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 (

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:

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 Registration #:

Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual”, under “” 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.

  • 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 ( on the “Basic Information” page.
  • 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 (
  • 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 ( 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

Table of Contents

1.0 Objectives

2.0 Background

3.0 Inclusion and Exclusion Criteria

4.0 Recruitment Methods

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

10.0 Risks

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

15.0 Resources Available

16.0 Other Approvals

17.0 Multi-Site Study

18.0 Adverse Event Reporting

19.0 Study Monitoring, Auditing, and Inspecting

20.0 Future Undetermined Research: Data and Specimen Banking

21.0 References

22.0 Confidentiality, Privacy and Data Management