IRB Approval of Amendment

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date
d

August 19, 2022

From

Jerrell Little
IRB Administrator
Human Research Protection Office

Subject

IRB Approval of Amendment to CDC Protocol 2087, "The National Birth Defects Prevention
Study” (Expedited)

To

Elizabeth Ailes, PhD
NCCBDDD/DCDD
CDC's IRB-Committee 2 has reviewed and approved your administrative request to amend
protocol 2087, “The National Birth Defects Prevention Study”. These changes included the
following:
Modification 1: MA Center Medication Validation Protocol.
The MA CBDRP will use a triangulation approach to validating reported medication use in the
BD-STEPS I interviews by using three semi-independent data sources: 1. Abstracted medical
records; 2. Pharmacy claims data via the All-Payer Claims Data (APCD); and 3. Prospective
medication use collection via the Ovia Pregnancy app. The use of multiple sources will allow
MA CBDRP to validate the reporting of prescription medications (all sources), over-the-counter
medications (medical records and Ovia Pregnancy app), and medications obtained from other
sources (i.e., “medication sharing”) that were used during pregnancy and the periconceptional
period. We will be able to evaluate the prescription and/or use of a prescribed medication
(medical records), whether a prescription was filled (APCD), and the use of prescribed, overthe-counter, or otherwise obtained medications (Ovia pregnancy App). AttMA62_BD-STEPS
Medication Validation Protocol_Final_4.13.2022 (New)
The MA CBDRP is adding a questionnaire/medication validation consent for its medication
validation project protocol. This consent will be sent to eligible women and ask them if they
used the Ovia pregnancy App. If they answer yes, they will be asked to read and sign the consent
form that allows Ovia Health to share their medication information with the MA Center. If they
answer no, they are asked to still return the first page with their questionnaire answer in the
postage paid envelope. AttMA62A_MA OviaConsentForm_Final_4.14.2022 (New)
For their medication validation project protocol, the MA Center is adding two new study
materials: a medication validation intro letter and a thank you letter. The intro letter will be
sent to the eligible study participants to introduce them to this study component. It will be sent
with the questionnaire/consent form mentioned above. The medication validation TY letter will
be sent with a $10 gift card when the study subject returns the questionnaire (alone) or the
questionnaire/consent (together).

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

AttMA62B_MA IntroductoryLettertoOviaInformedConsentFinal_4.13.2022 (New)
AttMA62C_MA Ovia_InformedConsentThankyouLetter_Final_4.13.2022 (New)
Modification 2: The North Carolina (NC) Center has received approval from the NC Division of
Public Health (DPH) to extend the expiration date on the NC DPH Written Consent EDSS
Release Form one year post signature date to “conclusion of the BD-STEPS study.” As a result
of the initial one-year expiration, some NC participants' NC DPH Written Consent EDSS
Release Form have expired. NC CBDRP plans to recontact participants with expired forms to
provide the updated form. For North Carolina (NC), the NC DPH Written Consent EDSS
Release Form (Att NC6) has been revised with minor changes to update the expiration section.
NC has also provided documents related to recontacting NC participants for whom the initial
signed NC DPH Written Consent EDSS Release Form has expired. Attached are English
versions of the following documents:
1) Attachment NC1 - revised NC DPH Written Consent EDSS Release Form (track 1-4; clean 13)
2) Attachment NC6 - revised NC DPH Written Consent EDSS Release Form (page 1 track/clean)
3) Attachment NC9 -NC DPH EDSS Release Form Cover letter (New)
4) Attachment NC10 - NC DPH Communicable Disease Branch Release Form Email Text and
Telephone Scripts (New)
5) Attachment NC11 - NC DPH Written Consent EDSS Release Form Thank You Letter (New)
Modification 3: After discussion with the CDC leadership team, the NYCBDRP has decided to
conclude the texting pilot. This modification affects the following attachments: Att_NY3 PreIntro Letter_NY; Att_NY8 NY_Texting Pilot_Proposal; Att_NY9, NY_Texting
Pilot_AddCorectForm; and Att_NY10, NY_Texting Pilot_Scripts. Att_NY8, Att_NY9, and
Att_NY10 will no longer be used, and Att_NY3 was modified to remove all references to the
texting pilot. The clean and tracked versions of this document are attached. Also, NYCBDRP will
be reverting back to the CDC-approved address correction form,
Att11_ENG_AddCorrectForm_Mar24_2015, which does not have any references to the NY
texting pilot. There are no changes to the protocol, as the texting pilot was described in Att_NY8,
the texting pilot proposal. Att_NY3 Pre-Intro Letter_NY (page 1, track and clean)
Remove:
AttNY8, Texting Pilot_Proposal_01.28.2020
AttNY9_Texting Pilot_AddCorrectForm_01.28.2020
AttNY10_Texting Pilot_Text Scripts_01.28.2020
Modification 4: The NYCBDRP has also decided to conclude the Language Pilot after
discussions with the CDC leadership team. Att_NY1_ and Att_NY2 will no longer be used. No
other documents are affected by this change or require modification. There are no changes to the
protocol for this modification.
Remove:
AttNY1_NY_Language ID Sheet_downstate_1-17-18
AttNY2_NY_Language ID Sheet_western_1-17-18

