Research in the classroom and beyond- A
comprehensive review of IRB policies and procedures
Steven Fletcher and Sara Villanueva
CTE Teaching Symposium August 22nd, 2013
The Purpose of this forum….
• Learn what questions you have (5 min)
• Address common tips for successful IRB
submission (15 min)
• Preview new IRB website and submission
process (15min)
• Answer any questions you have (15 min)
Pre-activity
• Take a moment to jot down any questions or
concerns you have about working with the IRB
on research here at SEU.
• Turn to a colleague and share your thoughts.
• Share out.
St. Edward’s University IRB Members
2013-2014 IRB committee
Leadership.
Chair: Steven Fletcher, Vice-Chair: Sara Villanueva
School reps.
Kelly Green, James Kallman, Henry Altmiller, Joel Bergh, Bob Strong
Stephanie Martinez, Shannan Butler, Elizabeth Katz, Sunny Landsdale
OSP. (ex officio)
Gloria White
Admin. (ex officio)
Sandra Pancheco
Consultant.
David Blair
Institutional Review Board
IRB Review
• The purpose of IRB review is
to maximize research
participant benefit and
minimize risk.
• Using the information in the
protocol submission
documents, the IRB reviewers
weigh the benefits of
participation against researchrelated risks for the
prospective research subjects.
8 tips for success
1.
2.
3.
4.
5.
6.
7.
8.
Complete submission
Clarity in description of proposal
Information consistency
Strong data security measures
Research team member roles and responsibilities are clearly
described.
Well defined research design
Research related activities are clearly described
Submitted documents are “research-ready.”
Does my research require IRB review?
No
Does the study involve human subjects?
Yes
Is there any potential for psychological or physical
harm to those participating in the study?
Yes
No
Is there any chance that confidential
information will be disseminated?
Yes
No
Will participants be coerced or in any way
unable to legally give consent?
Yes
No
Does the study involve any vulnerable populations
such as children, pregnant women, mentally
disabled, institutionalized persons, or prisoners?
Yes
No
Is there any chance that the results will be published
or presented outside of the classroom setting?
Yes
No
NO your research study does not
require IRB review.
YES your research study
requires IRB review.
For complete information on IRB policies and proceedures visit: http://academic.stedwards.edu/irb/reviewprocess
Levels of Review: Exempt
Exempt Research: Although the category is called "exempt," this type of research does
require IRB review and registration.
To qualify, research must fall into six (6) federally-defined exempt categories.
These categories present the lowest amount of risk to potential subjects because,
generally speaking, they involve either collection of anonymous or publicly-available data,
or conduct of the least potentially-harmful research experiments.
Some examples of Exempt research are:
• anonymous surveys or interviews
• passive observation of public behavior without collection of identifiers
• retrospective chart reviews
• analyses of discarded pathological specimens without patient identifiers.
Levels of Review: Expedited
Expedited Research: To qualify for an expedited review, research must fall into nine (9)
federally-defined expedited categories. These categories involve collection of samples
and data in a manner that is not anonymous and that involves no more than minimal risk
to subjects.
• Some examples of expedited research are:
• studies involving collection of hair, saliva or dental plaque samples,
• studies of blood samples from healthy volunteers,
• analyses of voice recordings
• studies of existing pathological specimens with patient identifiers.
Expedited review as defined by federal regulations allows the IRB chairperson or one or
more experienced reviewers designated by the chairperson from among members of the
IRB to evaluate and approve specific types of research. Reviewers conducting an
expedited review may exercise all of the authority of the IRB except that they may not
disapprove a study. When a subcommittee cannot approve the research under expedited
review, the study is referred to the full Committee for review.
Levels of Review: Full Board
Full Committee Review: Proposed human subject research which does not fall into
either the exempt or expedited review categories must be submitted for full
committee review. This is the most rigorous level of review and, accordingly, is
reserved for research projects that present more than minimal risks to subjects.
