B.2.6 LOI2-PHYS-15 IRB Approval Letters

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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
Amendment
May 12, 2011
Omar Abdul-Rahman, MD
School of Nursing
University Of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216-4505
RE:

IRB File # 2010-0292
DEVELOPMENT OF A VISIT ASSESSMENT TOOL TO ADDRESS BIRTH
DEFECTS AND DYSMORPHOLOGY FOR THE NATIONAL CHILDREN'S
STUDY

Dear Dr. Abdul-Rahman:
Your Amendment was reviewed and approved by the Expedited review process on May
12, 2011. You may implement the amendment.
Please note the following information about your approved research protocol:
•
•
•
•

Protocol Approval period:
Parental Permission Document:
Recruitment/Retention Material:
Sponsor:

•
•
•
•

Approved Enrollment #:
Participant Population:
Performance Sites:
Amendment Description:

Amendment Review History:
Receipt Date
Submission
Type
05/09/2011
Amendment

May 12, 2011 - January 18, 2012
Spanish version, Version 4-4-11
Permission to Contact Form, Version 4-4-11
National Institute of Child Health and Human
Development (NICHD)
50
Minors < 18
UMMC
Spanish translation of Parental Permission
Document and Permission to Contact Form

Review
Process
Expedited

Review Date

Review Action

05/12/2011

Approved

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

Please remember to:
Æ Use the IRB file number (2010-0292) on all documents or correspondence with the
IRB concerning your research protocol.
Æ Review and comply with all requirements on the enclosure, UMMC Investigator
Responsibilities, Protection of Human Research Participants.
A copy of the approved, date-stamped consent/assent/parental permission document(s)
to use when obtaining consent/assent/parental permission will be available online at,
http://irbweb.umc.edu/WebKit/. 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 of any sort (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/. For additional information please go to
http://irb.umc.edu/GuidanceInfo/ClinTrialRegistry.htm.
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.
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.
Sincerely,

Gailen D. Marshall, Jr., M.D., Ph.D.
Chairman, Institutional Review Board 2
GDM/kc
Enclosure(s): (1) Investigator Responsibilities, Protection of Human Research Participants
(2) Recruitment Material – Permission to Contact Form

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

5

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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
Amendment
March 2, 2011
Omar Abdul-Rahman, MD
School of Nursing
University Of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216-4505
RE:

IRB File # 2010-0292
DEVELOPMENT OF A VISIT ASSESSMENT TOOL TO ADDRESS BIRTH
DEFECTS AND DYSMORPHOLOGY FOR THE NATIONAL CHILDREN'S
STUDY

Dear Dr. Abdul-Rahman:
Your Amendment was reviewed and approved by the Expedited review process on
March 2, 2011. You may implement the amendment.
Please note the following information about your approved research protocol:
•
•
•

Protocol Approval period:
Consent Document:
Sponsor:

•
•
•
•

Approved Enrollment #:
Participant Population:
Performance Sites:
Amendment Description:

March 2, 2011 - January 18, 2012
Version 02/18/2011
National Institute of Child Health and Human
Development (NICHD)
50
Minors < 18
UMMC
Update consent document
Change Dr. Omar Abdul Rahman to Principal
Investigator and change Dr. Sharon Wyatt to
Co-Investigator

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

Amendment Review History:
Receipt Date
Submission
Type
02/28/2011
Amendment

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

Review
Process
Expedited

Review Date

Review Action

03/02/2011

Approved

Please remember to:
Æ Use the IRB file number (2010-0292) on all documents or correspondence with the
IRB concerning your research protocol.
Æ Review and comply with all requirements on the enclosure, UMMC Investigator
Responsibilities, Protection of Human Research Participants.
A copy of the approved, date-stamped consent/assent/parental permission document(s)
to use when obtaining consent/assent/parental permission will be available online at,
http://irbweb.umc.edu/WebKit/. 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, as a condition for publication of study results, the International Committee
of Medical Journal Editors (ICMJE) requires all clinical research studies that began
enrolling participants on or after July 1, 2005, to be entered in a public registry before
enrollment begins. Additionally, Public Law 110-85, Title VIII, enacted September 27,
2007, requires registration of clinical trials and submission of results data through
ClinicalTrials.gov. For additional information please go to
http://irb.umc.edu/GuidanceInfo/ClinTrialRegistry.htm
Penalties for responsible parties who fail to register applicable clinical studies are
significant and may include civil monetary penalties and, for federally-funded studies,
withholding or recovery of grant funds.
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.
Sincerely,

Gailen D. Marshall, Jr., M.D., Ph.D.
Chairman, Institutional Review Board 2
GDM/dr

Enclosure(s): (1) Investigator Responsibilities, Protection of Human Research Participants

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

5

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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
Initial Review (Response To Revisions)
January 19, 2011
Sharon B. Wyatt, RN, CS, PhD
School of Nursing
University of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216-4505
RE:

IRB File # 2010-0292
DEVELOPMENT OF A VISIT ASSESSMENT TOOL TO ADDRESS BIRTH
DEFECTS AND DYSMORPHOLOGY FOR THE NATIONAL CHILDREN'S
STUDY

Dear Dr. Wyatt:
Your Initial Review (Response To Revisions) was reviewed and approved by the
Expedited review process on January 19, 2011. You may begin this research.
Please note that you may not enroll non-English speaking participants until you submit a
Request for Change with the translated document and certification of translation, or
translated and back-translated documents with the qualifications of each translator.
Please note the following information about your approved research protocol:
•
•
•
•
•

