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IRB APPROVAL It is what you need and what you want!

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IRB APPROVAL It is what you need and what you want! IRB Ken Kepler, MSESS Institutional Review Boards University of Florida He takes guarding humans very seriously. – PowerPoint PPT presentation

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Title: IRB APPROVAL It is what you need and what you want!


1
IRB APPROVALIt is what you need and what you
want!
IRB
  • Ken Kepler, MSESS
  • Institutional Review Boards
  • University of Florida

He takes guarding humans very seriously.
2
The History
  • The Tuskegee Syphilis Study
  • 1932 - 1972
  • Nazi War Crimes of a Medical Nature
  • 1942 - 1946
  • Willowbrook State School
  • 1956 - 1970s
  • The Jewish Chronic Disease Study
  • 1963

3
Tuskegee Syphilis Study
  • 400 African Americans
  • 40 years of monitoring
  • Denied cure

4
Nazi War Crimes of a Medical Nature
  • Altitude
  • Hypothermia
  • Potability of sea water
  • TB
  • Insemination
  • Sterilization

5
Jewish Chronic Disease Study
  • Injected live cancer cells
  • Patients were not told
  • They are going to die anyways

6
Willowbrook State School
  • Infected with Hepatitis C
  • Natural disease progression
  • Coercion
  • They are going to get it anyways

7
Guidelines Ethical Considerations
  • Nuremberg Code
  • Voluntary consent is essential
  • Research should be beneficial to society
  • The experiment should avoid unnecessary suffering
    and injury

8
Guidelines Ethical Considerations
  • Declaration of Helsinki
  • More specific guidance
  • Duty to protect life, health, privacy and dignity
  • Emphasized subject understanding

9
Belmont Report1979
  • Respect for Persons
  • Informed Consent
  • Privacy and Confidentiality
  • Nazis, Jewish Chronic Disease, Tea Room
  • Beneficence
  • Risk/Benefit Analysis
  • Scientific Merit
  • Tuskegee, Nazis
  • Justice
  • Review of subject selection
  • Tuskegee, Willow brook

10
Federal Regulations
  • Federal Policy adopted in 1981
  • Common Rule (1991)
  • DHHS Regulations for the Protection of Research
    Subjects
  • 45 CFR 46, Subpart A

11
Who is Covered?
  • Dept. of Agriculture
  • Dept. of Energy
  • Dept. of Commerce
  • Dept. of HUD
  • Dept. of Justice
  • Dept. of Defense
  • Dept. of Education
  • Dept. of Veterans Affairs
  • Dept. of HHS
  • Dept. of Transportation
  • NSF
  • NASA
  • EPA
  • CIA

12
Responsibilities in Research
  • Institutional Responsibilities
  • Federal Wide Assurance
  • IRB Responsibilities
  • IRB review
  • Investigator Responsibilities

13
IRB Responsibilities
  • 4 IRBs
  • Review all proposed human subject research at
    the University of Florida
  • Federal regulations and guidance
  • Authority to approve, request modification in,
    and/or disapprove research

14
Investigator Responsibilities
  • Investigators have the primary responsibility
    for protecting the rights and welfare of human
    research subjects and are responsible for
    complying with all applicable provisions of their
    institution's Assurance.

15
Investigator Responsibilities
  • Investigators are expected to be knowledgeable
    about the requirements of the Federal
    regulations, applicable state law, their
    institution's Assurance, and institutional
    policies and procedures for the protection of
    human subjects.

16
Do you need IRB approval for your new study?
  • All research that involves intervention/interactio
    n with human subjects or their identifiable
    protected health information must be reviewed by
    the IRB BEFORE it is conducted.

