Texas Woman's University Institutional Review Board (IRB)
Instructions for Expedited and Full Review Application Form
Denton and Dallas
Mail the signed original to the address below. If electronic submission is preferred, combine all parts of
application into single .pdf document and email to irb@twu.edu. If the application is submitted
electronically as a fully signed .pdf, the original copy is not required.
TWU’s Office of Research & Sponsored Programs
Institutional Review Board
PO Box 425619
Denton, TX 76204-5619
Applications may also be hand delivered to the Denton campus ACT 7th floor or the Dallas campus Office
of Research IHSD 8th floor.
Houston
All parts of the application (including the signed cover page and appendices in order) should be
combined into one single .pdf or Word document and emailed to irb-houston@twu.edu. The original
copy is not required. If you have any difficulty with preparing a .pdf file, please contact the Houston
Office of Research via email for assistance.
The application must be typed using a font no smaller than 11-point.
Cover Page
Principal Investigator (PI) Information: Provide the requested information (name, phone, status, email,
department, and colleague id #) of the individual with primary responsibility for the project. If there is
more than one PI, one must be designated here as the primary / contact PI. All IRB correspondence will
be sent to this PI, who will be responsible for sharing IRB communications with other members of the
research team. Note that the colleague id # is the 7-digit found on the TWU ID.
Title of Study: The title of the study should be listed here. This title should match the title on the
consent form if a consent form is being used.
Student Information: If the PI is a student, provide the name, department, and email address for the
faculty advisor.
Estimated Beginning Date of Study: This is the estimated beginning date of the study. Research
projects that involve human participants must be reviewed by, and receive approval from, the IRB PRIOR
to initiation.
Estimated Duration of Study: This is the expected length of time of the study. If the study lasts more
than one year, annual reviews are required.
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Campus: Indicate whether this is a Denton, Dallas, or Houston study. Typically, the campus of the
protocol is determined by the campus of the PI if a faculty or staff member or the campus of the faculty
advisor if the PI is a student.
Level of Review: Indicate either expedited or full. The IRB has the authority to change the level of
review.
Type of Project: Mark the appropriate box(es).
Signatures:
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Principal Investigator (PI): All PIs, including the PI named on the cover sheet and any PIs named in
question # 17, must sign here. The PI(s) is the person with primary responsibility for the research
project.
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Faculty Research Advisor: This signature line is required only for student research. Signature
certifies that the faculty member has read, reviewed, and approved the content of the application
and is responsible for the supervision of this research study.
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Academic Administrator: This signature certifies that the administrator has read, reviewed, and
approved the content of the application. The academic administrator is generally the department
chair, director, or associate dean.
Methodology
1. Describe the purpose of study, including research questions and/or hypotheses.
List the broad, long-term objectives and the goal of the specific research proposed, e.g., to test a stated
hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical
practice, address a critical barrier to progress in the field, or develop new technology. For thesis or
dissertation research, the purpose stated in the prospectus should be used.
Define any unusual terminology in layman’s terms so that the reviewers will understand what is being
studied. Spell out and clarify any acronyms that will be used.
2. Participant information:
a. Describe participants in study: Provide a general narrative description of the participants.
b. Provide the approximate number of participants you plan to include in your study.
c. Mark any vulnerable populations to be used (check all that apply). All local, state, and federal laws
must be considered when working with any vulnerable populations. If using minors, consider the
federal mandate to report child abuse. According to the Texas Family Code, anyone, including
individuals conducting research, must report known or suspected child abuse. Report child abuse by
calling the Child Abuse Hotline at 1-800-252-5400 or your local law enforcement office. All researchers
conducting expedited or full review studies must include the following statement in their consent form:
"Confidentiality will be protected to the extent that is allowed by law."
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d. List the age (or age range) of participants (e.g., 18 years and up; 14 year olds; 60 – 70
years of age). Provide the rationale for inclusion / exclusion on the basis of age.
e. Provide the sex of participants. Provide the rationale if you are including or excluding participants on
the basis of sex.
f.
Will participants be excluded based on ethnicity? If yes, you must explain the criteria to be used and
provide the rationale for using these criteria. If using non-English speaking individuals, make certain
that issues regarding the translation of documents provided to participants are addressed throughout
the application (specifically the questions regarding the instruments and consent form). Describe how
the documents will be translated, the language(s) of the translations, and the qualifications of the
translator.
g. List and provide rationale for any other inclusion/exclusion criteria that will be used to select research
participants.
