Human Research Protection Program

MCW/FH IRB SOPs, Policies, and Guidelines

IRB Policies  |  IRB Guidelines

MCW/FH IRB Standard Operating Procedures (SOPs)

FH/MCW Standard Operating Procedure (SOP)*(pdf)
This document describes the requirements that both the IRB and clinical investigators must satisfy. Contents include IRB organization and approval criteria, informed consent requirements, and investigator responsibilities. The addendum below is also incorporated and includes the MCW/FH recruitment policy.

FH/MCW Standard Operating Procedure (SOP) - Addendum*(pdf)

 MCW/FH IRB Policies

• Banking: Accumulating Health Care Data or Biospecimens for Future, Unspecified Research Purposes (pdf)
  The activity of collecting and storing data or biospecimens for future, unspecified research purposes is considered a "research activity" subject to IRB review and approval - independently of the IRB review/approval required for specific studies with the same data/biospecimens.

  • Required training for Bank Custodians & key personnel (on ANGEL website)

• Case Report / Case Study (pdf)
  Definitions

• Decreased Decisional Ability (pdf)

• Definition of Human Subjects (pdf)

• Definition Research (pdf)
  Definition

• Eclipsed Progress Reporting Policy (pdf)
  Principal Investigators (PI) who fail to submit and obtain approval for a Continuing Progress Report (CPR) or fail to submit a Study Close-Out Report to the IRB prior to the study’s IRB approval expiration fail to comply with one of the PI’s primary responsibilities under federal regulation and MCW IRB policies.

• Humanitarian Use Device (HUD) (pdf)

  The FDA requires IRB review and approval for local use of an HUD, including Full Committee review and at a minimum, annual continuing review, which may be expedited. This is the only situation where federal regulations require IRB approval and monitoring of an activity that is clearly not research. However, if the HUD is being used in research or in a clinical investigation the IRB must comply with all FDA regulations related to IRB review of research.

• IRB Action Guidelines for HRPP and MCW/FH IRB (pdf)

  MCW SOP 1.1.2 (a) describes the authority of the MCW IRB to place restrictions on a research study or suspend or terminate approval of a research study that is not being conducted in accordance with institutional procedures or applicable law, or that has been associated with unexpected serious harm to subjects.

• Modifications to an Approved Protocol (pdf)

  Investigators who wish to change or modify an ongoing IRB-approved research study must submit an amendment to the IRB and receive IRB approval before implementing any modification.

• Use of National Cancer Institute Central IRB (pdf)

  As of 10/23/2007, a determination had been made that MCW/FH would discontinue use of NCI CIRB as the IRB of record for all new cooperative group studies. A small group of ongoing studies may maintain NCI CIRB oversight while being conducted here.

• Protocol Deviations Policy
  

  Every research study must follow the procedures documented in the protocol approved by the Institutional Review Board (IRB). Any departure or "exception" from the approved procedures constitutes a protocol deviation that must be reported according to the requirements listed within the policy.

• Reportable Events Policy

• Research Involving Froedtert Emergency Department Resources (pdf)

  Ensure appropriate resources and notification to the Emergency Medicine department when proposed research studies may require use, contact or involve the Emergency Medicine Department.

• Study Closure (pdf)

  MCW SOP 7.1.1 (b) (ix) requires investigators involved in human subject research to file a final report to the overseeing IRB within 3 months after termination or completion of a research study or the investigator's part of the research study.

• Submission, Review and Evaluation of National Cancer Institute Cooperative Group Consent Form (pdf)

  An outline of the procedures for submission of a consent form that involves one or more NCI Cancer Cooperative Group.

• Submission of Continuing Progress Reports (CPR) (pdf)

  In accordance with HHS and FDA regulations 45 CFR 46.109(e), 21.CFR 56.109(f), a continuing progress report must be submitted for IRB review and approval at intervals appropriate to the degree of risk, but not less than once per year.

• Submitting New Studies (pdf)

  Investigators must submit all new protocols or studies which involve human subjects as defined by HRPP's Definition of Human Subjects to the MCW/FH IRB for review and approval prior to initiation of research activities. The IRB will determine what type of review is required for the protocol based upon information provided in the submission and any attached documents.

MCW/FH IRB Guidelines

• FDA IND or IDE Documentation Requirements (pdf)

• Guidelines for Registering a Clinical Trial on ClinicalTrials.Gov (pdf)