Appendix F: IRB Approval Memo

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

December 11, 2019

From

Jerrell Little
IRB Administrator
Human Research Protection Office

Subject

CDC IRB Approval of Amendment #2 to CDC Protocol #7207, "Human health effects of
drinking water exposures to per- and poly-fluoroalkyl substances (PFAS): A multi-site crosssectional study " (Expedited)

To

Marian Pavuk
ATSDR/DTHHS

CDC's IRB-Committee 2 has reviewed and approved your request to amend protocol #7207,
“Human health effects of drinking water exposures to per- and poly-fluoroalkyl substances
(PFAS): A multi-site cross-sectional study”. The modification includes the following changes:
Following the OMB review and approval as well as activities
related to preparation and start of data collection on the proof
of concept Pease Study the changes were made in number of
documents. We have revised the Multi-site Study protocol and
information collection materials to reflect the changes made to
the Pease protocol.
Protocol
1. Date revised to reflect current submission (p.1)
2. Updated the site selection criteria (Sections 1.1.3 and
2.3) and text reflecting the Notice of Funding Opportunity
(NOFO) process and the fact that the selection has occurred
(p. 7 and p. 12).
3. Added information on the seven research partners awarded
the cooperative agreement to conduct the Multi-site Study
and the location where they each will conduct their work
(Section 2.3, p. 14-15).
4. Updated and rephrased Section 2.4 General Approach for
Study Recruitment to reflect that awardees have propose
sampling methodologies as described in the protocol (p. 1517).
5. Added “2” for section 2.5 (p. 17)

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6. Added sentence specifying that each awardee will attempt to
meet a target recruitment of 300 children; also added
‘minimum’ in the proposed sample size of 2,000 (Section
3.3.1, p. 27).
7. Added sentence specifying that each awardee will attempt to
meet a target recruitment of 1,000 adults; also added
‘minimum’ in the proposed sample size of 6,000 (Section
3.3.2, p. 30).
8. Updated text and the table in the Section 3.6.5.1.1
Child/Parent Neurobehavioral Assessments. After the pilot
testing and review by child psychologist a few subtests of
the NEPSY-II test were removed to keep proposed testing at
no more than 90 min per child participant. Subtest removed:
Auditory Attention and Response, Inhibition, Word List
Interference, and Sentence Repetition.; Affect Recognition
replaced Theory of Mind (p. 42).
9. Added information on two approaches to assess the potential
and magnitude of possible selection bias and information
biases (p. 58).
10. Added Attachment 3c Sampling and Recruitment Strategies
Across Sites to the list of attachments (p. 72).
Att1 Investigators and Key Study Personnel
1. Revised to reflect the cooperative agreement primary
investigators.
Att7b Consent Package
2. Updated headings for study principal investigators at study
site institution and ATSDR as well as the number of
children (n=300) and adults (n=1000) taking part in the
study (p.3, 9 and p.13)
3. Added “or guardians” when referencing parents (p. 3)
4. Rephrased eligibility regarding prisoners/house arrest (p.
3, 13)
5. Replaced ATSDR investigators with the site study
investigators for questions about study (p.4 and p14),
release of school records (p. 12), and in permission for
medical record abstraction (p. 21).
6. Rephrased risks of the study paragraph (p.4 and p.14) and
other blood tests (p.6 and p.16).
7. Deleted “and urinary” when referencing PFAS analyses (p. 4
8. Added “potential” to study overview/purpose (p. 5, 15)
9. Replaced “consent” with “permission” (p. 7, 17)
10.
Revised language regarding reporting of results (p. 78, 17)

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11.
Added a rephrased bullet point requiring permission
for any future genetic testing (p.8 and p.17).
12.
Replaced “match” with “might relate” (p. 9)
13.
Corrected number of digits in the SSN numbers (p.10
and p.19).
14.
Updated consent for children and adults for additional
uses of leftover biospecimen in new studies that are
related to PFAS and are not about PFAS (p. 11, 20).
15.
Deleted phrase “Study methods will inform the design
of future studies” (p. 13)
16.
Deleted phrasing on ability to meet participants at
their home (p.13)
17.
Added in a bullet regarding target sample size and age
criteria (p.13)
18.
Added in a bullet regarding past participation in PFAS
biomonitoring programs (p. 15)
19.
Deleted “child’s” from PFAS Measure in Blood section
(p. 16)
20.
Added “may” in Use of Collected Information section
(p.17)
21.
Replaced “/” with “and” (p. 19)
22.
Added Parkinson disease, allergies, infertility,
eczema, and preeclampsia in permission for medical
abstraction to be consistent with changes in medical
abstraction forms Att19a and Att19b (p.21).
Att7c Study Fact Sheet
1. Numerous language changes
made to align with previously
approved fact sheet for the
Pease Study (p.1-5)
2. information regarding sitespecific sample size was
added (p.1)
3. An overview of the potential
reasons for being excluded
from the study was added
(p.1-2)
4. Information on what the
participant can expect on the
day of the appointment has
been added (p. 2)
Att12 Manual of Procedures
1. Date on title page updated, as well as in the document
footer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

