HRP-591 - Protocol For

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.

1. 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.
2. 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.
3. 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”.
4. 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3.3.2Follow-up for withdrawn subjects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)