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Institutional Review Boards IRBs and Human Subjects Research Protection Programs HRPP A short course


Part 1: Brief Description of the IRB and Research at Lifespan. Part 2: IRB ... forms to research subjects and keep the originals in secured research files ... – PowerPoint PPT presentation

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Title: Institutional Review Boards IRBs and Human Subjects Research Protection Programs HRPP A short course

Institutional Review Boards (IRBs) and Human
Subjects Research Protection Programs (HRPP)A
short course
Course Content
  • Part 1 Brief Description of the IRB and
    Research at Lifespan
  • Part 2 IRB Support Staff Function
  • Part 3 Researcher Responsibilities
  • Part 4 How to submit items for
    review by the IRB
  • Part 5 Brief discussion about
    Informed Consent

Part 1
  • Brief overview of the IRB and Research at Lifespan

What is an IRB?
  • IRB Institutional Review Board
  • at least 5 members
  • at least 1 must have a scientific background
  • at least 1 must be a non-scientist (this member
    must attend a meeting to achieve quorum)
  • at least 1 non-affiliated member (not affiliated
    with the institution)
  • Members should have expertise in the research
    that will be reviewed.

IRBs are regulated by State and Federal
  • Federal
  • FDA (Food and Drug Administration, Title 21 CFR )
  • OHRP (Office for Human Research Protection, Title
    45 CFR Part 46)
  • State of Rhode Island
  • Section 16, Rules and Regulations for Licensing

Why is research so heavily regulated?
  • The history of Research has not always been one
    of ethics and regulations Nazi war crimes
    Tuskegee syphilis study Yale Milgram experiments
    (obedience to authority, 1961-62) tea room
    experiments (homosexual behavior in public
    restroom mid 60s)

The Modern IRB is Born
  • 1974- National Research Act mandated specific
    requirements for institutional review committees
    which became known as Institutional Review Boards
  • 1979- The Belmont Report provided guidance as to
    how the new rules should be applied. The Belmont
    Report defined the three philosophical principles
    relevant to research
  • Respect to persons must provide adequate
    information and obtain voluntary consent
  • Beneficence Minimize harm maximize benefits
  • Justice Selection of subjects must be fair and

  • The Primary Concern of the IRB is the Rights and
    Welfare of the Research Participants

The Main Purpose of IRB Review
  • To assess the risk/benefit ratio.
  • To ensure that informed consent is obtained in an
    appropriate manner
  • To verify that the recruitment methods/materials
    are not misleading or coercive
  • To ensure that the selection of subject is
    equitable and justified

Research at Lifespan
  • Lifespan has three IRBs (2 at RIH and 1 at TMH)
  • Researchers at Lifespan may submit to any of the
    3 IRBs. The exception is prison protocols which
    must be submitted to TMH IRB.
  • The Lifespan Research Program is considered to
    be of medium size when compared across the
  • Currently we have
  • 1,250 active protocols
  • TMH has 335 and the RIH IRBs have 915

Lifespans HRPP hierarchy
  • Dr. Arthur Klein, Sr.VP Institutional Official
  • oversight responsibilities for the HRPP,
    delegated to Dr. Klein through the Presidents at
    each Lifespan Affiliate
  • Peg McGill -Director
  • Lifespan Office of Research Administration
  • Pat Houser- Manager
  • Research Review Committees

Who are the members of Lifespans IRBs?
  • Lifespans IRBs are made up of physicians, PhDs,
    pharmacists, nurses, clergy, retirees, and
    community members who VOLUNTEER their time to
    review human subject research proposals.
  • Members typically spend 2 hours per month
    reviewing protocols and 2 hours at the IRB
    meeting. Chairpersons spend considerably more
    time in service to the IRB.

Accreditation of the Human Research Protection
  • Lifespan is seeking accreditation of our human
    research protection program
  • This accreditation seeks to accredit the entire
    human research protection program for all of
    Lifespan not just the IRBs. That means were all
    in this together.

