№ files_lp_4_process_2_68696
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Administrative research oversight worksheet listing required checks and documentation used by Institutional Review Board staff to screen Human Research submissions before formal ethical review.
Year:
2026
Date:
February 16, 2026
Document Code:
HRP-308
Document Type:
Worksheet
Subject:
Human Research Ethics Review and IRB Pre-Review Screening
Responsible Body:
Institutional Review Board (IRB)
Purpose:
Screening of submission materials for Human Research review
Related Documents:
HRP-309 Ancillary Review Matrix; HRP-330 HIPAA Authorization Worksheet; HRP-024 SOP New Information; HRP-306 Drugs Worksheet; HRP-307 Devices Worksheet; HRP-801 Establishing Reliance Agreements; HRP-815 Institutional Profile Form; HRP-830 Communication and Responsibilities Worksheet
Regulatory Areas Referenced:
Human Research Regulations; EU GDPR; HIPAA; NIH Policy; FERPA; PPRA
Primary Users:
IRB staff conducting submission screening
Scope:
Initial review, modification review, and pSite review for studies relying on the IRB
Key Topics:
regulatory oversight determination, ancillary reviews, ethics training verification, conflict of interest disclosure, consent documentation, research protocol completeness, drug and device oversight, multi-site research coordination, HIPAA authorization review, protection of vulnerable populations
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Note:
Study Summary 1.1 Please provide a brief summary of the study in the table below. A complete description of the study with detailed information should be provided in the body of the protocol. For sections not applicable to the study, mark them as N/A. Study Title Study Design Primary Objective/Purpose Secondary Objective(s)/Purposes Research Intervention(s) ClinicalTrials.gov NCT # Study Population Sample Size Study Duration for individual subjects Study Specific Abbreviations/ Definitions
Background 3.1 Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. :
this section should be limited to only information directly related to the research questions and objectives. Do not include your full dissertation proposal. 3.2 Describe any relevant preliminary data (e.g. pilot data).
Procedures Involved 5.1 Describe and explain the study design. 5.2 Please select the methods that will be employed in this study (select all that apply):
☐ Audio/Video Recording ☐ Psychophysiological Recording ☐ Behavioral Interventions ☐ Record Review - Educational ☐ Behavioral Observations and Experimentations ☐ Record Review - Employee ☐ Deception ☐ Record Review- Medical ☐ Focus Groups ☐ Record Review - Other ☐ Interviews ☐ Specimen Collection or Analysis ☐ Investigational Medical Device – (e.g. Medical Mobile Applications) ☐ Surveys and/or Questionnaires ☐Psychometric Testing ☐ Other Social-Behavioral Procedures Provide a description of all research procedures being performed and when they are performed. (Upload any surveys, questionnaires, interview scripts, focus group scripts, debriefing scripts, psychometric tests, stimulus materials, intervention manuals, and data collection forms on the Local Site Documents page in the IRB application.) 5.3 Describe the procedures or interventions that are going to be conducted as part of the research project, but that would have been conducted anyway, even if the research was not occurring (i.e. standard of care procedures, activities that would occur in a classroom). 5.4 Describe the procedures performed to lessen the probability or magnitude of risks of items selected in 5.2.5. 5 If accessing or collecting existing data, describe: The data that will be collected during the study (e.g. demographics, medical history, etc.). Attach the data capture sheet(s) on the Local Site Documents page in the IRB application. How the data will be obtained, including how you have the authority to access the data. The source or location of the data (e.g. USF Epic, TGH Epic, Hillsborough County School records, CANVAS records, publicly available databases, etc.). 5.6 If collecting and/or analyzing biological specimens, describe: How the biological specimens will be or have been collected. How the biological specimens will be stored. How long the biological specimens will be stored. How the biological specimens will be used. The laboratories that will be used. Whether the collected biological specimens will undergo genetic testing. If so, indicate if this study is part of a Genome Wide Association Study (GWAS) and whether the data will be forwarded to the NIH dbGaP. 5.7 If there are plans for long-term follow-up (once all research related procedures are complete), what data will be collected during this period.
Data and Specimen Storage for Future Research 6.1 If data or specimens will be banked for future research studies, describe where the data or specimens will be stored, how long it/they will b:
the process to request a release, approvals required for release, who can obtain data or specimens, and the data to be provided with specimens.
Note:
Year
Topic:
Procurement, Equipment, Services, Software
Document Type:
Checklist
Organization:
County APD
Year:
2023
State:
Wisconsin
Type of Document:
Questionnaire / Data Collection Form
Institution:
Department of Health Services, Division of Public Health
Program:
Trauma Program
Target Audience:
Hospitals seeking Level IV trauma classification
Reporting Period:
12 months prior to PRQ submission
Submission Deadline:
45 days before scheduled site visit
Contact Email:
[email protected]
Note:
Year
Note:
Year
Context:
This document outlines the process for Clinical Faculty to complete a Pre-Review of Payroll Statements in the PAC system for certification.
