New Coordinator Training

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New Coordinator Training

• Developed and Presented by the Study
  Coordinators' Advisory Committee

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Study Coordinators' Advisory Committee

• Mission Statement
• The Wayne State University (WSU) Study
  Coordinators Advisory Committee (SCAC)
• Provides guidance, networking, and mentoring to
  study coordinators, and
• Acts as liaison to the IRB for the WSU research
  community to discuss areas of concern regarding
  human research.
• The committee is open to all who are interested

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Resources From the WSU IRB

• The Investigator Handbook - comprehensive
  document containing everything you need to know
  to gain Institutional Review Board (IRB)
  approval.
• Join the IRB Research Listserv - form changes,
  training opportunities, policy changes and other
  occasional announcements.
• Tools, links, and resource documents
• All are at IRB website www.irb.wayne.edu

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Key Points

• Acronym
• IRB Institutional Review Board
• View IRB as a helpful collaborator
• No human research activity without IRB approval
• You cannot exempt yourself, all studies must be
  reviewed by IRB.
• Call if you are unsure if the project requires
  IRB review

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Contact Information

• Institutional Review Board (IRB)
• 87 E. Canfield, Second Floor
• Detroit , MI 48201
• [phone]
• www.irb.wayne
• Education Coordinator [phone]
• IRB Operations Manager [phone]
• Link to SCAC information, membership list , SCAC
  Handbook and listserv sign-up at the IRB
  website
• http//irb.wayne.edu/study_coord_adv_comm.php

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Review Process

• Review Boards
• Medical (M1, MP2, MP4, PH1)
• MP2 MP4 - Pediatrics and adults
• M1 adults and VA
• PH1- Phase 1clinical trials
• Social, Behavioral , Education (B3)
• Types of Reviews Exempt, Expedited, Full Board
• No submission deadlines for exempt and expedited
  review
• See IRB website for deadlines for full board
  review

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Review Process

• IRB is the Final step for most protocols.
• Some units of WSU and its affiliates require
  pre-review (VAMC, DMC, KCIs PRMC, Oakwood
  Psychiatry, etc.) before the protocol is
  submitted to the WSU IRB
• Always check with your institution about other
  reviews prior to sending

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IRB Forms

• http//irb.wayne.edu/forms-requirements-categories
  .php
• Essential to have the correct version, always
  download a new copy
• Medical/Behavioral Protocol Summary Form
• For all expedited and full board Studies
• Appendices-Children, Prisoners, Biological
  Specimens, etc.
• Medical Exempt Protocol Summary Form
• Social, Behavioral , Education Exempt Protocol
  Summary Form
• HIPAA Summary Form
• Amendment Submission Form
• Continuation Form-submit 7 weeks before
  expiration.
• Closure Form-Submit when all data collection is
  done and before expiration.
• Repeatedly submitting after expiration is
  considered non-compliance.

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Consent Templates

• Behavioral Template
• Behavioral Assent Template
• Medical Template
• DMC/Tenet Template
• Parental Permission Template
• Parental School Permission Template
• Parental School Information Sheet
• Humanitarian Use Device Template
• Assent Template
• Information Sheet
• Short Form Consents are available in 19 languages
• Available on IRB website

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Other IRB Forms

• Unexpected Problem Form
• Unexpected Problem Follow-up Form
• Single Time Emergency Use of a Test Article
• Coordinating Center Application
• Humanitarian Use Device (HUD) Form
• Administrative Application
• Authorization to Use Another IRB for Protocol
  Approval Agreement
• Authorization to be the IRB of Record for
  Collaborating Entity
• Data Use Agreement
• Additional Key Personnel List
• Expedited and Full Board Amendment Forms
• Continuation Form

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Mandatory CITI Training

• https//www.citiprogram.org/
• Required training must be completed prior to
  submitting a new protocol or adding new personnel
• Renewal at WSU required every 3 years
• Transferable to other institutions that use CITI
  program for mandatory education

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Additional Training

• Offered by the Education Coordinator
• Monthly training scheduled on website
• http//irb.wayne.edu/education.php
• IRB 101, Initial Submissions, Submitting
  Continuations and Amendments, Informed Consent
  Highly Recommended
• Other Presentations
• Unexpected Problem Reporting
• Research Non-Compliance
• Others tailored to your needs

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The Informed Consent Process and Options

