IRB Approval

Appendix E. IRB Approval Memo (Pease Health Study)
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

September 12, 2018

From

Jerrell Little
IRB-Committee 2 Administrator
Human Research Protection Office

Subject

CDC IRB Approval of New Protocol 7161.0, "Human health effects of drinking water exposures
to per- and polyfluoroalkyl substances (PFAS) at Pease International Tradeport, Portsmouth, NH
(Pease Study - Proof of Concept)" (Expedited)

To

MARIAN PAVUK, PhD, MD
ATSDR/DTHHS
CDC's IRB-Committee 2 has reviewed the request for approval of new protocol 7161.0, "Human
health effects of drinking water exposures to per- and polyfluoroalkyl substances (PFAS) at
Pease International Tradeport, Portsmouth, NH (Pease Study - Proof of Concept)" and has
approved the protocol for the maximum allowable period of one year. CDC IRB approval will
expire on 8/26/2019. The protocol was reviewed in accordance with the expedited review
process outlined in 45 CFR 46.110(b)(1), categories 2a, 2b, 4, and 7.
This approval confirms that CDC’s IRB-Committee 2 has determined that a Certificate of
Confidentiality applies to this study and protects the privacy of individuals who are subjects of
this research, pursuant to subsection 301(d) of the Public Health Service Act.
The IRB determined that the study poses minimal risk to subjects. The IRB approved the
inclusion of pregnant women under 45 CFR 46.204 and the inclusion of children under 45 CFR
46.404.
If other institutions involved in this protocol are being awarded CDC funds through the CDC
Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to
the CDC PGO award specialist handling the award. You are also required to verify with the
award specialist that the awardee has provided PGO with the required documentation and have
approval to begin or continue research involving human subjects as described in this protocol.
As a reminder, the IRB must review and approve all human subjects’ research protocols at
intervals appropriate to the degree of risk, but not less than once per year. There is no grace
period beyond one year from the last IRB approval date. It is ultimately your responsibility to
submit your research protocol for continuation review and approval by the IRB. Please keep this
approval in your protocol file as proof of IRB approval and as a reminder of the expiration date.
To avoid lapses in approval of your research and the possible suspension of subject enrollment
and/or termination of the protocol, please submit your continuation request at least six weeks
before the protocol's expiration date of 8/26/2019.

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Any problems of a serious nature should be brought to the immediate attention of the IRB, and
any proposed changes to the protocol should be submitted as an amendment to the protocol for
IRB approval before they are implemented.
If you have any questions, please contact your National Center Human Subjects Contact or the
CDC Human Research Protection Office at (404) 639-7570 or email at [email protected]).

CC:
NCEH/ATSDR Human Subjects

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Date

November 20, 2018

From

Jerrell Little
IRB-Committee 2 Administrator
Human Research Protection Office

Subject

IRB Approval of Amendment to CDC Protocol 7161, "Human health effects of drinking water
exposures to per- and polyfluoroalkyl substances (PFAS) at Pease International Tradeport,
Portsmouth, NH (Pease Study - Proof of Concept)" (Expedited)

To

Marian Pavuk, PhD, MD
ATSDR/DTHHS
CDC's IRB-Committee 2 has reviewed and approved your request to amend protocol 7161,
“Human health effects of drinking water exposures to per- and polyfluoroalkyl substances
(PFAS) at Pease International Tradeport, Portsmouth, NH (Pease Study - Proof of Concept)”.
These changes included the following:
The Manual of procedures (MOP, Attachment 14; placeholder in the original submission) has
been prepared and revised; especially the section on data management and security (Section 13).
Changes in sample volumes (Attachment 3) reflect input and revisions from NCEH/DLS.
The action was reviewed in accordance with the expedited review process outlined in 45 CFR
46.110(b)(1), under categories 2a, 2b, 4, and 7 to previously approved research during the period
(of one year or less) for which approval is authorized.
Reminder: IRB approval of protocol #7161 will still expire on 8/26/2019.
Any problems of a serious nature must be brought to the immediate attention of the CDC
IRB, and any proposed changes to the protocol should be submitted as an amendment to
the protocol for CDC IRB approval before they are implemented.
If you have any questions, please contact your National Center Human Subjects Contact or the
CDC Human Research Protection Office (404) 639-7570 or e-mail: [email protected].

cc:
NCEH/ATSDR Human Studies

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Date

March 5, 2019

From

Jerrell Little
IRB-Committee 2 Administrator
Human Research Protection Office

Subject

IRB Approval of Amendment to CDC Protocol 7161, "Human health effects of drinking water
exposures to per- and polyfluoroalkyl substances (PFAS) at Pease International Tradeport,
Portsmouth, NH (Pease Study - Proof of Concept)" (Expedited)

To

Marian Pavuk, PhD, MD
ATSDR/DTHHS
CDC's IRB-Committee 2 has reviewed and approved your request to amend protocol 7161,
“Human health effects of drinking water exposures to per- and polyfluoroalkyl substances
(PFAS) at Pease International Tradeport, Portsmouth, NH (Pease Study - Proof of Concept)”.
These changes included the following:
1. Informed Consent package (Attachment 9b) contains changes reflecting requirements to conversion
to 2018 Common Rule. This affects the storage and future use of collected biospecimens (see p. 7-8,
12, 19-20, 22 tracked changes document).
2. Corresponding changes in the study protocol with additions on the future use of stored
biospecimens (p. 55-56 tracked changes document).
3. Text message script added in Attachment 10. Allowing contractor to send a short reminder text in
addition to reminder telephone call about the upcoming appointment to a cell phone number on
record (no additional burden). Corresponding change also made in the protocol (p. 35).
In addition,
1. CDC research partner was added; Abt Associates were awarded contract to conduct the study, see
form 1370.
2. We also request this outside institution to rely on CDC IRB approval; see form 1372.

The action was reviewed in accordance with the expedited review process outlined in 45 CFR
46.110(b)(1), under categories 2a, 2b, and 7 to previously approved research during the period
(of one year or less) for which approval is authorized.
Reminder: IRB approval of protocol #7161 will still expire on 8/26/2019.

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Any problems of a serious nature must be brought to the immediate attention of the CDC
IRB, and any proposed changes to the protocol should be submitted as an amendment to
the protocol for CDC IRB approval before they are implemented.
If you have any questions, please contact your National Center Human Subjects Contact or the
CDC Human Research Protection Office (404) 639-7570 or e-mail: [email protected].

cc:
NCEH/ATSDR Human Studies