2. Updated table of contents to add appendix F (p. 2-8)
3. Inserted updated blood pressure guideline table (p. 21-22)
4. Updated blood collection procedure guidelines (p. 24)
5. Updated Serum Materials and Equipment list (p. 25)
6. Updated number of vials needed (p. 26)
7. Updated blood collection procedure guidelines (p.27)
8. Updated number of centrifuges needed (p. 29)
9. Updated shipping address to CDC Biorepository (p. 35)
10.
Revised HIPPA to HIPAA (p.39)
11.
Deleted two extra steps in 11.4B (p. 41)
12.
Added sample questions from the Pease questionnaire to
replace Anniston samples (p. 44-47)
13.
Removed “Not sure” as a potential response (p. 48)
14.
Added “paper” to indicate questionnaire format (p.48)
15.
Removed text regarding different font styles, as they
are not being used in the Pease questionnaire (p. 48-50)
16.
Deleted “Nested Questions” section (p. 50-51)
17.
Changed information regarding the telephone contact
quality control information (p. 52)
18.
Replaced “CATI” with “REDCap” (p.52)
19.
Added Appendix F-CDC IRB Consent Form (p. 77-96)
Att15 Child Questionnaire - Long Form
1. Question modified to specify how many times the participant
has donated blood (C5; p.5).
2. Added autism (point m.) and deleted ‘how is child treated
for behavioral problems’ (modified per OMB’s request on
Pease questionnaire) (F1; p.14).
3. Added autism (H4; p. 17) and renumbered “n” due to the
addition.
Att15a Child Questionnaire – Short Form
1. Added autism (point m.), deleted ‘how is child treated for
behavioral problems’ ( modified per OMB’s request on Pease
questionnaire) (F1; p.8).
2. Added autism (G1; p. 10) and renumbered “d” due to the
addition.
Att16 Adult Questionnaire
1. Modified order of the first two questions: What is your
age is now question A1 and what is your sex is question A2
(p.1).
2. Participants are asked how many times they donated blood
(C3; p.5).
Att17a Medical Record Abstraction Form - Child

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
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1. Several health outcomes were added in the form to be
consistent with the questionnaire, specifically autism,
pregnancy induced hypertension/preeclampsia, (p. 2) and
gestational diabetes (p.3). Renumbered due to the
addition of autism (p.2).
Att17b Medical Record Abstraction Form - Adult
1. Several health outcomes were added in the form to be
consistent with the questionnaire, specifically Parkinson
disease (p. 2), atopic dermatitis/eczema, allergies,
infertility, pregnancy induced hypertension/preeclampsia,
and gestational diabetes (p. 3). Renumbered due to
addition of Parkinson disease.
Att18. Child/Parent Neurobehavioral Test Battery
1. Updated NEPSY-II subtests battery following the pilot
testing. Subtest removed: Auditory Attention and Response,
Inhibition, Word List Interference, and Sentence
Repetition.; Affect Recognition replaced Theory of Mind (p.
2-5). Description of Affect Recognition added (p.4)
Att18a. Neurobehavioral Test Battery – Time Estimation Table, by
Age in years
1. Updated table removing subtests and revising time estimates
for NEPSY-II subtest.
Att19 - Body and Blood Pressure Measures Report
1. Replaced ‘OR’ with ‘AND’ for hypertensive crises and for
elevated blood pressure in the status section.
The action was reviewed in accordance with the expedited review process outlined in 45 CFR
46.110(b)(2), with minor changes to previously approved research during the period (of one year
or less) for which approval is authorized.
Reminder: IRB approval of protocol #7207 will still expire on 4/2/2021.
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 HS Mailbox (CDC)