IRB
The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of University of Maryland, Baltimore. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by UMB IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB.
The IRB also functions independently of but in coordination with other committees. For instance, research proposals involving the use of radiation above and beyond standard of care, and for the purpose of research, are required to be reviewed by the Radiation Safety Committee. The IRB, however, makes its independent determination whether to approve or disapprove the protocol based upon whether or not human subjects are adequately protected, which includes determination of a favorable benefit/risk analysis of the research.
Research that has been reviewed and approved by an IRB may be subject to further review and disapproval by officials of the institution. Those officials may not, however, approve research if it has been disapproved by the IRB.Furthermore, approved research is subject to continuing IRB review and must be reevaluated at least annually (and more frequently, as specified by the IRB).
UMB IRB is comprised of five panels, which meet monthly on Thursday afternoons. Committees #1 through #5 meet the corresponding week during the month.
All panels of the UMB IRB review biomedical and social behavioral research, and are constituted of appropriate expertise to review the type of research conducted at UMB. Each panel has at least two, and sometimes three non-scientist and non-affiliated members. In addition, a Research Subject Advocate sits on each panel.
The IRB is led by a Chair and four Vice-Chairs, who are experienced researchers, former IRB Members, and are respected among the research community.
The IRB Chair reports directly to the Institutional Official, Dr. Bruce E. Jarrell, School of Medicine, and is supported administratively by the Human Research Protections Office.
IRB Members
CICERO Reviewer Instructions
Reviewer Checklists
The primary goals of these checklists are 1) streamline and improve the efficiency of the review process and the Committee meetings and 2) to verify and document that we are in compliance with the regulations and our own policies and procedures.
Below are the checklists that will be used for review by the IRB Members.
Worksheets
HRP-301 - WORKSHEET - Review Materials
HRP-302 - WORKSHEET - Calculation of Approval Intervals and Expiration Dates
HRP-303 - WORKSHEET - Communication of Review Results
HRP-305 - WORKSHEET - Evaluation of Quorum and Expertise
HRP-306 - WORKSHEET - Review of Information Items
HRP-307 - WORKSHEET - Scientific or Scholarly Review
HRP-308 - WORKSHEET - IRB Composition
HRP-309 - WORKSHEET - Human Research Determination (Obsolete - Replaced by HRP-401)
HRP-310 - WORKSHEET - Engagement Determination
HRP-311 - WORKSHEET - Criteria for Approval and Additional Considerations
HRP-312 - WORKSHEET - Advertisements
HRP-313 - WORKSHEET - Payments
HRP-317 - WORKSHEET - Emergency Use of a Test Article
HRP-318 - WORKSHEET - Short Form of Consent Documentation
HRP-321 - WORKSHEET - Contract Items Related to Human Subject Protections
HRP-330 - WORKSHEET - FERPA Compliance
HRP-331 - WORKSHEET - HIPAA Authorization
CHECKLISTS
HRP-401 - CICERO CHECKLIST - Pre-Review and Administrative Review
HRP-402 - CICERO CHECKLIST - Non-Committee Review Evaluation
HRP-403 - CICERO ACTIVITY - Not Human Subjects
HRP-404 - CICERO ACTIVITY - Expedited Determination (New)
HRP-405 - CICERO ACTIVITY - Expedited Determination (Modification)
HRP-406 - CICERO ACTIVITY - Expedited Determination (Continuing Review)
HRP-407 - CICERO ACTIVITY - Create Reviewer Checklist
HRP-408 - CICERO CHECKLIST - Reportable New Information
HRP-410 - CICERO CHECKLIST - Committee Review
HRP-411 - CICERO CHECKLIST - Human Research Evaluation
HRP-412 - CHECKLIST - Exemption Determination
HRP-412 - CICERO ACTIVITY - Submit Exempt Review
HRP-413 - CHECKLIST - Eligibility for Review Using the Expedited Procedure
HRP-415 - CHECKLIST - Waiver or Alteration of the Consent Process
HRP-415 - CICERO CHECKLIST - Waiver or Alteration of the Consent Process
HRP-416 - CHECKLIST - Waiver of Written Documentation of the Consent Process
HRP-416 - CICERO CHECKLIST - Waiver of Written Documentation of the Consent Process
HRP-417 - CHECKLIST - Research Involving Prisoners
HRP-417 - CICERO CHECKLIST - Research Involving Prisoners
HRP-418 - CHECKLIST - Research Involving Pregnant Women
HRP-418 - CICERO CHECKLIST - Research Involving Pregnant Women
HRP-419 - CHECKLIST - Research Involving Non-Viable Neonates
HRP-419 - CICERO CHECKLIST - Research Involving Non-Viable Neonates
HRP-420 - CHECKLIST - Research Involving Neonates of Uncertain Viability
HRP-420 - CICERO CHECKLIST - Research Involving Neonates of Uncertain Viability
HRP-421 - CHECKLIST - Research Involving Children
HRP-421 - CICERO CHECKLIST - Research Involving Children
HRP-422 - CHECKLIST - Research Involving Cognitively Impaired Adults
HRP-422 - CICERO CHECKLIST - Research Involving Cognitively Impaired Adults
HRP-423 - CHECKLIST - Non-Significant Risk Device
HRP-423 - CICERO CHECKLIST - Non-Significant Risk Device
HRP-424 - CHECKLIST - Waiver of the Consent Process for Planned Emergency Research
HRP-430 - CHECKLIST - Investigator Quality Improvement Assessment
HRP-431 - CHECKLIST - Minutes Quality Improvement Assessment
HRP-441 - CHECKLIST - HIPAA Waiver of Authorization
HRP-441 - CICERO CHECKLIST - HIPAA Waiver of Authorization
Training Sessions
You now have access to all of the IRB Training Sessions from our archive.
- June 2004: Applicability of 21CFR & Adverse Event Reporting Under 21CFR
- July 2004: Requirements for Approval of Pediatric Research
- August 2004: Obtaining Informed Consent for Research Participation From Older Adults
- September 2004: AAHRPP Accreditation
- October 2004: Exceptions to Written Informed Consent in Human Subject Research
- November 2004: Criteria for IRB Review
- December 2004: AAHRPP Preparation - IRB Member Question & Answer
- January 2005: IRB Member Conflicts of Interest
- February 2005: Readmininstration of Needs Assessment
- March 2005: HIPAA Security Rule Awareness For IRB Members
- April 2005: Stored Samples for Future Research
- May 2005: Typical Lifestyle of the Amish Population
- June 2005: VA Research
- July 2005: Overview of AAHRPP Accreditation: What IRB Members Should Know
- August 2005: U.S. Cancer Cooperative Groups
- January 2006: AAHRPP Accreditation Status
- February 2006: Informed Consent – The Process: Information, Comprehension and Decisional Capacity
- March 2006: Treatment Research in Dual Diagnosis: Substance Abuse/Severe Mental Illness
- May 2006: Review of IND Process