Competency to Consent to Research

  • Barbara Stanley
Part of the Contemporary Issues in Biomedicine, Ethics, and Society book series (CIBES)

Abstract

A determination of competency must be made prior to recruiting an individual as a research subject. If a person is considered to be incompetent, special protection must be afforded him or her before participation in research is permissible. By convention, this special protection is provided by obtaining the consent of a legal guardian, if one has been appointed, or a competent close relative. Thus, some form of competent consent is a prerequisite for almost any research and as a result the determination of competency plays an important role in the research process.

Keywords

Dementia Assure Stein Stake Protec 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    National Commission. Research Involving those Institutionalized as Mentally Disabled. DHEW Publ. No. OS 78–0006, 1978.Google Scholar
  2. 2.
    B. Stanley, M. Stanley, N. Schwartz, A. Lautin, and J. Kane, “The ability of the mentally ill to evaluate research risks.” IRCS Medical Science: Clin. Pharmacol. Ther.; Psychol. Psychiat.; Surgery Transplantation, 8, 1980, 657–658.Google Scholar
  3. 3.
    B. Stanley, M. Stanley, A. Lautin, J. Kane, and N. Schwartz, “Preliminary findings in psychiatric patients as research participants: A population at risk?” Am. J. Psychiat. 138 (5), 1981, 669–671.PubMedGoogle Scholar
  4. 4.
    B. Stanley, M. Stanley, C. Peselow, J. Kane, and J. Stein, Informed consent and psychiatric patients: Empirical evidence Arch. Gen. Psychiat. in press.Google Scholar
  5. 5.
    P. Applebaum, and T. Gutheil, “Drug refusal: A study of psychiatric inpatients.” Am. J. Psychiat. 137 (3), 1980, 340–346.Google Scholar
  6. 6.
    L. Grossman, and F. Summers, “A study of the capacity of schizophrenic patients to give informed consent.” Hosp. Commun. Psychiat. 31 (3), 1980, 205–207.Google Scholar
  7. 7.
    D. A. Soskis, and R. L. Jaffe, “Communicating with patients about anti-psychotic drugs.” Compr. Psychiat. 20, 1979, 126–131.PubMedCrossRefGoogle Scholar
  8. 8.
    Roth, C. Lidz, P. Soloff, and K. Kaufman, “Competency to consent to and refuse ECT: Some empirical data. Paper presented at the Annual Meeting of the Am. Psychiat. Assn., 1980.Google Scholar
  9. 9.
    D. A. Soskis, “Schizophrenic and medical inpatients as informed drug consumers.” Arch. Gen. Psychiat. 35, 1978, 645–647.PubMedGoogle Scholar
  10. 10.
    A. Berg, and K. Hammitt, “Assessing the psychiatric patient’s ability to meet the literacy demands of hospitalization.” Hosp. Comm. Psychiat. 31 (4), 1980, 266–268.Google Scholar
  11. 11.
    G. Coles, L. Roth, and I. Pollack, “Literacy skills of long-term hospitalized mental patients.” Hosp. Commun. Psychiat. 29, 1978, 512–516.Google Scholar
  12. 12.
    P. Applebaum, S. Mirken, and A. Bateman, “Competency to consent to psychiatric hospitalization: An empirical assessment.” Am. J. Psychiat. 138, 1981, 1170–1176.Google Scholar
  13. 13.
    A. Palmer and J. Wohl, “Voluntary admission forms: Does the patient know what he’s signing?” Hosp. Commun. Psychiat. 23, 1972, 250–252.Google Scholar
  14. 14.
    S. Dabrowski, K. Gerard, S. Walczak, B. Woronowicz, and T. Zakowska-Dabrowska, “Inability of patients to give valid consent to psychiatric hospitalization.” Int. J. Law Psychiat. 1 (4), 1978, 437–443.CrossRefGoogle Scholar
  15. 15.
    H. A. Taub, “Informed consent, memory and age. The Gerontologist. 20, 1980, 686–690.PubMedCrossRefGoogle Scholar
  16. 16.
    H. A. Taub, G. Kline, and M. Baker, “The elderly and informed consent: Effects of vocabulary level and corrected feedback.” Exp. Aging Res. 7, 1981, 137–146.PubMedCrossRefGoogle Scholar
  17. 17.
    B. Stanley, J. Guido, M. Stanley, and D. Shortell, The elderly patient and informal consent: Empirical findings. DAMA, 252, 1984, 1302–1306.Google Scholar
  18. 18.
    B. Stanley, M. Stanley, and N. Pomara, Informed consent and elderly phypsychiatric patients. Paper presented at the American Psychiatric Association Meeting, Los Angeles, May 1984.Google Scholar
  19. 19.
    L. H. Roth, A. Meisel, and C. W. Lidz, “Tests of competency to consent to treatment,” Am. J. Psychiat. 134 (3), 1977, 279–284.PubMedGoogle Scholar
  20. 20.
    P. Friedman, “Legal regulation of applied behavior analysis in mental institutions & prisons.” Arizona Law Rev. 17, 1975, 39–104.Google Scholar
  21. 21.
    J. Bergler, C. Pennington, M. Metcalfe, and E. Fries, “Informed consent: How much does the patient understand?” Clin. Pharmacol. Ther., 27, 1980, 435–439.PubMedCrossRefGoogle Scholar
  22. 22.
    B. R. Cassileth, R. B. Zupkis, K. Sutton-Smith, and V. March, “Informed consent—why are its goals imperfectly realized?” New England J. Med. 302 (16), 1980, 896–900.CrossRefGoogle Scholar
  23. 23.
    G. Robinson and A. Merav, “Informed consent: recall by patients tested post-operatively.” Ann. Thoracic Surg. 22, 1976, 209.CrossRefGoogle Scholar
  24. 24.
    B. Stanley and M. Stanley, “Psychiatric patients as research participants; protecting their autonomy.” Comp. Psychiat. 22 (4), 1981, 420–427.CrossRefGoogle Scholar
  25. 25.
    G. D. Mellinger, C. L. Huffine, and M. B. Baiter, “Assessing comprehension in a survey of public reactions to complex issues.” Institute for Research in Social Behavior, 1980.Google Scholar
  26. 26.
    Department of Health & Human Services. Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects. Federal Register 4616, 1981, 8366.Google Scholar
  27. 27.
    P. Applebaum and L. Roth, “Psychiatric issues in competency & informed consent. Paper presented at NIMH conference “Empirical Research on Informed Consent with Subjects of Uncertain Competence” January 12, 1981.Google Scholar
  28. 28.
    A. McCullum and A. Schwartz, “Pediatric research hospitalization: Its meaning to parents.” Pediat. Res. 3, 1969, 199–204.Google Scholar

Copyright information

© The Humana Press, Inc. 1985

Authors and Affiliations

  • Barbara Stanley

There are no affiliations available

Personalised recommendations