Transcript All you need to know and more about... Committee on the

Institutional Review Board
and YOU!
Choya Washington
Division of Research Affairs
Graduate & Research Affairs
San Diego State University
Overview
 What is the IRB?
 Important Historical Events
 The IRB and You
What is the IRB?
 The IRB stands for the Institutional Review Board
 IRBs are composed of individuals with the
expertise and background needed to conduct a
complete and adequate review of the research
planned by an institution
 The IRB reviews all research with human subjects
conducted at SDSU
Who is on the Board
 M.D.s
 Faculty members from various colleges(including
Psychology)
 Community Member
 Non Scientist
 We also invite outside experts to assist with the
review of protocols as necessary
 Advocates for certain classes of participants are
invited to aid in the review of certain types of
research
Why Does the IRB exist?
Important Historical Events
 Willowbrook Study
 Tea Room Study
 1974: National Research Act
 1979: The Belmont Report
The Willowbrook Study:
Mid 1950’s – Early 1970’s
 Vulnerable population: Involved infecting mentally
disabled children with a Hepatitis virus to study the
progression of the disease and to test new vaccinations.
 Undue Influence: The study was extremely coercive as
parents often had a difficult time getting their children
admitted to any mental health care facilities.
 Parents were manipulated by the researchers into allowing
their children to participate and were told that their
children could not enroll at Willowbrook unless they
agreed to participate.
 Risks outweigh Benefits: The nature of the experiments
were extremely cruel and unjust.
Tea Room Study A student was conducting research for his
dissertation.
 Deception-He would pose as a “look out” for
police.
 Privacy-However, he also took notes on the
characteristics of the men and the behaviors they
engaged in.
 He also recorded the license plate numbers of
these men went to their homes and interviewed
them and their families.
1974: National Research Act
 Created the National Commission for the
Protection of Human Subjects of
Biomedical & Behavioral Research
 Required informed consent for all
government sponsored studies
 Established IRBs
1979 Belmont Report
 Belmont Report outlines acceptable ethical practices in
research
 Foundation of current federal regulations
 Three basic tenets of the Belmont Report include:
 Respect:
– Informed Consent
– Voluntary Participation
– Privacy & Confidentiality
 Beneficence:
– Maximize benefits
– Minimize risk-Qualifications of researcher to carry out the study in a safe
and appropriate manner?
 Justice:
– Fair subject selection
– Equitable distribution of risks & benefits
What is Reviewed by the IRB
 What is research involving human subjects
– [Research]
 Defined by 45 CFR 46.102(d) as:
YOU: A systematic investigation designed to
develop or contribute to generalizable
knowledge.. (hypothesis or research question to
answer)_
 Generalizable knowledge:
– YOU: publication (article, thesis or dissertation)
– professional presentation
Are Human Subjects Involved? A
few examples:
 Reviewed by the IRB:
(Helpful question for YOU, are the data to be collected specific to an
individual)
– Studies that use medical records, or case files (this is
individual information about subjects). Studies that will
involve the opinions, feelings, experiences, or
characteristics of individuals
 Not reviewed by the IRB:
– Studies concerning amount of people using a given
resource center (does not involve individual information
about subjects; it is information about individual
facilities). Also, aggregate data (e.g., census data, etc).
Benign
Exempt
1
Minimal Risk
>1
Greater than
Expedited
Full Committee
Minimal Risk
>6
Risk level
Reviewers required
Review level
You-Making a determination
Full Committee:
greater than minimal risk
–deception
–vulnerable subjects-depending on what the research tasks are.
–Tasks/questions being asked
–Deadline Dates apply
 Expedited- research involving no more than minimal risk*
–*Minimal risk = probability of harm/discomfort in research is not greater than that encountered in
daily life (You- explaining your populations and the tasks and why it is min risk)
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
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Deadline dates do not apply
Exempt Examples:
Adults who complete a non-sensitive survey/interview
Observation of public behavior
Non-anonymous data as long as no risk is posed if confidentiality is breached
Analysis of existing data-may need to ck w/ IRB
Examples of Full Committee
Research
Study inside of classrooms asking
students to complete a survey that
asks about incest, dating violence,
sexual assault, dating and sexual
practices to determine the relation
between molestation and/or violence
and dating violence.
•Privacy
•Confidentiality
•Risk Management
Expedited and Exempt
Examples
Expedited
 Adult anonymous
online survey asking
about childhood
experiences
(molestation, etc.)
and dating practices
from late adolescence
into adulthood
Exempt
 Asking school
counselors their
opinions on the needs
(programs, resources
that should be
available) of
teenagers who have
experienced child
molestation.
Subject Selection/ Recruitment
 Subjects should be chosen to participate because
they best represent the population under study
 Recruitment should be done in a neutral fashion;
avoid persuasive language or situations.
– -Things to think about?? Do you know potential
participants outside of this research study (personal
contacts, co –workers, your students, etc.)