Year:
2023
Region / City:
United States
Topic:
Healthcare, Medicare, MIPS, Value Pathways
Document Type:
Guidelines
Organization:
Centers for Medicare & Medicaid Services (CMS)
Author:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
General public, healthcare professionals, clinicians
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
Not provided
Region / City:
Not specified
Topic:
Research ethics, manuscript submission
Document type:
Template
Author:
Not specified
Target audience:
Authors submitting research articles
Period of validity:
Not provided
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / city:
United States
Topic:
Merit-based Incentive Payment System (MIPS)
Document Type:
Instructions and Template
Agency / Institution:
Centers for Medicare & Medicaid Services (CMS)
Author:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
General public, healthcare professionals, and stakeholders in the Medicare program
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Cincinnati
Subject:
Social and Behavioral Sciences Research
Document Type:
Research Protocol Submission Guidelines
Institution / Organization:
University of Cincinnati
Author:
Not specified
Target Audience:
Researchers submitting to the IRB-S
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
United States
Topic:
Mortgage Insurance, FHA, Real Estate
Document Type:
Official Form
Organization:
U.S. Department of Housing and Urban Development (HUD)
Author:
HUD
Target Audience:
Lenders, Mortgagees
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
United States
Topic:
Disaster Assistance
Document Type:
Supporting Statement
Organization:
Federal Emergency Management Agency (FEMA)
Author:
Federal Emergency Management Agency (FEMA)
Target Audience:
Individuals applying for disaster assistance
Period of Validity:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2025
Region / city:
N/A
Topic:
Manuscript submission guidelines
Document type:
Guidelines
Organization / institution:
Journal of Crustacean Biology
Author:
N/A
Target audience:
Authors preparing manuscripts for submission
Effective period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
2022
Region / city:
Japan
Topic:
Academic manuscript submission guidelines
Document type:
Instruction manual
Organization / institution:
Nara Women’s University, IDEA Consultants, Suma Aqualife Park
Author:
Aya Miyajima, Keiji Wada
Target audience:
Authors submitting academic manuscripts
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
November 4, 2022
Year:
2022
Region / City:
Japan
Theme:
Life histories, sexual dimorphism, marine biology
Document type:
Manuscript
Organization / Institution:
Suma Aqualife Park, Nara Women’s University, IDEA Consultants, Inc.
Authors:
Aya Miyajima, Keiji Wada
Target audience:
Researchers, marine biologists
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Note:
Year
Year:
2026
Event:
National Communication Association Convention
Location:
New Orleans, Louisiana, USA
Division:
Organizational Communication Division
Document Type:
Call for Submissions
Audience:
Scholars, educators, and practitioners in organizational communication
Submission Deadline:
March 25, 2026
Formats Accepted:
Individual Papers, Paper Sessions, Panel Discussions, Performance Sessions, Extended Abstracts
Theme:
MOVE/MENTS in Communication
Submission Platform:
NCA Convention Central
Style Guide:
APA 7th edition
Requirements:
Original work, double-spaced, 12-point Times New Roman, 1-inch margins, compliance with human participant protections
Year:
2026
Region / City:
United States
Theme:
Aging, Communication, Media
Document Type:
Call for Submissions
Organization / Institution:
National Communication Association (NCA)
Author:
Ivan Gan
Target Audience:
Researchers, Academics, Students, Conference Participants
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2025
Region / City:
New York, USA
Subject:
Immigration, Habeas Corpus
Document Type:
Legal Memorandum
Organization / Institution:
United States District Court for the Southern District of New York
Author:
[Client Name]
Target Audience:
Legal professionals, Court
Period of Validity:
Ongoing
Approval Date:
[Date]
Date of Changes:
[Date]
Year:
Not specified
Region / City:
Not specified
Topic:
Manuscript formatting for submission
Document Type:
Template
Organization / Institution:
Crop Science
Author:
Not specified
Target Audience:
Authors submitting manuscripts to Crop Science
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
Template for preparing manuscripts for submission to the journal Crop Science, including sections like abstract, introduction, methods, results, acknowledgments, and references.
Year:
2025
Region / City:
Edinburgh
Topic:
Glaucoma, Medical Conference
Document Type:
Guidelines
Organ / Institution:
The UK and Eire Glaucoma Society, Glaucoma UK
Author:
UKEGS Committee
Target Audience:
UKEGS Members, Medical Professionals
Period of validity:
Until 29 September 2025
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Context