Elements of informed consent
| Consent category . | Consent element . | Case example . |
|---|---|---|
| Threshold elements (preconditions) | Competence/capacity | In this case, Mr. Smith is assumed to be competent to make a decision about treatment of his leukemia, including the genetic testing that has been recommended. It is possible, however, that if he had a large intracranial chloroma or large burden of CNS disease (or unrelated neurologic dysfunction) that he may not be able to competently make these decisions and provide informed consent for his treatment plans. |
| Voluntariness | Mr. Smith must be given the opportunity to make a voluntary decision about how to proceed in treating his acute myeloid leukemia, free of coercion. | |
| Information elements | Disclosure | The clinician-investigators must disclose risks and benefits of the proposed interventions, including risks and benefits of leukemia sequencing, to Mr. Smith, as well as other disclosures relevant to Mr. Smith’s decision (including that the sequencing is part of a research study, not standard clinical care). |
| Recommendation | To help Mr. Smith make an informed choice about whether to enroll on the sequencing trial, his clinician-investigators should recommend to him the intervention they feel best aligns with his values and beliefs, given his present clinical condition and circumstances. | |
| Understanding | In order to proceed, Mr. Smith should be able to demonstrate to his team that he understands the information about the clinical trial (including the sequencing that is part of it) that has been disclosed to him and the plan that his team has recommended. | |
| Consent elements | Decision | Mr. Smith should be able to clearly state which available option he has chosen and why that is his choice. |
| Authorization | Prior to initiation of therapy (and enrollment on the trial, if he opts to enroll), Mr. Smith should confirm that he authorizes his team to proceed and to carry out his stated decision. |
| Consent category . | Consent element . | Case example . |
|---|---|---|
| Threshold elements (preconditions) | Competence/capacity | In this case, Mr. Smith is assumed to be competent to make a decision about treatment of his leukemia, including the genetic testing that has been recommended. It is possible, however, that if he had a large intracranial chloroma or large burden of CNS disease (or unrelated neurologic dysfunction) that he may not be able to competently make these decisions and provide informed consent for his treatment plans. |
| Voluntariness | Mr. Smith must be given the opportunity to make a voluntary decision about how to proceed in treating his acute myeloid leukemia, free of coercion. | |
| Information elements | Disclosure | The clinician-investigators must disclose risks and benefits of the proposed interventions, including risks and benefits of leukemia sequencing, to Mr. Smith, as well as other disclosures relevant to Mr. Smith’s decision (including that the sequencing is part of a research study, not standard clinical care). |
| Recommendation | To help Mr. Smith make an informed choice about whether to enroll on the sequencing trial, his clinician-investigators should recommend to him the intervention they feel best aligns with his values and beliefs, given his present clinical condition and circumstances. | |
| Understanding | In order to proceed, Mr. Smith should be able to demonstrate to his team that he understands the information about the clinical trial (including the sequencing that is part of it) that has been disclosed to him and the plan that his team has recommended. | |
| Consent elements | Decision | Mr. Smith should be able to clearly state which available option he has chosen and why that is his choice. |
| Authorization | Prior to initiation of therapy (and enrollment on the trial, if he opts to enroll), Mr. Smith should confirm that he authorizes his team to proceed and to carry out his stated decision. |
Adapted from Beauchamp and Childress.6