Informed Consent

  • Robert A. Greenwald


No component of IRB functioning attracts more attention or engenders more controversy than the concept of informed consent. For most IRBs, review and revision of the consent form submitted by the investigator constitutes the committee’s major interaction with the project. Although the properly functioning IRB must review project design, the criteria for subject selection, the risk/benefit ratio, and similar components of the proposal, most IRBs will reject totally only a small percentage of projects that come up for consideration, and the majority of submitted proposals will eventually be approved, usually subject to some modification of the consent form as submitted by the investigator. Many research proposals originate outside the institution where they will actually be conducted (e.g., clinical trials of new drugs or new procedures sponsored by pharmaceutical firms, or multiinstitutional cooperative therapeutic trials). In most such cases, the research design has usually been constructed with sufficient expertise such that a local IRB is unlikely to find serious shortcomings with the overall proposal; it is generally the consent form and its applicability to the local patient population that requires action by the IRB.


Consent Form Final Regulation Research Office Human Subject Research Oral Consent 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Annas, G., 1978, Informed consent, Annu. Rev. Med. 29:9.CrossRefGoogle Scholar
  2. Brady, J., 1979, A consent form does not informed consent make, IRB: A Review of Human Subjects Research 1(7):6.Google Scholar
  3. Cassileth, B. R., Zupkis, R. V., Sutton-Smith, K., and March, V., 1980, Informed consent—Why are its goals goals imperfectly realized? N. Engl. J. Med. 302:896.CrossRefGoogle Scholar
  4. Curran, W., 1979, Compensation for injured research subjects, regulation by informed consent, N. Engl. J. Med. 301:648.CrossRefGoogle Scholar
  5. Holder, A., 1979, What commitment is made by a witness to a consent form? IRB A Review of Human Subjects Research 1(7):7.Google Scholar
  6. Lebacqz, K., and Levine R., 1977, Respect for persons and informed consent to participate in research, Clin. Res. 25:101.Google Scholar
  7. Levine, R., 1979a, Address to the PRIM & R conference, in: The Role and Function of Institutional Review Boards and the Protection of Human Subjects, Public Responsibility in Medicine and Research, Boston.Google Scholar
  8. Levine, R., 1979b, Advice on compensation: More responses to DHEW’s “interim final regulation,” IRB: A Review of Human Subjects Research 1(2):5.Google Scholar
  9. Levine, R., 1979c, What should consent forms say about cash payments, IRB: A Review of Human Subjects Research. 1(6):7.Google Scholar
  10. Morrow, G., 1980, How readable are subject consent forms? J. Am. Med. Assoc. 244:56.CrossRefGoogle Scholar
  11. Morrow, G., Gootnik, J., and Schmale, A., 1978, A simple technique for increasing cancer patients’ knowledge of informed consent to treatment, Cancer 42:793.CrossRefGoogle Scholar
  12. Woodward, W., 1979, Informed consent of volunteers: A direct measurement of comprehension and retention of information, Clin. Res. 27:248.Google Scholar

Copyright information

© Plenum Press, New York 1982

Authors and Affiliations

  • Robert A. Greenwald
    • 1
    • 2
  1. 1.Division of Rheumatology, Department of MedicineLong Island Jewish-Hillside Medical CenterNew Hyde ParkUSA
  2. 2.Department of MedicineState University of New York at Stony BrookStony BrookUSA

Personalised recommendations