CITIProgram HSRCatalog Rev.17June2015HumanSubj.docx

CITI Program HSR Catalog Rev. 17 June 2015
Human Subjects Research (HSR) Series
CITI Program’sHSR series consists of modules from
two basictracks, Biomedical (Biomed)
and Social-Behavioral-Educational (SBE), and a set of
Additional Modules of Interest.
Organizations may group thesemodules to form a
basicBiomed 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 basicBiomed modules have threecorresponding sets of
refresher modules and the
basicSBE 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 basiccourse).
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 areasassociated
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
(BIOMED) REFRESHER 1 26
BEHAVIORAL-EDUCATIONAL (SBE) REFRESHER 1
35
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

CITI Program HSR Catalog Page
1
Basic Course Options
For a basiccourse 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
basiccourse 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. Theyoffer historic and

current information on regulatoryand
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

2
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
This module provides a link to the Belmont Report.
It also offers additional information
regarding the CITI Program’swebsite and the availability
of the Belmont Report in English,
Chinese, Spanish, and French.
Language Availability
English (ID: 1127)
Spanish (ID: 16459)
Korean (ID: 15895)
Russian (ID: 16303)
French (ID: 16448)
Khmer (ID: 16273)
Vietnamese (ID: 16241)
Tamil (ID: 16384)

History and Ethics of Human Subjects Research
This module discusses ethical principles for the conduct
of research involving human
subjects. It provides an overview of the historical
events that influenced the development of
the current regulatoryrequirements, a review of
the Belmont Principles, and a discussion of
3
the contemporary ethical standards that guide
research today.
English (ID: 498)
Spanish (ID: 1478)
Portuguese (ID: 1507)
Korean (ID: 15924)
Basic Institutional Review Board (IRB)
Regulations and Review Process
IRBs are a standard within the area of human
subjects research. This module provides basic
information about the human subject protection
regulations and IRBs, including the role,
authority, and composition of the IRB. The information
presented is based on the Common
Rule as codified by the U.S. Department of Health
and Human Services (HHS) at 45 CFR 46.
The different types of IRB review processes are

discussed,providing the learner with an
overview of the essential issues associatedwith exempt,
expedited, and full (convened) IRB
reviews. This module concludes with a discussion of
the otherregulations and
requirements (such as the U.S. Foodand Drug
Administration [FDA] and the International
Conference on Harmonisation [ICH]) and regulatory
groups (for example, the National
Institutes of Health [NIH] and the Department of
Education [DOE]) that require compliance
based on certain types of research.
English (ID: 2)
Spanish (ID: 1479)
Korean (ID: 15923)
Chinese (ID: 1588)
Khmer (ID: 15546)
Informed Consent
The process and documentation of informed consent
are fundamental tenets of human
subjects research. It is important for researchers to
understand theseconcepts. To that end,
this module provides the learner with the framework
for informed consent found within the
Common Rule. Some of the special challenges
associatedwith informed consent are also
discussed,including informed consent as it relates to
vulnerable populations. The module
concludes with a review of the requirements for
waiver of informed consent as well as the
differences between U.S. Foodand Drug Administration

(FDA) and U.S. Department of
Health and Human Services (HHS) regulations.
English (ID: 3)
Spanish (ID: 12194)
Korean (ID: 15926)
Chinese (ID: 1589)
4
Khmer (ID: 16248)
Social and Behavioral Research (SBR) for
Biomedical Researchers
Because biomedical researchers employ a variety
of SBR techniques within the framework
of biomedical research, it is important to
understand the nature, risks, and benefits
associatedwith thesetechniques. This module discusses
the types of studies that utilize SBR
techniques, along with the kinds of data
collected. A review of someof the risks and
benefits
that are unique to SBR completes the course.
English (ID: 4)
Spanish (ID: 1718)

Korean (ID: 15927)
Chinese (ID: 1590)
Khmer (ID: 16250)
Records-Based Research
Researchers may make important advances in the
fields of education, medicine, psychology,
and public policy by using previously
collected information that does not involve
prospective interaction with human subjects.
Records-based research has its own risks, and
researchers who propose to conduct such research
must have an understanding of those
risks and how to minimize them. As a compliment
to that review, this module also provides
learners with an overview of the types of review
processes required for records-based
research. This overview includes the questions that must be
addressed in order to make the
appropriate determinations with respect to review.
English (ID: 5)
Spanish (ID: 1490)
Korean (ID: 15928)
Chinese (ID: 1591)
Khmer (ID: 16329)
Genetic Research in Human Populations
Although continued advancements in genetic research
present exciting opportunities in
biomedicine, they also present someof the most
difficult challenges with respect to the
protection of human subjects. This module begins

with an introduction to the types and
complexity of genetic research. The learner is
then provided with a review of ethical, legal,
and regulatoryissues associatedwith genetic research. A
discussion of the issues
surrounding the use of stored biological samples
concludes this module.
English (ID: 6)
5
Spanish (ID: 1672)
Korean (ID: 15929)
Chinese (ID: 1592)
Khmer (ID: 16254)
Populations in Research Requiring Additional
Considerations and/or Protections
This module provides an introduction to potentially
vulnerable populations or those
requiring additional protections and/or considerations in
research. It describes different
sources of vulnerability and distinguishes between
populations in research who are
specifically protected in the federal regulations
and those who are not. The module also
discusses the impact on autonomy, beneficence,

and justice that may arise due to research
on or with vulnerable individuals or groups.
English (ID: 16680)
Spanish (ID: 1483)
Korean (ID: 15930)
Chinese (ID: 1593)
French (ID: 16447)
Khmer (ID: 16258)
Note: This module does not hold CE credit
designation.
Vulnerable Subjects - Research Involving Prisoners
This module describes the special requirements for
conducting research with prisoners.
The learner is provided with a review of why
incarcerated individuals need special
protection, as well as the regulatorydefinition of
what constitutes a prisoner. This module
also includes a discussion of each of the
permitted categories for research involving
prisoners and the required IRB considerations and
determinations.The module concludes
with the topicof what happens if an enrolled subject
becomes a prisoner.
English (ID: 8)
Spanish (ID: 1482)
Korean (ID: 15931)
Chinese (ID: 1594)

Vulnerable Subjects - Research Involving Children
This module describes the major historical events
that influenced how research with
children can be conducted. It describes problems
with this type of research that may violate
ethical standards. It reviews the assent and
informed consent requirements, and the current
efforts by the U.S. Foodand Drug Administration (FDA)
to ensure the inclusion of children
in studies on the safety and efficacy of new
drugs. An overview of the categories of
research
involving children is provided, including examples.
6
English (ID: 9)
Spanish (ID: 1498)
Portuguese: (ID: 12822)
Korean (ID: 15932)
Chinese (ID: 1595)
Vulnerable Subjects - Research Involving Pregnant
Women, Human Fetuses,
and Neonates
This module describes the historical exclusion of women
of childbearing potential and the
special requirements for conducting research

involving pregnant women and fetuses. It
includes a discussion of each of the permitted
categories for research involving the
pregnant women, human fetuses, and neonates, as
well as Institutional Review Board (IRB)
review requirements and determinations.Informed consent
requirements associatedwith
the different categories of research permitted with
pregnant women and human fetuses are
also discussed.
English (ID: 10)
Spanish (ID: 1499)
Portuguese: (ID: 12821)
Korean (ID: 15933)
Chinese (ID: 1598)
Avoiding Group Harms - U. S. Research
Perspectives
This module is designed for U.S. research perspectives
and describes somedistinct groups
or communities of people who are vulnerable to
group harms. In addition, learners are
presented with examples of research that has caused
group harms. This module concludes
with strategies that researchers can take to reduce
the risk of group harms.
English (ID: 14080)
Spanish (ID: 1719)
Korean (ID: 15934)
Chinese (ID: 1599)
Khmer (ID: 16269)

