0
July 14, 1989, Vol 262, No. 2 >
ARTICLE | July 14, 1989

Informed Consent in Emergency Research: Title and subTitle BreakPrehospital Thrombolytic Therapy for Acute Myocardial Infarction FREE

Pamela S. Grim, MD; Peter A. Singer, MD, FRCPC; Gregory P. Gramelspacher, MD; Ted Feldman, MD; Rory W. Childers, MD; Mark Siegler, MD
[+] Author Affiliations

The opinions expressed in this article are those of the authors and do not necessarily represent those of the supporting foundations.

Reprint requests to University of Chicago Hospitals, 5841 S Maryland Ave, Box 161, Chicago, IL 60637 (Dr Grim).


JAMA. 1989;262(2):252-255. doi:10.1001/jama.1989.03430020094036
Text Size: A A A
Published online
Article
References

Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.

(JAMA. 1989;262:252-255)

REFERENCES

1 +
 Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction . Lancet . 1986;;1:397-402.
2 +
O'Rourke M, Baron D, Keogh A, et al.  Limitations of myocardial infarction by early infusion of recombinant tissue-type plasminogen activator . Circulation . 1988;;77:1311-1315.
3 +
Koren G, Weiss AT, Hasin Y, et al.  Prevention of myocardial damage in acute myocardial ischemia by early treatment with intravenous streptokinase . N Engl J Med. 1985;;313:1384-1389.
4 +
Grim PS, Feldman T, Childers RW.  Evaluation of patients for thrombolytic therapy in the prehospital setting . Ann Emerg Med. 1989;;18:483-488.
5 +
Grim PS, Feldman T, Childers RW.  Cellular telephone transmission of 12-lead electrocardiograms from ambulance to hospital . Am J Cardiol. 1987;;60:715-720.
6 +
 Final regulations amending basic Department of Health and Human Services policy for the protection of human research subjects . Federal Register . (January 26) , 1981;;46:8366-8390.
7 +
 Protection of human subjects: informed consent, Department of Health and Human Services, Food and Drug Administration . Federal Register . (January 27) , 1981;;46:8942-8980.
8 +
Smith HL.  Myocardial infarction: case studies of ethics in the consent situation . Soc Sci Med. 1974;;8:399-404.
9 +
Fost N.  Consent as a barrier to research . N Engl J Med. 1979;;300:1272-1273.
10 +
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: Government Printing Office; 1979. OPRR report, publication 887-809.
11 +
Abramson NS, Meisel A, Safar P.  Informed consent in resuscitation research . JAMA . 1981;; 246:2828-2830.
12 +
Abramson NS, Meisel A, Safar P.  Deferred consent: a new approach for resuscitation research on comatose patients . JAMA . 1986;;255:2466-2471.
13 +
Levine R. Ethics and Regulation of Clinical Research . 2nd ed. Baltimore, Md: Urban & Schwarzenberg; 1986;:130-134.
14 +
Boisaubin EV, Dresser R.  Informed consent in emergency care: illusion and reform . Ann Emerg Med. 1987;;16:62-67.
15 +
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Washington, DC: Government Printing Office; 1982;1.
16 +
Lidz CW, Applebaum PS, Meisel A.  Two models of implementing informed consent . Arch Intern Med. 1988;;148:1385-1389.
17 +
Rosner F.  The ethics of randomized clinical trials . Am J Med. 1979;;82:283-290.
18 +
Toulmin SE.  Technical progress and social policy: the broader significance of medical mishaps . In: Siegler M, Toulmin SE, Zimring FE, Schaffner KF, eds. Medical Innovations and Bad Outcomes: Legal, Social and Ethical Reponses . Ann Arbor, Mich: Health Administration Press; 1987;:21-34.

Figures

Tables

Interactive Graphics

Video

Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
 Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction . Lancet . 1986;;1:397-402.
2 +
O'Rourke M, Baron D, Keogh A, et al.  Limitations of myocardial infarction by early infusion of recombinant tissue-type plasminogen activator . Circulation . 1988;;77:1311-1315.
3 +
Koren G, Weiss AT, Hasin Y, et al.  Prevention of myocardial damage in acute myocardial ischemia by early treatment with intravenous streptokinase . N Engl J Med. 1985;;313:1384-1389.
4 +
Grim PS, Feldman T, Childers RW.  Evaluation of patients for thrombolytic therapy in the prehospital setting . Ann Emerg Med. 1989;;18:483-488.
5 +
Grim PS, Feldman T, Childers RW.  Cellular telephone transmission of 12-lead electrocardiograms from ambulance to hospital . Am J Cardiol. 1987;;60:715-720.
6 +
 Final regulations amending basic Department of Health and Human Services policy for the protection of human research subjects . Federal Register . (January 26) , 1981;;46:8366-8390.
7 +
 Protection of human subjects: informed consent, Department of Health and Human Services, Food and Drug Administration . Federal Register . (January 27) , 1981;;46:8942-8980.
8 +
Smith HL.  Myocardial infarction: case studies of ethics in the consent situation . Soc Sci Med. 1974;;8:399-404.
9 +
Fost N.  Consent as a barrier to research . N Engl J Med. 1979;;300:1272-1273.
10 +
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: Government Printing Office; 1979. OPRR report, publication 887-809.
11 +
Abramson NS, Meisel A, Safar P.  Informed consent in resuscitation research . JAMA . 1981;; 246:2828-2830.
12 +
Abramson NS, Meisel A, Safar P.  Deferred consent: a new approach for resuscitation research on comatose patients . JAMA . 1986;;255:2466-2471.
13 +
Levine R. Ethics and Regulation of Clinical Research . 2nd ed. Baltimore, Md: Urban & Schwarzenberg; 1986;:130-134.
14 +
Boisaubin EV, Dresser R.  Informed consent in emergency care: illusion and reform . Ann Emerg Med. 1987;;16:62-67.
15 +
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Washington, DC: Government Printing Office; 1982;1.
16 +
Lidz CW, Applebaum PS, Meisel A.  Two models of implementing informed consent . Arch Intern Med. 1988;;148:1385-1389.
17 +
Rosner F.  The ethics of randomized clinical trials . Am J Med. 1979;;82:283-290.
18 +
Toulmin SE.  Technical progress and social policy: the broader significance of medical mishaps . In: Siegler M, Toulmin SE, Zimring FE, Schaffner KF, eds. Medical Innovations and Bad Outcomes: Legal, Social and Ethical Reponses . Ann Arbor, Mich: Health Administration Press; 1987;:21-34.

Letters

Submit a Letter
CME Course for:


You need to register in order to view this quiz.


To understand the clinical management of acute heart failure syndromes.
Accreditation Information The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
To view and print your certificate and access a summary of your CME courses go to My CME.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s “Cited By” API will populate this tab (http://www.crossref.org/citedby.html).
Compression-Only CPR: Pushing the Science Forward
Cone
AAM 2010;304:1493-1495.
All you need to read in the other general journals
BMJ 2010;341:c5893-c1494.
Submit a Response

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

© 2012 American Medical Association. All Rights Reserved.
Powered bySilverchair Information Systems