JacksonIRBApproval

UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
2500 North State Street
Jackson, Mississippi 39216-4505
DHHS FWA # 00003630

Institutional Review Board
Telephone (601) 984-2815
Facsimile (601) 984-2961

Approval Notice
Amendment
May 31, 2006
Thomas H. Mosley, M.D.
Medicine
University of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216-4505
RE:

IRB File # 1985-0122
Atherosclerosis Risk in Communities (ARIC) Study

Dear Dr. Mosley:
Your Amendment was reviewed and approved by the Expedited review process on
May 31, 2006. You may implement the amendment. The expansion of long-term
follow-up being done with currently enrolled participants is approved. If new
participants are going to be enrolled, please let us know.
Please note the following information about your approved research protocol:
•
•
•
•

Protocol Approval period:
Approved Enrollment #:
Performance Sites:
Amendment Description:

May 31, 2006 - January 30, 2007
100000
UMC
Revised protocol

Amendment Review History:
Receipt Date
05/26/2006

Submission
Type
Amendment

Review
Process
Expedited

Review Date

Review Action

05/31/2006

Approved

Please remember to:
Æ Use the IRB file number (1985-0122) on all documents or correspondence with the
IRB concerning your research protocol.
Æ Review and comply with all requirements on the enclosure, UMC Investigator
Responsibilities, Protection of Human Research Participants.
Please note that the UMC 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.
As a condition for publication of study results, the International Committee of
Medical Journal Editors (ICMJE) requires all clinical research studies that begin
enrolling participants on or after July 1, 2005 to be entered in a public registry before
enrollment begins. For additional information please go to
http://dor.umc.edu/proposalprep/policies/RegisteringClinicalTrialinPublicRegistry.doc.
We wish you the best as you conduct your research. If you have questions or need
additional information, please contact the IRB office at (601) 984-2815.
Sincerely,

Gailen D. Marshall, Jr., M.D., Ph.D.
Chairman, Institutional Review Board 2
GDM/kc
Enclosure: (1) UMC Investigator Responsibilities, Protection of Human Research
Participants

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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 IRB webpage, http://irb.umc.edu/, and in hard copy by request from the IRB 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 consent documents, 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 process 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 informed
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 informed 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

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research expires, the IRB will send you a reminder to submit a Renewal Application.
Although the IRB sends reminders, 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, informed consent document, instruments, surveys
or recruiting material, you must submit the amendment or revisions to the IRB for
review using the UMC Amendment Application. 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. Adverse or Unanticipated Events: Any serious and unexpected adverse event,
participant complaint, and all unanticipated problems that involve risks to participants
or others, as well as any research related injury occurring at a UMMC performance
site, must be reported to the IRB within fourteen (14) days of discovery of the
incident. You must also report any instances of serious or continuing problems, or
non-compliance with the IRB’s requirements for protecting human research
participants. The only exception to this policy is death - the death of a UMMC
research participant must be reported within 48 hours. All reportable events
should be submitted to the IRB using the Adverse Event/Unanticipated Problem
Report form available on the IRB webpage, http://irb.umc.edu/.
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

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must submit a Final Report to the IRB using the Final Report form found on our web
page, http://irb.umc.edu/.
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 IRB office at 601 984-2815.

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