Avoiding Group Harms - International Research
Perspectives
This module is designed for international research
perspectives and describes somedistinct
groups or communities of people who are
vulnerable to group harms. In addition,
learners
are presented with examples of research that has caused
group harms. This module
concludes with strategies that researchers can take to
reduce the risk of group harms.
7
English (ID: 14081)
Korean (ID: 15935)
FDA-Regulated Research
This module addresses U.S. Foodand Drug Administration
(FDA)-regulated clinical research
and the responsibilities of investigators, Institutional
Review Boards (IRBs), and sponsors
when an U.S. FDA-regulated product is utilized in
a study. In particular, this module
includes
information on when an Investigational New Drug
(IND) application is necessary and the

requirements of the FDA Form 1572. A sub-
module discusses the International Conference
on Harmonisation (ICH) guidelines.
English (ID: 12)
Spanish (ID: 1493)
Korean (ID: 15936)
Chinese (ID: 1600)
Khmer (ID: 16260)
Recognizing and Reporting Unanticipated Problems
Involving Risks to Subjects or
Others in Biomedical Research
The U.S. Foodand Drug Administration (FDA) and the
U.S. Department of Health and
Human Services (HHS) human subject protection
regulations require institutions to have
policies and procedures to ensure prompt
reporting of unanticipated problems (UPs)
involving risk to subjects or others to the
Institutional Review Board (IRB), regulatory
agencies, and appropriate institutional officials. In
addition, FDA regulations require
investigators to promptly report to the IRB all
UPs involving risk to subjects or others and
unanticipated adverse device effects. The purpose of
this module is to provide guidance to
investigators on complying with HHS and FDA
reporting requirements by providing an
overview of UPs, unanticipated adverse device effects,
and the relationship between
adverse events and UPs involving risk to subjects or
others. As a part of the discussion, this
module includes a discussion on how to detect

UPs and how to report them.
English (ID: 14777)
Korean (ID: 15939)
Research and HIPAA Privacy Protections
This module discusses the requirements of the Health
Insurance Portability and
Accountability Act (HIPAA) and how they supplement
the U.S. Department of Health and
Human Services (HHS) and FDA requirements.
Situations where full HIPAA privacy
protections are required and those that can qualify
for waivers, alterations or exemptions
with more limited requirements are discussed.This module
also includes a discussion of the
8
responsibilities of investigators and institutions for
meeting HIPAA privacy requirements
and for appropriate data security protections that
are necessary to protect privacy.
English (ID: 14)
Korean (ID: 15942)
Chinese (ID: 1725)

9
Human Subjects Research – Social-Behavioral-
Educational (SBE) Modules
These basicmodules provide an introduction to
issues that arise in the context of SBE
designations:
Credits TM
• Other Participants: 9 AMA PRA Category 1
Credits TM
Module title Recommended Use

Required
History and Ethical Principles – SBE Required
Defining Research with Human Subjects – SBE
Required
The Federal Regulations – SBE Required
Assessing Risk - SBE Required
Informed Consent - SBE Required
Privacy and Confidentiality - SBE Required
Research with Prisoners – SBE Supplemental
Research with Children – SBE Supplemental
Research in Public Elementary and Secondary
Schools – SBE Supplemental
International Research – SBE Supplemental
Internet-Based Research - SBE Supplemental
Unanticipated Problems and Reporting Requirements in
Social
and Behavioral Research
Required

10
This module provides a link to the Belmont Report.
It also provides additional information
regarding the CITI Program’swebsite and the availability
of the Belmont Report in English,
Chinese, Spanish, and French.
English (ID: 1127)
Spanish (ID: 16459)
Korean (ID: 15895)
Russian (ID: 16303)
French (ID: 16448)
Khmer (ID: 16273)
Tamil (ID: 16384)
History and Ethical Principles – SBE
This module discusses the evolution of the ethical
principles in the U.S. that guide research
design as well as the development of the federal
regulations that govern the conduct of
research relevant to researchers in the social
and behavioral sciences. It reviews why ethics
are necessary when conducting research involving
human subjects including major
historical events that have influenced how human
subjects’ research is conducted. It
describes problems with past studies that have violated
ethical standards or have raised

ethical concerns that have contributed to the
national dialog related to the protection of
human subjects. The Belmont Report principles are
discussed as the basisfor the ethical
standards for research that guide us today.
English (ID: 490)
Spanish (ID: 16460)
Korean (ID: 15896)
Russian (ID: 16299)
French (ID: 16449)
Tamil (ID: 16377)
Defining Research with Human Subjects – SBE
This module discusses an interpretation of definitions
of the terms “human subject” and
“research” with an emphasis on the interpretation
for human subjects research in the social
and behavioral sciences. Also included is a
discussion as to the differences between
private
and public information and behavior, a critical
aspect of many types of social and
behavioral
research.
English (ID: 491)
Spanish (ID: 16461)
Korean (ID: 15897)
Russian (ID: 16294)

11
French (ID: 16450)
Khmer (ID: 15548)
Tamil (ID: 16378)
The Federal Regulations – SBE
This module provides an overview of the federal
regulations and their basicprovisions. A
closereading of the regulations includes research
methods and topics of inquiry relevant
for researchers in the social and behavioral
sciences and the humanities. Methods include
surveys, interviews, focus groups, oral history,
participant observation, observations of
public behavior, and the analysis of existing data.
This module provides specific examples of
the ways in which the federal regulations are
particularly pertinent to social and behavioral
science researchers and the methodologies noted. In
addition, regulatoryinformation
pertinent to social and behavioral researchers is
covered, including the criteria for
expedited and full board review and the authority of
the Institutional Review Board (IRB).
English (ID: 502)
Spanish (ID: 16462)
Korean (ID: 15898)
Russian (ID: 16298)
French (ID: 16451)

Tamil (ID: 16379)
Assessing Risk - SBE
This module discusses the challenges in identifying
and evaluating risks associatedwith
participation in social and behavioral sciences
research. Unlike biomedical clinical trials,
risks associatedwith social and behavioral science
research are oftenelusive and less
predictable. Topics include assessing risks,
balancing risks and potential benefits,
minimizing and managing risks, certificates of
confidentiality,and ways to address risks in
the informed consent document and process.
English (ID: 503)
Spanish (ID: 16463)
Korean (ID: 15899)
Russian (ID: 16295)
French (ID: 16452)
Khmer (ID: 16330)
Tamil (ID: 16380)
Informed Consent – SBE
This module discusses the process and documentation of
informed consent, including
informed consent guidelinesas well as the required
and additional elements of informed
consent as described by the regulations. There is
also a discussion of the circumstances

12
under which an Institutional Review Board
(IRB) may waive the requirements for
informed
consent with examples of how this is commonly
applied in social and behavioral sciences
research. This module also includes information related
to recruitment, consent
comprehension, timing of consent, and exculpatory
language, topics that are important to
the overall concept of informed consent.
English (ID: 504)
Spanish (ID: 16464)
Korean (ID: 15900)
Russian (ID: 16297)
French (ID: 16453)
Tamil (ID: 16381)
Privacy and Confidentiality – SBE
This module defines privacy and confidentiality.It
includes a discussion on protecting
privacy in research and guidelinesfor designing
confidentiality procedures. Topics include
private versus public behavior, controlling access
to private information, privacy and
exempt research, privacy and research methods,
confidentiality,privacy and reporting laws,
and certificates of confidentiality.The discussion
focuses on how theseconcepts apply to
social and behavioral science research.

English (ID: 505)
Spanish (ID: 16465)
Korean (ID: 15901)
Russian (ID: 16296)
French (ID: 16454)
Khmer (ID: 15545)
Tamil (ID: 16382)
Research with Prisoners – SBE
This module describes the requirements for conducting
research with prisoners. Included
in the discussion is a review of the
regulatorydefinition of a “prisoner,” the
permitted
categories of research involving prisoners and Institutional
Review Board (IRB) review
considerations. Importantly, this module contains a
discussion on essential elements
related to designing prisoner research, including consent
issues and the assessment of risk.
This module concludes with information related to
accessing prisoner populations.
English (ID: 506)
Korean (ID: 15902)
Research with Children – SBE
This module describes regulations that apply to
research with children. It defines “children”
and discusses examples of research that meet the criteria
of exempt research and expedited
review and issues involved in obtaining and
documenting parental permission and child

13
assent. Included in the discussion is a review
of the criteria for waiver of parental
permission and/or childassent.
English (ID: 507)
Spanish (ID: 16466)
Korean (ID: 15903)
French (ID: 16455)
Research in Public Elementary and Secondary
Schools – SBE
This module provides an overview of the types of
public school research and the regulations
that apply to research in thesesettings. Individual
sections discuss the Family Educational
Rights and Privacy Act (FERPA), the Protectionof
Pupil Rights Amendment (PPRA), and
Subpart D at 45 CFR 46: Additional Safeguards
for Children. Examples of activities that may
qualify for exemption are discussed.This module
concludes with a discussion of parental
permission and childassent issues, as well as
research-related harms to children and
requirements for reporting observed childabuse and
neglect.

