University of Texas at El Paso
Institutional Review Board
(IRB) / Quality Improvement
Project Application
DIRECTIONS: This form is to be submitted to the IRB for Quality Improvement projects.. The IRB will then determine whether the submission is a QI project or research. Please submit this completed form, along with finalized copies of all recruitment materials (e.g. telephone scripts, advertisements, etc), tests, surveys, interviews, and copies of human participants training completion certificates for all key personnel to the IRB via www.IRBNet.org
TRAINING: All UTEP researchers (faculty, staff, and students) and outside collaborators who will have intervention and/or interaction with humans must complete a human subjects ethics training course. The Project Manager and/or key personnel must complete the designated CITI training modules. For more information and registration please visit www.citiprogram.org
Definition of Quality Improvement:
“[A] systematic pattern of actions that is constantly optimizing productivity, communication, and value within an organization in order to achieve the aim of measuring the attributes, properties, and characteristics of a product/service in the context of the expectations and needs of customers and users of that product.”
-Institute of Medicine
Definition of Research:
45 Code of Federal Regulations Part 46.102 (d) defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Ethical Considerations as defined in the Belmont Report:
Respect for Persons (autonomy)- Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection.
Beneficence- Human participants should not be harmed and the project should maximize possible benefits and minimize possible harms.
Justice- The benefits and risks of project must be fairly distributed.
Please note it is your responsibility to resubmit the application if there are any modifications made to the originally submitted documents. For further guidance or assistance, please contact the IRB Office at (915) 747-7693 or by email at
1. Project Title:2. Project Manager Contact Information
Name (Last Name, First Name, MI) / Highest Earned Degree
University Title / Department
Campus Phone No. / E-Mail Address
Faculty Staff Student Other:
Name (Last Name, First Name, MI) / Highest Earned Degree
University Title / Departments
Campus Phone No. / E-Mail Address
Faculty Staff Student Other:
If Project Manager is a student, list Faculty Advisor, Mentor or Committee Chair
Name (Last Name, First Name, MI)
/ Highest Earned Degree
University Title
Department
Campus Phone No.
E-Mail Address
3. Check Yes or No
Yes No
1. / Does the protocol include children?
2. / Does the protocol include prisoners, fetuses, pregnant women or human in vitro fertilization?
3. / Does the protocol involve more than minimal risk?
4. / Does the protocol involve deception?
5. / Does the protocol include cognitively impaired participants?
4. Summary of Project Activity
Attach copies of all written materials that will be used in the interaction with the participants.
4.1 Briefly state the purpose of this project activity:
What is your PICO question:
4.2 What is the goal/outcome of the project?
Anticipated Start Date: Anticipated Date of Completion:
4.3 How will the project be conducted?
In person (interviews, surveys, focus groups)
Online
Telephone
Observational
Secondary and/or Archival Data
Publicly available media
Other: (please describe)
4.4 Will you also submit to other IRBs for determination of the same project?
Yes No
If yes, provide the following for each IRB that is expected to review any part of this project:
Institution / IRB Contact Person / Phone Number
5. Participants and Recruitment
Include all project materials that will be used in the course of your project
5.1 Maximum number of participants :
5.2 Expected Age Range:
5.3 Participant Recruitment Procedure
Advertisement Telephone Script
Verbal scripts for face-to-face meeting E-Mail (publicly available)
Letters to potential participants Web-Based (social media)
Other, please list:
5.4List project site(s):
*Please include Site Authorization Letter allowing permission to conduct project at above listed site(s)*
5.5 List Inclusion criteria:
5.6 List Exclusion Criteria:
5.7 Does your survey, interview, or questionnaire deal with sensitive and private aspect of behavior, such as sexual preference, substance abuse, or illegal conduct?
Yes No
If yes, please describe and include a copy of survey, interview questions, or questionnaires.
5.8 Describe the task(s) that participants will be asked to perform.
Describe the frequency and duration of procedures, psychological tests, educational tests, and experiments; including screening intervention, follow-up, etc. Reminder: No personal or sensitive information can be sought under Minimal Review guidelines. (If you intend to pilot a process before recruiting for the main project, please explain.)
5.9 Explain how participants will be fully informed of this project to their participation (through use of a study information sheet, letter, e-mail invitation, etc.) Note: Please SUBMIT a copy.
5.10 Will you be audio or video recording?
No
Yes. Please ensure to complete the Confidentiality Section below.
5.11 Will identifiers or links to an identifier of the participants be recorded?
Yes No
If yes, what information that could be linked to the participants will be recorded?
5.12 Will the participants be paid?
No Yes. State the type and amount of compensation:
5.13 Does this project pose any risk to the individual?
No
Yes
If yes, list the risks:
5.14 How will you help to minimize potential risks that individuals may be exposed to while participating in the project? Potential risks may include psychological, social, legal, physical, etc.
**Q/I projects should not impose additional risk to the standard of care already being received**
6. Confidentiality
6.1 Describe provisions that will be taken to maintain confidentiality of data. Will they contain individual’s names or images? (e.g., surveys, video, audio tapes, database):
6.2 Could the information obtained or recorded about individuals place them at risk for criminal or civil liability or be damaging to their financial standing, employability, insurability, or reputation?
No
Yes. Please explain:
6.3 Describe the security plan for data, including where data will be stored, and for how long, noting that you may not keep identifiable data indefinitely (i.e., password protection, encrypted, locked filing cabinet, etc.):
6.4 Will identifiable data be made available to anyone other than the Project Manager?
Yes No
If yes, explain who and why they will have access to the identifiable data?
6.5 With whom will the results of the project be shared?
ASSURANCES – Conflict of Interest and Fiscal Responsibility
Do you or any person responsible for the design, conduct, or reporting of this project have an economic interest in, or act as an officer or director of any outside entity whose financial interests may reasonably appear to be affected by this project?
☐ YES If yes, please explain any potential conflict of interest Click here to enter text.
☐ NO
Do you or any person responsible for this project have existing financial holdings or relationships with the facility supporting this project?
☐ YES If yes, please explain any potential conflict of interest Click here to enter text.
☐ NO
☐ N/A
With this submission I certify that:
☐ I am responsible for keeping training records on file for all project personnel.
☐I agree to fully comply with the ethical principles as indicated in the Belmont Report.
☐I agree that the information provided in this form and all other supporting documents and forms are accurate and complete.
☐I understand that any changes in procedure with affect to participants must be submitted to the IRB prior to implementation. Furthermore, I understand that any adverse events and significant changes in risk for participants must be immediately reported in writing to the UTEP IRB.
Q/I Application April 2015 5