Transcript Human Subjects - University Research Services Administration

University Research Services
and Administration
Office of Research Integrity
Institutional Review Board
Human Research Protections Program
Human Subjects
 Defined:
– Individual about whom an investigator,
whether professional or student, conducting
research obtains:
• Data through intervention or interaction with the
individual or
• identifiable private information
45CFR46.102(f)
Research
 Defined:
– a systematic investigation, including research
development, testing and evaluation, designed
to develop or contribute to generalizable
knowledge
45CFR46.102
Historical Ethical Violations
 The Willowbrook Hepatitis Study
– (1963-1966)
– New York
– Conducted on mentally retarded,
institutionalized children
– Involved systematically infecting the children
with hepatitis
– Parents were coerced into consenting
 The Brooklyn Jewish Chronic Disease
Cancer Study
– (1963)
– Indigent, elderly subjects were injected with
live cancer cells without their consent
 The Stanford Prison Experiment
– (1971)
– A psychology study of how ordinary people,
college students, can behave in aggressive and
dehumanizing ways based on the situation
– Subjects were divided into two groups,
“guards” and “prisoners”; the guards were
allowed to inflict escalating levels of pain and
humiliation on the “prisoners” over an
extended period of time which resulted in
extreme psychological stress
 Tuskegee Syphilis Study
– (1932-1972)
– US Public Health Service
– 400 poor, rural, southern African American
males
– Penicillin was accepted as the treatment for
syphilis in 1943, it was deliberately withheld
– “Sometimes, with the best of intentions,
scientists, public officials and others, involved
in working for the benefit of us all, forget that
people are people"
 Nazi Medical War Crimes
– “Medical experiments” were performed on
thousands of concentration camp prisoners,
and included deadly studies and tortures
– In December 1946, 23 physicians and
administrators were indicted before the War
Crimes Tribunal at Nuremberg, and 16 found
guilty in the August 1947 verdict
– Judges included a section called “Permissible
Medical Experiments,” now known as the
Nuremberg Code
Historical Guidelines
 Broad ethical guidelines that assist
scientists, subjects and society in
understanding the ethical issues related to
human subject research
 These historical guidelines have evolved
since the 1940's and serve as a framework
for current regulations
Historical Documents
 The Nuremberg Code, 1947
– Legal responsibilities
– (written by lawyers)
 The Declaration of Helsinki, 1964
– Ethical responsibilities
– (written by physicians)
 The Belmont Report, 1979
– Separation of research from practice
– (written by physicians)
Nuremberg Code
 10-point policy for ethical constraints obligatory
on anyone designing and conducting clinical
research studies
 Established the right of persons to choose
whether to participate in research
 Declared fundamental and sacred dignity of
human subjects who participate in research
Declaration of Helsinki
 Internationally recognized document which
addresses research personnel conduct and
other fundamental principles for
experimentation involving humans
 Established human subject protection
through presumption of investigator
integrity and ethical behavior
Belmont Report
 Ethical Principals
 Applications
– Respect for Persons
– Informed Consent
– Beneficence
– Risks and Benefits
– Justice
– Selection of Subjects
Elements of the Informed
Consent Document
 Study involves
research
– Purpose, duration,
procedures,
experimental




Risks/discomforts
Benefits
Alternative treatments
Confidentiality
 Compensation for
injury
 Contact Person
– Rights as subject
– Research related
injury
– Research in general
 Participation is
voluntary
Additional Consent Elements
as Appropriate
 Additional costs to
subject
 Number of subjects in
study
 Consequences of
subject’s decision to
withdraw
 Conveyance of
significant new
findings
 Investigator
termination of subject
 Unforeseeable risk to
subject, fetus or
embryo
The Informed Consent Should . . . .
 Give subjects all the information that they may
need to make a decision. The information
should be factual, complete, and accurate
 Ensure that subjects understand the information
– The document should be written at the lowest reading
level of the population being studied
– Give subjects an opportunity to consider participation
in the study on an initial and ongoing basis
 It is important to understand that the
informed consent is a process of
communication that occurs between the
subject and the researcher (s) throughout
the study
 It is not merely written information or a
signature on a page
Child Assent
 Parents must give consent for their children
to participate, but the children must assent
to participate
– Assent is an affirmative action on the part the
child indicating willingness to participate
– A child is a person who has not attained the
legal age of consent, 18 years in the state of
Georgia
 The child assent form must include the same
elements as the consent form, but must be written
at the appropriate age level for comprehension
 The average age when assent can be given is
generally age 6 and above
 Ages 6-10: verbal assent must be obtained and
documented by the researcher
 Ages 11-17: This age group must sign a separate
assent document
 The template for a model consent form can
be found on our website
– http://www.gsu.edu/irb
Institutional Review Board
(IRB)
Defined:
Any board, committee, or other group
formally designated by an institution to
review, to approve the initiation of, and to
conduct periodic review of research
involving human subjects
45 CFR 46
What Requires IRB Review?
