Long Island University

Institutional Review
Board:
AN OVERVIEW
Objectives

 Identify the purpose of the IRB and define important terms

 Understand the 3 principles of the Belmont Report
 Respect for Persons
 Justice
 Beneficence
 Explain 3 types of IRB review
 Describe required human subjects training
 Provide quick tour of IRBManager
Purpose of the IRB

 Protect human subjects during research

 Definitions
 Research: Research means a systematic investigation designed to
develop or contribute to generalizable knowledge.

 Human subject means a living individual about whom an

investigator conducting research:
I. Obtains data information or biospecimens through intervention
or interaction with the individual, and uses, studies, or analyzes
the information or biospecimens; or
II. Obtains, uses, studies, analyzes, or generates identifiable
private information or identifiable biospecimens.

 Human Subjects Determination Form

Belmont Report
 Created the basic ethical principles underlying the acceptable
conduct of research involving human subjects

 3 Principles
 Respect for Persons
 Beneficence
 Justice

More info:
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
Respect for Persons
 Recognizes the personal dignity and autonomy of
individuals
 Provides special protection of those persons with
diminished autonomy
 Informed Consent requires that:
 Participants are provided with sufficient information about the
research
 Participants understand the research and study requirements
 Participation is voluntary
Elements of Consent

Ifyou are being asked to be in a

study, what would you want to
know?
Justice
 Requires that research is designed to
share the benefits and burdens of research
fairly
 Fairor “just” selection of research
subjects
 One group in society should not bear the
costs of research while another group
reaps its benefits.
 History of racial injustice in relation to
research (e.g., Tuskegee syphilis study)
Beneficence
An obligation to protect persons from harm by
maximizing anticipated benefits and minimizing
possible risks of harm

 Whatare some examples of individual benefits

and harms?
 Whatare examples of societal benefits and
harms?
Categories of harm in SBE
research

 Invasion of privacy
 Breach of confidentiality
 Study procedures
Determination of Risk

 RISK: The probability of harm or injury (physical,

psychological, social, or economic) occurring as a
result of participation in a research study.

 MINIMAL RISK:
 harm or discomfort ≤ experience in daily life
Institutional Review Board

 Comprised of professors from LIU and

outside members
 Reviews and discusses human subject
research proposals
 Ensures the rights of human subjects in
research are protected according to the
three principles of the Belmont Report
Types of IRB Review

 Exempt (very little risk)

 Expedited (no more than minimal risk)

 Full Board (more than minimal risk)

Exempt Projects
 Research activities that involve least amount of risk
to human subjects AND

 Fall into specific categories* (46.104.d):

1. Educational research
2. Tests, surveys, interviews, or observations (no kids!)
3. Benign behavioral interventions
4. Secondary research

 Reviewed by the IRB Administrator

*Certain criteria must also be met
Expedited Projects
 Non-exempt, minimal risk research activities
that fit into certain categories
 Collection of a blood sample under certain conditions
 A survey of children
 Exercise studies
 Review is completed by 1-2 IRB members
 Nothing to be afraid of!
 Full Board Projects
 Involve more than minimal risk

 Involve protected subjects (e.g., children, prisoners,

individuals with intellectual disabilities)

 Involve procedures that are personally intrusive, stressful,

or potentially traumatic

 Are reviewed by the IRB at a monthly scheduled meeting

What type of review? (exempt,
expedited or full board)

Study on the effect of listening to

classical music on math test results
What type of review? (exempt,
expedited or full board)

Study of drug use among ER nurses.

What type of review? (exempt,
expedited or full board)

Interview with high school juniors

about future college plans.
Human Subjects Training

 HS training must be complete before a study can be

approved

 Collaborative Institutional Training Initiative (CITI):

citiprogram.org
1. Human subjects training (Social/behavioral OR biomedical)
2. Responsible conduct of research training
Logging into CITI

 Go to https://www.citiprogram.org/
Affiliating with LIU

 If you already have an affiliation with another institution,

you will need to add LIU:

 Then search for LIU:

Adding a Course

 Click “View Courses”:

 Then click “Add a Course”
 For Question 1 (Human Subjects Training) Choose 1 based on
your discipline and/or research design:
RCR Training

 For Question 2 choose “All Learner Groups”

 Scroll down to the bottom and click Submit:

How to submit any type of
application
 IRBManager is our online submission system:
https://liu.my.irbmanager.com
 Instructional
guides are
in IRBManager:
IRBManager
 One Application regardless of review type
 Self-select review type, with final determination made by IRB Administrator
 Automatic Routing
 Once submitted, will automatically be forwarded to next stage/person
 Other Advantages
 Always know where your application is in the review process
 Stores all application documents
 Syncs to CITI, so training information will be in system
 Automatic reminders
Timeline for Approval
 Applications are initially reviewed by IRB Administrator
 Identify any missing components
 Request clarifications to facilitate approval
 Exempt Applications
 Are reviewed by IRB Administrator
 Decision in ~2 weeks
 Expedited
 Are reviewed by 1-2 IRB members
 Decision in ~3 weeks
 Full Board
 Reviewed by all IRB members
 Decision timeline dependent on Board review, meetings once a month
The ideal application…

 Iswritten for a lay audience (most IRB members

are not from your discipline)

 Has been edited in its entirety for grammar,

typos, formatting issues, etc.

 Includes all necessary attachments

The Review Process

 In general, the better your application, the faster

it will get approved—invest time BEFORE you
submit!

 Feedback will depend on review type—

expedited and full board reviews will likely
receive more feedback
 I’m approved! Now what?

 An amendment must be submitted for any changes to

your study and it must be approved prior to
implementation
 Exempt and expedited studies require an annual “check-
in”
 Fullboard studies require a continuing review that must
be approved prior to study expiration date
Common Challenges

 The application is poorly written.

 There is not enough information to determine what it is the researcher is
doing.
 The consent forms are not adequate or fail to include necessary information.
 There are missing information and/or documents:
 Required CITI human subjects training
 Letters from collaborators
 Measurement tools
 Recruitment materials
IRBManager
https://liu.my.irbmanager.com/
Dashboard (or homepage)
Human Subjects Research
Determination Form
Starting a new application
xForm
Starting a new application
xForm, cont.
Initial application
Make sure to click submit!
Objectives

 Identify the purpose of the IRB and define important terms

 Understand the 3 principles of the Belmont Report
 Respect for Persons
 Justice
 Beneficence
 Explain 3 types of IRB review
 Describe required human subjects training
 Provide quick tour of IRBManager
If you have questions…..

 ContactDr. Lacey Sischo, IRB

Administrator:

Email: Lacey.Sischo@liu.edu
Phone: 516-299-3591
Office: 211 Bush Brown Hall