How to enroll participants in research ethically

JAMA

Volumn 305, Issue 15, 2011, Pages 1587-1588

  Wendler, David ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CIVIL RIGHTS; CLINICAL RESEARCH; CRIMINAL LAW; ETHICS; INFORMED CONSENT; NOTE; OFFENDER; PRIORITY JOURNAL; ARTICLE; COMPREHENSION; DECISION MAKING; HUMAN; JURISPRUDENCE; MEDICAL RESEARCH; MENTAL CAPACITY; PATIENT SELECTION; STANDARD;

BIOMEDICAL RESEARCH; COMPREHENSION; DECISION MAKING; HUMANS; INFORMED CONSENT; JURISPRUDENCE; MENTAL COMPETENCY; PATIENT SELECTION;

EID: 79955018233     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2011.421     Document Type: Note

References (10)

1. Berg JW, Appelbaum PS, Lidz CW, Parker LS. Fulfilling the underlying purpose of informed consent to research. In: Berg JW, Appelbaum PS, Lidz CW, Parker LS, eds. Informed Consent: Legal Theory and Clinical Practice. New York, NY: Oxford University Press; 2001:279-303.
2. European Parliament and the Council of the European Union. Directive 2001 /20/ec of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. European Commission Web site. http://ec.europa.eu/health/human-use/clinical-trials. Accessed December 28, 2010.
3. WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. 59th WMA General Assembly, Seoul, Korea, October 2008. World Medical Association Web site. http://www.wma.net/en/30publications /10policies/b3/index.html. Accessed December 28, 2010.
4. Informed Consent-FAQs: What is informed consent and when, why, and how must it be obtained? US Department of Health & Human Services Web site. http: //answers.hhs.gov/ohrp/categories/1566. Accessed January 8, 2012.
5. Appelbaum PS, Lidz CW, Klitzman R. Voluntariness of consent to research: A conceptual model. Hastings Cent Rep. 2009;39(1):30-39.
6. Miller FG, Wertheimer A. Preface to a theory of consent transactions: Beyond valid consent. In: Miller FG, Wertheimer A, eds. The Ethics of Consent: Theory and Practice. New York, NY: Oxford University Press; 2010:79-105.
7. R v Lifchus, 3 SCR 320 (1997). Canadian Legal Information Institute Web site. http://www.canlii.org/en/ca/scc/doc/1997/1997canlii319/1997canlii319.html. Accessed December 21, 2010.
8. Miller v Minister of Pensions, 2 All ER 372 (1947).
9. Wendler D. Can we ensure that all research subjects give valid consent? Arch Intern Med. 2004;164(20):2201-2204. (Pubitemid 39452979)
10. Applebaum PS, Lidz CW, Klitzman R. Voluntariness of consent to research: A preliminary empirical investigation. IRB. 2009;31(6):10-14.