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HRPP Policy - Auditing
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
Quality Improvement Office (QIO)
This policy applies to the conduct of human subjects research under the jurisdiction of the IU Human Research Protection Program (HRPP). This includes research under the oversight of the IU IRBs and research for which IU or its affiliates are relying on an external IRB for oversight.Back to top
Research personnel are expected to fully cooperate with all audits, monitoring visits, and compliance inspections (audits) conducted by IU's QIO (internal audits) or regulatory agencies, funding agencies, or study sponsors (external audits), including taking appropriate steps to make necessary improvements to align their conduct of research with applicable federal regulations, state laws, and institutional policies.
QIO staff conduct not-for-cause (scheduled) and for-cause (directed) internal audits of research studies. QIO develops an audit plan that describes the criteria for selecting and prioritizing research protocols and/or PIs for not-for-cause audits. The audit plan is reviewed and approved by the IU IRB Executive Committee on a semiannual basis. For-cause (directed) audits may be requested by the IRB or appropriate institutional officials.
Research personnel must immediately notify QIO upon notification of an external audit. QIO staff serve as a liaison designated by the institution to serve as a resource to the PI, study team, and institution to monitor the progress of the audit and to coordinate key aspects of any written response to the inspecting agency. Research personnel shall immediately provide to QIO all audit-related correspondence and communications to and from the inspecting agency. Research personnel must respond to both FDA Form 483 and Warning Letter correspondence within 15 business days of receipt; for other FDA correspondence (e.g., Untitled Letters), research personnel must seek guidance from QIO regarding whether a response should be prepared. QIO must review responses prior to their submission to the FDA.
Findings from audits must be reported to and reviewed by the IRB in accordance with the IU HRPP Policy on Reportable Events.
For internal audits, QIO staff tracks audit findings and prepares periodic summary reports which are presented to the University Director, HRPP, and IRB Executive Committee. Reports describe general audit finding trends, any serious or continuing noncompliance, and any unanticipated problems involving risks to subjects or others determinations made in relation to the audit findings.
When an audit report is received, research personnel are expected to respond to all requests. The response should include an action plan to correct any problems identified and an action plan to prevent recurrences, as applicable. Some findings may require additional information, including an explanation of the circumstances that identifies the suspected root cause, the individual(s) responsible for corrective and preventive actions, and a timeline for their completion.
If the study team fails to respond, the department chair may be contacted for assistance. QIO staff may involve an appropriate IRB or other applicable authority for additional assistance at any time.
For internal audits, research personnel must respond within fourteen (14) days unless an extension is granted by QIO staff. The final report is submitted to the IRB via KC IRB.
For-cause audits involving the VA are conducted in cooperation with the local VA research office. Audit findings are promptly shared with the local VA Research Office for audits that include VA subjects.
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
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Element 1.5.A
- Element 1.5.B
- FDA Information Sheet Guidance for IRBs, Clinical Inspectors, and Sponsors: FDA Inspections of Clinical Investigators (June 2010)
- FDA Compliance Program Guidance Manual, Program 7348.811 - Biomedical Research Monitoring, Clinical Investigators (December 8, 2008)
- Memorandum of Understanding Between Richard L. Roudebush Veterans Affairs Medical Center and Indiana University Concerning Utilization of Indiana University's Institutional Review Boards
audit (see also for-cause (directed) audit, internal audit, and not-for-cause (scheduled) audit) A systematic and independent examination of study-related activities and documents to determine whether the evaluated study-related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to applicable federal regulations, state laws, and institutional policies. Includes audits, monitoring visits, and compliance inspections.
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.
for-cause (directed) audit (see also audit, internal audit, not-for-cause (scheduled) audit) Internal audit requested by an IRB, IRB chair, the University Director of the IU HRPP, or the Associate Vice President of Research Compliance when circumstances require an on-site record review, generally related to reported or suspected noncompliance.
internal audit (see also audit, for-cause (directed) audit, not-for-cause (scheduled) audit) Audit conducted by the IU QIO.
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.
not-for-cause (scheduled) audit (see audit, for-cause (directed) audit, internal audit) Internal audit which is a part of the IU HRPP audit plan.
preventive action A process implemented to prevent occurrence of an event in the future.
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.
regulatory agencies Government organizations, anywhere in the world, that set standards, establish policies, advocate laws, and provide oversight of specified activities within a country, such as the United States Food and Drug Administration (FDA).
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.
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.
sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.Back to top