Human Subjects Protection

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Human Subjects Protection University of Houston
- Downtown
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The first step in the evolution of ethics is a
sense of solidarity with other human beings.
Albert
Schweitzer
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Historical Background

• 5th Century Hippocrates Primum non nocere
  (First do no harm.)
• 1900 - Walter Reed conducted his yellow fever
  experiments with Spanish immigrant workers and
  soldiers in Cuba.
• 1941 to 1945 - Experimentation at concentration
  camps.
• 1947 - Judgment at Nuremberg Doctors Trial. Of
  the 23 physicians/scientists tried, 16 were found
  guilty and 7 were sentenced to death.

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Historical Background (cont)

• 1932 1972 the U.S. Public Health Service
  conducted an experiment in Tuskegee, Alabama.
  More than 400 uneducated, poor black men were
  enrolled to follow the natural course of
  syphilis.
• 1964 World Medical Association adopts Helsinki
  Declaration. Recognized the difference between
  therapeutic and non-therapeutic research.
• 1966 The Office for Protection from Research
  Risks (OPRR) was established in NIH. Established
  the use of local institutional review boards
  (IRBs).

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Historical Background (cont)

• 1973 Final Report of Tuskegee Syphilis Study
  concluding that Society can no longer afford to
  leave the balancing of individual rights against
  scientific progress to the scientific
  community.
• 1974 National Research Act upgraded OPRR
  policies to regulations and is now known as the
  Common Rule. Established the National Commission
  for the Protection of Human Subjects.
• 1975 HHS promulgates Title 45 of Federal
  Regulations titled Protection of Human
  Subjects.

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Historical Background (cont)

• 1979 National Commission for the Protection of
  Human Subjects issues the Belmont Report.
  Establishes 3 basic ethical principles respect
  for person, beneficence and justice.
• 1991 Subject commits suicide after
  participating in a study on relapse of
  schizophrenics withdrawn from medication at
  UCLA.
• 1999 18-year old subject dies in a gene
  therapy experiment at U of Pennsylvania.

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Historical Background (cont)

• 2000 OPRR becomes the Office of Human Research
  Protection (OHRP) and is moved from the NIH to
  the Department of Health and Human Services
  (HHS).
• 2001 Healthy volunteer dies in an asthma study
  at Johns Hopkins University.

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The moral test of any society is how it cares for
the people in the dawn of life the children the
twilight of life the elderly and the shadows of
life the sick and disenfranchised.
Hubert H.
Humphrey
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FEDERAL REGULATIONS

• 45 CFR 46, a.k.a. the common rule,
• is the federal regulation which applies to most
  research using human subjects.
• 21 CFR 50 56 applies to research which falls
  under the Food Drug Administration.

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WHAT IS RESEARCH?
Research is defined as a systematic
investigation, including research development,
testing and evaluation, designed to develop or
contribute to generalizable knowledge. 45 CFR
46.102(d)
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WHAT IS A HUMAN SUBJECT?
Human subject means a living individual about
whom an investigator (whether professional or
student) conducting research obtains (1) data or
(2) identifiable private information through
intervention or interaction with the individual.
45 CFR 46.102(f)
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45 CFR 46

• Besides defining research and human subjects, 45
  CFR 46 defines the responsibilities of
  institutions engaged in research and their
  Institutional Review Boards (IRB). At UHD, the
  Human Subjects Committee is the IRB charged with
  these responsibilities.
• IRB membership The committee must include at
  least five members with the professional
  competence necessary to review research
  activities, plus at least one member whose
  primary concerns are in nonscientific areas and
  one member not affiliated with UHD.
• The IRB has the authority to approve, require
  modifications, or disapprove research.

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45 CFR 46

• In order to approve research, the IRB shall
• determine that all of the following have been
  
• satisfied
• (1) risks to subjects are minimized (2)
  risks to subjects are reasonable in relation to
• anticipated benefits (if any) and the
  importance of the knowledge that may be
  expected (3) selection of subjects is
  equitable (4) informed consent will be
  sought (5) informed consent will be
  documented (6) when appropriate, data safety
  monitoring and (7) when appropriate, there are
  adequate provisions made
• to protect the privacy of subjects and maintain
• confidentiality.

