Download:
pdf |
pdfOFFICE OF HUMAN RESEARCH ETHICS
Medical School Building 52
Mason Farm Road
CB #7097
Chapel Hill, NC 27599-7097
(919) 966-3113
Web site: ohre.unc.edu
Federalwide Assurance (FWA) #4801
To: David Couper
Biostatistics
From: Non-Biomedical IRB
Approval Date: 7/18/2013
Expiration Date of Approval: 7/17/2014
RE: Notice of IRB Approval by Expedited Review (under 45 CFR 46.110)
Submission Type: Renewal
Expedited Category: 5.Existing or non-research data
Study #: 96-0467 (Former IRB Number 96-090)
Study Title: Atherosclerosis Risk in Communities (ARIC) Analysis
This submission has been approved by the IRB for the period indicated.
Study Description:
The Collaborative Studies Coordinating Center (CSCC) provides support with preparation of
datasets, conducting analysis, and submitting mauscripts for the Atherosclerosis Risk in
Communities (ARIC) study. ARIC is a multicenter study involving ARIC field centers, where all
participant contact is conducted with IRB approval through collaborating institutions.
Submission Description:
The following personnel have been added to the study:
Silvana Lawvere, Eunsil Yim, Sheila Burgard and Allison McGee
The following personnel have been removed from the study:
Carter Church, Ashley Buchanan, Viet Nguyen, Gary Wolgast, and Lie Liu
Regulatory and other findings:
This research meets criteria for waiver of research consent [45 CFR 46.116(d)] and waiver of
HIPAA authorization [45 CFR 164.512(i)(2)(ii)].
Investigator’s Responsibilities:
Federal regulations require that all research be reviewed at least annually. It is the Principal
Investigator’s responsibility to submit for renewal and obtain approval before the expiration date.
You may not continue any research activity beyond the expiration date without IRB approval.
page 1 of 2
Failure to receive approval for continuation before the expiration date will result in automatic
termination of the approval for this study on the expiration date.
You are required to obtain IRB approval for any changes to any aspect of this study before they can
be implemented. Any unanticipated problem involving risks to subjects or others (including adverse
events reportable under UNC-Chapel Hill policy) should be reported to the IRB using the web portal
at http://irbis.unc.edu.
This study was reviewed in accordance with federal regulations governing human subjects
research, including those found at 45 CFR 46 (Common Rule), 45 CFR 164 (HIPAA), 21 CFR 50 &
56 (FDA), and 40CFR 26 (EPA), where applicable.
CC:
Gina Andrews, Biostatistics
Christopher Anderson, Biostatistics
Nancy Cohn, Biostatistics
Kimberly Ring, Biostatistics
Silvana Lawvere, Biostatistics
page 2 of 2
FWA #00000287
Institutional Review Board Office
615 N. Wolfe Street / Suite E1100
Baltimore, Maryland 21205
Office Phone: (410) 955-3193
Toll Free:
1-888-262-3242
Fax Number:
(410) 502-0584
E-mail Address: [email protected]
Website:
www.jhsph.edu/irb
CONTINUING REVIEW
APPROVAL NOTICE
Date:
January 10, 2013
To:
Josef Coresh, MD, PhD
Department of Epidemiology
From:
Elizabeth A. Skinner, MSW
Chair, IRB-X
Re:
Study Title: “Atherosclerosis Risk in Communities (ARIC) Study - Morbidity/Mortality
Follow-up Field Center”
IRB No: H.34.99.07.02.A1
Study Expiration Date: December 19, 2013
The JHSPH IRB-X reviewed and approved the Progress Report submitted for the above referenced
study at its meeting on December 20, 2012. Approval of the study is valid for the period of
December 20, 2012 to December 19, 2013.
This approval is inclusive of all previously approved documents. If you are actively enrolling,
or if participants are in follow-up, you may only use previously approved consent forms and
other study documents.
Single Reviewer Convened
DHHS 46.110 . . DHHS…....
FDA 56.110 . . . FDA………
Category: 5 & 7
GWAS ..................................
Vulnerable Populations:
Children ................................
Foster Care Children ...............
DHHS FDA
46.404 . . . . 50.51 .......
46.405. . . . 50.52 .......
