Dum vivimus, vivamus
Since we are living, let us live well (Horace)
The accelerated progress in medicine and social sciences is the result of intensive research and development activities that lead to revolutionary discoveries that improved the length an quality of life. The early modern clinical research was paved with abuses against research subjects, that lead to the National Research Act of 1974 and the development of the Belmont Report.
These documents outlined the fundamental ethical principles in human subjects research: “respect for persons”, “beneficence”, and “justice”.
In United States, an institutional review board (IRBs) is a committee formally designated to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects capable of making such choices.
An IRB may only approve research for which the risks to subjects are balanced by potential benefits to society, and for which the selection of subjects presents a fair or just distribution of risks and benefits to eligible participants. A bona-fide process for obtaining informed consent from participants is also generally needed. However, this requirement may be waived in certain circumstances – for example, when the risk of harm to participants is clearly minimal.
Life & Land Prospect consultancy can help medical practices or institutions interested in human subject research:
• Safeguard the rights, safety, and well-being of all trial subjects with special attention to vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension.
• Produce trial protocols/amendments, written Informed Consent Form(s) (ICFs) and consent form updates the investigator proposes for use in the trial,
• Produce subject recruitment procedures (advertisements), written information to be provided to subjects, available safety information,
• Review information about payments and compensation available to subjects,
• Provide and review any other documents the IRB may need to fulfill its responsibilities, e.g. the investigator’s current curriculum vitae and/or other documentation evidencing qualification
• Review both the amount and method of payment to subjects to assure neither presents problems of coercion or undue influence on the trial subjects.
• Ensure that the proposed trial is reviewed within a reasonable time and document opinions and decisions in writing, required modifications prior to approval, disapproval of a proposed trial, or termination/suspension of any prior approval.
• Continuing review of ongoing trials required at intervals appropriate to the degree of risk to human subjects
For more information please contact us: