Att_34 IRB Approval Biomedical Exams

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Date:
To:
From:
Subject:

National Institutes of Health
National Institute of
Environmental Health Sciences
P. O. Box 12233
Research Triangle Park, NC 27709
http://sharepoint.niehs.nih.gov/ohrc/default.aspx

July 03, 2013
NIEHS IRB Chair, through the Office of Human Research Compliance
Chief, Epidemiology Branch and PI, the GuLF STUDY
Expedited Amendment to Protocol # 11-E-NO7 titled “The Gulf Long-term Follow-up Study“

An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more
experienced reviewers designated by the chairperson from members of the IRB in accordance with the requirements set forth in 45 CFR
46.110. Additional information on determining the appropriate level of review for a submission can be found at
http://ohsr.od.nih.gov/irb/Attachments/Chapter7.htm.
Note: If an NIH investigator is added to the protocol, attach a signed/cleared Personal Financial Holding Clearance form along with an email from the new investigator stating they are aware they are being added to the protocol.

Expedited Amendment Summary and Justification:
We request expedited review and approval of an addendum to the GuLF STUDY protocol to fully describe our
plans for carrying out the Biomedical Surveillance Sub-cohort clinical examination referenced in the current study
protocol. A subset of 6,000 cohort members will be invited to take part in the exam, which includes repeated
measures from the baseline home visits and comprehensive neurobehavioral, mental health, and pulmonary
function testing. We believe that the exam presents minimal risk to participants and may, in fact, present less risk
than the home exam because it is being carried out in a clinical setting under the direction of physicians. The
specific details of the updates to the protocol and the file names for the associated attachments are detailed below.
I. Protocol and Questionnaires
{Attachment: GuLF_Study_Protocol_V19.0_07022013_CLEAN.docx;
GuLF_Study_Protocol_V19.0_07022013_TRACKED.docx; Clinical Exam Questionnaires
_V1.0_07022013_CLEAN.docx; Mental Health Questionnaire for the Clinical Exam_V1.0_07022013_
CLEAN.docx}
About 6,000 cohort members will be eligible to take part in the clinical examination component of the study, and
we expect that about 4,000 (67%) will complete the exam. The exams will be carried out by collaborators from
the University of South Alabama (USA) and Louisiana State University (LSU) Health Sciences Center. The
eligible population includes all members of the Biomedical Surveillance Sub-cohort (N~4,000) and a
“supplemental” sample of members of the Active Follow-Up Sub-cohort (N~2,000). The supplemental sample
will be selected on based on potential exposures and baseline measures of mental health status and pulmonary
function.
The exam will take approximately 4 hours to complete, and participants will receive $150.00 for their time and
effort. Exam components include anthropometric and clinical measurements, biological sample collection,
neurobehavioral and lung function testing, a comprehensive mental health assessment, and questionnaire about
health and lifestyle. Participants will receive the results of clinically relevant exam findings at the time of the visit
and will receive health care referrals, if requested. A subset of participants (N~1,000) will be asked to collect
serial saliva samples at home following the exam, and they will receive an additional $20.00 for returning the
samples.
III. Invitational and Pre-visit Material
{Clinic_Exam_Lead_Letter_V1.0_07022013.docx; Calling_Scripts_Clinic_Exam_V1.0_07022013.docx;
GuLF_STUDY_Clinic_Exam_Confirmation_Letter_V1.0_07022013.docx; Clinic
Visit_Frequently_Asked_Questions_V1.0_07022013.docx; Clinic_Visit_Instructions_V1.0_07022013.docx}

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Eligible cohort members will receive an invitation mailing that encourages them to take part in the exam. Clinical
staff will actively contact participants to schedule visits. Standardized scripts will be used to guide scheduling
calls. After visits are scheduled, participants will receive a visit confirmation package, which includes a cover
memo, a summary of the informed consent form, answers to frequently asked questions, information on how to
prepare for their visit, and directions to the clinic.
II. Consent(s)
{Consent_Form_Summary_Sheet_V1.0_07022013.docx; GuLF_Informed_Consent_Booklet_Clinic
Exam_V_1.0_07022013.docx}
The one-page consent form summary that is include with the visit confirmation package briefly covers key topics
in the informed consent form, such as exam procedures, benefits, risks, remuneration, and privacy and
confidentiality. At the time of the examination, study staff will review the Informed Consent Form with
participants, address any questions or concerns, and obtained written informed consent before carrying out any
study procedures.
IV. Other
{Blood_Pressure_Results_V1.0_07022013.docx; BMI_Results_V1.0_07022013.docx;
Cholesterol_Results_V1.0_07022013.docx; Hemoglobin_A1c_Results_V1.0_07022013.docx;
HR_Results_V1.0_07022013.docx; PFT_Results_V1.0_07022013.docx;
Clinic_Visit_Gift_Card_Receipt_V1.0_07022013.docx; Saliva_General_Instructions_V1.0_07022013.docx;
Saliva_Collection_Instructions_V1.0_07022013.docx; Saliva_Mail_Instructions_V1.0_07022013.docx;
Saliva_Collection_Log_V1.0_07022013.pdf }
Participants will receive results of clinically relevant findings during their exam, including blood pressure and
heart rate, body mass index, cholesterol levels, hemoglobin A1c, and pulmonary function testing. Results will be
provided on handouts that include standardized clinical interpretations and advice for seeking care.
A subset of ~1,000 participants will be asked to provide serial saliva samples for the measurement of salivary
cortisol. Five salvia samples will be collected on two different days during a one week period using an in-home
procedure. Participants will complete a collection log that details their activities at the time that the sample was
collected.
Participants will receive a gift card for their time and effort following the completion of their clinic examination.
A gift card receipt will be signed by the study staff and the participant to document that they have received their
remuneration. The gift card receipt will be maintained with the study files.

Principal Investigator, NIEHS
I authorize the above changes to my study and have included updated edited and clean versions of all
revised documents as attachments for submission via my NIH e-mail account to the NIEHS Office of
Human Research Compliance.
For Approving Official Use Only:
The attached expedited amendment request is a minor change in the research that does not increase risks to subjects
or reduce potential benefits and falls within the OHRP Categories of Research that May be Reviewed by the IRB
through an expedited review procedure. Approval is hereby granted.

N. Almodovar
Protocol Specialist
Office of Protocol Services

7/12/13
Date

Y
Amendment
Letter

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Protocol eSign History
Protocol Number: 11-E-N076
Date/Time
07/02/2013 6:25 PM

Review: Amendment 07/02/2013
User

Dale Sandler

07/02/2013 6:25 PM Dale Sandler

07/02/2013 6:25 PM Dale Sandler

07/02/2013 6:34 PM

Dale Sandler

07/02/2013 6:34 PM Dale Sandler

07/03/2013 2:00 PM Frederick Miller

Type

Action

Electronic signature

eSignature Verified Principal

access

Investigator

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eSignature Verified Accountable

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Investigator

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eSignature Verified Branch

access

Chief

Electronic signature

eSignature Verified Accountable

access

Investigator

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eSignature Verified Branch

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Chief

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eSignature Verified Clinical

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Director

Electronic signature
07/08/2013 12:49 PM David Resnik

(25)

access

eSignature Verified IRB Chair