UTPA IRB GUIDANCE DOCUMENT
Version 7 [2/14/2008]
UTPA is moving toward increased research productivity, increasing the demand for an efficient and
clear IRB process at our university. As we move toward this goal, the UTPA IRB policies and
procedures are continually evolving. The current document presents up-to-date information on UTPA’s
IRB policies and procedures, by answering the most commonly asked questions.
Whenever you begin a new study, please visit the IRB website to check for policy/procedure
updates and to ensure that you are using the most up-to-date versions of all IRB forms and
templates.
If, after reading the provided materials, you require further guidance on a specific research study, please
feel free to contact me (preferably via e-mail at gbenham@utpa.edu).
For administrative questions, please contact the IRB at irb@utpa.edu or call the IRB Administrator at
956.381.3002.
Sincerely,
Grant Benham, Ph.D.
UTPA IRB Chair
Table of Contents:
(Click topic to follow link)
 Background:
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 How is human subjects research defined?
4
 What if I am working with de-identified data that was not collected through intervention or
interaction for the purposes of the current research?
5
 Is IRB submission required for class “research” activities?
5
 Is IRB submission required for independent student research, honors theses, graduate theses, and
dissertations?
5
 What if my research activities are not associated with my work at UTPA?
6
 Is IRB submission required for program development, program assessment, or quality
improvement studies?
6
 I am conducting an oral history study. Does this require IRB review?
6
 What if my research is exempt from federal regulations?
7
 What if my research is not exempt?
7
 Where can I find guidance on Informed Consent forms?
7
 Do all studies require a signed consent form?
8
 Who needs to provide a certificate of human subjects protection training?
8
 If I am submitting a grant application, when should I seek IRB approval?
8
 What needs to be submitted to the IRB?
8
 What happens once my study is approved?
9
 Can I make changes to my research protocol after it has been approved?
9
 How long does IRB approval last and what is the process for renewing approval?
9
 What events do I need to report to the IRB?
10
 What if my study involves children, prisoners, or individuals from other “vulnerable populations”? 10
 What if I intend to quote statements made by research subjects in my publications/presentations?
10
 What if my research involves educational or health records?
10
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 What if my research involves biological specimens or recombinant DNA molecules?
10
 What if my research involves payment to participants?
11
 What if my study involves multiple stages of research, for example the development of measures –
how can I submit those materials as part of my IRB protocol if I have not yet created the final
measures?
11
 What if I am conducting online research?
11
 What if non-UTPA individuals will be working with me collaboratively on the research?
12
 What if my research is conducted off-campus?
12
 What if my research is conducted outside of the United States?
12
 What if non-UTPA individuals want to recruit UTPA staff/faculty/students as participants in their
research – can I assist?
13
 What other information is available about human subjects protection?
13
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Background:
Our institution, like many other universities, has an agreement with the U. S. Department of Health and
Human Services (HHS) Office for Human Research Protections (OHRP) that is called a Federalwide
Assurance (FWA). As such, we agree that all human subjects research will be guided by ethical
principles as described in the federal regulations and the Belmont Report.
To receive federal research funding, our institution must have an active FWA. If our FWA is revoked
because of failure to follow the regulations, we lose the ability to obtain funding and currently funded
research may be stopped in its tracks. Our FWA (FWA00000805) stipulates that federally funded research
will, at a minimum, be reviewed by our Institutional Review Board according to federal regulations,
which include the “common rule” regulations 45CFR46. FWAs include an option checkbox to apply
these same standards to research that is not federally funded. We recently elected to “uncheck” this box.
However, while IRB review of non federally-funded research is now no longer required by our FWA,
our institutional IRB policies and procedures still require review of all human subjects (guided by
ethical principles as described in the federal regulations and the Belmont Report).
The regulations were based primarily on biomedical research issues and, as such, use a language that is
sometimes disconnected from social/behavioral research. However, it is important for faculty to
recognize that federal regulations must be applied to all types of human subjects research.
