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CITI Program HSR Catalog Rev. 17 June 2015

Human Subjects Research (HSR) Series CITI Program’s HSR series consists of modules from two basic tracks, Biomedical (Biomed) and Social-Behavioral-Educational (SBE), and a set of Additional Modules of Interest. Organizations may group these modules to form a basic Biomed or SBE course, or a course that combines the two tracks. The Additional Modules of Interest should be used in any course variation, if relevant.

The basic Biomed modules have three corresponding sets of refresher modules and the basic SBE modules have two corresponding sets of refresher modules. These refresher modules are intended to provide learners with a review of what was covered in the basic level modules. It is generally recommended that organizations select refresher module requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle at an interval specified by your organization (for example, Refresher Stage 1: 3 years after completion of basic course; Refresher Stage 2: 6 years after completion of basic course).

Three additional standalone courses are available: Institutional/Signatory Official: Human Subject Research, and IRB Chair. The Institutional/Signatory Official: Human Subject Research course provides a general introduction to the roles and responsibilities of the institutional official at an organization holding a Federalwide Assurance (FWA). The IRB Administration course offers members of an Institutional Review Board’s (IRB) administrative office a comprehensive review of the critical areas associated with IRB, human research protection program (HRPP), and HRPP/IRB office operations. The IRB Chair course provides detailed training for current and future IRB chairs.

This catalog provides a listing and description of each module within the HSR series, as well as their recommended use, continuing education (CE) eligibility, and language availability.

CITI Program HSR Catalog Rev. 17 June 2015

Table of Contents

BASIC COURSE OPTIONS

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) MODULES 1

HUMAN SUBJECTS RESEARCH – SOCIAL-BEHAVIORAL-EDUCATIONAL (SBE) MODULES 9

HUMAN SUBJECTS RESEARCH – ADDITIONAL MODULES OF INTEREST 15

REFRESHER COURSE OPTIONS

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) REFRESHER 1 26

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) REFRESHER 2 29

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) REFRESHER 3 32

HUMAN SUBJECTS RESEARCH – SOCIAL-BEHAVIORAL-EDUCATIONAL (SBE) REFRESHER 1 35

HUMAN SUBJECTS RESEARCH – SOCIAL-BEHAVIORAL-EDUCATIONAL (SBE) REFRESHER 2 37

INSTITUTIONAL/SIGNATORY OFFICIAL: HUMAN SUBJECTS RESEARCH COURSE

INSTITUTIONAL/SIGNATORY OFFICIAL: HUMAN SUBJECTS RESEARCH COURSE 39

IRB CHAIR COURSE

IRB CHAIR COURSE 41

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Basic Course Options For a basic course in the HSR series, organizations may select modules from the Biomedical (Biomed) track, Social-Behavioral-Educational (SBE) track, and set of Additional Modules of Interest. For recommendations on how to set up a basic course using HSR modules, see the Using CITI Program Content: Human Subjects Research (HSR) document. In order to meet the needs of subscribing institutions, the CITI Program can assist administrators in creating courses that best meet their institutional needs, including combining modules from across the CITI Program. To discuss course recommendations that combine modules from different CITI Program offerings, please contact the CITI Program Help Desk at (305) 243-7970.

Human Subjects Research – Biomedical (Biomed) Modules These modules provide an introduction to biomedical research with a focus on the protection of human subjects. They offer historic and current information on regulatory and ethical issues important to the conduct of research involving human subjects.

Continuing Education (CE) Credits and Units These modules hold the following credit designations:

• Physicians: Up to 9 AMA PRA Category 1 Credits TM • Psychologists: 9 CEP Credits • Nurses: 6 CNE Credits/Contact Hours • Other Participants: Up to 9 AMA PRA Category 1 Credits TM

Credit Designation Period:

• Physicians, Psychologists, and Other Participants: 1 July 2013 to 30 June 2016 • Nurses: 2 December 2013 to 2 December 2016

Module Title Recommended Use

Belmont Report and CITI Course Introduction Required

History and Ethics of Human Subjects Research Required

Basic Institutional Review Board (IRB) Regulations and Review Process

Required

Informed Consent Required

CITI Program HSR Catalog Page

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Social and Behavioral Research (SBR) for Biomedical Researchers

Required

Records-Based Research Required

Genetic Research in Human Populations Required

Populations in Research Requiring Additional Considerations and/or Protections

Required

Vulnerable Subjects - Research Involving Prisoners Supplemental

Vulnerable Subjects - Research Involving Children Required

Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates

Supplemental

Avoiding Group Harms - U.S. Research Perspectives Elective

Avoiding Group Harms - International Research Perspectives Elective

FDA-Regulated Research Required

Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research

Required

Research and HIPAA Privacy Protections Required

Belmont Report and CITI Course Introduction This module pro