CUNY Human Subjects Protections Program: Moving Forward

1
CUNY Human Subjects Protections ProgramMoving
Forward

• Patricia MacCubbin, Director
• Office of Research Conduct
• September 8, 2006

2
Who Are These People?
3
Way Back When

• 1997-1999
• OHRP Site Visits
• Restrictions
• Remediation Plan

4
Since Then

• Established Office of Research Conduct
• Strengthened CUNY-Wide IRB
• Increased Training Efforts
• IRB Members and Staff
• PIs and Key Personnel
• Central Office and RF Office
• CITI Requirement

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Whats Next?

• IRBManager
• Revised Policies and Procedures
• Revised IRB Forms
• Revised CUNY RF Websites
• CITI Refresher Modules

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IRBManager
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IRBManager

• May 2006, CUNY/RFCUNY signed a subscription
  agreement with BEC for IRBManager
• IRBManager is web-based
• All IRB members, IRB staff and PIs will have
  access to system, at differing levels

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IRBManager(Continued)

• IRBManager provides the functionality to
• submit IRB protocols electronically
• track protocol status (IRB and PI)
• generate agendas, minutes, correspondence
• review on-line

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IRBManager(Continued)

• Many campus IRBs have been trained and are
  currently using IRBManager at Admin level
• Campuses will be trained throughout the fall
  semester
• Goal all campuses using IRBManager by end of
  year
• Extensive presentation in last panel today by Ari
  Samson

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Policies and Procedures
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Policies and Procedures

• Contracted with HRP Associates, Inc., to revise
  PPs
• PPs will be in compliance with OHRP requirements
  and accreditation standards
• PPs will be CUNY-Wide policies
• All campuses will be following the same policies
• Ready for review by IRB members and staff
• Next step Policy statement from Board of
  Trustees

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What Are We Voting on at Convened Meeting?

• For Against Abstain
• For, Against or Abstain?
• from what???

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What Are We Voting on at Convened Meeting?

• If the protocol is perfect
• Approval
• If the protocol needs revisions
• Revisions to be made
• Additional information needed
• How revisions will be reviewed
• If the protocol cannot be approved
• Disapproval
• If the funding agency needs concept approval
• Approval in Principle

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Why is There New Language?

• All members are clearer about what they are
  voting on
• Clearer designation of how revisions will be
  reviewed
• PI will understand next steps
• OHRP Letters of Determination site visit
  observations

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Board Decisions

• Approval
• Deferred for Nonsubstantive (Directed) Changes
• Deferred for Substantive Issues
• Deferred for Additional Information
• Disapproved
• Approval in Principle 45 CFR 46.118

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Board Decisions(Continued)

• Approval
• The study is approved as submitted.

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Board Decisions(Continued)

• Deferred for Nonsubstantive (Directed) Changes
• The protocol and/or consent form require minor
  revisions, with replacement language provided.
• The needed revisions are agreed upon at the
  meeting.

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Board Decisions(Continued)

• Deferred for Nonsubstantive (Directed) Changes
  (Continued)
• These revisions are presented to the PI for
  incorporation by simple concurrence.
• The IRB Chair, Vice Chair, or a subcommittee of
  the IRB may approve the study upon receipt of the
  revisions without further action by the IRB or at
  convened meeting.

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Board Decisions(Continued)

• Deferred for Substantive Issues
• Substantial modification or clarification
  regarding the protocol and/or consent form is
  required, or materials are missing.
• IRB approval of the proposed research must not
  occur until the modifications submitted by the
  investigator are reviewed and approved at a
  convened IRB meeting.

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Board Decisions(Continued)

• Deferred for Additional Information
• Insufficient information is provided in the
  protocol or consent form to judge the protocol
  application adequately.
• The protocol must be resubmitted with the
  necessary information and reviewed at a convened
  IRB meeting.

