Institutional Review Board Application Procedures ...and more!

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Institutional Review Board Application
Procedures ...and more!

• Choya Washington
• Division of Research Affairs
• Graduate Research Affairs
• San Diego State University

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Overview

• What is the IRB?
• Important Historical Events
• What is reviewed by the IRB
• How to submit a protocol to the IRB

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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

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Who is on the Board

• M.D.s
• Faculty members from various colleges
• 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

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Why Does the IRB exist? Important Historical
Events

• Willowbrook Study
• Tuskegee Study
• 1974 National Research Act
• 1979 The Belmont Report

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The Willowbrook Study Mid 1950s Early 1970s

• Vulnerable population Involved infecting
  mentally retarded 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 The nature of the experiments were
  extremely cruel and unjust.

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Tuskegee Study-200-300 Black men w/ syphilis were
enrolled to document the effects of the disease
untreated over time

• This study exemplifies
• Unfair subject selection syphilis can
  potentially affect all human beings not just
  African American men.
• Denial of informed consent subjects were not
  told of their disease or given the option to opt
  out of the study.
• Excessive Risk The risks far exceeded any
  potential benefits. 1943-Penicillin was
  discovered as a treatment, but was withheld from
  the subjects.

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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

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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

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What is Reviewed by the IRB

• Is it research?
• Are human subjects involved?
• Types of review and risk

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What is Reviewed by the IRB

• Research involving human subjects
• Defined by 45 CFR 46.102(d) as
• A systematic investigation designed to develop
  or contribute to generalizable knowledge
• Generalizable knowledge
• publication (article, thesis or dissertation)
• professional presentation

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Are Human Subjects Involved? A few examples

• Reviewed by the IRB
• 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). 
• Aggregate data (e.g., census data, etc)

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Read the Guidebook
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Pass the Tutorial
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Benign Exempt
Minimal Risk Expedited Greater than
Full Committee Minimal Risk
1 gt1 gt6
Risk level Reviewers required
Review level
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Full Committee Review

• Research that involves
• an intervention or manipulation of the subject's
  environment (sometimes but not always-whether
  full committee review is required is dependant on
  risk involved)
• deception
• vulnerable subjects e.g. children, prisoners,
  mentally disabled, pregnant women (sometimes but
  not always-whether full committee review is
  required is dependant on risk involved)
• greater than minimal risk

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Full Committee Example

• Research concerning factors that may lead to
  low school performance in a particular racial
  group
• Includes interviews about students sexual
  practices, illegal behaviors (drug use)

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Full Committee Deadline Dates

• Protocols due 2 weeks prior to meeting.
• Dates are listed on the web site
• Expect notification of review outcome within
  one-week of IRB meeting

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Common Problems in Full Committee Research

• Adequately addressing risks and risk management
  plans for vulnerable subject populations and/or
  asking subjects to complete high-risk tasks.
• 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.

• Undue Influence during recruitment
• Vulnerable populations
• Informed Consent Process

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Expedited Review

• Expedited review includes certain kinds of
  research involving no more than minimal risk
• Deadline dates do not apply
• Minimal risk probability of harm/discomfort in
  research is not greater than that encountered in
  daily life

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Expedited Example

• Using confidential methods like survey, focus
  group, interview to obtain information.
• Interviewing teachers in a focus group at their
  place of employment -Includes questions about
  what their feelings on administration, school
  policies and their peers.

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Exempt Review

• Children in a normal classroom setting
• Adults who complete a non-sensitive survey
• Observation of public behavior
• Non-anonymous data as long as no risk is posed if
  confidentiality is breached
• Food studies of wholesome foods without additives
• Analysis of existing data-may need to ck w/ IRB

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Exempt Prospective Examples

• Anonymous survey of teachers opinions on current
  school policy and improvements needed.
• Non-anonymous, benign study in which parents are
  asked about which produce their children like to
  eat and how often they eat it.

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Prior to Submission

• Access the templates on IRB website
• Submit a vIRB Questionnaire by following these
  steps
• Login to the vIRB through the WebPortal
• Choose Yes to access the Questionnaire then
• You will receive a response within 5-7 days.
• Have your faculty sponsor READ and APPROVE of
  your protocol and supporting documents before
  submitting!!!

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Step 4 Using the virtual IRB (vIRB)

• Access your WebPortal Account
• Click Activate Research Role
• Click Launch IRB
• All notifications are electronic
• You will receive an email when your submission
  is
• received
• reviewed
• approved

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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

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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

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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.

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Common Issues

• Inadequate responses to conditions-comments often
  have several parts ensure you respond to each
  part of the comment
• Inadequate consent forms-Language should be
  understandable
• Non -coercive
• Not just a written form, but an on-going open
  discussion of participants rights and study
  details

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Types of Consent Forms

• Informal Consent (Exempt)
• Formal Informed Consent (Full Committee and
  Expedited)
• Children in research
• Assent forms
• Parental Permission forms
• Save yourself time and stress use SDSU templates!

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Beneficence/ Fair Subject Selection

• 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.
• 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

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Upload Supporting Documents

• Upload all applicable documents
• Letters of Authorization
• Recruitment Materials
• Informed Consent Forms
• Study Instruments
• Grant Narrative (if funded)

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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.

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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!!!

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Good luck!

• IRB Contact Information
• Phone [phone]
• Office Student Services East, 1410
• E-mail irb_at_mail.sdsu.edu

Amy McDaniel amcdanie_at_mail.sdsu.edu
619-594-0758 Brianne Larsen blarsen_at_mail.sdsu.ed
u 619-594-3380
Choya Washington cwashing_at_mail.sdsu.edu 619-594-38
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