**SUBCOMMITTEE FOR HUMAN STUDIES**

**NEW YORK HARBOR HEALTHCARE SYSTEM**

**Phone 212-951-3286; Fax 212-951-3468**

#####  PROTOCOL REVIEW CHECKLIST

Principal Investigator:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Dept:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Project#:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Title:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reviewer:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Meeting Date:
\_\_\_\_\_/\_\_\_\_\_/\_\_\_\_\_\_

**All appropriate requirements have been met .**

**All appropriate requirements have been met except those checked
below:**

1\. Risks to subjects are not minimized.

> No adequate description of the statistical methods and justification
> for the sample size?
>
> Procedures are not combined with those used for treatment to minimize
> risk whenever
>
> appropriate?

2.  Risks to subjects are not reasonable in relation to anticipated
    benefits, if any, to subjects, and the

importance of the knowledge that may be reasonably expected to result.

3\. Selection of subjects is not equitable.

4\. The consent process does not include or alters the following
required element(s) of informed consent:

a.  Confidentiality has not been discussed

b.  Benefits are not reasonably described

c.  Subject has not been advised of alternate treatments available.

d.  Subject has not been advised of notification of new findings in
    relation to willingness to

Continue participation in research

e.  Consent does not indicate voluntary participation

f.  Procedures are not defined as experimental clearly described

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5.  When appropriate, the research plan does not make adequate provision
    for monitoring the data

collected to ensure the safety of subjects.

6\. The research plan does not provide for a Data and Safety Monitoring
Board.

#### 7. There are not adequate provisions to maintain confidentiality. 

8\. There are not adequate safeguards included to protect vulnerable
subjects.(see attached)

Is this an Investigator-initiated study? No Yes

Is this a Phase I/Healthy Volunteer study? No Yes

Is there an adequate literature review? No Yes

Do you recommend an independent consultant? No Yes

The consent form is not written in second person (except the last
paragraph) at a level that a person with eighth grade education can
understand

Assessment of Risk (Circle or underline)

Minimal Risk \_\_\_\_\_\_\_\_\_\_ Greater than Minimal Risk
\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Minimal Risk is defined (CXFR 536.55) as the probability and magnitude
of physical or psychological harm that is normally encountered in daily
lives, or in the routine medical, dental or psychological examination of
healthy persons.

After evaluation of the information provided to me as a reviewer of this
application, it is my determination that the protocol should be:

# Recommendations 

\_\_\_ Approval without modifications \_\_\_ Approval with minor
modifications required

\_\_\_ Deferral/Tabled \_\_\_ Not approved

\_\_\_ Approved with major revisions

FOR CONTINUING REVIEW: Do you suggest a QA audit on this study? No Yes

CONTINUING REVIEW INTERVAL \_\_\_\_\_\_ six months \_\_\_\_\_\_\_\_ one
year \_\_\_\_\_\_\_ other

# If you recommend modifications to the consent form and/or protocol, [please write your comments on the document and attach it to this form.]{.underline}

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reviewer Date

Summary:

Comments:

Recommendations: