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No clinical investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent from the subject. Informed Consent is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to participate in the study. The informed consent document must include all the basic elements of informed consent (outlined below) or it may be a short form written consent document stating that the elements of informed consent have been presented orally (§50.27). If the short form method is used, there must be a witness to the oral presentation.
An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
The written consent form must be approved by the Institutional Review Board (IRB) and contain the following basic elements (§50.25):
The consent form must be signed by the subject or the subject's legally authorized representative. Each signed consent must be maintained by the clinical investigator and a copy of the informed consent must be provided to the human subject.
A combination of oral and written consent may be used. The short form method of informed consent includes a written summary and a "short form." A written summary is a document of what is to be said to the subject or representative and must be approved by the IRB. The summary must include all the basic elements of informed consent (discussed above). A short form is a document stating that the elements of informed consent (§50.25) have been presented orally to the subject or the subjects legally authorized representative.
After oral presentation is provided, the summary must be signed by the witness and the presenter (investigator or investigators representative). The short form must be signed by the subject (or the representative) and the witness. A copy of the summary must be provided to the subject (or the representative) in addition to a copy of the short form. The signed documents must be maintained by the clinical investigator.
Exception from Informed Consent Requirements for Emergency Research
Criteria for exception from informed consent
There are special cases under emergency care research in which the human subject is in a life-threatening situation and it is not feasible to obtain informed consent. In order to allow such research to proceed, there are special provisions for exception from informed consent requirements (§50.24).
The IRB responsible for the review, approval, and continuing review of the clinical investigation may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following:
- Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;
- Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;
- Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;
- Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and
- If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.
IRB Responsibilities
The IRB is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the subject's inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document.
The IRB must also ensure that there is a procedure to inform the subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the subject's legally authorized representative or family member, if feasible.
If an IRB determines that it cannot approve a clinical investigation because the investigation does not meet the criteria or because of other relevant ethical concerns, the IRB must document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation.
Records of IRB determinations must be retained by the IRB for at least 3 years after completion of the clinical investigation. These records must include the IRB determinations of exemption from informed consent and also the documentation of IRB denial, including documentation of findings and disclosure of the findings to the clinical investigator and the sponsor. The records must be accessible for inspection and copying by FDA [§56.115(b)].
Sponsor Responsibilities
The sponsor must monitor the progress of all investigations involving an exception from informed consent. When the sponsor receives information concerning the public disclosures under (7)(b) and (7)(c) above from the IRB, the sponsor must promptly submit copies of the information that was disclosed to the IDE file and to Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, identified by the IDE number.
The sponsor also must monitor such investigations to determine when an IRB determines that it cannot approve the research because it does not meet the exception criteria or because of other relevant ethical concerns. The sponsor must promptly provide this information in writing to FDA, investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation, and other IRB's that have been asked to review this or a substantially equivalent investigation.
IDE Application
Protocols involving an exception to the informed consent requirement under this section must be performed under a separate investigational device exemption (IDE) that clearly identifies such protocols as protocols that may include subjects who are unable to consent. The submission of those protocols in a separate IDE is required even if an IDE for the same device already exists. Applications for investigations under this section may not be submitted as amendments to an approved IDE [§812.35].
References:
Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators, 1998
http://www.fda.gov/oc/ohrt/irbs/default.htmA Guide to Informed Consent
http://www.fda.gov/oc/ohrt/IRBS/informedconsent.htmlFrequently Asked Questions on Informed Consent Process and Informed Consent Document Content
http://www.fda.gov/oc/ohrt/IRBS/faqs.htmlDeclaration of Helsinki
http://www.fda.gov/oc/health/helsinki89.html
(World Medical Associations recommendations to every physician in biomedical research involving human subjects)The Belmont Report, April 18, 1979
http://www.fda.gov/oc/ohrt/irbs/belmont.htmlSignificant Differences in FDA and HHS Regulations for Protection of Human Subjects
http://www.fda.gov/oc/ohrt/irbs/appendixe.htmlGuidance on IDE Policies and Procedures
Text-http://www.fda.gov/cdrh/ode/idepolcy.html
PDF-http://www.fda.gov/cdrh/ode/idepolcy.pdfGuidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent - Requirements for Emergency Research
http://www.fda.gov/OHRMS/DOCKETS/98fr/000805GL.pdf
Recommended Links
Information for Health Professionals - Clinical Trials and Institutional Review Boards http://www.fda.gov/oc/oha/default.htm#clinical
Institutional Review Board Guidebook, 1993, National Institutes of Health, Office of Extramural Research, Office for Protection from Research Risks http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm
Last modified date01/02/2002
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