46.406 . . . . 50.53 .......
Consent/Parental
Permission Required From:
Adult Participant .............
LAR ..................................
One Parent ......................
Two Parents....................
Legal Guardian ................
(Foster Care Children)
Written Consent…………………….
Waiver of Signature……………….
(Oral Script)
Waiver of Informed Consent….
HIPAA Authorization………………
HIPAA Waiver.……………………….
No Longer Enrolling……………….
Assent Required From:
No children (waived) . …
Form of Consent/Permission:
Pregnant Women/Fetuses
46.204 ............................
Children aged:________
Neonates
46.205 ............................
Form of Assent:
Written .......................... Prisoners
Oral ............................... 46.305 ............................
Assent Statement in 46.306 ............................
Parent Permission .......... Epidemiological Research ....
JHSPH IRB Continuing Review Approval Notice
Version #13, 21Feb12
1
Study Site(s):
U.S. International
List Country(ies):
Sample Size:
(screened plus enrolled)
4,020
Final Enrollment=
Secondary Data Analysis:
(# specimens/participants)
50,000
And is inclusive of the following documentation:
Informant Interview for Surveillance-Introductory Statement (12-20-12)
Annual Follow-Up Form (Version #1.0, 4-20-11)
Heart Failure Survey (Version #1.0, 5-2-11)
First Letter to Participant to Request Medical Records Release (12-20-12)
Second Letter to Participant to Request Medical Records Release (12-20-12)
Letter to Legal Representative to Request Medical Records Release (12-20-12)
First Letter to Informant to Request Interview (12-20-12)
Second Letter to Informant to Request Interview (12-20-12)
Thank You Letter/Request for Medical Records Release to Informant (12-20-12)
Letter to Vital Statistics to Request Death Certificate (12-20-12)
Letter to Vital Statistics to Request Death Certificate (12-20-12)
First Letter to Request Medical Records at Hospital (12-20-12)
Second Letter to Request Medical Records at Hospital (12-20-12)
First Letter to Request Medical Records at Hospital with Waiver of Authorization (1220-12)
Second Letter to Request Medical Records at Hospital with Waiver of Authorization
(12-20-12)
Reply Letter from Informant (12-20-12)
Letter to Power of Attorney to Request Copy of Power of Attorney Form (12-20-12)
JHSPH IRB Continuing Review Approval
Version #13, 21Feb12
2
As principal investigator of the study, you are responsible for fulfilling the following requirements of
approval:
1) The co-investigators listed on the application should be kept informed of the status of the
research.
2) Submit an Amendment Request Form for any changes in research. These changes in research
are required to be reviewed and approved prior to the activation of the changes, with the
following exception: changes made to eliminate an apparent immediate hazard to the research
participant may be instituted immediately and the JHSPH IRB should be informed of such
changes promptly.
3) Unanticipated problems involving risks to participants or others must be reported to the JHSPH
IRB in accordance with the JHSPH IRB Organizational Policy on Reports of Unanticipated
Problems Involving Risks to Participants or Others. An Adverse Event Form must be
submitted to the IRB immediately.
4) Only consent forms with a valid JHSPH IRB approval stamp may be presented to participants,
unless otherwise approved by the IRB. All consent forms signed by participants enrolled in the
study should be retained on file. The Office of Graduate Education and Research conducts
periodic compliance monitoring of protocol records, and consent documentation is part of such
monitoring.
5) Federal regulations require review of approved research not less than once per year.
Therefore, a Progress Report for continuing review must be submitted to the IRB Office
no later than six weeks prior to the study expiration date of December 19, 2013. This will
allow sufficient time for review of the Progress Report to be completed prior to the expiration
date. Failure to submit a Progress Report for continuing review prior to the expiration date will
result in termination of the research, at which point new participants may not be enrolled and
currently enrolled participants must discontinue participation in the study. All ongoing research
activities must stop immediately, including data analysis.
6) If your research involves international travel, please don’t forget to register with the International
Travel Registry https://apps4.jhsph.edu/ITR/Default.aspx so that the School may locate you in
the event of an emergency.
