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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.1

table ii.3.g.1: WAIVERS AND ALTERATIONS OF CONSENT - US DHHS REGULATIONS

Required written materials

WAIVER OR ALTERNATION OF THE CONSENT PROCESS—PUBLIC DEMONSTRATION PROJECT

  • The research is conducted by or participant to the approval of state or local government officials.
  • The research or demonstration protocol is designed to study, evaluate, or otherwise examine:
  • Public benefit or service programs.
  • Procedures for obtaining benefits or services under those programs.
  • Possible changes in or alternatives to those programs or procedures.
  • Possible changes in methods or levels of payment for benefits or services under those programs.
  • The research cannot practicably be carried out without the waiver or alteration.
  • The research is not regulated by the US FDA.

WAIVER OR ALTERNATION OF CONSENT PROCESS—OBTAINING CONSENT NOT PRACTICABLE

  • The research involves no more than minimal risk to the participants.
  • The research cannot practicably be carried out without the requested waiver or alteration.
  • If the research involves using identifiable private information or identifiable biospecimens, the research cannot practicably be carried out without using such information or biospecimens in an identifiable format.
  • 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.

(See below for FDA requirements.)

WAIVER OR ALTERNATION OF THE CONSENT PROCESS— SCREENING, RECRUITING, DETERIMINING ELIGIBILITY

  • The investigator will obtain information through oral or written communication with the prospective participant or legally authorized representative, or 
  • The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
  • The research is not regulated by the US FDA.

WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—CONFIDENTIALITY

  • The only record linking the participant and the research will be the consent document.
  • The principal risk will be potential harm resulting from a breach of confidentiality.
  • Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
  • The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
  • The IRB or EC will determine whether the researcher should provide participants with a written statement regarding the research.
  • The research is not regulated by the US FDA.

WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—CONSENT NORMALLY NOT REQUIRED OUTSIDE THE RESEARCH CONTEXT

  • The research 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 will determine whether the researcher should provide participants with a written statement regarding the research.
(Also applies to research regulated by the US FDA.)

WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—DISTINCT CULTURAL GROUPS

  • The research presents no more than minimal risk of harm to participants.
  • The participants or legally authorized representatives are members of a distinct cultural group or community in which signing consent documents is not the norm.
  • There is an appropriate alternative mechanism for documenting that informed consent was obtained.
  • The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
  • The IRB or EC will determine whether the researcher should provide participants with a written statement regarding the research.
  • The research is not regulated by the US FDA.

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