aim-1mm MAP-I amid Centers. for Disease Genital "um" and Prevention . REQUEST FOR AUTHORIZATION . To GIVE ASSURANCE OF CONFIDENTIALITY UNDER SECTEON 308w) ea THE PUBLIC HEALTH ACT NO TE. De net ebtar'n signature on this teen entit 0680 and the Project O?ieer have agreed on I?Enet versions of the 308(6) Justification. Assurance and Security Statement ?Aseerariee Cent'dentietIty ApptIeatIen Procedure en REQUESTED ear1.3.5. DEPARTMENT 9F HEALTH 8i HUMAN E-I3 Put-I've Heal'lh Senna: 2130 r? Name at Project Of?certPEincEpai Investigaier Elegtth Ne? Nu: DmEiry Kieein Chamblee m7 . (we) 438-6408 CentertinetituteI'Ot?ce: Division: eaH Request Status: Peried at time aut?rieri'zeiien needed ter data collection. (Indicate "ongoing?! if prejrect wiil continue inde?niteim New Amended Request El Extension Request From: EDELE To: 3! 115'. 5i . . Approval of Request by Center?ns?tutet?f?ee Director or Dasignee?. Ursula Bauer, MPH. ?55592;er eatietzete Name and Organizatieeat ?I'Ttte Signature Date National Assisted Reproductive System i I ?wsneiemee STATEMENT: Ptease attach thejesrifieation statement. {See "Asserenee et' ApetieaEtien for further detatts. *4 .. FOR 0550 USE ONLY . I, . . .. Transmitted to Review GIeep adDate Hr wu-m I i Confidentiality Review Group recommends: IE Approval Disappre-Irai :5 3/ I eat at .I Date 5 i 1 Er - l: Srgnatrtre?; .-. CDC SSOCIAT eieec FOR SCIENCE We . IE .- CCFC- Her :Itzeca REQUEST F?t?t TO GIVE EESURAMCE 0F 1 cm enter.- end-mat. 5 it entree-I: Her-elm REQUEST FOR EXTENSION OF ASSURANCE OF CONFIDENTIALITY FOR THE NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY SURVEILLANCE SYSTEM DIVISION OF REPRODUCTIVE HEALTH NATIONAL CENTER OR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION Original Application 3I19f2001 Application Amended 6f20r?2005 Extension Requested 212112006 Extension Application Finalized 4?tii?2009 Application Amended 1235:9013 This document is an updated Assurance of Con?dentiality for the National Assisted Reproductive Technology Surveillance System (NAS S). A. Purpose of project in 1992, Congress passed the Fertility Clinic Success Rate and Certi?cation Act which requires that CDC collect data from all assisted reproductive technology (ART) clinics and report success rates, de?ned as all live births per ovarian stimulation procedures or ART precedures, for each ART clinic. ART is de?ned to include all treatments or procedures that involve the handling of human eggs and sperm for the purpose of establishing a pregnancy, including in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), embryo cryopreservation, and Surrogate birth. The Society for Assisted Reproductive Technology (SART) has collected data covering ART outcomes since 1986 and has been compiling and publishing clinic- specific reports since 1989. To avoid duplication of efforts, CDC purchased SART data on procedures performed between 1995 and 2003. During that period, ART programs that were not SART members were required to use the SART data entry software to submit data to the CDC. Beginning with ART procedures performed in 2004, CDC contracted with Westat for the development of a data collection system that allows clinics to submit data through an independent mechanism. In collaboration with SART and the infertility consumer interest group RES OLVE, CDC has published annual ART Success Rates Reports for ART procedures performed in 1995 through 2011. In compliance with the CSRCA requirements, each annual report includes a national summary report that uses information ?om all ART clinics as well as clinic-specific reports for each ART clinic. The annual report for 2010 and later is divided into two separate publications; the first consists of clinicuspeci?c data and the second contains national summary data. Beginning with ART procedures performed in 2002, CDC has produced an annual Surveillance Summary that presents results grouped by state, and research articles that employ the data to address public health research questions on CDC has held an Assurance of Con?dentiality under section 308(d) of the Public Health Service (PHS) Act (42 USC 242m(d)) protecting the NASS data since 200]. The Assurance covers ART procedures performed 1995-present, and specifically protects data that would permit direct or indirect identi?cation of women or infants, and could link assisted reproductive technology clinic identi?ers with sensitive information. An amendment of the Assurance of Con?dentiality was approved on June 20, 2005 to recognize the changes in the data acquisition mechanism, to expand 308(d) protection to include information collected through contract with Westat, and to clarify the detailed nature of information protected by 308(d). The present amendment further expands 308(d) protection to future data acquisition mechanisms that CDC may require in order to ful?ll the mandate set forth by Law, and incorporates the availability of a de-identi?ed, public use dataset available through the Research Data Center. B. Justification l. Extent to which the Assurance of Con?dentiality is important to protection of the individual or institution. The NASS collects the following data for each ART procedure: 1) Patient demographic information such as date of birth and residence; 2) Patient history information such as prior full term and preterm births, months of infertility since the last birth, and number of prior ART procedures; 3) ART procedure information, such as the reasons for ART, the ART procedure start date, the type of ART procedures employed; and 4) Outcome information such as whether an ultrasound was performed and the date, the pregnancy outcome and date, the source of the pregnancy outcome information, the number of infants born, 5) Other applicable data as necessary and provided to CDC or its contractor. Some of the data in the NASS are sensitive because they a) may be used to identify an individual woman or child, a clinic location, or clinic personnel and b) relate to issues about which people may have strong ethical, religious, andfor cultural concerns. In compliance with the ART clinics and key personnel are fully identi?ed in the annual report, which provides aggregate information on procedures and outcomes. This Assurance seeks to restrict further linkage of clinic identi?ers with detailed, cycle-speci?c information. Potential