HRPP Policy Manual

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Action for Failure to Obtain Required Subject Authorization for the Use of Protected Health Information

Privacy Office Policy

Authority of the UofL IRB

HRPP Chapter 6.1

Deferral to NCI CIRB

HRPP Chapter 13, Guide 031

Institutional Review Board Membership

HRPP Chapter 6

IRB Report of Findings Policy

HRPP Chapter 3.6

Lapse in Approval (Continuation Review)

HRPP Chapter 3.5

Local Adverse Events, External Adverse Events, UPIRTSOs,

HRPP Chapter 15.3, Guide 023

Paying Human Subjects Policy

HRPP Chapter 10.4, Guide 030

Suspension or Termination of Previously Approved Research

HRPP Chapter 3.5

University of Louisville Non-Compliance Policy

HRPP Chapter 3

University of Louisville Non-Retaliation Policy

Research Integrity Program Policy

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

1

THE HUMAN SUBJECTS PROTECTION PROGRAM PLAN
AAHRPP Standards:  I.1.B, I.1.D, I.3

Description of the Organization, its purpose, and how the HSPP relates to the organizations mission

I.1.D

1.2

University of Louisville Organizational Chart and The Organizational Official

I.1.B, I.1.D

1.3

Primary Officials and Individuals of the HSPP

I.3

1.4

Administrative Units  - Schools, Centers, Divisions and Branches

1.5

Goal and Objectives of the HSPP

1.6

Organizations Covered by the HSPP and their Components Assurance of Compliance

1.7

Essential Functions of the Offices primarily involved in the HSPP

1.8

Laws Applicable to the University of Louisville

1.9

Types of Research Conducted

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

2

RESOURCES SUPPORTING THE HUMAN SUBJECTS PROTECTION PROGRAM
AAHRPP Standards:  I.2, II.3.A, I.1.D

2.1

Sufficient Human and Fiscal Resources

I.2

2.2

Matching IRBs to Volume and Types of Human Research

I.2

2.3

Human Research Protection, Care of Participants, and Safety

I.2, II.3.A

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

3

COMPLIANCE MONITORING
AAHRPP Standards: I.1.D, I.5.A, I.5.B, I.5.C, I.5.D, I.6.A, I.6.B, I.6.D, II.2.F, II.2.G

3.1

Policies, Procedures, and Resources Available to Investigators and Research Staff

I.1.D

3.2

Investigators’ Conflicts of Interest (COI)
-Individual Conflict of Interest Policies
-Disclosure of Financial Interests

I.6.D

3.3

Role of the IRB
-Review of Potential Conflicts of Interest with Initial Approval
-Review of Conflicts of Interest disclosed after IRB approval of Research
-Recordkeeping

I.6.A

3.4

Institutional Conflicts of Interest

I.6.A

3.5

Non-compliance and IRB Report of Findings
-Definitions and Examples
-Review of Allegations or Findings of Non-compliance
-If Non-compliance is not Found
-Investigation of Non-compliance
-Non-compliance Finding for Lapse in IRB Approval
-Safety of Subjects during a Lapse in IRB Approval
-Serious or Continuing Non-compliance Referred to the IRB
-Possible IRB Actions for Serious or Continuing Non-compliance
-Suspension or Termination of Previously Approved Research

II.2.G

Internal and External Report of Findings
-Event Reporting to the IRB
-Reportable Determinations

I.5.D, II.2.F
II.2.G

3.7

Research Compliance Monitoring Program Activities
-Compliance Monitoring
-Reporting of Compliance Monitoring Results
-Other Review Activities
-Research Community Feedback
-IRB Performance Metrics

I.5.A, I.5.B

3.8

Investigators’ Input to the HSPP

I.5.C

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

4

KNOWLEDGE OF THE HUMAN SUBJECTS PROTECTION PROGRAM REQUIREMENTS
AAHRPP Standards:   I.1.D, I.1.E

4.1

Education of Individuals Responsible for Human Subjects Research Review
-Human Subjects Protection Program Office (HSPPO) Staff
-Evaluation of Qualifications
-Contributing to the Improvement of Expertise
-Educational Materials and Resources
-Education Planning
-Attendance at Local, Regional and National meetings

I.1.E

4.2

Required Training in Human Subjects Protections
-HSPPO and IRB Staff Required Training
-IRB Member Required Training
-Institutional Officials Required Training
-Investigator Required HSP Training