English (ID: 508)
Korean (ID: 15904)
International Research – SBE
Social and behavioral scientists conduct research
around the globe. This module includes a
discussion of applicableregulations and guidelines
and the importance of the local context.
Because international research may also include
collaborating institutions, this module
provides information related to “engagement” in
research. Additional topics include
determining where research should be reviewed,
exempt research, and informed consent
considerations.
English (ID: 509)
Spanish (ID: 16467)
Korean (ID: 15905)
French (ID: 16456)
Internet-Based Research – SBE
The Internet, with an estimated 2.3 billion users
worldwide, has much to offer researchers,
both as a research tool and as the object of
study. This module presents the problems
associatedwith obtaining consent online and explains
why privacy and confidentiality may
be of particular concern for Internet research. In
addition, several problems with assessing
risks of harmassociatedare included as it may oftenbe
difficult for investigators to assess
theserisks if they do not have previous experience
with web-based research.

English (ID: 510)
Spanish (ID: 16468)
14
Korean (ID: 15907)
French (ID: 16457)
Khmer (ID: 16331)
Unanticipated Problems and Reporting Requirements in
Social and Behavioral
Research
This module defines unanticipated problems, describes
the reporting requirements
associatedwith unanticipated problems, and identifies the
types of actions an Institutional
Review Board (IRB) may take in response to an
unanticipated problem.
English (ID: 14928)
Spanish (ID: 16469)
Korean (ID: 15906)
Russian (ID: 16300)
French (ID: 16458)
Tamil (ID: 16383)

15
Human Subjects Research - Additional Modules of
Interest
These modules may be added to either HSR –
Biomedical or SBE courses.
designations:
Credits TM
Module Title Recommended Use
Cultural Competence in Research Supplemental
Conflicts of Interest in Research Involving Human
Subjects Required

Hot Topics Supplemental
Humanitarian Use Devices (HUDs) Supplemental
International Studies Supplemental
Consent Modules
Consent and Subject Recruitment
Challenges: Remuneration
Supplemental
Consent in the 21st Century Supplemental
Consent Tools Used in Research Supplemental
Community-
Engaged Research
Modules
Introduction To Community-Engaged
Research (CEnR)
Supplemental
Introduction to Community-Based
Participatory Research (CBPR)
Supplemental
Ethical and Practical Considerations in
Community-Engaged Research (CEnR)
Supplemental

16
IRB-Focused
Modules
External IRB Review Supplemental
I HaveAgreed to be an IRB Community
Member. Now What?
Supplemental
The IRB Administrator’s Responsibilities
Supplemental
The IRB Member Module - "What Every
New IRB Member Needs to Know”
Supplemental
Phase I Research
Modules
Phase I Research: Understanding Phase I
Research
Supplemental
Phase I Research: ProtectingPhase I
Subjects

Supplemental
Population-Specific
Modules
Gender and Sexuality Diversity (GSD) in
Human Research
Supplemental
Illegal Activities or Undocumented Status
in Human Research
Supplemental
Research Involving Subjects at the End of
Life
Supplemental
Research with Critically Ill Subjects Supplemental
Research with Decisionally Impaired
Subjects
Supplemental
Research with Older Adults Supplemental
Research with Persons who are Socially or
Economically Disadvantaged
Supplemental
Research with Subjects with Physical

Disabilities & Impairments
Supplemental
Students in Research Supplemental
Vulnerable Subjects - Research Involving
Workers/Employees
Supplemental
StemCell Research
Modules
StemCell Research Oversight (Part I) Supplemental
StemCell Research Oversight (Part II) Supplemental
17
Cultural Competence in Research
This module provides learners with an overview of
the essentials of practicing cultural
competence in research. It reviews its definition
and the importance of understanding the
demographics, historical contexts, communication styles,
customs, values, and beliefs of
study populations involved in research. The module
continues with a discussion of how
Institutional Review Boards (IRBs) and researchers
can operate to support this work.

English (ID: 15166)
Russian (ID: 16304)
Tamil (ID: 16385)
Conflicts of Interest in Research Involving Human
Subjects
This module describes conflicts of interest, which
are frequentlydebated and defined by
varying regulatoryrequirements. It includes a general
discussion of conflicts of interest
with an emphasis on financial conflicts of interest
and the ethical concerns that arise in
human subjects research. This is followed by a
review of the current reporting and
disclosure requirements for investigators, including the
2011 Public Health Service (PHS)
amendment and the U.S. Foodand Drug Administration
(FDA) regulations. The role of
Institutional Review Boards (IRBs) and the primary
strategies for eliminating, reducing, and
managing conflicts of interest completes this module.
English (ID: 488)
Spanish (ID: 1669)
Korean (ID: 15943)
Chinese (ID: 1728)
Russian (ID: 16301)
Khmer (ID: 16262)
Tamil (ID: 16375)
Hot Topics
This optional module is designed to provide

learners with current information on recent
developments in the Institutional Review Board
(IRB) universe. It is updated annually, with
previous content archived and accessible to learners.
English (ID: 487)
Korean (ID: 15945)
Khmer (ID: 16261)
designation.
18
Humanitarian Use Devices (HUDs)
This module provides a basicoverview of the FDA
regulations and responsibilities
regarding HUDs. It describes the Humanitarian Use
Device (HUD) program and
Humanitarian Device Exemption (HDE) regulatory
process, and explains the applicable
requirements and differences between 1) a
“clinical use” of a HUDto treat or diagnose
patients or 2) a “HUD investigation.” This module
also categorizes the FDA regulations and
IRB review requirements for HUDinvestigations within
and outside of the HDE approved
indications, and identifies additional federal rules or

institutional requirements that may
apply to the clinical use of a HUDor HUD
investigations.
English (ID: 16306)
designation.
International Studies
This module provides information for U.S. researchers
and collaborating international
research investigators who receive funding from the
U.S. federal government sources and
who plan to conduct human subject research outside
the U.S. This module is focused on
international research ethics, U.S. government, and
international guidelines. It includes a list
of ethical review hyperlinks for countries and
regions of the world. It is intended to
help
researchers and their staff members identify ethical
requirements of their global research
partners.
English (ID: 971)
Spanish (ID: 1481)
Korean (ID: 15940)
Chinese (ID: 1601)
Russian (ID: 16302)
Tamil (ID: 16376)

Consent Modules
Consent and Subject Recruitment Challenges:
Remuneration
This module explores the types of remuneration in
research, regulatoryrequirements
regarding remuneration to research subjects, how to
distinguish between remuneration
and reimbursement,and strategies to reduce the
potential for undue influence. It also
identifies ways of disclosing remuneration plans in
consent and advertising materials.
English (ID: 16881)
19
Consent in the 21st Century
This module explores how technology has impacted
the informed consent process in the
21st Century, especially electronic informed consent (eIC).
This module covers technology
and tools used in the recruitment and consent
process, describes alternatives to paper-
based informed consent forms, and explores
confidentiality issues. This module reviews
federal guidance concerning multimedia tools and
eIC.

English (ID: 17060)
Consent Tools Used by Researchers
This module provides an overview of the potential
barriers to informed consent and
discusses strategies and tools that may be used to
enhance and ensure research subjects’
understanding of study information, including subject
capacity assessments, the teach-back
approach, tools for childassent, use of framing and
graphics, and video and multimedia
presentations. This module discusses ways to present
research information to subjects in
several simple, practical, and inexpensive ways.
English (ID: 16944)
Community-Engaged Research Modules
Introduction to Community-Engaged Research (CEnR)
This module discusses the meaning of the term
"community," the disciplines and social
movements that contributed to the development of
CEnR, and the principles that guide
CEnR. It also identifies the differences between a
traditional research approach and the
CEnR approach.
English (ID: 16994)
Introduction to Community-Based Particapatory
Research (CBPR)

The module discusses the historical context for CBPR’s
framework and philosophical
foundation, strategies for effectively using CBPR,
and the ways a CBPR approach benefits
and otherwise impacts communities, as well as
academic researchers and their
organizations. It also identifies the ways CBPR differs
from traditional approaches to
research.
English (ID: 16995)
20
Ethical and Practical Considerations in to Community-
Engaged Research (CEnR)
This module identifies the ethical and practical
considerations particular to the design,
review, and conduct of CEnR. It also demonstrates
how to apply ethical risk-benefit
assessments for CEnR, the varying impacts that
risks and benefits may have on individual
research participants as well as on communities
and groups, and strategies for training and
educating community members on a research team.
English (ID: 16996)

