Data Use Agreements (DUAs)
Good morning,
Does your IRB require an executed DUA for IRB approval for a study that required health department data? For us, this approach would mean providing conditional approval and then waiting weeks to months before providing final approval, during which lawyers from the state and the data requestor's organization go back and forth etc, and then writing a final approval letter. I prefer not to have so many protocols in a holding pattern.
Thanks in advance for responses.
Does your IRB require an executed DUA for IRB approval for a study that required health department data? For us, this approach would mean providing conditional approval and then waiting weeks to months before providing final approval, during which lawyers from the state and the data requestor's organization go back and forth etc, and then writing a final approval letter. I prefer not to have so many protocols in a holding pattern.
Thanks in advance for responses.
Jessica
Jessica M. Robbins, Ph.D.
Public Health Epidemiologist
PDPH / AHS
500 South Broad Street, Philadelphia, PA 19146
jessica.robbins@phila.gov
IRB Administrator
Philadelphia Department of Public Health
1900 North 20th Street, Philadelphia, PA 19121
(215) 685-0869 / Fax (215) 685-0867
<https://www.phila.gov/services/mental-physical-health/medical-professionals/submit-a-research-study-to-the-institutional-review-board-irb/>http://www.phila.gov/health/irb
pronouns: she/her/hers
All data contained on this system is owned by the City of Philadelphia and it may be monitored, intercepted, recorded, read, copied, or captured in any manner or disclosed in any manner by authorized persons. There is no right of privacy on this system.
[cid:1b5499e6-96b3-4a35-9ad5-844d54ca3475]
Our IRB verifies a data use agreement is being drafted at the time of review, but our legal/compliance staff won't fully execute an agreement unless the IRB has approved or granted an exemption for the research. Rather than make approval conditional, it is not uncommon for us to affirm in our communications some of the language from the protocol that indicates a data use agreement will be a component of the data protections for the research. That is to say, we often include a statement like: "Data must not be used or disclosed for this research without a fully executed data use agreement," in the determination notices we issue.
Best,
-Ian
This sounds like a lot of time; however, it has added 2-3 weeks to the overall time-frame. The DUA used has been standardized and reviewed by our legal team. As the IRB administrator I do have some additional work; however, this has ensured that no data is released until all agreements are complete and allows for one comprehensive package. The PI's like it because there is only one contact person to deal with.
IRB approval of the study does not obligate any City agency or department to participate in the study, or to carry out any specific activities. Participation in all research activities is at the discretion of unit managers.
Approval by the IRB does not, in and of itself, constitute approval for the implementation of this research. Other City approvals may be required before study activities are initiated. Research undertaken in conjunction with individuals or entities external to the City will typically require a data license agreement or other contractual arrangement. If any of these approvals require changes to the IRB-approved protocol, recruitment materials, or informed consent/assent document(s), the changes must be submitted to and approved by the IRB prior to beginning the research study. Principal investigators are responsible for assuring receipt of all required approvals.
We cribbed some of that from somebody else, maybe Penn.
Jessica
Jessica M. Robbins, Ph.D.
Public Health Epidemiologist
PDPH / AHS
500 South Broad Street, Philadelphia, PA 19146
jessica.robbins@phila.gov
IRB Administrator
Philadelphia Department of Public Health
1900 North 20th Street, Philadelphia, PA 19121
(215) 685-0869 / Fax (215) 685-0867
<https://www.phila.gov/services/mental-physical-health/medical-professionals/submit-a-research-study-to-the-institutional-review-board-irb/>http://www.phila.gov/health/irb
pronouns: she/her/hers
All data contained on this system is owned by the City of Philadelphia and it may be monitored, intercepted, recorded, read, copied, or captured in any manner or disclosed in any manner by authorized persons. There is no right of privacy on this system.
[cid:38f7cb07-515b-41b3-ab5f-65572e55201c]
Janice Hicks, PhD
IRB Coordinator
Evaren Page, MPH | Director of Science and Institutional Review Board (IRB)
Center for Health Statistics | Oklahoma State Department of Health
p. 405-426-8022 | f. 405-271-9061
Oklahoma.gov<https://oklahoma.gov/> | health.ok.gov<http://omes.ok.gov/>
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