University%20of%20Indianapolis%20Institutional%20Review%20Board

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University of IndianapolisInstitutional Review
Board

• Protecting Study Volunteers in Research

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University of Indianapolis Institutional Review
BoardMembership 2007-2008

• Donna Konradi, IRB Chair
• Cory Clasemann, Human Protections Administrator
• Kristen LaEace (Community IRB Member)
• Jennifer Fogo, Occupational Therapy
• Tracy Marschall, Social Sciences
• Frederick May, Nursing
• Gordon Mendenhall, Teacher Education
• Peter Rundquist, Physical Therapy
• John Somers, Teacher Education
• Jacquie Wall, Psychology

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UIndy IRB Website

• http//irb.uindy.edu

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University of Indianapolis IRB Website

• Announcements
• IRB Committee Members
• IRB Meeting Schedule
• Researcher Training
• Policies and Procedures
• Forms and Documents
• External Links

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Maximize Benefit Minimize RiskIRB Purposes

• Protect the rights and welfare of human subjects
  recruited to participate in research activities
  conducted under the auspices of University of
  Indianapolis.

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IRB Purposes

• Develop and implement institutional policies and
  procedures that reflect the ethical principles of
  the Belmont Report consistent with federal
  regulation.
• Provide the UIndy community with Human Subjects
  Protections education.
• Maintain an accurate system for tracking the
  status of research protocols.

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IRB Purposes

• Conduct prospective reviews of proposed research
  in order to safeguard the rights and welfare of
  participants.
• Conduct continuing reviews of research in
  progress. The timeframe for the continuing
  reviews is determined for each protocol by the
  IRB. The maximum amount of time between reviews
  is 1 year.

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What is the IRB?

• Committee that reviews research proposals that
  involve the use of human participants
• Primary goal is to ensure that human participants
  are protected
• Resource for students and faculty wanting to
  conduct research involving human participants

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Who is the IRB?

• At least 5 members
• Varied professions, both scientific and
  nonscientific
• At least one community member NOT associated with
  institution
• Experience, expertise and diversity to review
  proposals
• Knowledge of the federal regulations pertaining
  to research with human participants

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What Does the IRB DO?

• Approve, disapprove or modify research protocols
• Conduct continuing review of ongoing protocols
• Observe, monitor and audit protocols
• Suspend or terminate approval of protocols
• The IRB CANNOT approve research that is already
  underway or is completed.

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What an IRB is NOT

• Group wanting to develop your research design
• Group wanting to micromanage your project
• Faculty with endless time to give to your project

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Definition Research

• A systematic investigation designed to develop
  or contribute to generalizable knowledge. (45
  CFR 46.102d)
• In other words to develop or contribute to the
  general body of knowledge

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Definition Human Participant

• A living individual about whom an investigator
  obtains data or private, identifiable information
• 45 CFR 46.102f

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Definition Vulnerable Populations

• Women and fetuses
• Prisoners
• Children
• Mentally Disabled
• Economically or Educationally Disadvantaged

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Definition Minimal Risk

• Probability of harm no greater than in daily life
  activities or during routine physical or
  psychological tests

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Exempt or Expedited Review

• No more than minimal risk
• Noninvasive data collection
• Video, voice and image recordings where risk of
  breach of confidentiality is minimal
• Research involving the evaluation of normal
  educational practices

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Exempt or Expedited Review

• The Federal standards describe the minimal review
  procedures required for various types of
  research. The IRB always has the option of
  reviewing any protocol using more vigorous
  procedures.
• Submit 4 copies of protocol to the IRB office
• Reviewed by IRB chair and 1 or more experienced
  reviewers using the reviewer template as a
  blueprint.
• Does NOT mean review is quicker!

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Full Review

• Requires quorum of members to take action
  regarding a protocol at a IRB convened meeting
• Submit 11 copies at least 2 weeks prior to IRB
  meeting
• A primary review team (approximately 3 IRB
  members) is assigned to complete a preliminary
  review and lead the committees discussion. The
  reviewer template is used as the blueprint for
  the review

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Informed Consent

• A processnot just a document
• The researcher has the responsibility of
  documenting that the research participant is
  fully informed and meets all inclusion criteria
  prior to the initiation of research procedures
• Participant and/or legally authorized
  representative (specific elements may vary by
  state)
• Language suitable to participant group
• No exculpatory language

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Informed Consent

• The participant must have sufficient time to
  consider options
• The researcher must design informed consent
  procedures that minimize coercion and undue
  influence/pressure to participate

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Key Elements of Informed Consent

• Statement that activity is research
• Purpose of study
• Duration of study
• Number of participants
• Description of all related procedures

• Estimated time commitment
• Identification of risks
• Identification of benefits
• Alternatives to participation