IRB-Focused Modules
External IRB Review
This module reviews the history and developments of
external IRB review, the variety of
relationships between institutions and IRBs, and
the agreements and obligations involved
in those relationships. It covers major
argumentsfor and against institutional acceptance
of
an external IRB, defines several types of
relationships between research institutions and
external IRBs, describes differences in operations
of internal and external IRBs and their
organizations, describes different types of agreements
between institutions and external
IRBs, and discusses the factors that contribute to
the increasinguse of centralized IRB
review.
English (ID: 16711)
designation.
I HaveAgreed to Be an IRB Community
Member. Now What?
This module is designed for new Institutional Review
Board (IRB) community members, but
may be useful to anyone involved with human
subjects research. It provides the basic
information and tools related to IRBs, including an
overview of definitions and the
regulations, and provides strategies for a community

member to become a well-informed
IRB member. This module offers an overview of
various aspects of the IRB review processes
as they relate to specific types of protocols.
English (ID: 13018)
Korean (ID: 15947
designation.
The IRB Administrator’s Responsibilities
This module is intended for Institutional Review
Board (IRB) administrators and directors;
however, all individuals within an IRB office
might benefit from the information presented
in this module. An overview of the basicpolicies
and procedures that institutions should
21
have with regard to the human subjects protection
program, including the IRB, provides the
foundation for the IRB administrators’/directors’
responsibilities.
English (ID: 13813)
Korean (ID: 15949)

The IRB Member Module – “What Every New
IRB Member Needs to Know”
This module is designed as an overview and
resource for individuals joining an Institutional
Review Board (IRB). It includes discussions on
time commitment, liability, the role of the
IRB chair, and the levels of review. An
overview of IRB tools, including the content of
new
submissions as well as what is oftenseen during
committee review provides a foundation
for new IRB members and is complimented by a
discussion of how an IRB member can
review protocols. This module concludes with information
related to the IRB meeting,
including the importance of quorum, the types of
IRB decisions, and the review of minutes.
This module is designed for new scientific and non-
scientific members, but may also be
useful for any IRB member who continues to serve
on an IRB.
English (ID: 816)
Korean (ID: 15946)
Phase I Research Modules
Phase I Research: Understanding Phase I
Research
This module increases awareness of phase I
research as it relates to regulatory
requirements, Institutional Review Board (IRB)
review, and safeguards for protecting

human research subjects.
English (ID: 16873)
designation.
Phase I Research: ProtectingPhase I Subjects
This module identifies ways in which researchers
and staff involved in phase I research can
apply the necessary safeguards to protect
subjects involved in phase I research.
English (ID: 16874)
22
Population- Specific Modules
Gender and Sexuality Diversity (GSD) in Human
Research
This module provides a starting pointto develop
cultural competency for human subject
researchers and research team members, who will come
in contact with subjects or
prospective subjects of a variety of sexuality
and/or gender identities. It is also meant to

be
a resource for IRB members and administrative staff.
The module begins with a short
overview of the constituent parts of the GSD
community from a broad perspective,
continues with a summary of the legal and
social/cultural vulnerabilities faced by members
of thesegroups and describes research considerations
for members of thesecommunities,
and concludes with a discussion on what IRBs and
researchers should do with respect to
thesepopulations.
English (ID: 16556)
designation.
Illegal Activities or Undocumented Status in Human
Research
This module provides training and insight to
researchers, administrators, and IRBs
regarding added risks and challenges of conducting
research with individuals who are
engaged in illegal activities or who have
undocumented status. It presents examples of
vulnerable groups and identifies ethical
considerations when including them in research.
The module also describes research design issues,
recruitment methods, informed consent
issues, and additional safeguards specific to
research with groups of individuals involved in
illegal activities or who have undocumented status.

English (ID: 16656)
designation.
Research Involving Subjects at the End of Life
Persons at the end of life may be vulnerable
for numerous reasons, including cognitive and
physical impairments, which may progress as death
approaches. This module describes the
ethical challenges of research with subjects at
the end of life, including voluntariness and
withdrawal from research. It also describes how
cognitive impairment may impact
vulnerability in end of life research and identifies
strategies to overcome this challenge.
Barriers to subject recruitment and special
challenges for researchers and IRBs in
assessing
risk of harmand potential benefits in end of life
research are also examined.
English (ID: 16658)
designation.
Research with Critically Ill Subjects
Well-designed and implemented basicscience and
interventional trialshave the potential
for reducing morbidity and mortality of patients with
critical illness, as well as decreasing
the cost and burden of care. However, critically ill
patients represent a particularly

23
vulnerable population in research and may have
limitations in their ability to give informed
consent, or may be at risk of exploitation. This
module discusses ethical considerations and
additional safeguards for critically ill subjects
participating in research.
English (ID: 16592)
designation.
Research with Decisionally Impaired Subjects
This module provides an overview of the nature
and sources of decisional impairment. It
also discusses the obligations imposed on IRBs and
researchers to ensure that appropriate
protections are in place when research
involves adultsubjects who are or may be
decisionally impaired and may have impaired consent
capacity.
English (ID: 16610)
designation.

Research with Older Adults
This module provides education and training regarding
the conduct of research with older
adults. It discusses information for both researchers
and IRBs in order to begin the process
of addressing underrepresentation of olderadults in
research, while at the same time
providing critical information to consider when
conducting research with this group. The
module also covers the demographic and social
issues concerning the exclusion of older
adults in research, barriers to inclusion, and
research design considerations to enhance
inclusion and protect this potentially vulnerable
population.
English (ID: 16502)
designation.
Research with Persons who are Socially or
Economically Disadvantaged
This module provides education and training regarding
the conduct of research with
individuals who are socially or economically
disadvantaged. It describes the ethical and
regulatorymandates for the inclusion of thesepopulations
in research, as well as the
additional protections that may be used to minimize
risk. The module also describes
considerations for IRBs and researchers when
planning, reviewing, or conducting research
with socially or economically disadvantaged persons.

English (ID: 16539)
designation.
Research with Subjects with Physical Disabilities &
Impairments
This module provides an overview of physical
disabilities and impairments, and the
obligations imposed on IRBs and researchers to
ensure that appropriate research
24
protections are in place when research
involves subjects who are physicallydisabled and
may require additional tailored protections. Additional
barriers, vulnerabilities, and
challenges that individuals with physical disabilities
face when participating in research are
identified. The module also discusses safeguards
and additional protections that IRBs and
researchers can implement to protect this
potentially vulnerable population, as well as
ways to make research studies more accessible to
individuals with physical disabilities.

English (ID: 16657)
designation.
Students in Research
This module is designed as a "one-stop shop"
for students who may be involved in human
subjects research as an investigator and/or a
subject. Degree requirements in
undergraduate, masters, or doctoral degree programs
oftenrequire students to conduct or
assist in research projects that include human
subjects. In addition, students may be asked
or be "required" to participate as subjects in
research projects. A review of the history
and
principles of ethics for research involving human
subjects, including a definition of research
and categories of review; students as researchers;
the role and operations of Institutional
Review Boards (IRBs); and the issues related to
students as subjects are provided, as well as
a resource section.
English (ID: 1321)
Spanish (ID: 1671)
Korean (ID: 15948)
Vulnerable Subjects – Research Involving
Workers/Employees
This module describes why workers may be a
vulnerable population when they participate

in research, and the potential risks and benefits
associatedwith research involving
workers/employees. This module also discusses protections
that need to be afforded to
workers/employees. It proposes that while workers
may serve as study subjects for
political as well as scientific reasons, adequacy of
the science and adherence to the Common
Rule are paramount.
English (ID: 483)
Spanish (ID: 1720)
Korean (ID: 15944)
Chinese (ID: 1726)
StemCell Research Modules
StemCell Research Oversight (Part I)
This module is the first of a pair of modules on
human stem cells and it introduces the
learner to the nature and characteristics of both
adultand embryonic stem cells. Learners
25
are provided with a review of the requirements of
the federal regulations associatedwith
stem cell research and the role of both state and local
requirements.