EAS/sro
JHSPH IRB Continuing Review Approval
Version #13, 21Feb12
3
UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
2500 North State Street
Jackson, Mississippi 39216-4505
Institutional Review Board
Telephone (601) 984-2815
Facsimile (601) 984-2961
DHHS FWA #00003630
IORG #0000043
IRB 1 Registration
#00000061
IRB 2 Registration
#00005033
Approval Notice
Continuing Review
10/23/2013
Thomas Mosley, PhD
Medicine - Division of Geriatrics
University of Mississippi Medical Center
2500 North State Street
Jackson, MS 392164505
RE: IRB File #1985-0122
Atherosclerosis Risk in Communities (ARIC) Study
Your Continuing Review was reviewed and approved by the Convened Review process on
10/22/2013. You may continue this research.
Please note the following information about your approved research protocol:
Protocol Approval Period:
Sponsor:
Approved Enrollment #:
Participant Population:
Performance Sites:
10/22/2013 - 10/21/2014
National Heart, Lung, and Blood Institute (NHLBI)
100000
Adults - Healthy
UMMC
Documents / Materials:
Type
Description
Version #
Date
Recruitment Letters
90337-ARIC Recruitment Letter.pdf
1
10/03/2011
Other Consent/Assent
Home Visit Consent 05 20 11 Changes Cleared.pdf
1
10/29/2012
90332-ARIC Informant Consent 03 08 11.pdf
1
10/29/2012
Consent Document
Clinic Visit Consent 05 20 11 Changes Cleared.pdf
1
11/13/2012
Recruitment Letters
ARIC Participant Recruitment Letter 19 Feb 2013
1
02/19/2013
Recruitment Letters
ARIC Proxy Recruitment Letter 19 Feb 2013
1
02/19/2013
Document
Other Consent/Assent
Document
Recruitment Letters
ARIC Proxy Letter 2nd Mailing
1
06/10/2013
Recruitment Letters
ARIC Proxy Letter Other Field Center
1
06/10/2013
Recruitment Letters
ARIC Participant Letter Other Field Center
1
06/10/2013
Recruitment Letters
Participant Recruitment Letter 2nd Mailing
1
06/10/2013
Recruitment Letters
MRI Recruitment Letter
1
09/10/2013
Related Publication
1.pdf
1
10/08/2013
Related Publication
2.pdf
1
10/08/2013
Related Publication
3.pdf
1
10/08/2013
Related Publication
4.pdf
1
10/08/2013
Review History:
Date
Type
Decision
10/22/2013
Convened Review
Approved
Please remember to:
- Use the IRB file number (1985-0122) on all documents or correspondence with the IRB
concerning your research protocol.
- Review and comply with all requirements on the enclosure, UMMC Investigator
Responsibilities, Protection of Human Research Participants.
The IRB has the prerogative and authority to ask additional questions, request further
information, require additional revisions, and monitor the conduct of your research and the
consent process.
Please note, if this study involves an intervention (whether or not it involves a drug or device)
you (or the "responsible party") must register the study before enrollment begins and report
results within 12 months of study closure through Clinicaltrials.gov http://www.clinicaltrials.gov/.
Penalties for responsible parties who fail to register applicable clinical studies are significant
and include civil monetary penalties and, for federally-funded studies, withholding or recovery
of grant funds. For additional information please go to http://irb.umc.edu/GuidanceInfo/
ClinTrialRegistry.htm.
We wish you the best as you conduct your research. If you have questions or need additional
information, please contact the Human Research Office at (601) 984-2815.
IRB 2
Enclosure(s): (1) Investigator Responsibilities, Protection of Human Research Participants
UMMC Investigator Responsibilities
Protection of Human Research Participants
The IRB reviews research to ensure that the federal regulations for protecting human research
participants outlined in UMMC policy, the Department of Health and Human Services (DHHS)
regulations (45 CFR 46) and the Food and Drug Administration (FDA) regulations (21 CFR
Parts 50 & 56), as well as other requirements, are met. The University of Mississippi Medical
Center's Federalwide Assurance (FWA), FWA# 00003630, awarded by the Office for Human
Research Protections (OHRP) at DHHS, is a written pledge to follow federal guidelines for
protecting human research participants in accordance with the principles of the Belmont
Report. All investigators must read both the Belmont Report and the UMMC FWA to
understand their responsibilities in conducting research involving human participants.
