IRB Tutorial Common Questions and Errors

IRB Tutorial
Common Questions and Errors
Timing is Essential
Start the IRB process well in advance of your
expected research start date.
The IRB review can take longer than expected depending on the
complexity of your study, level of potential risk to participants
and how thoroughly you have completed the IRB protocol form,
including required attachments.(Read Carefully)
IRB Training
Prior to submitting the IRB protocol, be sure you have
completed the IRB training.
 Protocols cannot be approved without completion of the IRB training. See
the IRB website for more info:
http://stcloudstate.edu/irb/training/default.asp
 IRB Training for SCSU Faculty and Staff
 IRB Training for Graduate Students
 IRB Training for Undergrad Students
 Undergraduate students are strongly encouraged to take the IRB training at
the graduate student level if considering graduate school, as training is
typically valid for five years. Print the completion certificate for your file.
Types of Research and Review Timeline
Review Level
Risk Level
Review Timeframe
Exempt Review
Minimal Risk
2-3 Weeks
1 IRB Reviewer
Expedited Review
Minimal Risk
3-4 Weeks
1-2 IRB Reviewers
Full Board Review
More than Minimal Risk
4+ Weeks
Reviewed at IRB meeting
Minimal Risk means the harm or discomfort anticipated in the research is no greater than
that encountered in daily life or during routine physical/psychological exams or tests.
Exempt Review-Minimal Risk
Examples which could fall under exempt review research are:
 Educational tests (cognitive, diagnostic, aptitude, and achievement)
 Anonymous surveys
 Interviews which are not recorded (audio, video, etc.); no direct quotes
 Observation of public behavior
 Existing data (secondary data)
 Research and demonstration projects conducted by or subject to the
approval of department or agency
 Taste and food quality
 No recruitment from a specific vulnerable population
 No precautions needed to minimize or prevent potential risk
Vulnerable Populations
Children (under age 18)
 Prisoners
 Pregnant women
 Economically/Educationally disadvantaged individuals
 Elderly individuals (over age 65)
 Non-English speaking

 Attach translated consent and data collection instruments

Cognitively impaired individuals
Precautions Needed to Prevent Harm?
Precautions needed if your research involves:
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Physical pain, discomfort or injury from procedures or drugs?
Undesired and/or unexpected psychological changes (e.g. depression,
anxiety, emotional discomfort, confusion, hallucination, stress, guilt,
embarrassment, loss of self-esteem)
Invasion of privacy/absence of informed consent (e.g. covert observation,
review of private medical or educational records)
Sensitive information (e.g. alcohol/drug use, sexual orientation, illegal
activities, suicidal thoughts, physical/mental illness, violence, depression,
psychological/physical abuse, gang related activities, pro-life/pro-choice,
relationship issues)
Deceptive techniques (e.g. giving false feedback about performance, staging
an event or situation, concealing the purpose of the research). A debriefing
statement is required.
Expedited Review-Minimal Risk
Examples which could fall under expedited review research are:
 Involves a vulnerable population
 Precautions are needed to prevent potential harm to participants
 Non-invasive voice, video, digital or image recording of data from
participants
 Research on individual/group characteristics
 Minimal blood draws
 Moderate exercise
 Collection of data through non-invasive procedures
 Collection of biological specimens
Full Board Review
Full board review is used when:
 Project involves greater than minimal risk to participants
 An IRB member has requested full board review of the protocol
 Risk where the identification of participants or their responses could place them
at risk for criminal or civil liability or damaging to their financial standing
 Classified research involving living individuals
Full board review requires:
 A quorum of voting members present at the meeting, excluding members who
are directly or indirectly involved with the research
 Approval obtained through a majority vote of members constituting a quorum
Most Common Errors
REVIEW CAREFULLY AS ERRORS SLOW DOWN THE REVIEW PROCESS
Project Title
Project Summary

3-5 sentences describing your study to be shared with IRB members
Data Collection (start and end dates)

