TableĀ 1.

Scenarios Addressing the Choice to Use Broad Consent, Study-Specific Consent, or Waiver of Consent

Background: An AMC has a National Cancer Institute designation. The AMC has a cancer research center that not only conducts primary research but also operates a tissue bank that regularly supplies tissue samples to investigators at the AMC and to investigators at other institutions. A physician at the AMC both treats patients and conducts cancer-related clinical trials. The representative of a large pharmaceutical company has approached him about participating in a multisite clinical trial of a new drug to treat prostate cancer. The physician believes he has several patients who would benefit from participation in the study. The pharmaceutical company is especially interested in recruiting minority research subjects. The recruitment goal for each site is 7 to 10 subjects. After recruitment into the study, a biopsy will be performed, and the tumor will be given a Gleason score. The subject will be administered the test drug for 6 months, and additional biopsies will be taken in the 6th month and the 12th month of the study. The results of the biopsies will be compared to determine the efficacy of the drug. The samples will be labeled with the subject's name, age, race, and sex. The physician has requested and obtained permission to collect additional tissue samples to be placed in the AMC's tissue bank. The company would like to start the trial as quickly as possible.
Drug study consentFor the study sponsored by the pharmaceutical company, the physician must obtain study-specific consent. Because a test drug and prostate biopsy present greater than minimal risk, he cannot obtain a waiver of consent from the IRB. Further, because the research subjects are his patients, the physician cannot argue that the research could not practically be carried out without the waiver. Although the biopsied tissue is identifiable, he cannot use broad consent because this study is not secondary research. His only option is to obtain a study-specific consent to conduct the drug study.
Tissue sample collection consentWith regard to the collection of additional tissue samples to be stored in the AMC's tissue bank, the physician could obtain broad consent now to collect and store the tissue for use in research at some future date. The tissue samples are identifiable and would be collected for secondary research, not the current study.
Secondary research consentIf the physician decides to conduct research with the stored tissue, he has the widest range of options. If he wants to perform genetic tests on samples obtained from the tissue bank, he could seek study-specific consent from the original donors to conduct the genetic testing. If the criteria for a waiver of consent are met, he could obtain a waiver of consent from the IRB for the genetic testing. If broad consent had been obtained at the time of the drug study and if the scope of the broad consent were sufficiently broad to cover genetic testing, the physician could conduct the study without having to obtain additional consent from the donor.
  • AMC, academic medical center; IRB, institutional review board.