Sharing individual level data from observational studies and clinical trials: A perspective from NHLBI

Trials

Volumn 14, Issue 1, 2013, Pages

  Coady, Sean A ^a   Wagner, Elizabeth ^b  

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

^b Division of Blood Diseases and Resources   (United States)

Author keywords

Clinical trials; Cohort studies; Data sharing; HIPAA

Indexed keywords

CLINICAL TRIAL (TOPIC); HUMAN; INSTITUTIONAL REVIEW; NATIONAL HEALTH ORGANIZATION; NOTE; OBSERVATIONAL STUDY; POLICY;

CLINICAL TRIALS AS TOPIC; COOPERATIVE BEHAVIOR; DATABASE MANAGEMENT SYSTEMS; DATABASES, FACTUAL; GUIDELINES AS TOPIC; HUMANS; INFORMATION DISSEMINATION; NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (U.S.); PATIENT RIGHTS; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; TIME FACTORS; UNITED STATES;

EID: 84879999670     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-201     Document Type: Note

References (14)

1. Peng RD, Dominici F, Zeger SL. Reproducible epidemiologic research. Am J Epidemiol 2006, 163:783-789. 10.1093/aje/kwj093, 16510544.
2. Vickers AJ. Whose data set is it anyway? Sharing raw data from randomized trials. Trials 2006, 7:15. 10.1186/1745-6215-7-15, 1489946, 16704733.
3. Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011, 12:249. 10.1186/1745-6215-12-249, 3264537, 22112900.
4. Gøtzsche PC. Strengthening and opening up health research by sharing our raw data. Circ Cardiovasc Qual Outcomes 2012, 5:236-237. 10.1161/CIRCOUTCOMES.112.965277, 22438464.
5. Krumholz HM. Open science and data sharing in clinical research: basing informed decisions on the totality of the evidence. Circ Cardiovasc Qual Outcomes 2012, 5:141-142. 10.1161/CIRCOUTCOMES.112.965848, 22438459.
6. Ross JS, Lehman R, Gross CP. The importance of clinical trial data sharing: toward more open science. Circ Cardiovasc Qual Outcomes 2012, 5:238-240. 10.1161/CIRCOUTCOMES.112.965798, 3318983, 22438465.
7. Kost RG, Lee LM, Yessis J, Coller BS, Henderson DK. Assessing research participants' perceptions of their clinical research experiences. Clin Transl Sci 2011, 4:403-413. 10.1111/j.1752-8062.2011.00349.x, 3640854, 22212221.
8. McCann SK, Campbell MK, Entwistle VA. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials 2010, 11:31. 10.1186/1745-6215-11-31, 2848220, 20307273.
9. Benitez K, Malin B. Evaluating re-identification risks with respect to the HIPAA privacy rule. JAMIA 2010, 17:169-177. 3000773, 20190059.
10. Malin B, Karp D, Scheuermann RH. Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research. J Invest Med 2010, 58:11-18.
11. Psaty BM, Arnett D, Burke G. A New Era of cardiovascular disease epidemiology. JAMA 2007, 298:2060-2062. 10.1001/jama.298.17.2060, 17986701.
12. Pearce N, Smith AH. Data sharing: not as simple as it seems. Environ Health 2011, 10:107. 10.1186/1476-069X-10-107, 3260112, 22188646.
13. Spertus JA. The double-edged sword of open access to research data. Circ Cardiovasc Qual Outcomes 2012, 5:143-144. 10.1161/CIRCOUTCOMES.112.965814, 22438460.
14. Summary of the HIPAA Privacy Rule. U.S. Department of Health and Human Services 2012, http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/, Summary of the HIPAA Privacy Rule. U.S. Department of Health and Human Services.