Research Proposal, Farmers Rights

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					Human Subjects
 Research 101
    Revised January 2008
             Presentation Goals
   Discuss Human Subjects Research
    – Definitions
   Historical Background
   Identify Ethical and Legal Requirements
    – Belmont Report
    – 45 CFR 46 – “The Common Rule”
   Describe Institutional Review Board
    – Structure & Policies
   Implications For Student Research
          Why Discuss
     Human Subjects Research?
   Federal guidelines
   Messiah College policy regarding all
    research involving human subjects
   Preparation for graduate studies
   What Is Human Subjects
     Research? – Part I
     Federal definition of research

A systematic investigation, including
research development, testing, and
evaluation designed to develop or
contribute to generalizable knowledge.
      What Is Human Subjects
       Research? – Part II
    Federal definition of human subject
    A living individual about whom an
    investigator (professional or student)
    conducting research obtains
   Data through intervention or
    interaction with the individual, or
   Identifiable private information.
     Definitions Continued
   Intervention includes both physical
    procedures by which data are gathered
    and manipulations of subject or
    subject’s environment that are
    performed for research purposes.
   Interaction includes communication or
    interpersonal contact between
    investigator and subject.
     Definitions Continued
   Private information includes
    information about behavior that occurs
    in a context in which an individual can
    reasonably expect that no observation
    or recording is taking place, and
    information which has been provided for
    specific purposes by an individual and
    which the individual can reasonably
    expect will not be made public.
         The Nuremberg Trial
   Trial of Nazi doctors who experimented
    on 300 Dachau concentration camp
    prisoner-subjects, of whom 30% died.
   Held from December 9, 1946 to August
    20, 1947.
   23 defendants charged with murder,
    torture, and other atrocities committed
    in the name of medical science. 15
    found guilty.
       Nuremberg Code - 1947
   Written as part of the judgment of the
    Nazi trials.
   Became the “ethical yardstick” by which
    the defendants had been measured and
    guilt determined.
   Essential reading for everybody
    involved in human subject research.
Principles of Nuremberg Code
   Voluntary informed consent is essential
   Research should yield useful results
   Risk must be outweighed by importance
    of research
   Base research on prior animal
   Avoid physical and mental suffering
Principles of Nuremberg Code
   Only qualified scientists may conduct
   Subjects may withdraw from study
   Investigators must be willing to withdraw
   No expectation of death or disabling
     Effect of Nuremberg Code
   Code largely ignored until 1964
    because researchers did not see the
    relevancy to their own work
    – Hippocratic oath

   Missed a lot of important aspects of
    – Children and informed consent
    – People with diminished mental capacity and
      informed consent
    Declaration of Helsinki - 1964
   Rules developed by researchers and
   Reinterpretation of Nuremberg
   Became required for publication in
    scientific journals to state that the
    research abided by the Declaration of
    Public Health Service Policy
   1966: All PHS supported research must
    undergo prior review to:
    – Protect the rights and welfare of subjects
    – Assure appropriate informed consent
    – Determine acceptable risk/benefit balance

            Beginnings of the IRB
         (Institutional Review Board)
         Era of Standards
 Standards   accepted by researchers
 Standards accepted by the media
 Standards became the accepted
  principles for judgment of research
  – Thalidomide Trial
  – Jewish Chronic Disease Study
  – Willowbrook Hepatitis Study
  – Hidden Recorder Studies
  – Milgram Study
  – Tuskegee Study
        The Tuskegee Study
 Purpose: identify the natural history of
  untreated syphilis
 Began in 1932
 Involved 300 black males with syphilis
 1933 – added 300 controls
 Was initially supposed to last 1 year
 Study stopped in March of 1973 after
  government investigations and public
       Syphilis Study Problems
   Lack of respect for persons
    – No informed consent
    – Deception
    – Coercion
   Lack of good will to subjects
    – Withholding effective treatment (penicillin)
    – No continuing review of the research
   Unjust
    – Used an extremely vulnerable population: illiterate,
      poor farmers in rural Alabama
    Response to Research Abuses
   1974 – Congress passes the National
    Research Act
    – Requirements for informed consent
    – Necessary review of research by IRB
 May 1974 – First version of 45 CFR 46
 April 1979 – The Belmont Report
 1981 – Revision of 45 CFR 46
 1991 – Common Rule: 56 FR 28003
 2001 – Latest revision of 45 CFR 46
  incorporates Common Rule
       The Belmont Principles:
       How They Came About
 1974 – establishment of the National
  Commission by the federal government
 Task
    – “Identify basic ethical principles that underlie the
      conduct of human research.”
    – Develop guidelines to ensure that human research
      follows these principles
   1979 – The Belmont Report: current set
    of federal regulations
     The Belmont Principles

 Respect   for persons
 Beneficence

 Justice
          Respect for Persons
   Treat individual as autonomous agents
   Do not use people as a means to an
   Allow people to choose for themselves
   Give extra protection to those with
    limited autonomy and have an inability
    to choose for themselves
   Do no harm
   Prevent harm
   Prevent evil
   Promote good
   Maximize possible benefits and
    minimize risk
    – Benefits to individual and/or to society
    – Risk: consider physical, social, legal, economic,
   Fair sharing of burdens and benefits of
    – Selection of subjects should not systematically
      draw from certain classes simply because of their
      easy availability
    – Inclusion of diverse populations/groups
    – Subjects should have a future chance of benefiting
      personally from the subsequent applications of
      research findings
Rules Derived From Principles
   Respect for persons
    – Informed Consent
    – Respect for privacy
        • Confidentiality
        • Anonymity
   Beneficence
    – Good research design
    – Competent investigators
    – Favorable risk/benefit analysis
   Justice
    – Equitable selection of research subjects
Conflict in Belmont Principles
   Conflict is expected
    – Sometimes decisions that are made utilizing the
      principles may yield different outcomes,
      depending on which principle is being considered:
      one decision is to approve the research, one to
      limit the research, one to deny the research
   Remember: all 3 principles are on
    equal footing with equal moral force.
    – Consider each situation individually
    – Carefully review the principles
    – Avoid the tendency to always put one principle
      above another
Code of Federal
  45 CFR 46
       Title 45 of CFR Part 46
   Codified by the government in 1991
    – Based on Belmont Principles, 56 FR 28003
    – Title 45: Public Welfare and Human Services
    – Part 46: Protection of Human Subjects

