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Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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References

Agency for Healthcare Research and Quality (AHRQ). 2004a. CFACT Data Center (CFACT-DC). [Online]. Available: http://www.meps.ahrq.gov/datacenter.htm [accessed June 30, 2004].

AHRQ. 2004b. CFACT Data Center (CFACT-DC): User Guide/Application Information. [Online]. Available: http://www.meps.ahrq.gov/datacenter/dcuserguide.htm [accessed June 30, 2004].

AHRQ. 2004c. Overview of the Medical Expenditure Panel Study. [Online]. Available: http://www.meps.ahrq.gov/WhatIsMEPS/Overview.HTM [accessed June 30, 2004].

AHRQ. 2004d. FAQs About the Data Center. [Online]. Available: http://www.meps.ahrq.gov/FAQs/FAQ_DataCenter.HTM [accessed May, 2004].


Ball LK, Evans G, Bostrom A. 1998. Risky business: challenges in vaccine risk communication. Pediatrics 101(3 Pt 1):453-458.

Ball LK, Ball R, Gellin BG. 2004. Chapter 12: Developing Safe Vaccines. New Generation Vaccines. 3rd ed. New York: Marcel Dekker, Inc. Pp. 127-144.

Bardenheier B, Yusuf H, Schwartz B, Gust D, Barker L, Rodewald L. 2004. Are parental vaccine safety concerns associated with receipt of measles-mumps-rubella, diphtheria and tetanus toxoids with acellular pertussis, or hepatitis B vaccines by children? Arch Pediatr Adolesc Med 158(6):569-575.

Baylor N, Flak LA, Midthun K. 2004. Chapter 11: The Role of the Food and Drug Administration in Vaccine Testing and Licensure. New Generation Vaccines. 3rd ed. New York: Marcel Dekker, Inc. Pp. 117-125.

Bernard S. 2004 (October 21). Advocacy Experience with NIP Iterative Approach to VSD Analysis & Disclosure of Preliminary Findings. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

Bernier R. 2004a (August 23). Reflections of the NIP on the VSD Data Sharing Program. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

Bernier R. 2004b (October 21). Charge to the IOM on Sharing Preliminary Findings from the Vaccine Safety Datalink. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×

Calman KC. 2002. Communication of risk: choice, consent, and trust. Lancet 360(9327): 166-168.

Centers for Disease Control and Prevention (CDC). 1971. Public Health Service recommendations on smallpox vaccination. MMWR 20:339-345.

CDC. 1993. Pertussis Outbreaks—Massachusetts and Maryland, 1992. MMWR 42, 11: 197-200.

CDC. 1999a. Ten Great Public Health Achievements—United States, 1900-99. MMWR 48(12):241-243.

CDC. 1999b. Thimerosal in vaccines: a joint statement of the American Academy of Pediatrics and the Public Health Service. MMWR 48(26):563-5.

CDC. 2000. Vaccine Safety Datalink (VSD) Project: Publications and Presentations. [Online]. Available: http://www.cdc.gov/nip/vacsafe/vsd/references.htm [accessed June 16, 2004].

CDC. 2001. About NIP. [Online]. Available: http://www.cdc.gov/nip/webutil/about/default.htm [accessed November 11, 2004].

CDC. 2002. Guidelines for Data Sharing Proposals from External Researchers: Vaccine Safety Datalink (VSD) Project—Version #A. Submitted to the Committee on Review of NIP’s Research Procedures and Data Sharing Program on site visit to NIP on September 7, 2004.

CDC. 2003a. Guidelines for Data Sharing Proposals from External Researchers: Vaccine Safety Datalink (VSD) Project—Version #B. Submitted to the Committee on Review of NIP’s Research Procedures and Data Sharing Program on site visit to NIP on September 7, 2004.

CDC. 2003b. CDC/ATSDR Policy on Releasing and Sharing Data. [Online]. Available: http://www.cdc.gov/od/ads/pol-385.htm [accessed June 16, 2004].

CDC. 2003c. NCHS Staff Manual on Confidentiality. [Online]. Available: http://www.cdc.gov/nchs/data/misc/staffmanual2004.pdf [accessed February 11, 2005].

CDC. 2004a. Procedures and costs for use of the research data center: notice and request for action. Federal Register 69(222):67584-67592.

CDC. 2004b. Procedures for Use of the RDC. Submitted via email to the Committee on Review of NIP’s Research Procedures and Data Sharing Program by CDC on August 20, 2004.

CDC. 2004c. General Description. Submitted via email to the Committee on Review of NIP’s Research Procedures and Data Sharing Program by CDC on August 20, 2004.

CDC. 2004d. Responses to Questions Raised by the IOM Committee on the Review of NIP VSD Data Sharing Program. Submitted via email to Committee on Review of NIP’s Research Procedures and Data Sharing Program on October 4, 2004.