3. Describe the participant recruitment process in detail. Attach any recruitment materials or scripts.
Consider the following when stating the recruitment details:
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If using any type of list to contact potential participants, how will you obtain this list and from whom
or where will you obtain it?
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Will you use written materials for recruitment (e.g., flyers, brochures, letters, email)? All written
materials must include the PI’s name and contact information, the title of the study, a statement
that participation is voluntary and that participation may be discontinued at anytime.
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Will the participants be recruited via face-to-face contact? Describe the location and setting where
recruitment will take place. A written version of the script to be used must be attached to the IRB
application for review and approval by the IRB.
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How will participant contact be made? (e.g., Will PI or another member of research team contact
the participants? Will the participants contact the PI? What method will be used to make this
contact?)
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Is anyone involved in the recruitment process who is not part of the research team? If yes, explain
who this person is, the relationship to the participants, and the role in the recruitment process.
4. Describe in detail the research procedures.
Describe step-by-step the process that will be used for this research study. This section should explain the
steps of the research chronologically and in detail. Explain what the research participants will be expected
to do or what intervention will be used and what will be done to them. It should be written so that an
educated layperson can understand the terminology. It is crucial that sufficient detail is provided in this
section in order to give the committee a clear picture of the study.
If you will be video or audio-recording, explain the purpose of the recordings and who will have access to
the recordings. If the recordings will be made publicly available for any reason, this must be disclosed in
the consent form and participants must be allowed to specifically consent to this use. If applicable, explain
how confidentiality of non-consenting individuals in the recording will be maintained. If the recordings will
be digitized, explain the security precautions used for these digital files.
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If you will be using e-mail, internet, and/or online meeting platforms, provide a detailed explanation of
how it will be used. Explain how access to email lists, listservs, or web postings will be obtained. If using a
server, the IRB will need assurance that the data will be secure. This includes encryption methods, data
retrieval and data storage information. If you are downloading survey information that is identifiable, the
method you use to retrieve the data should encrypt the information. When using any internet tools
caution should be taken to ensure that the data requested are not identifiable.
The following statement is required in the risk section of the application and on the consent document
“There is a potential risk of loss of confidentiality in all email, downloading, electronic meetings and
internet transactions.”
5. What is the time commitment for the participants? Include the number of sessions, maximum time
commitment per session, and the maximum cumulative time commitment.
Consider the following when describing the time commitment for each procedure:
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How long will it take the participants to complete any interviews or written / on-line instruments (e.g.,
demographic questionnaires, surveys, evaluations)?
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If the study involves multiple sessions over a period time, provide the number of sessions, the length
of each session, and the schedule of these sessions. Calculate a total amount of time that these
sessions represent.
For example, Dr. Smith is conducting a study with classroom children. Each child will be pulled out of
class and receive special instruction two times per week for 1 hour each time for 12 weeks. Therefore,
the total time commitment for this child to participate in the study would be 24 hours (1 hour x 2
sessions per week x 12 weeks = 24 hours).
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If participants are traveling from a distance to participate, include this as part of the time commitment.
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Assure the committee that procedures will be in place for breaks if needed based on length of
sessions, needs of participants, etc.
6. Site / location of the study.
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If the study will take place at a specific agency or organization, provide the following:
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Name of site
Affiliation of Principal investigator with this site, if any
Affiliation of participants with this site
Description of any privacy issues such as proximity to other individuals and how these
issues will be handled.
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Explain the physical location (i.e. library within hospital, conference room at clinic, school classroom,
meeting room at church, restaurant, e.g.). Describe the privacy arrangement (i.e. one-on-one, group,
proximity of other individuals, etc.).
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The IRB requires a letter from all study sites on official letterhead and signed by an agency official
stating that the research may be conducted on the premises. If an approval letter is not included
with this application, explain. The IRB may approve a study prior to receipt of the letter, but no data
may be collected at the site until the letter is received.
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POTENTIAL RISKS AND PROTECTION OF PARTICIPANTS
7. List all potential risks to participants and the steps to minimize these risks. Consider the vulnerability
of the population you are studying when completing this section. This information must exactly
match the risk information in the consent form.
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Risks to participants can include, but are not limited to:
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Loss of confidentiality (this risk exists in most studies)
Possibility of embarrassment
Physical or psychological harm
Physical or emotional discomfort
Fatigue
Loss of time
Monetary loss (transportation, time off work, etc.)
