Att_32 IRB Approval Annual Recontact

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

August 24, 2012
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 of the proposed annual request for updated contact information for participants who
have completed the telephone enrollment interview. Requests for updated contact information will be sent to
participants by email and USPS mail and will include a link to the Update Contact Information page on the study
website. Participants will be able to view and confirm their information by entering a combination of their last
name, date of birth, and last for of their SSN or their unique PIN number on the secure and encrypted site.
Participants may also call the study hotline to confirm or update their information. As study findings and updates
become available, the email / letter requests will include an annual newsletter with study information. The
newsletter will be submitted to the IRB prior to distribution. The email / letter to participants and a detailed
description of the annual re-contact procedures are attached (GuLF STUDY Annual Re-contact Request v1.0
080242012; GuLF STUDY Annual Recontact Plan v1.0 08242012.docx).
As of August 21, 2012, 27,588 persons have enrolled in the Full Cohort and almost 18,000 are in-progress and
pending final disposition; over 4,000 of these participants speak either Spanish or Vietnamese. In addition, target
efforts are underway to identify and recruit rig workers who responded to the clean-up effort in the area of the
well-head. Since rig-workers reached the worksite through alternate means, many were not included in the initial
worker lists we obtained from BP and its contractors. We only recently learned of this omission and were able to
obtain information needed to recruit them in the past few months. As described in the Protocol, we intentionally
started enrollment at a slower pace to ensure that data collection efforts work as planned, followed by a ramp-up
of enrollment efforts in the fall of 2011. Furthermore, a large proportion of the contact information for the
participants is incomplete or out-of-date resulting in increased efforts to trace these individuals for additional
contact information and recruitment attempts. Although we are now enrolling at a steady pace and our numbers
have increased substantially since last review, the slower start and extensive tracing effort has left us behind
where we had hoped to be at this time. Thus, we propose extending the accrual period from 18 to 21 months for
Full Cohort Enrollment and extending the timeframe for completion of home visits for the Active Follow-up Subcohort from 18 to 24 months. This change has the support of our Scientific Advisory Board and will allow for
more pending cases to be finalized and increase overall enrollment. Further, it will allow us sufficient time to
enroll Spanish and Vietnamese participants and the rig workers, who are currently under-represented.
I. Protocol
{Attachment: GuLF STUDY Protocol V12.0 08242012 TRACKED.docx, GuLF STUDY Protocol V12.0 08432012
CLEAN.docx}
Summary of Changes
Page #

Section

Description of change

Page 1 of 2

Throughout

•

Updated version number and date in footer

8

Protocol Summary

•

Changed accrual period to end 12/2012

10

Précis

•

Changed 18 to 21 months

24

2.3.1 Recruitment Database

•
•

Changed 18 to 21 months for Full Cohort
Changed 18 to 24 months for home visits

58

2.14.1 Annual Update of Contact
Information

•

Revised plans for annual updates of
participant contact information

All

GuLF STUDY 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.

Dawn Roy
Protocol Specialist
Office of Protocol Services

9/14/12 N
Date

Amendment
Letter

Page 2 of 2

Protocol eSign History
Protocol Number: 11-E-N076
Date/Time
08/27/2012 9:13 PM

Review: Amendment 08/27/2012
User

Dale Sandler

08/27/2012 9:13 PM Dale Sandler

08/27/2012 9:13 PM Dale Sandler

08/28/2012 5:42 PM

Dale Sandler

08/28/2012 5:42 PM Dale Sandler

08/30/2012 3:35 PM Frederick Miller

Type

David Resnik

Action

Electronic signature

eSignature Verified Principal

access

Investigator

Electronic signature

eSignature Verified Accountable

access

Investigator

Electronic signature

eSignature Verified Branch

access

Chief

Electronic signature

eSignature Verified Accountable

access

Investigator

Electronic signature

eSignature Verified Branch

access

Chief

Electronic signature

eSignature Verified Clinical

access

Director

Electronic signature
08/30/2012 4:37 PM

(14)

access

eSignature Verified IRB Chair