CDC. 2004e. Responses to Questions Raised by the IOM Committee on the Review of NIP VSD Data Sharing Program: Appendix A. Submitted via email to the Committee on Review of NIP’s Research Procedures and Data Sharing Program by CDC on October 4, 2004.

CDC. 2004f. Responses to Questions Raised by the IOM Committee on the Review of NIP VSD Data Sharing Program: Appendix C. Submitted via email to the Committee on Review of NIP’s Research Procedures and Data Sharing Program by CDC on October 4, 2004.

CDC. 2004g. Procedures and costs for the use of the Research Data Center; Amendment. Federal Register 69(241):75316.

CDC and FDA. 2003. Vaccine Adverse Event Reporting System (VAERS). [Online]. Available: http://www.vaers.org/search/README.txt [accessed September 2, 2004].

CDC and FDA. 2004. Vaccine Adverse Event Reporting System (VAERS) Data. [Online] Available: http://www.vaers.org/info.htm [accessed September 2, 2004].

CDC and FDA. 2005. Frequently Asked Questions About VAERS. [Online]. Available: http://www.vaers.org/pdf/VAERS_brochure.pdf [accessed February 2005].

Census Bureau. 2004a. CES RDC Research Proposal Guidelines. [Online]. Available: http://148.129.75.160/ces.php/guidelines [accessed July 8, 2004].

Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×

Census Bureau. 2004b. The Research Data Center Program. [Online]. Available at: http://148.129.75.160/ces.php/research [accessed July 8, 2004].

Chen RT. 2004. Evaluation of vaccine safety after the events of 11 September 2001: role of cohort and case-control studies. Vaccine 22(15-16):2047-2053.

Chen RT, Glasser JW, Rhodes PH, Davis RL, Barlow WE, Thompson RS, Mullooly JP, Black SB, Shinefield HR, Vadheim CM, Marcy SM, Ward JI, Wise RP, Wassilak SG, Hadler SC. 1997. Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team. Pediatrics 99(6):765-773.

California Health Interview Survey (CHIS). 2003. CHIS Research Clearinghouse. [Online]. Available: http://www.chis.ucla.edu/rc/ [accessed November 3, 2004].

CHIS. 2004a. About the California Health Interview Survey. [Online]. Available: http://www.chis.ucla.edu/about.html [accessed June 28, 2004].

CHIS. 2004b. The Data Access Center at the UCLA Center for Health Policy Research. [Online]. Available: http://www.chis.ucla.edu/chis_dac.html [accessed June 28, 2004].

Copeland CW, Simpson M. 2004. The Information Quality Act: OMB’s Guidance and Initial Implementation. [Online]. Available: http://www.ombwatch.org/info/dataquality/RL32532_CRS_DQA.pdf [accessed November 18, 2004].

Council of Public Representatives (COPR) and the National Institutes of Health (NIH). 2004. Enhancing Public Input and Transparency in the National Institutes of Health Reserach Priority-Setting Process. [Online]. Available: http://copr.nih.gov/reports/enhancing.pdf [accessed December 29, 2004].

Cvetkovich G, Siegrist M, Murray R, Tragesser S. 2002. New information and social trust: asymmetry and perseverance of attributions about hazard managers. Risk 22(2): 359-367.


Davis R. 2004 (August 23). Vaccine Safety Datalink: Overview. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

DeMets D. 2004 (October 21). Interim Analysis of Randomized Clinical Trials. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

DeStefano F. 2004 (October 21). VSD Studies That Utilized Iterative Analyses. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

DeStefano F, Gu D, Kramarz P, Truman BI, Iademarco MF, Mullooly JP, Jackson LA, Davis RL, Black SB, Shinefield HR, Marcy SM, Ward JI, Chen RT. 2002. Childhood vaccinations and risk of asthma. Pediatr Infect Dis J 21(6):498-504.

Dittmann S. 2001. Vaccine safety: risk communication—a global perspective. Vaccine 19(17-19):2446-2456.


Egan W. 2000. Statement By William Egan, Ph.D., Acting Office Director, Office of Vaccine Research and Review, Center for Biologics Evaluation and Review, Food and Drug Administration, Department of Health and Human Services. Before the Committee on Government Reform: U.S. House of Representatives. [Online]. Available: http://www.fda.gov/ola/2000/vaccines.html [accessed February 7, 2004].


Food and Drug Administration and Center for Biologics Evaluation and Research. 2002. Vaccine Product Approval Process. [Online]. Available: http://www.fda.gov/cber/vaccine/vacappr.htm [accessed February 3, 2005].

Fienberg S. 1994. Sharing statistical data in the biomedical and health sciences: ethical, institutional, legal, and professional dimensions. Annual Review of Public Health 15:1-18.