Navigating through the IRB
website
http://academic.stedwards.edu/irb
#1: The complete submission
•
•
When required information is missing from the initial IRB submission, the
IRB staff will contact the researcher with requests for additional pieces of
information. The IRB will not distribute an incomplete protocol to committee
members for review.
Carefully review your institution’s submission checklist and make sure that
all required elements are included with the protocol submission
a) Description of the informed consent process
b) Letters of informed consent / assent
c) Letters of cooperation / agreement
d) Recruitment materials
e) Verification of Human Subjects’ Protections Training
f) Data collection tools
a) Informed consent /
Assent process elements
WHO will be responsible for obtaining the informed consents?
WHO will answer the prospective participants questions about the
research study?
WHERE will informed consent take place?
WHAT information will be provided to each participant?
HOW will participants receive information about the study?
HOW will the members of the research team verify that participants
understand the essential informed consent elements?
WHEN will the participants provide their informed consent?
b) Informed Consent document elements
Include all of the required elements on the informed
consent document.
Provide the IRB with an exact copy of all consent / assent
documents. After the IRB has approved the protocol, any
& all changes to the letter of informed consent must be
submitted as a project “revision” for approval.
Develop the Informed Consent document on institutional
letterhead.
d) Recruitment Materials
Provide the IRB with exact copies
for all recruitment documents &
scripts (e-mails, phone scripts,
announcement postings, inperson announcement scripts,
etc).
Provide the IRB with detailed
information about your
recruitment procedures and
strategies.
d) Required recruitment elements
1.
2.
3.
4.
5.
6.
7.
Name and address of the researchers and the research
facility
Purpose of the research
Eligibility criteria for participation
Anticipated participant benefits (if any)
Time or other commitments required of the participant
Location of the research
Individual to contact for additional information
Resource Recruiting Study Subjects, United States Food and Drug
Administration (FDA).
e) Ethics training
Provide the IRB with verification
of human subjects
protections training for all
members of the research
team (CITI training).
Resource OHRP Investigator
Responsibility Frequently Asked
Questions, United States
Department of Health and Human
Services (DHHS).
f) Data Collection Tools & Measures
• Provide the IRB with all study-related tools,
measures, surveys, and data recording forms. The
IRB must receive these tools and measures in the
exact form that they will be used in the research and
distributed to the research participants.
• If participants will be accessing a survey or other
measures electronically (ie. from an online survey
hosting service), provide the IRB with a live link to
the online survey.
Tip #2: Clarity of Submission
The protocol should include a clear explanation &/or
description of all research process elements
If the information provided by the researcher is
confusing or unclear, the IRB will contact the
researcher with requests for clarifications.
• Significant and distracting grammar errors that result in
unclear communication
• Spelling errors and lack of precision with “word choice”
• Missing, confusing &/or inaccurate information
• Use of jargon
Tip #4: Protocol Consistency
The description provided for participant research related activities
should be consistent across all protocol documents
–
–
–
–
–
Protocol description of research activities
Informed consent document(s)
Protocol description of informed consent processes
Recruitment materials
Letter of cooperation/agreement
When the information provided in the protocol is contradictory &/or
inconsistent, the IRB is unable to evaluate participant risks and
benefits.
#4: Common Inconsistencies
The amount of time required for study participation is not
the same on all study-related documents. Example:
Identifies in the protocol that the focus groups will meet
for 90 minutes; identified in the letter of consent that the
focus groups will meet for 60 minutes.
The number of individuals needed for research study
participation is not the same on all study documents.
Example: Identifies a projected sample size of 50
participants in the protocol; identifies a projected
sample size of 65 on the letter of informed consent.
#4: Common Inconsistencies
• The words anonymous and confidential are used
interchangeably.
– Anonymous means that there is no link between the participants
and the data they provide.
– Confidential means that there is a link between participants and
the data they provide.
Example: Describes a procedure for coding data that includes
using a key to link individual participants to the information they
provide on a survey document; States on the letter of informed
consent that the method of data collection is anonymous.
