PSYC 510 CITI Training Overview and Guided Notes 1
Social and Behavioral Researchers Basic CITI Course
When conducting research, the researcher is responsible for ensuring the welfare of the subjects.
Through the years, institutional, federal, and even international measures have been put into place to
protect subjects from harm, and these regulations are constantly evolving. It is essential for
researchers to keep up-to-date on the major concepts, laws, and regulations governing research.
To expand the concepts covered in your e-book in regards to ethical human research, you must also
successfully complete the CITI Ethics Program titled “Social & Behavioral Researchers Basic
Course”. To do so, you will need to complete all required modules and several elective modules,
earning a minimum of 80% to pass the course and receive your certificate.
To enroll and complete the CITI training follow these directions:
1. Go to www.citiprogram.org.
2. If you have not previously created an account, select Register. This will take you to the registration
page.
a. Do not select ; this option is for individuals who already have a CITI account.Log in
b. If you have previously created an account, even if it was while you were associated with
another institution, use your existing username and password.
3. Affiliate with “ .” Check the box to agree to Liberty University Note: Do not enter “Liberty IRB.”
Terms of Service, and then check the box to affirm you are an affiliate of Liberty University.
4. Enter your name and email address.
5. Create a username, password, and establish a security question.
6. Select your country of residence.
7. Select whether or not you would like to receive continuing education credits. Note: This costs
money that you would be responsible for paying – receiving CECs is NOT required for this course.
8. Select whether or not CITI may contact you later regarding research surveys and/or marketing
information.
9. Respond to the University-specific information as required (LU Email Address, Highest Degree,
Department, and Role in Research).
10.Answer the following questions, making sure you select the appropriate course under QUESTION
1:
a. QUESTION 1: HUMAN SUBJECTS RESEARCH (HSR)
i. Select - Social & Behavioral Researchers
b. QUESTION 2: ANIMAL CARE AND USE (ACU)
i. Skip this question!
c. QUESTION 3: BIOSAFETY/BIOSECURITY
i. Select “Not at this time”!
d. QUESTION 4: RESPONSIBLE CONDUCT OF RESEARCH
i. Select “Not at this time.”
e. QUESTION 5: CONFLICT OF INTEREST
i. Select “No”.
f. QUESTION 6: RESEARCH ADMINISTRATION
i. Select “No”.
g. QUESTION 7: STATISTICAL ANALYSIS
i. Select “Not at this time”!
11.Click “Complete Registration”.
12.Check your email, and click the confirmation link to verify your CITI registration.
13.Return to the login page and enter your username and password.
PSYC 510 CITI Training Overview and Guided Notes 2
14.Begin your coursework.
Once you begin, make sure to take the following elective modules by clicking on the title of each
within the CITI webpage (Choose any of the others that are most relevant to your personal career
trajectory – you can take them all, but the following are required, and you must complete enough to
earn your CITI certificate). Required “elective” modules:
Research with Children
Research in Public Elementary and Secondary Schools
Internet-based Research
Students in Research
Once you successfully complete the course, make sure you View/Print your “Completion Certificate”.
You can then SAVE your certificate. You will include it in your homework for Week 1 and may need it
in the future (e.g., thesis / dissertation / other research methods courses). This certificate is valid for
three years and you will be able to access it as long as you remember your log-in and password.
(Note: If you already have a valid (unexpired) certificate, you can use it in this class.)
The certificate will be inserted into your homework post as a portion of your grade. Here is mine as an
example (note mine has “refresher” course yours won’t have listed). To insert it into your homework,
you can take a screenshot of it, use the snipping tool, or save it and then insert it within word.
As the training is rather lengthy and there is a lot of information provided, here is an outline of major
objectives you should focus on for each of the required modules (including the required “elective”
modules). The material from this outline may be used in course assessments (e.g., homework,
discussion boards, and exams) beginning with Week 1. Please complete this form as you take the
CITI course so that you have the necessary information that will be emphasized in this course. The
title of each module is presented, along with guided notes to take for each module. Note all of the
information is important as a researcher, but the information covered in the guided notes will
be used in graded activities (e.g., homework, quizzes) for PSYC 510/515. You must complete
PSYC 510 CITI Training Overview and Guided Notes 3
enough modules, however, to earn the certificate. The certificate is a large portion of the grade
for your first assignment.
