Appendix 9

IRB Forms/Protocol Guidelines

GUIDELINES FOR SUBMITTING CLINICAL RESEARCH PROTOCOLS

1. Cover Memo signed by Principal Investigator

a. intention to register protocol for the next meeting ,
b. proposed name of protocol,
c. if investigational agent is involved indicate the name of the drug and anticipated source.

2. Protocol (Original Copy)

a. Title of Protocol ON TITLE PAGE
b. Table of Contents
c. Protocol

Abstract
Objectives
Background
Background Drug Information
Patient Eligibility
Treatment Plan
Pretreatment Evaluation
Evaluation During Study
Criteria for Response and Toxicity
Criteria for Discontinuing Therapy
Statistical Considerations
Data and Protocol Management
Reporting Requirements
References

d. Appendices
e. Informed Consent (Model Informed Consent attached) Informed Consent: Labeled and numbered appropriately. Text is written at or below 8th grade reading level.

Financial Disclosure statement if applicable
Purpose of the Study
Description of Research
Risk, Side Effects and Discomforts
Potential Benefits
Alternate Procedures or Treatments
Voluntary Participation and Right to Withdrawal
Confidentiality
Access to Study Records
Retention of Records
Reporting Injury as a Result of the Study
Cost of Treatment
Compensation
Contact Person and Number to address questions about research and rights as participants
Signature sheet (Consent: Parent(s)/Guardian and Relationship, Witness, Signature of Principal Investigator or Co-Investigator Explaining the Protocol; Assent: Child 7 years of Age or Older)

f. Principal Investigator Co-Investigators

Signature & Date Signature & Date
Type Name & Degree Type Name & Degree
Complete Mailing Address Of
Principal Investigator And
Telephone Number

3. For retrospective chart reviews and other clinical research protocols that do not involve treatment or potential risk to the patient of any kind or degree, the protocol can be abbreviated to include only 1, 2, 3 a, b, and c 1, 2, 3, 5, 11, 12, 14, e and f (as applicable). For resident proposals the cover memo must be signed by the sponsoring staff members.

4. DEADLINE FOR SUBMISSIONis no later than 5pm on the 4th Monday of every month. For further information contact the IRB office at 694-4619.

How to Reach Us

The Driscoll Children's Hospital Institutional Review Board is available to provide information and guidance to participants in clinical research studies and their families regarding their rights as Human Research Subjects. The Institutional Review Board is available to advise and inform investigators who are submitting clinical research protocols and monitor approved research activities in its jurisdiction.

Jucel Nazareno, BSN, R.N., IRB Monitor
(361) 694-4619
Fax: 361-694-5466

Institutional Review Board
Driscoll Children's Hospital
3533 South Alameda St.
Corpus Christi, TX 78411
(361) 694-5000

Appendix 9

IRB Forms/Protocol Guidelines

How to Reach Us

Institutional Review Board

For Patients and Parents

Additional Resources