Office of Human Research Protection
University of Nevada
Policy II5 IRB Requirements for Recordkeeping, and Biological Specimen
Retention and Transfer
Scope
This policy describes the minimal requirements for the retention of human subjects research records,
including Institutional Review Board (IRB) protocol documents; subject information and biological
specimens collected from research participants; and protocol records and data created or maintained in
the course of human subjects research (henceforth referenced as “research records, data and
specimens”). This policy also describes University of Nevada, Reno (the University) IRB considerations
for the transfer of research records, data and specimens; and for the storage of research records, data
and specimens from student-initiated research. This policy applies to the University Office of Human
Research Protection (OHRP) and University and affiliate investigators.
Policy Statement
All University human research records and data will be retained for no less than three years from the
conclusion of the research. Records and data will be retained in accordance with applicable legal,
regulatory and contractual requirements including but not limited to FDA, funding agency, patenting
and HIPAA requirements. When University human research records and data are no longer deemed
useful following the proscribed record retention period, the records and data will be de-identified or
destroyed in accordance with University media control or biological specimen policies (for VA
researchers, in accordance with VA policy).
Principal Investigators who wish to transfer University human research records, data or biological
specimens to another institution during the course of the retention period may request approval for said
transfer. Other investigators may request the transfer of copies of data records or partial biological
samples.
Transfer requests will generally be approved unless one of the exceptions described herein applies.
Transfers may be subject to further contractual agreements with the proposed accepting institution,
funding agency agreements or the University so that the University may comply with any lingering legal,
regulatory or contractual obligations associated with the University having created, collected or stored
such records during the conduct of the research.
Reason for the Policy
Human research records, data and biological specimens are subject to a complex array of obligations
such as funding agency agreements; and patent and licensing, human subject and HIPAA regulatory, and
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Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer
state medical record retention requirements. This policy is meant to ensure that human research
records are maintained, transferred and eventually destroyed in accordance with the legal, regulatory,
contractual or policy obligations applicable to a given set of records or biological specimens.
This policy also intends to clarify when an investigator may transfer original research records or copies
of research records to a new institution. The University, as owner of all records collected, obtained,
created or maintained by University and affiliate investigators, is responsible for ensuring that records
and biological specimens are available to appropriate University personnel for further research,
treatment, and administrative purposes. Hence, the University acting through the IRB will consider the
current or anticipated needs of other University faculty and staff in determining whether human
research records and biological specimens should be transferred to a new institution.
Definitions
Human Subject or Human Participant
A living individual
(1) about whom an investigator (whether professional or student) conducting research obtains
either
(a) data through intervention or interaction with the individual; or
(b) identifiable private information; or
(2) who is or becomes a participant in research involving drugs or devices, either as a recipient of a
test article or as a control.
Note: Both “human subject” and “human participant” are used interchangeably in IRB policies and
procedures. While the term “participant” conveys the voluntary nature of an individual’s agreement to
participate in the research, it also can convey a sense of partnership that is not reflected in all types of
research. In some research activities, a true sense of partnership may be lacking in which case “subject”
would be the more appropriate term.
Record
A record is any information preserved in a fixed medium, whether on paper, electronically or otherwise.
IRB protocol records include protocol submissions, approved protocol documents (e.g., protocol
application, recruitment materials, assessment instruments, and consent forms); all relevant
correspondence between the IRB and investigators; and documentation of IRB review (e.g., reviewer
checklists, file notes).
Research
A clinical investigation or a systematic investigation, including research and development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.
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Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer
Student-Initiated Research
Research originated and conducted by a University student investigator to fulfill academic requirements
for a class project, thesis or dissertation.
University Human Research Records
Records which are created or received in the course of conducting human subjects research, including
subject responses to questionnaires, information obtained from subjects’ medical or educational
records, and biological specimens and associated data.
University Records
Records created or received by a University faculty member, staff member, student or trainee in her or
his role as a University employee, or by a University student or trainee in the course of providing a
service to the University or to others as part of her or his education or training, except the following:

intellectual property which by University policy is owned, licensed, or otherwise legally
controlled by a Record User; and

records created or received by faculty members while participating in the peer review of any of
the following:
(i) a manuscript,
(ii) a sponsored research application, or
(iii) the qualifications of a person seeking employment at another institution.
II5A Minimum Requirements for Retention of IRB Records
Note: The OHRP is transitioning from a paper-based system to electronic document management and
online submission. The documentation retained will remain the same, although the media type will
change over time.
II5A1 Record Retention: Not Human Subjects Research Determinations and
Exempt Submissions
For projects determined by the IRB to qualify for a not human subject research designation or exempt
status the IRB record will contain the applicable application form and relevant investigator-IRB
correspondence related to the submission. Records for requests for human subject research
determinations will include the letter confirming that the IRB or OHRP senior staff determined that the
activities do not constitute human subjects research. Records for human subjects research that is
exempt from 45 CFR 46 will include the checklist completed by the designated reviewer and the
certification of approval for the exempt research. If investigators wish to amend exempt research, all
relevant correspondence related to the amendment and the certification of approval will be retained in
the file.
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Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer
II5A2 Record Retention: Expedited and Full Board IRB Protocols
For research submitted for IRB review, whether via expedited procedures or during a convened meeting,
IRB records contain the following:

initial protocol application and the following attachments, as applicable to the proposed
research:
1. recruitment materials including scripts,
2. consent documents including information sheets,
3. screening scripts and logs, as applicable,
4. assessment instruments and data collection logs,
5. intervention materials,
6. HIPAA authorization or waiver, as applicable,
7. debriefing logs, if applicable,
8. documentation of site permission,
9. documentation of external IRB approval,
10. documentation of training for external investigators if other than CITI,

