The University of Texas at Brownsville – Human Subjects IRB Protocol Review Checklist

The University of Texas at Brownsville
IRB – Human Subjects
Protocol Review Checklist
________________________________________________________
Research Projects that involve human participants must be reviewed and
approved by the IRB Committee before research begins.
Submit Protocols with the following materials to:
Research Integrity and Compliance Office – BRHP 2.210 or submit online at
[email protected] or [email protected].
For questions, please contact Lynne Depeault at (956) 882-7731.
______________________________________________________________________
I.
What is Research?
o Intent to Present or Publish – If there is a possibility that a student’s
proposed research project may result in a formal presentation or
publication, the investigator should submit the project for review before
beginning the study.
o Previously Existing Data – Cases where the investigator wishes to use
data for research that originally was collected without the intent to
contribute to “generalizable knowledge”. Any study should be
submitted for review when an investigator wishes to analyze or publish
about previously existing data.
o Intent to Contribute to Generalizable Knowledge – Research results do
not have to be published or presented at a professional meeting to
qualify the experiment or data gathering as research. The intent to
contribute to “generalizable knowledge” makes an experiment or data
collection research, regardless of publication. Research that is never
published is still research. Participants in research studies deserve
protection whether or not the research is published.
II.
What is Not Research?
o Activities are designed for educational purposes only; and
o Data will not be generalized outside the classroom (reporting of data
within the class is acceptable because the activities were performed
solely for teaching purposes); and
o Data will not result in an article, master’s thesis, doctoral dissertation,
poster session, abstract, or other publication or presentation; and
o Student volunteers or other participants are clearly informed that the
activities are an instructional exercise, and not actual research.
o Exception: Use of experimental drugs, agents, devices, or medical
procedures, even when done by students, always constitutes human
subjects research and requires prior IRB approval.
Revised: April 2012
The University of Texas at Brownsville
IRB – Human Subjects
Protocol Review Checklist
________________________________________________________
III.
Application
o New Protocols: Protocol Review Form
o Annual Protocols: Continuing Review Form
o Modifications to Approved Protocols: Protocol Amendment/Modification
Form
o Project Termination: Project Completion Report
IV.
Research Protocol
Attach a 7-10 page protocol that includes the following:
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Purpose/Aims/Rationale
Background/Significance
Clearly Identified Hypothesis (Research Question)
Methods (must include the following):
 Setting
 Sampling Plan (include the number of participants)
 What will you be doing?
 Who will conduct the procedure?
 Data Collection Plan
 Analysis – How do you plan to analyze the data you collect?
 Bibliography
V.
Consent Form or a Waiver of Documentation of Informed Consent:
 Consent Forms using the Model of a Standard Consent
Form (on separate pages from protocol). Minimum required
elements of informed consent:
 Statement identifying yourself and your affiliation with
The University of Texas at Brownsville.
 An invitation to participate in the study as part of a
research project.
 Explanation of the purposes of the research, the
expected length of time of the subject’s involvement, a
description of the procedures to be followed, and
Revised: April 2012
The University of Texas at Brownsville
IRB – Human Subjects
Protocol Review Checklist
________________________________________________________
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identification of any procedures which are experimental in
nature.
Description of any benefits to the subject or others which
may reasonably be expected from the research.
Description of compensation for participation (money,
extra course credit, etc.), if any.
Statement describing the participant’s anonymity to the
extent to which confidentiality of records identifying the
participant will be maintained.
Affiliation name, address and phone number of the
person(s) to contact for questions about the research.
Office to contact for questions about the person’s rights
when they choose to participate in a research project
(Research Integrity and Compliance Office – BRHP
2.210, (956) 882-7731.
Assurance that participation is voluntary and that the
subject may withdraw from participation at any time.
Suggestion: Provide a copy of the informed consent
statement to each subject for their reference.
 Waiver of Documentation of Informed Consent – The IRB
can waive the requirement that the consent process include
a signed consent form. Investigators desiring to not have a
signed consent form must still provide participants with a
consent document disclosing all of the required elements
necessary for informed consent. In such cases, the IRB
encourages investigators to use the consent template and
remove the signature section. Investigators are free to
format the consent document as necessary. According to 45
CFR 46.117 an IRB may waive the requirement for the
investigator to obtain a signed consent form for some or all
subjects if it finds:
 The research presents no more than a minimal risk and
the research involves procedures that do not require
written consent when performed outside of a research
setting. OR
 The principle risks are those associated with a breach of
confidentiality concerning the subject’s participation in the
research; and the consent document is the only record
linking the subject with the research; and each participant
Revised: April 2012
The University of Texas at Brownsville
IRB – Human Subjects
Protocol Review Checklist
________________________________________________________
will be asked whether the participant wants
documentation linking the participant with the research
(participant’s wishes will govern); and the study is not
FDA regulated.
VI.
Instruments
Attach any copies of any instruments you are using (surveys,
questionnaires, interview questions, online instruments, and/or any other
instruments that will be administered to participants.
VII.
Letters of Approval
Attach any signed letters of approval for studies conducted with organizations
other than The University of Texas at Brownsville.
VIII.
CITI Training - https://www.citiprogram.org/default.asp?language=english
Submit with the above materials the up-to-date (within three years) CITI
Training (list of modules taken with pass dates) for the Principal Investigator,
any Co-Investigators and/or students working on the research protocol. If their
name is listed as part of the protocol, then we need to have their CITI training
for Social and Behavioral Responsible Conduct in Research and the Social
and Behavioral Research Course.
For any concerns or questions regarding participant’s rights when they
choose to participate in research:
Research Integrity and Compliance Office
Lynne Depeault
BRHP 2.210
(956) 882-7731
[email protected] or [email protected]
Revised: April 2012