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Board Decisions(Continued)

• Disapproved
• Questions are of such significance that the IRB
  feels approval of the study is unwarranted.
• Approval of a previously disapproved protocol
  requires full IRB review.
• Should be rare occurrence.
• PI has right to appeal to CUNY-Wide IRB following
  disapproval.

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Board Decisions(Continued)

• Approval in Principle 45 CFR 46.118
• Study procedures are to be developed during the
  course of the research, but human subjects
  approval is required by the sponsoring agency.
• The involvement of human subjects depends on the
  outcomes of work with animal subjects.

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Board Decisions(Continued)

• Approval in Principle 45 CFR 46.118 (Continued)
• The IRB may then grant approval in principle
  without having reviewed the, as yet, undeveloped
  recruitment, consent, and intervention materials.
  
• If funded, the PI must submit the materials to
  the IRB for approval at least 60 days before
  recruiting human subjects into the study, pilot
  or pre-tests.

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Board Decisions(Continued)

• Approval in Principle 45 CFR 46.118 (Continued)
• Granted to satisfy sponsoring agency requirements
  or to allow investigators to have access to
  funding to begin aspects of the project that do
  not involve human subjects.
• Approval letters must clearly state that approval
  to engage human subjects in the research has not
  yet been granted.

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IRB Forms
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IRB Forms

• Extensive revisions
• Application
• Continuing Review
• New Forms
• Amendment Form
• Separate Protocol Deviation and Adverse Event
  Forms
• Research Determination Form

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IRB Forms(Continued)

• More direct questions to aid PIs in providing
  sufficient information for review
• More information should lead to less questions
  from IRB
• New forms will help PIs stay in compliance
• Will be templates on IRBManager and forms on
  websites

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Letters and Memos

• IRBManager
• All templates on IRBManager
• Generates letters and memos
• Provides complete documentation
• All CUNY IRBs MUST use CUNY Letter Memo
  Templates
• All templates reflect new Board Decision
  terminology
• Letters To PIs not on campus
• Memos To PIs on campus

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Letters and Memos(Continued)

• Signatures
• Chair/Vice Chair or member designee
• Approvals
• Noncompliance correspondence
• IRB Admin or Chair (Admin)
• Requests for revisions
• Renewal reminders
• Incomplete applications, etc.

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Website Upgrades
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Website Upgrades

• Updated information on both the CUNY and RF
  websites
• Added links to campus IRB websites
• Added more useful links to OHRP, DHHS, NYC Board
  of Education, etc.

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Website Upgrades(Continued)

• Coming Soon
• Updated forms for use with IRBManager
• Information and FAQs for IRBManager
• Continued expansion of links and resources
  including archives of HIPAA and other
  presentations

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Website Upgrades(Continued)

• Coming Soon (Continued)
• CUNY Policies and Procedures
• New, updated PI Manual
• FAQs
• Reorganization of CUNY site in a more
  user-friendly design
• Web address!!!

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CITI Refresher
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CITI Refresher Modules

• CITI began July 1, 2005
• CITI certification expires after 3 years
• CUNY will soon select refresher modules that will
  be available for recertification
• Refresher certification will be valid for 3 years

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Current Issues
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Current Issues

• Informed Consent Waivers and Alterations
• Review of Grant Applications
• Membership Rosters
• Quorum Issues
• Education Training

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Informed ConsentWaivers and Alterations
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Informed Consent Options

• Regulations are flexible and allow many
  alternatives to written informed consent
  containing all required elements
• IRB must make and document protocol-specific
  findings in order to allow deviations

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Informed Consent Options (Continued)

• On a protocol-specific basis the IRB may allow
• Alteration or waiver of some or all required
  elements (46.116(c) (d))
• Short form with oral explanation (46.117(b))
• Waiver of documentation (signature) (46.117(c))
• Waiver of informed consent (46.116(c) (d))

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Waiver or Alteration of Elements of Informed
Consent 46.116(c)