Protocol Approval period:
Parental Permission Document:
Recruitment/Retention Material:
Research Protocol:
Sponsor:

•
•
•
•

Approved Enrollment #:
Participant Population:
Performance Sites:
Expedited Category(ies):

January 19, 2011 - January 18, 2012
Version date 1-19-11
Permission to Contact form
Version 12-6-10
National Institute of Child Health and Human
Development (NICHD)
50
Minors < 18
UMMC
45 CFR 46.110(b) and/or 21 CFR 56.110(b)

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

(4) - Collection of data through noninvasive
procedures (not involving general anesthesia
or sedation) routinely employed in clinical
practice, excluding procedures involving X-rays
or microwaves. Where medical devices are
employed, they must be cleared/approved for
marketing. (Studies intended to evaluate the
safety and effectiveness of the medical device
are not generally eligible for expedited review,
including studies of cleared medical devices for
new indications.) Examples: (a) physical
sensors that are applied either to the surface of
the body or at a distance and do not involve
input of significant amounts of energy into the
subject or an invasion of the subject's privacy;
(b) weighing or testing sensory acuity; (c)
magnetic resonance imaging; (d)
electrocardiography, electroencephalography,
thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound,
diagnostic infrared imaging, doppler blood flow,
and echocardiography; (e) moderate exercise,
muscular strength testing, body composition
assessment, and flexibility testing where
appropriate given the age, weight, and health
of the individual.
(6) - Collection of data from voice, video,
digital, or image recordings made for research
purposes.

Initial Review (Response To Revisions) Review History:
Receipt Date

Review
Process
Expedited

Review Date

Review Action

12/10/2010

Submission
Type
Initial Review

12/16/2010

01/05/2011 –
01/19/2011

Response To
Revisions

Expedited

01/19/2011

Revisions
Required
Approved

Please remember to:
Æ Use the IRB file number (2010-0292) on all documents or correspondence with the
IRB concerning your research protocol.
Æ Review and comply with all requirements on the enclosure, UMMC Investigator
Responsibilities, Protection of Human Research Participants.

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

A copy of the approved, date-stamped consent/assent/parental permission document(s)
to use when obtaining consent/assent/parental permission will be available online at,
http://irbweb.umc.edu/WebKit/. 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, as a condition for publication of study results, the International Committee
of Medical Journal Editors (ICMJE) requires all clinical research studies that began
enrolling participants on or after July 1, 2005, to be entered in a public registry before
enrollment begins. Additionally, Public Law 110-85, Title VIII, enacted September 27,
2007, requires registration of clinical trials and submission of results data through
ClinicalTrials.gov. For additional information please go to
http://irb.umc.edu/GuidanceInfo/ClinTrialRegistry.htm
Penalties for responsible parties who fail to register applicable clinical studies are
significant and may include civil monetary penalties and, for federally-funded studies,
withholding or recovery of grant funds.
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.
Sincerely,

Gailen D. Marshall, Jr., M.D., Ph.D.
Chairman, Institutional Review Board 2
GDM/kc
Enclosure(s): (1) Investigator Responsibilities, Protection of Human Research Participants
(2) Recruitment Material – Permission to Contact form
cc:

Kimberly W. Hoover, Ph.D., R.N., Dean, School of Nursing
Vice Chancellor for Health Affairs
Office of Integrity and Compliance

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

ATTACHMENT B.2.6 IRB APPROVAL
LETTERS LOI2-PHYS-15

OMB#: 0925-0593
EXPIRATION DATE: 07/31/2013

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.

6

Office of Research/Human Subjects Committee
SAD Room 124
Box 2201 SDSU
Brookings, SD 57007

To:

Bonny Specker, National Children’s Study/E.A. Martin Program

Date:

September 15, 2010

Project Title: Development of a Visit Assessment Tool to Address Birth Defects &
Dysmorphology
Approval #:

IRB-1009004-EXP

The committee approved your project using expedited procedures as described in 45 CFR
46.110. The activity was deemed to be no greater than minimal risk, and the following
expedited categories from 63 FR 60364-60367 were found to be applicable to your activity:
(4) Collection of data through noninvasive procedures (not involving general anesthesia or
sedation) routinely employed in clinical practice, excluding procedures involving x-rays or
microwaves.
and
(6) Collection of data from voice, video, digital, or image recordings made for research
purposes.
Please note the following special conditions:
• Because a photograph of the infant is taken at/near the time of birth, if that photo is
used, no additional information needs to be conveyed to the mother.
• If a separate photo is taken or taken at a time not explained through a VIS, please
prepare a VIS that explains this procedure and submit it to the IRB.
• If/when protocol 2 (e.g., measurements) is implemented, please prepare the necessary
VIS as needed and submit it to the IRB.
One-year approval of your project will be dated starting 9/15/10. If you require additional time
to complete your project, please submit a request for extension before 9/14/11. Protocol
changes must be approved by the Committee prior to implementation. Forms may be found on
the Human Subjects web page. If there are any unanticipated problems involving risks to

subjects or others, please contact the SDSU Research Compliance Coordinator. At the end of
the project please inform the committee that your project is complete.
If I can be of further assistance, don’t hesitate to let me know.
Sincerely,
Norm

Norman O. Braaten
SDSU Research Compliance Coordinator