English (ID: 13882)
Korean (ID: 15937)
StemCell Research Oversight (Part II)
This module builds on the content presented in
Part 1 and provides a framework for
institutional review of stem cell research, national
guidelinesas well as current federal law
and policy. This module provides an overview of
the National Academy of Sciences (NAS),
International Society for StemCell Research (ISSCR),
and National Institutes of Health (NIH)
guidelinesrelated to human stem cell research and
Consideration is given to U.S. Department of
Health and Human Services (HHS) and U.S.
Foodand Drug Administration (FDA) regulatory
requirements, StemCell Research
Oversight (SCRO) committee composition and
responsibilities, categories of research, and a
comprehensive definition of provenance as it applies
to human stem cell research. A
detailed overview of the recommendations of the
NAS, ISSCR, and NIH Guidelines as well as
information related to the procurement, banking,
and use of human stem cell lines are
provided via the hyperlinks that follow the
module.
English (ID: 14584)
Korean (ID: 15938)

26
Refresher Courses
Refresher courses in the HSR series should be
completedafter a basiccourse and in
sequential order within each track. For
recommendations on how to use a refresher
course,
see the Using CITI Program Content: Human
Subjects Research (HSR) document.
Refresher 1
This course provides summaries of the important
concepts for each module in the Human
Subjects Research – Biomedical (Biomed) track. It
is to be completedafter the basicHuman
Subjects Research - Biomed modules. In order to
receive credit for the course, a learner
must
complete all of the modules listed below.
designations:
• Physicians: 3 AMA PRA Category 1 Credits
TM

Credits TM
April 2013 to 18 April 2016
• Nurses: 14 April 2014 to 14 April 2016
Biomed Refresher 1 – History and Ethical
Principles Required
Biomed Refresher 1 – Regulations and Process
Required
Biomed Refresher 1 – Informed Consent Required
Biomed Refresher 1 – SBR Methodologies in
Biomedical
Research
Required
Biomed Refresher 1 – Records-Based Research
Required
Biomed Refresher 1 – Genetics Research Required
Biomed Refresher 1 – Research Involving Vulnerable
Subjects Required
Biomed Refresher 1 – Vulnerable Subjects -
Prisoners Required

Children Required
27
Principles
English (ID: 975)
Korean (ID: 15953)
English (ID: 981)
Korean (ID: 15954)
Biomed Refresher 1 – Informed Consent
English (ID: 980)
Korean (ID: 15955)
Biomedical Research
English (ID: 982)
Korean (ID: 15956)

English (ID: 983)
Korean (ID: 15957)
Biomed Refresher 1 – Genetics Research
English (ID: 984)
Korean (ID: 15958)
Biomed Refresher 1 – Populations in Research
Requiring Additional Considerations
and/or Protections
English (ID: 985)
Korean (ID: 15959)
Prisoners
English (ID: 973)
Korean (ID: 15960)
Children
English (ID: 974)
Korean (ID: 15961)
Biomed Refresher 1 – Vulnerable Subjects –
Pregnant Women,
Required
Biomed Refresher 1 – FDA-Regulated Research
Required

28
Pregnant Women, Human Fetuses,
and Neonates
English (ID: 986)
Korean (ID: 15962)
English (ID: 987)
Korean (ID: 15963)
29
Human Subjects Research - Biomedical (Biomed)
Refresher 2
This course provides summaries of the important
concepts for each module in the Human
Subjects Research - Biomedical (Biomed) track.

This refresher course is to be completedafter
the Biomed Refresher 1 course. In order to
must
designations:
Credits TM
September 2013 to 31 August
2016
• Nurses: 23 June 2014 to 23 June 2016
Principles Required
Required
Biomedical Research Required

Required
Subjects Required
Prisoners Required
Children Required
Pregnant Women,
Required
Required
30
Biomed Refresher 2 – HIPAA and Human
Subjects Research Required

Biomed Refresher 2 – Conflicts of Interest in
Research Involving
Human Subjects
Required
Principles
English (ID: 511)
English (ID: 512)
Biomedical Research
English (ID: 515)
English (ID: 516)
English (ID: 518)
and/or Protections

English (ID: 519)
Prisoners
English (ID: 520)
Children
English (ID: 521)
Pregnant Women, Human Fetuses,
and Neonates
English (ID: 522)
31
English (ID: 514)
English (ID: 524)
Biomed Refresher 2 – HIPAA and Human
Subjects Research

English (ID: 526)
Biomed Refresher 2 – Conflicts of Interest in
Research Involving Human Subjects
English (ID: 681)
32
Refresher 3
This course provides of summaries of the
important concepts for each module in the Human
Subjects Research – Biomedical (Biomed) track.
This refresher course is to be completed
after the Biomed Refresher 2 course. In order to
must
designations:

Credits TM
November2013 to 31 October
2016
• Nurses: 5 May 2014 to 5 May 2016
Principles – Research
vs. Practice
Required
Principles – Belmont
Principles
Required
Biomed Refresher 3 – Regulations and Process –
IRB Authority
and Composition
Required

IRB
Responsibilities
Required
Biomedical
Research
Required
Subjects Required
Prisoners Required
33
Children Required
Pregnant Women,
Required

Principles – Research vs. Practice
English (ID: 993)
Korean (ID: 13745)
Principles – Belmont Principles
English (ID: 12640)
Korean (ID: 13748)
IRB Authority and Composition
English (ID: 12644)
Korean (ID: 13750)
IRB Responsibilities
English (ID: 12645)
Korean (ID: 12645)
English (ID: 1003)
Korean (ID: 13754)
English (ID: 12633)
Korean (ID: 13763)

Biomedical Research
English (ID: 1004)
Korean (ID: 13757)
and/or Protections
English (ID: 12643)
34
Prisoners
English (ID: 12647)
Children
English (ID: 12648)
Pregnant Women, Human Fetuses, and
Neonates
English (ID: 12649)

35
Educational (SBE)
Refresher 1
Subjects Research – Social-Behavioral-Educational (SBE)
track. It is to be completedafter the
basicHuman Subjects Research - SBE modules. In
order to receive credit for the course, a
learner must complete all of the modules listed
below.
designations:
TM
• Social Workers: 3 LCSW, LMHC, LMFT Credits
Credits TM

April 2013 to 18 April 2016
• Nurses: 6 June 2014 to 6 June 2016
• Social Workers: 9 June 2014 to 31 March 2015
SBE Refresher 1 – History and Ethical Principles
Required
SBE Refresher 1 – Federal Regulations for
ProtectingResearch
Subjects
Required
SBE Refresher 1 – Defining Research with Human
Subjects Required
SBE Refresher 1 – Informed Consent Required
SBE Refresher 1 – Assessing Risk Required
SBE Refresher 1 – Privacy and Confidentiality
Required
SBE Refresher 1 – Research with Prisoners Required
SBE Refresher 1 – Research with Children Required
SBE Refresher 1 – Research in Educational
Settings Required

SBE Refresher 1 – International Research Required
36
English (ID: 936)
ProtectingResearch Subjects
English (ID: 937)
Subjects
English (ID: 15029)
SBE Refresher 1 – Informed Consent
English (ID: 938)
SBE Refresher 1 – Assessing Risk
English (ID: 15034)
English (ID: 15035)

SBE Refresher 1 – Research with Prisoners
English (ID: 939)
SBE Refresher 1 – Research with Children
English (ID: 15036)
SBE Refresher 1 – Research in Educational
Settings
English (ID: 940)
SBE Refresher 1 – International Research
English (ID: 15028)
37
Educational (SBE)
Refresher 2
Subjects Research – Social-Behavioral-Educational (SBE)
track. It is to be completedafter the
SBE Refresher 1 course. In order to receive
credit for the course, a learner must
complete all

of the modules listed below.
designations:
TM
• Social Workers: TBA
Credits TM
September 2013 to 31 August
2016
• Nurses: 5 May 2014 to 5 May 2016
Required
ProtectingResearch
Subjects
Required
Subjects Required

SBE Refresher 2 – Informed Consent Required
SBE Refresher 2 – Assessing Risk Required
Required
SBE Refresher 2 – Research with Prisoners Required
SBE Refresher 2 – Research with Children Required
SBE Refresher 2 – Research in the Public Schools
Required
SBE Refresher 2 – International Research Required
38
English (ID: 12702)
ProtectingResearch Subjects
English (ID: 15040)
Subjects

English (ID: 15038)
SBE Refresher 2 – Informed Consent
English (ID: 12620)
SBE Refresher 2 – Assessing Risk
English (ID: 12624)
English (ID: 12622)
SBE Refresher 2 – Research with Prisoners
English (ID: 12627)
SBE Refresher 2 – Research with Children
English (ID: 15043)
SBE Refresher 2 – Research in the Public Schools
English (ID: 15042)
SBE Refresher 2 – International Research
English (ID: 15045)

39
Institutional/Signatory Official: Human Subject
Research
Course
This course provides a general introduction for
institutional officials (IOs) in a variety of
organizations – biomedical, behavioral, social
sciences, and others, as well as a variety of
organizational structures – academic medical centers,
colleges and universities,
independent IRBs, research sites, and others. It
introduces the learner to the roles and
responsibilities of the IO, including the regulatoryrole
and expectations, obligations
imposed on the organization by the Federalwide
Assurance(FWA), and functions that are
part of the human research protections program
(HRPP). For recommendations on how to
use this course, see the Using CITI Program
Content: Human Subjects Research (HSR)
document.
Introduction to Being an Institutional Official
(IO) Required

