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HRPP Policy - Reporting to oversight agencies
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
This policy applies to the conduct of human subjects research under the jurisdiction of the IU Human Research Protection Program (HRPP), and all Indiana University (IU) institutional review boards (IRBs). This policy does not apply to IRB review of administrative holds, events occurring at a site not under the jurisdiction of the IU IRBs, or suspensions not initiated by the IU IRB.Back to top
When the IRB determines that reviewed information represents an unanticipated problem involving risks to subjects or others (UPIRTSO), or serious and/or continuing noncompliance, or if the IRB suspends or terminates approval of research, appropriate institutional officials and the federal department or agency head are notified of the determination, surrounding circumstances, reason for the determination, as well as relevant subsequent actions and information.
When members of the HRPP become aware of any of the following, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) must be notified as soon as possible, but not later than 48 hours:
- Any negative actions by a government oversight office, including OHRP determinations, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA Restrictions placed on IRBs or investigators, and corresponding actions taken under non-US authorities related to human research protections
- Any litigation, arbitration, or settlements initiated related to human research protections
- Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the HRPP
When the convened IRB makes any of the determinations in 2.0 above, the determination is promptly reported to the appropriate entity as follows:
- If the research is conducted at the VA, the VA facility Director and the ACOS/R&D within 5 business days
- If the study is subject to HHS regulations, Office for Human Research Protections (OHRP)
- If the study is subject to FDA regulations, Food and Drug Administration (FDA)
- If the research is federally-funded and all study activities were suspended or terminated, Director of Grant Services
- IU Office for the Vice President General Counsel or counsel for engaged institutions, if applicable
- Institutional official or designee, Indiana University
- If the IU IRBs are serving as the IRB of record for external sites or research personnel, the Relying Institution(s)
- If the study is under the oversight of an external IRB, the Reviewing IRB
The following individuals are provided with a copy of the report, as appropriate:
- The Principal Investigator (PI)
- For IU faculty, the PI's department chair or division chief
IRB determinations related to local research deaths, serious adverse events (SAEs) and serious problems, and apparent serious and/or continuing noncompliance must be reported in accordance with the IU HRPP Policy on Reportable Events, section 3.2.
The IRB must notify the VA facility Director and the ACOS/R&D within 5 business days of suspending or terminating VA research.
- AAHRPP Standards
- Element 1.5.D
- Element II.2.F
- Element II.2.G
- Element II.2.H
- 21 CFR 56, especially 56.108(b) and 56.113
- 46 CFR 46, especially 46.108(4)
- Memorandum of Understanding Between Richard L. Roudebush Veterans Affairs Medical Center and Indiana University Concerning Utilization of Indiana University's Institutional Review Boards
- OHRP Guidance
- VHA Handbook 1058.01 – Research Compliance Reporting Requirements
administrative hold A voluntary interruption of research enrollment and ongoing research activities by an appropriate facility official, research personnel or investigator, or sponsor.
continuing noncompliance (see also noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) A pattern of the same or similar instances of noncompliance, occurring in reasonably close proximity, which continues to occur after discovery of noncompliance and implementation of a preventive action plan, or results from failure to implement a preventive action plan approved by the IRB.
deparment or agency head The head of any federal department or agency and any other officer or employee of any department or agency to whom authority provided by the Common Rule to the department or agency head has been delegated.
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.
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.
noncompliance (see also continuing noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, requirements of VHA Handbook 1200.05, or institutional policies governing human subjects research or the requirements or determinations of the IRB.
principal investigator (see also research personnel, Investigator, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, student, fellow, resident PI, site-specific PI) Responsible leader of a team of research personnel who has the ultimate responsibility for the conduct of the research.
relying institution An institution that agrees to accept IRB review and oversight from a reviewing IRB.
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.
reviewing IRB The IRB responsible for review and oversight of a research project. Also known as the IRB of record or the single IRB (sIRB).
serious adverse event (SAE) Any adverse event that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability/incapacity, congenital anomaly, or birth defect, or that requires medical or surgical intervention to prevent such an outcome.
serious problem (VA) For research subject to VA regulations, problem that may reasonably be regarded as (1) involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research subjects, research staff, or others; or (2) substantively compromising the effectiveness of a facility's human research protection or human research oversight programs.
suspension Temporary cessation of some or all activities in a currently approved research study.
unanticipated problem involving risks to subjects or others (UPIRTSO) In general, this includes any incident, experience, or outcome that meets all of the following criteria: 1) is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; 2) is related or possibly related to participation in the research ("possibly related" means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and 3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.Back to top