Fisher BL. 1999. Shots in the Dark: Attempts at Eradicating Infectious Diseases Are Putting our Children at Risk. [Online]. Available: http://www.nextcity.com/contents/summer99/16shots.html [accessed January 13, 2005].

Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×

Fisher BL. 2004a (August 23). Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

Fisher BL. 2004b. Statement to the Committee on Review of NIP’s Research Procedures and Data Sharing Program. Submitted to the Committee on Review of NIP’s Research Procedures and Data Sharing Program on August 23, 2004.


Government Accountability Office (GAO). 2004. Health Information: First-Year Experiences under the Federal Privacy Rule. GAO-04-965.

Geier MR, Geier DA. 2004 (August 23). Researcher Experience with the Vaccine Safety Datalink (VSD) Data Sharing Program. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

Gellin BG, Maibach EW, Marcuse EK. 2000. Do parents understand immunizations? A national telephone survey. Pediatrics 106(5):1097-1102.

Gough M, Milloy S. 2000. The Case for Public Access to Federally Funded Research Data. Cato Policy Analysis; No. 366.

Gust DA, Strine TW, Maurice E, Smith P, Yusuf H, Wilkinson M, Battaglia M, Wright R, Schwartz B. 2004. Underimmunization among children: effects of vaccine safety concerns on immunization status. Pediatrics 114(1):e16-22.


Habte M. 2004 (August 23). UCLA Center for Health Policy Research Data Access Center. UCLA Center for Health Policy Research. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

Department of Health and Human Services (HHS). 2002. IRB Authorization Agreement. [Online]. Available: http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf [accessed February 5, 2005].

HHS. 2003a. Summary of the HIPAA Privacy Rule. [Online]. Available: http://www.hhs.gov/ocr/privacysummary.pdf [accessed January 13, 2004].

HHS. 2003b. Charter: National Vaccine Advisory Committee. [Online]. Available: http://www.hhs.gov/nvpo/nvac/NVAC_Charter_2003.pdf [accessed February 11, 2005].

Health and Retirement Study (HRS). 2004a. Background Information. [Online]. Available: http://hrsonline.isr.umich.edu/intro/sho_intro.php?hfyle=uinfo [accessed June 16, 2004].

HRS. 2004b. HRS Restricted Data: Application Processing Overview. [Online]. Available: http://hrsonline.isr.umich.edu/rda/rdanarrative.htm [accessed July 1, 2004].

HRS. 2004c. HRS Restricted Data: Overview. [Online]. Available: http://hrsonline.isr.umich.edu/rda/index.html [accessed July 1, 2004].


Institute of Medicine (IOM). 1991. Adverse Events Following Pertussis and Rubella Vaccines. Washington, DC: National Academy Press.


Jansen VAA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ. 2003. Measles outbreaks in a population with declining vaccine uptake. Science 301(August):804.


Kemp T, Pearce N, Fitzharris P, Crane J, Fergusson D, St George I, Wickens K, Beasley R. 1997. Is infant immunization a risk factor for childhood asthma or allergy? Epidemiology 8(6):678-680.


Mawson AR. 2001. Could bronchial asthma be an endogenous, pulmonary expression of retinoid intoxication? Frontiers in Bioscience 6:d973-d985.

McCall MG. 2003. Facilitators and Barriers to Changing Health Behaviors. [Online]. Available: http://www.medscape.com/viewarticle/466708 [accessed February 11, 2005].

McComas KA. 2004a. When even the “best-laid” plans go wrong. European Molecular Biology Organization 5(Special Issue):S61-S64.

McComas KA. 2004b (October 21). Communicating Health Risks Identified Through Preliminary Analysis. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

McComas KA, Trumbo CW. 2001. Source credibility in environmental health-risk controversies: application of Meyer’s credibility index. Risk Analysis 21(3):467-480.

Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×

McNay LA, Tavel JA, Oseekey K, McDermott CM, Mollerup D, Bebchuk JD, ESPRIT Group. 2002. Regulatory approvals in a large multinational clinical trial. Controlled Clinical Trials 23(1):59-66.

Mullooly J, Drew L, DeStefano F, Chen R, Okoro K, Swint E, Immanuel V, Ray P, Lewis N, Vadheim C, Lugg M. 1999. Quality of HMO vaccination databases used to monitor childhood vaccine safety. Vaccine Safety DataLink Team. Am J Epidemiol 149(2):186-194.


National Academy of Sciences (NAS), National Academy of Engineering (NAE), Institute of Medicine (IOM). 1996. On Being a Scientist: Responsible Conduct in Research. Washington, DC: National Academy Press.

