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UTA IRB 10/23/13
Transcript of UTA IRB 10/23/13
The University of Texas at Arlington
Office of Research Administration; Regulatory Services
What is Research?
must be reviewed and approved by the IRB
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
The Office of Regulatory Services supports comprehensive programs of academic research by assuring institutional and investigator compliance with applicable regulations, policies, and industry standards while engaged in regulated research or scholarly activities.
What is a Human Subject?
A living individual about whom a researcher obtains data through:
Communication or interpersonal contact between researcher and subject
Physical procedures by which data are gathered
Manipulations of the subject/environment
Existing Data Analysis
Observation of Behavior
Various Psychological and Social Interventions
Drug / Clinical Trials
Medical Chart Reviews
Medical Device Testing
Sample Research Activities
What is an IRB? What does it do?
An ethics committee created to:
Protect the rights and welfare of human research participants
Make judgments focused on what is right/wrong and what is desirable/undesirable
Review and approve all research to be conducted when human subjects are involved
Ensure adequate informed consent is sought from participants (including requests for waiving or modifying the written informed consent process)
Contact Robin Dickey at
817-272-9329 or firstname.lastname@example.org
The IRB conducts a risk/benefit assessment to ensure adequate protection for the human subjects is in place
Informed Consent Process?
How do I get
For inquires about research with
Human Subjects or the IRB
All IRB protocols are submitted through the SMART IRB online submission system
-Templates and applications are found within the submission page
Once you have your research protocol outlined:
Go to the online research submission website
Create a protocol submission and attach all required forms and attachments
Includes application, consent forms, flyers, study tools (surveys, etc.
Forwarded to IRB Coordinator (Robin)
Once ready for approval review, forwarded to IRB members/Chair
All researchers are required to complete the Human Subjects Protection training (HSP) prior to approval of research involving human subjects.
Investigators on a non-exempt protocol must have a current Conflict of Interest Disclosure on file with a submission date no earlier than 8/24/12.
To be considered an “Investigator,” the person must have some responsibility over: the design of the research (such as developing objectives or procedures), the conduct of research (directing the procedures or progress), or reporting (writing publications, reporting to granting agencies, etc.). This definition could include any person, regardless of title, position, or status (faculty, staff, student). Do not include individuals that simply carry out procedures/tasks assigned to them that do not have actual responsibility over the design, conduct, or reporting of the research.
Annual Conflict of Interest Disclosure (COI)
6 Established categories
-No expiration; no annual review required
-Report modification requests
IRB Form #1A
*"Exempt" does not mean, "exempt from IRB review"
Minimum risk to participants
Most commonly submitted protocol type
Primary/Secondary IRB reviewers and IRB Chair/Vice-Chair approval
More than minimum risk
Reviewed at the monthly convened IRB meeting
plus all study-related
Mentally Incapacitated Persons #2A
Pregnant Women #2B
Waiver of Informed Consent
Non-Exempt Items to Submit:
Possible Additional Items:
Robin Dickey, MA, CIP
Regulatory Services Specialist
Why do I have to get IRB approval?
Previous to 1950, regulation of research conduct was minimal.
The Nuremberg Trials:
23 Nazi physicians were accused of performing medical experiments, without the subjects' consent, on prisoners of war and civilians of the occupied countries.
Tried in Nuremberg, Germany for war crimes and crimes against humanity after WWII
Resulted in the Nuremberg Code (1949): http://www.hhs.gov/ohrp/archive/nurcode.html
Tuskegee Syphilis Study
The Belmont Report
Three basic ethical principles:
Respect for Persons
Assessment of risks and benefits
Selection of subjects
Dr. Henry Murray
Professor at Harvard
Previously an officer in the OSS
Devised interrogation tests
Continued his research at Harvard with students
Burden to participants
Many of the former subjects describe the experiment as one of the worst experiences of their life.
But, the person who responded more strongly to the experiment than anyone else (according to the data recorded at the time of the experiment) was none other than the young…
Department of Health and Human Services (DHHS)
Title 45,Part 46-Protection of Human Subjects
AKA-“The Common Rule”
Defines human subject research
Recordkeeping guidelines and policies
Criteria for review of research
including vulnerable populations
Role as a Researcher
Ensure that each potential subject understands the nature of the research and of their participation
Provide a copy of the IRB-approved informed consent document (ICD) to each subject at the time of consent, unless the IRB has specifically waived this requirement.
Retain all signed (original) ICD
Promptly report proposed changes in previously approved research to the IRB for approval.
Report progress of approval research to the IRB
Promptly reports to the IRB unanticipated injuries or problems involving risks to subjects or others.
If you are a student conducting research with human subjects you MUST have a faculty sponsor/advisor.
The faculty advisor must approve your application prior to IRB submission
Your online submission must go to them before the IRB will review it.
At least 5 members with varying backgrounds qualified through experience and expertise
Diverse in race, gender, and cultural backgrounds
At least one scientist, one non-scientist, and one unaffiliated member
14 voting members ; 2 alternate
-1 unaffiliated member – Prisoner Rep
-1 Student member
1 Medical Doctor consultant
If anything needs to be changed, approval must be obtained before implementing the changes
Examples: number of participants, protocol personnel, updates to data collection tools
Continuing Review (notified 30 days prior to expiration)
Annual review of protocol, renewed for 12 months when approved (non-exempt only)
Reporting Unanticipated Problems or Adverse Event
To report email Robin at email@example.com
If you do not obtain approval prior to making modifications to your protocol your study will fall out of compliance.
Non-compliance report is filed
Research is halted
Potentially results in inability to use collected data/continue research
If you do not submit for continuing review/approval your study will automatically expire
Nothing research related may continue
A new protocol will need to be submitted
To close an exempt study
To close a non-exempt study
Submit a Continuing Review and select Study Closure
American tax dollars, through the National Institutes of Health, paid for syphilis-infected prostitutes to sleep with prisoners.
When the prostitutes did not succeed in infecting the men, some prisoners had the bacteria poured onto scrapes made on their body parts, and in some cases it was injected by spinal puncture.
Ted Kaczynski a.k.a "The Unabomber"
From 1946 to 1948, American public health doctors (Dr. John Cutler) deliberately infected nearly 700 Guatemalans — prison inmates, mental patients and soldiers — with venereal diseases in what was meant as an effort to test the effectiveness of penicillin.
What are your subjects doing?
Who are your subjects?
What are the risks involved?
Are the risks minimized?
Are the subjects informed of potential risks?
To seek (a woman) in love or marriage
Does the Selection of subjects make sense?