Below, I have attempted to provide some guidance for researchers seeking IRB approval, with links to
documents when available.
How is human subjects research defined?
Federal regulations 45CFR46 define research as a “…systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
…and they define a human subject as “…a living individual about whom an investigator (whether
professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.”
Thus, certain types of research, even if they do not involve interaction with people themselves, are
classified as human subjects research.
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What if I am working with de-identified data that was not collected through intervention or
interaction for the purposes of the current research?
OHRP has provided several guidance documents to address whether or not obtaining and analyzing data
should be considered human subjects research. If you are not obtaining either identifiable private
information or data through intervention/interaction with living individuals, then the research activity
does not involve human subjects.
If your data falls under this category, please read the following document: Guidance on Research
Involving Coded Private Information or Biological Specimens. Based on the guidance document, if you
believe your study is not human subjects research, please contact the IRB for official determination.
Please be aware that identifiable private information is not limited simply to names or Student ID
numbers, etc., but includes circumstances under which data can be linked to specific individuals by the
investigator(s) either directly or indirectly through coding systems.
Is IRB submission required for class “research” activities?
Based on the federal regulations, the issue of whether class exercises involving human subjects
“research” activities require IRB review centers on the definition of “research”. In most cases, class
research projects are pedagogical learning exercises that DO NOT involve systematic investigation
designed to develop or contribute to generalizable knowledge. However, IRB approval cannot be
provided retroactively. If a student believes that he/she will want to use the data for research purposes,
then he/she should seek prospective IRB approval. If a student completes a classroom research project as
a pedagogical exercise and produces some interesting results, IRB approval cannot be obtained
retroactively and the student should seek to replicate/extend the study after identifying a faculty mentor
and obtaining the necessary approvals. In this latter case, the activities during class have not been
“wasted” (e.g., literature review, design, creation of questionnaire or collection of materials/scales,
creation of an informed consent document, practice gathering data, etc.) and the student is poised to start
data collection early the next semester. Failure to obtain IRB review does not preclude the student from
presenting the class research activity at a class/department/college/university level session, as long as the
session is represented in terms of pedagogical activities (classroom research activity) rather than as a
research study.
Is IRB submission required for independent student research, honors theses, graduate theses, and
dissertations?
All human subjects research requires IRB approval, whether it is conducted by UTPA faculty, staff, or
students. If your study requires “research committee” approval (e.g. thesis or dissertation committee),
IRB approval should only be sought after committee approval has been obtained (i.e. after approval of
the thesis proposal). It is the responsibility of the student investigator AND the Faculty Advisor/
Committee Chair to ensure appropriate human subjects protection. In order to assure sufficient oversight
of student studies, IRB proposals from students should include valid human subjects protection
certificates from both the student and the Faculty Advisor.
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What if my research activities are not associated with my work at UTPA?
If an employee of UTPA is neither conducting research at UTPA nor conducting research as part of
his/her institutional duties/employment obligations the research activities are unlikely to require UTPA
IRB approval. For example, if the investigator is an employee at UTPA and a graduate student at
another institution, UTPA IRB review would not be required if human subjects data were not being
obtained at UTPA (however, if subjects are being recruited from UTPA, the PI should first obtain IRB
approval from his/her degree-granting institution and then contact the UTPA IRB to determine whether
or not additional review/approval is required). Similarly, a clinical psychologist employee who wishes to
conduct research with patients at his/her independent private practice would not require UTPA IRB
review as long as the study is not conducted as part of his/her institutional duties/employment
obligation. Under such circumstances, presentations and publications should not list UTPA as the
author’s institutional affiliation (instead “Private Practice”, or something similar, should be indicated).