Both documents are available on the Human Research Office webpage, http://irb.umc.edu/
, and in hard copy by request from the Human Research Office. Some of the responsibilities
investigators have when conducting research involving human participants are listed below.
1. Conducting the Research: You are responsible for making sure that the research is conducted
according to the IRB approved research protocol. You are also responsible for the actions
of the study's co-investigators and research staff.
2. Participant Enrollment: You may not recruit or enroll participants prior to the IRB approval
date or after the expiration date of IRB approval. All recruitment materials for any form of
distribution or media use must be approved by the IRB prior to their use. If you need to recruit
more participants than was noted in your IRB approval letter, you must submit an amendment
requesting an increase in the number of participants.
3. Informed Consent: Informed consent is a process that begins with the initial contact and
ends at some point after the study is complete. You are responsible for the conduct of the
consent process, ensuring that effective informed consent is obtained and documented using
only the IRB-approved and stamped consent document(s), and for ensuring that no human
participants are involved in research prior to obtaining their informed consent. Whoever is
presenting the consent document to the potential participant and conducting the consent
discussion must have all pertinent information at hand, be knowledgeable about the study
and the disease or condition involved, if any, and have the ability and experience to answer
questions regarding the study and any treatment involved. Please give all participants a
signed copy of each consent or assent document they sign, and keep the originals in your
secured research files for at least six (6) years. When appropriate, you should place a copy of
the consent document in the participant's medical record.
4. Continuing Review: The IRB must review and approve all IRB-approved research protocols at
intervals appropriate to the degree of risk, but not less than once per year. There is no grace
period. Prior to the date on which IRB approval of the research expires, the IRB will send
you three reminders to submit a Continuing Review, 90, 60 and 30 days prior to expiration.
Although reminders are sent, it is ultimately your responsibility to submit the renewal in
a timely fashion to ensure that a lapse in IRB approval does not occur. If IRB approval
of your research lapses, you must stop new participant enrollment, and contact the IRB
immediately.
5. Amendments and Revisions: If you wish to amend or change any aspect of your research,
including research design, interventions or procedures, number of participants, participant
population, consent document, instruments, surveys or recruitment and retention material,
you must submit the amendment or revisions to the IRB for review with a Request for
Change. You may not initiate any amendments or changes to your research without first
obtaining IRB review and written approval. The only exception is when the change is
necessary to eliminate apparent immediate hazard to participants. In that case the IRB
should be immediately informed of this necessity, but the change may be implemented before
obtaining IRB approval.
6. Unanticipated Events: All adverse events that are unanticipated (unanticipated means that
the event is serious,unexpected, related or possibly related to participation in the
study and places participants at greater risk of harm than previously recognized) and
serious protocol deviations, must be reported to the IRB within ten (10) business days
of discovery. The only exception to this policy is death - the death of a UMMC research
participant must be reported within 48 hours of discovery. Reportable events should be
submitted to the IRB with the Adverse Event/Unanticipated Problem Report form.
Events that do not meet the definition of an unanticipated problem involving risk to
participants or others, including research related injury occurring at a UMMC performance
site or to a UMMC study participant, participant complaints, problems, minor protocol
deviations and non-compliance with the IRB's requirements for protecting human research
participants should be reported as follows: Minor deviations and problems should be
submitted at the time of continuing review, as instructed on the form. All other events should
be reported in writing via letter or email to the IRB with sufficient detail to allow the reviewer
to understand the problem and any actions taken to prevent it from happening again.
7. Research Record Keeping: At a minimum, you must keep the following research related
records in a secure location for at least six years: the IRB approved research protocol and all
amendments; all versions of the investigator's brochure; all informed consent documents; all
recruiting materials; all renewal applications; all adverse or unanticipated event reports; all
correspondence to and from the IRB; and all raw data.
8. Reports to FDA and Sponsor: When you submit the required annual report to the FDA or you
submit required reports to your sponsor, you must provide a copy of that report to the IRB.
You may submit the report with your IRB continuing review application.
9. Provision of Emergency Medical Care: When a physician provides emergency medical care
to a participant without prior IRB review and approval, to the extent permitted by law, such
activities will not be recognized as research and the data cannot be used in support of the
research.
