Clinical Research Ethical Guidelines

Ethics in Clinical Research

Ethical Guidelines

The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.

The ethical guidelines in place today were primarily a response to past abuses, the most notorious of

And by definition, there is more uncertainty about risks and benefits in early-phase research than in later research. Depending on the particulars of a study, research risks might be trivial or serious, might cause transient discomfort or long-term changes. Risks can be physical (death, disability, infection), psychological (depression, anxiety), economic (job loss), or social (for example, discrimination or stigma from participating in a certain trial). Has everything been done to minimize the risks and inconvenience to research subjects, to maximize the potential benefits, and to determine that the potential benefits to individuals and society are proportionate to, or outweigh, the risks? Research volunteers often receive some health services and benefits in the course of participating, yet the purpose of clinical research is not to provide health

Trials are monitored using appropriately trained and qualified individuals. The sponsor will have procedures for these individuals to report on the progress of the trial, including possible scientific misconduct.

• These individuals verify compliance with good clinical practices, including (but not limited to) adherence to the clinical trial protocol, enrollment of appropriate research participants, and the accuracy and complete reporting of clinical trial data.

• if a sponsor learns that a clinical investigator is significantly deficient in any area, it will either work with the investigator to obtain compliance or discontinue the investigator’s participation in the study, and notify the relevant authorities as required.

Ongoing Safety Monitoring. all safety issues are tracked and monitored in order to understand the safety profile of the product under study. significant new safety information will be shared promptly with the clinical investigators and any Data and safety Monitoring board or committee (DsMb), and reported to regulatory authorities in accordance with applicable law.

Privacy and Confidentiality of Medical Information. sponsors respect the privacy rights of research participants and safeguard the confidentiality of their medical information in accordance with all applicable laws and