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While taking annual compliance training I came across this policy statement by my employer. No need to read it if you trust my synopsis which is essentially that all data must be kept for a minimum of three or five years following the completion of a project unless the gov't or funding agency requires longer.
Regards,
Michael
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Policy on Retention of and Access to Research Data
Issue Date: March 13, 2009
Contents:
I. Purpose and Scope
II. Policy Statements Regarding Ownership, Record Retention Responsibilities of Principal
Investigator, Access, and Disposition of Research Data Upon Departure
III. Notice to Retain Research Data
IV. Record Retention Responsibilities of the Medical Center
V. Administration of Policy
I. Purpose and Scope
Maintaining accurate and appropriate research records is essential for any research project. It
is necessary to support and substantiate funding, to protect intellectual property rights, to
facilitate management of the NYU Langone Medical Center's research program, to ensure
compliance with federal regulations and to address questions regarding research projects.
This Policy sets forth the rights and responsibilities of the Medical Center, the Principal
Investigator and all other investigators with respect to ownership, access, use and maintenance
of original Research Data created in connection with the design, conduct or reporting of
research performed at or under the auspices of NYU Langone Medical Center ("Research"). It
applies to all Medical Center faculty, staff, students, postdoctoral fellows, residents, trainees,
visiting scholars, and any other persons involved in the design, conduct or reporting of
Research, regardless of funding source or location.
For purposes of this Policy, "Research Data" means any recorded, retrievable information,
necessary for the reconstruction and evaluation of reported results of Research and the events
and processes leading to those results, regardless of the physical form or media, as well as the
materials and products generated by the Research. It includes research notes, laboratory
notebooks, case history records, study protocols, samples of chemicals and materials
synthesized during research, filed specimens, samples of human or animal tissue, tissue
databases, voucher specimens, computer files or other electronic data, software programs and
databases (including documentation thereof) and video and audio tapes, as well as the
synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA, DNA
sequences, mapping information, crystallographic coordinates, plants, animals, and
spectroscopic data generated as a result of the Research.
II. Policy Statements
A. Ownership
Research Data belong to the School of Medicine unless the School expressly waives ownership
rights under the applicable grant, contract, or agreement with a sponsor ("Sponsored Research
Agreement"), in which event the provisions of the Sponsored Research Agreement shall control.
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B. Record Retention Responsibilities of Principal Investigator
The Principal Investigator is responsible for the collection, management and retention of
Research Data. The Principal Investigator shall adopt an orderly system of data organization
which dates the records being retained, and communicate the system to all research
participants. Particularly for long-term projects, the Principal Investigator shall implement
procedures for the protection of essential Research Data in the event of a natural disaster or
other emergency. Research Data shall be retained in the unit where they are produced, unless
specific permission to do otherwise is granted by the Department Chair.
All Research Data shall be retained for the longer of (i) three years after the final project closeout
or (ii) five years after the final reporting or publication of a project except as follows:
1. Research Data arising out of sponsored research must be retained for the time
period specified in the Sponsored Research Agreement;
2. Research Data relating to projects subject to the review of the Institutional Review
Board (IRB) must be retained until five (5) years after the completion of the project;
3. Research Data that incorporates Protected Health Information (PHI) or other
pertinent human subject information (e.g., medical records, protocols, case history
forms, progress reports and final reports) must be retained for the period mandated
by New York State law (six years from date of discharge or three years after the
patient's age of majority (18 years), whichever is longer, or at least six years after
death);
4. Research Data relating to clinical trials involving an investigational drug or device
must be retained until two (2) years following the date the applicable FDA marketing
application is approved or, where the investigation is discontinued, two years from
the date that the FDA is notified that no marketing application will be filed; and
5. Research Data relating to a student project must be retained at least until the degree
is granted or it is clear that the student has abandoned the work.
6. Research Data in the form of human or animal tissues in institutional tissue banks
shall be retained so long as such tissues have commercial or scientific value.
Research Data must not be destroyed or altered during the required retention periods unless
written approval for such disposition is received from the Vice Dean for Science. Unless you
have been notified by Medical Center administration not to destroy Research Data (see Section
III below), the Research Data may be destroyed at the discretion of the Principal Investigator
and his/her department or laboratory following the applicable specified retention period.
If the retention obligations cannot be carried out by the Principal Investigator (e.g., the death or
disability of the Principal Investigator), the Department Chair shall assume responsibility for the
Research Data or shall appoint a successor investigator to carry out the obligations.
C. Access
The Medical Center has the right of access to the Research Data regardless of the location of
the responsible Principal Investigator. If the Medical Center believes it necessary for safekeeping,
the Medical Center may take physical custody of any Research Data in a manner
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specified by the Vice Dean for Science. Government officials and research sponsors shall have
access to Research Data to the degree specified in the Sponsor Research Agreement. Medical
Center Investigators associated with a research project shall also have the right to review all
records of Research Data relating to the project.
D. Disposition of Research Data upon Departure
Original Research Data must be retained at the Medical Center unless transfer of the Research
Data with the Principal Investigator is authorized by the Vice Dean for Science. Any investigator
who leaves the Medical Center may, to the extent feasible, take copies of the Research Data in
which the investigator is involved. If permitted by the applicable Sponsored Research
Agreement, the Vice Dean for Science may grant approval for transfer of original Research Data
to the Principal Investigator's new institution, provided that the new institution executes a written
agreement with the School of Medicine whereby the new institution (i) acknowledges the School
of Medicine's continued ownership of, and accepts custodial responsibilities for, the Research
Data, (ii) grants access to the Research Data to the Medical Center and any other party with a
right to access under this Policy, and (iii) agrees to return the original Research Data to the
Medical Center upon request, and the Principal Investigator agrees in writing with the School of
Medicine to comply with this Policy.
III. Notice to Retain Research Data
There may be situations where Research Data must be retained for periods beyond the time
frames specified in Section II(B) above. If the Medical Center gives the Principal Investigator
notice directing the Principal Investigator to segregate and retain Research Data for any reason,
including those noted below, or the Principal Investigator is independently aware of any of the
following events, the Principal Investigator shall retain such Research Data until further notice.
1. An investigation or audit (conducted either internally or by a governmental
agency), lawsuit, administrative proceeding or other form of legal process;
2. Research Data is required to obtain, protect and or defend intellectual property
rights resulting from the Research; and
3. An allegation of financial or scientific misconduct or conflict of interest has been
made.
IV. Record Retention Responsibilities of the Medical Center
As the owner of the Research Data, the Medical Center will assert its rights with respect to
Research Data in order to assure compliance with regulatory and contractual requirements. The
Medical Center will maintain financial records, supporting documents and all other records
pertinent to an award for Research for the periods required by OMB Circular A-110, Sect. 53
and this Policy.
V. Administration of Policy
Any disputes arising out of this Policy shall be adjudicated by the Vice Dean for Science. Any
questions relating to this Policy should be directed to the Office of Legal Counsel or the Office of
Research Compliance.