Protecting human research participants series#

The term “Human Research Participant Protection Program” (HRPPP), although perhaps unwieldy, reflects the committee’s vision of a system of components, functions, and accountability that should exist, at a minimum, when human research is conducted. In that report, the Committee on Assessing the System for Protecting Human Research Participants (“the committee”) developed terminology to describe a set of activities and functions critical to protecting research participants. The first-phase report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, was released in April 2001 (IOM, 2001a).

In October 2000, the Department of Health and Human Services (DHHS) asked the Institute of Medicine (IOM) to conduct a two-phase study to address concerns about protecting the rights and interests of research participants.

Protecting human research participants series#

Concern for their rights and welfare should permeate every aspect of the research process, from protocol design to dissemination of results.Ī series of events in the late 1990s involving mishaps and errors-some tragic-in the conduct of human research focused renewed attention on the ethical requirement to protect the rights and welfare of those who volunteer At the very least, they deserve respect and the highest level of consideration for their safety and well-being. In return, research participants deserve to be fully informed, treated with respect, listened to, and protected from foreseeable harms. By volunteering to participate, they provide researchers with a capability that they would otherwise lack. In some studies, research participants 1 assume great risks, even though the prospect for personal benefit is slim or nonexistent. Thus, those who participate as the subjects of research studies should share in the accolades usually accorded great scientists. Often, this progress has occurred by studying humans and the human condition. Scientific progress has been central to these efforts, leading to vast improvements in the way we live. Provides the definitions and terminology associated with clinical safety experience and the standards for expedited reporting of adverse drug reactions that occur during clinical trials.įDA Compliance Program 7348.809 - BIMO for Institutional Review Boards (PDF - 1050MB).įDA Compliance Program 7348.811 - Bioresearch Monitoring: Clinical Investigators.Since the beginning of modern history, we have sought cures for disease and injury and searched for ways to improve the well-being of societies through the understanding of cultures and civilizations. Additional links to information on subject protection from FDA and other government agencies.Ĭlinical Safety Data Management (PDF - 49KB). Topics include Institutional Review Boards and Sponsor-Investigator-IRB interrelationships, FDA clinical investigator inspections and sanctions, clinical trials protocols, informed consent, and documents necessary for the conduct of clinical trials. A series of Information Sheets providing the Agency's current guidance on the protection of people who are subjects of research. Guidance for Institutional Review Boards and Clinical Investigators. Comprehensive list of regulations governing human subject protection and the conduct of clinical trials. Regulations: Good Clinical Practice and Clinical Trials. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. This group review serves an important role in the protection of the rights and welfare of human research subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects.