The Common Rule and Human Research

Today 's human study in the US follows a common rule. The Common Rule consists of a number of institutions formulated in 1974 to address syphilis studies on human subjects, the theme of human theme protection, created by the Human Subject Protection Committee of the National Biomedical and Behavioral Research It is policy concerning. Serious abuse by Tuskegee (Iltis, 2011). Some of the important requirements of common rules are: ensuring compliance with research institutions, acquiring and documenting informed consent, membership qualifications of the Institutional Review Board (IRB), functions, operations, reviews or investigations, And keeping record.

Informed consent is a standard expectation of human participation research. Research funded by Americans and the federal government requires informed consent based on "common rules". The general rule is the US ethics of 1981 on biomedical and behavioral research for humans. This is the basic ethical standard of research funded by the US government and almost all American academic institutions include researchers in these rights statements, regardless of funding. (Wiki, 2017)

In the United States, certain types of human academic research are governed by regulations known as common rules. These regulations require that academic institutions establish a surveillance program to review and approve research research conducted at the Institutional Review Board (IRB) and its agencies, thereby establishing psychological and It is aimed at reducing the risk of physical harm. For example, researchers need to reveal the nature of the research to potential subjects, obtain meaningful consent, and implement controls to protect the security and confidentiality of the confidential data collected from subjects maybe.

Federal agencies involved in human subject research are called common rules. This rule ensures special reserves for children, women, and prisoners to the researchers who got informed consent and recorded, details the necessary procedures for the in-facility review committee, and the research institution regulates To ensure compliance with laws and regulations. In 1977, the US Food and Drug Administration revised its policy to exclude women with potential fertility in early drug studies and therefore sought improvement in drug response assessment as a guide for sex function. Include parents in drug research and encourage companies to analyze gender-specific phenomena

In 1820, 11 physicians gathered in Washington, DC and founded the US Pharmacopoeia.

Inspired by Belmont's report, common rules were developed to ensure that studies including human beings meet the highest ethical standards and practices. A distinguishing feature of common rules is that in addition to protecting those who can not give consent and respecting the autonomy and selection of research participants, informed consent of research participants is also required is. One way to reduce the burden on researchers is to not re-agree research participants when biological specimens of research participants and related personal information are used outside their intended consent is. For example, the revised common rules allow for the study of previously collected biological specimens without prior informed consent, unless the specimen is irrelevant or identifiable to the individual.