The Institutional Review Board An Introduction for SJSU Students and Faculty

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The Institutional Review BoardAn
Introduction for SJSU Students and Faculty

• Prepared by
• The Office of Graduate Studies Research

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What Is the IRB?

• A 10-15 member committee that reviews all
  research conducted by SJSU students, faculty, and
  staff that involves the use of human subjects to
  make sure that the research is being conducted in
  a manner compliant with SJSU and federal policy.
• SJSU Policy
• http//www.sjsu.edu/senate/S08-7.htm
• Federal Guidelines
• http//www.hhs.gov/ohrp/

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When Is IRB Review Needed?Two Criteria

• Is it research?
• A systematic investigation, including research
  development,
• testing and evaluation, designed to contribute to
  generalizable
• knowledge, including the dissemination,
  presentation,
• Publication, or use of research findings beyond
  the
• boundaries of a specific instructional setting.
• Examples Independent student project, masters
  thesis,
• activities intended to lead to publication.

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When Is IRB Review Needed?Two Criteria

• Does the project involve human subjects?
• Yes if
• People are asked to participate physically
  (physical procedures, manipulation of
  environment).
• People are asked to participate through
  interaction (communication, interpersonal
  contact, surveys, interviews, observation).
• Researcher seeks access to data that contains
  identifiable, private information through files,
  databases, or a third party.

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What Is Exemption?

• Research that involves minimal risk to
  participants, AND
• Does not involve a vulnerable population (minors,
  prisoners, institutionalized mentally disabled,
  pregnant women), AND
• Falls into one of the following categories..

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Examples of Exempt Research

• Educational assessment or evaluation of
  educational programs.
• Anonymous surveys or other data collected
  anonymously.
• Existing data information that is not publicly
  available and that contains individually
  identifying information (pathological specimens
  and DNA also fall under this category).

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Exemption Whats Required?

• Exempt status is determined by an IRB
  representative not the researcher.
• In order to confer this status, researcher must
  submit adequate information about the study to
  the IRB coordinator.
• All of the documents outlined in the checklist
  that follows are required except documentation of
  informed consent.
• But, Researcher must still provide participants
  with reasonable information so they may form
  their own decision to participate.

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Exemption Whats the Difference?

• Does not undergo IRB review. Is evaluated by IRB
  coordinator and registered with the IRB.
• Shorter Timeline 1-2 weeks for notification of
  registration.
• Less restrictive requirements (informed consent).
• But
• Protocol must still be well prepared.
• Cannot begin collecting data until you have been
  notified of registration.

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The IRB Protocol

• To ensure compliance IRBs require that
• all researchers submit a standard set of
  documents
• designed to procure all of the essential
  information
• about a particular study prior to initiation of
  the
• research. All of the documents and materials that
• are submitted to the IRB are what constitute the
• IRB protocol.

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The IRB Protocol Required Documents

• Training Verification
• Researcher or sponsoring professor (if applicant
  is
• a student) has completed a mandatory online
• IRB tutorial available at
• http//phrp.nihtraining.com/users/login.php
• Application
• Request to Use Human Subjects Application or
  Request
• for Exemption
• Sponsoring Professor
• If researcher is a student, must include a
  Responsible Faculty
• Member Form

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The IRB Protocol Required Documents

• Protocol Narrative
• In addition to the IRB Application or Request for
• Exemption the researcher should attach
• Abstract
• Statement of Purpose
• A complete description of the methods and
  procedures of the project that adequately
  explains the following

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The IRB Protocol Required Documents

• Protocol Narrative Continued
• Who the subjects are age and type of subjects
• How they will be recruited
• What they will be asked to do, step by step,
  duration
• Anticipated Risks (e.g., physical stress,
  psychological stress)
• Anticipated Benefits (e.g., direct, indirect
  benefits)
• Compensation

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The IRB Protocol Required Documents

• Protocol Narrative Continued
• Materials and/or devices that will be used
• a) How the researcher will recruit and get
  information from participants (attach tests,
  surveys, interview and focus group questions,
  recruitment flyers)
• b) How will the information be recorded by the
  researcher (e.g., written notes, audio/video
  recording, transcription)

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The IRB Protocol Required Documents

• Protocol Narrative Continued
• Mechanisms for maintaining confidentiality
• a) What kind of data will be reported? Will
  identifiers be included? Anonymity vs.
  confidentiality
• b) How will the researcher keep the data thats
  collected safe? Who else will have access to the
  data?

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The IRB Protocol Required Documents

• Protocol Narrative Continued
• Informed Consent Procedures
• Describe how informed consent will be obtained
  from
• participants and how assent will be obtained from
  minors.
• Exemption Requests Consent form or cover letter
  recommended but not required.
• Standard Application Consent form or cover
  letter required, but written consent may be
  waived under certain circumstances if requested.
• Research involving minors Consent form is
  always required written consent must be obtained
  from parents. Assent can be obtained verbally or
  in writing.

