176 ยท Representative Documents: Data Retention Policies
EMORY UNIVERSITY
Section 7.9.02C: Access to and Retention of Scientific Research Protocols and Data
http://policies.emory.edu/7.9
request and after execution of a material substance transfer agreement. The senior investigator should have the
latitude to make a fair and balanced response to requests for all research substances, including novel compounds
and reagents.
Clinical research requires special attention to issues of informed consent and confidentiality. Because patients have 5.
a right to assume that decision about their treatments are made in their best interests, the physician-investigator
should disclose all significant alternatives and risks to patient-subjects so that they can make an informed judgment
about participation. Signed copies of informed consent must be placed in the patient's clinical records as well as
with research records. Clinical research records remain the property of the University the administrative heads of
the department/division of the faculty conducting clinical trials are responsible for maintenance of the records.
Faculty members may make copies of the records upon departure from the University, as well as the company
which sponsors the clinical trials.
C. Access to and Retention of Scientific Research Protocols and Data
Both the research director and the University have responsibilities and, hence, rights concerning access to, use of, 1.
and maintenance of original research data. ("Ownership of Research Data". Estelle A. Fishbein, Academic Medicine,
66:129, 1992 and "Workshop Summary". L.J. Rhoades, Data Management in Biomedical Research: Report of a
Workshop, USPHS, pp. 2-9, 1990.) Consistent with the precepts of academic freedom and intellectual integrity, the
investigator/scholar has the primary authority to make judgments involving the use and dissemination of the data.
Each faculty member/preceptor is ultimately responsible for the maintenance and proper retention of research 2.
records. These records should include sufficient detail to permit examination for the purposes of replicating the
research, responding to questions that may result from unintentional error or misinterpretation, establishing their
authenticity, and confirming the validity of the conclusions.
Each preceptor should maintain a laboratory manual that describes all major procedures. Correspondence with 3.
institutional review committees and records of the use of controlled substances and radioactive materials should be
maintained as part of the research record in accordance with governmental, regulatory, and University policies.
A standardized system of data organization should be adopted and should be communicated to all members of a 4.
research group and to the appropriate administrative person. The appropriate administrative person should be
determined by the sub-unit.
Where feasible, all original primary data are to retained by the faculty member or by his or her designee. Accepted 5.
practices for retaining data vary among disciplines and depends on the perishability nature and logistics of retaining
each type of data. Each investigator should treat data properly to ensure authenticity, reproducibility and validity
and to meet the requirements of relevant grants and other agreements concerning the retention of data. Primary
data should be reserved for a reasonable duration to ensure that any questions raised by the researcher, colleagues,
or readers of any published results can be answered. It is recommended that, where feasible, data be retained for
seven years in circumstances where there are no federal or other requirements such as those referred to in the
Appendix, sub-units of the University may wish to establish uniform standards and procedures for retention and
destruction of data. Data should not be destroyed without proper notification of and approval by an appropriate
administrative person. In unusual cases (e.g., data used for a patent application filed by the University), it may be
necessary for original data to be kept at the University. Potentially patentable data should be signed and dated by
the preceptor at the time they are entered into notebooks or maintained by other methods of retention in the event
the results are questioned.
In the event the scholar leaves the University, an Agreement of Disposition of Research Data may be negotiated by 6.
the scholar and the department chair or dean to allow the scholar's data, notebooks, and other data retention
materials (other than clinical research records) to be transferred to the new institution. Consistent with the same
precepts, and to fulfill its obligations to funding sources and others, the University will ensure in such agreements
access to the transferred data for purposes of review. In unusual cases (e.g., data used for a patent application filed
by the University) it may be necessary for original data to be kept at the University. In such cases an individual
written agreement shall be signed which preserves the scholar's right to access and copy (where practical) such
data. In cases of multi- institutional studies, the institution of the primary study director is ultimately responsible for
guaranteeing appropriate access to, use of, and retention of original data.
7.9.03 References
"Policies and Procedures for Investigation of Misconduct in Research", Emory University, 2 March 1989.
Modified from "Ethical Guidelines for Publications of Research", Endocrine Reviews, 10:1, 1989.
"Authorship and Other Credits", N. Fotion and C. C. Conrad, Annals of Internal Medicine, 100:592, 1984.
Adapted from S. J. bird, President's Remarks, "Professional Responsibility", AWIS Magazine, 20:2, 1991.
"Ownership of Research Data", Estelle A. Fishbein, Academic Medicine, 66:129. 1992.
