IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates - PowerPoint PPT Presentation

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IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates

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IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates Mayra Lomeli, MSRA, CCRC IRB Specialist Mary Woo, RN, DNSc, FAAN, FAHA Professor – PowerPoint PPT presentation

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Title: IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates


1
IS IT ETHICAL??IRB AND Human Subjects
Challenges and NIH Grant Updates
  • Mayra Lomeli, MSRA, CCRC
  • IRB Specialist
  • Mary Woo, RN, DNSc, FAAN, FAHA
  • Professor
  • UCLA School of Nursing

2
UNETHICAL CONDUCTOF RESEARCH
  • Tuskegee Syphilis Study (1932 1972)
  • Guatemala STD Experiments ( 1946 1948)
  • Nazi Experiments WWII (1939 1945)
  • Thalidomide ( 1950s)

3
Regulatory Resulting from Unethical Research
  • Nuremberg Code (1948)
  • Declaration of Helsinki (1964)
  • Creation of NIH OPRR leading to IRBs (1966)
  • National Research Act (1974)
  • Belmont Report (1978)
  • Common Rule (1991)

4
What does the Institutional Review Board (IRB) do?
  • Protect the rights welfare of human subjects
  • Support the Universitys research mission
  • Review and conduct of UCLA research guided by the
    principles set forth in The Belmont Report
  • Respect for persons
  • Beneficence
  • Justice
  • www.hhs.gov/ohrp/humansubjects/guidance/belmont.ht
    m

5
WHEN is IRB Review Required??
  • All human subjects research requires prior IRB
    review and approval before initiation (New
    Studies)
  • All modifications or changes made to an
    IRB-approved study require IRB approval prior to
    initiation (Amendments)
  • All continuation of an IRB-approved study beyond
    its approval period requires IRB approval
    (Continuing Review)

6
WHO/WHEN is Review Required (continued)
  • All faculty and staff who are conducting studies
    involving Human Subjects within the course and
    scope of their duties
  • UCLA students who are conducting studies
    involving Human Subjects within the course of
    their studies
  • All research studies REQUIRE IRB APPROVAL
    regardless of the source of the funding (even if
    no funds are involved) WITHOUT EXCEPTION before
    Research is initiated.

7
UCLAs Research Responsibilities
  • The UC is legally responsible for the acts and
    omissions of its employees acting in the course
    and scope of their University duties
  • In the event of a suit against an employee in
    connection with an IRB-approved Research activity
    using Human Subjects, the University assumes the
    employees defense and indemnification
  • ONLY IF the employee has IRB approval and
    necessary certifications

8
What are the PIs (faculty, staff, student)
Research Responsibilities?
  • All investigators, co-investigators,
    collaborators, staff, and students must obtain
    IRB/Research certifications for UCLA
  • Health Insurance Portability and Accountability
    Act (HIPAA)
  • Collaborative Institutional Training Initiative
    (CITI)
  • Animal Research (as needed)
  • UCLA Certification, Education, and Training Web
    site
  • http//ohrpp.research.ucla.edu/pages/certification
  • PI must obtain UCLA IRB approval for the study
  • PI must adhere to all UCLA IRB rules and
    regulations

9
CONSEQUENCES What can happen if I DO NOT get IRB
approval/violate IRB regulations?
  • PIs Reputation
  • Adverse job review/letter in personnel file
  • Censure/unable to obtain future UCLA IRB approval
  • Loss of UCLA employment
  • School of Nursings Reputation
  • All of Schools research data and protocols can
    be reviewed by Office of Human Research
    Protection Program (OHRPP)
  • All of Schools research can be suspended until
    OHRPP review completed
  • UCLAs Reputation
  • All of UCLA research can be suspended until
    Federal review completed

10
RESOURCESUCLA SON Research Website
http//nursing.ucla.edu/body.cfm?id10 http//nurs
ing.ucla.edu/body.cfm?id276
11
TRAININGUCLA OHRPP Website
http//ohrpp.research.ucla.edu/
12
Human Subjects and NIH Grants
  • NIH scores INCLUDE evaluation of the Human
    Subjects section of the grant
  • Human Subjects section of an NIH grant includes
  • Risks and benefits to subjects
  • Description of protocols to maximize subject
    safety and/or privacy
  • Description of women and minorities
  • Description of children
  • Data and Safety Monitoring Board (DSMB) vs. Data
    and Safety Monitoring Plan (DSMP)

