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APPENDIX II: Sample Protocol

PREPARATION CHECKLIST

Before you submit your human subjects protocol to the Institutional Review Board for review, please print this checklist and use it to ensure that your application packet is complete.

Purpose Of The Study And Background

  • Purpose of the Study
  • Background:

Characteristics Of The Subject Population

  • Target Accrual
  • Gender of the Subjects
  • Age Range of Adult Subjects
  • Age Range of Pediatric Subjects
  • Race and Ethnic Origin
  • Inclusion Criteria
  • Exclusion Criteria
  • Vulnerable Subjects

Methods and Procedures

  • Methods and Procedures
  • Drugs and Devices
  • Data Storage Confidentiality

Risk/Benefit Assessment

  • Potential Risks
  • Protection Against Risks
  • Potential Benefits to the Subject
  • Potential Benefits to Society
  • Therapeutic Alternatives
  • Risk/Benefit Relationships

Financial Obligations and Compensation

  • Financial Obligations of the Subject
  • Study-Specific Research Costs versus Standard Treatment Costs
  • Financial Compensation for Participation

Subject Identification, Recruitment and Consent/Assent

  • Method of Subject Identification and Recruitment
  • Competing Protocols
  • Subject Competency
  • Process of Informed Consent
  • Subject/Representative Comprehension
  • Information Purposely Withheld
  • Consent/Assent Forms
  • Documentation of Consent/Assent