PROCEDURE
 

Investigator Responsibilities

• Describes in IRB application eForm (FOR200)
• Provides information in FOR200 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.
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OIRB Responsibilities

Reviewing Staff:

• Verifies the submission is 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;
• Refers expedited submissions to Expedited Reviewer in accordance with expedited review procedures.

Administrative Staff:

• 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;

Primary Reviewer:

• 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.

IRB:

• Following presentation by the Primary Reviewer(s) 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. 

Expedited Reviewer:

• 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.