Lastly, if a student conducts research outside of a UTPA course requirement (i.e. the research is not part
of required coursework, is not overseen by a faculty mentor, is not part of a thesis/dissertation, etc), the
student would not need UTPA IRB approval as long as the research is not conducted at UTPA. For
example, a local surgeon who has registered as a UTPA student for a research methods class decides to
conduct a study with his patients. Assuming that the study is not part of required class coursework,
UTPA IRB approval would not be required.
Is IRB submission required for program development, program assessment, or quality
improvement studies?
If you are conducting a study or survey that has limited generalizability, it may be exempt from the need
for IRB review. Surveys conducted by University personnel for the purposes of developing or improving
University services and programs are generally not considered research leading to generalizable
knowledge (though such surveys should still follow ethical principles such as voluntary participation,
confidentiality, etc.). If the results are likely to be represented as generalizable research rather than local
quality improvement/program development/program assessment (i.e. published or presented at a
scholarly conference), IRB approval may be required. If there is any doubt, please contact the IRB
office.
I am conducting an oral history study. Does this require IRB review?
Whether a study requires IRB review depends on whether or not it meets the definition of human
subjects research. Thus, the need for IRB review depends on whether or not the study is a systematic
investigation designed to “…develop or contribute to generalizable knowledge”. In many cases, oral
histories are not conducted with research intent (at least not based on the federal regulations’ definition
of research), but are simply biographical accounts obtained from one or more individuals. However, oral
history may at times attempt to develop or contribute to generalizable knowledge and thus may require
IRB review. If you are in any doubt, it is best to contact the IRB Chair to discuss your particular
situation.
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What if my research is exempt from federal regulations?
Although certain types of human subjects research are considered exempt under the 45CFR46
regulations, the determination of whether a study is exempt must be made by the IRB (normally by the
IRB Chair or an appointed IRB member). Even if a study is determined exempt from the 45CFR46
regulations, it still needs UTPA IRB approval. The federal regulations are set as a minimum and many
institutions, including UTPA, set slightly higher standards for human subjects protection. For example,
we generally require some form of informed consent process even if the research is exempt from the
federal regulations. In most cases, UTPA IRB policies allow for a simplified consent process for
“exempt” studies. Please read the following guidance document on “exempt” survey research
which includes a collection of simplified consent templates.
What if my research is not exempt?
Non-exempt research will either require full committee review or expedited review. Like exempt
research, there are certain types of research that can be reviewed as “expedited”. While in most cases
expedited review takes less time than full committee review, the term refers to the fact that the protocol
does not need to be reviewed at a convened IRB meeting, and a fast turnaround is not guaranteed (the
time for expedited review depends largely on the complexity of the study in terms of human subjects
protection). There is no specific submission deadline for expedited proposals; protocols are reviewed in
the order in which they are submitted.
If a study is not exempt or expedited, it must be reviewed by the full committee at a convened IRB
meeting. The committee consists of members from diverse backgrounds. Protocols are discussed in
relation to adherence to both regulations more generally to ethical principles. Research is also evaluated
on the basis of its “risk to benefit ratio”. Protocols may be approved, not approved, or tabled (generally
due to insufficient information or inadequate time for review). Approved protocols may be “approved
with contingencies”, meaning that specific issues need to be addressed by the researcher (e.g.
modifications to the informed consent form) before the study will be officially approved, but that the
review of those contingencies can be performed by the IRB Chair rather than by the convened
committee. IRB meetings generally take place around the 3rd week of each month during the Fall
and Spring semesters. To allow time for processing and review of the protocol materials, the protocol
submission deadline for FULL COMMITTEE REVIEW is the 1st Tuesday of each month.
Protocols and supporting materials should be submitted to:
IRB Chair
c/o REIN 1.111
Where can I find guidance on Informed Consent forms?
Informed consent forms should be based on our template. For some survey research, if it is exempt
from federal regulations, it makes more sense to integrate the important elements of informed consent
into a cover letter with a statement that return of the survey indicates the individual’s consent to
participate in the research. This negates the need for a signed informed consent. Please note that this is
only applicable to certain types of exempt research. In most types of human subjects research, a
signature (“documentation of consent”) is required.
