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This document is a supplement for studies requiring an external IRB as the IRB of record, providing instructions for the completion and submission of necessary forms in the UC Research Authorization Program.
Year:
2019
Region / City:
USA
Topic:
Research Protocol
Document Type:
Research Form
Institution / Organization:
University of California
Author:
UC IRB
Target Audience:
Researchers, Investigators
Period of Validity:
Not specified
Approval Date:
11/22/2019
Date of Changes:
Not specified
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Year:
2023
Region / City:
Provo, Utah
Topic:
Institutional Review Board Agreement
Document Type:
Legal Agreement
Organization:
Brigham Young University
Author:
Not specified
Target Audience:
Academic and research institutions, legal and regulatory bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Document Type:
Request for Proposal
Issuing Body:
City-County Information Technology Commission (CCITC)
Partner Organizations:
Marathon County; City of Wausau; North Central Health Care
Project Manager:
Rick Abreu, IT Support Manager
Submission Deadline:
January 5, 2018, 4:00 P.M. CDT
Contract Term:
5 years
Location:
Wausau, Wisconsin
Address:
407 Grant Street, Wausau, WI 54403-4783
Subject Matter:
Managed print services and multifunctional devices procurement
Applicable Regulation:
Marathon County Procurement Code, Sections 3.01–3.16
Related Law:
Open Records Law of the State of Wisconsin
Current Contract Expiration:
March 2018
Year:
N/A
Region / City:
N/A
Topic:
Human Research Protection Program, Institutional Agreements
Document Type:
Policy
Organization:
Texas A&M University (TAMU)
Author:
N/A
Target Audience:
Institutional researchers, IRB staff
Effective Period:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Year
Document Type:
Guarantee / Contractual Security
Parties Involved:
Consultant, Guarantor, Client
Legal Jurisdiction:
Irish law
Purpose:
Guarantee of Consultant’s obligations under the Contract
Key Provisions:
Indemnity, Continuing Guarantee, Partial Invalidity, Assignment
Authorized Signatories:
Guarantor, Attorney, Witness
Year:
2011
Organization:
Veterans Health Administration (VHA)
Document type:
Survey report
Target population:
Veteran enrollees in VA health care system
Sample size:
57,820 eligible contacts, 43,633 completed interviews
Survey method:
Computer-Assisted Telephone Interviewing (CATI)
Survey period:
March 4 – May 27, 2011
Cooperation rate:
75%
Data processing:
Weighted to represent 7,895,108 enrollees
Stratification criteria:
VISN, enrollee type, priority group, OEF/OIF/OND status
Purpose:
Inform Enrollee Health Care Projection Model, support planning and policy analysis
Contracted services:
ICF International
Institution:
George Washington University
Organ / Department:
GW Institutional Review Board (IRB)
Document Type:
Administrative form
Subject Area:
Human subjects research oversight
Purpose:
Request for IRB reliance agreement in collaborative research
Applicable Regulation:
45 CFR 46.114
Research Context:
Cooperative federally funded research involving multiple institutions in the United States
Related Agreements:
IRB Authorization Agreement (IAA); Reliance Agreement; Individual Investigator Agreement (IIA)
Research Scope:
Non-exempt human subject research
Associated Systems:
GW iRIS application system
Required Training:
CITI Training (Biomedical or SBR), HIPS when PHI is involved, GCP for clinical trials
Required Information:
Principal investigator contacts, collaborating institutions, research team members, conflicts of interest, study title, funding information, and research roles
International Research Policy:
Reliance on international IRB/Ethics Committee generally not permitted
Related Compliance Documents:
Data Use Agreement; Material Transfer Agreement
Target Participants:
GW researchers collaborating with investigators not affiliated with GW or institutions without Federal Wide Assurance
Year:
2023
Region / City:
India
Subject:
UAV Technology, Agriculture
Document Type:
Research Paper
Institution:
KCAET, KAU, Dr. NTR College of Agricultural Engineering, ANGRAU
Authors:
Ajay, S Sai Mohan
Target Audience:
Farmers, Agronomists, Researchers, Agricultural Engineers
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Keywords:
UAV, Precision agriculture, Remote sensing, NDVI, Satellite images
Description:
The document presents an in-depth study of drone technology in Indian agriculture, highlighting its applications, economic viability, and feasibility for improving farming practices.
