Human Participants
Research at the
University of Northern Iowa
Information for Students,
Faculty & Staff at UNI
Objectives
Understand the historical context in which
the ethical principles of research evolved.
Know the ethical principles governing
human research (the “Belmont principles”).
Understand how to apply the ethical
principles to one’s own research.
Understand the role of the IRB and how to
navigate the IRB review process.
Nazi Medical Experiments in WWII
Concentration Camps
International Response
Nuremburg War Trials
German doctors were charged with crimes against humanity for
“performing medical experiments upon concentration camp inmates
and other living human subjects, without their consent, in the course
of which experiments the defendants committed murders,
brutalities, cruelties, tortures, atrocities, and other inhuman acts.”
Nuremberg Code - 1947
As part of the verdict, the Court enumerated ten
rules for “Permissible Medical Experiments”,
now known as the “Nuremberg Code”. Among
others, the rules include:
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Voluntary consent is absolutely essential
Benefits outweigh risks
Ability of the subject to terminate participation
Did the Nuremberg Code Impact
the behavior of American
scientists who did research on
humans?
No
Well Known Cases Involving
Unethical or Questionable Research
in the U.S.
Tuskegee Syphilis Study: 1932-1972
Guatemalan Syphilis Study: 1946-1948
U.S. Radiation Experiments: 1944-1974
Willowbrook Study: 1956-1972
Milgram Authority/Conformity Study: 1961
Jewish Chronic Disease Hospital: 1963
Zimbardo’s Stanford Prison Study: 1971
Tearoom Trade Study: 1970
Tuskegee Syphilis Study (1932-72)
American medical research project
conducted by the U.S. Public
Health Service from 1932 to 1972
examined the natural course of
untreated syphilis in black men.
The subjects, impoverished
sharecroppers from Macon
County, Alabama, were unknowing
participants in the study; they were
not told that they had syphilis, nor
were they offered effective
treatment after a cure was found.
Guatemalan Syphilis Study
(1946-48)
U.S. Public Health
employees purposefully
infected over 1300
prostitutes, prisoners, mental
patients, and soldiers in
Guatemala with STDs
without their knowledge.
Only some were treated, and
83 may have died as a result
of the diseases.
US National Research Act of 1974
Revelations of Tuskegee Study resulted in
Senate investigation into research activities
Led to passage of National Research Act
Established National Commission for the
Protection of Human Subjects
Belmont Report – 1979
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Ethical Principles and Guidelines for the Protection of
Human Subjects of Research
Code of Federal Regulations – 45 CFR 46
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Creation of IRBs
Basic Principles of Belmont Report
Respect for persons
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Proclaims individuals capable of self-determination;
thus voluntary consent is essential (autonomy)
Beneficence
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Obligates researchers to maximize potential benefits
and minimize possible harm
Justice
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Requires the benefits and burdens of research be
fairly distributed
Federal Regulations for the Protection
of Subjects from Research Risks
45 CFR Part 46
Common Rule
1981/1991/2005
Federal Regulations and Policy
Additional Protections Included in 45 CFR 46:
Subpart B - Additional Protections for Pregnant
Women, Human Fetuses and Neonates Involved
in Research (revised December 13, 2001)
Subpart C - Additional DHHS Protections
Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
Subpart D - Additional DHHS Protections for
Children Involved as Subjects in Research
Federalwide Assurance (FWA)
What is an Institutional Assurance?
Issued by the Office for Human Research
Protections (OHRP) … the federal agency
regulating research involving humans
Documentation of institutional commitment to
comply with the Common Rule
Certifies that all research with human
participants conducted at UNI will be reviewed
for approval by the IRB in accordance with
federal regulations
Definition of Research
A systematic investigation, including
research development, testing and
evaluation, designed to contribute to
generalizable knowledge
Generalizable knowledge is interpreted to include research findings or data
intended for public dissemination or presentation in any form, including
via the Internet, poster presentation, scholarly paper, or report to external
sponsor. The definition also includes research undertaken by students for
the purpose of independent research papers, theses or dissertations.