patient?identifying information includes place of residence and birth date of both the women undergoing ART and 1 Continuous production and dissemination of research ?ndings is expected because ART is changing rapidly and its use is constantly expanding in the United States. The procedures in this Assurance are designed to allow research use of the data while maximizing protection of con?dential data. 2 resultant infants. The con?dentiality assurance is aiso necessary to protect data on details of the ART procedure, of the pregnancy, or of the pregnancy outcome which, if released, might lead to identifying the patient or cause harm to the clinic personnel. Depending on the type of data released together with identi?able information, women who elect to undergo ART treatment and the clinic personnel who may be involved in administering the treatment may face possible embarrassment, persecution and potentially legal and physical harm. An Assurance also helps ensure continual clinic participation and encourage more complete sharing of clinic information with CDC. Some clinics could choose not to submit their data to CDC if they did not believe that con?dentiality of data was protected. Such behavior would threaten ability to serve the public and ful?ll the requirements set forth by Thus, we are requesting an extension of the Assurance that protects all of the ART data that have been collected and are maintained by the CDC or other entity acting under contract with the CDC. 2. Extent to which the individual or establishment will not furnish or permit access to it unless an Assurance of Con?dentiality is given. Without an Assurance of Con?dentiality, obtaining clinic reporting of individually sensitive information could become di?icult. Clinic management may fear potential persecution by activist groups and potential harm to property, personnel and patients and may hesitate in reporting sensitive data if it is not protected by the Assurance. 3. Extent to which the information cannot be obtained with the same degree of reliability from sources that do not require an Assurance. requires that CDC collect data from all ART clinics and report success rates. The only reasonable way for CDC to obtain such population?based procedureulevel assisted reproductive technology data is through a contract. Whereas some states are putting a small amount of information about the use of ART on birth certificates, such information is limited was this child conceived using yesfno), uses inconsistent definitions of ART, and is not nationwide. Thus, there is no suitable attemative source of information. 4. Extent to which the information is essential to the success of the particular statistical or epidemiological project and is not dupiieative of other information gathering activities of the Department. Collecting ART information and publishing clinic success rates is required of CDC under 3 The ART Surveillance and Research Team in the Women?s Health and Fertility Branch of the Division of Reproductive Health, was created to promote the health of women and men who receive infertility services, the health of pregnancies achieved through these services and the health of infants conceived through these services by conducting surveillance and research, creating and maintaining strategic partnerships, and moving science to practice. The Team has obtained OMB approval for the ART data collection system (OMB No. 0920-0556). The Team also has obtained IRB approval (Protocol No. 2238) to conduct epidemiologic analyses using the ART data. The ART information is essential to ful?lling the federal mandate as well as to answering important assisted reproductive technology research questions. These activities are not done elsewhere at CDC or elsewhere within the Department. 5. Extent to which the Assurance of Con?dentiality will restrain CDC from carrying out any of its responsibility. It is not expected that the Assurance of Con?dentiality will restrain CDC from carrying out any of its responsibility of surveillance and reporting success rates and conduct of epidemiological studies using the NASS. However, we anticipate collaborating with researchers inside and outside the CDC, and these situations will require speci?c precautions to ensure 308(d) con?dentiality. The ART Surveillance and Research Team staff will be involved in all collaborations in which the ART data are used; this will help ensure protection of the ART data. Researchers from other CDC components requesting use data will be required to obtain Specific approval of the Technical and Business Stewards of the NASS, and sign the special 3080i) pledge (Attachment F). Occasionally, guest researchers, visiting fellows, and other non-CDC employees may have access to NASS data. Such an arrangement will be time-limited, and will take place under the direct supervision of the ART Surveillance and Research Team Leader. All guest researchers, visiting fellows, and non?CDC employees will be required to sign a special 308(d) con?dentiality pledge (Attachment G). Scientists outside the federal government have requested access to the NASS data for legitimate research purposes. For data collected on ART procedures performed in 1995 through 2003 (collected under contract with SART), in accordance with the Assurance, CDC will continue to be responsible for review and approval of data release requests submitted by third parties to SART. Beginning with data collected on ART procedures performed in 2004 (collected under contract with Westat), the CDC intends to release limited, de~identi?ed information to outside parties. CDC has developed a policy for releasing post-2003 data by creating a public-use dataset which will respect the constraints imposed by the Assurance. Thus, the Assurance will not unduly affect the ability of CDC to release data of public health significance. Whereas the intent and scope of data protected by the Assurance is the same as initially approved, we are 4 taking the opportunity of this extension to clarify the nature of protected information more in detail. In particular, data items that will not be released or disclosed without consent of the parties given this Assurance include but are not limited to cycle identi?cation number, patient identi?cation number, patient date of birth, infant date of birth or date of pregnancy outcome, gestational carrier date of birth, donor date of birth, patient country of residence, patient state of residence, patient city of residence, patient zip code, clinic name, laboratory name, clinic address, clinic city, clinic state, clinic zip code, clinic identi?cation number maintained by BART and Westat, names of laboratory and clinic personnel, and details of the ART procedure, of the pregnancy, or of the pregnancy outcome which, if released, might lead to identifying the patient or cause harm to the clinic personnel. Other data items have been altered to reduce the disclosure risk categorizing variables, top or bottom coding variables). Users of the public use, de- identi?ed dataset will be required to sign a special 308(d) con?dentiality pledge (Attachment H). 