HRP-591 - Protocol for
Human Subject Research
Protocol Title:
Provide the full protocol title as listed in CATS IRB ().
Principal Investigator:
Name:
Department:
Telephone:
E-mail Address:
Version Date:
Provide the date of this submission.
Clinicaltrials.gov Registration #:
Provide the registration number if applicable to this study.
If you need help…University Park and other campuses:
Office for Research Protections Human Research Protection Program
The 330 Building, Suite 205
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: / College of Medicine and Hershey Medical Center:
Human Subjects Protection Office
90 Hope Drive, Mail Code A115, P.O. Box 855
Hershey, PA 17033
(Physical Office Location: Academic Support Building Room 1140)
Phone: 717-531-5687
Fax number: 717-531-3937
Email:
Instructions for using this protocol template:
- Add this completed protocol template to your study in CATS IRB ( in the “Basic Information” section. Links to Penn State’s protocol templates are available in the same location where they are uploaded and their use is required.
- This template is provided to help investigators prepare a protocol that includes the necessary information needed by the IRB determine whether a study meets all criteria for approval.
- There may be sections in this template that do not apply. If a section or question does not apply to the research study in question, provide the response “Not Applicable”.
- DO NOT TYPE IN THE GRAY BOXES. All guidance language appears in gray boxes and these boxes MUSTbe deleted from the final version of the protocol prior to upload to CATS IRB.
Table of Contents
1.0Objectives
2.0Background
3.0Inclusion and Exclusion Criteria
4.0Recruitment Methods
5.0Consent Process and Documentation
6.0HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0Study Design and Procedures
8.0Data and Specimen Banking For Future Undetermined Research
9.0Statistical Plan
10.0Confidentiality, Privacy and Data Management
11.0Data and Safety Monitoring Plan
12.0Risks
13.0Potential Benefits to Subjects and Others
14.0Sharing Results with Subjects
15.0Economic Burden to Subjects
16.0Number of Subjects
17.0Resources Available
18.0Other Approvals
19.0Subject Stipend (Compensation) and/or Travel Reimbursements
20.0Multi-Site Research
21.0Adverse Event Reporting
22.0Study Monitoring, Auditing and Inspecting
23.0References
24.0Appendix
1.0Objectives
1.1Study Objectives
1.2Primary Study Endpoints
1.3Secondary Study Endpoints
2.0Background
2.1Scientific Background and Gaps
2.2Previous Data
2.3Study Rationale
3.0Inclusion and Exclusion Criteria
3.1Inclusion Criteria
3.2Exclusion Criteria
3.3Early Withdrawal of Subjects
3.3.1Criteria for removal from study
3.3.2Follow-up for withdrawn subjects
4.0Recruitment Methods
4.1Identification of subjects
4.2Recruitment process
4.3Recruitment materials
4.4Eligibility/screening of subjects
5.0Consent Process and Documentation
5.1Consent Process
.
5.1.1Obtaining Informed Consent
5.1.1.1Timing and Location of Consent
5.1.1.2Coercion or Undue Influence during Consent
5.1.2Waiver or alteration of the informed consent requirement
5.2Consent Documentation
5.2.1Written Documentation of Consent
5.2.2Waiver of Documentation of Consent
5.3Consent – Other Considerations
5.3.1Non-English Speaking Subjects
5.3.2Cognitively Impaired Adults
5.3.2.1Capability of Providing Consent
5.3.2.2Adults Unable To Consent
5.3.2.3Assent
5.3.3Subjects who are not yet adults (infants, children, teenagers)
5.3.3.1Parental Permission
5.3.3.2Assent
6.0HIPAA Research Authorization and/or Waiver or Alteration of Authorization
6.1Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
Authorization will be obtained and documented as part of the consent process.
Partial waiver is requested for recruitment purposes only(Check this box if patients’ medical records will be accessed to determine eligibility before consent/authorization has been obtained)
Full waiver is requested for entire research study (e.g., medical record review studies)
Alteration is requested to waive requirement for written documentation of authorization
6.2Waiver or Alteration of Authorizationfor the Uses and Disclosuresof PHI
6.2.1Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the individual
6.2.1.1Plan to protect PHI from improper use or disclosure
6.2.1.2Plan to destroy identifiers or a justification for retaining identifiers
6.2.2Explanation for whythe research could not be practicably be conducted without access to and use of PHI
6.2.3Explanation for why the research could not practicably be conducted without the waiver or alteration of authorization
6.3Waiver or alteration of authorization statements of agreement
7.0Study Design and Procedures
7.1Study Design
7.2Study Procedures
7.2.1EXAMPLE: Visit 1 or Day 1 or Pre-test, etc.(format accordingly)
7.2.2EXAMPLE: Visit 2 or Day 2 or Post-test, etc. (format accordingly)
7.3Duration of Participation
8.0Data and Specimen Banking For Future Undetermined Research
8.1Data and/or specimens being stored
8.2Location of storage
8.3Duration of storage
8.4Access to data and/or specimens
8.5Procedures to release data or specimens
8.6Process for returning results
9.0Statistical Plan
9.1Sample size determination
9.2Statistical methods
10.0Confidentiality, Privacy and Data Management
10.1Confidentiality
10.1.1Identifiers associated with data and/or specimens
10.1.1.1Use of Codes, Master List
10.1.2Storage of Data and/or Specimens
10.1.3Access to Data and/or Specimens
10.1.4Transferring Data and/or Specimens
10.2Privacy
11.0Data and Safety Monitoring Plan
11.1Periodic evaluation of data
11.2Data that are reviewed
11.3Method of collection of safety information
11.4Frequency of data collection
11.5Individual’s reviewing the data
11.6Frequency of review of cumulative data
11.7Statistical tests
11.8Suspension of research
12.0Risks
13.0Potential Benefits to Subjects and Others
13.1Potential Benefits to Subjects
13.2Potential Benefits to Others
14.0Sharing Results with Subjects
15.0Economic Burden to Subjects
15.1Costs
15.2Compensation for research-related injury
16.0Number of Subjects
17.0Resources Available
17.1Facilities and locations
17.2Feasibility of recruiting the required number of subjects
17.3PI Time devoted to conducting the research
17.4Availability of medical or psychological resources
17.5Process for informing Study Team
18.0OtherApprovals
19.0Subject Stipend (Compensation) and/or Travel Reimbursements
20.0Multi-Site Research
20.1Communication Plans
20.2Data Submission and Security Plan
20.3Subject Enrollment
20.4Reporting of Adverse Events and New Information
20.5Audit and Monitoring Plans
21.0Adverse Event Reporting
21.1Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
21.2Auditing and Inspecting
22.0Study Monitoring, Auditing and Inspecting
22.1Auditing and Inspecting
23.0References
24.0Appendix
Page 1 of 17(V.06/19/2014)