National Institutes of Health (NIH). 2004a. NIH Data Sharing Policy. [Online]. Available: http://grants.nih.gov/grants/policy/data_sharing/ [accessed June 16, 2004].

NIH. 2004b. Notice: Enhanced Public Access to NIH Research Information. [Online]. Available: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html [accessed January 14, 2004].

NIH. 2005a. Director’s Council on Public Representatives (COPR). [Online]. Available: http://copr.nih.gov [accessed January 11, 2005].

NIH. 2005b. NIH Calls on Scientists to Speed Public Release of Research Publications. [Online]. Available: http://www.nih.gov/news/pr/feb2005/od-03.htm [accessed February 4, 2005].

National Research Council (NRC) and Committee on National Statistics. 1985. Sharing Research Data. Washington, DC: National Academy Press.

National Vaccine Information Center (NVIC). 2004. National Vaccine Information Center Says IOM Played Politics in Report on Autism and Vaccines. [Online]. Available: http://www.nvic.org/PressReleases/pr51804iom.htm [accessed January 13, 2005].


Offit PA, Coffin SE. 2003. Communicating science to the public: MMR vaccine and autism. Vaccine 22(1):1-6.

Office of Management and Budget (OMB). 1999. OMB Circular A-110, uniform administrative requirements for grants and agreements with institutions of higher education, hospitals, and other non-profit organizations. Federal Register 64(195):54926-54930.


Phillips K. 2002. Public Access to Research Data. [Online]. Available: http://depts.washington.edu/ventures/About_Us/Presentations/Data_Rights/Public_Access.ppt [accessed February 11, 2005].

Pless R, Casey C, Chen R, and Vaccine Safety and Development Activity. 2004. Clinical Immunization Safety Assessment Centers: Improving the Evaluation, Management and Understanding of Adverse Events Possibly Related to Immunizations. [Online]. Available: http://www.cdc.gov/nip/vacsafe/cisa/intro-cisa.pdf [accessed February 4, 2005].

Poortinga W, Pidgeon NF. 2004. Trust, the asymmetry principle, and the role of prior beliefs. Risk 24(6):1475-1486.


SafeMinds. 2003. Analysis and critque of the CDC’s handling of the thimerosal exposure assessment based on Vaccine Safety Datalink (VSD) information. Submitted by S. Bernard on Behalf of SAFEMINDS on 1/18/04 to the Immunization Safety Review Committee: 1-46.

SafeMinds. 2004a. A Brief Analysis of Recent Efforts in Medical Mercury Induced Neurological and Autism Spectrum Disorders. [Online]. Available: http://www.safeminds.org/pressroom/press_releases/08Sep2004_A_Brief_Analysis.html#_Toc82334450 [accessed January 13, 2005].

SafeMinds. 2004b. SafeMinds Outraged That IOM Report Fails American Public. [Online]. Available: http://www.safeminds.org/pressroom/press_releases/040518-PR10-BadIOMReport.pdf [accessed January 13, 2005].

Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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Siegrist M, Cvetkovich G. 2001. Better negative than positive? Evidence of a bias for negative information about possible health dangers. Risk 21(1):199-206.

Simpsonwood Transcript. 2000. Scientific Review of Vaccine Safety Datalink Information, June 7-8, 2000. Simpsonwood Retreat Center, Norcross, GA.

Slovic P. 1987. Perception of risk. Science 236(4799):280-285.

Slovic P. 1993. Perceived risk, trust and democracy. Risk Analysis 13:675-682.


Verstraeten T. 2001. Presentation to Immunization Safety Review Committee. Vaccine Safety Datalink (VSD) Screening Study and Follow-Up Analysis with Harvard Pilgrim Data, Washington, DC.

Verstraeten T, Davis RL, DeStefano F, Lieu TA, Rhodes PH, Black SB, Shinefield H, Chen RT, Vaccine Safety Datalink Team. 2003a. Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases. Pediatrics 112(5):1039-1048.

Verstraeten T, DeStefano F, Chen RT, Miller E. 2003b. Vaccine safety surveillance using large linked databases: opportunities, hazards and proposed guidelines. Expert Rev Vaccines 2(1):21-29.


Weijer C. 2004 (October 21). When to release preliminary findings: Ethical considerations. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

Wharton M. 2004 (August 23). The Vaccine Safety Datalink (VSD) Data Sharing Program. Presentation to the Committee on Review of NIP’s Research Procedures and Data Sharing Program, Washington, DC.

World Health Organization (WHO). 2005. Vaccine Safety Websites Meeting Essential and Important Good Information Practices Criteria. [Online]. Available: http://www.who.int/immunization_safety/safety_quality/approved_vaccine_safety_websites/en/ [accessed January 13, 2005].

Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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Page 106
Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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Page 107
Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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Page 108
Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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Page 109
Suggested Citation:"References." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database.

In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

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