relevant correspondence the researchers and the IRB;

for funded studies, the grant application or contract with scope of work;

reviewer checklists and relevant email correspondence from the reviewer to IRB staff;

correspondence to investigator documenting the results of the IRB review (if revisions are
requested);

approved versions of the protocol application and attachments;

approved, date-stamped informed consent document (if applicable);

certification of IRB approval;

file notes (when necessary to document a decision or action)

amendment requests and the applicable checklists, review results and certifications of approval;

renewal requests and the applicable checklists, review results and certifications of approval;

for multicenter studies, the sponsor’s protocol;
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Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer

for studies involving an investigational drug or device, the investigational drug brochure;

for investigator-initiated studies involving a drug or device, all correspondence with the FDA
including the IND or IDE application and any other pertinent documentation;

reports of unanticipated problems involving risks to human subjects or others encountered in
the conduct of the research and documentation of IRB determinations and action;

reports of serious adverse events encountered in the conduct of the research and
documentation of IRB determinations and actions;

reports of subject complaints or potential noncompliance and documentation of IRB
determinations and actions;

a summary of compliance reviews conducted by the University IRB Program Manager; and

a summary of audits conducted by the DHHS OHRP, FDA, sponsor or other regulatory or
oversight body.
Research files are securely maintained by the OHRP. After the 3 year period has passed, records related
to VA research shall be sent to the VA Research Development Committee, care of the Associate Chief of
Staff for Research to be placed in long term storage in accordance with VA policy. Neither the IRB nor
the investigator may destroy VA related records.
II5B Minimum Requirements for Retention of Investigator Records
Principal Investigators are responsible for maintaining human research records for a minimum of three
years from the completion of the research.
NOTE: VA researchers will abide by VA policy for retaining records.
Human research records which must be maintained include the following:

complete copies of all IRB protocol submissions, including approvals,

primary source data collected or created in the course of the research project,

consent forms signed by participants (including master list for VA research),

biological samples and associated data, and

tabulations or other manipulations of the data created for the purpose of data analysis.
Secondary copies of the data and interim data manipulations need not be retained but are nonetheless
subject to University policies related to record protection. Data which has been de-identified in
accordance are no longer deemed to involve human subjects and are no longer subject to IRB policies
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Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer
and procedures but are subject to other University research policies related to data retention,
protection, and destruction.
Principal Investigators are responsible for consulting University policies as well as federal and state laws
and regulations related to data retention including but not limited to HIPAA, FDA, VA, medical records,
and funding agency requirements, as applicable. Records must be maintained for at least as long as the
longest record retention period applicable to a given set of research records. The required records,
including the investigator’s research records should be consistent with VHA requirements, VA
researcher’s VA protocol and all study files must be retained until disposition instructions are approved
by the National Archives and Records Administration (NARA) and are published in VHA's Records Control
Schedule (RCS 10‐1).
II5C Requests to Transfer University Human Research Records
Principal Investigators who are leaving the University and wish to transfer University human research
records to a new institution may submit a written request for approval to transfer the identifiable
records or biological samples. Such requests require that the following ethical, regulatory, and
professional obligations are respected:

obtaining IRB approval from the new institution for use and storage of the data or biological
samples;

recording disclosure of any PHI in accordance with HIPAA requirements for disclosures;

upholding any intellectual property rights of the University and research team members as coowners of the data;

considering expectations of research participants as delineated in the informed consent
documents;

ensuring access and audit rights of the sponsor are exercised and maintained in a manner
consistent with established agreements and legal or regulatory requirements; and

ensuring adequate continuation of patient care in clinical trials.
To initiate a data or bio-specimen transfer, the Investigator must submit a written request to the
Department Chair or designee, and to the IRB. The request must include a description of the data that is
to be transferred (e.g., lab note books, primary data scoring records, primary diagnostic information,
computer files, consent documents, tissue samples). The request for transfer must be approved by both
the Department Chair and the IRB. Requests to transfer data or copies of data or portions of biological
specimens will be approved when the following criteria are satisfied:

PI approval of the request for transfer of copies of the data, or portions of biological specimens
may be transferred, if someone other than the PI is requesting the data transfer;
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Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer

provisions are in place to permit representatives from the University, federal agencies and
sponsors to access the data and related research information at the new institution as needed
to conduct audits related to research compliance and adherence to federal and state law and
any governing research contracts with the research sponsor;

verification exists that other University research or clinical requirements are satisfied;

any requirements for a material transfer agreement are met for records that include biological
specimens (investigators should consult the Office of Sponsored Projects to determine if an
agreement is necessary);.

documentation of disclosure when the transferred data include PHI as defined by HIPAA and
prior patient or subject authorization for the disclosure have not been obtained;

transfer of IRB approval and oversight to the new institution for data and tissue that will be
maintained as a repository at an institution external to the University.
II5D Data for Student-Initiated Research
Data collected, obtained and created for student-initiated research is the property of the University, and
remains so after the student graduates. Students must arrange for all research-related data to be
securely stored on a campus location. Faculty advisors (for exempt research) and principal investigators
(for human subjects research approved by expedited procedures or the convened IRB), must have
access to the data at all times in the event an internal review or external audit are required.
Electronic data must be stored on a password-protected University computer. The faculty advisor or
principal investigator must be able retrieve the data either through a shared password or other
mechanism that allows multiple parties to access the files. If the data are encrypted, the faculty advisor
or principal investigator must have the means to remove the encryption to view the data.
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