Example:
Hello! I am your Language Arts teacher, I am also collecting data for my Masters
thesis at San Diego State University. It would really help me out if you
participate in a group discussion with me and some of your fellow classmates
about what you’re learning in class. THERE WILL BE PIZZA! It will only take
an hour of your time and it will get you out of P.E. Please see me after class and
let me know if I can count you in! Participation is voluntary.
What are some problems with this recruitment script?
You-What are some ways you
may Recruit? (Discussion)
 Who is doing the recruiting?
You- Is it better for me or someone else to recruit?
 Access
You- Do you have access to a person’s information for
research purposes? For example, you may have access to
grades/contact information in your position at a school,
but this does not automatically mean you can use this
information for research purposes without proper
permission.
The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a
Federal law that protects the privacy of student education records
.
Types of Consent Forms:
 Informal Consent (Exempt)
 Formal Informed Consent (Full Committee
and Expedited)
Save yourself time and stress… use SDSU templates!
You- These forms can be modified to fit your population (low literacy,
international, online, etc..)
 Children in research
– Assent forms
– Parental Permission forms
Respect for Persons-Consent
 Not just a written form, but an on-going open discussion of
participant rights and study details.
 Inadequate consent forms-Language should be
understandable to the audience it is written for
 Non -coercive
 Adequate Details so they are clear about whether or not to
participate.
Consent Examples
Purpose
The approach of the research is an
exploratory qualitative discussion that will
allow students the chance to ventilate how
they feel budget cuts have effected their
opportunities to learn.
Revised
The purpose of this study is to research the
effects that California’s recent budget cuts
to education might have had on student’s
opportunities to learn.
Description
You will be asked to
fill out a questionnaire
and be in a focus
group about the field
of psychology and
your attitudes about
the major of
psychology.
Participation will take
about one hour.
Adequate Details- Can participants skip ?’s, Recording-do
they have to agree?, Will there be consequences if they tell
you certain things?
Beneficence
 Maximize benefits
– To the individual, scientific knowledge, the population
from which study participants are drawn
 Minimize risks
– Some risk in research is acceptable, but risks should be
minimized to the greatest extent possible.
– You- Think through your risk management plan. Know
the possible repercussions and how you will protect
subjects whether it is their safety, or from social risks,
or illegal risks that may come from participation.
–
Be Consistent!
Anonymity vs. Confidentiality
– example, the study is anonymous no identifying
information will be collected
– example, the study is confidential, data will be
stored in a locked cabinet, a code will be
created between data and subject information,
this link will be destroyed at the end of the
study. Transportation of data.
Subjects and Research Activities:
Complete and Consistent
Protocol Document
Respond to section directions for EACH subject
group AND research activity. Use subheadings.
E.G.: Subject Involvement Section
Students/Patients: Will take 15 minute online survey
Staff: Will take a 10 minute online survey and will participate in
audiotaped 30-minute interview
Administrators: Will participate in two consecutive audiotaped 60-minute
interviews (for a total of 120 minutes spread over two days)
Supporting Documents
Upload recruitment materials, consent documents and study instruments
for EACH subject group.
Inadequate responses to conditions-comments often
have several parts ensure you respond to each part of
the comment
Common Inconsistency
problem
Response
 #1 This information is in
 Subject Involvement
the consent form.
section and Research
design
 #2 I will also be
Involvement section: Participation in
conducting interviews
this study will last approximately
30-45 minutes for the focus group
session.
Research design section: I will
conduct individual interviews
with current sophomore students
for 45 min
Go to our website for tips
http://www-rohan.sdsu.edu/~gra/grad/research/hrpp.html
 How to use vIRB
 Link to the tutorial
 Link to Guidebook
 Templates
 Faculty Assurance forms-You (Have your faculty
sponsor READ and APPROVE your protocol and supporting
documents before submitting!!!)
Contact Information
 List yourself as the Principal Investigator
(PI)
– Email address
– Phone number
 List your Thesis Chair (Masters) or Faculty
Sponsor (Doctoral) as the Co-I
– Email address
– Office phone number
Upload Supporting Documents
Upload all
applicable
documents:
 Letters of Authorization
 Recruitment Materials
 Informed Consent
Forms
 Study Instruments
 Grant Narrative (if
funded)
Additional IRB Review…
If you have other affiliations…
– Joint Students
– Hospital
– University
– If you will be conducting a study through
another institution, you must receive their IRB
approval before submitting to the SDSU IRB.
Step 5: Protocol Maintenance
 Once you have approval, you are
responsible for submitting requests for
changes to your protocol in the form of a
Modification request.
 Pay attention to expiration dates!!! You
must renew your protocol to continue
research activities before it expires by
submitting a Report of Progress!!!
Good luck!
Amy McDaniel
[email protected]
619-594-0758
Choya Washington
[email protected]
619-594-3822
IRB Contact Information
Phone: (619) 594-6622
Office: Student Services East,
1410
E-mail: [email protected]