(REV. 8/25/05)

RENEWAL APPLICATION FOR CONTINUING REVIEW

Health Sciences Institutional Review Board (HSIRB)

150 Parker Hall, Buffalo, NY 14214-8004

Phone 716-829-2752Fax 716-829-3610

E-mail eb

*Check if

Changed

Principal Investigator: / Renee Cadzow, MA
Address: / 462 Grider St. ECMC, CC-120, Buffalo, N.Y.14215
Project Title: / FMD0310205E
HSIRB Project #: / Assessing the Health Risks Faced by the Patients of an Urban Free Medical Clinic
Date Due: / January 20, 2006

*Include explanation of all changes in a cover memo.

Instructions for submission: (Everyone must complete the following regardless of status)

  • This form must be filled in completely or it will delay your approval process.
  • Incomplete applications will be returned.
  • Completed materials must be submitted by the due date. (Note: If approval for the research expires, all research activities must cease and no new subjects can be enrolled until approval is given.)
  • This application must be typed or legibly printed.
  • Sign and date this application

1) Research Status (Check ONLY one) Check
  1. Project continuing Unchanged– actively enrolling subjects

  1. Project continuing Unchanged – data collection only (for chart review studies)
/ X
  1. Project continuing Not started – awaiting funding.

  1. Project continuing Requesting changes – actively enrolling subjects

  1. Project continuing Unchanged – enrollment closed, subjects on follow up.

  1. Project continuing Unchanged – enrollment closed, no subjects on study or follow up (data analysis only)

  1. Project completed (attach final report with findings along with this form)

  1. Project closed denied funding / Was not conducted (return this form only).

2) Check all that Apply AND Submit all Applicable Documents: Check
  • Renewal application (this form) for continuing review. (REQUIRED for continuing projects)
/ X
  • New updated HS1A form. (REQUIRED)
/ X
  • New clean unstamped informed consent (if applicable).

  • New/revised recruitment materials (i.e. advertisements, radio/TV scripts, questionnaires, etc.).

  • Any amendments necessary for review and approval. (if applicable)

  • Data Safety Monitoring report. (if applicable)

  • Most recent literature search. (REQUIRED)
/ X
  • Summary of progress. (REQUIRED)
/ X
  • PI or Designee signature (page 2, #9) (REQUIRED)
/ X
3) RESEARCH ACTIVITIES – Fill in either A, B & C OR DE
FemaleAdults / MaleAdults / Minors / Total
  1. Total number of subjects enrolled since the start of the study:

  1. Total number of subjects enrolled during the past approval period:

  1. For those studies involving sub groups (i.e. hypertensive/non-hypertensive, pre/post-menopausal, diabetic/non-diabetic), indicate groups and total number of subjects in each group:

Total number of
Retrospective chart review studies only: charts reviewed
  1. Total number of charts reviewed since the start of the study:
/ 1003
  1. Total number of charts reviewed during the past approval period:
/ 1003
4) SUBJECT WITHDRAWAL’S (during past approval period)
  1. Have any subjects been withdrawn in the past approval periodby the Principal Investigator?
/ NO
  1. Have any subjects withdrawn themselves from the study in the past approval period?
/ NO
  1. Total number of subjects withdrawn in the past approval period:

  1. If you answered yes to either A or B please explain the reason for the subject withdrawal(s).

5) SUBJECT COMPLAINTS (during the past approval period)
  1. Have any subjects made complaint(s) about the research conducted this past approval period?
/ NO
  1. Total number of complaints made:

  1. If yes, describe the complaint and list any actions take by the investigator in response to the complaint(s).

6) SERIOUS ADVERSE EVENTS (during the past approval period)
During the last approval period, list all the ON SITE serious adverse events that have occurred at your site.
  1. Number of ON SITE SAE’s reported to the HSIRB:

  1. Briefly describe the events: (use additional sheets if necessary)

Description of Event / Serious / Anticipated / Related to the Study
YES / NO / YES / NO / YES / NO
YES / NO / YES / NO / YES / NO
YES / NO / YES / NO / YES / NO
YES / NO / YES / NO / YES / NO
YES / NO / YES / NO / YES / NO
7) DATA & SAFETY MONITORING – Indicate AAND B
The HSIRB must be able to assess whether the study’s plan for monitoring the safety of participants/subjects, the
validity and integrity of the data, and the efficacy of the intervention under investigation is adequate.
  1. Is there an independent Data Safety Monitoring Board for this project?
/ NO
A-1. If yes, has the Board met in the past year? (if yes, attach the most current report)
A-2. If they have not met, indicate the committee’s next scheduled meeting date:
  1. Has the person/committee responsible for the data and safety oversight assessed whether
there are any new risks or an increase in risks already inherent in the study?
If yes, explain and attach revised informed consent. / NO
8) PRINCIPAL INVESTIGATOR’S SUMMARY
  1. Are there any preliminary or other new information that could impact the conduct or design of the research? If yes, attach report.
/ NO
  1. Attach your most recent literature search. Include the source (i.e.Medline), date of search and key words used for the search.

  1. Attach a summary of the progress of the research, including interim findings

  1. Attach abstracts, presentations, publications, etc.

9) PRINCIPAL INVESTIGATOR
OR DESIGNEE SIGNATURE:
DATE:

1