 Any University research that uses humans,
human tissue, surveys of human subjects or
human subject’s records requires IRB
review, irrespective of the funding source
Scope of Review
IRB review and approval is required for any
research involving human subjects that:
 Is conducted by University faculty, staff or
students
 Is performed with or involves the use of
facilities or equipment belonging to the
University
 Considers the University to be engaged in
the research
More . . . .
 Satisfies a requirement imposed by the
University for a degree program or for
completion of a course of study
 Is certified by a dean or department head to
satisfy an obligation of a faculty
appointment at the University, including
clinical or adjunct appointments
What is Subject to Review?
 Research conducted
by “affiliated faculty”
 Research projects in
which the researcher
is a consultant
 Research conducted
in courses
 Research conducted
by students
 Research as pilot or
feasibility stage
 Research conducted at
another institution by
GSU personnel
 Research in foreign
countries
 Research involving
secondary use of data
 Research using
“waste and “extra”
material
Submitting an IRB Application
 New Projects
– Complete the IRB application electronically via iRIS
and route appropriately for signatures
– Necessary documents can be uploaded within iRIS:
•
•
•
•
•
Interview instrument (s)
Recruitment material
Audio visual material
Research protocol
If applicable
– Site permission letter
– Copy of the grant
● Informed
consent (s)
● Survey instrument (s)
● Newspaper Ad
Human Subjects Training
www.citiprogram.org
Collaborative Institutional Training Initiative
Human Subjects Training
 All researchers who interact with human subjects to
collect data or who handle data must complete a
required educational program on ethics and
procedures for the use of human subjects in research
before the IRB may approve a proposal.
 Georgia State University (GSU) has selected the
Collaborative IRB Training Initiative (CITI) as the
best and most efficient mechanism for delivering
education to GSU researchers involved with human
subjects research.
 The CITI certification is valid for three
years. At that time, it is necessary to
complete a refresher course.
 For Continuing Projects
– Completed Renewal Application
electronically via iRIS
– Upload all necessary documents
• Informed consents and/or assents (clean copy)
• If applicable, current site permission letters and
current approval letters from cooperating IRBs
– Because of the electronic system, reviewers
have access to all currently approved
documents being used (questionnaires,
recruitment materials, and scripts)
Review and Approval Process
 Exempt Protocols:
– Verified by IRB
member or IRB
compliance staff
– Process takes about 72
hours
 Expedited Protocols:
– Reviewed by:
• Compliance Staff
• IRB Member
• IRB Chairman
– Review process takes
approximately two
weeks
 Full Board Protocols:
– Reviewed and acted upon at regularly
scheduled monthly IRB meeting
Protocol Approval
 Protocols can be voted:
– Approved
– Approved, pending modifications: requires
modifications be made to protocol before
approval is obtained
– Deferred: requires major modifications and
will be reviewed again after revisions are
made
– Disapproved: extensive modifications and
complete resubmission required
Approved Protocols
 Expedited and Full Board protocols must
be reviewed and renewed to continue on an
annual basis
 Federal regulations require the IRB to
review continuing research at intervals
appropriate to degree of risk, but not less
than once annually
 GSU requires review of Exempt studies
every three years
 If you have contact with subjects or are analyzing
data, you are required to maintain current IRB
approval
 Investigators are sent reminder notices
approximately 60 days prior to the expiration
date of the IRB approval
 A lapse in approval mandates that the research
cease
 It is the ultimate responsibility of the investigator
to ensure the renewal application is completed
and received by the IRB for review and approval
in a timely manner
When the Research is Complete . . .
 Exempt Study . . .
– Study Closure Report
 Expedited Study . . .
– Study Closure Report
 Full Board Study . . .
– Study Closure Report
Deadlines
 Protocols requiring Full committee review
must be submitted no later than the 2nd
Monday of each month
 Protocols requiring Expedited or Exempt
review may be submitted at any time
Additional Information
 Susan Vogtner, BBA, CIM, CIP, Compliance Specialist, Sr.
[email protected]
404-413-3513
 Deonne McNeill, MS, Compliance Specialist
[email protected]
404-413-3503
 Christina Dobrovolny, MA, Assistant Director, HRPP
[email protected]
404-413-3638
 Shelia White, PhD, CIP, Director, HRPP
[email protected]
404-413-3514