E - IRB Amendment

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

August 8, 2013

From

Jason Abel

IRB Administrator Human Research Protection Office

Subject

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

To

Jennita Reefhuis

NCCBDDD/NBBB

CDC's IRB-B has reviewed and approved your request to amend protocol 2087, “The National Birth Defects Prevention Study”. These changes included the following: Modification 1: Change in defects studied; Although NBDPS ascertained 30 birth defects, BD-STEPS will focus on a subset of these. Infants are eligible for inclusion in BD-STEPS if they have one or more defects from the list of 17 birth defects included in Attachment 5. In addition to selecting birth defects with unknown or uncertain etiology, these defects were selected for the following reasons; the defect is considered to be a major defect (affecting survival, requiring substantial medical care, or resulting in marked physiological or psychological impairment); the defect is usually identifiable in the first six weeks of life; and the defect is consistently ascertainable and classifiable. See protocol pages 16-17 for description of BD-STEPS case defintion. Modification 2. Change in Questionnaire Questions. A large portion of the BD-STEPS interview will be maintained from the NBDPS to make pooling of the CBDRP’s NBDPS and BD-STEPS data possible; pooled data will facilitate the analysis of rare exposures and the examination of trends over time. While the BD-STEPS interview instrument contains many of the same sections,innovative questions have been added in response to some of the findings from NBDPS and in the literature. Changes include shortening the interview, adding questions about maternal diseases, and expanding sections to provide increased detail (e.g. indication and dose for specific medications). See protocol pages 27-28 for full description of the interview questions. The new questionnaire is included as Attachment 18. Modification 3. Centralized Interview. BD-STEPS interviewing for all the sites will be done by one central CDC-funded contract interviewing facility, which will increase consistency and efficiency. Contact information for the subjects will be encrypted and sent from the individual CBDRP to the interviewing facility via the CDC provided secure SAMS (Secure Access Management Services) system. Interviews will be conducted via the telephone using a system that allows eligible participants to see a local phone number displayed on their caller ID display for each of the sites (Voice over Internet Protocol, VoIP). See protocol page 26. Modification 4: Genetic data collection. Genetic data collection will be collected from saliva in BD-STEPS instead of cheek cells for NBDPS. All amended genetic collection materials are included as attachment 25-32. Modification 5: Collaborating Centers Collaborating Centers for BD-STEPS will most likely be a subset of the NBDPS Centers participating in NBDPS data collection. While existing NBDPS Centers will continue to participate in data analyses, it is expected that not all NBDPS Centers will collect new data as part of BD-STEPS. When Centers are named, an amendment will be submitted with named Centers; new partners will be added using Form 1370 if needed at this time. Modification 6. Medical Records. At the end of the interview, requests will be made of participants with certain procedures/conditions for mailing an additional consent for medical/dental records. Medical records contain specific information that might be hard for women to recall, and medical record review allows validation of exposures reported by the mother in the questionnaire. Initial topics for which medical records will be requested include fertility treatments and dental treatments. Complete study materials for collection of medical records are described on page 28 of the protocol and included as attachments 19-22. Modification 7. Consent Addition The written consent for saliva samples contains a new section, “Sharing your genetic and health information for future research,” that was not in the previous NBDPS written (genetics) consent. This section was added because of a new NIH GWAS policy that requires data from NIH-supported GWAS to be deposited into the NIH GWAS data repository, currently designated as the database of Genotypes and Phenotypes (dbGaP). See p. 3 of the consent (Attachment 26) for additional language that describes how these data will be potentially shared.

The action was reviewed in accordance with the expedited review process outlined in [45 CFR 46.110(b)(1), Category 0,3,5, and 7 or 46.111(b)(2), minor changes to previously approved research during the period (of one year or less) for which approval is authorized].

Reminder: IRB approval of protocol #2087 will still expire on 1/29/2014.

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:

Scott Campbell