Part I: What is the requirement for data sharing?

IRB Ethics and Human Research

Volumn 27, Issue 6, 2005, Pages 12-16

  De Wolf, Virginia A ^a   Sieber, Joan E ^a   Steel, Philip M ^b   Zarate, Alvan O ^c  

^a CALIFORNIA STATE UNIVERSITY   (United States)

^b U S CENSUS BUREAU   (United States)

^c NATIONAL CENTER FOR HEALTH STATISTICS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 28844438771     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563537     Document Type: Review

References (28)

1. See Fienberg SE. Sharing statistical data in the biomedical and health sciences: Ethical, institutional, legal, and professional dimensions. American Review of Public Health 1994;15:1-18;
2. Mackie C, Bradburn N, eds. Improving Access to and Confidentiality of Research Data: Report of a Workshop. Washington, DC: National Academy Press, 2000, http://www.nap.edu/books/0309071801/html/;
3. Sieber JE, ed. Sharing Social Science Data: Advantages and Challenges. Newbury Park, CA: Sage Publications, Inc., 1991.
4. Documents pertaining to NIH's data sharing policy can be found at http://grants2.nih.gov/grants/policy/data_sharing.
5. Standards for Privacy of Individually Identifiable Health Information, 45 CFR Parts 160 and 164 (2004), http://www.hhs.gov/ocr/combinedregtext.pdf.
6. See NSF's Grant Proposal Guide, NSF 04-23, Effective September i, 2004, http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpg.
7. http://www.icpsr.umich.edu/NACJD.
8. Hamilton DP. Data sharing: A declining ethic? Science 1990;248:952-958.
9. For an extensive list of social science archives worldwide see http://www.socsciresearch.com/r6.html.
10. http://www.icpsr.umich.edu/index.html.
11. See e.g., the U.S. Census Bureau, http://www.census.gov/main/www/pums. html.
12. See e.g., the National Center for Health Statistics, http://www.cdc.gov/ nchs/r&d/rdc.htm
13. and the U.S. Census Bureau, http:// www.ces.census.gov/ces.php/rdc.
14. Other important issues exist, such as ownership of data when commercial entities sponsor biomedical research; however, these are topics for another paper.
15. See Feinberg SE, Martin ME, Straf ML, eds. Sharing Research Data. Washington, DC: National Academy Press, 1985.
16. Sieber JE, Sharing scientific data I: New problems for IRBs to solve. IRB: A Review of Human Subjects Research 1989;11(6):4-7.
17. http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html; a useful NIH website, "NIH Data Sharing Policy and Implementation Guidance," provides a wealth of detailed information to any investigator, NIH applicant or not, who plans to share data, http://grants2.nih.gov/grants/ policy/data_sharing/data_sharing__guidance.htm.
18. Latanya Sweeney has written articles on the reidentification of individuals from supposedly anonymous data. One example describes how she reidentified the medical records of William Weld, the Governor of Massachusetts at the time, by linking data from a state employee health insurance file with information from the Cambridge, MA voter list. Sweeney L. k-Anonymity: A model for protecting privacy, International Journal on Uncertainty, Fuzziness and Knowledge-Based Systems 2002;10(5):557-570, http://privacy.cs.cmu.edu/people/ sweeney/kanonymity.html.
19. See ref. 5.
20. See ref. 4.
21. Joan Sieber served as NSF's Acting Program Director of Societal Dimensions of Engineering, Science, and Technology during 2001-2002 and was actively involved with aspects of NSF's data sharing program.
22. Circular A-110, "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations," http://www.whitehouse.gov/omb/circulars/a110/ a110.html.
23. For an informative discussion of issues surrounding the change to Circular A-110, see National Research Council, Science, Technology, and Law Panel. Access to Research Data in the 21st Century: An Ongoing Dialogue Among Interested Parties. Report of a Workshop. Washington, DC: National Academy Press, 2002, http://books.nap.edu/catalog/10302.html.
24. See ref. 21, Section C.35(d)(1) of Circular A-110.
25. Smith DG. Increasing the accessibility of data. British Medical Journal 1994;308:1519-1520.
26. http://www.murray.harvard.edu/mra/index.jsp.
27. For the websites of the NCHS Research Data Center and the Census Bureau's Research Data Center Program see ref. 10. For the Agency for Health Care Research and Quality's CFACT Data Center see http://www.meps.ahrq.gov/ datacenter.htm.
28. A description of remote access, as well as other types of restricted access used by federal statistical agencies, is available in the Confidentiality and Data Access Committee's publication entitled "Restricted Access Procedures," http://www.fcsm.gov/committees/cdac/cdacra9.pdf.