Accessibility Statement

We are committed to providing a website that is accessible to the widest possible audience. To do so, we are actively working with consultants to update the website by increasing its accessibility and usability by persons who use assistive technologies such as automated tools, keyboard-only navigation, and screen readers.

We are working to have the website conform to the relevant standards of the Section 508 Web Accessibility Standards developed by the United States Access Board, as well as the World Wide Web Consortium's (W3C) Web Content Accessibility Guidelines 2.1. These standards and guidelines explain how to make web content more accessible for people with disabilities. We believe that conformance with these standards and guidelines will help make the website more user friendly for all people.

Our efforts are ongoing. While we strive to have the website adhere to these guidelines and standards, it is not always possible to do so in all areas of the website. If, at any time, you have specific questions or concerns about the accessibility of any particular webpage, please contact so that we may be of assistance.

Thank you. We hope you enjoy using our website.

Skip to Main Content

APPENDIX II: Sample Protocol


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