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Legal & Ethical Issues

Historical Overview

Protecting human subject has began several decades with the discovery, after World War II of many atrocities committed by Nazi doctors in war-related experiments involving humans (McLaughlin, & Bulla, 2009).

a. a. The Nuremberg Code: This was established to judge the Nazi doctors and lead to the necessity of voluntary consent of the human subject

b. b. The Declaration of Helsinski: This is a declaration of ethical principles in medical research that involves human subjects to provide guidance to physicians and other participants.

c. The Belmont Report: In 1979, “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” known as The Belmont Report) (Cohen & Lynch, 2014). It explained the three basic principles: respect (reason for obtaining informed consent), beneficence (explanation of the risks and benefits), and justice (the fair selection of subjects).

Adams, Geni

Bonina, Nerissa

Brown, Shameka

Campbell, Judine

Chavez, Nicole

Presented by:

Guidelines and Procedures for Protecting Research Participants

Procedures of Protection

FAQs

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Nam dignissim.

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Suspendisse laoreet.

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1) An IRB will review and have the authority to approve, require any modifications and/or disapprove all research activities. 2) An IRB will require that information given to subjects is in accordance to the requirements. 3) An IRB shall require documentation of informed consent or may waive documentation according to the requirements of informed consent. 4) An IRB shall inform researchers and the institution in writing regarding the decision to either approve or disapprove the proposed research activity, or the necessary recommendations to secure IRB approval of the research activity. e) An IRB should conduct constant evaluation regularly to observe the research activities.

Role of the Institutional Review Board (IRB)