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The IRB Protocol Required Documents

• Consent Forms
• The purpose of consent forms is to inform the
  participants of the
• research, to inform participants of their rights
  (e.g., participation is
• voluntary), and to provide them with information
  on who to
• contact if they have any questions. Consent forms
  containing all the
• elements of informed consent should be submitted
  (and
• distributed) on SJSU letterhead. This is a legal
  document that
• protects your participants, yourself, and SJSU.
  Refer to the IRB
• website and follow the sample consent forms
  provided for adults
• or minors.

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Consent Form Elements

• Name of Researcher(s), Title (Student/Faculty)
• Affiliation
• Explain the purpose of research (You have been
  asked to participate in a research study
  investigating).
• Describe procedures, duration, location,
  materials, devices (You will be asked to).
• Describe risks or discomforts. Include provisions
  for addressing risks.
• Describe benefits.
• Describe compensation/incentive, if any.

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Consent Form Elements

• Describe the extent, if any, to which
  confidentiality will be maintained and how,
  including procedures for storing data.
• Provide contact information Questions about
  research (You). Complaints about research (Dept
  Chair). Questions about participant rights (Dr.
  Pamela Stacks, 408-924-2427).
• Provide information about participants rights
  Consent is voluntary. You have the right not to
  answer any questions you do not wish to answer.
  You can withdraw at any time with no negative
  effect on your relationship with SJSU or any
  participating agencies. No services of any kind
  will be lost or jeopardized by choosing not to
  participate.
• Participants receive a copy for their records,
  signed and dated
• by the researcher. Researcher receives signed
  copy if written
• consent was not waived by IRB.

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The IRB Protocol Required Documents

• Data Instruments
• Attach to the application all tests, data
  instruments, and other
• materials to be distributed to participants
  (e.g., surveys,
• questionnaires, interview questions, recruitment
  material).
• Translations
• If applicable, provide translations of both the
  consent forms and all data
• instruments to be distributed to participants AND
  provide a Verification
• of Translation Form signed by someone other than
  yourself who is adept
• in the language (The Verification of Translation
  Form is available on the
• IRB website).
• Resource Department of Foreign Languages.
• Permissions from Participating Institutions
• If applicable, obtain permission from outside
  institutions or agencies that either
• serve as a source of subjects, a source of
  records and information, or on whose
• facilities your project will be conducted.

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The IRB Protocol Required Documents

• Permissions from Participating Institutions
  Continued
• Participating Institutions may include
• Schools, hospitals, government agencies,
  community organizations.
• Other institutions may have their own IRBs if
  so, you must make your project known to them and
  go through the proper channels to get permission.
• Permission from participating institutions must
  be on their
• letterhead and must include the title of the
  study (indicating
• knowledge of it), the inclusive dates for which
  the permission
• is granted, and the title and type written name
  of the
• individual with the authority to grant such
  permission, in
• addition to their signature.

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IRB Procedures and Timelines

• Three types of review
• Exempt (IRB coordinator)
• Expedited (single reviewer)
• Full Review (entire IRB)
• Researcher submits 2 copies of complete IRB
• protocol to the IRB Coordinator. Any subsequent
• documents or revisions that are submitted must
• contain the researchers name and/or protocol
• number (2 copies of each).

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IRB Procedures and Timelines

• Submitted to Graduate Studies
• Pre-screening (1-7 days)
• Revisions if needed (varies)
• Forwarded to IRB Reviewer (7-20 days)

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IRB Procedures and Timelines

• Returned to IRB Coordinator (1-5 days)
• Exempt
• Fully Approved
• Provisionally Approved
• Declined/Need Re-submit
• Request for a Full IRB Review
• Forwarded to Associate Vice President of Graduate
  Studies for final approval (1-5 days)
• Allow at least 1-2 month(s) before data
  collection.

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Additional Information

• Addendums and Extensions
• Once a research protocol has received final IRB
  approval, researchers may submit any changes to
  their project to the IRB coordinator. Approval is
  granted for one year.
• Researchers must apply for an extension to
  continue with data collection beyond the one year
  approval period.
• The Extension Request Form is on the second page
  of the Request to Use Human Subjects in Research
  Cover Sheet.

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Contact Information

• Alena Filip
• IRB/Thesis Coordinator
• Graduate Studies and Research
• [phone]
• Alena.Filip_at_sjsu.edu
• http//www.sjsu.edu/gradstudies

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Your Questions

• And.
• THANK YOU FOR ATENDING
• THE IRB WORKSHOP!