Human Subjects
Research
created April, 2009
• Short pre-test
• Presentation Objectives
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NIH Comment
background
regulation, policy and Federal Assurance
considerations
SIT institutional processes involved in animal research
ethical considerations
available resources
• Reference Material
• Faculty Presentation
• Case Study and Discussion
• Short post-test
RCR
– Human Subjects
created April, 2009
“Investigators must balance their interest in gathering data
and answering research questions with society’s mandate
to protect the rights and safeguard the welfare of research
subjects.” (1)
National Institutes of Health
“Society has granted a conditional privilege to perform
research on human beings……the condition is that it must
be conducted in a way that puts the rights and welfare of
human subjects first.” (1)
National Institute of Health
RCR
– Human Subjects
created April, 2009
•
Nuremberg Code of 1947
(2)
result of medical experiments performed in German concentration camps
during World War II. “…The great weight of evidence before us it to the effect
that certain types of medical experiments…conform to the ethics of the medical
profession generally…however…certain basic principles must be observed in
order to satisfy moral, ethical and legal concepts…”
•
Declaration of Helsinki adopted in 1964
(3)
adopted by World Medical Association and forms the basis of most subsequent
documents addressing human subjects research. Introduced concept of
oversight by an ‘independent committee’ which became a system of Institutional
Review Boards
•
Belmont Report
(4)
culmination of the work a national commission began in 1974. It was adopted
by NIH in its entirety.
RCR
– Human Subjects
created April, 2009
45 CFR 46 – Protection of Human Subjects
-- http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf
Stevens’ Institutional Policy “Human Subjects/IRB”
Stevens’ Federal Wide Assurance with National Institutes of Health,
Office for Human Research Protections (NIH OHRP) – FWA00014433
Stevens’ IRB Registration with NIH/OHRP – IORG0004982
RCR
– Human Subjects
created April, 2009
(5)
The three most often cited concepts
associated with human subjects research
are:
• Autonomy
• Beneficence
• Justice
RCR
– Human Subjects
created April, 2009
AUTONOMY
(voluntary informed consent)
> Controversy in Berlin Led to Ethical Code & Inf. Consent
• Dr. Albert Neisser “treated” Berlin prostitutes without their knowledge using
serum from recovering syphilis patients in the belief he was discovering a cure
• Caused epidemic of syphilis among prostitutes & their customers.
• Rudolf Virchow recommended code for research with humans to prevent future
breaches of ethics.
> Berlin Code of 29 Dec 1900
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•
•
•
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Required unambiguous consent
Required study be conducted or directed by the institute medical director
Excluded use of minors or incompetent subjects
Req. documentation of fulfillment of code requirements in subjects records
Did not interfere with standard diagnostics, care and prophylaxis
(Slide information taken from “Time Passages: Local Military Medical History
Connections” Art Anderson MD, Office of Human Use and Ethics, USAMRID)
RCR
– Human Subjects
created April, 2009
(6)
BENEFICENCE
(good science & favorable benefit to risk ratio)
> 1777 Variolation* of the Troops Helped Win the
Revolutionary War
•
•
•
•
George Washington's experiences during the French and Indian
War convinced him that Smallpox was a bar to success of the
Revolution
Washington proclaimed smallpox to be his ““most dangerous
foe;””and, by 1777 he had all his soldiers variolated
He also ordered all new recruits to be variolated as soon as they
enlisted
Fortunately, in this case, the ends of these actions did justify
the means
(Slide information taken from “Time Passages: Local Military Medical History
Connections” Art Anderson MD, Office of Human Use and Ethics, USAMRID)
RCR
– Human Subjects
created April, 2009
(6)
JUSTICE (7)
(equal opportunity to participate and to not participate)
> “Tuskegee Study of Untreated Syphilis in the Negro Male”
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•
•
•
•
•
study conducted by the Public Health Service between 1932-1972
human subjects were 399 poor, mostly illiterate, African American
sharecroppers
study for research related to the natural progression of the disease if
left untreated
researchers failed to treat patients appropriately after 1940s
validation of penicillin as effective cure for syphilis
participants were prevented from accessing syphilis treatment
programs available to other people in the area
a leak to the press in 1972 resulted in its termination
RCR
– Human Subjects
created April, 2009
Often, human subjects research is done in conjunction with a sponsored
research project. Proposals for sponsored projects should be submitted to the
Faculty Support Center
Protocols for human subjects research as part of a sponsored project are
separate activities. Human subjects protocols should be submitted to the
IRB
Investigator must initiate and submit the human subjects research
protocol to the IRB – understanding sponsor requirements for
approvals and proposal deadlines
Funding for sponsored projects involving the use of human
subjects WILL NOT be enabled until IRB approval is received
and verified in OSR
RCR
– Human Subjects
created April, 2009
NIH, the most common federal agency to which PI’s would
submit research proposals that might include human
subjects typically has three submission cycles each year. The
timeline shown below is offered to help with planning the
preparation and submission of various required materials:
Feb. 5 Proposal
Deadline = mid
January FSC
Deadline
Mar-Apr = SIT IRB
Sep-Oct Council
review process Review = full SIT IRB
protocol
submitted to SIT
approval submitted for
IRB
JIT
PROPOSAL
SUBMISSION
PROPOSAL
SUBMISSION
Cycle
1
Cycle2
33
Cycle 1
Cycle 2 Cycle
Cycle
Feb
55
June
5 5
Feb.
June5 5 Oct
Oct.
PEER REVIEW
Cycle 1 Cycle 2 Cycle 3
Jun-Jul Oct-Nov Feb-Mar
COUNCIL REVIEW
Cycle 1 Cycle 2 Cycle 3
Sep-Oct Jan-Feb May-Jun
RCR
– Human Subjects
createdApril, 2009
EARLIEST FUNDING
Cycle 1 Cycle 2 Cycle 3
Dec.
April
July
• Be aware of the need for Institutional Review Board
review and approval
-- ‘exempt’ is a category, it does not imply an investigator is
‘exempt’ from the application process
(8)
RCR
–Animal Research
created April, 2009
• Office of Sponsored Research
• Can provide assistance and direction for investigators
contemplating animal research
• 201.216.8762 – Barbara DeHaven, Executive Director
• Institutional Review Board
• Duly constituted committee at Stevens charged with the review
and approval of all human subjects research done at the
Institute
• 201.216.5032 – Dr. Zvi Aronson, IRB Chair
• Office of Institutional Risk, Compliance and Audit
• Chuck Shaw – 3rd Floor Howe Center – 201.216.8568
RCR
– Human Subjects
created April, 2009
1.
2.
3.
4.
5.
6.
“Guidelines for the Conduct of Research Involving Human Subjects at
the National Institute of Health” http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf
“Nuremberg Code of 1947” http://www.hhs.gov/ohrp/references/nurcode.htm
“The Helsinki Declaration” http://www.cirp.org/library/ethics/helsinki/
“The Belmont Report” http://ohrp.osophs.dhhs.gov/humansubjects/guidance/Belmont.htm
“45 CFR 46
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
“Time Passages: Local Military Medical History Connections” Art
Anderson MD, Office of Human Use and Ethics, USAMRID)
http://www.geocities.com/artandersonmd/med_history.pdf
7.
“The Tuskegee Study of Untreated Syphilis in the Negro Male”
http://en.wikipedia.org/wiki/Tuskegee_Study_of_Untreated_Syphilis_in_the_Negro_Male
8.
www.cartoonstock.com
RCR
– Human Subjects
created April, 2009
Dr. Peter Dominick Asst. Professor,
Howe School of
Technology
Management
RCR
– Human Subjects
created April, 2009