Year:
2026
Institution:
University of Kansas Medical Center (KUMC)
Document Type:
IRB Request Form / Research Protocol Submission
Target Audience:
Principal Investigators and Research Staff
Applicable Regulations:
45 CFR 46, 34 CFR 97, HHS Common Rule
Research Type:
Minimal Risk Behavioral and Biomedical Studies, Secondary Data Analysis
Submission Method:
myIRB Electronic Application
Required Materials:
Completed Form, Data Collection Sheets, Consent Forms, Recruitment Materials
Notes:
Includes guidance for flexible IRB review eligibility and types of research activities
Note:
Year
Subject:
IRB Member Performance Evaluation
Document Type:
Worksheet
Organization / Institution:
University of Miami
Target Audience:
IRB Chairs, IRB Managers
Period of Effectiveness:
Annual
Document type:
Institutional review form
Organization:
University of New England Institutional Review Board
Jurisdiction:
United States
Scope:
International human subjects research
Applicable research formats:
In-person research; Online-only research
Intended submitter:
Principal Investigator
Regulatory framework:
U.S. federal human subjects research regulations
Review body:
Institutional Review Board
Contact information:
[email protected]
Version date field:
Yes
IRB number field:
Yes
Target audience:
Faculty, staff, and student researchers
Geographic focus:
Research conducted outside the United States
Compliance topics:
Ethics approval, informed consent, data protection, export control regulations
Note:
Year
Document type:
Checklist
Target audience:
Investigators, IRB staff
Context description:
A checklist for investigators and IRB staff to assess and ensure regulatory compliance in clinical and non-clinical research studies.
Year:
2025
Region / City:
Louisiana
Topic:
Alcohol and Drug Survey
Document Type:
Guidelines
Organization / Institution:
Louisiana Board of Regents
Author:
Dr. Allison Smith
Target Audience:
IRB administrators, researchers, university staff
Period of Validity:
2025
Approval Date:
October 4, 2024
Amendment Date:
November 15, 2024
Year:
2023
Region / City:
Emory University
Topic:
IRB Determination for Research Involving Minors
Document Type:
IRB Determination Checklist
Organization:
Emory University
Author:
Emory Institutional Review Board (IRB)
Target Audience:
Researchers, IRB members, Clinical researchers, Academic institutions
Effective Period:
Ongoing
Approval Date:
2023
Date of Changes:
Not specified
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
Document Type:
Checklist
Author:
Dr. Twyla Williams-Damond
Context:
A checklist for ensuring all components are complete for an IRB application, including informed consent, recruitment templates, and readability reports.
Note:
Year
Document Type:
Checklist
Target Audience:
IRB members, researchers, committee staff
Context description:
A checklist for ensuring that IRB meeting minutes fulfill specific requirements related to protocol reviews and compliance with regulatory standards.
Year:
2023
Region / City:
Boston
Topic:
Quality Improvement, Research Ethics, Institutional Review Board
Document Type:
Guideline
Organization / Institution:
Boston Medical Center
Author:
Nicholas Cordella, MD
Target Audience:
Faculty, Staff
Period of Validity:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Region / City:
N/A
Topic:
VA Informed Consent Addendum, NCI CIRB, Boilerplate Language Revision
Document Type:
Guidance
Organization / Institution:
Department of Veterans Affairs (VA)
Author:
ORD, Office of Research Oversight (ORO), NCI CIRB
Target Audience:
VA Facilities, Research Community
Effective Period:
N/A
Approval Date:
April 6, 2022
Date of Updates:
May 12, 2022
Contextual description:
Guidance document on revisions to VA boilerplate language for NCI studies overseen by the NCI CIRB, detailing required actions for VA Facilities.