SAMPLE IRB INSTRUCTION FORM IRB 5/25/2011

GRADUATE CENTER FOR VISION RESEARCH
STATE UNIVERSITY OF NEW YORK
STATE COLLEGE OF OPTOMETRY
Associate Dean for Graduate Studies and Research

INSTRUCTIONS FOR SUBMISSION
OF APPLICATIONS TO THE
INSTITUTIONAL REVIEW BOARD

Each IRB application should be submitted with your electronic signature.  This document can be uploaded at www.IRBNet.org  following registration on that site.   

In addition the IRB application, please upload from www.IRBNet.org  the following:
1.	Consent Form
2.	The PI’s CV
3.	Administrative Approval for Research Form (required signatures included)

GENERAL INFORMATION
	
Application Status (Circle one) 

New    

Renewal (Describe any changes.  If none, state so) 

Amendment (Describe any changes)

A. PROJECT TITLE		DATE:

B. PRINCIPAL INVESTIGATOR NAME, WITH SIGNATURE

C. ATTACH CURRICULUM VITAE OF PRINCIPAL INVESTIGATOR

D. OTHER INVESTIGATORS (list titles and affiliations)

E. SOURCE OF FUNDING, AMOUNT OF FUNDING, START DATE, AND DURATION:  IF AN APPLICATION HAS BEEN MADE TO ANY GRANT AGENCY, INTERNAL OR EXTERNAL, SUBMIT A COMPLETE COPY OF THE APPLICATION.

PROTOCOL INFORMATION

A. PURPOSE AND OBJECTIVES

B.	LITERATURE REVIEW: Describe the methods you used to review the literature, e.g., Medline and other databases.  Describe the extent you reviewed the literature to assure yourself of any potential benefits and risks to human volunteers and the scientific worthiness of the research. 

C.	GENERAL EXPERIMENTAL DESIGN AND METHODS
1.	APPARATUS (indicate if commercially available or experimental)

2.	STIMULI

3.	DRUGS (include FDA status and any reports of adverse effects, citation required)

4.	DESCRIBE IN DETAIL THE EXPERIMENTAL METHODS AND DATA ANALYSIS

D.	TYPE OF SUBJECT POPULATION
1.	GROUP CHARACTERISTICS

2.  WILL WOMEN AND CHILDREN BE INCLUDED?  IF NOT, WHY ARE THEY TO BE EXCLUDED?

3. AFFILIATION OF SUBJECTS

4. SPECIFIC HEALTH CONDITIONS

5. SPECIAL GROUPS: IF SUBJECTS ARE MINORS, MENTALLY INCOMPETENT, LEGALLY RESTRICTED, ETC., WHO WILL GRANT PERMISSION FOR PARTICIPATION AND SIGN THE CONSENT FORMS?

6. CRITERIA FOR ELIGIBILITY, EXCLUSION, OR WITHDRAWAL

7. WILL YOU ASSIGN SUBJECTS TO EXPERIMENTAL & CONTROL GROUPS?  WHAT PROCEDURES FOR RANDOM ASSIGNMENT WILL YOU USE?

E.  SUBJECT RECRUITMENT PRACTICES AND METHODS
1. WILL SUBJECTS BE PAID FOR VISITS? WHEN (AFTER EACH VISIT?)?  HOW MUCH? 

2. ATTACH A COPY OF ANY RECRUITMENT NOTICES YOU WILL USE.  IF VERBAL, PROVIDE A COPY OF THE VERBATIM STATEMENT THAT YOU WILL USE.

F.   SUBJECT PROTECTION
1. DESCRIBE IN DETAIL THE INFORMED CONSENT PROCESS

2. ATTACH A COPY OF THE CONSENT FORM AND ANY STATEMENTS ABOUT THE RESEARCH TO BE GIVEN TO THE SUBJECT. ARE THERE ANY RISKS OR BENEFITS?  PAY SPECIAL ATTENTION TO COMPENSATION AND SOURCE TO SUBJECTS IF INJURED.

3. ARE ANY DRUGS TO BE USED?  ARE THEY FDA APPROVED?  LIST ANY REPORTED SIDE-EFFECTS?  (A sample consent form is attached for you to use as a template).

4. HOW WILL THE CONFIDENTIALITY OF THE SUBJECTS BE PRESERVED, AND WHERE WILL THE SIGNED CONSENT FORMS BE KEPT? 

5. WILL THE RESULTS BECOME PART OF THE SUBJECT’S PATIENT RECORD?

6. WILL YOU BE USING SUBJECT IDENTIFIABLE INFORMATION?   

7. WILL THE RESULTS BE MADE AVAILABLE TO ANYONE ELSE, SUCH AS OTHER  INVESTIGATORS OR HEALTHCARE PROVIDERS?  YES____ NO________

IF YES, HOW WILL THE SUBJECT BE INFORMED AND HOW WILL APPROPRIATE SUBJECT AUTHORIZATION BE OBTAINED?

8.  DESCRIBE PRECISELY THE EXTENT OF THE ESTIMATED RISK TO THE SUBJECTS’ HEALTH OR STATE OF MIND; GIVE RATIONALE FOR SUCH RISKS. GIVE A VERBATIM DESCRIPTION OF HOW THE ESTIMATED RISKS WILL BE PRESENTED TO THE SUBJECT.

9. DOES THE RESEARCH INVOLVE DECEPTION OF THE SUBJECT? EXPLAIN.

10. WILL TREATMENT BE WITHHELD OR INTERRUPTED FOR THE PURPOSES OF THIS STUDY?

11.  DOES THE RESEARCH INVOLVE AN EXPERIMENTAL TREATMENT? IF SO, WILL THE SUBJECT BE TOLD BEFOREHAND?  WHY OR WHY NOT?

12. DOES THE RESEARCH INVOLVE ADDITIONAL COST TO THE SUBJECT?

13. WILL CLINICAL PATIENT CARE SERVICES BE PROVIDED FOR CLINICALLY NECESSARY TESTING OR TREATMENT?  
a.	WILL THESE SERVICES BY BILLED TO THE SUBJECT OR TO A THIRD PARTY?  IF SO, WILL THE BILLING BE IN A MANNER CONSISTENT WITH THIRD PARTY POLICIES?
b.	WILL THE INVESTIGATORS PERSONALLY PROFIT FROM SUCH BILLING, DIRECTLY OR INDIRECTLY?

14.  WHAT BENEFITS ARE FORSEEN FOR THE SUBJECTS?

15.  HOW WILL TERMINATION OF THE STUDY BE DETERMINED?  THE PI MUST NOTIFY IRB ADMINISTRATION WHEN A STUDY TERMINATES.

16.  ARE INJURY INCIDENTS ACCOUNTED FOR THE IN THE CONSENT FORM, AND ARE THEY CONSISTENT WITH THE EXTERNAL CONTRACT OR INTERNAL AGENCY (NOTE: EXTERNAL SPONSORS ARE TYPICALLY RESPONSIBLE FOR ALL INJURY COSTS). 

17. EVERY IRB APPROVED STUDY IS AUDITABLE WITHOUT NOTICE FOR FOLLOWING IRB APPROVED STUDY GUIDELINES. 

G. GIVE A 250-1000 WORD SUMMARY OF THE PROJECT, INCLUDING DETAILS OF THE EXPERIMENTAL DESIGN (USE ADDITIONAL PAGES IF NECESSARY).