Research Determination Form

Research Determination Form

Administrative Review

Instructions: Complete all questions regarding the proposed project. Use as much space as necessary and be specific. Refer to the end of the document for term definitions.

IMPORTANT: NO ACTIVITY MAY BEGIN ON THIS PROJECT UNTIL THE PRINCIPAL INVESTIGATOR HAS RECEIVED FORMAL NOTIFICATION FROM THE CSULB IRB THAT THE PROJECT HAS BEEN ACKNOWLEDGED AS A QUALITY ASSESSMENT/QUALITY IMPROVEMENT PROJECT UNDER ADMINISTRATIVE REVIEW.

1. BASIC INFORMATION

PI’s Name(Last, First, Degree) / Click or tap here to enter text. /
CITI Member ID # / Click or tap here to enter text. /
Completion of CITI Social & Behavioral Basic/Refresher Course (Check one) / YES ☐ NO ☐ Not Sure ☐
Department / Click or tap here to enter text. /
Affiliation / Student ☐ Staff ☐ Faculty ☐ Other ☐
Mailing Address / Click or tap here to enter text. /
Telephone Number / Click or tap here to enter text. /
Email / Click or tap here to enter text. /

1. PROJECT SUMMARY

Title of Project
Click or tap here to enter text. /
Provide the purpose and procedures of your project (250 word minimum)
Click or tap here to enter text. /
Is the project primarily for training purposes?
YES ☐ NO☐ OTHER (Explain): ☐Click or tap here to enter text.
Do the project activities involve face-to-face interactions with humans?
YES*☐ NO ☐
*If yes, which activities are involved in your project (check all that apply)
Surveys/Questionnaires ☐ One-on-One Interviews☐ Focus Groups☐ Interventions ☐ Educational Tests/Assessments ☐ Data Mining☐ Accessing Public Records ☐
Biospecimen Analysis ☐ Experimental Controls ☐ Other (Explain) Click or tap here to enter text.
Is there an experimental group compared to a control group?
YES ☐ NO ☐
What location(s) will the project take place?
Click or tap here to enter text. /
Do you have permission from the facility, institution or director of the organization to conduct your project? * If yes, please attach permission letter to this package.
YES*☐ NO ☐ IN PROGRESS ☐

1. DATA ACCESS

Who will have access to the data? / Click or tap here to enter text. /
Where will the data be stored? / Click or tap here to enter text. /
Will identifiable data be collected (PHI, PII, other)? / YES*☐ NO ☐ NOT SURE ☐
*If yes, why is it necessary for identifiable data to be collected?
Will you have access to external data i.e. medical charts, public records, proprietary information? / YES ☐ NO☐
Is it possible for the information collected to be traced back so as to identify the individual through the use of key or by other means? / YES NO

1. FUNDING

Is the project funded? (If no, skip to Section 5) / YES*☐ NO ☐
*If yes, is the project funded for research purposes? / YES ☐ NO ☐
Name of Funding Agency / Click or tap here to enter text. /
Grant Number (If applicable) / Click or tap here to enter text. /

1. RESULTS

Will the results of this project be published?
YES*☐ NO ☐
*If yes, for what purpose will the results be published? (Check all that apply)
Thesis ☐ Dissertation ☐ Research Journal/Article ☐ Employee Manual ☐ Pilot Data ☐
Research Conference ☐ Course/Department Improvements ☐ Course Assignments ☐
Personal Knowledge ☐ Training ☐ Other (Explain) ☐ Click or tap here to enter text.
What knowledge base will the results contribute to? (Check one)
Internal knowledge ☐ Generalizable knowledge ☐

PLEASE ATTACH ALL OTHER RELEVANT DOCUMENTS SUCH AS FACULTY ADVISOR LETTERS AND FACILITY PERMISSION LETTERS AS APPENDICIES TO THIS PACKAGE SUBMISSION IN IRBNet.

DEFINITIONS

These definitions help the IRB determine whether a project constitutes as research or QA/QI.

QA/QI Projects: Activities that are not designed to produce information that expands the knowledge base of a scientific discipline (or other scholarly field) and does not constitute as research when it is designed and implemented for internal knowledge/purposes. Some activities that qualify as QA/QI include: case management, internal course assignment assessments, patient care coordination, policy and guideline development, benchmarking activities and department procedural analyses.

Research: A systematic investigation (including research development, testing and evaluation) designed to produce information to expand knowledge of a scientific discipline (Or other scholarly field of study) and contributes to generalizable knowledge.

Generalizable Knowledge: Information that contributes to a theoretical framework of an established body of knowledge. The results are expected to be generalized or applied to a larger population beyond the site of data collection or population studied. Results are intended to be replicated in other settings.

Internal Knowledge: Information that solely benefits the intended site or population investigated. The results are used to assess the quality of procedures, services or activities and used to improve the quality of those procedures, services or activities.

Identifiable Data: Private health information such as medical record numbers, social security numbers, address, diagnosis, etc. Alternatively, personal identifiable information such as name, student ID numbers, demographic information, etc.

For federal regulations regarding QA/QI activities, please visit the Department of Health and Human Services (DHHS) website:

CSULB QA/QI FormVersion 9/20171