New Jersey Department of Health

Office of Commissioner

INSTITUTIONAL REVIEW BOARD

APPLICATION TO MODIFY HUMAN SUBJECTS RESEARCH

IRB ID Number

Project Title

Principal Investigator

Signature	Date Submitted

Type of Modification
Design

Procedure

Methodology

Instrument

Type:

Add Delete Modify

Study Sites

Add Delete	Recruitment Materials

Type:

Add Delete Modify

Personnel

Add Delete

Funding Agency

Add Delete

Consent

Document

Process

Add Translation	Research Subjects

Increase Number

Decrease Number

Change Inclusion Criteria

Change Exclusion Criteria

Add Source

Delete Source

Add Vulnerable Population

Other

1.	Provide a detailed description of the requested modification.

2.	Provide a justification for the requested modification.

3.	Provide a detailed explanation of how the requested modification a) creates a new risk, if any, or b) affects a previously identified risk. Include a detailed description of the risk (e.g., likelihood, magnitude, duration, etc).

4.	Provide a detailed explanation of how the requested modification a) creates a new benefit, if any, or b) affects a previously identified benefit. Include a detailed description of the benefit (e.g., likelihood, magnitude, duration, etc).

5.	Provide a detailed explanation of how the requested modification will affect currently enrolled research subjects.

6.	Provide a detailed explanation of how current research subjects will be re-consented.

APPLICATION TO MODIFY HUMAN SUBJECTS RESEARCH

(Continued)

IRB-3

JUL 12	Page 2 of 1 Pages.

JUL 12	Page 1 of 1 Pages.

IRB-3, Application to Modify Human Subjects Research

IRB-3, human subject research, application to modify, IRB, institutional review board,

ewhite

2007-09-10

NJDOH