Definition of Human
Participant
A human participant is a living individual
about whom an investigator (whether
professional or student) conducting
research obtains:
(1)
(2)
data through intervention or interaction
with the individual, or
identifiable private information
Thus, the scope of “human participant" is interpreted broadly. If you are
interviewing people, testing individuals, looking at records, or conducting a
survey, you are involving human participants in your research.
Which projects need review?
CRITERIA 1
Is it research?
• Systematic data
collection
• Intended to contribute to
generalizable knowledge
• Results will be made
public (e.g., presentation,
research article, Internet,
report)
Which projects need review?
CRITERIA 2
Is it research with
human subjects?
•
A living individual about
whom an investigator …
conducting research
obtains:
1. data through intervention
or interaction with the
individual or
2. identifiable private
information
Which projects need review?
Examples of projects needing review:
Mailed survey to ascertain opinions on a topic
Action research project in a local school
Testing athletes’ physiological response to running
Conducting interviews of Postville residents to obtain
opinions of economic climate following the ICE raid
An investigator obtains individually identifiable
information on the treatment outcomes of patients and
records data in a coded manner
Teacher utilizes student artifacts and test results
collected the previous semester
Which projects need review?
Examples of projects not needing review:
Program evaluation or quality improvement projects for
internal use only
Class research projects (results not shared outside of class)
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No more than minimal risk
Adults not from a vulnerable population
Data collection about organizations
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No personal opinions/data
Surveys performed as contracted services to inform
business decisions in which results are not made public
Observations of public behavior in which there is no
interaction with those being observed
Does this project require IRB review?
The Department of Residence at UNI conducts
activities on campus during the summer for
incoming students. DOR asks participants to
complete a satisfaction survey at the end of
each session. This information is used by the
director in planning future orientation sessions.
NO – it is intended to evaluate the orientation
program and is not collecting data that will
contribute to generalizable knowledge
Does this project require IRB review?
A staff member wishes to know whether UNI
students are committed to the university by
wearing clothing with the UNI name or logo on it.
She positions herself in a prominent location at
the Union and counts the number of students
wearing UNI clothing for an hour
NO – it is observation of public behavior. The
staff member is not interacting with subjects, nor
is she obtaining private information.
Does this project require IRB review?
An investigator hopes to understand business
outcomes for individuals who lost their
businesses to the floods of 2008. To do this, PI
conducts interviews with a sample of business
owners from Cedar Rapids.
YES – it is a systematic investigation designed
to contribute to generalizable knowledge.
Further, it involves interaction with the subjects
and gathers private information.
Does this project require IRB review?
A faculty member wishes to understand more
about attitudes of patrons of a local business
regarding Christmas shopping. With the
permission of the store owner, the researcher
stands on the public sidewalk outside the store
and asks customers to complete a short survey.
YES – it is a systematic investigation designed
to contribute to generalizable knowledge.
Further, it involves interaction with the subjects
and gathers private information.
Does this project require IRB review?
For a senior thesis, a student has access to an
existing dataset from a local business s/he is
assisting. The dataset contains individual-level
private information pertaining to company
employees.
YES – such projects require review. Several
questions relate. Is the dataset publically
available? Can personal identities be
established? Is the data coded? Special
application for projects involving existing data. If
any questions, contact the IRB.
What if you aren’t sure if the project
requires IRB review!
IF …
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there is a question
a project might become research
there is potential to publish or present
THEN …
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submit to the IRB
at least ask!
Institutional Review Board:
Role and Responsibilities
Disapproving a study at UNI is very rare, but
modifications are common
What is the IRB?
