Public disclosure to the community in which the clinical investigation will beconducted and <strong>from</strong> which the subjects will be drawn, prior to initiation of the clinicalinvestigation, or plans <strong>for</strong> the investigations and its risks and expected benefits.Public disclosure of sufficient in<strong>for</strong>mation following completion of the clinicalinvestigation to apprise the community and researchers of the study, including thedemographic characteristics of the research population, and its results;Establishment of an independent data monitoring committee to exercise oversight ofthe clinical investigation; andIf obtaining in<strong>for</strong>med consent is not feasible and a legally authorized representativeis not reasonably available, the investigator has committed, if feasible, to attemptingto contact within the therapeutic window the subject’s family member who is not alegally authorized representative, and asking whether he or she objects to thesubject’s participation in the clinical investigation The investigator will summarizeef<strong>for</strong>ts made to contact family members and make this in<strong>for</strong>mation available to theIRB at the time of continuing review.Additional PHRC ResponsibilitiesThe PHRC is responsible <strong>for</strong> ensuring that procedures are in place to in<strong>for</strong>m, at the earliestfeasible opportunity each subject, or if the subject remains incapacitated, a legally authorizedrepresentative of the subject, or if such a representative is not reasonably available, a familymember, of the subject’s inclusion in the clinical investigation, the details of the investigationand other in<strong>for</strong>mation contained in the in<strong>for</strong>med consent document, The PHRC must alsoensure that there is a procedure to in<strong>for</strong>m the subject, or if the subject remains incapacitated, alegally authorized representative of the subject, or if such a representative is not reasonablyavailable, a family member, that he or she may discontinue the subject’s participation at anytime without penalty or loss of benefits to which the subject is otherwise entitled. If the legallyauthorized representative or family member is told about the clinical investigation and thesubject’s condition improves, the subject is also to be in<strong>for</strong>med as soon as feasible. If a subjectis entered into a clinical investigation with waived consent and the subject dies be<strong>for</strong>e a legallyauthorized representative or family member can be contacted, in<strong>for</strong>mation about the clinicalinvestigation is to be provided to the subject’s legally authorized representative or familymember, if feasible.Record KeepingThe PHRC determinations required above must be retained by the PHRC <strong>for</strong> at least 3 yearsafter completion of the clinical investigation, and the records will be accessible <strong>for</strong> inspectionand copying by the FDA.Investigational New Drug (IND) or Investigational Device Exemption (IDE)Protocols involving an exception to the in<strong>for</strong>med consent requirement under FDA regulations50.24 must be per<strong>for</strong>med under a separate IND or IDE that clearly identifies such protocols asprotocols that may include subjects whoa are unable to consent. The submission of thoseprotocols in a separate IND/IDE is required even if an IND <strong>for</strong> the same drug product or an IDE<strong>for</strong> the same device already exists. Applications <strong>for</strong> investigations involving an exception to thein<strong>for</strong>med consent requirement may not be submitted as amendments to an existing IND/IDE.Notifying Investigators and FDA of Disapproval of a Clinical Investigation Involving <strong>Exception</strong><strong>from</strong> <strong>In<strong>for</strong>med</strong> <strong>Consent</strong> <strong>Requirements</strong> <strong>for</strong> <strong>Emergency</strong> ResearchIf the PHRC disapproves a clinical investigator because the investigation does not meet thecriteria in the exception requirement above, the PHRC must document its findings and providethese findings promptly in writing to the investigator and to the sponsor of the investigation. ThePolicy: <strong>Exception</strong> <strong>from</strong> <strong>In<strong>for</strong>med</strong> <strong>Consent</strong> Requirement <strong>for</strong> <strong>Emergency</strong> Research Page 4 of 5
sponsor of the clinical investigation must promptly disclose this in<strong>for</strong>mation to FDA and to thesponsor’s clinical investigators who are participating or are asked to participate in this or asubstantially equivalent clinical investigation of the sponsor, and to other IRB’s that have been,or are, asked to review this or a substantially equivalent clinical investigation by that sponsor.OTHER APPLICABLE PARTNERS HEALTHCARE POLICIES:<strong>In<strong>for</strong>med</strong> <strong>Consent</strong> of Research SubjectsREFERENCE:45 CFR 4621 CFR 50, 56, 312, 812OHRP Report <strong>In<strong>for</strong>med</strong> <strong>Consent</strong> <strong>Requirements</strong> in <strong>Emergency</strong> ResearchDEVELOPMENT AND CONSULTATIONHuman Research OfficeReviewed by: Original Review Date: Revision Approval Dates:Policy: <strong>Exception</strong> <strong>from</strong> <strong>In<strong>for</strong>med</strong> <strong>Consent</strong> Requirement <strong>for</strong> <strong>Emergency</strong> Research Page 5 of 5
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