Limited access data sets from studies funded by the National Heart, Lung, and Blood Institute

Clinical Trials

Volumn 1, Issue 6, 2004, Pages 517-524

  Geller, Nancy l ^a   Sorlie, Paul ^a   Coady, Sean ^a   Fleg, Jerome ^a   Friedman, Lawrence ^a  

^a NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; CONFIDENTIALITY; DATA BASE; ETHICS; HEALTH CARE ORGANIZATION; HUMAN; INFORMATION PROCESSING; PRIVACY; RESEARCH ETHICS; UNITED STATES;

CLINICAL TRIALS; CONFIDENTIALITY; DATA COLLECTION; DATABASES; ETHICS, RESEARCH; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); PRIVACY; UNITED STATES;

EID: 30444446282     PISSN: 17407745     EISSN: None     Source Type: Journal    
DOI: 10.1191/1740774504cn050oa     Document Type: Article

References (12)

1. Subcommittee on Disclosure Limitation Methodology, Federal Committee on Statistical Methodology. Statistical Policy Working Paper 22 Report on Statistical Disclosure Limitations Methodology, Statistical Policy Office, Office of Information and Regulatory Affairs, Office of Management and Budget, 1994, http://www.fcsm.gov/workingpapers/spwp22.html (accessed 4/29/2004).
2. Washington Statistical Society and Confidentiality and Data Access Committee of the American Statistical Association, “Privacy, Confidentiality and the Protection of Health Data: a Statistical Perspective on the HIPAA Privacy Rule”. Short course April 27, 2004, Washington, DC.
3. Jabine T.B. Procedures for restricted data access. J Official Stat 1993; 9: 537-589.
4. Clinical Research and the HIPAA Privacy Rule. National Institutes of Health, NIH Publication Number 04-5495, 2004, http://privacyruleandresearch.nih.gov/clin_research.asp (accessed 4/29/2004).
5. National Institutes of Health Office of Extramural Research NIH Data Sharing Policy, May 20, 2003. (http://grants.nih.gov/grants/policy/data_sharing).
6. Frequently Asked Questions on Data Sharing, March 5, 2003 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
7. The Post Coronary Artery Bypass Graft (POSTCABG) Trial Investigators (1997). The effect of aggressive LDL cholesterol lowering and low dose anticoagulation on obstructive changes in saphenous vein coronary bypass grafts. N Eng J Med 336: 153-162.
8. Pepine C.J., Geller N.L., Knatterud G.L. et al. The asymptomatic cardiac ischemia pilot (ACIP): Design of a randomized clinical trial, baseline data and implications for a long-term outcome trial. J Am Coll Cardiology 1994; 24: 1-10.
9. The Title 45 Code of Federal Regulations Part 46 Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) §46.116 General requirements for informed consent, 1991, http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm%2346.116 (accessed 5/29/2004).
10. NIH Protocol #01-H-0031 National Heart, Lung, and Blood Institute Data Repository, 2001.
11. Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences. Board on Life Sciences (BLS), National Academies Press, 2003, http://books.nap.edu/openbook/0309088593/html/index.html (accessed 4/16/2004).
12. National Heart, Lung and Blood Institute. NHLBI Limited Access Data Sets, 2004, http://www.nhlbi.nih.gov/resources/deca/default.htm (accessed 5/29/2004).