Authorized by federal regulations
A committee charged with the review of
human participants research to assure
that the participants’ rights and welfare
are adequately protected
Researchers are responsible for obtaining
IRB review and approval before their
research commences
IRB Composition
At least 5 members
Scientific and Nonscientific Members
At least 1 Non-affiliated Member
Collective Expertise
Sensitivity to Community Standards
Diversity of Perspectives
Knowledge of Vulnerable Subjects
The UNI IRB
In Office of Sponsored Programs (OSP)
Institutional Official – Christy Twait

Assistant Provost for Sponsored Programs
IRB Administrator – Anita Gordon
Interdisciplinary Committee
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Chair, Helen Harton
UNI’s Full Board
Bunker, Dr. Matthew P. -- UNI Department of Marketing (2009-2014)
Clohesy, Dr. William W. -- UNI Philosophy & World Religions (2008-2014)
Creighton-Smith, Belinda -- Prisoner Advocate (2009-2012)
Downs, Dr. William R. -- UNI Department of Social Work (2010-2014)
Etscheidt, Dr. Susan K. -- UNI Special Education (2009-2012)
Evans, Dr. Todd -- UNI HPELS-Athletic Training (2009-2012)
Gordon, Anita, M.S.W. -- UNI IRB Administrator (Ongoing)
Harton, Dr. Helen C. -- UNI Psychology (2007-2013) (Chair)
Hensley, Dr. Larry D. -- Community Member (2010-2013)
Larimer, Dr. Christopher -- UNI Political Sciences (2011-2013)
Ophus, Dr. John -- UNI Biology & Science Education (2011-2013)
Roth, Dr. Ronald R. -- Community Member (2008-2014)
Stalp, Dr. Marybeth – UNI Sociology, Anthropology & Criminology (2011-2013)
Criteria for IRB Approval
 Risks to participants are minimized
 Risks are reasonable in relation to anticipated
benefits
 Selection of participants is equitable
 Informed consent is sought from each
prospective participant
 Informed consent is appropriately documented
 When appropriate, data are monitored to
ensure safety of participants
 When appropriate, privacy and confidentiality of
participants is protected
Additional Protections for Vulnerable
Populations
Children
 Parent/guardian permission is generally
required for people under age 18
Prisoners
Pregnant women
Mentally disabled persons
Economically or educationally disadvantaged
persons
Others
Types of IRB Review
Exempt from Continuing Review
Expedited
Full Board
Modifications to Approved Protocols
Continuing Review (Annual)
Exempt from
Continuing Review
Minimal risk
Often includes anonymous surveys and archival
observations
Review usually takes less than 2 weeks
Does not require continuing approval
Changes to protocol DO require prior approval
Review IS required
Expedited
Minimal risk
May include surveys/measures in which
participant is identified
Review usually takes about 2 weeks
DOES require closure/continuing review forms
(usually 1 year period)
Changes to protocol DO require prior approval
Full Board Review
More than minimal risk studies
Often includes vulnerable populations
May include deception
Reviewed by full committee at monthly meeting
Investigators may attend but not required (is
recommended)
Plan ahead - review will take longer for these!
Minimal Risk
Minimal risk means that the probability and
magnitude of harm or discomfort
anticipated in the research are not greater
in and of themselves than those ordinarily
encountered in daily life or during the
performance of routine physical or
psychological examinations or tests.
Protections
Required:
Recruitment
Recruitment Issues
Equitable selection of participants
Minimize possibility of coercion or undue
influence: “an offer you can’t refuse”
 Indirect recruitment, third party
recruitment, assurances
Participants’ relationship to PI
Compensation
Compensation
Compensation ≠ benefits
Payment to participants for the time,
inconvenience, and expenses involved in
participating in a research project
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Monetary, gift cards, property … t-shirts, books, etc
Considered a recruitment incentive
Total payments ≥ $600 reported to IRS
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Individual payments > $74 requires PI to record name,
SSN, address and report to OBO
UNI employees or students – all compensation must be
submitted to OBO (and possibly financial aid)
Implications for informed consent
Students as
Participants
Same issues related to employees,
patients, or those subordinate to the
researcher
Because of potential for coercion or undue
influence, there is possibility that agreement
to participate will not be freely given
Whenever possible, PIs should avoid using
their own students or employees as
research subjects
Action, ethnographic, and
qualitative research
Practitioner researchers do not have right to
demand or compel participation in research
(Pritchard, 2002)
Qualitative research requires sustained, on-going
negotiation to informed consent and participation
Protections
Required:
Risks Minimized
Possible Risks
Physical
Psychological
Social
Emotional
Economic
Political
Invasion of privacy
Loss of confidentiality
Embarrassment
Financial
Stress/discomfort
Other
Risks to Participants
Risks must be reasonable in relation
to the benefits
IRB must weigh the benefits of the
research against the potential risks to
subjects
No risks vs. No foreseeable risks
Protections
Required:
Confidentiality/Privacy
Privacy and Confidentiality
“When appropriate, there are adequate
provisions to protect the privacy of
subjects and to maintain the confidentiality
of data”
Breaches of privacy and/or confidentiality
are the main risk in social-behavioral
research or research that is no greater
than minimal risk.