Module: Belmont Report and Its Principles
Identify the three principles and apply them to research.
oRespect for persons
The requirement to acknowledge autonomy
“…” to protect those with diminished autonomy
Autonomy = capacity for self-determination or the ability to be empowered to make
decisions concerning their own actions or well-being
oApplication: Informed Consent
Elements of Informed Consent
Information
oDisclosing information needed to make an informed decison
oOne problem is when all of the information may effect the results of the
study
oTell subjects that all aspects of the study may not be revealed; this is
justified when
Incomplete disclosure is necessary to accomplish goals of
research
There are no undisclosed risks
There is an adequate plan for debriefing subjects
oKey information must appear first
Comprehension: facilitating the understanding of what has been disclosed
o8th grade reading level or lower
Voluntariness: promotin voluntariness of the decision
oResearch particpants must feel they are able to choose to volunteer in
research and or end or decline participation in research
oBeneficence
Do not harm
Maximize benefits and minimize harm
Most common risk of harm is psychological harm due to the risk of PII
oApplication: Assessment of Risk and Benefits
The nature and scope of risks and benefits
The systemic assessment of risks and benefits
Considerations:
oBrutal or inhumane treatment
oReduced risk
oJustification of risk
oAppropriate use of vulnerable populations (when necessary)
oRisk and benefits must be thoroughly explained in informed consent
oJustice
Treating people equally
Ways to treat people equally
Split equally
By need
By effort
Societal contribution
By Merit
PSYC 510 CITI Training Overview and Guided Notes 4
Application: Selection of Subjects
Fair procedures and outcomes in the selection of subjects
Module: Populations in Research Requiring Additional Considerations and/or Protections
Popular vulnerable populations: Pregnant, prisoners, minorities, institutionalized, neonates,
fetuses, children, physically disabled, socially disadvantaged, mentally disabled, sick, economically
disadavantaged
-Four common types of abuses in human research:
oPhysical Control: physically: forced to participate
oCoercion: threatened to participate
oUndue Influence: misuse of position to participate (ex. Boss)
oManipulation: deliberate design and management of conditions or information to
participate
-NBAC identified six broad areas that may contribute to being able to provide voluntary
informed consent. What are they?
oCognitive or Communicative Vulnerability
Capacity-related (ex. Child or mentally impaired)
Situational cognitive (ex. Person in an emergency or with an acute illness)
Communicative (ex. Language barriers)
oInstitutional Vulnerability
Under the formal authority of another (ex. Prisoners, employees, college
students)
oDeferential Vulnerability
Informal power relationship (ex. Gender or doctor/patient)
oMedical Vulnerability
Subjects have serious health conditions.
oEconomic Vulnerability
Income, housing, healthcare (ex. Giving money to participants)
oSocial Vulnerability
Undervalued social groups
-List the four examples of vulnerable subjects identified in HHS at 45 CFR 46.111.
oChildren, prisoners, individuals with impaired decision-making capacity, economically or
educationally disadvantaged
-When a subject cannot consent for themselves, researchers may obtain consent from
o a LAR, which stands for: Legally Authorized Representative
Module: History and Ethical Principles
-1979 Belmont Report.
-Three principles and definitions (add this information to your notes from the Belmont Report
module):
Module: Defining Research with Human Subjects
-Define research: A systematic investigation including research development, testing and
evaluation designed to develop or contribute to a generalized knowledge
oSystematic investigation: research plan (what and how)
-Define human subject: A living individual about whom an investigator conducting research:
(i) obtains information or biospecimens or (ii) obtains, uses, analyzes, or generates
identifiable private information or biospecimens
PSYC 510 CITI Training Overview and Guided Notes 5
Module: Federal Regulations
-Most recent general compliance date (day, month, year) for the revised Common Rule:
-Portions most relevant to researchers
oWhat research must be reviewed
oWho must review research with human subjects
oWhat questions should be addressed during a review
oWhat kinds of review need to take place during the course of a project
-Some research is eligible to be exempt from IRB review
-If research is not eliglible for exemption then expedieted review or convened review
oExpedieted review is conducted by one or more experienced members
Eligibility:
Pose no more than minimal or no risk to subjects
Consist of research activities for expedited review
oCovened review is conducted by a quorum
-IRB Reviewers
oIndividuals identified by an institution to screen research for exempt status
oOne or more experienced IRB members for expedieted reviews
oConvened Meeting
-IRB is a review committee established to esure that the rights and of human research
subjects are protected
-Must have 5 members (non-affiliate, scientist, non-scientist)
-IRBs can:
oApprove/disapprove research
oRequire modification to secure approval
oConduct continuing reviews
oSuspend/terminate approval
oObserve research process
Module: Assessing Risk
-Risk of Harm Typical Types: social, psychological, economic, and legal – Rarely physical
oCategories:
Invasion of Privacy: personal information is accessed without consent or
personal information is revealed after assuring anonimity
Breach of Confidentiality
Study Procedures
-Assessing Risk
-
oProbability of Harm – likelihood that harm will happen
PSYC 510 CITI Training Overview and Guided Notes 6
oMagnitude of Harm – the severity of harm
oRisk of harm are specific to time, situation, and culture
oSubject population – ex. Adults vs Teenagers
-Minimizing and Managing Risk
oPrimary source of risk is the data
Collect data anonymously.
safeguard data in a various number of ways
Consult IT for securing data
oCertificates of Confidentiality: prohibits the investigator and others from disclosing
PII
Permanent, does not expire
Still able to report abuse
oPrimary risk is consent document
May apply for waiver of consent
Module: Informed Consent
-Which basic principle from the Belmont Report embodies the need for informed consent?
