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 . 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 . 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.

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:

  • 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.
  • 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.
  • 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 generalnarrative 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."

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:

  • 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?
  • 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 maybe discontinued at anytime.
  • 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.
  • 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?)
  • 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.

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:

  • How long will it take the participants to complete any interviews or written / on-line instruments (e.g., demographic questionnaires, surveys, evaluations)?
  • 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 sessionsper week x 12 weeks = 24 hours).

  • If participants are traveling from a distance to participate, include this as part of the time commitment.
  • 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.

  • If the study will take place at a specific agency or organization, provide the following:
  • 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.
  • 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.).
  • 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.

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.

  • Risks to participants can include, but are not limited to:
  • 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
  • To minimize the risks of fatigue or discomfort, assure participants that they can take a break or stop the study at any time.
  • 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.
  • 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.

The participants must have the opportunity to ask questions. This can be done in a variety of ways and at different times such as:

  • 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. Identifiabledata

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.

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.