13
Impact of Inadequate Discussion of Human Subjects
in NIH Grants
  • Worse overall scores for NIH grants
  • Inadequate discussion of safety protocols can
    destroy a grant
  • Especially on inadequate subject representation
    (women, minorities, children)
  • Can prevent funding until NIH questions on Human
    Subjects are discussed
  • Human Subject COMMENT
  • Human Subject CONCERN

14
Safety and Privacy Protocols MUST BE DESCRIBED
  • Most common red flags screening for
    inclusion/exclusion criteria
  • Emotion/Depression what are you going to do if
    you detect significant depression/anxiety/etc.?
  • Physical what are you going to do if you detect
    physical symptoms? example sleep problems,
    high blood pressure, etc.
  • Qualitative data collection/interviews how will
    you insure subject privacy?
  • Transmission of data/information about subjects
    security procedures?

15
Women and Minorities
  • MUST have a separate page/section on Women and
    Minorities in NIH grant submissions
  • Women and minorities MUST be included in studies
    unless they are NOT at risk for a diagnosis (ex
    not many women have prostate cancer)
  • Inconvenience is NOT an adequate excuse for low
    women and minority representation
  • Dont forget to mention HOW you will achieve
    adequate women and minority representation
  • Dont forget to include non-patients (such as
    families/healthcare providers) to be studied

16
Children
  • MUST have a separate page/section on Children in
    NIH grant submissions
  • CHILDREN are defined as persons who are lt 21
    years of age (for NIH grants)
  • Children MUST be included in studies unless
  • They are not at risk for the target diagnosis
  • Their etiologies and responses to the target
    diagnosis/disease or treatment are significantly
    different from adults
  • Incidence of the disease is very low
  • Inconvenience is inadequate justification for
    not including children

17
DSMBs vs. DSMPs
  • Data and Safety Monitoring Board (DSMB)
  • Independent (i.e. should NOT consist ONLY of
    members of the research team)
  • Must have described/standardized review plan
  • What will they review
  • When will they review
  • REQUIRED for all interventional grants (clinical
    trials)
  • Data and Safety Monitoring Plan (DSMP)
  • Does NOT have to include non-members of the
    research team
  • Must describe standardized review plan
  • What will they review
  • When will they review
  • Good idea to have if there are ANY potential
    risks associated with the proposed study

18
DSMB and Clinical Trials
  • Types of Clinical Trials
  • Phase I
  • physiologic, toxicity, and dose-finding studies
  • Often has a small number (usually less than 100)
    of subjects
  • Phase II
  • Efficacy trials
  • Often has a moderate number (usually 100s of
    subjects)
  • Phase III
  • Efficacy, effectiveness, and comparative trials
  • Often has thousands of subjects
  • All clinical trials require monitoring
    including adverse psychological, physiological,
    and privacy issues
  • DSMB does NOT replace reporting adverse events to
    IRB

19
When is a DSMB Required?(Continued)
  • When the trial has the power to detect
    statistically significant differences in tangible
    outcomes (mortality and significant morbidity).
  • When the risks associated with the therapeutic
    components are not known. This is particularly
    applicable to pivotal phase 3 trials of
    investigational agents.
  • When the therapeutic components in either arm are
    known to be associated with severe adverse
    effects. This includes trials intended to
    evaluate approved agents for new medical
    indications.

20
NIH Grant Updates
  • Latest news from NIH
  • February, 2012

21
NIH Emphasis of Institutes
  • Potential new emphasis of expertise areas of
    institutes
  • May limit the type of science/subject matter for
    each institute at NIH
  • Still in discussion (with lots of upset
    reviewers)
  • Cover letters should include BOTH requested
    institute AND requested study section
  • Standard percentages of grants to be reviewed
  • 50 of new investigator/early stage investigator
    grants
  • 40 of all other research grant types

22
NIH Requirement That Grants Be Different
  • Submitted grant applications must be
    significantly different (more than 60) from
    prior grant submissions
  • How do they (NIH) do this?
  • Initial flag by software (comparison to
    previously submitted grants by the investigators)
  • Primary decision is made by a roomful of human
    reviewers
  • Emphasis appears to be on the Specific Aims page
    and the Background pages of the grant
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