Training

Training and Education

When using human participants for research studies, it is important that the researchers are properly trained and educated in University and federal policies and standards.

Prior to submitting research protocols for review and approval by the HU-IRB, all research personnel listed on a Howard IRB submission, regardless of their position, must complete the web-based Collaborative Institutional Training Initiative (CITI) Program in the Protection of Human Subjects in Research available at: http://www.citiprogram.org. Additionally, those persons who will be involved in research with animals, must also take the CITI Animal Care and Use courses.

The Collaborative Institutional Training Initiative (CITI)

The Collaborative Institutional Training Initiative Program (CITI) is a leading online training program maintained by the University of Miami. It offers curricula in human subjects research, animal research, and the responsible conduct of research.

Who Has to Take the CITI?

The training requirement applies to anyone conducting human subjects and animal research activities at Howard. This means anyone working directly with animals, human participants or with identifiable data or biological specimens for research purposes under Howard University auspices. Investigators, research nurses, coordinators, students, technicians working with identifiable data, and faculty advisors would all need to obtain CITI certification.

Which CITI course do I have to take?

You must take the course that is the most appropriate for your type of research.

Consider the following examples:

Colleges of Medicine, Dentistry, Nursing & Allied Health Sciences, Pharmacy, and all medical science researchers should take the biomedical basic course.

The Graduate School, College of Arts and Sciences, School of Communications, Law, Divinity, and Social Work and all sociobehavioral researchers should take the social science basic course.

The Refresher Course should only be taken if you have completed the Basic Course and it has expired.

CITI can be accessed at www.citiprogram.org.

HIPAA

Information and education focused on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104-191) is provided by the Howard University Office of Research Compliance.

Individually Identifiable Information

Health information including demographic information, that identifies the individual or with respect to which there is a reasonable basis to believe the information can be used to identify the individual.

Protected Health Information

Individually identifiable health information that is transmitted by electronic media or transmitted or maintained in any other form or medium.

De-Identified

Information that has certain identifiers removed in accordance with 45 CFR 164.514; no longer considered to be Protected Health Information. It is important to note that voice recordings are considered identifiers. If you plan to audio record interviews for transcription, even if you plan to destroy the source, these recordings are considered identifiable.

The Belmont Report

All employees, faculty, staff, students and/or agents of Howard University engaged in the conduct of human subject research must have reviewed and be familiar with the principles of “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research”, along with applicable Federal and State laws and institutional policies regarding research including human participants. For more information, visit:

Belmont Report

Responsible Conduct of Research (RCR)

The Howard University Responsible Conduct of Research (RCR) Training Workshop is designed to provide graduate students with information and training on research ethics and integrity. The objective of the RCR workshop is to discuss and provide knowledge-based tools to address the often complex issues which confront scholars during the course of their research careers. For more information, visit:

Responsible Conduct of Research

Good Clinical Practice (GCP) training

To ensure a well-trained professional workforce in clinical research and enhance our human subject protection program, the Howard University's (HU) Office of Regulatory Research Compliance (ORRC) now mandates the Good Clinical Practice (GCP) course for relevant research personnel.

Good Clinical Practice (GCP) training