10. Final Reports: When you have completed the study, (no further participant enrollment,
interactions, interventions or data analysis) or stopped work on it, you must submit a Final
Report to the IRB using the Final Report form.
11. On-Site Evaluations, FDA Inspections, or Audits: If you are notified that your research will
be reviewed or audited by the FDA, OHRP, the sponsor, any other external agency, or any
internal group, you must inform the IRB immediately and submit all audit reports received as
a result of the audit to the IRB.
If you have questions or need assistance, please contact the Human Research Office at 601
984-2815.
To: Gerardo Heiss
Epidemiology
From: Non-Biomedical IRB
Approval Date: 10/15/2013
Expiration Date of Approval: 10/14/2014
RE: Notice of IRB Approval by Expedited Review (under 45 CFR 46.110)
Submission Type: Renewal
Expedited Category: 7.Surveys/interviews/focus groups
Study #: 96-0484 (Former IRB Number 96-156)
Study Title: Atherosclerosis Risk in Communities (ARIC) Study
This submission has been approved by the IRB for the period indicated.
Study Description:
The ARIC study is a multi-center, bi-ethnic cohort study of 15,800 men and women. The goals
of the study are to monitor the secular trends of cardiovascular risk factors and morbidity and
mortality rates, as well as to study novel risk factors for non-invasively determined
atherosclerosis and the clinical sequelae of atherosclerosis in the coronary and the cerebral
arteries. In the current phase of the study the only activity which includes continued participant
contact involves an annual telephone interview of all surviving ARIC participants, as has been
done since the inception of the ARIC study.
The cohort inducted by the Forsyth Co. Field Center during 1987-89 and followed since then
numbers 4035.
Investigator’s Responsibilities:
Federal regulations require that all research be reviewed at least annually. It is the Principal
Investigator’s responsibility to submit for renewal and obtain approval before the expiration date.
You may not continue any research activity beyond the expiration date without IRB approval.
Failure to receive approval for continuation before the expiration date will result in automatic
termination of the approval for this study on the expiration date.
You are required to obtain IRB approval for any changes to any aspect of this study before they
can be implemented. Any unanticipated problem involving risks to subjects or others (including
adverse events reportable under UNC-Chapel Hill policy) should be reported to the IRB using
the web portal at http://irbis.unc.edu.
This study was reviewed in accordance with federal regulations governing human subjects
research, including those found at 45 CFR 46 (Common Rule), 45 CFR 164 (HIPAA), 21 CFR
50 & 56 (FDA), and 40CFR 26 (EPA), where applicable.
IRB Informational Message—please do not use email REPLY to this address
O f fi ce o f R es ear c h
INSTITUTIONAL REVIEW BOARD.
MEMORANDUM
______________________________________________________________________________________
To:
Lynne Wagenknecht, Dr.P.H.
Public Health Sciences
From:
Assistant Director, Institutional Review Board
Date:
11/18/2013
Subject:
Human Protocol: BG86-0155
Atherosclerosis Risk in Communities
Amendment 26 for IRB Study #BG86-0155 (Personnel Change Request)
Study Documents:
Protocol Version: ARIC Protocol revised 8-5-2013.docx, ARIC Surveillance Coronary Heart Disease
Protocol update, ARIC Surveillance Heart Failure Protocol update, AVID PROTOCOL AV-45-A14 1
Amendment 3.pdf, AVID PROTOCOL LIST OF CHANGES Amendment 3.pdf, Study Protocol for ARIC
Holter, WFU ARIC PET Protocol Mar 2013.docx; Informed Consent Version: Clinic Visit Consent May
2011.docx (approved), Holter Monitor Addendum Consent August 23. 2013.docx (approved), Home Visit
Consent May 2011.docx (approved), Informant Consent April 2011.docx (approved), MRI Addendum
Consent Jan 2013.docx (approved), PET Addendum Consent Jan 2013.docx (approved); Investigator's
Brochure: AV-45 IB version 8 0 USPI Ref - FINAL approved with sig pdf.pdf; Advertisements: WFU
ARIC PET Study Brochure Dec 2012.pdf; Other Documents: 6 item screener_1 11.doc, ARIC
Forms.docx.doc, ARIC large scale genetic memo to IRB July 2012.docx, ARIC NCS Forms