Part 2
  • Research Review Committee Office

Who Are We?
  • The Research Review Committee Office is made up
    of the following
  • IRB Manager-
  • Responsible for the management of research
    activity and IRB support staff involved in the
    daily activities of processing research.
  • Assures regulatory compliance of IRBs as well as
    researchers and protocols
  • Assists the research community with information
    needed to ensure compliance
  • Committee Assistants-
  • Provide administrative support to the IRB,
    researchers and coordinators.
  • Process, maintain, and update the database,
    paperwork and files of all research projects.
  • Committee Coordinators-
  • Review initial IRB applications, continuing
    review, adverse events and amendments
  • Act as a communication liaison between the
    committees and the Investigator
  • Review all submissions to the IRB for appropriate
  • Transcribes the IRB meeting minutes and follows
    up with the investigator with IRB requests for

What Do We Do?
  • Review all submissions for completeness and
  • Make a preliminary determination of whether the
    submission qualifies for exempt, expedited, or
    full board review
  • Process new applications, revisions to current
    protocols, adverse events, continuing reviews,
    and protocol deviations/exception reports
  • Prepare the agenda and distribute review
    materials to IRB members
  • Prepare meeting minutes and communicate with
    researchers as to what the IRB requires
  • Serve as resource to the research community
  • Maintain the database

Part 3
  • Researcher Responsibilities

Responsibility of the PI
  • Is to know and understand the regulations and
    policies prior to initiating any human research.
  • Acknowledge and accept their role to protect the
    rights and welfare of the research subjects by
    complying with all of the regulations.

GCP and the PI
  • When a principal investigator receives an
    approval letter from the Lifespan IRB, they are
    notified that this institution and the
    investigator complies with ICH GCP guidelines as
    they correspond to the FDA/DHHS regulations.
  • Good Clinical Practice (GCP) is an international
    ethical and scientific quality standard for
    designing, conduction, recording and reporting
    trials that involve the participation of human
  • Compliance with GCP standards provides public
    assurance that the rights, safety and well being
    of trial subjects are being protected and that
    clinical trial data is credible.

GCP and the PI
  • The investigators responsibility according to
    ICH GCP guidelines
  • 4.1 Investigator qualifications and agreements
  • 4.2 Adequate resources
  • 4.3 Medical care of trial subjects
  • 4.4 Communication with IRB
  • 4.5 Compliance with the protocol
  • 4.6 Investigational product
  • 4.7 Randomization procedures and unblinding
  • 4.8 Informed consent of trial subjects
  • 4.9 Records and reports
  • 4.10 Progress reports
  • 4.11 Safety reporting
  • 4.12 Premature termination or suspension of a
  • 4.13 Final report by the investigator

So what are some of the other PI requirements?
  • Ensure that research activities are carried out
    according to the IRB approved protocol
  • Protect subject confidentiality by storing
    electronic research data on password protected
    computers, and paper data in locked cabinets
    within locked offices
  • Follow HIPAA regulations when the research
    involves the use or disclosure of PHI -obtain
    authorization from prospective subjects.
  • Ensure that only IRB approved recruitment
    materials and research authorizations are used
  • Provide signed copies of consent and
    authorization forms to research subjects and keep
    the originals in secured research files
  • When appropriate, place copy of the consent form
    and authorization in the subjects medical record.

So what are some of the other requirements for
  • Human Subject Protection (HSP) Training is
    required for all research personnel who interact
    with human subjects or their identifiable data.
    Re-certification is required every 3 years.
  • Each PI must also sign a HIPAA Security Assurance
  • HIPAA for Research training is an annual
    requirement. Each department in Lifespan must
    provide this training to their employees.
  • HSP and HIPAA training can be done on-line at

Part 4
  • Process for Submission to the IRB

Process for Submission to the IRB
  • This section will cover
  • New Applications
  • Continuing Review (progress reports)
  • Requests for Revision to Protocol
  • Adverse Events/Unanticipated Problems

IRB forms and Instructions are posted at
IRB forms and Instructions are posted at
  • From the ORA web page, select Human Subject

IRB forms and Instructions are posted at
  • From the IRB web page, select Human Subject
    Committee forms