IO Knowledge Requirements: Human Subject
Protections Required
Expectations of the IO Required
Challenges of Being an IO: Human Subject
Protections Required
Introduction to Being an Institutional Official
(IO)
This module focuses on general administrative topics
that are defined/controlled by each
organization. These administrative topics include:
who in the organization has the authority
to appoint/name the IO, functions that are part of
the HRPP, and typical IO duties. This
module also covers IO leadershiptopics including:
communication, evaluation, resource
allocation, delegating authority, and succession
planning.
English (ID: 16640)
IO Knowledge Requirements: Human Subject
Protections
This module focuses on the federal regulations
for human subject research, the ethical
principles relevant to research, and the current model
for structuring portions of an
organization that play a role in research involving
human subjects. It contains somespecific
“need-to-know” areasfor the institutional official
including functions that are part of the
HRPP, the role of the IRB, the major ethical
principles for human subjects research, and the

regulatoryexpectations for research organizations.
English (ID: 16641)
40
Expectations of the IO
This module focuses on the role of the IO and
what federal regulators expect to be within
the scope of those duties. It presents some
techniques that have been successfully used by
others and ways the IO can promote an
organizational culture of respect, commitment,
caring, and compliance. The required communications
with the federal officials are also
examined,as well as the processes that are part of
the FDA’s Human Subject
Protection/Bioresearch Monitoring (HSP/BIMO)
Initiative. Finally, the role of an internal
quality improvement (QI) program and how it fits
into the HRPP is explained.
English (ID: 16642)
Challenges of Being an IO: Human Subject
Protections
This module focuses on the IO as the designated
leader of the HRPP. It examines the
executive role of the IO in the HRPP, provides

someeffective techniques and strategies for
fostering organizational communication and improvingits
effectiveness, and describes
ways in which the IO can assist the function of
key parts of the HRPP. The IO’s role is
examined in promotingan organizational culture of
respect, commitment, caring, and
compliance, and seeking to continually improve
the quality of services the organization
delivers while protecting subjects of research.
English (ID: 16643)
41
IRB Chair Course
This course is intended for current and future
chairs of Institutional Review Boards
(IRBs). It provides detailed training in regards to
their role and responsibilities, meeting
responsibilities, and role outside of the IRB
meeting. For recommendations on how to use
this course, see the Using CITI Program Content:
Human Subjects Research (HSR)

document.
designations:
TM
• Nurses: Approval 2 CNE Credits/Contact Hours
Credits TM
December 2012 to 30
November2015
• Nurses: 1 October 2014 to 1 October 2016
Role and Responsibilities of an IRB Chair
Required
IRB Chair Meeting Responsibilities Required
The IRB Chair’s Role Outside of the IRB Meeting
Required
Role and Responsibilities of an IRB Chair
This module describes the qualifications of an IRB
chair, expectations, and time

commitments oftenassociatedwith being an IRB chair,
and the relationship between the
IRB chairand IRB administrator. It also presents the
ethical principles, regulations, and
policies and procedures that affect the IRB and
the role of its chair.
English (ID: 15386)
IRB Chair Meeting Responsibilities
This module details the critical areasrelated to
preparation for the IRB meeting, the
responsibilities associatedwith running an IRB meeting,
and the activities and procedures
that occur after a convened meeting.
42
English (ID: 15387)
The IRB Chair’s Role Outside of the IRB Meeting
This module explains the additional duties required of
an IRB chairoutside of the convened
meeting, the role of a chairin making expedited
reviewer designations, unanticipated
problems and the role of an IRB chair, and
suspensions and terminations of approved
research.

English (ID: 15388)
Effective Teachers: An Investigation from The Perspectives of
Elementary School Students
Jludith F. E-vans
Manhattan C'ollege
Abstract
The topic of effective teachers is of significance to the fiei'd of
teacher education as well as to the entire
education community While an abundance of research oi this
subject identifies findings from adult
viewpoints, this qualitative study uses ethnographic interviews
with fijth grade studen7ts to eramine the
characteristics of effective teachersfrom the perspectives qf
children, the consumers in education.
Categories of characteristics and themes Jbund in the
descriptive data of transcripts reveal the way
children define effective teachers and identify their skills,
knowledge, and dispositions. Implications
fir the goals and content of teacher education programs are
discu.ssed. Based on findings from this study,
the author argues in support of including the voices of children
in the research arena. The article concludes
that in an age of technolog,y, elementary school students ietain
a humanistic vision of teaching and learning.

Introduction
The goal of teacher education is to prepare effective teachers
who are able to facilitate learning for all students. The
various aspects of becoming an effective teacher are topics
intro(duced in the Elementary Education Program at Manhattan
College in Riverdale, NY, when students first begin their
teacher preparation. This subject is revisited throughout the
program as understandings are modified as a result of course
worlk and field experiences.
Manhattan College, a small LaSallian Catholic liberal arts
college, is located in the heart of Community School
District 10, the largest of New York City's 32 school districts.
This is a diverse, multicultural district serving 41,000 students,
from 108 countries in 44 schools (Community. 1999-2000). The
Program has a commitment to prepare effective teachers
able to work in urban multicultural environments in the 21st
Century. Many of our students have come from Catholic schools
and some seek teaching positions in Catholic schools after
graduation. However, in recent years. most of the students have
pursued jobs in both urban and suburban public schools. District
I 0 and neighboring suburban communities are the contexts
in which students in the Manhattan College Elementary
Education Program receive their teacher preparation.
Conceptual Frame/Rationiale for the Study
Teacher effectiveness has become a standard for teacher
preparation (Saphier & Gower, 1987; Wonig & Wong, 1998;
Myers & Myers, 1995), a basis for staff development
(Danielson, 1996), and a guideline for teacher evaluation
(Flores, 1999).
tn fact, the topic has been of such interest to the education
community since the middle of the twentieth century that there
has

been an abundance of research on teacher effectiveness from
different perspectives.
Researchers have studied teacher behaviors in relation to
student achievement. They have found that students
achieved higher on standardized tests when teachers manage
direct instructional time effectively (Stalling, 1978; Powell,
1980), establish clear structure and routines (Soar & Soar,
1979), are well-organized, and have greater control over
classrooms
(Powell, 1980). Learning is also promoted when teachers
explain what students are to learn and provide continuous
feedback
(Rosenshine, 1983; Brophy & Good, 1986; Rose, 1989).
Other studies have focused on models or approaches to leaching
which affect the arrangement of curriculum and
environments in order to foster student learning. These models
have evolved as psychological theories about teaching and
learning have shifted from behaviorist-driven theory to
constructivism. They range from traditional direct instruction
models that focus on content learning to progressive models that
feature social-emotional development as students interact
with others and the environment in order to leam (Joyce & Weil,
1996; Coffin, 1994; Brophy & Good, 1986; Burden & Byrd,
1994). Research suggests that when models are combined, they
have greater potential for improving student learning and
teacher effectiveness (Harris, 1998).
Another strand of research has examined teacher artistry, "he
creative and personalized ways teaching is carried out.
Through artistry effective teachers generate excitement for
learring and make purposes for learning clear (Harris, 1998;
Rubin, 1985). Artist teachers establish good relationships with
students and a sense of well-being in their classroom-ns (Smith,
1999; Rogers & Renard, 1999). Teachers achieve such a climate

by knowing their subjects, knowing their students, and
serving as guides for learning (Cruickshank & Haefele, 2001).
Teacher artistry results in increased motivation, learning, and
positive feelings (Rose, 1989).
51
Studies have also approached the topic of effective teachers by
establishing categories of teacher characteristics.
Within this construct, researchers have generated lists of
teacher skills, knowledge, and dispositions. Teacher skills are
those
actions and interactions that facilitate learning. Essential skills
frequently identified in research are: building positive rela-
tionships with students; generating enthusiasm; establishing
well-organized and managed classrooins: providinig clear and
accurate communications; stating objectives and purposes for
learning; using questioning and discussioll techniques that fos-
ter critical thinking; providing feedback to students; responding
to questions; varying instructional patlerns; conveyinig higlh
expectations; motivating, encouraging and rewarding students;
and involving students actively in learninlg (Kauchak &
Eggan, 1998; Wong & Wong, 1998; Danielson, 1996; Myers &
Myers, 1995; Burden & Byrd, 1 994; Saphier & Gower, 1987).
Other researchers have noted several areas of knowledge found
in effective teachers. These teachers have knowvledge
of subject matter, the content, the concepts, and skills of the
disciplines they teach. I'hey know their students both academi-
cally and personally. They have knowledge of pedagogy, the
teaching strategies and models of instruction. And finally. effee
tive teachers have knowledge of management of learning and
behavior (Good & Brophy, 1987; Eggen & Kauchak. 1997;
Tobin, 1987; Wilson, Shulman, & Richert, 1987; Shulman,