   Last revised in November 2001
   Supporting agencies
    – Department of Health & Human Services
    – National Institutes of Health
    – Office for Human Research Protections
      Title 45 of CFR Part 46
   Subpart A – Basic DHHS Policy for the
    Protection of Human Research Subjects
   Subpart B – Pregnant Women, Human
    Fetuses and Neonates Involved in
   Subpart C – Prisoners
   Subpart D - Children
Institutional Review
     Institutional Review Board
   DHHS requirement for all human
    subjects research sponsored by federal
   Regulations for IRB found in 45 CFR
             IRB Structure
   Minimum of 5 members with varying
    academic backgrounds
   Every nondiscriminatory effort will be
    made to ensure diversity (e.g., race,
    gender, cultural)
   One member who primary training is in
    nonscientific areas
   One member whose primary training is in
    scientific areas
   One member from the community
       Primary Duties of IRB
   Protect human subjects from undue risk &
    deprivation of human rights and dignity
   Ensure confidentiality and voluntary
    participation of subjects
   Balance potential benefits with risks
   Determine appropriateness of research
    design & study methods
   Assist researcher through peer review and
    institutional approval
   Ensure research compliance with DHHS
    regulations & other funding agencies
Is Any Research Exempt From
Yes, if the research involves no more
than minimal risk to subjects, no ethical
concerns, does not involve vulnerable
subjects, and meets at least one of the
exempt research categories established
by the government regulations. IRB
chair can make this determination.
            Expedited Review
   Nine governmentally designated
    research categories that allow for
    expedited review
   Proposal distributed to all IRB members
    and all must agree on expedited review
   Approval by one designated reviewer
    – Reviewer cannot disapprove research. Must go to
      full IRB for rejection.
   Decision reported to IRB at next
Informed Consent
               Informed Consent
   “Informed consent is a process of
    information exchange that takes place
    between the prospective subject and
    the investigator, before, during, and
    sometimes after the study.”
    Dunn & Chadwick (1999), Protecting Study Volunteers in Research

 Information
 Comprehension
 Voluntariness
       Essential Basic Elements
   Research                Compensation for
    – Purpose/Duration       injury
    – Procedures
    – Experimental          Whom to contact
   Risks                    re:
                             – Study, subject’s
   Benefits                   rights, event of
   Alternatives
   Confidentiality         Right to refuse or
         Additional Elements
   Currently unforeseeable risks
   Termination of participation
   Additional costs to subjects
   Consequence of withdrawal
   Informing of new findings
   Number of subjects
         Other Considerations
   There are situations where DHHS
    regulations allow for waiver of informed
   There are also situations where DHHS
    regulations allow for exception to
    providing written documentation of
    informed consent.
     Informed Consent Process
   Sufficient time to make decision
   Sufficient opportunity to ask questions
   Strategies to minimize coercion
   Avoid overstating benefits
   Ensure an understanding of
   Be sensitive to subject’s needs
     Informed Consent Process
   Train individuals obtaining consent
   Fully explain use of technology or
    innovative approaches
   Make adjustments in process, as
   Obtain IRB approval for changes
 Implications For
Faculty and Student
What Does This Mean For Me?
   MC policy applies only to research in certain cases;
    determination can be made by IRB in consultation
    with IRB chair.
   Approval must be obtained from the IRB prior to
    beginning research, including any research that will
    be disseminated beyond the classroom, including
    public presentations and publications.
   Student projects that will not be disseminated beyond
    the classroom are considered course assignments
    and not subject to regulations.
   However, all research must be done with due
    consideration of Messiah’s ethical and legal
    responsibility to protect subjects.
Research Likely Exempt From
         Review - #1
Educational tests (cognitive, diagnostic,
aptitude, achievement), survey
procedures, interview procedures, or
observation of public behavior, if
minimal risk, no correlation between
subjects/responses, and no vulnerable
population included. (Category #2)
         Anonymous Versus
   Anonymous: No way to trace
    responses to an individual person. Will
    not use any coding system or be able
    to trace responses to a person (e.g.,
    ethnicity, gender, etc.)
   Confidential: Can trace responses to
    an individual, even though this may not
    be revealed beyond the investigative
 Research Likely Exempt From
          Review - #2
Research involving the collection or
study of existing data, documents,
records, or specimens if these sources
are publicly available or the information is
recorded in such a way that subjects
cannot be identified, indirectly or through
identifiers linked to the subjects.
(Category #4)
Research Likely Exempt From
         Review - #3
Taste and food quality evaluation and
consumer acceptance studies if
wholesome foods without additives are
consumed or food contains ingredients
approved by FDA, EPA, or USDA.
(Category #6)
    If You Plan on Conducting a
          Research Study
   Complete Form 100 – Request for
    Review of Faculty Project
   If a student: Work with course
    professor to complete Form 050 –
    Request for Review of Student Project
   Submit application and proposal to
    Provost’s Office, Box 3016.
   If you have questions, contact Jenny
    Dose, IRB Chair (ext. 2320).

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