Library Document Details

Procedure for Determination that Research Risks to Subjects Are Minimized - IRB PRO127

Abstract:
This procedure outlines the responsibilities of the investigator, OIRB and IRB for determining that research risks to subjects are minimized.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

  

HRPP Document:     PRO127
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure for Determination that Research Risks to Subjects Are Minimized

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Describes in FOR200 the Human Subjects Protocol (HSP) past experimental and/or clinical findings, including those conducted by the investigator, leading to the formulation of the study;
  • Provides information in the HSP to support the safety of the research and includes relevant literature on safety and effectiveness of a test article when not supplied in the research protocol or Investigator's Brochure;
  • Describes the study methodology that will affect the participants, particularly in regard to any inconvenience, danger or discomfort;
  • Lists the procedures (including screening), the length of time each will take, and their frequency;
  • Identifies procedures being performed as part of standard diagnostic or treatment procedures;
  • Lists any possible physical, psychological, social, legal, or economic risks associated with study procedures, their frequency, severity, and reversibility;
  • Describes any alternative treatments and any withholding of normal treatment;
  • Describes the anticipated risk-benefit ratio and the expected knowledge to be gained by the research;
  • Describes the precautions that will be taken to avoid hazards for the participants and the means to detect hazards.

OIRB Responsibilities

The Senior staff:

  • Verifies investigator-submitted HSP, Investigator’s Progress Report, or protocol modifications are complete and sufficient for IRB review;
  • Verifies submission of inclusion of departmental scientific review and approval (e.g., Protocol Oversight Review Form or departmental equivalent), as applicable;
  • Documents for the minutes IRB determinations that risks are minimized and substantive discussions, as appropriate;
  • Documents for the minutes IRB determinations that anticipated benefits, if any, and the importance of knowledge that is expected to be gained by the research outweighs the research risks and substantive discussions as appropriate;
  • For protocols submitted for expedited review:
    • Reviews the HSP, Investigator's Progress Report, or protocol modifications to verify investigator has provided information that is complete and sufficient for IRB review;
    • Reviews submissions of (e.g. Protocol Oversight Review Form or departmental equivalent), verifying the submission has undergone adequate departmental scientific review and approval, as applicable;
    • Refers submissions to experienced IRB reviewer in accordance with expedited review procedures.

IRB Responsibilities

Each Primary Review Team member:

  • Reviews and assesses the following elements:
    • Whether the protocol and procedures are consistent with sound research design
    • Whether the procedures do not unnecessarily expose participants to risk;
    • Whether the protocol uses procedures already being performed as part of routine diagnostic or treatment purposes, when appropriate; and
    • Whether the research provides for detecting harms promptly and avoiding hazards.
  • The scientific member presents the assessment of the above elements to the IRB for consideration during convened review.

The IRB:

  • Following presentation by the Primary Review Team and subsequent IRB discussion, approves the research only after finding that:
    • Risks to subjects are minimized by using procedures are consistent with sound research design and which do not unnecessarily expose participants to risk;
    • Risks to subjects are minimized by using procedures which are already being performed on the subjects for diagnostic or treatment purposes, when appropriate; and
    • Risks to subjects are reasonable in relationship to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
  • Determines whether protocol modifications are necessary to minimize risks;
  • Determines whether sufficient provisions are included to promptly detect harms and avoid hazards to the research subjects, or requests modifications to include additional provisions, as needed. 

For expedited review of initial or continuing submissions or submissions of modifications/amendments, an experienced IRB member:

  • Assesses the information presented regarding risks to participants and determines that the research qualifies for expedited review under criteria for minimal risk;
  • Determines if the risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that is expected to result;
  • Documents that criteria are met before approval; or
  • In cases where the reviewer is unable to make the determination, refers the protocol to the convened IRB.  

Approved on March 23, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director