I.1.D

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

5

DRUGS, DEVICES AND BIOLOGICS
AAHRPP Standards: I.7.A, I.7.B, I.7.C

5.1

Research with Test Articles

I.7.A

5.2

Research with Drugs

I.7.A

5.3

Research with Devices

I.7.A

5.4

Radiology Devices and Radioactive Materials

I.7.A

5.5

Research with Biologics

I.7.A

5.6

Sponsor-Investigator Research

I.7.A, I.7.B

5.7

Internal Handling of Test Articles

I.7.B

5.8

Expanded Access to Investigational Drugs and Devices for Treatment Use
-Drugs
-Devices

5.9

Emergency Use of a Test Article

I.7.C

5.10

Humanitarian Use Device (HUD); Orphan Drugs

5.11

Planned Emergency Research

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

6

AAHRPP Standards: I.2.A, I.1.C, II.1.B, II.1.C, II.1.D,

6.1

Institutional Authority, Authority of the IRB and Independence of IRB
-Purpose
-Organizational Structure that provides independence
-Prohibition against Others Usurping IRB Approval Authority or Using Undue Influence
-Decisions of the IRB
-Responsibilities to Regulatory Agencies

I.1.A, I.1.C

6.2

Review of IRB Composition, Members and IRB Chairs
-Appointment of Members and Length of Service
-Appointment of IRB Chair and Length of Service
-Compensation of IRB Members
-Alternate Members
-Administrative Designees
-Ex Officio IRB Members
-Removal of IRB Members
-Liability Coverage for IRB members

II.1.B, II.1.C

6.3

IRB Member Duties and Responsibilities

6.4

Scientific and Scholarly Expertise of IRB Members

6.5

Obtaining Additional Expertise – Consultants and Ad Hoc Reviewers

6.6

IRB Member, IRB Staff, and Consultant Conflicting Interest

II.1.D

6.7

Separating Competing Business Interests from Ethics Review Functions

II.1.C

6.8

Assessment and Evaluation of the IRB

II.1.B

6.9

Relationships with Other Affiliated Institutions
-Jefferson County Public Schools
-KentuckyOne Health (dba Jewish Hospital St. Mary’s Healthcare and University of Louisville Hospital)
-Norton Healthcare, Inc.

6.10

Review by Other University Committees
-Institutional Biosafety Committee
-Radiation Safety Committee

6.11

Review by Other University Offices
-Clinical Contracts Division (formerly Office of Industry Contracts)
-Conflict of Interest Office
-Office of Sponsored Program Administration
-Office of Technology Transfer
-Privacy Office
-Research Integrity Program

6.12

Relationships with IND Sponsors and Other IND or IDE Holders

6.13

Chapter Definitions

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

7

FUNCTIONS OF THE IRB:  SYSTEMATIC REVIEW OF SUBMISSIONS TO THE IRB
AAHRPP Standards:  I.1.A, I.1.D, II.1.A, II.1.E, II.2.A, II.2.B, II.2.C, II.2.D, II.2.D.1, II.2.D.2, II.2.D.3, II.2.E, II.2.E.1, II.2.E.2, II.2.E.3, II.5.A, II.5.B,   III.2.D

7.0

FUNCTIONS OF THE IRB:  SYSTEMATIC REVIEW OF SUBMISSIONS TO THE IRB
-Ethical Principles Governing Human Subjects Research
-Scientific and Scholarly Merit and Departmental Review
-Essential Definitions and Determinations of Research Covered by the HSPP

I.1.A, I.1.D

7.1

Use of Decision Trees and Guide for Determination of Is It Research?

7.2

Protocol Review
-Requirements to be Satisfied to Approve Research
-Fundamental Considerations for Approval of Research
*Study Design
*Risks
*Benefits
*Equitable Selection of Subjects
*Informed Consent/Assent
*Monitoring for Data Safety

• Review of Data Safety Monitoring Plan
• IRB Continuation Review and Data Safety Monitoring Findings

*Privacy and Confidentiality
*Special Considerations for Projects Involving Vulnerable Populations

• Use of University Students as Subjects
• Use of Employees as Study Subjects
• Pregnant Women, Fetuses, In Vitro Fertilization
• Prisoners
• Children
• Persons with Impaired Decision Making Capacity

II.2.D, II.2.D.1, II.2.D.2
II.2.D.3
II.2.E
II.2.E.1
II.2.E.2
II.2.E.3

7.3

Levels of Review Required
-IRB Exemption Determination
-IRB Expedited Review by Chair(s) and Senior Members
-IRB Full Board Review
-IRB or Administrative Determination of Not Human Subjects Research (NHSR)
-Administrative Determination of Not Engaged in Research (NEIR)

