Association for the Accreditation
of Human Research Protection Programs, Inc. ®

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Download as PDF
Latest Update: April 5, 2024
Get Accredited

Table of Contents

INTRODUCTION
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION
THE FIVE SECTIONS OF ELEMENTS AND STANDARDS
GLOSSARY OF TERMS
LIST OF STANDARDS AND ELEMENTS
SUMMARY OF REVISIONS
DOMAIN I: ORGANIZATION
STANDARD I-1  
ELEMENT I.1.A. ELEMENT I.1.B. ELEMENT I.1.C. ELEMENT I.1.D. ELEMENT I.1.E. ELEMENT I.1.F. ELEMENT I.1.G. ELEMENT I.1.H.
STANDARD I-2
STANDARD I-3
STANDARD I-4  
ELEMENT I.4.A. ELEMENT I.4.B. ELEMENT I.4.C.
STANDARD I-5  
ELEMENT I.5.A. ELEMENT I.5.B. ELEMENT I.5.C. ELEMENT I.5.D.
STANDARD I-6  
ELEMENT I.6.A. ELEMENT I.6.B.
STANDARD I-7  
ELEMENT I.7.A. ELEMENT I.7.B. ELEMENT I.7.C.
STANDARD I-8  
ELEMENT I.8.A. ELEMENT I.8.B. ELEMENT I.8.C. ELEMENT I.8.D. ELEMENT I.8.E.
STANDARD I-9
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
STANDARD II-1  
ELEMENT II.1.A. ELEMENT II.1.B. ELEMENT II.1.C. ELEMENT II.1.D. ELEMENT II.1.E.
STANDARD II-2  
ELEMENT II.2.A. ELEMENT II.2.B. ELEMENT II.2.C. Element II.2.D. Element II.2.E. Element II.2.F. Element II.2.G. Element II.2.H. Element II.2.I.
STANDARD II-3  
ELEMENT II.3.A. ELEMENT II.3.B. ELEMENT II.3.C. ELEMENT II.3.D. ELEMENT II.3.E. ELEMENT II.3.F. ELEMENT II.3.G.
STANDARD II-4  
ELEMENT II.4.A. ELEMENT II.4.B. ELEMENT II.4.C.
STANDARD II-5  
ELEMENT II.5.A. ELEMENT II.5.B.
DOMAIN III: RESEARCHER AND RESEARCH STAFF
STANDARD III-1  
ELEMENT III.1.A. ELEMENT III.1.B. ELEMENT III.1.C. ELEMENT III.1.D. ELEMENT III.1.E. ELEMENT III.1.F. ELEMENT III.1.G.
STANDARD III-2  
ELEMENT III.2.A. ELEMENT III.2.B. ELEMENT III.2.C. ELEMENT III.2.D.
TABLES
TABLE II.2.A.1.
TABLE II.2.C.1.
TABLE II.2.F.1.
TABLE II.3.F.1.
TABLE II.3.G.1
TABLE II.3.G.2.
INTERNATIONAL ADDENDA
Country-Specific Addenda

TABLE II.3.G.2.

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

Required written materials

WAIVER OR ALTERATION 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.
  • If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not 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.

WAIVER OR ALTERATION 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.


Proceed To: INTERNATIONAL ADDENDA