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”).
Information for Students, Faculty & Staff at UNI
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.”
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.Tuskegee Syphilis Study (1932-72)
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.
Additional Protections Included in 45 CFR 46:
What is an Institutional Assurance?
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.
A human participant is a living individual about whom an investigator (whether professional or student) conducting research obtains:
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.
Is it research?
Is it research with human subjects?
Examples of projects needing review: Research Risks
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 semesterWhich projects need review?
Examples of projects Research Risksnot needing review:
Program evaluation or quality improvement projects for internal use only
Class research projects (results not shared outside of class)
No more than minimal risk
Adults not from a vulnerable population
Data collection about organizations
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 observedWhich projects need review?
Disapproving a study at UNI is very rare, but modifications are common
Minimal risk review!
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 requiredExempt from Continuing Review
More than minimal risk studies review!
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!Full Board Review
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.
Invasion of privacy
Loss of confidentiality
Informed consent documents should be on UNI letterhead or state that research is being conducted by faculty/students/staff at UNI.
Changes to all studies, even those exempt from continuing review, must be approved by IRB
When risks or protections change
Participant pool changes
Consent document changes
Research sites change
Email request to IRB Administrator
Include original protocol #
Attach any new/changed materials
Forwarded to reviewerChanges to Protocols
Approval period no longer than 1 year review, must be approved by IRB
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 datesContinuing Approval
Download form from IRB website review, must be approved by IRB
Send in any time after completion of study
Important for students to remember before they leave campusProject Closure
Changes as needed
leading to final approval
with all supporting
Exempt, expedited or FB
Renewal/amendment or closure
PI receives reviewer comments