CPHS: The Cliff Notes

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CPHS The Cliff Notes

• Robert Nobles, MPH
• Assistant Director
• Office of Research

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(No Transcript)
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Whitney, et al. Article Overview

• Qualitative e-mail survey with 14 response rate
• Population federally funded principal
  investigators
• Comments were analyzed to show underlying themes
• In general, there was consensus that it is
  important to protect human subjects from research
  abuse, but disagreement over how well the IRB
  system is functioning

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Whitney, et al. Article Overview (2)

• Six primary questions in survey
• 1. What has been your experience with the human
  subjects protection system in general? What do
  you like? What would you change?
• 2. What has been your experience with the
  informed consent process with potential subjects?
  Is there anything you would change?
• 3. Do you feel your IRB does its job well? If so,
  what helps you the most? If not, how could it
  improve?

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Whitney, et al. Article Overview (2)

• Six survey questions continued
• 4. Do you feel that your IRB usually understands
  your protocols adequately?
• 5. Have you ever served on an IRB?
• 6. What other thoughts do you have on informed
  consent and the human subjects protection system?

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Whitney, et al. Article Overview (3)

• Positive Comments
• IRB functions as a safeguard against
  overoptimistic investigators protects subjects
  against both nonphysical and physical harms and
  promotes social justice.
• Negative Comments
• The constraints placed upon investigators and
  indeed research subjects by OHRP and so-called
  ethicists approaches the absurd.

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Whitney, et al. Article Overview (4)

• Negative Comments Continued
• Getting protocols approved gets worse each year
  because you have to document more and more and
  more USELESS stuff.
• For most of my work I receive coded samples
  devoid of patient identifiers, yet I have to fill
  in all sorts of crap and repeat over and over
  again that I couldn't track down these subjects
  if I tried.

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January 15, 2009 Presentation Outline

• Research Quiz
• IRB Overview
• HIPAA Documents
• Research Misconduct
• Obtaining Informed Consent
• Questions and Answers

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Research Quiz

• Question 1
• What is the purpose of an IRB?
• Question 2
• What is the definition of research and how does
  research differ from standard practice?

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Research Quiz (2)

• Question 3
• What are quality improvement projects and when do
  they qualify as research projects?
• Question 4
• How long does it take for studies to get
  approved? Why?

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IRB Overview

• Mission
• To protect the rights and welfare of human
  research participants.
• Definition of Research
• Systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.

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Key Features Of Research

• Intent generate new knowledge, principles, or
  theories that revises or improves existing
  knowledge, programs or processes.
• Systematic collection and/or analysis of data.
• Anticipated results that are valid and
  generalizable

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Functions of the IRB

• Reviewing research to ensure
• Risks are minimized
• Risks are reasonable vs. benefits
• Selection is equitable
• Informed Consent is obtained
• Data and Safety are protected/monitored
• Privacy and confidentiality are upheld
• Vulnerable population protections are enhanced

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CPHS Logic Model
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Materials Submitted for Review

• Application
• Protocol
• Consent Forms
• Letters of Approval/Cooperation
• Recruitment Flyers
• HIPAA Forms
• Investigator Brochure

• Pediatric Risk Assessment
• Grant Application
• Data Collection Forms (questionnaires)
• Translations
• Change Request
• Continuing Review

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Protocol Elements

• literature review/current state of knowledge
• justification for the study
• potential use of study findings
• study design and locations
• hypothesis 

• Methodology
• Description and source of study population
• Inclusion and exclusion criteria
• Number of participants
• Sampling and participant selection

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Protocol Elements (2)

• Recruitment/enrollment activities
• Consenting process
• Confidentiality/privacy
• Data monitoring
• Explanation of study instruments
• Data analysis plan.

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Types of Review

• Exempt Research
• Case studies and retrospective chart reviews
• Expedited Review
• Minimal Risk Protocols and minor changes to
  approved research
• Collection of blood samples
• Prospective collection of biological specimens by
  noninvasive means
• Collection of data through noninvasive procedures
  routinely employed in clinical practice
• Research on individual or group characteristics
  or behavior
• Research employing survey, interview, oral
  history, focus group, program evaluation, human
  factors evaluation, or quality assurance
  methodologies

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Types of Review

• Full Committee Review
• Protocols that have risks that are unknown or
  more than minimal
• Clinical trials
• Including studies on drugs, devices, and
  procedures
• Cohort Studies
• Case Control Studies
• Cross-sectional study techniques in certain
  settings
• Bio-banking and sample repositories

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HIPAA Documents and the IRB

• HIPAA Exempt
• HIPAA Waivers subject to approval
• Retrospective Chart Review
• Screening and Recruitment
• Decedent Data
• HIPAA Authorization for PHI

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Misconduct Defined

• (1) Fabrication, falsification, plagiarism and
  other forms of misappropriation of ideas, or
  additional practices that seriously deviate from
  those that are commonly accepted in the research
  community for proposing, conducting, or reporting
  research.
• (2) Material failure to comply with federal and
  University requirements for the protection of
  researchers, human subjects, or the general
  public or for ensuring the welfare of laboratory
  animals.

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Misconduct Defined (2)

• (3) Failure to adhere to other material legal
  requirements governing the field of research.
• (4) Failure to comply with established standards
  regarding author names on publications.
• (5) Retaliation of any kind against a person who
  reported or provided information about suspected
  or alleged misconduct and who has not acted in
  bad faith.

