Bronx Kaplan HCHS Visit 2 IRB Approval

Science at the heart of medicine

Institutional Review Board
Yeshiva University
FWA #00000140
Montefiore Medical Center
FWA #00002558
North Bronx Healthcare Network
FWA #00009807

East Campus IRB
Jack and Pearl Resnick Campus
1300 Morris Park Ave., Belfer 1002
Bronx, NY 10461
718.430.2237 fax 718.430.8817
West Campus IRB
Montefiore Medical Center
3308 Rochambeau Avenue
Bronx, NY 10467
718.798.0406 fax 718.798.5687
http://www.einstein.yu.edu/irb

Notification of Approval
Date: January 15, 2014
Principal Investigator
Robert Kaplan

Study Title:
Grant Title:

IRB #:
Type of Submission:

Approval Date:

Visit 2 of the Hispanic Community Health Study/Study of Latinos
Hispanic Community Health
Study - Study of Latinos Field Center
Reference #:
2013-2749
001443
Submission Response for
Initial Review Submission
form
01/15/2014

Expiration Date:

01/14/2015

The above titled submission was reviewed and approved by expedited review under 45 CFR 46.110 and 21 CFR
56.110 as the research fits into the following categories:
Category 2(b): Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from other adults
and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of
blood to be collected, and the frequency with which it will be collected.
Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies.
This submission was approved with the following stipulations:
 Use only IRB stamped copies of the consent form(s) in your research. Do not use expired consent forms.
 A fully translated foreign language informed consent document must be approved by the Einstein IRB
prior to enrolling non-English speaking participants.
 The HIPAA Authorization was incorporated into the approved consent.
All changes to a study must receive IRB approval before they are implemented. The only exception to the
requirement for prior IRB review and approval is when the changes are necessary to eliminate apparent
immediate hazards to the subject (45 CFR 46.103(b)(4), 21 CFR 56.108(a)). In such cases, report the actions
taken as a reportable event.
Reportable Events must be reported to the IRB in compliance with the Einstein IRB policy.
Expiration Notice: IRB approval for this study is limited to the period specified above. In order to gain reapproval, you must submit a Progress Report prior to the expiration of the study. When the research is
completed, submit a final Progress Report. The iRIS system will generate an email notification 60 days prior to the

expiration of this study’s approval. However, it is your responsibility to ensure that a Progress Report has been
submitted by the required time.
Approved Documents: To obtain a list of documents that were approved with this submission, follow these
steps: Go to Study Assistant – My Studies and open the study – Click on Submissions History – Go to Completed
Submissions – Locate this submission and click on the Details button to view a list of submitted documents and
their outcomes.
For a list of all currently approved documents, follow these steps: Go to Study Assistant – My Studies and open
the study – Click on Informed Consent to obtain a list of approved consent documents and Other Study
Documents for a list of other approved documents.