International Collaboration: In Vitro Testing of Peripheral Blood from Human Volunteers Previously Immunized Against AIDS

CLINICAL RESEARCH STUDY STUDY NO.:
REVIEW APPLIC TION
APPLICATION TYPE: Annual Review (Complete Part 1 Only) l Triennial Review (Complete Parts I & 2)
Part 1 (To be completed by the Principal Investigator Only)
"International Collaboration: In ACTIP REQUESTED:
STUDY TITLE: Renew - Patient accrual to continue
vitro testing of peripheral blood from D Renew - Patient followup only
n Terminate - Study discontinued
h immunized PRI PAL INVESTIGATOR:
against AIDS" Yunchanged since last review
Changed since last review:
Previous name:
Reason for change:
SU MARY OF STUDY SUBJECTS:
Cumulative number approved by the ICRS
Number studied since last review
Numberatui ncetotalofalstrview INVESTIGATIONAL NEW DRUG/INVESTIGATIONAL DEVICE EXEMPTIONS USAGE:
&None
IONIZING RADIATION USAGE: l IND'
None Name:
[] Medically indicated only Number:
L Research indicated: Sponsor:
El Research usage HAS NOT changed since originally approved by ICRS l IDE'
& RSC Name:
El Research usage HAS changed since originally approved by the ICRS & Number
RSC (Complete a detailed statement of the changes, their cause and Sponsor:
effect, and attach to this application.) (Attach a copy of the current study consent and FDA progress report to this application.)
INFORMED CONSENT DOCUMENT: NO CONSENT FORM NEEDED. HAVE ANY NEW OR UNANTICIPATED HAZARDS OR SERIOUS DISCOMFORTS
No revisions pending or required; current consent incorporates all BEE NOTED DURING THE CONDUCT OF THIS STUDY?
amendments identified since the last review RNo
L Consent requires revision due to information that has appeared in the l Yes (Complete a detailed statement describing the hazard or discomfort, its
literature cause and effect, and attach to this application.)
O Consent requires revision due to changes in the protocol made since HAS A EARCH OF THE PERTINENT LITERATURE DISCLOSED ANY NEW OR
last review UN ICIPATED HAZARDS RELEVANT TO THIS STUDY?
L Consent requires revision due to information that has evolved from the No
results of this or similar studies L Yes (Complete a detailed statement describing the hazard, its cause and
effect, and attach it to this application.)
Part 2 (The Principal Investigator must attach to this application a memo to the ICRS Chair, with the following content)
1. Findings
2. Reasons supporting continuation of study
3. Changes in the Principal Investigator, Associate Investigator(s), or Medically Responsible Investigator
4. Detailed statements indicated from Part 1: hzzards, serious discomforts, or a change in research radiation usage
5. Any other changes since last review
Signature Date Send to Branch or
SC1 stigator Department Chief
Recommendations '. //Date9 Send to Chair, ICRS
Branch ief or clinical Center partmenfhief of Principal Investigator
Approvals Date ZSend to Clinical Director
halr, Instil IcResearch Subp I
_____________________________Date ____________Send to Chair, RSC (if Required)
Clinical Director
___________________________Date ____________Send to CPSS, MRD (1011N225)
Chalr, Radiation Safely Committee
__________________________Date ___________Send to CPSS, MRD (101N225)
Director, Clinical Center
Completion _____________________Date ___________
credentials & Protocol Specialist

Date Received
(GP40/oN225)
(CP s-/lO/1N225)
Wio

ClInical Resarch Study Review Application
NIH-1195 (6-89)

Cre11oqtials and Protocol Services Section