Do You Consider This Research Study to Be Of

/ Initial Review Application
Document No.: / Edition No.: / Effective Date: / Page:
HRP-200 / 003 / 22 August 2016 / Page 1 of 2
Use for New Proposals
Title of Study:
IRB ID (if known):
Principal Investigator (PI):
PI E-mail: / PI Phone:
CollegeAffiliation (e.g. COLFA, EHD, etc.): / Department:
Point of Contact (POC)
(if other than the PI):
POC E-mail: / POC Phone:
REQUIREDfor students:
Faculty Sponsor (FS):
Faculty Sponsor’s E-mail: / FS Phone:

1. Do you consider this research study to be of:

Minimal Risk (Something that a normal person would expect to encounter in his or her daily life.)

OR More than Minimal Risk (This level of risk could place participants at risk of civil or criminal liability; damage their financial standing, employability or reputation;orplace them at risk of emotional or physical damage.)

2.1 Is the research funded?

Yes–provide information in table below

No– Skip to 2.2

2.1 Funding Sources (Add more rows as needed.)
Name of Funding Source / Funding Source ID / Grant Proposal ID

2.2 Will the research be conducted in any location other than UTSA?Does the research involve any sites where the principal investigator is responsible for the research (i.e., personally conducts, or oversees the research) and does not ordinarily have privileges to conduct the research? Off-site approval is required (e.g., letter), note that here.

Yes–provide information in table below(add rows needed)

No– Skip to 2.3

2.2 Non-UTSA Sites (Provide a letter from each site administrator.)
SITE Name / Contact Name / Contact phone/email

2.3 Does the research involve the use of a drug, biologic, or nutritional supplement?

Yes–Complete the Use of Drugs in Research Worksheet

No

2.4 Does the research involve the use of a device?

Yes–Complete the Use of a Device in Research Worksheet, then continue to Submission Requirements

No

Submission Requirements
Provide the following documents with this application:
• Investigator Protocol(UTSA IRB form“Protocol")
◦ If the study is grant supported, submit acomplete grant application and protocol (proposal) as well.
• A completed Research Personnel Form(HRP 201).
• Allof the following documents if they are to be used in the study:
◦ Recruitment materials and scripts ◦ Advertisements (printed, audio, and video)
◦ Data collection instruments and surveys ◦ Any written/visual materials meant to be seen or heard by subjects
◦ Consent documents OR Information Sheet (If consent will not be documented in writing) ◦ Sponsor sample consent document, when applicable
(NOTE: Non-English versions should be submitted after English versionsare approved.)
Once your protocol is approved, and prior to implementing any changes to the study (following IRB initial approval), you must revise andsubmit the revised documents to for further approval.
ALL Principal Investigators, Research Associates, Co-PIsand Faculty SponsorsMUSTcomplete the requisite CITI & COI trainings prior to IRB approval.
COI Training CITI Training
All questions regarding new submissions should be directed to the Office of the IRB at 210-458-6473 or .
Access to all forms and information is available at
Investigator Compliance
By submitting this form, investigatoracknowledges and confirms compliance with "INVESTIGATOR GUIDANCE: Investigator Obligations (HRP-800)" throughout the conduct of the study.

Revised Document (by UTSA IRB office) revised 07/2716

Created by WIRB Copernicus Group, Inc. for University of Texas San Antonio