Confidentiality
Maintain confidentiality of research data
Methods may include:
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Coding identifiers, limiting access to research
data, storing data safely throughout the study,
destroying data upon completion of the study,
encryption, and training the research team on
the importance of confidentiality
Remember that several “vague” identifiers
(e.g., gender and race) together may
individually identify participants
Confidentiality on the Internet
Application to Internet-based research
and online surveys
Statement on consent document should
advise participants that no absolute
guarantee can be made about the
confidentiality of data sent via the
Internet.
Protections
Required:
Informed Consent
Informed Consent
Respect for Persons or Autonomy
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Fundamental principle from Belmont Report
Individuals empowered to make free
decisions, and given adequate information to
make good decisions
Arguably, the most important ethical
principle in research
Informed Consent:
Criteria for IRB Approval
According to federal regulations ….
1.
2.
Informed consent will be sought from
each prospective subject (46.116)
Informed consent will be appropriately
documented (46.117)
Informed Consent
A process not a form!
No coercion or undue influence
(recruitment)
Language understandable to the
participant
No exculpatory language
8 required elements of consent
6 additional elements, where appropriate
What would you want
to know if you were a
research participant?
Required Elements
1. Statement that the study is research and
explanation of purposes and procedures

2.
3.
4.
5.
Duration, location, procedures, etc.
Reasonably foreseeable risks or discomforts
Benefits which may be reasonably expected
Alternative procedures or treatments
Statement about confidentiality of data
Required Elements (cont.)
6. If more than minimal risk … statement
regarding compensation for injuries
7. Contact information

Usually PI and IRB Administrator
8. Statement that participation is voluntary and
one can withdraw at any time without penalty
Informed consent documents should be on UNI letterhead or state
that research is being conducted by faculty/students/staff at UNI.
Types of Consent
Various methods
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A written consent document or form
Orally
Electronically presented
Presented in a letter
Waiver of documentation of consent
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Consent information still provided
Parental permission required for children
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No passive consent allowed
Do I have to interact with
the IRB again postreview?
YES!
When Further Contact with
IRB is Required
Changes to protocol
Continuing approval
Closure
Adverse events
Changes to Protocols
Changes to all studies, even those exempt from continuing
review, must be approved by IRB
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When risks or protections change
Participant pool changes
Procedures change
Consent document changes
Instrument changes
Research sites change
Email request to IRB Administrator
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Include original protocol #
Attach any new/changed materials
Forwarded to reviewer
Continuing Approval
Approval period no longer than 1 year
PI must seek continuing approval

No grace period
Applies to Full Board or Expedited studies
Use Annual/Update form
Form and reminder email sent out by IRB
office 30 days before expiration dates
Project Closure
Download form from IRB website
Send in any time after completion of study
Important for students to remember before
they leave campus
Adverse Events
Federal regulations require PIs report to
the IRB problems or adverse events that
occur during course of study
IRB required to report to OHRP
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Unanticipated problems
Serious or continuing noncompliance by PI
Suspension or termination of a study
IRB Review Process
Renewal/amendment
or closure
Start
Changes as needed
leading to final approval
Initiate a
complete application,
with all supporting
documents
PI receives
reviewer
comments
Administrative
review
Exempt, expedited or FB
review
IRB Forms
Standard Application
Survey Application
Existing Data Application
Annual Renewal/Update form
Project Closure form
Informed Consent Checklist
Supplemental Materials
May Include
Recruitment letters/scripts
Copies of instruments
Consent documents
Letters of cooperation
Debriefing scripts
Training certificates
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Required for all key personnel
How to Find Us
Office of Sponsored Programs
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www.uni.edu/osp - Click on Research Policies
213 East Bartlett Hall
Anita.Gordon@uni.edu or 273-6148
Helen.Harton@uni.edu or 273-2235
Questions?
Thank You!