-Define Broad consent: is prospective consent for unspecified future researching using PII
or biospecimens
-Key Information: the concise and focused information that explain why or why not to
participate in a study
o
-Vulnerable: subjects vulnerable to possibility of coercion or undue influence
-Two parts of Informed Consent:
oUnderstand of consent verses of consentprocess documentation
oThe Process
Begins with recruitment and screening and continues throughout the subjects
involvement
oDocumentation: provides a record that consent took place
-NINE items typically included in informed consent:
oStatement that the study involves research, explanation of purpose, duration of
participation, a description of procedures
oDescription of risks
oDescription of benefits – or what the researcher hopes to learn
oDisclosure of alternative treatments
oDescription of the extent of confidentiality of records
oFor research involving more than minimal risk – an explanation of medical treatmens
or compensation if injury occurs
oExplanation on who to contact on research/research subject rights or injury
oExplanation participation is voluntary and can exit research anytime without penalty
oA statement PII or Biospecimens
-Incentives must be described in the consent process
-Recruiment strategies must be approved by an IRB
-Waivers of the elements of consent:
oNo more than minimal risk
Mininmal risk means: the probability and magnitude of harm or discomfort
anticipated in the research are not greater than those ordinarily encountered
PSYC 510 CITI Training Overview and Guided Notes 7
in daily life or during the performance of routine physical or psychological
examinationsor test
oThe research could not be carried out without the requested waiver or alteration
Module: Privacy and Confidentiality
The common rule states that IRBmust determine that there are adequate provisions for protecting
privacy and maintaining confidentiality
-Distinguish privacy from confidentiality
oPrivacy: having control over the extent, timing, and circumstances of sharing oneself
with others
oConfidentiality: Treatment of information that an individual has disclosed in a
relationship of trust and with the expectation that it will not be divulged to others, in
ways that are inconsistent with the understanding of the original disclosure
-Private information: information about behavior obtained in a setting
-Define Privacy and know examples:
-Define Confidentiality:
oDescribed during informed consent process
-Define snowball sampling: participants provide other subjects
-Invasion of privacy can occur by being asked questions. sensitive nature
oExamples: sexual behavior, childhood abuse, use of psychotropic medications, other
personal topics
-State reporting laws – may limit promise of (e.g., suspected child abuse and confidentiality
neglect)
-Can obtain a certificate of confidentiality for sensitive research through (even if research isNIH
not funded through them)
Module: Unanticipated Problems and Reporting Requirements in Social and Behavioral
Research
-Unanticipated problems should be reported to the and when appropriate, IRB Federal
agencies.
-Unanticipated problems are: unexpected, related to participation in the research, research puts
people at a greater risk of harm than recognized
-
Elective Module: Research with Children
Federal definition of “children”: Are persons who have not attained the legal age of consent
Three layers of regulations / policies to protect child research subjects:
Parental is obtained first, then researcher contacts the child for the child to provide permission
assent
Type of assent (as determined by the IRB) should be tailored to the child’s age, and maturity
degree of literacy.
Elective Module: Research in Public Elementary and Secondary Schools
List the TWO additional regulations that govern research in private and public schools IF they receive
federal funds:
PSYC 510 CITI Training Overview and Guided Notes 8
Even if an IRB waived the requirement to secure parental permission in accordance with the
Common Rule, __________________ requires that, in accordance with school system procedures,
parents be notified about the proposed research and be given the opportunity to ask that their
children not take part.
Elective Module: Internet-based Research
Avatars, non-player characters (NPCs) as examples of the difficulties in internet research in
defining what is “living individuals”
One method to determine whether content on a webpage is public or private is to:
As stated in this module, If individually identifiable information available online is public, it may
be compared to collecting information about people from _________________ (which the IRB
is not required to review).
oHowever, individuals may have privacy expectations that are _____________ with the
technology they are using.
oOnline surveys that offer researchers the option to be given data without an
_______________ is an added measure to protect confidentiality and privacy of
respondents
The Common Rule allows IRBs to waive the requirement to document consent, but waiving the
requirement to document consent does not waive the requirement for
________________________.
Elective Module: Students in Research
List the FOUR requirements that are implied by the term “Voluntary consent”:
Who makes up an IRB?
What does an IRB have the authority to do?
The IRB is charged with reviewing all projects involving human subjects for compliance with
__________________________________________________________________
List / define the three levels of review:
Federal definition of research
State categories of studies that are NOT human subjects research, and know examples of each:
Define Informed consent
Differentiate “Consent” from “Assent”
Faculty advisors may be chosen by the student investigator or assigned to the student. Their role
as the advisor is to do what?