#4: Common Inconsistencies
Once involved in the research process, participants are
asked to provide personal information beyond the scope
of what was described during the recruitment process or
during informed consent processes. Example:
Participants are informed that they will be completing a
functional assessment tool for range of motion. After
signing the letter of informed consent, participants are
asked to provide information about their workman’s
compensation status.
Tip #4: Data security
Specific IRB Concerns
• Data security measures are insufficient for the type of data collected.
• Procedures for data storage, retention, and security are not
described.
• Procedures for data storage, retention and security are not
appropriate for the type or format of the data.
• Procedures for data coding (if performed) are not addressed or
insufficiently described.
• Does not include sufficient data security strategies for protecting the
data “key” (the information that matches the participant identifiers to
the coded data).
Tip #5: Research Team Member
Responsibilities & Qualifications
To ensure that participant risks are minimized, investigators
must provide evidence that they are sufficiently qualified
to perform their research-related tasks and
responsibilities.
If information about the researchers’ qualifications &/or
credentials is unclear, the IRB will ask the investigators
to provide this data.
Tip #8: Strong research design
• The relationship between the current study and previous research is
clearly established.
• The links between the research questions (hypotheses statements);
the research design; the specific types of data collected; the data
collection tools or measures, and the data analysis procedures are
clear, consistent, &/or accurate.
• The link between the type of research methodology (grounded
theory, ethnography, focus group, etc.) and specific research
procedures is clearly described.
• Rationale for collecting specific pieces of personal information is
provided.
• Rationale for sample size is provided.
Considerations of Research Design
IRB Guidebook, Chapter 4
• The value of research depends upon the integrity of study results.
For example, one of the ethical justifications for research involving
human subjects is the social value of advancing scientific
understanding and promoting human welfare by improving health
care. But if the research study is so methodologically flawed that
little or no reliable information will result, it is unethical to put
subjects at risk or even to inconvenience them through participation
in such a study.
• One question that every IRB member asks is "To what degree is it
our responsibility to review the underlying science of the proposed
research?" Clearly, if it is not good science, it is not ethical.
Tip # 7: Clear description
of the research activities
Clear and complete information provided about the
research-related activities or interventions helps the
IRB evaluate participant risk.
If the description of the research activities is insufficient
or unclear, the IRB will ask the researcher to provide
additional clarifying information.
Clearly Describe All Research-Related
Activities
Where will the research be conducted?
Which members of the research team are involved in
each procedure?
What will each participant in the research study do?
How long will each research-related activity take?
What are the risks associated with each activity?
What are the specific participant benefits associated
with each activity?
Tip # 8: Research-Ready Documents
• Documents must be research-ready: If post-IRB approval
changes to the letters of informed consent/assent and/or
recruitment materials are needed, a “Request for Revisions”
must be submitted to the IRB for approval before these
documents can be used in the research process.
• Active links to electronic surveys.
• Appropriate documents on letterhead.
• If survey data collection is anonymous or if there is an
intention to code the survey data, remove from the survey
documents requests for the participants’ names and
significant identifying information.
IRB Resources
Much of the information in this presentation was adapted from a 2010
University of Indianapolis IRB forum.
The standards for IRB review are derived from Code of Federal
Regulations Title 45 Public Welfare Part 46 Protection of Human
Subjects (45 CFR 46).
A good resource for information about the IRB review process standards is
the Office for Human Research Protections (OHRP) IRB Guidebook
IRB Guidebook Chapter 3, Basic IRB Review: Includes information about
informed consent, selection of subjects, privacy, & incentives.
IRB Guidebook Chapter 4, Considerations of Research Design
IRB Guidebook Chapter 5, Biomedical and Behavioral Research
A comprehensive source of information about IRB guidelines and
processes: Bankert, E. & Amdur, R. (2005). Institutional Review Board:
Management and Function, Jones & Bartlett.