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HRPP Policy - EFIC
About This Policy
- Effective date:
- Last updated:
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IU Human Research Protection Program (HRPP)
This policy applies to non-exempt human subjects research requesting exception from informed consent (EFIC) under the oversight of the Indiana University Institutional Review Boards (IRBs).Back to top
The IRB may approve research without requiring that informed consent of all research subjects be obtained, if the IRB finds the following:
- The human subjects are in a life-threatening situation, available treatments are either unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
- Obtaining informed consent is not feasible because:
- The subjects will not be able to give their informed consent as a result of their medical condition;
- The intervention under investigation must be administered before consent from the subjects' legally authorized representative (LAR) is feasible; and
- There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the research.
- Participation in the research holds out the prospect of direct benefit to the subjects because:
- Subjects are facing a life-threatening situation that necessitates intervention;
- Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence supports the potential for the intervention to provide a direct benefit to the individual subjects; and
- Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.
- The research could not practicably be carried out without the waiver.
- The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact an LAR for each subject within that window of time and, if feasible, to asking the LAR contacted for consent within that window rather than proceeding without consent. The investigator must summarize efforts made to contact LARs and make this information available to the IRB at the time of renewal.
- Informed consent consistent with the IU HRPP Policy on Informed Consent will be obtained and documented from subjects or their LARs when feasible.
- Procedures and information exist which provide an opportunity for a family member to object to a subject's participation in the research in accordance with this policy.
- Additional protections of the rights and welfare of the subjects are provided, including, at least all of the following:
- Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the research will be conducted and from which the subjects will be drawn;
- Public disclosure to the communities in which the research will be conducted and from which the subjects will be drawn, prior to initiation, of plans for the research and its risks and expected benefits;
- Public disclosure of sufficient information following completion of the research 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 oversee the research; and
- If obtaining informed consent is not feasible and a LAR 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 an LAR, and asking whether he/she objects to the subject's participation in the research. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review. Please note that, for Indiana subjects, all family members may serve as LAR per Indiana law and IU HRPP Policy; as such, this provision is not applicable to Indiana subjects.
The IRB may not approve the following research allowing exception from informed consent under this policy:
- Research which is federally-funded and involves pregnant women, human in vitro fertilization, or prisoners
- Research subject to VA regulations
- Research subject to Department of Defense (DoD) regulations unless a waiver is obtained from the U.S. Secretary of Defense.
The IRB must ensure procedures are in place to inform, at the earliest feasible opportunity, each subject or, if the subject remains incapacitated, his/her LAR, of the following:
- That the subject was enrolled in the research
- The details of the research
- Other information contained in the informed consent document
- That he/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 LAR or family member is told about the research and the subject's condition improves, the subject is also to be informed as soon as feasible.
If the subject dies before an LAR or family member can be contacted, information about the research is to be provided to the subject's LAR or family member, if feasible.
For studies enrolling subjects without informed consent pursuant to this policy, the study team completes the IRB application and provides protocol-specific information related to the determinations required by 2.0 above. The IRB considers the information in the IRB application and documents its determinations as appropriate.
If the IRB finds the research is not also subject to FDA regulations, the IRB must report to OHRP that the conditions outlined in 2.0 above have been met.
The research must be performed under a separate investigational new drug application (IND) or 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 IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists.
If the IRB determines that the criteria required by 2.0 above are not met, or that the research cannot be approved due to other relevant ethical concerns, the IRB must document its findings and provide these findings promptly in writing to the PI and to the sponsor. The sponsor of the clinical investigation must promptly disclose this information to the FDA and to the sponsor's clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other IRB's that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
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