INSTRUCTIONS FOR HOWARD UNIVERSITY FACULTY AND STAFF
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EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

Among the initiatives that the Federal government instituted in Fiscal 2000 to demonstrate its commitment to the protection of human participants in research is the policy on education and training. An announcement by HHS Secretary Donna Shalala on May 30, 2000, was intended to remind institutions that they have a responsibility to oversee their human research programs and their institutional review boards. This policy on education and training became effective on October 1, 2000, and stipulates that an education program must be provided to investigators by institutions whose activities are amenable to the federal regulations governing human participant research.


Collaborative IRB Training Initiative (CITI): An Internet-Based Educational Program

The Howard University Institutional Review Board reviewed a number of educational programs conducted by other academic institutions and those offered by federal agencies. The board has determined that the internet-based program sponsored by a consortium of institutions involved in the Collaborative IRB Training Initiative (CITI) and the University of Miami is optimal for assuring Howard University's compliance with the federal mandate. This course consists of fourteen (14) modules which cover all aspects of the human research regulations, the history of the IRB system, in which Howard University has played a major role in shaping, as well as issues not only of importance to maintaining a program which is in full compliance with regulatory aspects of human research programs but also those which are in concert with the ethical implications of research involving human participants. All principal investigators, co-investigators, key personnel, students, and others who come in contact with human participants, and/or data and identifiers are required to complete this training prior to their involvement in such activities. This education requirement is applicable to all human research conducted at Howard University or Howard University Hospital including theses and dissertations.

All individuals seeking funds from any source, including the university, to support any activity involving human participants in any way, will be required to complete this educational requirement. It will be a part of the IRB review of all protocols involving human participants. The course takes approximately two (2) to three (3) hours to complete however, it does not have to be completed in one session and can be completed in any order. Each module is followed by a quiz and the cumulative score of all of them will be automatically tallied to give a final score for the course. A score of 70% is required for certification of completion of this educational requirement to be granted by the IRB.

Because of the diversity of the population which Howard University and its Hospital serve and the complexity of its various programs involving or potentially involving human participants, the IRB requires that all principal investigators, other key personnel and students complete all fourteen (14) of the modules which are as follows:

Module 1: History and Ethical Principles
Module 2: Regulations and Process
Module 3: Informed Consent
Module 4: Social/Behavioral Research

Module 5:

Records - Based Research
Module 6: Genetics Research
Module 7: Research With Protected Populations
Module 8: Research With Vulnerable Populations: Prisoners
Module 9: Research With Vulnerable Populations: Minors
Module 10: Research With Vulnerable Populations: Pregnant Women and Fetuses In Utero
Module 11: Community Consultation and IRB Review: Research With American Indian & Alaska Native, And Other Vulnerable Populations
Module 12: Research With Investigational Drugs, Devices and Biologics
Module 13: Human Participant Research At Veteran's Administration Facilities
Module 14: HOT TOPICS!! e.g., Tissue Banking and Stored Samples

The content of this educational program will be periodically up-dated to keep it current as changes or modifications in federal or institutional policies and regulations occur. Module 14 is designed to serve that purpose. Re-certification will be required every two (2) years.

IRB Sponsored Workshops and Lectures

In addition to the on-line educational program, the IRB anticipates hosting at least two workshops per year to keep the university's constituencies apprized of the latest information on the regulations and policies that relate to the involvement of human participation in research and other activities. The purpose of these workshops include the dissemination of institution-specific information, review of information pertinent to the responsible conduct of research (RCR), regulations, invited intra-mural and extra-mural guest lecturers and presentations of case reports. In contrast to the internet-based course, these workshops will facilitate face-to-face interactions between individuals at all levels of the institution. They should be of particular interest to those who have a vested interest in assuring that the challenge that institutional compliance with regulations and guidelines is effectively discharged. These workshops are intended to give the issue of compliance the level of importance that is required to maintain the viability and credibility of the university's various programs that involve humans in any capacity.

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