Informed Consent and Ethics Committees

Informed Consent Process in Clinical Trials: A Step-by-Step Guide to Ethical Participant Engagement

Posted on digi By digi

The informed consent process is a continuous, interactive communication between the research team and the potential participant. It begins before a participant agrees to enroll and continues throughout the study. It ensures participants fully understand the study’s purpose, procedures, risks, benefits, and alternatives and emphasizes their right to ask questions and withdraw at any time without penalty.
Click to read the full article.

Informed Consent and Ethics Committees, Informed Consent Process

Re-Consent Procedures in Clinical Trials: Ensuring Continuous Ethical Participation

Posted on digi By digi

Re-consent refers to obtaining renewed informed consent from participants after significant changes occur during a clinical trial that could affect their willingness to continue participation. It reinforces the principle that informed consent is not a one-time event but a continuous, evolving process aligned with participants’ rights and interests.
Click to read the full article.

Informed Consent and Ethics Committees, Re-Consent Procedures

Ethics Committee Submissions in Clinical Trials: A Step-by-Step Guide to Successful Approval

Posted on digi By digi

Ethics committees, commonly known as Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs), are independent bodies that review clinical trial protocols to ensure participant protection, risk minimization, ethical soundness, and regulatory compliance. Before any participant can be enrolled, trial documents must be reviewed and approved by the relevant ethics committee(s).
Click to read the full article.

Ethics Committee Submissions, Informed Consent and Ethics Committees

Consent in Emergency Research: Ethical and Regulatory Frameworks for Critical Clinical Studies

Posted on digi By digi

In emergency research, participants may be incapacitated, lack decision-making capacity, or require immediate intervention, making traditional informed consent procedures unfeasible. Regulatory agencies like the FDA (21 CFR 50.24), EMA, and national authorities provide frameworks permitting enrollment under specific conditions when prior informed consent cannot reasonably be obtained. These exceptions require stringent ethical safeguards, community engagement, and independent review to uphold participant rights and public trust.
Click to read the full article.

Consent in Emergency Research, Informed Consent and Ethics Committees

Informed Consent and Ethics Committees in Clinical Trials: Foundations of Ethical Research Conduct

Posted on digi By digi

Informed consent is the voluntary agreement of a participant to join a research study after receiving comprehensive, understandable information about the study’s purpose, procedures, risks, and benefits. Ethics committees—also known as Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs)—are independent groups that review research protocols to ensure that participant rights and welfare are protected, ethical standards are maintained, and regulatory requirements are met.
Click to read the full article.

Informed Consent and Ethics Committees

Ethical Considerations in Clinical Trials Involving Vulnerable Populations: Protecting Participant Rights and Welfare

Posted on digi By digi

Vulnerable populations in clinical research are individuals or groups who may experience diminished autonomy, increased risk exposure, or limited capacity to provide fully informed, voluntary consent. Ethical guidelines such as the Belmont Report, Declaration of Helsinki, ICH-GCP, and national regulations provide specific protections to prevent exploitation, enhance autonomy, and ensure equitable treatment of these populations.
Click to read the full article.

Ethical Considerations in Vulnerable Populations, Informed Consent and Ethics Committees