6. Extent to which the advantages of assuring con?dentiality outweigh the disadvantages of doing so. The advantages of assuring confidentiality include 1) protection of clinics and patients from unwarranted access to sensitive information by parties that may subject them to embarrassment or harm, 2) increased con?dence of clinics and patients in intention and ability to protect the information that is submitted to the government, and as a consequence, 3) higher participation and better quality of information provided by CDC to the public. These advantages greatly outweigh the limited disadvantages of restricting access to identi?able information in the NASS. ATTACHMENT A CDC ASSURANCE OF CONFIDENTIALITY ASSURANCE OF CONFIDENTIALITY FOR THE NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY SURVEILLANCE SYSTEM Surveillance of assisted reproductive technology (ART) procedures performed in the United States is being conducted by the Division of Reproductive Health (Dill-E), National Center for Chronic Disease Prevention and Health Promotion of the Centers for Disease Control and Prevention (CDC), an agency of the United States Department of Health and Human Services. The information compiled by CDC has been collected by the Society for Assisted Reproductive Technology (SART) for the years 1995-2003, and will be collected by Westat for the years 2004-2015. Other contractors may collect this information on behalf of CDC in future years. The in formation on each ART procedure is gathered from Assisted Reproductive Technology clinics. This information includes in part clinic information such as its address and services offered, patient demographic information such as dates of birth of the mothers and city and state of residence, patient history information such as gravidity and parity, and details of the ART procedure, of the pregnancy, or of the pregnancy outcome which, if released, might lead to identifying the patient or cause harm to the clinic personnel. The data are used by CDC scientists to publish an annual Assisted Reproductive Technology Success Rates Report as mandated by law as well as to study the risks associated with the use of assisted reproductive technology for both the women and the resulting infants. information collected as part of this surveillance both in the past under contract with SART (ART procedures performed in 1995 through 2003), under contract with Westat (ART procedures performed in 2004 through 2015), and potentially under contract with other organizations in the future, that would permit direct or indirect identification of women or infants (including but not limited to cycle identi?cation number, patient identi?cation number, patient date of birth, infant date ofbirth, patient place of residence) andfor could link assisted reproductive technology clinic identi?ers (including but not limited to clinic name, laboratory name, clinic address, clinic identi?cation number, and key personnel) with details of the ART procedure, of the pregnancy, or of the pregnancy outcome which, if released, might lead to identifying the patient or cause harm to the clinic personnel, and collected by CDC andfor its contractor under Section 306 of the Public Health Service (PHS) Act (42 USC 242k) is protected with an assurance that it will be held in strict con?dence in accordance with Section 308(d) of the PHS Act (42 USC 242m(d)). it will be used only for purposes stated in this Assurance, and it will not otherwise be disclosed or released without the consent of the parties given this Assurance. This protection will continue, even following the death of the women and infants in this surveillance system or the closing or reorganization of the ART clinics. information collected by the CDC will be used without personal identi?ers for publication in statistical and analytic Summaries and epidemiologic studies. Institutional identifiers will be used as required for publication of the annual Success Rates Report but will not be used for publication of other statistical and analytic summaries and epidemiologic studies and in no way will institutional 6 identi?ers be linked with further details that might compromise the con?dentiality of the information provided by the patients. Information that contains identi?ers will not be shared with researchers outside of DRH except for very rare occasions. These rare occasions may occur if a guest researcher, expert consultant, or other similar non-employee, is invited to work on-site at the Division of Reproductive Health using the NASS database. Such an arrangement wit] be timed-limited, and wiil take place under the direct supervision of the Technical Steward of this Assurance. These individuals will be required to sign a special 308(d) cen?dentiality pledge containing language approved by the CDC Information within this surveillance program will be kept con?dential and, aside from authorized personnel, no one wilt be allowed to see or have access to the information. Such individuals will be required to handle the information in accordance with procedures outlined in the CDC Staff Manual on Con?dentiality and to follow the speci?c procedures documented in the Con?dentiality Security Statement for this project. No identifying information will be made available for any purpose other than those outlined in this Assurance Statement. For example, such information will not be disclosed to insurance companies; any party involved in civil, criminal, or administrative litigation; family members; or any member of a public or private organization.