Regulations & Policies

Principles

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Regulations & Guidance

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have passed regulations regarding human subjects research (45 CFR Part 46 and 21 CFR Parts 50 and 56). DHHS, through its Office for Human Research Protections (OHRP), and the FDA also issue periodic guidance documents for institutions and investigators. Sections of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Part 160 and Part 164 are also relevant to IRB review of research. Questions regarding the regulations or guidance documents may be directed to (715) 847-2569. 

*Department of Health and Human Services Office for Human Research Protections (OHRP)

• Regulation - Title 45, Part 46 [45 CFR 46] Protection of Human Subjects
• OHRP Policy & Guidance Library
• Guidance - Categories of Research That May Be Reviewed by the IRB Through Expedited Review
• OHRP IRB Guide Book

*Food and Drug Administration (FDA)

Code of Federal Regulations (FDA):

• Title 21, Part 50 [21 CFR 50] -- Protection of Human Subjects
• Title 21, Part 56 [21 CFR 56] -- Institutional Review Boards
• Title 21, Part 312 [21 CFR 312] -- Investigational New Drug Application
• Title 21, Part 812 [21 CFR 812] -- Investigational Device Exemptions
• Guidance - Informed Consent

ICH Guidelines

• Good Clinical Practice

Aspirus Wausau Hospital IRB Policies & Procedures

Available through the Aspirus Intranet Onbase Policy and Procedure link.  (To view these policies, you must be logged on to the Aspirus Intranet site)

If you unable to access the Aspirus intranet to obtain a copy, contact the IRB Office (715) 847-2569.

Policy

• Protection of Human Subjects in Research Policy & Procedure #4966
• Review of Communications Regarding Research #5314
• Investigator & Supporting Staff Requirements #6656
• Clinical Research Conflict of Interest (COI) #5737
• Compensation for Identifying, Enrolling or Referrals of Subjects #10314
• Handling Allegations of Non-Compliance in Research #10315
• Scientific Misconduct #5738

IRB Standard Operating Procedures (SOPs)

• Review of Exempt Projects #6649
• Emergency Use Review Process #6650
• Expanded Access Review #12229
• Expedited Review # 6791
• Initial Review Process - Criteria for IRB Approval #6658
• Continuing Review and Renawal Process #6744
• Review of Humanitarian Devices (HUD) #6654
• Reviews Requiring Special Considerations - Vulnerable Populations #7495
• Adverse Event and/or Unanticipated Problem Reporting #6653
• Deviations and Protocol Exceptions in Research #10313
• Informed Consent for Research Subjects #6660
• Informed Consent for Non-English Speaking Research Subjects #12061
• Human Subject Protection Education & Training #6652
• IRB Membership #6651
• IRB Administration #6655
• IRB Meeting Operations #6657
• IRB Signatory Authority #7253
• IRB Review Fees #12013
• IRB of Record #12858

Aspirus Inc. Policy

• Use and Disclosure of Protected Health Information (PHI) for Research Purposes #6572
• Corporate Ethics Policy - Conflict of Interest #2348
• Corporate Signature Authority #6553

Federal-Wide Assurance (FWA)

Aspirus Wausau Hospital has negotiated a document with the Department of Health and Human Services in regard to the protection of human research subjects. This document, called a Federal-Wide Assurance (FWA), assures that all of our activities related to human subject research will be guided by the ethic principles in The Belmont Report and will comply with the procedural standards at 45 CFR 46. The FWA requires that we have a formal mechanism for monitoring compliance, and that we establish a continuing program to educate IRB members, IRB staff, and research investigators about human subject protection requirements. The FWA names Aspirus Wausau Hospital IRB as the IRB responsible for the review, approval, and ongoing monitoring of human subject research activities conducted at or by staff of Aspirus Clinics & Aspirus Wausau Hospital.  A detailed list of the terms of the FWA can be found at Federalwide Assurance (FWA) for the Protection of Human Subjects. The FWA number is FWA00002047.