№ files_lp_3_process_9_45115
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Internal institutional procedure outlining the annual evaluation process of the Human Research Protection Program and Institutional Review Board operations in accordance with federal regulations.
Year:
Annual (beginning in May)
Subject Area:
Human Research Protection Program (HRPP) oversight and Institutional Review Board (IRB) evaluation
Document Type:
Procedure
Applicable Regulations:
21 CFR §56.106; 21 CFR §56.107; 45 CFR §46.107; 45 CFR §46 Subpart E
Responsible Authority:
Organizational Official
Involved Roles:
IRB Executive Chair; HRPP Administrator; IRB members; IRB Chair; IRB Vice-Chair; HRPP staff
Scope:
Evaluation of HRPP performance, IRB composition, member qualifications, training compliance, and subject outreach program
Key Activities:
Collection of updated résumés or curricula vitae; performance evaluation; review of regulatory compliance and audits; assessment of resources; update of IRB and organizational registrations
External Registry:
Office for Human Research Protections (OHRP) electronic filing system
Review Cycle:
Annual
Outputs:
Written evaluation; corrective and administrative actions; reappointment correspondence
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Year:
Not specified
Region / City:
Not specified
Theme:
Human Research Protection Program
Document Type:
Table of Contents
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, Institutional Review Boards (IRBs)
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A table of contents for a toolkit containing standard operating procedures, forms, templates, and other resources related to human research protection.
Year:
2026
Region / City:
Covenant Medical Center, Texas
Subject:
Research clearance procedures
Document type:
Instructional document
Institution:
TTUHSC, PSJH
Author:
TTUHSC faculty
Target audience:
TTUHSC faculty, researchers
Effective period:
Ongoing
Approval date:
2026
Modification date:
Not specified
Note:
Year
Theme:
Human Research Protection Program (HRPP)
Document type:
Procedure
Target Audience:
HRPP staff, investigators
Year:
2018
Region / City:
N/A
Subject:
Research ethics, human subjects, federal regulations
Document type:
Worksheet
Organization / Institution:
HRPP
Author:
N/A
Target audience:
HRPP staff, Principal Investigators (PIs), IRB members
Period of validity:
Until initial IRB review submission
Approval date:
N/A
Amendment date:
N/A
Year:
2025
Region / City:
N/A
Theme:
Human Research Protection Program
Document Type:
Standard Operating Procedure (SOP)
Organization:
West Virginia University (WVU)
Author:
WVU OHRP Director
Target Audience:
Institutional Review Board (IRB) managers and investigators
Effective Period:
Quarterly
Approval Date:
12/15/2025
Revision History:
None
Year:
2026
Institution:
Western Washington University
Document Type:
Administrative Form
Target Audience:
Principal Investigators, Research Staff, Students
Purpose:
Requesting modifications to IRB/HRPP-approved research protocols
Submission Method:
Email attachments only
Compliance:
Federal regulations and university HRPP policy
Required Information:
Protocol number, study title, principal investigator, modification details, supporting materials
Processing Time:
5–7 business days for non-extensive reviews
Instructions:
Complete all applicable sections, attach relevant documents, submit only as Word document
Year:
2025
Region / City:
West Virginia
Topic:
Emergency response, HRPP
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
West Virginia University
Author:
WVU OHRP Director
Target Audience:
Institutional personnel, HRPP staff, researchers
Effective Period:
Ongoing
Approval Date:
12/15/2025
Revision Date:
None
Emergency Response Plans:
Yes
Scope of Document:
Procedures for HRPP emergency response
Related Documents:
HRP-040, HRP-060, HRP-063, HRP-101, HRP-108, HRP-351, HRP-352, HRP-542, HRP-801
Note:
Contextual Description
Year:
2022
Organization:
Human Research Protection Program (HRPP)
Document type:
Guidance / Procedural Notice
Audience:
Human research investigators and research staff
Region:
Not specified
Effective period:
Until further updates or resumption of normal operations
Date issued:
December 9, 2022
Related documents:
HRP-108 - FLOWCHART, HRP-351 - WORKSHEET
Year:
2024
Region / City:
Bellingham, WA
Topic:
Research Study Closure
Document Type:
Form
Organization / Institution:
Western Washington University
Author:
HRPP Office
Target Audience:
Researchers and Investigators
Effective Period:
Ongoing
Approval Date:
Not provided
Date of Last Revision:
Not provided
Year:
2025
Region / City:
USA / WVU
Subject:
Human Research Protection Program Evaluation
Document Type:
Standard Operating Procedure (SOP)
Institution / Organization:
WVU Office of Human Research Protection
Author:
WVU OHRP Director
Target Audience:
IRB members, IRB staff, Institutional Officials, Organizational Officials
Period of Validity:
Annual
Approval Date:
12/15/2025
Revision Date:
None
Note:
Year
Institution:
Western Washington University
Target Audience:
Researchers, Survey Participants
Year:
2024
Region / City:
Bellingham, Washington
Subject:
Modification Request
Document Type:
Form
Organization / Institution:
Western Washington University
Author:
HRPP
Target Audience:
Principal Investigators, Research Team Members, Students, HRPP Staff
Period of Validity:
Until modifications are approved
Approval Date:
N/A
Modification Date:
N/A
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.