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Additional Definitions

• Plagiarism appropriation of another persons
  ideas, processes, results, or words without
  giving appropriate credit
• Fabrication making up data or results and
  recording or reporting them.
• Falsification manipulating research materials,
  equipment, or processes, or changing or omitting
  data or results such that the research is not
  accurately represented in the research record.

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Additional Definitions (2)

• Noncompliance Noncompliance is a failure by an
  investigator to abide by research related
  requirements, good clinical practice
  requirements, CPHS requirements and applicable
  regulatory requirements.
• Failure to obtain approval for research prior to
  initiating the research activities,
• Continuing research activities beyond the
  expiration date without obtaining continuing
  review approval,
• Failure to obtain informed consent when required,
• Failure to file an adverse event report,
• Implementing changes to the protocol without
  prior approval.

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Examples of Violated Research Ethics

• 1945-1946 - Nuremburg Trials
• Included studies on hypothermia, infectious
  disease, altitude, pharmacologics, sterilization,
  surgery and traumatic injuries
• 1950s Willowbrook Hepatitis Study (New York)
• Intentionally infected healthy retarded
  children by feeding them feces from children with
  active hepatitis (with food)
• 1955 The Wichita Jury Study (Kansas)
• Audiotaped jurors to analyze decision-making
  without consent
• 1962 The Thalidomide Experience (nationwide)
• Investigational treatment given to pregnant women
  to alleviate unpleasant symptoms

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Examples of Violated Research Ethics Cont.

• 1966 Ethics of Clinical Research published by
  Dr. Beecher (Harvard Medical School), NE Journal
  of Medicine
• Cited ethical violations in 22 published articles
• 1960s Jewish Chronic Disease Hospital Studies
  (New York)
• Injected live cancer cells in demented patients
  with weakened immune systems
• 1960s Milgram Studies of Obedience to
  Authority (Yale University)
• Participants deceived into thinking the study was
  evaluating the role of negative reinforcement on
  learning
• 1970s San Antonio Contraception Study
• Clinic randomized patients to active birth
  control or placebo

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Examples of Violated Research Ethics Cont.

• 1970s Tearoom Trade Study
• PhD Dissertation of Laud Humphreys from
  Washington University
• Observed men participating in sexual activities,
  served as a watch queen, copied license plates,
  and followed up with men one year later in
  disguise to gather additional information (i.e.
  marital status, employment, etc.)
• 1932 1972 Tuskegee Syphilis Study (Alabama)
• Evaluated the natural history of untreated
  syphilis
• Led to the creation of NIH Office for the
  Protection
• from Research Risks (now OHRP) and IRBs

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Oversight Of Human Subject Research

• 1949 Nuremberg Code
• 1964 WMA Declaration of Helsinki
• 1966 PHS policy leading to IRBs
• 1974 National Research Act of 1974 established
  45 CFR 46
• 1978 The Belmont Report
• 1991 Common rule

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Overview of Informed Consent Process and Forms

http//www.uth.tmc.edu/orsc/training/vids/informed
consent.html
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Informed Consent Overview

• All modern codes of ethics concerning research
  with human subjects affirm the moral importance
  of a principle of informed consent.
• The voluntary consent of the human subject is
  absolutely essential

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Overview (2)

• Obtaining consent is an ongoing process of
  communication and mutual understanding
• The process is misrepresented as
• A piece of paper
• A moment in time
• A legal contract

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Overview (3)

• Must be obtained for each research subject
• Must be obtained prior to initiation of screening
  procedures
• Must be tailored to the level of understanding
• If a medical term is essential, a lay definition
  is needed
• Sufficient opportunity must be given for
  consideration, no coercion

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Four Tenets

• Accurate Information
• Understanding
• Voluntariness
• Decision Making Capacity

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Practical Benefits

• Increases subject adherence to the protocol and
  the quality of the research.
• Provides the benefit of an additional layer of
  risk review tailored to the interests of the
  individual subject.
• Fosters public trust

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Four Reasons to Waive Informed Consent

• 1) Investigations that do not constitute research
  involving human subjects
• 2) Human subjects research that is exempt from
  compliance with federal regulations

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Four Reasons to Waive Informed Consent (2)

• 3) Non-exempt human subjects research in which it
  is not possible to obtain participants written
  informed consent
• For reasons of age, cognitive impairment, or the
  like, some individuals are incapable of providing
  informed consent
• Research in emergency medicine

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Four Reasons to Waive Informed Consent (2)

• 4) Non-exempt human subjects research in which it
  is not desirable to obtain participants written
  informed consent.
• a signed informed consent document may pose a
  risk to subjects, and
• obtaining informed consent may diminish the
  scientific merit of the research.

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CPHS Reviewer Checklist
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Office of Research Support Website
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IRIS

• https//iris.uth.tmc.edu/Login.jsp
• Electronic submission of protocols to the IRB
• Initial submission
• Change requests and amendments
• Continuing reviews
• Adverse Events, etc.
• Electronic routing and review by CPHS
• Notifications are electronic and available via
  e-mail and within iRIS

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Important Information

• iRIS Web Site http//iris.uth.tmc.edu
• CPHS Web Site http//www.uth.tmc.edu/orsc/index.h
  tml
• iRIS assistance 713-500-7960
• Office of Research Support Committees
  713-500-7943
• Robert Nobles 713-500-7937

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Discussion/Questions