated with the research. A robust IC process holds particular relevance in the context of cancer research, where inadequate communication can strain patient-researcher relationship and trust, jeopardizing entire research studies. Furthermore, the level of subject understanding directly correlates with engagement throughout the research journey. Research indicates that well-informed subjects are more likely to stay engaged and continue participating in the study until its completion, leading to more meaningful research outcomes. High retention rates are crucial for the statistical power and integrity of the research. Thus, in cancer research, IC transcends mere regulatory compliance; it acts as a critical compass guiding the ethical conduct of cancer research. However, challenges persist in obtaining and ensuring meaningful IC, including information or comprehension gaps, limited understanding, and potential pressures on participants. It is crucial for researchers to address these challenges to uphold the principles of autonomy and protect participants' interests. To facilitate the IC process, a Laboratory Information Management System (LIMS) emerges as a valuable tool. It offers a secure platform to manage participant consent. By anonymizing Protected Health Information (PHI) and providing secure data management, a LIMS ensures the confidentiality of participants. It also streamlines document management, granting researchers access to the latest approved consent forms, and aids in associating participants with specific studies, enhancing the traceability and integrity of the IC process in cancer research.

Learning Objectives:

1. Summarize what Informed Consent (IC) is, and the challenges and benefits of obtaining IC in cancer research.

2. Describe what the basic and additional elements for IC writing are under the FDA and Common Rule.

3. Explain how a LIMS can help manage IC.