IRB forms and Instructions are posted at
  • Each of the forms are available as hyperlinks on
    the forms list.
  • The new application form includes a checklist
    that details each of the IRB forms that are
    required for your new application.
  • Form specific instructions are also available for
    download by clicking on the LINK in the third

When in doubt- read the instructions
  • Instructions and helpful tools are available for
  • From the IRB forms page, select the first item on
    the list,
  • How do I submit an IRB application and other

How to submit an application to the IRB
  • Develop a research plan/grant application or
    obtain a study protocol from the sponsor
  • Obtain required forms for IRB review from the ORA
    website http// refer
    to IRB application checklist and instructions for
    further information
  • Determine when the application is due
  • Deadlines are posted on the IRB web page and are
    labeled Deadline/Meeting dates
  • In most cases, any of the three Lifespan IRBs
    can review an application for use at a Lifespan
  • Special circumstances for research to be
    conducted at Bradley or Newport, and research
    involving prisoners

How to submit an application to the IRB
  • Do you need Full Board, Expedited, or Exempt
    review? Reminder Expedited/exempt projects do
    not have a deadline and only require 2 complete
  • Financial Considerations before you submit your
  • provide Dept cost center if internally funded,
  • submit business forms to Grants and Contracts
    Office if externally funded
  • Submit the completed application, with the
    required number of copies, to Review Committee
    staff by the due date.

What happens Next?
  • Research Review Committee staff review the
    submitted application for completeness. After
    the application is accepted, it is processed for
  • Expedited/Exempt projects Research Review
    Committee staff will contact the PI when the item
    comes back from the reviewer
  • Full Board Review -Applications that are accepted
    for full board review are placed on the agenda
    for the next committee meeting. Principal
    Investigators, or their representatives, are
    required to appear before the committee to
    address any questions or concerns raised by the

What happens Next?
  • 3. After the IRB meeting, Review Committee staff
    prepare the minutes from the meeting and send a
    summary of the application discussion and
    comments to the investigator.
  • Investigators make the committee required changes
    and return any requested information/clarification
    s to Review Committee staff.
  • Review Committee staff verify that the requested
    corrections have been made and process approval
    as appropriate.

What happens Next?
  • 6. If the study is funded by an external source
    (grant/contract), then the approval letter will
    specify that the project is approved but not
    activated and that no activity is allowed until
    the activation is in place. When the
    grant/contract has been finalized, an activation
    notice with the new cost center will be sent to
    the investigator from the Grants and Contracts
    Office. If the project will use Dept. funds,
    and a cost center has been provided, then the
    IRB approval letter will also include an
    activation notice.
  • Investigators cannot begin any project involving
    human subjects until IRB approval and financial
    activation have been received.

Congratulations, Your Study Has Been Approved!
Now What?
  • Projects are approved for a period up to 12
    months. The IRB may require more frequent review
    depending on the level of risk.
  • Before IRB approval expires, Review Committee
    will send a progress report to be completed by
    the PI. It is ultimately the PIs responsibility
    to submit the continuing review report in a
    timely fashion to ensure a lapse in IRB approval
    does not occur.

Congratulations, Your Study Has Been Approved!
Now What?
  • Be sure to answer all questions. Follow the
    checklist at the back of the progress report to
    ensure that all required documents have been
  • Progress reports are processed and reviewed in
    the same manner as new applications.
  • Please note the following
  • Continuation of the project beyond the
    anniversary date is contingent upon submission of
    this report. If the progress report is not
    received by the due date, approval will expire
    and no work will be allowed until the report is
    submitted, reviewed, and approved.

Steps to submitting a Request for Revision to
Protocol for review by the IRB
  • 1. Determine which aspects of the project will
    be revised (e.g. protocol, consent forms,
    advertisements, personnel, etc)
  • Obtain required form for IRB review from the ORA
    website and submit with all required attachments

Steps to submitting a Request for Revision to
Protocol for review by the IRB
  • If the revision includes information that must
    be communicated to currently enrolled subjects
    (such as altered schedules, revised compensation,
    newly identified side effects), then you must
    describe the plan for notifying enrolled
    subjects and attach any documentation that will
    be used for this purpose.

