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III. Informed Consent Guidance - FDA Regulated Studies
Investigators who conduct research involving investigational drugs may be asked by commercial sponsors to conform to GCP guidelines, including the guidelines for consent documents (http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf ). The International Conference on Harmonization has published a list of the 20 required elements for consent forms used in studies of investigational pharmaceutical agents. Pharmaceutical sponsors write consent forms to meet the GCP standard.
Note: The GCP document of required elements for consent is not a regulatory requirement in the United States. FDA regulations on consent do not require all consent elements recommended by GCP guidance.
These required elements under GCP are:
(a) That the trial involves research.
(b) The purpose of the trial.
(c) The trial treatment(s) and the probability for random assignment to each treatment.
(d) The trial procedures to be followed, including all invasive procedures.
(e) The participant's responsibilities.
(f) Those aspects of the trial that are experimental.
(g) The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant.
(h) The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this fact.
(i) The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks.
Note: FDA regulations do not require a list of benefits and risks associated with alternatives to participation.
(j) The compensation and/or treatment available to the participant in the event of trial related injury
(k) The anticipated prorated payment, if any, to the participant for participating in the trial.
(l) The anticipated expenses, if any, to the participant for participating in the trial.
(m) That the participant's participation in the trial is voluntary and the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled.
(n) That the monitor(s), the auditor(s), the IRB/IEC [Institutional Ethics Committee], and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant's legally acceptable representative is authorizing such access.
(o) That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant's identity will remain confidential.
(p) That the participant or the participant's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the trial.
(q) The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury.
(r) The foreseeable circumstances and/or reasons under which the participant's participation in the trial may be terminated.
(s) The expected duration of the participant's participation.
(t) The approximate number of participants involved in the trial.
Note: This is an optional element in FDA regulations, guided by whether including this information could influence enrollment.
The GCP standards for consent forms may be found at the following web site: