Informed Consent Checklist
Required Elements
The following elements must be present in the informed consent document:
- Clearly state that the study involves research.
- State which drug(s), treatment(s), or delivery technique(s) is/are experimental.
- Clarify the study purpose(s) is layman’s terms.
- State the patient’s expected duration of participation in study (e.g., the patient will be treated until there is evidence that therapy is no longer effective).
- Give a brief description of the procedure(s) to be performed to monitor the patient during study (e.g., X-rays, lab evaluations, etc.). An exhaustive list is not necessary.
- Give a description of the experimental aspect(s) or new delivery techniques(s) of the study.
- State in specific terms the route of administration of each drug (e.g., I.V., oral, continuous infusion, etc.)
- State estimated time of delivery of each drug or time of procedure (e.g., 5 minutes, 30 minutes, 24 hours, etc.).
- State which risks are attributed to specific drug(s) or procedure(s).
- Clarify and describe expected benefit(s) to be derived from participation in this study.
- In general terms, discuss alternative treatment(s) to participation in this study (e.g., conventional chemotherapy, irradiation, hormonal therapy, surgery, etc.).
- State the extent to which confidentiality of records will be maintained.
- State that a qualified representative of FDA may inspect patient/study records.
- State that a qualified representative of the NCI may inspect patient/study records.
- State that a qualified representative of the collaborating pharmaceutical sponsor may inspect patient/study records.
- State if compensation for study-related injury will be provided by the institution or other insurer.
- State if emergency treatment of injury will or will not be provided by the institution.
- Provide space in the form or list the names(s) and number(s) of contact person(s) for research related questions.
- Provide space in the form or list name(s) and number(s) of the contact person(s) (not involved in the research) for patients rights related questions.
- Clearly state that participation is voluntary.
- State that refusal to participate will involve no loss of benefits or penalize the patient’s care.
- State that discontinuation of participation in the study will involve no loss of benefits to which the patient is entitled.
Additional Elements
The following elements may be appropriate for some studies:
- State that unforeseeable or unexpected risk(s) may be involved.
- State the circumstances under which the patient’s participation may be terminated by the investigator without the patient’s consent.
- State that additional costs may be incurred by the patient’s participation in the study.
- State the consequences of the patient’s decision to withdraw from the study.
- State that significant new findings that relate to the patient’s treatment will be discussed with the patient.
- State the approximate number of patients involved in the study.
Suggested Elements
- State that a copy of the informed consent form shall be given to the patient.
- The form should be written in layman’s terms.
- Reference to approval by the IRB, NCI, or Cooperative Group may be misleading to the patient.
Please also consult NCI web site, www.cancer.gov, under Conducting Clinical Trials, Guide to Understanding Informed Consent, Safeguards-Simplification of Informed Consent Documents: Templates