• An IRB may approve a consent procedure which does
  not include, or which alters, some or all of the
  elements of informed consent set forth above, or
  waive the requirement to obtain informed consent
  provided the IRB finds and documents that

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Waiver or Alteration of Elements of Informed
Consent 46.116(c)(Continued)

• (1) The research or demonstration project is to
  be conducted by or subject to the approval of
  state or local government officials and is
  designed to study, evaluate, or otherwise examine

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Waiver or Alteration of Elements of Informed
Consent 46.116(c) (Continued)

• (i) public benefit or service programs
• (ii) procedures for obtaining benefits or
  services under those programs
• (iii) possible changes in or alternatives to
  those programs or procedures or
• (iv) possible changes in methods or levels of
  payment for benefits or services under those
  programs and

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Waiver or Alteration of Elements of Informed
Consent 46.116(c) (Continued)

• (2) The research could not practicably be carried
  out without the waiver or alteration.
• (Normally not a CUNY issue)

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Waiver or Alteration of Elements of Informed
Consent 46.116(d)

• An IRB may approve a consent procedure which does
  not include, or which alters, some or all of the
  elements of informed consent set forth in this
  section, or waive the requirements to obtain
  informed consent provided the IRB finds and
  documents that

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Waiver or Alteration of Elements of Informed
Consent 46.116(d) (Continued)

• (1) The research involves no more than minimal
  risk to the subjects
• (2) The waiver or alteration will not adversely
  affect the rights and welfare of the subjects
• (3) The research could not practicably be carried
  out without the waiver or alteration and
• (4) Whenever appropriate, the subjects will be
  provided with additional pertinent information
  after participation.

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Documentation of Informed Consent 46.117(a)

• Except as provided in paragraph (c) of this
  section, informed consent shall be documented by
  the use of a written consent form approved by the
  IRB and signed by the subject or the subject's
  legally authorized representative. A copy shall
  be given to the person signing the form.

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Documentation of Informed Consent 46.117(b)

• Except as provided in paragraph (c) of this
  section, the consent form may be either of the
  following

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Documentation of Informed Consent
46.117(b)(Continued)

• (1) A written consent document that embodies the
  elements of informed consent required by 46.116.
  This form may be read to the subject or the
  subject's legally authorized representative, but
  in any event, the investigator shall give either
  the subject or the representative adequate
  opportunity to read it before it is signed or

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Documentation of Informed Consent
46.117(b)(Continued)

• (2) A short form written consent document stating
  that the elements of informed consent required by
  46.116 have been presented orally to the subject
  or the subject's legally authorized
  representative. When this method is used, there
  shall be a witness to the oral presentation.

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Documentation of Informed Consent
46.117(b)(Continued)

• Also, the IRB shall approve a written summary of
  what is to be said to the subject or the
  representative. Only the short form itself is to
  be signed by the subject or the representative.
  However, the witness shall sign both the short
  form and a copy of the summary, and the person
  actually obtaining consent shall sign a copy of
  the summary. A copy of the summary shall be given
  to the subject or the representative, in addition
  to a copy of the short form.

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Documentation of Informed Consent 46.117(c)

• An IRB may waive the requirement for the
  investigator to obtain a signed consent form for
  some or all subjects if it finds either

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Documentation of Informed Consent
46.117(c)(Continued)

• (1) That the only record linking the subject and
  the research would be the consent document and
  the principal risk would be potential harm
  resulting from a breach of confidentiality. Each
  subject will be asked whether the subject wants
  documentation linking the subject with the
  research, and the subject's wishes will govern or

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Documentation of Informed Consent
46.117(c)(Continued)

• (2) That the research presents no more than
  minimal risk of harm to subjects and involves no
  procedures for which written consent is normally
  required outside of the research context.

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Documentation of Informed Consent
46.117(c)(Continued)

• In cases in which the documentation requirement
  is waived, the IRB may require the investigator
  to provide subjects with a written statement
  regarding the research.