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Modification 5: AR Infectious Disease Informed Consent
The AR site is requesting to add the following section: RELEASE OF REPORTABLE HUMAN
IMMUNODEFICIENCY VIRUS (HIV) INFORMATION on Att47_Infectious Disease Consent
(pages 4-5/track and clean). The inclusion of this additional section in the consent form is asking
participants to submit their names to the Arkansas Department of Health (ADH's) infectious
disease monitoring program. Specifically, it will allow for us to consent BDSTEPS participants
so that ADH may release HIV reported information. It further explains how, when, and where
the collected information will be used and stored. These changes were requested and approved
by ADH.
Modification 6: BDSTEPS Stillbirth COVID Protocol.
The proposed modifications to the BDSTEPS Stillbirth Protocol are being submitted as an
addendum to the current protocol. They consist of one-time changes that will not impact all study
participants. The BDSTEPS Stillbirth Study is collaborating with the CDC COVID-19 Stillbirth
Project to better understand the impact of SARS-CoV-2 acute infection in pregnancy on
stillbirth, with special attention to the pathological findings that might contribute to our
understanding of the mechanisms involved.
The BDSTEPS Stillbirth Study will provide a comparison group consisting of stillborn infants
delivered between January 1, 2017 and October 31, 2019 who have placental and fetal tissue
samples available for testing.
Three sites that are part of the Surveillance for Emerging Threats to Mothers and Babies
Network (SET-NET) will participate in this project: Arkansas, Massachusetts, and Tennessee.
These jurisdictions have already been identifying stillbirths among women with laboratoryconfirmed SARS-CoV-2 infection in pregnancy. Arkansas and Massachusetts also participate in
the stillbirth component of BD-STEPS and will provide a COVID-19-unexposed comparison
group.
Total sample size goals across all sites are to have 90 stillbirths from pregnancies exposed to
SARS-CoV-2 (30 stillbirths from each trimester of SARS-CoV-2 infection) plus 30 stillbirths from
pregnancies not exposed to SARS-CoV-2 (Pre-COVID BDSTEPS Comparison Stillbirths) for a
total of 120 stillbirths.
The BD-STEPS Stillbirth COVID Protocol is described in detail in
Att55_BDSTEPS_Stillbirth_COVID_Protocol (new) and include:
1. The development of four new forms, two study introduction letters and two consent forms for
participant signature that will be mailed to participants inviting them to participate in the CDC
COVID-19 Stillbirth Study.
2. The methods and process for selecting which participants are potentially eligible for the CDC
COVID-19 Stillbirth Study are described beginning on Page 2 of the addendum.
3. Participants who were interviewed will be sent:
a. Att55A_BDSTEPS_Stillbirth_COVID_IntroLetter_Interviewed (new)
b. Att55B_BDSTEPS_Stillbirth_COVID_Consent_Interviewed (new)
4. Participants who were not interviewed will be sent:
a. Att55C_BDSTEPS_Stillbirth_COVID_IntroLetter_NotInterviewed (new)
b. Att55D_BDSTEPS_Stillbirth_COVID_Consent_NotInterviewed (new)

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Modification 7: Change in CDC Key Personnel.
The Primary Contact in Question 2 above has changed from Brandi Martell to Mary Jenkins.
These actions were reviewed in accordance with the expedited review process outlined in 45CFR
46.110 (b) (2) categories 3, 5, and 7, minor changes to previously approved research during the
period of one year for which approval is authorized.
Reminder: IRB approval of protocol #2087 will still expire on 1/29/2023.
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].