Training & Education

1. Introduction

Training and education in the ethical conduct of human research is essential in protecting the rights and welfare of humans participating in research studies. In recognition of this principle, Sterling IRB requires investigators to ensure that each key member of the research team has successfully completed training in human research participant protection. Key study personnel include the principal investigator, the sub-investigator(s), and the study coordinator(s). This training includes, but is not limited to, the following topics:

    • Good Clinical Practice (GCP)
    • The Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule)
    • The Belmont Report
    • FDA and DHHS regulations

Please note: Your institution may have additional training requirements. Please check with your institutional official to verify the training requirements for which you and your study personnel are responsible.

Sterling IRB accepts training completed in a variety of formats and from a variety of sources. The most common training formats include online training modules, live lectures and seminars, self-study texts that provide CEU and CME credit, and college courses. The various sources through which one may obtain training include government entities, professional organizations, non-profit institutions, and commercial businesses.

2. CITI

Sterling IRB is pleased to offer Collaborative Institutional Training Initiative (CITI) educational resources to participating Investigators and their staff. For additional information on this program, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. .

3. Internet Links

Online training information can be found at any of the following internet links:

Guidance on Good Clinical Practice (GCP)

The Belmont Report

HIPAA Guidance

Human Subject Protections Education for Research Teams
(provided by the National Institutes of Health, NIH)

Human Subject Assurance Training
(provided by the Office for Human Research Protections, OHRP)

Back to Basics: Does My Project Fall Within the Scope of the Regulations?
(provided by the Office for Human Research Protections, OHRP)

Introduction to Clinical Trials
(provided by the Association of Clinical Research Professionals, ACRP)

FDA and Good Clinical Practice Guidance:
GCP in FDA-regulated Clinical Trials

FDA Information Sheet Guidances

HIPAA Guidance:
http://www.hhs.gov/ocr/hipaa

http://privacyruleandresearch.nih.gov

http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html
(Summary of the HIPAA Privacy Rule)

Research with Medical Devices:
http://www.fda.gov/MedicalDevices/default.htm (FDA Center for Devices and Radiological Health, CHRH)

Title 21 CFR (Code of Federal Regulations):
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
Federal regulations governing the proper conduct of clinical research and the makeup of institutional review boards (IRBs). Elements of informed consent documents are also discussed.

Title 45 CFR Part 46 (Code of Federal Regulations):
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
Federal regulations governing the proper conduct of clinical research and the makeup of institutional review boards (IRBs) pertaining to federally funded research. Elements of informed consent documents are also discussed.

Government Agencies and Commissions:
Center for Drug Evaluation and Research, CDER
Contains important information concerning the conduct of FDA-regulated studies.

U.S. Food and Drug Administration, FDA
Provides a wealth of information on all aspects of the drug and device approval processes, including the protection of human research participants.

National Institutes of Health, NIH
Dedicated to the latest information regarding health issues and ongoing scientific research and special reports.

Office for Human Research Protections, OHRP
Provides guidelines for human research participant protection.

International Conference on Harmonisation, ICH
Provides access to all available guidance issued by the ICH organization.

The President's Commission for the Study of Bioethical Issues
Offers current information on national meetings regarding research participant protection with the use of biologic materials as well as other ethical dilemmas.

3. Recommended Books

Protecting Study Volunteers in Research
In addition to addressing current and emerging issues that are critical to our system of human subject protection oversight, Protecting Study Volunteers in Research has been expanded to include a chapter on how to implement the HIPAA Privacy Rule in research. Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2003, page 47342) and was designed to help organizations provide the highest standards of safe and ethical treatment of study volunteers. This manual is referenced routinely for ethical considerations and insights and for a comprehensive review of regulations and guidelines not conveniently found elsewhere.

4. Foundations and Associations

Association of Clinical Research Professionals (ACRP) www.acrpnet.org
ACRP offers the training you need to be successful in clinical research today. Whether you are new to clinical research or a seasoned professional, ACRP's educational offerings aim to meet your needs. With fundamental and intermediate level training for monitors and coordinators, GCP's for physicians, timely audio-conferences on hot topics, SOP writing, budgeting, negotiation skills, accompanied site visits, FDA audit preparation, certification exam review and many other relevant and timely courses, ACRP offers you the training you need to be successful in clinical research today.

PRIM&R - Public Responsibility in Medicine and Research www.primr.org
PRIM&R is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research. Since 1974, PRIM&R has been the preeminent source for education, professional development, and resource sharing in all areas pertaining to the ethical, regulatory, and societal aspects of the research enterprise. PRIM&R serves governmental officials, academics, human research protection programs, medical and legal professionals, pharmaceuticals and biotechnology leaders, and the full array of representatives of research institutions and related professions.

Drug Information Association (DIA) www.diaglobal.org
The Drug Information Association (DIA) is the premier member-driven organization encompassing the full continuum of disciplines in the pharmaceutical and related industries. The mission of DIA is to serve and develop members by providing a neutral, global forum that promotes the exchange of information critical to their professional performance and achievement. The goal of DIA is to be the most effective means for members to obtain the knowledge they need to advance their career, their profession, and their organization.

To learn more or if you have any questions, call 1-888-636-1062 (toll-free) or This email address is being protected from spambots. You need JavaScript enabled to view it. .

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