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Key Elements of Informed Consent

• Description of the extent of confidentiality
• Compensation ( or lack of) for injury
• Whom to contact with questions

• Whom to contact in event of injury
• Right to refuse to participate (voluntary)
• Right to withdraw at any time

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IRB Decisions

• Approve
• Modify (approve pending clarifications and
  revisions)
• Table
• Disapprove (reserved for full review only)

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Principal Investigator (PI) Obligations

• Faculty advisors are ULTIMATELY RESPONSIBLE for
  the research study and are identified as the
  Principal Investigators
• All members of research team must be identified
  by name and must complete on-line training.
  Verification of training is a prerequisite for
  IRB review.
• Submit a project update when new team members are
  added

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Investigator Obligations

• Design ethical research
• Comply with federal regulations
• Obtain approval from IRB before recruiting
  participants
• Implement research only as approved by the IRB.
  Obtain PRIOR approval for protocol modifications
  and updates

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Investigator Obligations

• Obtain and document informed consent/assent.
• If an informed consent document is used, a copy
  of the document must be given to the
  participants. If the document is signed, the
  participants must receive a signed copy.
• Submit progress and revision reports as required.

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Investigator Obligations

• Report unanticipated problems promptly (adverse
  events).
• Notify the IRB when the research is completed.
• Retain records for at least 3 years.

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What is the IRB Looking For?
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I. Introduction, Purpose and Background

• Are the purposes clearly specified?
• Are there adequate preliminary data to justify
  the research?
• Is there appropriate justification for this
  research protocol?
• Are adequate references provided?

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II. Scientific Design

• Is the scientific design adequate to answer the
  research question?
• Are the research objectives likely to be
  achievable within a given time period?
• Is the scientific design described and adequately
  justified?

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III. Inclusion/Exclusion Criteria For Subjects

• Are inclusion and exclusion criteria clearly
  specified and appropriate?
• If women, minorities, or children are included or
  excluded, is this justified?
• Is the choice of subjects appropriate for the
  question being asked?
• Is the principle of distributive justice
  adequately incorporated into the inclusion and
  exclusion criteria?
• Is subject selection equitable?

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IV. Recruitment of Subjects

• Are the methods for recruiting potential subjects
  well defined?
• Are the location and timing of the recruitment
  process acceptable?
• Is the individual performing the recruitment
  appropriate for the process?
• Are all recruitment materials submitted and
  appropriate?
• Are there acceptable methods for screening
  subjects before recruitment?

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V. Research Procedures

• Are the rationale and details for the research
  procedures accurately described and acceptable?
• Is there a clear differentiation between research
  procedures and standard care?
• Are the individuals performing the procedures
  appropriately trained, and is the location of
  performing the procedure acceptable?
• Are there adequate plans to inform subjects about
  specific research results if necessary?

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VI. Devices and Drugs

• Is the significant risk or non-significant risk
  status of the device described and appropriate?
• Are the device or drug safety and efficacy
  sufficient to warrant the type of testing?
• Is the drug dosage and route of administration
  appropriate?

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VII. Data Analysis and Statistical Analysis

• Is the rationale for the proposed number of
  subjects reasonable?
• Are the plans for data and statistical analysis
  defined and justified?
• Are there adequate provisions for monitoring
  data?

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VIII. Potential Risks, Discomforts and Benefits
for Subjects

• Are the risks and benefits adequately identified,
  evaluated, and described?
• Are the potential risks minimized and likelihood
  of benefits maximized?
• Is the risk/benefit ratio acceptable for
  proceeding with the research?

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IX. Research Costs and Compensation for
Participants

• Is the amount or type of compensation or
  reimbursement reasonable?
• Are there adequate provisions to avoid
  out-of-pocket expenses by the research subject,
  or is there sufficient justification to allow
  subjects to pay?
• If children or adolescents are involved, who
  receives the compensation, and is this
  appropriate?

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X. Privacy and Confidentiality

• Are there adequate provisions to protect the
  privacy and ensure the confidentiality of the
  research subject?
• Are there adequate plans to store and code the
  data?
• Is the use of identifiers or links to identifiers
  necessary, and how is this information protected?

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XI. Informed Consent

• Is an informed consent waiver appropriate based
  on the regulations (46.116c, 46.116d, 46.117c)?
  If a waiver is appropriate, specify the criteria
  that have been met.

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XII. Other Issues

• Is there a potential conflict of interest for the
  investigator?
• When should the next review occur?
• If frequent reviews are necessary, how should the
  interval be determined?

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Questions?

• Talk with your faculty member
• Review the University of Indianapolis IRB Website
• Schedule an appointment with an IRB member

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Questions Still Unanswered?

• Contact the IRB Chair