TableĀ 2.

Scenarios Illustrating Limitations to the Use of Broad Consent

Study/Specimen TypeResearch Scenario
Primary researchAn 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 specimensA 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 specimensAn 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 specimensAn 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 purposesIn 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.
  • IRB, institutional review board.