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Do all studies require a signed consent form?
Many “exempt” survey studies can be conducted using a simplified consent process, generally without
the need for a signed consent form. Under certain circumstances, even “non-exempt” (expedited or full
review) research may qualify for a “waiver of consent” (standard required elements may be altered or
waived entirely) or a “waiver of documentation” of consent (a waiver of the need for a signature). There
are specific criteria that must be met in order for such waivers of consent or waivers of documentation of
consent to be approved.
Who needs to provide a certificate of human subjects protection training?
Certificates of human subjects protection training must be provided for all individuals engaged in
conducting the study. IRB proposals from student investigators should include valid human subjects
protection certificates from both the student and the Faculty Advisor. Research assistants who are
interact with participants or who work with research data should complete the online training. If the
name of the research assistant(s) is not known at the time of IRB protocol submission, this should be
clearly stated in the protocol; each RA’s certificate must be submitted before he/she becomes involved
in the study.
If I am submitting a grant application, when should I seek IRB approval?
If research is dependent on grant funding, researchers should submit an IRB protocol only after
notification that their grant has been awarded, or after notification of a fundable score, unless the
granting agency requires IRB approval (or perhaps just IRB submission) as part of the grant
application. To reduce the burden placed on IRBs, many granting agencies will now accept IRB
approval following the award notification, but please check with your funding agency well in advance of
your grant submission deadline.
What needs to be submitted to the IRB?
The following materials should be submitted to the IRB:
1) A UTPA IRB New Study Application Form.
2) An Exempt Survey/Interview Checklist form (only if your study meets Exemption category #2
criteria and you are requesting exempt review).
3) Informed consent form(s) or simplified consent forms and, if applicable, assent forms for children.
4) Certificate(s) of human subjects protection training (through CITI program). Instructions for user
registration and course completion requirements are provided in the following document.
5) Supporting materials (e.g. copy of survey/scale/interview questions).
6) A copy of any recruitment materials (such as flyers or advertisements), if applicable.
7) Letters of permission, if applicable (e.g. from school principal, clinic director, etc).
8) A copy of the associated grant proposal and award or fundable score letter if the research
will be supported through a grant.
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What happens once my study is approved?
You will receive a letter of approval from the IRB Chair or an appointed IRB member. All informed
consent forms must be stamped with IRB approval. The PI will receive an Adobe Acrobat PDF of the
stamped/approved form(s) via e-mail from the Office of Research and Sponsored Projects. These
stamped forms are the only ones that may be used in the research study. Any revisions to the approved
protocols (including modifications to the informed consent forms) must be reviewed and approved
by the IRB prior to being implemented.
Can I make changes to my research protocol after it has been approved?
Changes can be made to an approved protocol, but only after additional IRB review and approval. Any
changes to the research protocol (including, but not limited to, study population, recruitment procedures,
consent/assent document, survey or test materials, researchers or research assistants) must be reviewed
and approved by the IRB prior to implementation of changes. Depending on the nature of the changes
(particularly in terms of whether it increases risk to participants), the research may either be reviewed
through an expedited review procedure or may require full committee review.
How long does IRB approval last and what is the process for renewing approval?
Research that is not exempt from federal regulations can be approved for a maximum of one year (for
certain studies, the IRB may determine that continuing review should occur sooner than one year).
Research that will extend beyond the approval expiration date (including the analysis of individually
identifiable data) must be renewed through the IRB through a process called “continuing review”. To
avoid delays in research, continuing review must be performed before the approval expiration date;
research cannot be conducted without current IRB approval. If continuing review is not secured before
the IRB approval expiration date, human research activities must be immediately halted. Most renewals
are reviewed and approved by the IRB Chair or designated IRB member, but if the research was deemed
more than minimal risk when it was initially reviewed, the continuing review must be performed by the
full committee at a convened meeting. If the researcher fails to obtain study renewal, the research must
cease until approval has been gained through a new IRB submission.