1986).
Studies have also investigated teacher dispositions, the beliefs,
attitudes, values, and personality traits of effective
teachers. These studies inform us about what kinds of people
effective teachers are. Repeatedly, they are listed as respectful,
fair, democratic, caring, good listeners. They are stimulating,
creative, confident, positive, approachable, and responsive to
students. Effective teachers are also good role models who are
understanding, have high expectations for students, have a
sense of humor, and love learning (Cooper, 1999; Kauchak &
Eggen, 1998; Wong & Wong, 1998; Myers & Myers, 1995;
Burden & Byrd, 1994). They are reflective practitioners who
engage in self-evaluation to improve the effectiveness of their
teaching (McIntyre & O'Hair, 1996; Myers & Myers, 1995;
Burden & Byrd, 1994; Brophy & Good, 1988,; Schon, 1983).
The
construct of teacher characteristics guides students in my
program in the development of their evolvillg understanding and
analyses of effective teachers.
Regardless of its focus in the past, however, research on teacher
effectiveness to date has had one thing in common.
It has yielded findings from the adult perspectives of teachers,
administrators, educational researchers, and teacher educators.
Rarely have the perspectives of elementary school students,
themselves, been sought.
Additionally, despite the recent trend toward more student-
centeredness in classrooms, where the voices of students
are valued, student knowledge has remained largely
unacknowledged in the arena of educational research. One
exception has
been the work of the Santa Barbara Classroom Discourse Group
that has sought student knowledge, the voices of those who
are involved in learning, in their research on literacy at the

elementary level (Green, Bloome, & Berrera, 1998).
Another example of research dedicated to children's voices in
educational research appears in a 1995 monographl
issued by the Journal of Teaching in Physical Education.
Studies emphasized the value of teachers' knowiing how
students
think about, value, and understand physical education as a way
of allowing teachers to change the ways they teach and relate
to students (Graham, 1995). While the focus these groups differ
from mine, we, as researchers, share a belief in the value of
student understandings of teachers and learners, and their
ability to inform the educational process. Thlus. the work of
these
groups provided my rationale for engaging in research with
children, while the model of characteristics of effective teachers
provided the conceptual frame for the qualitative study reported
here.
Purpose and Research Questions
The purpose of this study was to learn what elementary school
students know about effective teachers and what they
value in their teachers. Guided by the construct of teacher
characteristics I formulated the following research questions:
1. How do students define effective teachers?
2. What kinds of knowledge do students have about the
characteristics of effective teachers?
3. What qualities do students value in their teachers, and why?
4. How might student knowledge of effective teachers be
infused into the content and experiences
of teacher education programs?
Method

Beginnings
In order.to shape the study and identify participants wbo would
be able to articulate their understandings about them-
selves and their teachers, I first conducted a pilot study
interviewing four children between the ages of six and eleven
years
old. Students in this pilot study easily discussed what good
teachers had to know, do, and be like as people in order to help
them learn. I discovered that upper elementary students who had
worked with a number of classroom and special-subject
teachers, were able to consider questions thoughtfully and
objectively, and were able to convey their ideas clearly. They
also
52
.-r
had experience in school doing social studies and science
research, so they understood the nature and process of
conducting
systematic inquiries. They expressed definite ideas about
significant qualities they valued and expected in their teachers.
Their responses excited me about the potential of my study to
produce worthwhile findings for other education professionals.
The Participants
Four considerations influenced my selection of participants for
this study. They were: the initial findings from the
pilot study, the location of the College, the backgrounds of my
students, and the relevance of a variety of settings to them. I

selected a purposive sample from volunteers of fifth grade girls
and boys in urban and suburban public and Catholic schools.
As coordinator of field placements in the elementary education
program, I have built up relationships with
administrators in many public, private, and Catholic schools in
the area of the College. Those administrators became my
gatekeepers when seeking access to potential participants. First,
I ,poke to administrators personally to introduce them to the
proposed study. These conversations were followed up with
written packets that included a detailed description of the study,
a letter of explanation to parents, parent consent forms, and
student participation agreements. Each administrator had
autonomy to grant permissioni for me to conduct my research in
his/her building. Simultaneously, I submitted a proposal for
the study that was approved and supported by the Summer
Grants Committee and the Provost of the College.
When administrators expressed interest in participation, tley
were asked to discuss the study with their fifth grade
teachers to see who would be willing to have their students
participate. A single section of the grade was selected in each
school. I was then invited to give an information dissemination
session to each identified class. It was here that I had a chance
to introduce myself, explain my work, and outline the role of
students in the study. We talked about research the children
have conducted in science and social studies, and compared it tc
the kind of research they would do with me. Finally, I
responded to questions by students and teachers.
Atthe end of each session, students were invited to volunteer for
the study. All those who did were given parent con-
sent forms and urged to discuss this project at home. Once
consent forms were returned to me, I met with the teacher
and administrator to select a sample that appeared to be
representative of the population by gender, ethnicity, and school

achievement. This was the method though which the purposive
sample of participants was selected for the study (Nachmias
& Nachmias, 1987).
Inmall, 14 students, nine girls and five boys between the ages of
ten and eleven, became participants in this study. Six
are Caucasian, four are African American, three are Hispanic,
and one is Eastern European. All of the participant children
are fluent English speakers even if their primary language was
not English. The children attend four different schools: an
urban public school (UPS), an urban Catholic school (UCS), a
suburban public school (SPS), and a suburban Catholic
school (SCS). With the exception of the SPS, the schools are
ethnically diverse as the sample of participants reflects. The
population of the SPS is mostly middle-class Caucasian. These
schools are located in areas that range socio-economically
from lower class to middle and upper-middle class.
Procedures
Data were collected over a 14-month period through
ethnographic interviews conducted in the schools. Initially, each
participant was interviewed individually. At each first
interview, I reiterated the student's right to withdraw at any
time and
my assurances of confidentiality. Students were then given a
participation agreement that we both signed. Interviews
contained both closed and open-ended questions designed to
elicit the children's understanding of effective teachers. The
children were asked such questions as, "Over the years, who
have been your really good teachers?" What made them good?"
"How would you define a really good/effective teacher?" "What
advice would you give to future teachers about they ways
they could become effective teachers?"
Conversations were recorded on audiotape, transcribed,

nmaintained in a data log, and then analyzed and placed into
categories for teacher characteristics of skills, knowledge and
dispositions. As categories were linked, data were also
examined
for ideas or themes that meaningfully ran through the data.
These themes were then expanded into findings as statements
(Bogdan & Biklen, 1982). New ideas, not originally included in
the focus of the study, were pursued in ensuing individual
interviews as well as in group interviews.
After each child had been interviewed individually, all of the
students in a school were brought together for a group
interview where I could probe for clarifications, pursue new
ideas, and respond to comments and questions from the
participants. I conducted a total of eighteen individual and four
group interviews. While there was structure to the interviews,
the recursive nature of my data collection and analysis led to
new strands of inquiry. The children were also invited to
contact me by telephone, e-mail, or snail mail should they think
of information they wanted to add to their responses or have
me delete later. Four of the fourteen participants contacted me
after I had left the field.
53
I used several techniques to insure the trustworthiness of this
qualitative study. I wanted to be sure that the findings
made sense to the participants, were a function of the
participants' experiences rather than of researcher bias, and
were
consistent over time (Guba & Lincoln, 1985). These techniques
were used to confirmn "a fit between what was recorded as
data and what actually occurs in the setting under study"
(Bogdan & Biklen, 64).

