Federal Guidelines for Human Research

Guidelines for Conducting Research Using Human Subjects
Clinical trials involving human research must be done before a new drug or medical device can be marketed to the public. The stakes are high for those anticipating profits from their products. In an effort to protect people involved in clinical trials, both the Department of Health and Human Services and the Food and Drug Administration (FDA) have established regulations and guidelines for conducting research on human subjects.

Three Ethical Principles for the Protection of Human Subjects
The regulations and guidelines for conducting research on human subjects are based on three fundamental ethical principals outlined in the Belmont Report, a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research:

Respect for Persons. –The principle of respect for persons divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
Beneficence. – Persons are treated in an ethical manner by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. Two general rules apply: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
Justice. – Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.

Application of Three Basic Ethical Principles
Along with the three overall ethical principles for clinical trials, the Belmont Report specifically addresses three applications of these principles:

Informed Consent. –The person participating in the research must have understood the nature of the research, the risks of the research, and the extent of involvement in the research. Informed consent is the centerpiece of the Belmont Report and the federal regulations and guidelines. Read more about informed consent of human subjects of clinical trials.
Assessment of Risks. –It is the responsibility of researchers, sponsors of research and others involved in clinical trials to assess the risks to the human subjects. When a human subject is injured during a clinical trial, the process used to assess risk and the communication of that risk to the injured person should be considered.
Selection of Subjects. –It is the responsibility of those in charge of a clinical trial to assess the benefits to the human subject verses the burdens imposed on the human subject. Also vulnerable people need to be protected. Researchers should take special care when involving vulnerable people in a cinical trial.

If You Have Been Treated Unethically in a Clinical Trial
Contact Pritzker | Ruohonen
If you or someone you love has been seriously harmed due to participation in a clinical trial, contact Pritzker | Ruohonen & Associates, P.A. Call us toll-free at 1-888-377-8900, email us at info@pritzkerlaw.com, or fill out our online free consultation form. We understand the difficulties you are facing and will keep your information strictly confidential.

Senior Partner Fred Pritzker has 29 years of experience fighting for justice for people who have been harmed by big pharmaceutical and biomedical corporations. In recognition of his successes and outstanding legal skills, he has been named a Super Lawyer and has been selected for inclusion in the 2005-2006 edition of The Best Lawyers in America.

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