Researchers are responsible for submitting renewal requests using the appropriate UTPA IRB continuing
review forms. Generally, the IRB will send researchers notice of impending approval expiration, along
with a continuing review form, however, timely application for renewal through the continuing review
process is ultimately the responsibility of the PI and PIs must leave sufficient time for IRB
review/renewal prior to the approval expiration date. In the event that the study has been completed,
researchers should indicate this on the continuing review form so that the IRB office may close out the
file.
If research is determined to be exempt from federal regulations (e.g. certain survey studies), IRB
approval does not expire and study renewal is not required. However, as with protocols reviewed via
“expedited” or “full” review, changes to the protocol must still be reviewed and approved by the IRB
prior to implementation.
Please note that copies of signed informed consent documents must be retained by the researcher for
three years after the close of the study and may be subject to inspection by federal authorities and the
IRB.
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What events do I need to report to the IRB?
If human subjects involved in research projects approved by the IRB are harmed, including any physical
or psychological injury, any adverse events, improper disclosure of private information, economic loss,
and other harmful or potentially harmful occurrences, the Principal Investigator(s) must notify the IRB
and the Office of Research and Sponsored Projects immediately. The ORSP will report adverse events to
the Office of Human Research Protections, Department of Health and Human Services, as appropriate.
What if my study involves children, prisoners, or individuals from other “vulnerable
populations”?
Regulations afford specific additional protections for certain vulnerable populations. These regulations
provide additional safeguards. For example, survey research that may be exempt for studies using adult
participants is generally not exempt if children are being surveyed. In most instances, parental consent is
required for research with children. If the child is capable of understanding the basic study procedures,
they will also be given the opportunity to decide whether or not they want to participate – this is known
as “assent” and is most often documented through use of a child assent form. Research with vulnerable
populations may also necessitate an advocate to be present at the IRB committee meeting, thus such
proposals should be submitted as early as possible to provide sufficient time for arrangements to be
made. If you will be conducting research with vulnerable populations, you should consider the ethical
implications and familiarize yourself with the additional regulations.
What if I intend to quote statements made by research subjects in my publications/presentations?
If you anticipate including quotes in your research presentations/publications, you must integrate the
following statement into your consent form (or something like it): "Your responses may be quoted in
whole or in part in publications or presentations about this research. If quotes are used, your real name
will be replaced by a made up name (pseudonym) and any additional information that might directly
identify you will be removed." Under certain circumstances, the nature and extent of the quotes will not
warrant such a statement, thus each study will be evaluated based on the intended use of quotes. It is
also possible that attribution of quotes to certain individuals may be an important part of the research.
Such activities may be approved if the subjects are made aware of the intended use of identifiable quotes
and the IRB determines that such practices would be of minimal risk.
What if my research involves educational or health records?
There are additional regulations covering certain types of research that make use of education and/or
health records. The IRB does not review protocols for adherence to these regulations. As a researcher,
you are responsible for determining that your study does not violate these regulations. If applicable,
familiarize yourself with the FERPA, PPRA, and HIPAA regulations before submitting your IRB
protocol so that you can design the study appropriately and avoid the need for a revised IRB submission.
What if my research involves biological specimens or recombinant DNA molecules?
Researchers using or collecting any microbiological/infectious agents (including saliva and/or blood
samples) and/or recombinant DNA molecules are responsible for obtaining any necessary approvals
from the University’s Institutional Radiation and Biosafety Safety Committee (IRBC) and for complying
with UTPA’s Bloodborne Pathogen Exposure Control Plan.
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What if my research involves payment to participants?
If participants will be paid using University funds (e.g. Faculty Research Council award) or external
funds paid through the University’s Grants and Contracts Office or Accounts Payable department it is
the responsibility of the Primary Investigator(s) to see that appropriate records of payments to human
subjects are maintained. This is indirectly an IRB issue, because it may affect the nature of individually
identifiable records maintained as part of research participation. Please contact the IRB for up-to-date
policy information on this issue.