II.2.A
II.2.B
II.2.E

7.4

Types of IRB Study Applications
-IRB Submission Application
-Case Report Application
-Emergency Use (EU) Application
-IRB Authorization Agreement Application

• Deferral to NCI CIRB Application submitted as an IAA

-Not Human Subjects Research (NHSR) Application

7.5

IRB Applications - Electronic Submission System (ESS)
-Initial Submission
-Continuing Review Submission
-Amendment Submission
-Serious Adverse Event Submission
-Unexpected Problems Involving Risks to Subjects or Others
-Deviations/Violations/Miscellaneous

7.6

Receipt of Submissions
-Intake process
-Administrative Review by IRB Analysts Prior to Assignment to IRB Members
-Assignment of Protocols to IRB Members
-Assignment of Primary Reviewer
-Approval Criteria

II.1.E

7.7

Review of Initial Submissions by the Convened IRB
-Quorum
-Materials Available at Convened Meetings
-Meeting Deliberations
-Utilizing Guidance Documents for Special Findings When Approving a Protocol
-Range of Actions on Research Protocols at Convened Meetings
-Approval Date and Determination of Approval Expiration
-Preparation of Final Approval
-Rebuttal or Appeal of IRB Determinations

II.2.C

7.7.1

Review of Initial Submissions by Expedited Review
-Range of Actions for Decisions on Protocols Subjects to Expedited Review

7.7.2

Review of Initial Submissions Deferred to NCI CIRB

7.8

Review of Continuing Review Submissions by the Convened IRB
-Continuing Review Procedures
-Lapse in IRB Approval

7.8.1

Review of Continuing Review Submissions by Expedited Review

7.9

Review of Amendment/Modification Submissions

7.10

Review of Event Reporting

III.2.D

7.11

Review of Closures

7.12

Applications and Checklists

-See Appendix 1

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

8

DOCUMENTATION OF IRB ACTIVITIES
AAHRPP Standards:

8.1

Staff Support of IRB Membership

II.1.A,

8.2

Quorum Requirements and Voting at IRB Meetings

8.3

Meeting Times, Materials and Preparation for IRB meetings

II.2.C

8.4

IRB Study Files

II.5.A

8.5

Records Retention

II.5.A

8.6

IRB Minutes

II.5.B, II.2.D, II.2.D.1
II.2.D.2
II.2.D.3

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

9

RISKS TO RESEARCH PARTICIPANTS:  AAHRPP Standards: II.3.A, II.3.D, II.4.A

9.1

Steps to Minimizing Risk
-Identifying Potential Risks (PI Input)
-Minimal Risk
-Physical Risks
-Psychological Risks
-Social, Legal and Economic Risks
-Ensuring Risks are Minimized (IRB Determination)
-Potential Risks v. Anticipated Benefits (PI Input)
-Potential Risks v. Anticipated Benefits (IRB Determination)

II.3.A

9.2

Data Monitoring Plan
-IRB Review of the Data Monitoring Plan
-Continuing Review – Timeframe for Reporting Data Monitoring Findings to the IRB

II.3.D

9.3

Risks to Vulnerable Populations
-Considerations in Reviewing Research Involving Vulnerable Populations
-Children
-Prisoners
-Decisionally Impaired Participants
-Pregnant Women, Fetuses and Neonates
-Other Potentially Vulnerable Participants

II.4.A

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

10

PARTICIPANT RECRUITMENT, SELECTION, AND ADDRESSING PARTICIPANT CONCERNS
AAHRPP Standards: II.3.C, II.3.C.1, III.1.G, I.4.A, I.4.B

10.1

Equitable Selection

II.3.C

10.2

Vulnerable Subjects

10.3

Non-English Speaking Participants

10.4

Review of Recruitment Methods, Advertising Materials and Payment

II.3.C.1

10.5

Addressing Concerns of Research Participants

I.4.A III.1.G

10.6

Participant Education and Outreach

I.4.B

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

11

PRIVACY AND CONFIDENTIALITY
AAHRPP Standards:  II.3.D., II.3.E, III.2.C

11.0

Privacy and Confidentiality
-Introduction
-Definitions

11.1

Protecting the Privacy of Participants

II.3.D

11.2

Protecting the Confidentiality of Participant Information
-Anonymity
-Limits
-Confidentiality Requirements for approval
-Certificates of Confidentiality (CoC)
-Continuing Confidentiality

