Institutional Review Board

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Institutional Review Board

• POLICIES AND PROCEDURES
• 2008-2009

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Purpose

• To ensure that human subjects are protected while
  participating in UNCW research projects
• To ensure UNCW researchers are meeting all of the
  regulatory requirements while conducting human
  subjects research

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IRB Functions

• Review and approve all research with human
  subjects conducted by UNCW faculty, students, and
  staff
• Monitor approved research
• Investigate reports of policy non-compliance

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Defining Research
A systematic investigation, including
development, testing, and evaluation, intended to
develop or contribute to generalizable knowledge.
(45 CFR 46.102(d))
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Systematic Investigation.
A cohesive approach involving data collection
(quantitative or qualitative) from one or more
individuals and analysis to address a question or
test a hypothesis
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Generalizable Knowledge.
The results or outcomes gained from systematic
investigation that may be published, archived,
presented, or viewed in some way as relevant
beyond the specific participant population
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Defining Human Subjects
A living individual about whom an investigator
conducting research obtains

• data through intervention or interaction with the
  individual
• or identifiable private information.

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Types of Research

• Research with human subjects may include some
  forms of
• program evaluation
• interviews
• surveys and questionnaires
• complex behavioral interventions.

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Exception to Definition of Research

• Undergraduate research need not be submitted to
  the IRB IF
• conducted on campus
• will not be published or presented externally
• (The relevant professor or advisor should review
  such research to ensure its ethical integrity.)

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New This Year

• Newly updated IRB Website!
• Meeting schedule and deadlines
• Forms
• Resources
• Policies and Procedures
• Links to training website
• IRB resources

UNCW Academic Affairs Research Services and
Sponsored Programs - Human Subjects Research
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New This Year, cont.

• Updated IRB Policy
• Posted on IRB website and UNCW policy website.
• Updated Forms
• please use most recent version of all IRB forms.
  Most recent version is posted on IRB website or
  by calling RCO.
• New Submission Requirement
• Researchers must submit new protocol forms at
  least ten (10) days prior to desired start date
  to allow adequate time for review and approval.

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Required IRB Training
CITI Collaborative IRB Training Initiative

• Social-behavioral module
• Biomedical module
• Discipline-specific Responsible Conduct of
  Research course (social-behavioral, humanities,
  biomedical, physical sciences).
• Soon available in Spanish

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Researcher Training Certification

• All those involved with the design and conduct of
  research with human subjects must complete the
  researchers training found on the Training page
  of the IRB website.
• UNCW Academic Affairs Research Services and
  Sponsored Programs - Human Subjects Research
• CITI now sends certificates of completion
  directly to RCO. If training completed on old
  system, hard copy must be submitted unless
  already on file at ORSSP. Call RCO if unsure
  about training status.

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IRB Approval Procedures

• Go to IRB website for most current version of the
  protocol form
• SUGGESTION - - when completed, send e-copy of
  protocol form to RCO before you print hard copy.
  RCO can help you troubleshoot before you finalize
  protocol.
• Hard copy must have PIs signature. If student
  research, also student researchers signature.

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Off-campus Research Procedures

• Day Care Centers - Public Schools - Nursing
  Homes, etc. Researcher needs to obtain site
  letter of support
• Shows research activities are approved
• Signed by site administrator (principal,
  director, etc.)
• Ask to send letter directly to you, so you can
  follow-up if letter is not sent.
• Include with protocol form as supporting
  documentation.

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Consent/Assent Procedures

• Preparing consent and permission/assent forms
• Use the one of the Templates, or
• Informed Consent Checklist
• Both located on the Forms page of the IRB website
  
• For research involving minors
• Parents must give permission, and
• Minors must give assent
• Leave space for minors signature if old enough
  to sign name.

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Exception to Consent Requirement

• Consent may be waived by the IRB IF
• Minimal risk research, and
• Anonymous Data (no name or identifying
  information linked to answers), and
• Straightforward survey/questionnaire (no photos
  or scenarios to react to), and
• A statement like this appears at top of survey
  Your participation in this research is entirely
  voluntary. You may refuse to participate or you
  may stop participating at any time without
  penalty or loss of benefits.

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IRB Protocol Review

• Preliminary review conducted by Lee
• TIP Dont submit forms directly to Candace
  she will just send them to Lee
• Assigns protocol number
• Checks training documentation and other
  requirements
• Sends to Candace
• IRB Chair determines review category
• Exempt from further IRB review,
• Expedited review,
• Full committee review

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Types of Review

• Exempt review
• Virtually no risk to project - totally innocuous
  survey questions and/or activities
• Activities meet a category for exempt research in
  DHHS regulations for human subjects protections
• Annual renewal and closure forms not required
  after project is approved
• Amendment forms still required since a change in
  activities may change exempt status

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Types of Review

• Expedited protocols
• Project involves no more than minimal risk to
  subject - questions might be more personal,
  activities might be more involved than exempt
  projects
• Activities meet a category in DHHS guidance for
  expedited review.
• Requires annual renewal, amendment and closure
  forms following approval

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Types of Review

• Full Review protocols
• Project involves potentially vulnerable
  population, OR
• Subjects are deceived in potentially upsetting
  ways during study, OR
• Activities or questions involve a higher degree
  of risk to subjects

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What Do We Mean by Risk?