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Informed Consent Process

• Must occur before any study procedures are done
• Do not rush
• Present a summary first to give the potential
  participant a basic idea of the study
• Present the full consent, reading to the
  participant if needed
• Allow time for questions
• Go over key points in consent again
• If requested provide an unsigned copy to take
  home for further consideration

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Informed Consent Process

• Must make sure the participant fully understands
  his/her rights and responsibilities
• Each page must be initialed by the participant,
  parent, and/or legally authorized representative
  (LAR)
• Signatures and printed name with dates are
  obtained from the participant or their LAR
• Person obtaining consent signs and dates
• Witness signs if applicable

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Informed Consent Process

• PI or person obtaining consent also signs and
  dates consent
• Assent required for children 7-17
• Refer to IRB Policy on Consent Process
• Provide copies of the signed and dated Informed
  Consent to the participant
• Encourage review of the consent at each visit
• Signature page should always be on last page,
  with IRB approval stamp box

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Informed Consent Process

• Informed consent is an ongoing, interactive
  process, rather than a one-time information
  session
• Any changes related to risk approved by the IRB
  must be re-consented.
• Both parents must sign if pediatric study is high
  risk. (Risk Level 3)

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Documentation

• Must include key points of Informed Consent
  process
• Was obtained before any study procedures occurred
  
• Presented consent
• Time was allowed for questions
• Verbalized understanding
• Other pertinent details (witnesses, LAR, etc.)
• Signed copies given

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Informed Consent Options

• Written Consent
• Parental Permission Form
• Assent
• Oral Consent
• Information Sheet
• Waiver of Consent

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Assent

• Simplified
• Used for children under 18 and cognitively
  impaired adults
• Adult (Parent/LAR)still has to sign full informed
  consent or parental permission form
• Exception Mother under 18 can consent for her
  child, but not for herself-requires parental
  permission
• 7-12 years oral assent 13-17 years signed assent

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Languages

• If planning to enroll non-English speaking
  participants get informed consent document
  translated in to language and IRB approved prior
  to use
• Certified translation or
• Forward and backward translation by two
  independent people
• If unplanned enrollment-use short form on website
  and have translator available for it and
  translating English version of consent

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HIPAA

• Health Insurance Portability and Accountability
  Act of 1996 -Purpose
• To improve portability of and continuity of
  health insurance coverage , combat waste, fraud,
  and abuse in health insurance and health care
  delivery and simplify administration of health
  insurance
• The Office of Civil Rights (DHHS) has oversight
• PHI Protected Health Information private health
  information that is identifiable because it
  contains(name, address, phone, e-mail, MRN, SS,
  Health Insurance , DL, unique ID code, etc.)

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The Privacy Rule and HIPAA

• When medical records, databases, archives,
  tissues, path reports, images etc. are accessed
  for research data collection purposes, HIPAA
  rules apply.
• A HIPAA Summary Form must be completed when this
  is the case.
• If consent is being obtained, an HIPAA
  authorization must also be signed.
• If a waiver of consent is being requested (for
  retrospective chart reviews, for example) a
  waiver of authorization should be requested.

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HIPAA and Research

• PHI that is USED and DISCLOSED must be clearly
  identified on HIPAA Summary Form and HIPAA
  Authorization Form and must match.
• The recipients (entities) to which PHI is
  disclosed must be clearly identified on both
  forms.
• A Disclosure occurs when PHI is sent outside of
  WSU and its affiliate institutions. (to sponsors,
  etc.)
• HIPAA Language from sponsor templates must not be
  included in informed consent form.
• Authorized members of the institutions workforce
  have access to participants records.

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HIPAA and Recruitment into Research

• Someone with a clinical relationship must first
  introduce the study to potential participant,
  prior to research team members approaching
  subject.
• This person does not need to be named as key
  personnel on research.
• Mining research records to identify participants
  to contact (if PHI is documented) must be covered
  by a waiver of authorization(and consent waiver).
• Review of medical records to determine
  feasibility of studying certain population does
  not require waivers prior to accessing record.

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Questions?

• Dont hesitate to call the IRB if you need help
• [phone]
• Consult the Investigator Handbook on the IRB
  website (www.irb.wayne.edu)
• Contact a member of the SCAC
• Link to SCAC information, membership list , SCAC
  Handbook and listserv
• http//irb.wayne.edu/study_coord_adv_comm.php
• Research Subject Advocate- Office of Research
  Compliance - [phone]