II.3.E
III.2.C

11.3

HIPAA - Health Insurance Portability and Accountability Act Regulations
-HIPAA Coordination

11.4

Confidentiality Breach - Unauthorized Release of Information
-HIPAA Violations

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

12

INFORMED CONSENT AND ASSENT
AAHRPP Standards: I.1.C, I.1.G, II.3.F, II.4.A, II.4.B, II.4.C

12.1

Requirements for Informed Consent
-Elements of Informed Consent
-Additional Consent Requirements
-Consent Templates and Glossary of Lay Terms
-Short Form Consent Process

II.3.F

12.2

Consent Procedures for Vulnerable and Other Special Populations Including Consent by a Legally Authorized Representative
12.2.1  Adults with Impaired Decision-Making Capacity – “Decisionally impaired”
12.2.2  Pregnant Women, Fetuses and Neonates
12.2.3  Children and Consenting Minors
12.2.4  Illiterate Participants
12.2.5  Non-English Speaking Participants
12.2.6  Prisoners

I.1.C
I.1.G
II.3.F
II.4.A
II.4.B
II.4.C

12.3

IRB Review of the Consent Process, including Consent Documents

II.3.F

12.4

Documentation of Informed Consent – Signature Requirements

II.3.F

12.5

Waiver or Alteration of Informed Consent Requirements
12.5.1 Waiver or Alteration of the Consent Process
12.5.2 Waiver of Documentation of Consent – (“waiver of signature”)

II.3.G

12.6

Exceptions to Informed Consent in Emergency Situations

II.4.C

12.7

Observation of the Consent Process

I.1.C

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

13

AAHRPP Standards:I.2, II.2.4

13.1

Definitions

13.2

Communication among IRBs in Multi-Site Research
-University of Louisville Serving as Participating Institution

I.2

13.3

Information Management in Multi-Site Research
- Reporting to the IRBs in Multi-Site Research
-Identifying Material Changes in Multi-Site Protocols

II.2.4

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

14

PRINCIPAL INVESTIGATOR STANDARDS
AAHRPP Standards: II.3.C, II.3.C.1, II.3.C.2, III.1.C, III.1.D, III.1.F, III.1.F, III.1.G

14.1

Identification and Management of Conflict of Interest

III.1.B

14.2

Sound Study Design

III.1.C

14.3

Detection of Harm, Minimization of Risks and Mitigation of Potential Injuries through Study Design and During the Course of the Research

III.1.C

14.4

Recruitment

II.3.C II.3.C.1
II.3.C.2
III.1.E

14.5

Human Research Protection Resources

III.1.D

14.6

Consent Process

III.1.F

14.7

Response to Participants’ Requests for Information and Complaints

III.1.G

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

15

INVESTIGATOR COMPLIANCE
AAHRPP Standards: III.1.A, III.2.A, III.2.B, III.2.C, III.2.D

15.1

Investigator Attestations

15.2

Qualification of Principal Investigators and Research Staff
-Training in the Protection of Human Subjects and HIPAA
-Knowledge of Applicable Federal, State and Local Laws
-Knowledge of the Definition of Human Subject Research

III.2.A

15.3

Events Reportable to the IRB
-PI Responsibilities for Reporting Unanticipated Problems involving Risks to Subjects or Others
-Assessment by Principal Investigator

III.2.D

15.4

Research Oversight
-Oversight of Research Staff during Recruitment
-Selection of Study Participants
-Informed Consent
-Study Conduct
-Compliance with the IRB
-Progress Report and Continuing Review Application
-Closure Report (amendment)
-Confidentiality of Records and Personal Data
-Privacy Rule (HIPAA)
-Delegation of Research Responsibilities
-Special Considerations for the Oversight of Research Protocols in FDA-Regulated Drug or Device Studies

III.2.B
III.2.C

15.5

Data Monitoring Plan (DMP)
-Sponsor Responsibilities

III.2.D

CHAPTER

CHAPTER TITLE

AAHRPP
STANDARD

16

SPONSORED RESEARCH
AAHRPP Standards: I.1.D, I.8.A, I.8.B, I.8.C, I.8.E

16.1

Agreement Includes Protections for Research Participants

I.1.D

16.2

Provision Addressing Medical Care for Participants

I.8.A

16.3

Communications from Sponsors Affecting IRB Oversight

I.8.B, I.8.C,
I.8.E

16.4

Publication of Research Results

I.8.B