Academic
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Zvi Aronson, Ph.D. Industrial/Organizational Psychology
Peter Dominick, Ph.D. Industrial/Organizational Psychology
Patricia Holahan, Ph.D.
Organizational behavior
Ann Mooney, Ph.D.
Organizational behavior
Medical and Mental Health
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Glen Atlas, M.D. Anesthesiologist at UMDNJ
Terence Hannigan, Ph.D. Clinical Psychologist
Vincent Grasso M.D.
@ P. Dominick, 2009
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Twelve Submissions in the past two years
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Ten accepted with no or minimal revisions
Two were rejected each after two rounds of review
@ P. Dominick, 2009
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Any studies that will involve human subjects
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Medical and biomedical
Social sciences
 Psychology
 Sociology
 Anthropology
 Ethics
Management practices
 Computer science
 Some studies in biology and chemistry

@ P. Dominick, 2009
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Subjects ostensibly assigned to be “learners”
or “teachers”
“Teachers” must administer shocks to
“learners” each time they make a mistake
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“Learners” and “teachers” located in different
rooms
Shocks are painful but not harmful
“teachers” will hear “learners” react to the pain
@ P. Dominick, 2009
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What concerns would you have?
Who do you think might be harmed by this
research?
What questions would you ask of the
researcher?
Would you reject it?
Might you seek to modify the experiment?
@ P. Dominick, 2009

Original Studies made profound contributions
to Social Psychology
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68 percent of “teachers” complied with
experimenters instructions and administered 450
volt shocks repeatedly
Also considered the paradigmatic example of
why psychology experiments must be reviewed
by IRB’s
Many said they “would never be replicated”
@ P. Dominick, 2009

Studies were replicated in 2006
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Stopped at 150 volts instead of 450 volts
Immediate feedback to participants
15 volt “test shock”
Two step screening process to ensure participants could handle the
experience
“Of course, I also needed IRB approval. I knew from my own
participation on the IRB that the proposal would be met with concern
and perhaps a little fear by the board’s members. . . . To address these
concerns, I created a list of individuals who were experts on Milgram’s
studies and the ethical questions surrounding this research. I offered to
make this list available to the IRB. More important, Steven Breckler, a
social psychologist who currently serves as the executive director for
science at the American Psychological Association, graciously provided
an assessment of the proposal’s ethical issues that I shared with the IRB.
“ Jerry Burger
@ P. Dominick, 2009
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Instructional strategies conducted in established or commonly
accepted educational settings
The use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or
observation of public behavior
Collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if sources are
publicly available, or if the information is recorded with complete
anonymity
Taste and food quality evaluation and consumer acceptance
studies, if:
wholesome foods without additives
 food that contains an ingredient that is found to be safe
 agricultural chemical or environmental contaminant at or below the
level FDA, EPA and or the Food Safety and Inspection Service of the
U.S.D.A. deems to be safe