Steps to submitting a Request for Revision to
Protocol for review by the IRB
  • Most minor revisions can be processed for
    expedited review.
  • Changes which substantially alter the protocol,
    or change the RiskBenefit ratio require review
    by the convened IRB (full board review). Contact
    the IRB Coordinator/Manager for guidance.
  • Please Note The IRB Chairperson has the
    authority to refer any item to the full board for

Reporting Unanticipated Problems
  • The principal investigator must report to the IRB
    those unanticipated problem/adverse events
    occurring locally or at another site, that are
  • specific to a study approved by a Lifespan IRB,
    and that
  • involve risk to human subjects or others (i.e.
    subject family members, research staff) and are
  • Unanticipated, serious, and related to the
    research activity Or, are
  • Expected but occurring at greater frequency or
    severity than anticipated. Or,
  • The AE indicates an increase in the risk to
    participants, regardless of severity

Reporting Unanticipated Problems
  • The principal investigator must also report to
    the IRB
  • any deviations from the protocol or an
    accidental or unintentional change to the
    protocol taken without prior IRB approval to
    eliminate apparent immediate hazard to a research
    participant (submit a deviation report for this
    event as well)
  • a breech in confidentiality that may involve
    risk to that individual or others
  • a complaint of or from a participant that
    indicates an unanticipated risk or which cannot
    be resolved by the research staff.

Reporting Unanticipated Problems
  • Adverse Event and Deviation Reporting forms are
    posted on the IRB webpage at

Part 5
  • Informed Consent
  • Its a Process not a form

Historical Background
  • The requirement that researchers obtain informed
    consent from research subjects originates with
    Principal 1 of the Belmont Report Respect for

Respect for Persons
  • Individuals are treated as autonomous agents.
    This means that the subjects are not controlled
    by others and are able to make independent
  • Persons with diminished autonomy are given
    protection (e.g. vulnerable subjects such as
    children, prisoners, mentally disabled)
  • Consent to participate in research is voluntary
    and informed

Informed Consent - Process
  • Informed consent is a process that begins when
    you first approach the potential research subject
    and continues throughout the course of the study.

Informed Consent- Process
  • The first contact with research subjects may be
    through any of the following
  • direct advertising
  • medical record review to screen for eligible
  • physician referral

Informed Consent - Process
  • Obtaining Informed Consent involves
  • Providing information to the subject in a
    language that is understandable to the subject or
    their representative
  • Ensuring that the subject understands what they
    are being asked to do
  • Answering any questions that the subject may have
  • Allowing enough time for the person to think
    about the research before consenting to
  • Obtaining voluntary agreement of the subject to
    participate in the study

Informed Consent - Process
  • The consent process continues each time that an
    investigator has contact with a research
  • The consent dialogue is renewed every time that
    the study is revised, or if new information
    becomes available that would impact upon a
    subjects decision to participate,

Informed Consent - Elements
  • Elements of informed consent
  • Information that the study involves research
  • Risks or discomforts
  • Benefits
  • Alternatives
  • Confidentiality
  • Compensation/treatment offered
  • Contact for additional information
  • Contact information for research subject rights
  • Statement that participation is voluntary

Informed Consent - Waivers
  • Federal regulations allow for some types of
    research to be conducted without obtaining
    written informed consent from research subjects.
  • Typically, waivers are only granted for studies
    that present no greater than minimal risk. The
    most frequent types of studies that are eligible
    for waivers are chart reviews and surveys.

Want to learn more about research and the IRB?
  • The Office of Research Administration has an
    online Human Subjects Protection course through
    the CITI program.
  • This site also offers
  • A good clinical practice course (GCP)
  • A Recombinant DNA course
  • For information and instructions go

Contacts for IRB Questions
  • If you have any questions you can contact
  • Patricia Houser, Manager Research Review
    Committees and Communication at 444-2099
  • Adrienne McParlin, Coordinator Research Review
    Committees at 444-3527
  • Jacqui Poore, Coordinator Review Committees and
    Compliance at 444-2093
  • Dawn Roux, Coordinator Research Review Committees
    at 444-7547
  • Deb Temple, Manager Compliance and Training at 444-5843
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