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Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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Latest Update: May 15, 2022

Table of Contents

INTRODUCTION DOMAIN I: ORGANIZATION DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE DOMAIN III: RESEARCHER AND RESEARCH STAFF TABLES

TABLE II.3.G.2.

table ii.3.g.2.: WAIVERS AND ALTERATIONS OF CONSENT - US FDA REGULATIONS

Required written materials

WAIVER OR ALTERNATION OF THE CONSENT PROCESS – OBTAINING CONSENT NOT PRACTICABLE

  • The clinical investigation involves no more than minimal risk to the participants.
  • The clinical investigation cannot practicably be carried out without the waiver or alteration.
  • The waiver or alteration will not adversely affect the rights and welfare of the participants.
  • When appropriate, the participants will be provided with additional pertinent information after participation.

WAIVER OR ALTERNATION OF THE CONSENT PROCESS – CONSENT NOT NORMALLY REQUIRED OUTSIDE THE RESEARCH CONTEXT

  • The clinical investigation presents no more than minimal risk of harm to participants.
  • The research involves no procedures for which written document of the consent process is normally required outside of the research context.
  • The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
  • The IRB or EC has determined whether the participant should be provided written information.

FOR WAIVER REQUIREMENTS FOR PLANNED EMERGENCY RESEARCH, SEE ELEMENT II.4.C.