@ P. Dominick, 2009
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Collection of hair and nail samples
Collection of excreta and external secretions
Recording of data from subject 18 years of age or older
using noninvasive procedures
Collection of blood samples in minimal amounts
Collection of dental plaque and calculus
Voice recording
Moderate exercise by health volunteers
Study of existing data
Research on an individual or group behavior that
involves no manipulation of the subjects and is not
stressful
@ P. Dominick, 2009
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Most research that involves children, prisoners,
pregnant women, fetuses and other vulnerable
populations
Research that involves experimental drugs or
devices
Research that involves most invasive
procedures
Survey research that involves sensitive
questions or is likely to be stressful for the
subject
@ P. Dominick, 2009

Contact Zvi Aronson if engaging in any
research that involves human subjects
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Confidentiality form (Anonymity)
Consent Form (Justice)
Rationale Form (Beneficence)
 Brief descriptions of ( usually just a few paragraphs)
 key research question
 types of participants sought
 experimental procedures/protocol (including any
deception)
 procedures for ensuring confidentiality and subject wellbeing
 Procedures for attaining consent
@ P. Dominick, 2009

Autonomy
Will people have the opportunity to opt in or out of my research?
 Are those involved capable of making an informed decision about
participation?
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Beneficence
What are the major benefits to be derived from my research?
 How do they compare to any risks?
 In what ways might people better off because of my study?
 Subjects
 General population?
 Are there other less invasive ways to learn the same things?

Justice

Is this study fair to those who are involved?
 Will it deny them other opportunities that may be of benefit to them?
 How might they be affected or changed as a result of their experience?

@ P. Dominick, 2009
Bob is working hard to complete his Master’s degree in the Psychology
Department’s program of Research and Related Ethics through the
Institute for Social and Humane Ethics at Prestigious University. His
thesis focuses on the residual effects of severe psychological trauma
throughout a lifetime. Specifically, he’s chosen to focus on Holocaust
survivors from World War II. He’s gotten into a significant time crunch as
the literature review took longer than anticipated and he had an
unexpected family emergency during that same time. He needs
interviews with survivors in order to make his data credible but knows he
needs to submit a protocol to his institutional IRB for review and approval.
That will add an additional two months (minimum) to his timeline that he
frankly doesn’t have. Bob is sensitive to his research population and he’ll
be careful. He really needs the interview data and decides to go ahead
without submitting the protocol for review. Since he’s doing the
interviews without IRB approval he decides he doesn’t need to be
concerned about the informed consent.
Consider the following:
RCR
–Human Subjects
created April, 2009
Q:
A:
Who will, or might be affected by Bob’s decision
to forego the required IRB application, review and
approval process?
-- The Holocaust survivors
-- Bob
-- The Institute for Social and Humane Ethics
-- Prestigious University
RCR
–Human Subjects
created April, 2009
Q:
A:
What are the possible consequences of Bob’s
decision not to observe the requirement for
protocol application, review and approval?
The Holocaust survivors could definitely be affected as recalling
memories of such experiences could be severely distressing, cause
panic, or even result in an adverse medical event for this extremely
aged population
Bob will be affected if it is discovered that he has violated one of the
integral tenets of human subjects research. His degree could be in
jeopardy and he would be disgraced. There is a likelihood that none
of his data would be accepted in support of the thesis.
Lastly, the Institute for Social and Humane Ethics would probably be
embarrassed……at a minimum
RCR
–Human Subjects
created April, 2009
Q:
A:
Are there any laws, regulations, or institutional
policies that may apply to this situation?
------
The Nuremberg Code
The Helsinki Declaration
The Belmont Report
45 CFR 46
Prestigious University’s Policy on the inclusion of human subjects
in research
-- Code of professional ethics of the American Psychological
Association
RCR
–Human Subjects
created April, 2009
Q:
A:
If Bob had submitted the protocol for review
as required, what items might the IRB have
been concerned with?
-- Informed Consent
* IRB would have wanted adequate description of the
benefits and risks for this population
* IRB would have wanted a warning that some of the questions might
cause distress and that subjects could stop at any time
* IRB would have wanted to ensure Bob had planned for the possibility
that recalling the subject matter content for some of the subjects might
even result in an adverse medical event and what were his plans if that
happened
* IRB would have required Bob to include resources for subjects
who might need psychological assistance as the result of recalling
repressed memories
RCR
–Human Subjects
created April, 2009
created April, 2009
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RCR – Human Subjects - Stevens Institute of Technology