Research guidelines: Hopkins deals with research volunteer death and aftermath

Journal of Law, Medicine and Ethics

Volumn 30, Issue 1, 2002, Pages 111-112

  Lezama, Lorraine A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

HEXAMETHONIUM; GANGLION BLOCKING AGENT;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; COUGHING; DEATH; FEMALE; HOSPITAL ADMISSION; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; PERSUASIVE COMMUNICATION; PRACTICE GUIDELINE; SHORT SURVEY; ARTICLE; CASE REPORT; CLINICAL TRIAL; FATALITY; HUMAN EXPERIMENT; LEGAL ASPECT; LUNG FUNCTION TEST; SAFETY; UNITED STATES; UNIVERSITY HOSPITAL;

ADULT; BALTIMORE; CLINICAL TRIALS; FATAL OUTCOME; FEMALE; GANGLIONIC BLOCKERS; HEXAMETHONIUM; HOSPITALS, UNIVERSITY; HUMAN EXPERIMENTATION; HUMANS; RESPIRATORY DISTRESS SYNDROME, ADULT; RESPIRATORY FUNCTION TESTS; SAFETY;

EID: 0036511689     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (11)

1. See Office of Human Research Protections, Letter to Johns Hopkins University, "Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011," dated July 19, 2001, available at 〈http://ohrp.osophs.dhhs.gov/detrm_letrs/jul01a.pdf〉.
2. See Johns Hopkins University, Letter to Office of Human Research Protections, "Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011," dated July 21, 2001, available at 〈http://www.hopkinsmedicine.org/press/2001/JULY/ActionPlanLetter. htm〉; Press Release, "Actions Taken to Strengthen Research Oversight at Johns Hopkins," at 〈http://www.hopkinsmedicine.org/press/2001/ AUGUST/actionplan.htm〉 (last visited January 30, 2002); Office of Human Research Protections, Letter to Johns Hopkins University, "Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011," dated July 22, 2001, available at 〈http://www.hopkinsmedicine.org/press/2001/ JULY/OHRPReinstate.htm〉.
3. See Johns Hopkins University, Letter to Office of Human Research Protections, "Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011," dated July 21, 2001, available at 〈http://www.hopkinsmedicine.org/press/2001/JULY/ActionPlanLetter. htm〉; Press Release, "Actions Taken to Strengthen Research Oversight at Johns Hopkins," at 〈http://www.hopkinsmedicine.org/press/2001/ AUGUST/actionplan.htm〉 (last visited January 30, 2002); Office of Human Research Protections, Letter to Johns Hopkins University, "Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011," dated July 22, 2001, available at 〈http://www.hopkinsmedicine.org/press/2001/ JULY/OHRPReinstate.htm〉.
4. See Johns Hopkins University, Letter to Office of Human Research Protections, "Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011," dated July 21, 2001, available at 〈http://www.hopkinsmedicine.org/press/2001/JULY/ActionPlanLetter. htm〉; Press Release, "Actions Taken to Strengthen Research Oversight at Johns Hopkins," at 〈http://www.hopkinsmedicine.org/press/2001/ AUGUST/actionplan.htm〉 (last visited January 30, 2002); Office of Human Research Protections, Letter to Johns Hopkins University, "Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011," dated July 22, 2001, available at 〈http://www.hopkinsmedicine.org/press/2001/ JULY/OHRPReinstate.htm〉.
5. See Hopkins Internal Investigative Committee, Report of Internal Investigation into the Death of a Volunteer Research Subject (July 16, 2001), available at 〈http://www.hopkinsmedicine.org/press/2001/JULY/ report_of_internal_investigation.htm〉 (last visited February 14, 2002).
6. See S. Hellman et al., Report of Johns Hopkins University External Review Committee (August 8, 2001), available at 〈http://www.hopkinsmedicine.org/ external.pdf〉.
7. See Gary Briefel, IRB Protocol Approval Notice (September 18, 2000), available at 〈http://www.hopkinsmedicine.org/protocol.pdf〉.
8. See id.
9. See supra note 3.
10. See supra note 3.
11. In October 2001, Johns Hopkins University arrived at an out-of-court settlement with the Roche family. See Press Release, "Settlement with Roche Family" (October 11, 2001), available at 〈http://www.hopkinsmedicine. org/press/2001/OCTOBER/011011.htm〉.