We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.
We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.
from Part II - Basic science
Published online by Cambridge University Press: 06 January 2010
Introduction
Over 300 000 Americans die each year from catastrophic medical and surgical emergencies. New interventions, based on sound research, could save lives. These research studies must be done in an ethical framework that traditionally includes obtaining prospective informed consent from the research subject. The ethical framework for the conduct of Human Research began with the development of the Nuremberg Code in 1949. This code states that (1) informed consent of volunteers must be obtained without coercion of any form, (2) human experiments should be based on prior animal experiments, (3) the anticipated scientific results should justify the experiment, (4) only qualified scientists should conduct medical research, (5) physical and mental suffering should be avoided, and (6) no death or disabling injury should be expected from the research study.
The Declaration of Helsinki was issued in 1964 and defines rules for clinical research. It repeats the ethical concerns stated in the Nuremberg Code, but also gives a provision for enrolling certain patients in clinical research without their consent, by using either proxy consent, or waiver of consent in minimal risk studies.
The subsequent Belmont Report, which was published in 1979, is the cornerstone of ethical principles upon which current federal regulations for the protection of subjects are based. The Report conveys the three major premises of ethical conduct of studies: respect for persons, beneficence, and justice. The Report also provides elements used by Institutional Review Boards for evaluating the ethical standards for individual research proposals.
To save this book to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.
Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
Find out more about the Kindle Personal Document Service.
To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.
To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.