Proposed start date to allow sufficient time for IRB review (allow a minimum of 2
weeks; takes longer if there are review questions)
Researcher and advisor/course instructor, if applicable, must sign under the
Certification Statement
IRB Training completed at the appropriate level (undergraduate, graduate,
faculty/staff). Website link: http://www.stcloudstate.edu/irb/training/default.asp./
Most Common Errors – Cont’d
EXPLAIN THE WHO, WHAT, WHEN, WHERE AND WHY OF YOUR PROJECT
Project Description
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Explain completely. Do NOT attach thesis or proposal paper.
Q1 – Subject Population
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Provide range (min. – max.) for number of participants
Explain who the participants will be (age, demographics)
Q3 – Vulnerable Populations
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Are you targeting any of these particular groups? If so, provide rationale and
include specifics on how you are going to protect the participants
 Non-English speakers would require a translator to ensure accurate communication
 Children under age 18 would require a parent/guardian consent form
Most Common Errors – Cont’d
Q4-6 – Participant Recruitment (colleges classes, membership directories, etc.)
 Q4 Explain participant identified and recruitment in detail
 Q5 Attach recruitment materials
 Q6 Explain who is providing you access; include documentation of cooperation
 If recruiting at SCSU, attach email permission from course instructor
 If recruiting through an agency/institution, need a letter from them outlining their
knowledge of your project and what they are agreeing to provide to you
Q7 – Compensation for Participation to Avoid Coercion
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Compensation must be reasonable in relation to participant time commitment
Classroom research offering extra credit to participants must have other extra
credit opportunities available to students
Most Common Errors – Cont’d
Q8 – Research Methods and Procedures
 Explain completely. Do NOT attach thesis or proposal paper. Your project cannot be reviewed if the
reviewer does not understand your project or how it will be facilitated.
 Attach ALL survey/interview questions, demographic information questions or other data
collection instruments
Q9 – Data Collected, Recorded and Securely Stored
 What process and/or programs are you using to collect your data?
 Who will have access to the raw data collected?
 If data is being recorded (audio, video), how are you securely storing the data and when will it
be destroyed?
 How are you securely storing data collected? (password protected computer or file space, locked
file cabinet and its location, encrypted file space or storage device)
 Note: unprotected devices are not allowed
Protecting participant identity is an essential component of ethical research.
Therefore, the storage of this information is critical.
Most Common Errors – Cont’d
Q10 – Data with Participant Identifiers and the Coding Process
 Explain in detail the process of how identifiable data will be coded
 Include who will have access to the coded data and its secure storage
 Typically recordings as destroyed soon after viewing or transcribing
Q11 – Timeline when Raw Data and/or Coding Key will be Destroyed
 Generally destroyed when study is completed, degree is awarded or within three
years. Need sufficient justification to retain beyond these timeframes.
Conversion of identifiable data into aggregate or unidentifiable forms for
both quantitative and qualitative research is important.
Most Common Errors – Cont’d
Q13 – Potential Risks in Research (think about potential risks of your study)
 Physical pain, discomfort or injury
 Undesired and/or unexpected psychological
 Invasion of privacy/absence of informed
 Sensitive information
 Deceptive techniques
Q14 - How can risk be minimized or prevented?
 Refer participants to counseling services
 Outline safe practices to protect participants
What is the benefit of the research?
 Benefits must always outweigh risks
 State how the research contributes to the greater good of society
Anonymous vs. Confidential
Anonymous

You are not collecting any demographic information or responses from
participants which could lead to their identification. Implied consent form
may be used.
Confidential
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
You are collecting identifiable information from participants and agree
not reveal identity to others. Informed consent form must be used.
To prevent identification of participants, data collected will be presented
in aggregate form with no more than 1-2 descriptors presented together.
 Means demographic data would be combined together (aggregate) and only 1-2
demographic descriptors could be presented together (e.g. age, gender, occupation,
race – limited to reporting your results only using 2 of these descriptors)
Q15 - Consent Form Basics

Present information to enable individuals to be knowledgeable about the project and to
voluntarily decide whether or not to participate
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Use implied consent for anonymous data collection of exempt review categories
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Use informed consent for anonymous/confidential data collection of expedited or full
board review categories
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Respond to participant questions or concerns timely and communicate any new findings
which may affect their willingness to continue participating
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If you plan to use direct quotes from participants, ask for their permission in the consent
form and let them know not to say anything they would feel uncomfortable sharing with
others in the final report of the study (IRB does not recommend use of direct quotes)