What if my study involves multiple stages of research, for example the development of measures –
how can I submit those materials as part of my IRB protocol if I have not yet created the final
measures?
In order to conduct a review of human subjects research procedures, the IRB must be able to review the
materials that will be used in the study. This includes recruitment materials (flyers, letters, etc), consent
forms, and copies of scales/questionnaires/surveys that will actually be administered to subjects. It is not
possible to approve a study without such materials to review. IRB approval is not necessary unless you
are actually interacting with subjects for research purposes or analyzing individually identifiable private
data. Therefore, the literature review and creation of initial scales does not need IRB review. However,
administration of developed questionnaires or measures, even pilot testing of measures, must be
approved by the IRB. A reasonable approach for researchers under such circumstances is the following...
It is not uncommon when developing new measures, questionnaires, or scales, for the researcher to
require modification of the initial measure(s) after a process of pilot testing or statistical (e.g. factor)
analysis. While it is impossible to anticipate what the final measure will look like under such conditions,
IRB approval can be given for the overall process with the contingency that specific modifications
(revisions) to the measures are submitted for IRB review and approval prior to be administered (this can
be accomplished by submitting a short memo along with the revised measure that references the
approved protocol). If the measure or process is substantially different from the original, the original
consent form/process might also need to be modified slightly, but in many cases the same consent
document will suffice.
Thus, the standard process would be as follows:
AFTER the initial measures have been developed, submit an IRB application that details the intended
process (and, if possible, timeline). For example, "the initial measure will be administered to 300
students. A revised measure will then be created based on the results of this pilot testing. Following IRB
approval of the revised (final) measure, it will then be administered to an additional 400 students."
What if I am conducting online research?
The use of the internet as a medium for research continues to increase. While it provides many
advantages, it can also complicate the process of human subject protection. Research using electronic
communication cannot be promoted as anonymous, even if attempts are made to secure the transmission
of data. In addition to interception of data, there exists the possibility of spyware that can track
keystrokes on computers and/or electronic surveillance of employee computer use. Please contact the
IRB to discuss how to best handle human subjects protection issues in online research, particularly in
terms of the process of informed consent. In most cases, documentation of informed consent can be
waived, but it should be recognized that no guarantees can be made regarding the tracking or
interception of subject responses by third parties. Currently, all consent statements for online research
must include the following text: "All survey responses that we receive will be treated confidentially and
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stored on a secure server [only state if accurate]. However, given that the surveys can be completed
from any computer (e.g., personal, work, school), we are unable to guarantee the security of the
computer on which you choose to enter your responses. As a participant in our study, we want you to be
aware that certain "keylogging" software programs exist that can be used to track or capture data that
you enter and/or websites that you visit."
What if non-UTPA individuals will be working with me collaboratively on the research?
Our FWA only covers researchers at our institution. If non-UTPA individuals will be involved, they
must either:
1) be from an institution with its own FWA and obtain IRB approval from their IRB. This does not
negate the need for the UTPA researcher to obtain UTPA IRB approval for his/her involvement in the
study. For many collaborative studies, this is the most common approach to take. It is important to note
that different IRBs may handle the same protocol differently, thus approval by one IRB does not negate
the need for review by, and approval from, the other IRB. Dual IRB review can add time to the review
and approval process, so researchers must plan to submit well ahead of intended start dates.
2) be from an institution with its own FWA and we sign an Authorization Agreement stating that
either UTPA’s IRB or the other institution’s IRB will be responsible for human subjects oversight for
the entire project. Note that this process may be time consuming and somewhat impractical for
individual projects because it involves revision of the other institution’s FWA to include/designate
UTPA’s IRB.
3) be from an institution without an FWA and sign an “Individual Investigator Agreement” and
complete human subjects protection (CITI) training.
