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HRPP Policy - EFIC
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
This policy applies to the conduct of all non-exempt human subjects research under the oversight of the IU IRBs when research personnel request exception from informed consent (EFIC).
This policy is not applicable to:
- federally-funded research which 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 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 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
Applicability of this policy to federally-funded research moved from 3.2 to 1.0; removed requirement in 2.0 that this research be subject to FDA regulations; minor wording revision to 3.2.Back to top
device (medical device) As regulated by the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the National Formulary, or the United States Pharmacopeia, or any supplement to them; 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3) intended to affect the structure or any function of the body of man or other animals, and; which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
drug As regulated by the FDA, A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and B) rticles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
enrollment Enrollment begins at the time of consent for the study. For research for which consent is not required, enrollment begins at time of data collection or when the subject agrees to participate.
federally-funded Supported, either directly or indirectly, by funds provided by the federal government. This includes federal pass-through funding (i.e., received as a subrecipient through subcontracts). Use of administrative services funded by a federal grant, alone, is not sufficient to consider research federally-funded.
informed consent An ongoing process by which a subject (or his/her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.
intervention Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
investigational device exemption (IDE) As regulated by the FDA, authorization allowing an investigational device to be used in a clinical investigation in order to collect safety and effectiveness data.
investigational new drug application (IND) Request for authorization from the FDA to administer an investigational drug or biological product to humans.
investigator (FDA, see also research personnel, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI) In research subject to FDA regulations, an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
legally authorized representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to the participant's participation in the procedure(s) involved in the research. For definition of LAR in Indiana, see the IU HRPP Policy on Adult Individuals Lacking Consent Capacity.
life threatening Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of the clinical trial analysis is survival. Also includes severely debilitating, meaning diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of arm, leg, hand, or foot).
prisoner Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute; individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples of individuals considered prisoners are available in the OHRP Prisoner Research FAQs.
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
research personnel (See also investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), Student, Fellow, Resident PI, site-specific PI) Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.
sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.
written/in writing Writing on a tangible medium (e.g. paper) or in an electronic format.Back to top