docx.doc.2.doc, Correspondence-Case Physician Letter, Correspondence-Informational Flyer,
Correspondence-NOK Case Physician Letter , Correspondence-NOK Letter, Correspondence-NOK Refusal
Script, Correspondence-Refusal Script, Cover Letter Explanation of Consent Forms for WFU IRB
12.23.10.docx, Data Collection Case Letter, Data Collection-NOK PHI Release, Data Collection-NOK
Telephone Screener Script, Data Collection-PHI release, Data Collection-Physician Form, Data CollectionTelephone Screener Script, Dementia Ascertainment Scripts.pdf, Dementia Rating Interview-Deceased
Participants_highlighted 7-22-13.pdf, Dementia Rating Interview-Living Participants_highlighted 7-2213.pdf, Documentation of INFORMANT Consent.docx, Forsyth Co Participant Newsletter.pdf, Holter
Recruitment Ltr., Holter telephone Questionnaire, Participant Results Letter - Depression.docx, Participant
Results Letter - Echocardiogram.docx, Physician Results Letters - Echocardiography and AAA.docx,
Prototype Recruitment Letter.docx
The amendments listed below have been approved in accordance with HHS regulations for the protection
of human research subjects that provides for the expedited review and approval of minor changes in
previously approved research [45 CFR 46.110(b)(2)]. This action of the Board does not extend the term of
approval for this protocol.
The amendment includes the following:
Beverly Belle, Mary Brewer, Becky Clutts, Heather Duncan, Barabara Lasater, Robert Mortis, Susan
Moxley, Holly Smith, Kathryn Stewart, Carol Thomas, and Pradeep Garg removed from the study team.
Medical C enter Bou leva rd, Winst on-Sa lem, NC 27157-1023
(336) 716-4542 / fax (336) 716-4480
Lorrie Caldwell added to the study team.
Changed the study coordinator to a different project manager who is currently on the study and keeping the
current study coordinator as a team member.
This IRB is in compliance with the requirements of Part 56, 21 Code of Federal Regulations published as of
April 1994 and Part 46, Subpart A of 45 CFR published January 26, 1981.
Brian Moore
The IRB: Human Subjects Committee renewed its approval of the referenced study listed below:
*Study Number:* 8412M01053
*Principal Investigator:* Aaron Folsom
*Expiration Date:* 05/28/2014
*Approval Date:* 05/29/2013
*Title(s):*
Atherosclerosis Risk in Communities Study
Atherosclerosis Risk in Communities (ARIC) Study
Atherosclerosis Risk in Communities (ARIC) Study--Field Center
Parkinson's disease case validation in the ARIC Study
Identifying Epidemiological Risk Factors for Abdominal Aortic Aneurysm
ARIC Neurocognitive Study (ARIC-NCS) IRB #1005M81992
Atherosclerosis Risk in Communities - Parkinson's Disease Olfactory Testing
Longitudinal Study of Predictors and Consequences of Chronic Kidney Disease
-----------------------------------------------------------------------This e-mail confirmation is your official University of Minnesota HRPP notification of continuing review
approval. You will not receive a hard copy or letter. This secure electronic notification between
password protected authentications has been deemed by the University of Minnesota to constitute a
legal signature.
You may go to the View Completed section of http://eresearch.umn.edu/ to view or print your
continuing review submission.
For grant certification purposes you will need this date and the Assurance of Compliance number, which
is FWA00000312 (Fairview Health Systems Research FWA00000325, Gillette Childrens Specialty
Healthcare FWA00004003). Approval will expire one year from that date. You will receive a report form
two months before the expiration date.
In the event that you submitted a consent document with the continuing review form, it has also been
reviewed and approved. If you provided a summary of subjects' experience to include non-UPIRTSO
events, these are hereby acknowledged.
As Principal Investigator of this project, you are required by federal regulations to inform the IRB of any
proposed changes in your research that will affect human subjects. Changes should not be initiated until
written IRB approval is received. Unanticipated problems and adverse events should be reported to the
IRB as they occur. Results of inspections by any external regulatory agency (i.e. FDA) must be reported
immediately to the IRB. Research projects are subject to continuing review.
