HRP-591
Protocol for Human Subject Research
Protocol Title:
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu).
Knowledge about and attitudes toward open science practices among Penn State researchers
Principal Investigator:
Name: Rick Gilmore
Department: Psychology
Telephone: 814-865-3664
E-mail Address: rog1@psu.edu
Version Date:
Provide a version date for this document. This date must be updated each time this document is submitted to the IRB office with revisions. DO NOT revise the version date in the footer of this document.
20221225
Clinicaltrials.gov Registration #:
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual”, under “ClinicalTrials.gov” for more information.
Not applicable.
Important Instructions for Using This Protocol Template:
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the IRB to determine whether a study meets all applicable criteria for approval.
- GENERAL INSTRUCTIONS1:
Prior to completing this protocol, ensure that you are using the most recent version by verifying the protocol template version date in the footer of this document with the current version provided in the CATS IRB Library.
Do not change the protocol template version date located in the footer of this document.
Some of the items may not be applicable to all types of research. If an item is not applicable, please indicate as such or skip question(s) if indicated in any of the instructional text.
GRAY INSTRUCTIONAL BOXES: Type your protocol responses below the gray instructional boxes of guidance language. If the section or item is not applicable, indicate not applicable.
Do NOT delete the instructional boxes from the final version of the protocol.
The protocol should be written in lay language. Do NOT copy and paste grant proposal information into the protocol.
- Add the completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic Information” page.
- CATS IRB LIBRARY:
- Documents referenced in this protocol template (e.g., SOP’s, Worksheets, Checklists, and Templates) can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).
- PROTOCOL REVISIONS:
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in the guides available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes.
Update the Version Date on page 1 each time this document is submitted to the IRB office with revisions.
If you need help…
All locations:
Human Research Protection Program
Office for Research Protections
101 Technology Center
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
https://www.research.psu.edu/irb
Table of Contents
3.0 Inclusion and Exclusion Criteria
5.0 Consent Process and Documentation
6.0 HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0 Study Design and Procedures
8.0 Number of Subjects and Statistical Plan
9.0 Data and Safety Monitoring Plan
11.0 Potential Benefits to Subjects and Others
12.0 Sharing Results with Subjects
13.0 Subject Payment and/or Travel Reimbursements
14.0 Economic Burden to Subjects
19.0 Study Monitoring, Auditing, and Inspecting
20.0 Future Undetermined Research: Data and Specimen Banking