EMORY UNIVERSITY
Section 7.9.02C: Access to and Retention of Scientific Research Protocols and Data
http://policies.emory.edu/7.9
request and after execution of a material substance transfer agreement. The senior investigator should have the
latitude to make a fair and balanced response to requests for all research substances, including novel compounds
and reagents.
Clinical research requires special attention to issues of informed consent and confidentiality. Because patients have 5.
a right to assume that decision about their treatments are made in their best interests, the physician-investigator
should disclose all significant alternatives and risks to patient-subjects so that they can make an informed judgment
about participation. Signed copies of informed consent must be placed in the patient's clinical records as well as
with research records. Clinical research records remain the property of the University the administrative heads of
the department/division of the faculty conducting clinical trials are responsible for maintenance of the records.
Faculty members may make copies of the records upon departure from the University, as well as the company
which sponsors the clinical trials.
C. Access to and Retention of Scientific Research Protocols and Data
Both the research director and the University have responsibilities and, hence, rights concerning access to, use of, 1.
and maintenance of original research data. ("Ownership of Research Data". Estelle A. Fishbein, Academic Medicine,
66:129, 1992 and "Workshop Summary". L.J. Rhoades, Data Management in Biomedical Research: Report of a
Workshop, USPHS, pp. 2-9, 1990.) Consistent with the precepts of academic freedom and intellectual integrity, the
investigator/scholar has the primary authority to make judgments involving the use and dissemination of the data.
Each faculty member/preceptor is ultimately responsible for the maintenance and proper retention of research 2.
records. These records should include sufficient detail to permit examination for the purposes of replicating the
research, responding to questions that may result from unintentional error or misinterpretation, establishing their
authenticity, and confirming the validity of the conclusions.
Each preceptor should maintain a laboratory manual that describes all major procedures. Correspondence with 3.
institutional review committees and records of the use of controlled substances and radioactive materials should be
maintained as part of the research record in accordance with governmental, regulatory, and University policies.
A standardized system of data organization should be adopted and should be communicated to all members of a 4.
research group and to the appropriate administrative person. The appropriate administrative person should be
determined by the sub-unit.
Where feasible, all original primary data are to retained by the faculty member or by his or her designee. Accepted 5.
practices for retaining data vary among disciplines and depends on the perishability nature and logistics of retaining
each type of data. Each investigator should treat data properly to ensure authenticity, reproducibility and validity
and to meet the requirements of relevant grants and other agreements concerning the retention of data. Primary
data should be reserved for a reasonable duration to ensure that any questions raised by the researcher, colleagues,
or readers of any published results can be answered. It is recommended that, where feasible, data be retained for
seven years in circumstances where there are no federal or other requirements such as those referred to in the
Appendix, sub-units of the University may wish to establish uniform standards and procedures for retention and
destruction of data. Data should not be destroyed without proper notification of and approval by an appropriate
administrative person. In unusual cases (e.g., data used for a patent application filed by the University), it may be
necessary for original data to be kept at the University. Potentially patentable data should be signed and dated by
the preceptor at the time they are entered into notebooks or maintained by other methods of retention in the event
the results are questioned.
In the event the scholar leaves the University, an Agreement of Disposition of Research Data may be negotiated by 6.
the scholar and the department chair or dean to allow the scholar's data, notebooks, and other data retention
materials (other than clinical research records) to be transferred to the new institution. Consistent with the same
precepts, and to fulfill its obligations to funding sources and others, the University will ensure in such agreements
access to the transferred data for purposes of review. In unusual cases (e.g., data used for a patent application filed
by the University) it may be necessary for original data to be kept at the University. In such cases an individual
written agreement shall be signed which preserves the scholar's right to access and copy (where practical) such
data. In cases of multi- institutional studies, the institution of the primary study director is ultimately responsible for
guaranteeing appropriate access to, use of, and retention of original data.
7.9.03 References
"Policies and Procedures for Investigation of Misconduct in Research", Emory University, 2 March 1989.
Modified from "Ethical Guidelines for Publications of Research", Endocrine Reviews, 10:1, 1989.
"Authorship and Other Credits", N. Fotion and C. C. Conrad, Annals of Internal Medicine, 100:592, 1984.
Adapted from S. J. bird, President's Remarks, "Professional Responsibility", AWIS Magazine, 20:2, 1991.
"Ownership of Research Data", Estelle A. Fishbein, Academic Medicine, 66:129. 1992.