I carried out several member checks while the study was in
progress. In these conversations, the findings,
interpretations, and conclusions were checked by the
participating students. I tallied categorized responises to
examine the
dependability of the study by confirming the consistency of
findings over time, and by differentiating between the force and
frequency of responses. Finally, I belong to a writers' support
group comprised of educators engaged in qualitative research.
These colleagues served as peer reviewers throughout the study
as they read data, explored meanings derived from the
analysis, and monitored the work for researcher biases (Guba &
ILincoln, 1985).
Findings
As transcripts were examined, data were analyzed by codes and
subsequently shaped into categories. Findings fell
into two distinct groupings: information related to teacher
characteristics, and underlying themes about teachers and
learners
that had emerged from patterns in the descriptive data. Citations
for direct quotations from data are designated by (log
number: page:line).
Teacher Characteristics
Definition. The essence of the definitions of effective teachers
from students across schools was captured in the
words of one girl from SPS who said, "The most important thing
teaclhers do is help children learn" (15:7:15-17). Learning
was at the heart of the children's explanations about their good
teachers. For example, they noted that effective teachers like
to help students understand, and "will try to explain it to you if
you need more help" (11:1:24). An effective "teacher is very

clear in her words. Sle can explain everything very well
verbally" (22:8:11-12). Finally, an effective teacher is one who
'can
make teaching fun so that students will want to learn" (4:2:25-
26). That kind of teacher "really knows how to do things in
her class" (6:2:11).
As our conversations continued we discussed what the children
thought that teachers had to be able to do, to know.
and to be like as people that helped their students learn.
Through these lines of questioning, the children went on to
recognize specific skills, knowledge, and dispositions they
found and valued in their effective teachers.
Teacher skills. I questioned the children about their teachers'
skills by asking them what their teachers did in their
classrooms that helped students learn. They identified a
numbers of teacher actions and behaviors. For instance, five
participants discussed their teachers' abilities to explain
information clearly, while four others noted their teachers'
willingness to address and answer questions. To be able to
explain and help students understand work, the children thought
that teachers needed to relate well and communicate effectively
with children. "She knows how to explain things so that we...
could understand it. She substitutes the big words to words we
understand" (6:3:1-4). Then, as noted by four children each,
effective teachers also foster student independence, and use
peer teaching to promote leaming.
The participant students seemed to feel strongly that effective
teachers make learning fun. Among all skills reported
this was the most frequently rnentioned skill, cited ten times in
both individual and group interviews. According to these
students, teachers make learning fun by using a variety of
materials and strategies in their teaching. IThey use projects
and

give choices, show tricks to motivate students, give examples
and draw things, teach songs to help students memorize,
and as four participants noted, play games. "She made
everything exciting. She made everything a fun game. She made
everything very interesting to me" (22:2:6-8).
Finally, to be effective, teachers need to control their
classrooms. In order to do this, the students explained,
teachers must be attentive to behavior, state clearly what they
want from students, teach children how to behave, hanidle
misbehavior with warnings, have strict rules, and set a good
example. "You can't necessarily be strict. You have to state
firmly what you want" (17:13:3). As the participants talked
about their teachers' skills, they realized that in order to do
these
things successfully, teachers needed various kinds of
knowledge.
Teacher knowledge. The students cited several kinds of
knowledge needed by effective teachers: knowledge of
subjects, knowledge of teaching and knowledge of students.
First, as noted by seven of the participants, teachers need to be
smart and know all the subjects. "An effective teacher has to
know a lot about all the subjects" (16:4:19). "My teacher doesn't
have to look up the answers. She knows everything off the top
of her head" (15:9:21). Also, reiterated by four children from
their earlier discussion of eftective teachers' skills, teachers
have to know how to explain and teach the subjects to students.
But by far, the most important area of knowledge for teachers,
as identified by these participants, is knowledge of their
students. Six students felt that teachers should know about
children's feelings and their personal lives while four others
said
54

that teachers need to know who they are and what they like to
dlo. Seven participants identified teachers' knowledge ol
student abilities, how they learn, and who needs help as
significant. "... should understand what they're going through
and ...
understand when a kid needs help in a subject" (12:3:17). And
eight children wanted teachers to know about their interests,
behavior, and personalities. "She should know how they behave
at home. Sometimes they behave differently at home and
in schiool (11:5:10-11). The frequency and scope of knowledge
about students mentioned by these children indicate the
importance they place on their teachers' knowledge of them
beyond their academic achievements.
Teacher dispositions. The children's emphasis on teacher
knowledge of them also indicates that students are acutely
aware of their teachers' personal qualities, what kinds of people
th-y are, and how they treat their students. Trhis information
was elicited with such questions as, "What are effective
teachers like as people?" and "What adjectives would you use to
describe effective teachers?" The children responded
definitively.
Over and over students articulated the significant dispositions
they associated with their effective teachers. Six
identified their effective teachers as respectful of students while
seven recognized them as fair. '"They're like fair... they don't
have a favorite. They like the kids equally" (11: 1:29). While
the) are fair, they should also be strict, but not too strict. Five
noted kindness, four cited caring, and seven described teachers
as nice. "They were so kind to the students. They are all just
really nice and stuff' (4:4:17). Seven students said that effective
teachers are fun. Finally, four participants found teachers to
helpful to students and able to relate to them. "I think a teacher

should be someone, like a person who can relate to the
children, who understands all the things they talk about and
stuff... ya know, get along with their students" (12:1 :28-33).
The
children also see their effective teachers as confident people. As
one student noted, "Effective teachers have confidence in
themselves and believe in themselves" (5:2:12). By the
frequency with which these descriptors were mentioned in both
individual and group interviews, it became evident that students
fi-om all schools care deeply ab:out the kind of people their
teachers are, and can articulate what kinds of personalities they
respond to most positively.
Themes Representing Student Beliefs and Understandings
During the analysis process, several persistent ideas threa(led
their way through student responses found in the data.
These ideas suggested underlying themes representing the
childrer 's beliefs and understandings related to effective
teachers.
"We care about the wav our teachers treat us"
First and foremost, students across schools indicated that they
care deeply about the way they are treated by their
teachers. The issues of fairness and respect for students came up
in my conversations with students in all schools. Repeatedly,
children stated that they want to be treated fairly, but most of
all, they want to be treated with respect. Effective teachers treat
students "with kindness, fairness and equalness" (11:9:22).
Sometimes a teacher makes expectations for respect clear to
students by telling them how they can show respect to her and
to each other. Students and teaclhers show respect for eachi
other by talking politely to each other and doing nice things for
each other. The collective feelings of the participants were
sumnmed up representatively by a student from SCS who said,

"..treat me fairly, like I would like to be treated (26:8:31-32)...
treat me like they would want me to treat them... with respect
(26:11:7).
When asked why it was important for teachers to treat students
with respect, the children explained that mutual
respect results in student loyalty, and builds self-confidence.
Three participants each explained that respect of students brings
about feelings of well-being, and develops interest and
motivation to learn. Students showed that they understood that
teacher
treatment of students affected their leaming, and learning was at
the heart of the education process. This led to the next themne
that runs through these students' responses.
"Effective teachers help us learn"
Again and again, students framed their answers to questions on
a variety of topics with their definitions of effective
teachers. T hey are the ones who help students learn. The skills,
Icnowledge and dispositions students identified earlier are
what enable teachers to bring about student learning. According
to these children, helping students learn is the defining
ability of effective teachers.
As mrentioned earlier, teachers know and use a variety of
techniques to make learning interesting and fun, rather thall
boring. Respondents emphasized that children are interested in
learning when they have fun. The importance olf making
school fun was underscored in the comment of a student from
SE'S when he said, "Fun things... make up a good teacher"
(15:2:14),
55

Also essential to student learning, as reported by seven of the
participants, is effective teachers' ability to explain
information clearly and their willingness to work with students
until they all understand. In fact, students at SCS, particularly,
placed the ability of teachers to explain information, concepts,
and expectations for work and behavior at the core of their
definition of effective teachers. "She's just very clear in her
words. She can explain everything very well verbally (22:8:10)
"...And she comes to us and she helps us a lot" (22:8:21).
Insightfully, students across schools focus on what it is that
helps
them learn. They realize that when they learn, they feel
successful and confident, and that they are able to do their
work.
Over the years, however, not all of their teachers have treated
them well or helped them learn. Participant students
wanted to discuss the disparities they have found among their
teachers over time. And so, as they talked, a third theme
emerged from the data.
"We know the difference"
Differences among teachers provided a significant line of
discussion that evolved during our conversations. I'hese
students were able to articulate the distinctions they made
between effective, popular, and ineffective teachers. The

comparisons the children constructed were based on their
definitions of effective teachers. For example, when
summarizing
their ideas about effective teachers, discussions continued to
focus on teachers' helping students learn and their treatment of
students. Effective teachers reach their students, are helpful to
students in groups and individually, and explain work clearly.
They know their students, are nice and kind, and show that they
like them and care about them.
According to these students, popular teachers are also nice and
are fun, but may not be as effective. They let kids
play and don't give a lot of homework, so students may not be
learning. As one student differentiated, "...the popular ones...
children actually like them because of what they do. And a good
teacher is one that children like because they help them
learn" (24:6:38-49). Finally, ineffective teachers do not focus
on student learning or treat students as well as effective and
popular teachers. They often teach everybody at once, are hard
to understand, and sometimes don't know what they're doing.
"Sometimes it is hard for me to understand things that they
taught me cuz they wouldn't really break it down for me"
(6:4:3-
5). "Some even assign work and never correct it. They didn't
really care. They just let us do whatever" (26:5:10). "We had
homework and she never corrected it" (26:5:38). Ineffective

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