If such a collaborative research arrangement is anticipated, it is best to contact the IRB Chair prior to
preparing IRB documents. Depending on the specific role of the collaborating investigator, he/she may
or may not be considered “engaged in research”. This, in turn, will affect what the UTPA IRB requires
of him/her.
What if my research is conducted off-campus?
Most research conducted in the local community requires Spanish translations of informed consent
documents and relevant research material. For community research, if the research is limited to English
speaking individuals only, there must be some justification for exclusion of non-English speaking
individuals other than one of convenience.
If research is conducted at a site off-campus, such as a business, school, medical clinic, etc., the
appropriate permission must be obtained from an individual with authorization to grant access. This
permission should be obtained prior to IRB review; the IRB should be provided with a signed letter
of permission as part of your IRB protocol submission. The permission letter should be prepared on
company/school letterhead and should include specific information about the nature of the research
activities for which permission is being granted.
What if my research is conducted outside of the United States?
Research conducted in foreign countries must take the local customs and laws into account. IRB review
of research conducted in foreign countries is complicated by this issue. In most cases, it is best
(sometimes necessary) to additionally obtain local review of the research through a local IRB or human
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subjects protections committee. Failing this, the IRB may require consultation with individuals familiar
with the local culture and norms and investigation of any additional human subjects regulations
particular to the country. Researchers planning to do research in foreign countries are responsible for
familiarizing themselves with the country’s human subjects protection laws/regulations (if any) and
should be prepared to submit an IRB application well in advance of the anticipated research start date.
Researchers should familiarize themselves with the information on the OHRP website regarding
International Issues and should check The International Compilation of Human Subject Research
Protections for country-specific guidance.
What if non-UTPA individuals want to recruit UTPA staff/faculty/students as participants in their
research – can I assist?
Our FWA only covers researchers at our institution. If, as an “agent” of UTPA, your involvement is
limited to informing participants (e.g. students) about a research participation opportunity, you are not
“engaged in research”. However, if you assist with the informed consent process or with the research
activities (including, but not limited to, analysis of individually identifiable private data), then you are
engaged in research and would need to submit a UTPA IRB protocol prior to conducting the study.
Additionally, all research that recruits our staff/students/faculty must be locally reviewed by the UTPA
IRB for appropriate levels of human subjects protection. The level of review depends on the nature of
the study. Generally, simple survey studies can be approved quickly, after having reviewed the survey
materials and procedures. A letter/memo of IRB approval from the PI’s institution is also required prior
to UTPA IRB approval.
UTPA IRB approval is limited to the review of research for adequate human subjects protection. The
IRB does not have the authority to approve use of university facilities or to provide e-mail lists of
students/faculty/staff. Non-affiliated researchers should receive approval at the appropriate level (e.g.
Department Chair for recruitment/facility use limited to a department, Dean for recruitment/facility use
limited to a college, and Provost for campus-wide recruitment/facility use).
Please note: Simply informing students about the availability of an online research study/survey would
not require any UTPA IRB oversight. However, agreeing to allow a researcher to visit UTPA and solicit
students for, say, a paper-and-pencil survey research study would require that the non-affiliated PI
receive clearance from the UTPA IRB.
What other information is available about human subjects protection?
Please see below for some helpful links:
DHHS Office for Human Research Protections (OHRP)
Human Subject Regulation Decision Charts
45 Code of Federal Regulations 46
21 CFR 50 and 21 CFR 56
NIH Guidance: Does your proposed research involve human subjects?
NIH Guidance: Human subjects research definitions
Texas state reporting requirements for suspected child abuse
Texas state reporting requirements for suspected elder abuse or abuse of individuals with disabilities
Association for the Accreditation of Human Research Protection Programs (AAHRPP)
http://videocast.nih.gov/ram/ohrp_kaneshiro.ram
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http://videocast.nih.gov/ram/ohrp_carome.ram
http://www.hhs.gov/ohrp/education/#materials
14