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HRPP Policy - IRB records and retention
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
HRPP Policies and IRB membership rosters, agendas, and minutes are retained indefinitely or until the Associate Vice President, Research Compliance, gives the authority to dispose of such records.
The IRB study file includes all documents reviewed by the IRB in connection with the research, including where applicable:
- IRB application
- Protocol or research plan
- Investigator brochures, package inserts, or instructions-for-use documents for medical devices
- Data collection instruments, including surveys, questionnaires, interview questions, etc.
- Recruitment materials
- Informed consent documents
- HIPAA authorization forms
- Documentation of scientific review, when provided by an external committee
- Modifications to previously approved research
- Records of renewal activities, including progress reports and data safety monitoring reports
- Reports of reportable events, including unanticipated problems involving risks to subjects or others and noncompliance
- Reports of injuries to subjects
- All correspondence between the IRB and researchers
- Documentation of the permissible category of exemption or expedited review category
- Description of the action taken by the reviewer
- IRB determinations findings required by federal laws and regulations, state and local laws and regulations, and institutional or agency policy or procedure
The IRB study file is retained while the study is active and for a period of three (3) years following closure, termination, or expiration of IRB approval, and may be destroyed after that time. The file is retained electronically for research not subject to 21 CFR Part 11 requirements or VA regulations.
Until destruction of IRB records has occurred, they are accessible for inspection and copying by interested parties, including but not limited to representatives of federal agencies and departments, sponsors, and institutional officials, at reasonable times and in a reasonable manner.
The IRB will not accept or retain data in its records which is classified as Critical Data per the IU Policy on Management of Institutional Data.Back to top
- AAHRPP Standards
- Element II.5.A
- Element II.5.B
- 21 CFR 56.115
- 45 CFR 46.115
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Guideline for Good Clinical Practice E6(R2), especially section 3.4
- OHRP Guidance:
- VHA Handbook 1200.05 - Requirements for the Protection of Human Subjects in Research, especially section 14
authorization Per the Privacy Rule, an individual's permission to allow a covered entity to use or disclose the individual's protected health information (PHI) described in the authorization for the purpose(s) and to the recipient(s) stated in the authorization.
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.
HIPAA The Health Insurance Portability and Accountability Act of 1996. See also Privacy Rule.
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.
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.
recruitment Initial identification and contact with potential subjects, which may include both direct interactions with individuals and/or accessing identifiable data or specimens for the purpose of determining whether an individual or their data or specimen may participate or be included in a study.
reportable event An event which may represent noncompliance or an unanticipated problem involving risks to subjects or others. Reportable events are reported to the IRB in accordance with the IU HRPP Policy on Reportable Events.
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.
sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.
termination Determination made by the IRB to permanently withdraw approval for some or all activities of a currently approved research study.Back to top