If you have any questions, please call the IRB office at (612) 626-5654.
The IRB wishes you continuing success with your research.
To: Sally Stearns
Health Policy and Management
From: Non-Biomedical IRB
Approval Date: 10/30/2013
Expiration Date of Approval: 10/29/2014
RE: Notice of IRB Approval by Expedited Review (under 45 CFR 46.110)
Submission Type: Renewal
Expedited Category: 7.Surveys/interviews/focus groups,5.Existing or non-research data
Study #: 10-2064
Study Title: Cardiovascular Outcomes Research Center for the Atherosclerosis in Communities (ARIC)
Study
This submission has been approved by the IRB for the period indicated.
Study Description:
Purpose: This project (CORC) will examine the comparative effectiveness of treatments related to heart
failure for participants in the Atherosclerosis Risk in Communities (ARIC) Study. This IRB application is
ONLY for CORC activities, as the main ARIC Study has its own IRB approval (IRB #96-0484). Participants:
The CORC will use secondary data for members of ARIC study cohort. Procedures (methods): The CORC
will suggest additional questions to be included in ARIC study questionnaires (to be reviewed under the
ARIC IRB) and will also use CMS Medicare data linked to ARIC data to examine the relationship between
health service utilization and outcomes.
Submission Description:
The following personnel have been added to the study: Hadi Beyhaghi, Lei Zhou, Samuel Savitz. The
following personnel have been removed from the study: Shrikant Bangdiwala, Michael Pignone.
Regulatory and other findings:
Please note that no human subjects may be involved in any project supported by this award until the
project has been reviewed and approved by the IRB.
This research is for data analysis only.
Investigator’s Responsibilities:
Federal regulations require that all research be reviewed at least annually. It is the Principal
Investigator’s responsibility to submit for renewal and obtain approval before the expiration date. You
may not continue any research activity beyond the expiration date without IRB approval. Failure to
receive approval for continuation before the expiration date will result in automatic termination of the
approval for this study on the expiration date.
You are required to obtain IRB approval for any changes to any aspect of this study before they can be
implemented. Any unanticipated problem involving risks to subjects or others (including adverse events
reportable under UNC-Chapel Hill policy) should be reported to the IRB using the web portal at
http://irbis.unc.edu.
This study was reviewed in accordance with federal regulations governing human subjects research,
including those found at 45 CFR 46 (Common Rule), 45 CFR 164 (HIPAA), 21 CFR 50 & 56 (FDA), and
40CFR 26 (EPA), where applicable.
CC:
Carla Dupree, Medicine
Anna Kucharska-Newton, Epidemiology
IRB Informational Message—please do not use email REPLY to this address
Partners Human Research Committee
116 Huntington Avenue, Suite 1002
Boston, MA 02116
Tel: (617) 424-4100
Fax: (617) 424-4199
Continuing Review: Notification of IRB Approval/Activation
Protocol #: 2005P000100/BWH
Date:
September 11, 2013
To:
Scott D Solomon, MD
BWH
Medicine / Cardiology
From:
Partners Human Research Committee
116 Huntington Avenue, Suite 1002
Boston, MA 02116
Title of Protocol:
Version Date:
Cardiac Imaging Lab (CIL)
1/12/2005
IRB Continuing Review #:
IRB Review Type:
Risk:
Expedited Category/ies:
IRB Approval Date:
Approval Activation Date:
IRB Expiration Date:
9
Expedited
Minimal Risk
(5)
9/11/2013
9/11/2013
9/11/2014
This project has been reviewed by BWH IRB . During the review of this project, the IRB specifically
considered (i) the risks and anticipated benefits, if any, to subjects; (ii) the selection of subjects; (iii) the
procedures for obtaining and documenting informed consent; (iv) the safety of subjects; and (v) the privacy of
subjects and confidentiality of the data.
Please note that if an IRB member had a conflict of interest with regard to the review of this project, consistent
with IRB policies and procedures, the member was required to leave the room during the discussion and vote
on this project except to provide information requested by the IRB.
Approved for Ongoing Data Collection for Repository.