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45 CFR 46

• 45 CFR 46 also defines the required elements of
  informed consent, and gives standards for IRBs to
  use in deciding how informed consent must be
  documented and when it may be waived.
• It sets up two special review categories for
  low-risk research exempt and expedited.
  Both still require IRB review and approval, but
  may be reviewed by an IRB subcommittee instead of
  the full committee. In addition, IRBs may decide
  not to require the yearly periodic review of
  exempt projects that is required of all other
  research projects.
• Finally, the federal code provides definitions
  and guidance on conditions that must be met to
  study vulnerable populations, such as prisoners,
  children, and pregnant women.

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The UHD Application Form
The UHD application form was designed to
assist the applicant in providing all the
information needed by the Committee to approve a
project. It can be downloaded and filled out on
the investigators computer before being printed,
signed, and copied. It must be submitted 4-6
weeks before IRB approval is needed. The
form can be found on the UHD Human Subjects
Protection website http//www.uhd.edu/researc
h/phs/
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UHD Application (cont.)
The first page of the UHD application asks for
contact information on the investigator(s), the
type of review requested, the title of the
project, and the projected time frame for your
study. For student applicants, information must
also be supplied about the faculty sponsor.
It then requests a lay summary of the project,
which means a short summary that a nonscientist
can understand. It specifically asks you to
include information on the who (subjects),
where, how (methodology) and why (thesis)
of your project.
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UHD Application (cont)

• The second third pages of the application ask
  for more specific information about procedures
  and your projects risks benefits.
• Two requests frequently cause confusion
• The Informed Consent Process
• Anonymity Confidentiality Precautions

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UHD Application (cont.)

• The Informed Consent Process must include these 8
  basic elements
• Who you are
• What you are doing
• Why you are doing it
• What subjects will be asked to do how long your
  participation will take
• That participation is voluntary
• That there will be no penalty for not
  participating or for withdrawal from the study
• How confidentiality/anonymity will be handled
• Who to call with any questions or concerns
  regarding the research project

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UHD Application (cont)
Please note Informed consent is a process
not a piece of paper. It must be obtained in a
manner that allows subjects to voluntarily agree
or decline to participate. Consent scripts
and forms must therefore be requested in language
easily understood by all potential subjects,
generally considered an 8th grade reading level
for the general public. They must include all 8
basic elements of informed consent, and you must
give copies to all your subjects.
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UHD Application (cont.)

• Anonymity and confidentiality protect your
  subjects privacy, but in different ways
• Anonymity protects subjects privacy by
  maintaining no record of their identity. Even
  informed consent forms constitute a record, which
  is why they are sometimes waived.
• Confidentiality protects subjects privacy by
  keeping identifying information separate from the
  data gathered, coding any identity category on
  the data set, and locking up the list of subjects
  by code until the list is destroyed.

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UHD Application (cont.)

• The last page of the application asks you to
  attach all the research materials your
  application refers to, or which are required.
  Examples
• Recruitment letter/ad/protocol
• Informed Consent script/form/letter
• Child Assent form
• Questionnaire
• Cover letter
• Debriefing script/form
• Certification of Human Subjects Training
• Consent from Site

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For A Successful Review

• Dont wait until you have a project pending to
  start preparing.
• Learn about human subjects protection,
  including taking the online course required
  before applying.
• Think through all the aspects of human subjects
  protection before planning your project.
• Make sure your application specifies all of the
  information requested.
• Submit your application to the committee 4-6
  weeks before you need to start collecting data.

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Summary

• Human Subjects Protection is a professional and
  institutional responsibility, which requires
• education
• conscious research planning
• peer review
• You have just taken the first steps to fulfill
  this responsibility.
• Thank you!