• We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
Logo of heartHeartVisit this articleSubmit a manuscriptReceive email alertsContact usBMJ
Heart. Dec 2001; 86(6): 632–637.
PMCID: PMC1730006

Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity?


OBJECTIVE—To investigate how patients included in trials on treatment in the early phase of acute myocardial infarction experience the consent procedure.
DESIGN—A combined qualitative and quantitative interview concerning the patients' knowledge of the trial, their feelings about being asked to participate, and their attitudes towards the consent procedure.
SETTING—Tertiary referral centre.
PATIENTS—31 patients who had given written informed consent for their participation in randomised intervention trials of acute myocardial infarction.
RESULTS—The patients interviewed had only fragmentary knowledge about the trial they were involved in. Most considered that reading and signing a consent form was an unwanted or unnecessary procedure. Instead, they would have preferred to have been given concise verbal information about the study. Most were willing to allow a physician to decide for them in the event of their being too ill to be asked about their participation.
CONCLUSIONS—Patients who are asked to participate in intervention trials in the early phase of acute myocardial infarction often appear to lack sufficient knowledge to reach an autonomous choice. There were problems and disadvantages associated with the process of obtaining written informed consent in this particular situation, especially regarding the need for the patient to sign a consent form during the acute phase of the disease.

Keywords: informed consent; clinical trial; acute myocardial infarction; patient attitudes

Full Text

The Full Text of this article is available as a PDF (111K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Ockene IS, Miner J, Shannon TA, Gore JM, Weiner BH, Ball SP. The consent process in the Thrombolysis in Myocardial Infarction (TIMI--phase I) trial. Clin Res. 1991 Feb;39(1):13–17. [PubMed]
  • Smith HL. Myocardial infarction--Case studies of ethics in the consent situation. Soc Sci Med. 1974 Jul;8(7):399–404. [PubMed]
  • Williams BF, French JK, White HD. Is our method of obtaining consent appropriate for randomised controlled trials in acute myocardial infarction? N Z Med J. 1997 Aug 8;110(1049):298–299. [PubMed]
  • Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA. 1995 Apr 26;273(16):1283–1287. [PubMed]
  • Kremers MS, Whisnant DR, Lowder LS, Gregg L. Initial experience using the Food and Drug administration guidelines for emergency research without consent. Ann Emerg Med. 1999 Feb;33(2):224–229. [PubMed]
  • Grim PS, Singer PA, Gramelspacher GP, Feldman T, Childers RW, Siegler M. Informed consent in emergency research. Prehospital thrombolytic therapy for acute myocardial infarction. JAMA. 1989 Jul 14;262(2):252–255. [PubMed]
  • Bean WB. Masquerades of myocardial infarction. Lancet. 1977 May 14;1(8020):1044–1046. [PubMed]
  • Kannel WB, Abbott RD. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med. 1984 Nov 1;311(18):1144–1147. [PubMed]
  • Mays N, Pope C. Rigour and qualitative research. BMJ. 1995 Jul 8;311(6997):109–112. [PMC free article] [PubMed]
  • Britten N. Qualitative interviews in medical research. BMJ. 1995 Jul 22;311(6999):251–253. [PMC free article] [PubMed]
  • Katz J. The Nuremberg Code and the Nuremberg Trial. A reappraisal. JAMA. 1996 Nov 27;276(20):1662–1666. [PubMed]
  • Nilstun T. Nya forskningsetiska riktlinjer från CIOMS. Föredömlig avvägning autonomi-nytta-rättvisa. Lakartidningen. 1994 Jan 19;91(3):157–161. [PubMed]
  • Kucia AM, Horowitz JD. Is informed consent to clinical trials an "upside selective" process in acute coronary syndromes? Am Heart J. 2000 Jul;140(1):94–97. [PubMed]
  • Yuval R, Halon DA, Merdler A, Khader N, Karkabi B, Uziel K, Lewis BS. Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Arch Intern Med. 2000 Apr 24;160(8):1142–1146. [PubMed]
  • Spivey WH, Abramson NS, Iserson KV, MacKay CR, Cohen MP. Informed consent for biomedical research in acute care medicine. Ann Emerg Med. 1991 Nov;20(11):1251–1265. [PubMed]
  • Levine RJ. Research in emergency situations. The role of deferred consent. JAMA. 1995 Apr 26;273(16):1300–1302. [PubMed]
  • Passamani ER, Weisfeldt ML. 31st Bethesda Conference. Emergency Cardiac Care. Task force 3: Special aspects of research conduct in the emergency setting: Waiver of informed consent. J Am Coll Cardiol. 2000 Mar 15;35(4):862–880. [PubMed]
  • Boisjolie CR, Sharkey SW, Cannon CP, Brunette D, Haugland JM, Thatcher JL, Henry TD. Impact of a thrombolysis research trial on time to treatment for acute myocardial infarction in the emergency department. Am J Cardiol. 1995 Aug 15;76(5):396–398. [PubMed]

Articles from Heart are provided here courtesy of BMJ Group


Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...


  • MedGen
    Related information in MedGen
  • PubMed
    PubMed citations for these articles
  • Substance
    PubChem Substance links

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...