The administration of drugs or radiation
Unusual physical exertion
Subjection to deceit
Public embarrassment and/or humiliation
Topics of a sensitive nature
Anxiety
Harassment
Invasion of privacy
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To minimize the risks of fatigue or discomfort, assure participants that they can take a break or stop
the study at any time.
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If there is a possibility of emotional discomfort or psychological harm, provide all participants with a
referral list of agencies that provide counseling, crisis intervention, or other services. Referral
information should be provided to the participants at the time they are provided informed consent
information. Be mindful of the characteristics of the subject population when determining what
agencies are included on the referral list.
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If using email or internet as a way to communicate with participants or obtain data, add the following
statement, “There is a potential risk of loss of confidentiality with any email, downloading, and
internet transactions” to the cover letter or consent form.
8. Will participants be told about the intent of the study prior to participating?
This section must be completed. Initially withholding the intent of a study from participants is considered
to be deceptive. If participants will not be informed of the intent of the study before it begins, provide a
detailed explanation of the need for this deception, how the participants will be briefed on the intent after
the study, how participants’ questions will be answered, and how participants will be informed of the
option to allow or disallow the use of their data in the study.
9. Describe how, when, and in what format (verbal, cover letter, consent form) participants will be
informed of their right to ask questions at any time during the study.
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The participants must have the opportunity to ask questions. This can be done in a variety of ways and at
different times such as:
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during the interview or session
during recruitment
when the researcher is explaining the intent of the study
when the researcher is explaining the consent form
Explain here how the participants will be made aware that they may ask questions at any time
throughout the study and explain when and how they may do so.
10. Identifiable data
This question addresses how identifiable data will be handled. Identifiable data include documents,
audio and video recordings, electronic data, and blood or other human specimens where the
participants can be identified.
a. What type of identifiable data will be collected? Examples of identifiable data include surveys with
identifying information, information from medical or school records, etc.
b. Where will this data be stored? Describe the exact location, storage arrangements, and the security
measures that will be in place (i.e., locked cabinet in office, password protected computer in the lab,
etc.). Use caution when storing data electronically, especially when storing the data on a laptop or
external drive. This includes the storage of digital audio or video recordings.
c. What is the exact date that study data will be destroyed? If data will be retained indefinitely, explain
why and include the explanation on the consent form.
d. How will the identifiable data be destroyed on the specified date? Hardcopies of any collected data
with identifiable information should be shredded. Electronic data should be deleted or destroyed in
a manner that insures the information cannot be retrieved.
e. Because the academic component of TWU is classified as a non-covered HIPAA entity, identifiable
health or health-related data cannot be transmitted electronically. Health-related data is data that
would be found in a medical record. You must be able to answer “no” to at least one of the
questions in order for your study to be approved. If you must answer “yes” to all three of these
questions, then appropriate TWU administration will be contacted regarding the feasibility of
conducting the study.
BENEFITS/REMUNERATION
11. What will the participants receive?
Explain what the participants will receive as a result of participating in the study. If providing monetary
remuneration such as cash, gift cards, or entry in a drawing for a prize, explain the conditions that must
be met to receive the remuneration (example: participants will receive $10 for completing the initial
survey and $25 for participation in all subsequent study activities). Detailed information about
remuneration and benefits must be on the consent form.
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12. Generalizable benefits
Explain what the general benefits of the study are (e.g., this information could further the understanding
of how or why certain concepts should or shouldn’t be used, the results could assist administrators to
develop a curriculum for schools in rural areas, the results will contribute to the body of knowledge in a
certain field).
13. Results of the study
Explain whether or not the results of the study will be accessible to all research participants or if the
participants must request the results. If the results will be provided, explain how this will occur. If the
results are not going to be provided to the participants, explain why.