17
Types of research that require IRB approval
  • Therapeutic/Clinical research
  • Surveys
  • Chart reviews
  • Studies involving tissues
  • Published quality assurance research
  • Exempt research

18
IRB approval NOT required
  • Decedent research
  • Case Reports
  • Designed to contribute to generalized knowledge,
    but not a systemic investigation.
  • Quality Assurance
  • Systemic investigation , but does not contribute
    to generalized knowledge.
  • Note intent to publish

19
So you need IRB approval Now What?
  • Visit our website
  • www.irb.ufl.edu
  • See the required reading
  • Belmont report
  • FWA
  • CFR
  • http//irb.ufl.edu/education/trainingreq.htm

20
Note the deadlines
http//irb.ufl.edu/irb01/deadlines.htm
21
FORMS
22
FORMSYou must download and use the most current
forms!!
  • All paperwork must be typed
  • All submissions must be signed by the PI
  • All supporting documentation must be attached
  • Protocol, grants, brochures, advertisements,
    questionnaires, surveys, data collection forms
    etc.
  • Once complete- you must submit with original
    signatures and 4 photocopies of EVERYTHING.

23
FORMSYou must download and use the most current
forms!!
  • Paperwork should be complete and correct at the
    time of submission.
  • Prior to submission- be intimately familiar with
    all IRB requirements.
  • That is why you are here
  • Attach a separate cover letter if you need to
    provide additional information.

24
IRB
25
Forms for New Studies
  • First determine if your study is
  • Exempt
  • Expedited
  • Full Board

26
Forms for New Studies
  • Exempt
  • Exemptions are determined by the IRB (reviewed by
    a single member).
  • A study is exempt unless otherwise required by
    OHRP or FDA if the only involvement of the human
    subject will be in one or more of the six
    categories described in 45 CFR 46.
  • See the GUIDELINES FOR EXEMPT AND EXPEDITED
    SUBMISSIONS form on the website.
  • http//irb.ufl.edu/docs/op-expedite-exempt20studi
    es.doc

27
Exempt Studies
  • IRB determined, and falls into one of the
    following six categories and involve minimal risk
  • 1. Research conducted in established or commonly
    accepted educational settings, involving normal
    educational practices.
  • 2. Research involving the use of educational
    tests, surveys, procedures, interviews or
    observation of public behavior UNLESS -
  • There are links, AND
  • Disclosure puts subject at risk

28
Exempt Studies
  • 3. Research involving the same as 2 for public
    officials or candidates, or if federal statutes
    require without exception that the
    confidentiality of the personally identifiable
    information will be maintained.
  • 4. Research involving the collection or study of
    existing data, documents, records, pathological
    specimens or diagnostic specimens, if these
    sources are publicly available, or if the
    information is recorded by the investigator in
    such a manner that subjects can not be
    identified, directly or through identifiers
    linked to the subject.

29
Exempt Studies
  • 5. Research and demonstration projects which are
    conducted by or subject to the approval of the
    department or agency heads, which are designed to
    study, evaluate or otherwise examine
  • 1. Public benefits or service programs
  • 2. Procedures for obtaining benefits, or
    services under those programs
  • 3. Possible changes in, or alternatives to those
    programs or procedures
  • 4. Possible changes in methods or levels of
    payments for benefits or services under those
    programs.

30
Exempt Studies
  • 6. Taste and food quality evaluations and
    consumer acceptance studies if
  • 1. Wholesome foods without additives is consumed
  • 2. A food is consumed, that it contains a food
    ingredient at or below the level found to be
    safe.

31
Forms for New Studies
  • If you meet the criteria for exempt fill out the
    INTRODUCTORY QUESTIONAIRE- EXEMPT STUDIES
  • http//irb.ufl.edu/docs/IQ-short.doc

32
Forms for New Studies
  • Expedited Review
  • Reviewed by a single member of the IRB.
  • A shorter turn around time (3-4 weeks).
  • Must fit into one of 9 Federally defined
    categories 45 CFR 46
  • See also the GUIDELINES FOR EXEMPT AND EXPEDITED
    SUBMISSIONS
  • http//irb.ufl.edu/docs/op-expedite-exempt20studi
    es.doc

33
Forms for New Studies
  • Expedited Review- Category 5 is the most common.
  • 5. Research involving materials (data, documents,
    records, or specimens) that have been collected
    or will be collected solely for non-research
    purposes (such as medical treatment or
    diagnosis). Note Some research in this category
    may be exempt from the HHS regulations for the
    protection of human subjects. 45 CFR
    46.101b4. This listing refers only to
    research that is not exempt.

