Institutional Review Board

Mission: PHMC maintains an active Federalwide Assurance (FWA) registered with the U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) in accordance with the HHS Common Rule (45 CFR 46). Under this FWA, PHMC operates an Institutional Review Board (IRB) to review all projects that meet the definition of human subjects research. This includes research led by PHMC investigators and research led by investigators at external institutions that involve PHMC clients, patients, consumers, and families.

IRB Committee: The IRB reviews social, behavioral, and educational research. The IRB includes a prisoner representative.

IRB Administration: IRB operations are managed by the Institutional Official and an IRB Coordinator. These responsibilities include, but are not limited to, reviewing all IRB submissions and reports; ensuring institutional compliance; ensuring IRB members and research personnel complete human subjects research training; developing and implementing human subject protections policies and procedures; and issuing IRB authorization agreements for multi-site studies.

IRB Registration Information:

IORG: 0001945

FWA: 00021142 (expires 06.22.2022)

IRB: 00002451

PHMC IRB Standard Operating Procedures:

Table of Contents

Part 1: The Human Research Protection Program
SOP 101. Overview of the Human Research Protection Program
SOP 102. Activities that Require IRB Review
SOP 103. Retroactive HSR Determination
SOP 104. Retroactive IRB Approval
SOP 105. Cooperative and Multi-Site Research
SOP 106. Transfer of Protocols Between IRBs
SOP 107. Training and Education
SOP 108. Maintenance of Standard Operating Procedures

Part 2: IRB Organization
SOP 201. IRB Composition
SOP 202. IRB Membership
SOP 203. IRB Meetings

Part 3: Review of Research
SOP 301. Criteria for IRB Approval
SOP 302. IRB Actions
SOP 303. Appeal of IRB Determinations
SOP 304. Initial Review of Exempt Research
SOP 305. Initial Review of Expedited Research
SOP 306. Initial Review of Full Board Research
SOP 307. Review of Amendments to Approved Research
SOP 308. When to Submit an Amendment vs. a New Protocol
SOP 309. Continuing Review of Exempt Research
SOP 310. Continuing Review of Expedited Research
SOP 311. Continuing Review of Full Board Research
SOP 312. Review of Requests to Close Approved Research
SOP 313. Premature Study Termination
SOP 314. Lapse in IRB Approval
SOP 315. Review of Grant Proposals

Part 4: Informed Consent
SOP 401. Elements of Informed Consent
SOP 402. Waiver and Alteration of Informed Consent
SOP 403. Legally Authorized Representatives
SOP 404. Remote Consent
SOP 405. Electronic Consent
SOP 406. Reconsent and Notification of New Information

Part 5: HIPAA for Research
SOP 501: Applicability to Research
SOP 502: Permitted Uses and Disclosures of PHI
SOP 503: HIPAA Authorization
SOP 504: Waiver and Alteration of HIPAA Authorization
SOP 505: Limited Data Sets and Data Use Agreements
SOP 506: Business Associate Agreements

Part 6: Post-Approval Reporting Requirements
SOP 601. Adverse Events
SOP 602. Protocol Deviations
SOP 603. Unanticipated Problems
SOP 604. Serious and Continuing Noncompliance
SOP 605. Research Misconduct

Part 7: Vulnerable Populations
SOP 701. Pregnant People, Fetuses, and Neonates
SOP 702. Prisoners
SOP 703. Children
SOP 704. People with Diminished Decision-Making Capacity
SOP 705. People with Limited English-Speaking Capacity

Part 8: Guidelines
SOP 801. Translation and Interpretation
SOP 802. Recruitment
SOP 803. Screening
SOP 804. Payment
SOP 805. Privacy and Confidentiality
SOP 806. De-Identification of Data Under 45 CFR 46
SOP 807. De-Identification of PHI Under HIPAA
SOP 808. Record Retention

Glossary

Part 1. The Human Research Protection Program

SOP 101. Overview of the Human Research Protection Program
SOP 102. Activities that Require IRB Review
SOP 103. Retroactive HSR Determination
SOP 104. Retroactive IRB Approval
SOP 105. Cooperative and Multi-Site Research
SOP 106. Transfer of Protocols Between IRBs
SOP 107. Training and Education
SOP 108. Maintenance of Standard Operating Procedures

Part 2. IRB Organization

SOP 201. IRB Composition
SOP 202. IRB Membership
SOP 203. IRB Meetings

Part 3. Review of Research

SOP 301. Criteria for IRB Approval
SOP 302. IRB Actions
SOP 303. Appeal of IRB Determinations
SOP 304. Initial Review of Exempt Research
SOP 305. Initial Review of Expedited Research
SOP 306. Initial Review of Full Board Research
SOP 307. Review of Amendments to Approved Research
SOP 308. When to Submit an Amendment vs. a New Protocol
SOP 309. Continuing Review of Exempt Research
SOP 310. Continuing Review of Expedited Research
SOP 311. Continuing Review of Full Board Research
SOP 312. Review of Requests to Close Approved Research
SOP 313. Premature Study Termination
SOP 314. Lapse in IRB Approval
SOP 315. Review of Grant Proposals

Part 5. HIPAA for Research

SOP 501: Applicability to Research
SOP 502: Permitted Uses and Disclosures of PHI
SOP 503: HIPAA Authorization
SOP 504: Waiver and Alteration of HIPAA Authorization
SOP 505: Limited Data Sets and Data Use Agreements
SOP 506: Business Associate Agreements

Part 6. Post-Approval Reporting Requirements

SOP 601. Adverse Events
SOP 602. Protocol Deviations
SOP 603. Unanticipated Problems
SOP 604. Serious and Continuing Noncompliance
SOP 605. Research Misconduct

Part 7. Vulnerable Populations

SOP 701. Pregnant People, Fetuses, and Neonates
SOP 702. Prisoners
SOP 703. Children
SOP 704. People with Diminished Decision-Making Capacity
SOP 705. People with Limited English-Speaking Capacity

Part 8. Guidelines

SOP 801. Translation and Interpretation
SOP 802. Recruitment
SOP 803. Screening
SOP 804. Payment
SOP 805. Privacy and Confidentiality
SOP 806. De-Identification of Data Under 45 CFR 46
SOP 807. De-Identification of PHI Under HIPAA
SOP 808. Record Retention

Glossary

Contact: For further information on PHMC’s IRB, please email This email address is being protected from spambots. You need JavaScript enabled to view it.