As Principal Investigator, you are responsible for ensuring that this project is conducted in compliance with all
applicable federal, state and local laws and regulations, institutional policies, and requirements of the IRB,
which include, but are not limited to, the following:
1. Submission of any and all proposed changes to this project (e.g., protocol, recruitment materials, consent
form, status of the study, etc.) to the IRB for review and approval prior to initiation of the change(s),
except where necessary to eliminate apparent immediate hazards to the subject(s). Changes made to
eliminate apparent immediate hazards to subjects must be reported to the IRB as an unanticipated
Official Version Generated from the Partners Human Research Committee Database
09/11/2013 11:14 AM
1
Partners Human Research Committee
116 Huntington Avenue, Suite 1002
Boston, MA 02116
Tel: (617) 424-4100
Fax: (617) 424-4199
problem.
2. Submission of continuing review submissions for re-approval of the project prior to expiration of IRB
approval and a final continuing review submission when the project has been completed.
3. Submission of any and all unanticipated problems, including adverse event(s) in accordance with the
IRB’s policy on reporting unanticipated problems including adverse events.
4. Obtaining informed consent from subjects or their legally authorized representative prior to initiation of
research procedures when and as required by the IRB and, when applicable, documenting informed
consent using the current IRB approved consent form(s).
5. Informing all investigators and study staff listed on the project of changes and unanticipated problems,
including adverse events, involving risks to subjects or others.
6. When investigator financial disclosure forms are required, submitting updated financial disclosure forms
for yourself and for informing all site responsible investigators, co-investigators and any other members
of the study staff identified by you as being responsible for the design, conduct, or reporting of this
research study of their obligation to submit updated Investigator Financial Disclosure Forms for this
protocol to the IRB if (a) they have acquired new financial interests related to the study and/or (b) any of
their previously reported financial interests related to the study have changed.
The IRB has the authority to terminate projects that are not in compliance with these
requirements.
Questions related to this project may be directed to Fausta M
Figueroa, [email protected], 617-424-4119.
CC: Chau Duong, BS, BWH - Medicine - Cardiology, Data Coordinator/Manager
Official Version Generated from the Partners Human Research Committee Database
09/11/2013 11:14 AM
2
Human Approval Letter
October 10, 2013
CHRISTIE MITCHELL BALLANTYNE
BAYLOR COLLEGE OF MEDICINE
MEDICINE: ATHERO & LIPO
Baylor College of Medicine
Office of Research
One Baylor Plaza, 600D
Houston, Texas 77030
Phone: (713) 798-6970
Fax: (713) 798-6990
Email: [email protected]
H-7492 - ATHEROSCLEROSIS RISK IN COMMUNITIES (ARIC) STUDY - MORBIDITY/MORTALITY FOLLOW-UP CENTRAL LIPID LABORATORY
APPROVAL VALID FROM 10/10/2013 TO 9/30/2014
Dear Dr. BALLANTYNE
The Institutional Review Board for Human Subject Research for Baylor College of Medicine and Affiliated Hospitals (BCM IRB) is
pleased to inform you that the research protocol named above was approved.
The study may not continue after the approval period without additional IRB review and approval for continuation. You will receive
an email renewal reminder notice prior to study expiration; however, it is your responsibility to assure that this study is not
conducted beyond the expiration date.
Please be aware that only IRB-approved informed consent forms may be used when written informed consent is required.
Any changes in study or informed consent procedure must receive review and approval prior to implementation unless the change
is necessary for the safety of subjects. In addition, you must inform the IRB of adverse events encountered during the study or of
any new and significant information that may impact a research participants' safety or willingness to continue in your study.
The BCM IRB is organized, operates, and is registered with the United States Office for Human Research Protections according to
the regulations codified in the United States Code of Federal Regulations at 45 CFR 46 and 21 CFR 56. The BCM IRB operates
under the BCM Federal Wide Assurance No. 00000286, as well as those of hospitals and institutions affiliated with the College.
Sincerely yours,
GABRIEL HABIB, M.D.
Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals
https://brain.bcm.edu/esp1/reports/Human/Approval.asp?protocol=276516&title_code=0[10/10/2013 2:32:15 PM]
| File Type | application/pdf |
| File Modified | 2014-03-10 |
| File Created | 2013-11-20 |