Exception from Informed Consent Requirements for Emergency

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PROCEDURES:Investigators requesting an exception or waiver from the requirement to obtain informed consentfor planned emergency research must provide sufficient information in the protocol submissionfor the PHRC to find and determine whether the research satisfies all of the requirements of 21CFR 50.54 for an exception from informed consent requirements for emergency research and45 CFR 46.101(i) for emergency research consent waiver.The emergency research consent waiver does not apply to research involving fetuses, pregnantwomen, and human in vitro fertilization (Subpart B of 45 CFR 46) and research involvingprisoners (Subpart C of 45 CFR 46).For the purposes of the emergency research consent waiver “family member” means any one ofthe following legally competent persons: spouses; parents; children (including adoptedchildren); brothers, sisters, and spouses of brothers and sisters; and any individual related byblood or affinity whose close association with the subject is the equivalent of a familyrelationship.Protocol Submission RequirementsWhen submitting research requesting an exception from informed consent requirements foremergency research, the investigator must address each of the required PHRC findings anddeterminations in the protocol submission, specifically: Justification for the research; Justification for waiver of informed consent; Relation of risks to anticipated benefits; Informed consent procedures and an informed consent document consistent with 21CFR 50.25 and 45 CFR 46.116; Impracticability of conducting the research without the waiver of informed consent; Therapeutic window and consent process; Plan for community consultation; Plan for public disclosure prior to and after completion of the clinical investigation; Establishment of an independent data monitoring committee to oversee the clinicalinvestigation; Procedures followed when attempting to contact a family member who is not a legallyauthorized representative, within the therapeutic window and asking whether he or sheobjects to the subject’s participation in the clinical investigation when obtaining informedconsent is not feasible and a legally authorized representative is not reasonablyavailable; Procedures to inform, at the earliest feasible opportunity each subject, or if the subjectremains incapacitated, a legally authorized representative of the subject, or if such arepresentative is not reasonably available, a family member, of the subject’s inclusion inthe clinical investigation, the details of the investigation and other information containedin the informed consent document, that he or she may discontinue the subject’sparticipation at any time without penalty or loss of benefits to which the subject is otherentitled;Procedures to inform the subject should the subject’s condition improve; andIf feasible, procedures to provide the subject’s legally authorized representative or familymember with information about the clinical investigation should the subject die before alegally authorized representative or family member can be contacted.PHRC Findings and DeterminationsPolicy: Exception from Informed Consent Requirement for Emergency Research Page 2 of 5
The PHRC must make and document the following findings and determinations:1. Conducting the research is justified because: The human subjects are in a life threatening situation; Available treatments are unproven or unsatisfactory; and The collection of valid scientific evidence, which may include evidence obtainedthrough randomized placebo-controlled investigations, is necessary to determine thesafety and effectiveness of particular interventions.2. Waiving informed consent is justified because: The subjects will not be able to give informed consent as a result of their medicalcondition; The intervention under investigation must be administered before consent from thesubjects’ legally authorized representative is feasible; and There is no way to identify prospectively the individuals likely to become eligible forparticipation in the clinical investigation.3. The risks are reasonable in relation to the anticipated benefits because: Subjects are facing a life-threatening situation that necessitates intervention; Approval animal and other preclinical studies have been conducted, and theinformation derived from those studies and related evidence support the potential forthe intervention to provide a direct benefit to the individual subjects; and Risks associated with the investigation are reasonable in relation to what is knownabout the medical condition of the potential class of subjects, the risks and benefitsof standard therapy, if any, and what is known about the risks and benefits of theproposed intervention or activity.4. The clinical investigation could not practicably be carried out without the waiver.5. The investigational plan defines the length of the potential therapeutic window based onscientific evidence, and the investigator has committed to attempting to contact a legallyauthorized representative contacted for consent within the window rather than proceedingwithout consent. The investigator will summarize efforts made to contact legally authorizedrepresentatives and make this information available to the IRB at the time of continuingreview.6. The IRB has reviewed and approved informed consent procedures and an informed consentdocument consistent with 21 CFR 50.25 and 45 CFR 46.116. These procedures and theinformed consent document are to be used with subjects or their legally authorizedrepresentatives in situations where use of such procedures and documents is feasible. TheIRB has reviewed and approved procedures and information to be used when providing anopportunity for a family member to object to a subject’s participation in the clinicalinvestigation consistent.7. The following additional protections of the rights and welfare of subjects will be provided: Consultation (including, where appropriate, consultation carried out by the IRB) withrepresentatives of the communities in which the clinical investigation will beconducted and form which the subjects will be drawn;Policy: Exception from Informed Consent Requirement for Emergency Research Page 3 of 5
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Exception from Informed Consent Requirements for Emergency

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