• Minimal Risk is defined as
• The probability and magnitude of harm or
  discomfort anticipated in research are not
  greater in and of themselves than those
  ordinarily encountered in daily life or during
  the performance of routine physical or
  psychological examinations or tests.
• Risks include physical, emotional, financial,
  social, or legal risks.

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Types of Review, cont.

• Full Committee Review
• At convened meetings, usually once per month
• See IRB website homepage for full schedule
  and submission deadlines
• PI is usually asked to attend for new projects to
  explain research and answer questions
• Prior to approval
• Questions may be asked
• Changes may be requested
• IRB members vote on approval at meeting based on

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IRB Review Procedures Principles of Review 1

• Respect for persons
• Individuals should be treated as autonomous
  agents (such as providing informed consent)
• Persons with diminished autonomy may need
  additional protections.

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IRB Review Procedures Principles of Review 2

• Beneficence
• Researchers should do all they can to maximize
  possible benefits and minimize possible harm to
  their research subjects.

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IRB Review Procedures Principles of Review 3

• Justice
• Researchers must treat participants fairly and
  equitably
• Including the equitable selection of subjects (in
  terms of who may bear the risks and who may
  receive the benefits of the research)

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IRB Protocol Review

• The IRB may request additional information or
  revisions to the protocol before approval can be
  granted.
• If revisions are requested during a convened
  meeting, the IRB Chair typically finalizes
  approval when all information is received.

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Approval Process

• When protocol is deemed acceptable, the IRB Chair
  signs in approval section (first page of protocol
  form)
• indicates type of review conducted
• indicates expiration date (usually one year from
  approval date)
• Exempt protocols do not expire
• Expedited and Full Review protocols must be
  renewed annually if continuing
• Sends copy of approval and any other approved
  documents (flyers, consent forms) to PI
• Returns original documents to RCO

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Protocol Renewal

• All approved expedited and full review research
  must be renewed annually, prior to the expiration
  date.
• If not renewed, data collection must cease and a
  new protocol must be submitted to the IRB.
• Forms page of the IRB website has renewal forms
• http//www.uncw.edu/orssp/conduct-human-forms.htm
  l

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Changes to Protocol

• All approved research must be conducted exactly
  as detailed in the protocol form.
• Any changes, however minor, must be submitted for
  approval to the IRB.
• This includes Exempt review protocols
• The Protocol Amendment Form can be found on the
  Forms page of the IRB website
• http//www.uncw.edu/orssp/conduct-human-forms
  .html

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Protocol Closure

• When a research project approved by expedited or
  full review ends, the IRB must be notified.
• Use the Protocol Closure Form found on the Forms
  page of the IRB website
• http//www.uncw.edu/orssp/conduct-human-forms.
  html

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Special Considerations

• HIPAA
• If protocol involves use of Protected Health
  Information (PHI) obtained from a covered entity,
  PI must submit supplemental form
• HIPAA Resource Materials are available on the
  Resource Materials page of the IRB Website
• http//www.uncw.edu/orssp/conduct-human-mater
  ials.html
• Prisoners
• If subjects are incarcerated, PI must submit
  supplemental form
• Protocol will receive full committee review

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Special Notifications

• Adverse Events and Problems
• PIs must notify IRB of any injuries or other
  unanticipated problems as soon as possible.
• Use Adverse Events form.
• Conflicts of Interest
• PIs must notify the IRB of any conflict of
  interest (real, potential or the appearance of).
• Conflict of interest section of protocol form.

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What Do We Mean by Conflicts of interest?

• Conflicts of Interest
• There is a conflict of interest when there is a
  matter that might unduly influence a researchers
  judgment in collecting or presenting data,
  identifying subjects or other research function.
• Conflicts of interest can be financial or other
  personal considerations that have the potential
  to or have the appearance of compromising a
  researchers objectivity.
• Any potential conflict must be disclosed so that
  it can be appropriately managed or eliminated.

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Thank You!
IRB Contact Info Leanne Lee Prete, Regulatory
Compliance Officer Office of Research Services
and Sponsored Programs Hoggard Hall, Room
180 910-962-7774, pretel_at_uncw.edu Dr. Candace
Gauthier, IRB Chair Bear Hall, Room 272 962-3558,
gauthierc_at_uncw.edu