<< Previous Section | < Previous Page | Next Page > | Next Section >> History of Rules About Research in Humans The Nuremberg Code 1947 "The great weight of evidence before us is to the effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:" Ten principles were then enunciated (http://www.ushmm.org/research/doctors/codeptx.htm) These have been condensed to: Autonomy - voluntary informed consent Beneficence - good science and favorable benefit to risk ratio Justice - equal opportunity to participate and to not participate The investigator was given the responsibility for seeing to it that the ethical requirements were met. The World Medical Association developed the Declaration of Helsinki, first in 1964. It has been amended repeatedly since then. http://www.wma.net/e/policy/b3.htm Ethical Principles for Medical Research Involving Human Subjects Thirty-two statements are made in the Declaration including (in paraphrase) The primary responsibility of physicians is the best care and research is secondary. Research is important to improve health care Investigators should be aware of the ethical, legal and regulatory requirements for research on humans. Research on humans must be scientifically sound and carried out by qualified persons. It must be voluntary and informed, with consent and ability to withdraw documented. Vulnerable populations may require surrogate consent. The research protocol must have been scrutinized and approved by an ethics committee for risks and benefits with minimization of the former and maximization of the latter. Investigators must monitor their research and report problems. The population studied should have a reasonable chance of benefiting from the results. Reporting and publication should adhere to the facts. A limitation was placed on jointly providing clinical care and research. Placebo use was strictly limited. Investigators should try to compare standard of care with the new agent. The Belmont Report 1979 (http//ohrp.osophs.dhhs.gov/humansubjects/guidance/Belmont.htm) This report was the culmination of the work of a national commission that began in 1974. It was adopted by the NIH in its entirety and became the basis for institutional arrangements with the NIH to review, evaluate and monitor research on humans. Its main provisions are as follows: << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links Research in Humans History of Rules About Research in Humans Definitions Federal Mandate Respect for Persons Beneficence Justice Common Rule IRB Mission Cases Bibliography Chapter 2 Download (PDF)