Understanding Broad Consent

John W. Maloy; Pat F. Bass

doi:10.31486/toj.19.0088

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Table 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 consent	For 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 consent	With 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 consent	If 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.

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Table 2.

Scenarios Illustrating Limitations to the Use of Broad Consent

Study/Specimen Type	Research Scenario
Primary research	An investigator plans to participate in a phase 2 study of a pediatric asthma drug. The investigator cannot use broad consent for this study because the asthma drug study is primary research; the investigator will be performing an intervention (ie, administering the study drug). Broad consent is only available for secondary research.
Secondary research/Identifiable specimens	A physician is collecting blood samples from research participants in a diabetes study. From experience, she has learned how difficult it is to re-consent research participants. She would like to collect blood samples for additional research in the future and label the samples with private health information related to the research participant. The physician can use broad consent in this context. Because of the inclusion of private health information, the samples will be identifiable, and the samples will be used in secondary research (the physician will not be using the samples in her current diabetes study).
Secondary research/Identifiable specimens	An investigator seeks broad consent from a potential research subject to obtain tissue samples for a university's tissue bank to be used in secondary research at a later time. During the consenting process, the subject asks about the types of research that might be done with the tissue samples. The subject wants an assurance that the tissue will not be used for certain types of research. The investigator explains the general types of research that might be performed and mentions research that the subject finds objectionable. The subject declines to sign the broad consent. The investigator cannot use this patient's tissue samples. The IRB cannot grant a waiver of consent once the investigator sought broad consent and the subject declined to grant it.
Secondary research/Deidentified specimens	An investigator wants to conduct research on deidentified tissue samples from the institution's tissue bank. Broad consent is not an option, because broad consent only applies if the samples are identifiable. Because the tissue samples are deidentified, obtaining study-specific informed consent may not be possible. Therefore, the investigator should seek a waiver of consent from the IRB.
Specimens collected for nonresearch purposes	In addition to her medical practice, a physician also conducts clinical research. A patient schedules a visit for a yearly wellness examination. As part of the examination, routine blood work is done; more blood was collected than necessary to complete these tests. The physician is also conducting a diabetes study comparing A1c levels of different ethnic groups. She wants to use broad consent to obtain the patient's permission to use the extra blood in her diabetes study; however, she cannot use broad consent because the blood was collected for nonresearch purposes. In this case, the detection of clinical abnormalities was part of a preventive treatment regime.