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Informed Consent Summary

• Waiver or alteration of required elements
  46.116(c) (d)
• Waive requirement to obtain IC 46.116(c) (d)
• Written IC read to subject or LAR 46.117(b)
• Short form summary 46.117(b)
• Waive signature 46.117(c)

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Review Of Grant Applications
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Review Of Grant Applications

• Regulations stipulate that, in addition to the
  review of the IRB application, the IRB must
  review the grant application for protocols
  receiving funding.
• Required procedure for accreditation

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Review of Grant Applications (Continued)

• HHS regulations at 45 CFR 46.103(f) require that
  an institution with an approved assurance shall
  certify that each application or proposal for
  research covered by the assurance has been
  reviewed and approved by the IRB.
• OHRP guidance

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Review of Grant Applications(Continued)

• (a) OHRP found numerous discrepancies between the
  title, date, and type of IRB approval reported on
  the face page of grant applications and the
  relevant documentation in IRB records.
• OHRP guidance

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Review of Grant Applications (Continued)

• (b) In reviewing IRB records, and in discussions
  with IRB members, IRB administrators, and
  research investigators, OHRP finds that the IRB
  consistently fails to review the grant
  application for proposed research.
• OHRP guidance

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Membership Rosters
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Membership Rosters

• Need updates by end of September for every IRB
• Submit electronically
• No CUNY IRB member may be included on roster, or
  serve, without CITI completion

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Quorum Issues
65
Quorum Issues

• IRB Membership
• Must have at least five members
• At least one member is a Nonscientist
• At least one member is unaffiliated with CUNY
  the Community member
• Community member is not necessarily the
  Nonscientist

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If there is no community member,there is no
IRB!No meetings!No decisions!No approvals!No
renewals!
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Nonscientist must be at convened meetingat all
times.Meeting must stop when there is no
Nonscientist present!No decisions can be made
without Nonscientist present!
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Quorum Issues(Continued)

• Recusal
• Anyone with a conflict MUST leave the room
• Must be documented in the minutes
• IRB Admin should confer with Chair when there is
  a possibility of losing quorum because of recusal
• Reorder agenda items
• Defer to next meeting

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Quorum Issues(Continued)

• Telephone conferencing
• Allowed on emergency basis
• All materials must be received sufficiently in
  advance of the meeting
• Still must have quorum
• Office of Research Conduct approval

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Education and Training
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Education and Training

• Institution is required by OHRP to provide
  training on ethical conduct of human subjects
  research
• Audience includes
• IRB members and staff
• Researchers and research staff
• Institutional officials and institutional
  administrative staff
• Students and faculty

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Education and Training(Continued)

• CITI
• CITI required for all PIs, key personnel, and IRB
  members and staff
• Old CUNY CBT only acceptable if lt 2 years old.
• July 1, 2007, only CITI acceptable
• CITI refresher required after 3 years

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Education and Training(Continued)

• Suggest keeping a log of all training
  opportunities conducted by or attended by the
  IRB, such as
• Seminars, lectures, classroom discussions
  presented by IRB
• Attendance of IRB members and staff at
  conferences, regional or national meetings
• Educational discussions and distribution of
  materials at IRB meetings

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Questions????
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(No Transcript)
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How to Find Us
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CITY UNIVERSITY OF NEW YORKOffice of Research
Conduct

• Patricia MacCubbin, Director
• 212.794.5476
• 535 East 80th Street
• NY, NY 10021
• Patricia.MacCubbin_at_mail.cuny.edu
• 212.794.5378 (Fax)

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• Arita Winter, CUNY-Wide IRB Administrator
• 212.794.5504
• 535 East 80th Street
• NY, NY 10021
• Arita.Winter_at_mail.cuny.edu
• 212.794.5378 (Fax)

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Please be advised a lack of planning on your
part does not constitute an emergency on the
IRB's part.

• Southern CT State University IRB

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Expediteddoesnt meanFaster.
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NOTES