Written in plain language so participants can understand – avoid technical jargon – nonvulnerable adult populations, write at 8th – 10th grade level
 MS Word – File – Options – Proofing -  Show Readability Statistics
 Then spell check document and when done, review the Flesch-Kincaid Grade Level
Implied Consent
When using an anonymous survey/questionnaire to collect data, you must provide
participants with a consent form which explains the following:
 Purpose of the research, procedures and expected duration of the participation
 Identify risks and benefits
 To be anonymous, results cannot identify participants
 Depending upon demographic information collected, may need to present in
aggregate form with no more than 1-2 descriptors presented together
 Need strong justification for use of identifiers in research results
 Contact information for questions about the research
 Researcher and faculty advisor email address and phone number
 Researcher contact information for study results and when the report is available
 Implied consent - taking the survey indicates your voluntary consent to participate
 Participation is voluntary, refusing to participate or discontinuing participation will
involve no penalty or loss of benefits to which the participant is otherwise entitled
 Confirm participants are 18 years of age or older (Unless parental/guardian consent)
Informed Consent
When collecting confidential data via focus groups, interviews or recorded events or subjects
are minors or from a vulnerable population, you must provide participants with a consent form
explaining:
 Purpose of the research, procedures and expected duration of the participation
 Identify risks and benefits
 To be confidential, results cannot identify participants and you must explain how confidentiality
will be maintained
 Depending upon demographic information collected, may need to present in aggregate form
with no more than 1-2 descriptors presented together
 Need strong justification for use of identifiers in research results
 If recording data, explain why recording is needed, how it will be used and when it will be
destroyed
 Contact information for questions about the research
 Researcher and faculty advisor email address and phone number
 Researcher contact information for study results and when the report is available
 Informed consent – must sign consent form in order to participate
 Participation is voluntary, refusing to participate or discontinuing participation will involve no
penalty or loss of benefits to which the participant is otherwise entitled
 Confirm participants are 18 years of age or older (Unless obtaining parental/guardian consent)
Parental/Guardian Informed Consent
When research involves individuals under age 18 or without capacity to consent for
themselves:

SCSU student under age18 with capacity to consent, can add parental/guardian
signature line on informed consent form
 Not SCSU student under age 18 with capacity to consent, must create separate child
assent and parental/guardian consent forms
 Participant without capacity to consent, must create parental/guardian consent form
Informed consent from one parent/ guardian is sufficient for research that involves
minimal risk or may directly benefit the child/minor
and
Signed assent form from children/minors who are capable of deciding whether or not to
participate

Assent form to be written in the grade level appropriate for the child(ren)
Language
 The language you use in your recruitment material, IRB protocol and
consent form(s) should be age appropriate and easy to understand.
 The use of technical or scientific language, specific to an area of study, can
often times be to complicated. When drafting the protocol or consent forms,
be sure they are written in such a way that anyone could understand. For
example, adult consent forms should be written at an 8-10th grade level.
 This also applies to any consent form translated into a language other than
English. The translated version must be submitted along with the English
version of the consent form with the IRB protocol.

To check for grade level of language used:
 MS Word – File – Options – Proofing -  Show Readability Statistics
 Then spell check document and when done, review the Flesch-Kincaid Grade Level
Incomplete Submissions
The #1 reason IRB requests are delayed is due to INCOMPLETENESS of the IRB protocol. Before
submitting your research proposal to the Office of Research and Sponsored Programs at SCSU,
please make sure to complete the following steps.
 Complete IRB training prior to submission

http://www.stcloudstate.edu/irb/training/default.asp
 View IRB Tutorial of Common Questions and Errors

http://www.stcloudstate.edu/irb/application/default.asp
 Complete current version of IRB protocol

http://www.stcloudstate.edu/irb/application/default.asp
 Include recruitment materials – Question 5
 Include documentation of cooperation – Question 6
 Include data collection instruments (surveys, interview questions, demographic questions,
handouts, etc.) – Question 8
 Include consent forms – Question 15
 If using deception, include a debriefing statement for participants
Please read each section and try not to overthink the process
Responding to your IRB Office
 Respond promptly and professionally to all correspondence from the
IRB office. If the researcher does not address IRB requests, the IRB
review process is at a standstill.
 The IRB members and individual reviewers are sensitive to the
proposed project and timeline. However, their primary concern is to
protect the participants in the research, not approve your study so you
can start on time. Submit the IRB protocol early.
 Once approved, the IRB approval letter is sent to the researcher, the
advisor/course instructor and SCSU co-PIs/other investigators listed.
Tap Into Your Resources
 Seek advice from your mentor or advisor
 Talk to other students who have submitted an IRB protocol
 Have an unusual situation? Before you submit the IRB
protocol, call or email the IRB office to set up an appointment
to address questions or concerns about your project
 Attend an IRB training sessions prior to submitting your IRB
protocol
 Get help with literature review searches from a librarian,
advisor or other professional in your field
 Email the IRB staff with questions: [email protected], call
320-308-3290 or stop by Miller Center Room 204K
2/29/16