INFORMED CONSENT PROCEDURES
14. Written informed consent
A consent form is necessary for studies in which risks are more than minimal and/or when minors are
participants.
a. Describe the process that will be used for obtaining informed consent, including where and when
the consent form will be signed, how the participants will have the opportunity to discuss the
information on the consent form with the researchers, etc. Example:
When a potential participant indicates an interest in participating in this study and all of the
inclusion criteria have been met, the principal investigator will explain the purpose of the study
and the interview process, including the estimated amount of time that will be spent in the
interview, the steps to maintain confidentiality, and how the information collected will be
handled. The participant will be given the opportunity to ask questions during this time. When
the participant indicates that he/she has no more questions and that he/she understands the
purpose of the study and his/her role in the process, the written consent form will be explained
and offered to the participant. The purpose of the study, the potential risks, and the anticipated
length of time for participation will all be reiterated and time will be allowed for additional
questions and answers. The participant will be assured that participation is voluntary and that
he/she can changes his/her mind at any time and withdraw from the study without
repercussions of any kind. Only after the consent form is signed and the participant indicates
understanding of his/her involvement in the study will data collection begin.
b. Unless there are unusual circumstances, investigators are required to document informed consent by
obtaining the participant’s signature (or the signature of their parent or guardian) on a written consent
form. Explain when and how that signature will be obtained. Explain where the signed consent forms
will be stored (specify precise location, preferably in a locked file cabinet with limited access), how
long the signed consent forms will be kept, and identify specific ways that the signed consent forms
will be destroyed at the end of this period of time. Note that a copy of the signed consent forms will
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need to be placed on file with the IRB when the study file is closed. IRB records (including signed
consent forms) should be kept for a minimum of four years from the file closed date.
Instructions for developing a written consent form can be found in the Guide to Writing a Consent
Form. The consent form must be consistent with the information provided to the IRB in the
application. Especially make sure that the title on the consent form matches that on the application
form, that the risks in the application are also included on the consent form, etc.
c. As required by federal guidelines, barring certain exceptions, no investigator may involve a human
being as a participant in research unless the investigator has obtained the legally effective informed
consent of the participant or the participant's legally authorized representative. The IRB may waive the
requirement for the investigator to obtain a signed consent form if it determines that: (1) the only
record linking the participants and the research would be the signed consent form and the risk of
potential harm resulting from a breach of confidentiality would be high (e.g., individuals participating
in a study of HIV/AIDS, sexual behavior, family violence, etc.); or (2) the research presents no more
than minimal risk of harm to participants and involves no procedure for which written informed
consent is normally required outside of the research context.
If a written informed consent will not be obtained, use this space to explain how consent will be
obtained for the study. For example, if an anonymous questionnaire or survey is to be used, the
following statement may be placed at the top of the survey, “The return of your completed
questionnaire constitutes your informed consent to act as a participant in this research.”
RESEARCH TEAM MEMBERS
15. Research team members
Provide the name, 7-digit colleague ID # (if applicable), email address, TWU department or name of
other institution, and the role on the project for all research team members other than the PI and
faculty advisor (who are already listed on the cover page).
The research team is defined as investigators who are individuals performing various tasks related to the
conduct of human subjects research activities, such as obtaining informed consent from subjects,
interacting with subjects, and communicating with the IRB. Such tasks could include:
 obtaining information about living individuals by intervening or interacting with them for research
purposes;
 obtaining identifiable private information about living individuals for research purposes;
 obtaining the voluntary informed consent of individuals to be subjects in research; and
 studying, interpreting, or analyzing identifiable private information or data for research purposes.
Research team members can include physicians, scientists, nurses, administrative staff, teachers, and
students, among others. In every human subjects research study, all research teams members have
certain responsibilities regarding the ethical treatment of human subjects.
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All research team members listed here are required to successfully complete the online training module
for researchers entitled “Human Participant Protections Education for Research Teams.” A link to this
training module is available on the TWU IRB website at http://www.twu.edu/research/irb.asp. A
current human subjects training certificate (less than 3 years old) must be on file for the investigator,
advisor, and all research team members before an approval letter will be sent. These training certificates
may be sent directly to the IRB separately or attached to this application in the attachment section. If a
current training certificate is already on file with the IRB, there is no need to attach another copy.
NOTE: If using an individual who is not a member of the research team but will have access to
identifiable information, a Confidentiality Agreement Form may be signed in lieu of the required
training. A person transcribing interviews or typing the results of completed surveys falls into this
category. The signed Confidentiality Agreement Form must be submitted to the IRB prior to the
individual gaining access to the identifiable data. A template for this form can be found on the IRB
website.
ATTACHMENTS
16. Attachments
List and describe all attachments including forms, scripts, flyers, consent forms, agency approval letters,
human subjects training certificates, signed confidentiality agreement forms, referral lists, surveys,
questionnaires, or any other instrument used in the study. Attachments should be listed in the same
order in which they are attached and all attachments listed should be attached. If an item is
exceptionally lengthy, an investigator may contact the IRB to request a waiver of this requirement.
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