Research on medical practices and the ethics of disclosure

Pediatrics

Volumn 135, Issue 2, 2015, Pages 208-210

  Magnus, David ^a   Wilfond, Benjamin S ^b  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID;

ARTICLE; ASTHMA; CHILD HEALTH CARE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CORTICOSTEROID THERAPY; DISEASE EXACERBATION; DRUG EFFICACY; DRUG SAFETY; EVIDENCE BASED PRACTICE; HEALTH CARE QUALITY; HUMAN RIGHTS; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MEDICAL ETHICS; MEDICAL PRACTICE; OXYGEN SATURATION; PATIENT SAFETY; PRACTICE GUIDELINE; RISK REDUCTION; CHILD; ETHICS; HUMAN; PUBLIC HEALTH SERVICE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; RISK ASSESSMENT; UNITED STATES;

CHILD; DISCLOSURE; ETHICS, MEDICAL; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; STANDARD OF CARE; UNITED STATES; UNITED STATES OFFICE OF RESEARCH INTEGRITY;

EID: 84922660742     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2014-3578     Document Type: Article

References (9)

1. Magnus D, Caplan AL. Risk, consent, and SUPPORT. N Engl J Med. 2013;368(20):1864-1865
2. US Department of Health and Human Services. Public meeting: matters related to protection of human subjects and research considering standard of care interventions: August 28, 2013. Available at: www.hhs.gov/ohrp/newsroom/rfc/Public%20Meeting%20August%2028%2c%202013/supportmeetingtranscriptfinal.html. Accessed October 27, 2014
3. US Department of Health and Human Services. (Draft) Guidance on disclosing reasonably foreseeable risks in research evaluating standards of care. Office for Human Research Protection; October 24,2014. www.regulations.gov/#!documentDetail;D5HHS-OPHS-2014-0005-0002. Accessed October 27, 2014
4. Coffey MJ, Wilfond B, Ross LF. Ethical assessment of clinical asthma trials including children subjects. Pediatrics. 2004;113(1 pt 1):87-94
5. Kaplan S, Garrick BJ. On the quantitative definition of risk. Risk Anal. 1981;1(1):11-27
6. Kim SYH, Miller FG. Informed consent for pragmatic trials - the integrated consent model. N Engl J Med. 2014;370(8):769-772
7. Protection of Human Subjects, 45 C.F.R. x 46.116 (1991).
8. Sugarman J, Califf RM. Ethics and regulatory complexities for pragmatic clinical trials. JAMA. 2014;311(23):2381-2382
9. Solomon MZ, Bonham AC, eds. Ethical Oversight of Learning Health Care Systems. Garrison, NY: The Hastings Center; 2013