34
Forms for New Studies
  • Expedited Review
  • If you meet the criteria for expedited review you
    will need the INTRODUCTORY QUESTIONAIRE and
    PROTOCOL forms.
  • http//irb.ufl.edu/docs/frm-iq.doc
  • http//irb.ufl.edu/docs/frm-prot.doc
  • Use the PROTOCOL TEMPLATE GUIDELINES
  • http//irb.ufl.edu/docs/prot20temp20guidelines2
    0v01.22.04.doc

35
Forms for New Studies
  • Full Board Reviews
  • Generally involves greater than minimal risk to
    the participants.
  • Do not fit the criteria for exempt or expedited
  • Forms for full board are the same as expedited-
    INTRODUCTORY QUESTIONAIRE and PROTOCOL

36
Forms for New Studies
INFORMED CONSENT
  • Both Expedited and Full Board reviews require
    INFORMED CONSENT.
  • Unless you request
  • Waiver of Informed Consent
  • Waiver of Documentation of Informed Consent
  • Modification of Informed Consent

37
Forms for New Studies
INFORMED CONSENT
  • See Section III of the Introductory
    Questionnaire- check the correct box
  • Must meet specific criteria (45 CFR 46 116 and
    117)
  • See the INFORMED CONSENT INSTRUCTIONS
  • http//irb.ufl.edu/docs/icf-instruct.doc

38
Forms for New Studies
INFORMED CONSENT
  • Informed Consent with HIPAA
  • Has additional information that covers PHI
  • http//irb.ufl.edu/docs/HIPAA/ICF-with-HIPAA-auth.
    doc
  • Informed Consent without HIPAA
  • http//irb.ufl.edu/docs/frm-icf.doc

39
Forms for New Studies
HIPAA or NO HIPAA
  • If you are collecting, creating or using health
    information you must use the HIPAA version of the
    INFORMED CONSENT form.
  • You may submit a REQUEST FOR WAIVER OF
    AUTHORIZATION to recruit and/or enroll if-
  • your study is Exempt
  • If you have a WAIVER OF CONSENT
  • if you have a WAIVER OF DOCUMENTATION OF CONSENT
  • http//irb.ufl.edu/docs/HIPAA/authorization-waiver
    .doc

40
Forms for Existing Studies
  • CONTINUING REVIEW/STUDY CLOSURE form
  • Studies reviewed annually unless specified by the
    board
  • Make sure the of patients flow from year to
    year
  • An IRB closed study officially starts the record
    keeping clock
  • IRB- 3 years
  • HIPAA- 6 years
  • Treatment records- 8 years
  • http//irb.ufl.edu/docs/frm-cr.doc

41
Forms for Existing Studies
  • When closing your study dont forget
  • The Cumulative Adverse Events Table
  • http//irb.ufl.edu/docs/AETable.doc

42
Forms for Existing Studies
  • Revising your study??
  • Any change including an increase in the of
    subjects is a revision
  • DO NOT implement the changes until the revision
    is approved.
  • Complete the REVISION MEMO
  • include all paperwork affected by the revision
  • http//irb.ufl.edu/docs/frm-rev.doc

43
Other Forms
  • The IRB wants an explicit change-
  • Complete the Explicit Change form.
  • http//irb.ufl.edu/docs/frm-explicit.doc
  • The IRB has tabled your project-
  • Fill out the Tabled Submission Response Form
  • http//irb.ufl.edu/docs/frm-tabled.doc

44
Other Forms
  • Emergency Use
  • The investigator, with the concurrence of another
    physician, believes the situation necessitates
    the use of a test article
  • The subject and/or legally authorized
    representative is unable to communicate consent
  • There is insufficient time to obtain consent and
  • No alternative exists that will provide an equal
    or better chance of saving the subject's life.
  • http//irb.ufl.edu/docs/frm-emergnew.doc

45
Other Forms
  • Temporary Transfer of Study Responsibility
  • Temporary PI must be on the existing IQ
  • http//irb.ufl.edu/docs/frm-transfer.doc
  • Unaffiliated Investigator Agreement
  • http//irb.ufl.edu/docs/frm-uia.doc

46
Standardized IRB Text
  • Blood draw risk
  • Employee subjects
  • MRI
  • Placebo / randomization
  • Reproduction Risks (pregnancy)
  • Storage of tissue
  • Student subjects
  • Videotaping of subjects

47
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