Pitt Research
Office of Research Protections

Do You Know Where Your Data Are?

Online journal clubs such as PubPeer and tools such as ImageTwin have greatly increased scrutiny of published literature, and accordingly have precipitated an increasing number of research integrity concerns. Such concerns are straightforward to address if a lab’s primary data are well-archived and easily retrieved, but difficult to counter if an investigator cannot substantiate the legitimacy of their findings.

The University’s standard is that data must be retained for seven years after the conclusion of a study. Policies of the National Institutes of Health require data to be retained for three years past the end of the grant, and the National Science Foundation has similar data retention policies.

Principal investigators must be able to retrieve their lab’s data on demand, including that collected by trainees and collaborators who have departed. Inability to provide original data during a research integrity assessment or inquiry may lead to sanctions from the University or a funding agency, as well as retraction of an article from a journal.

Clinical Investigators: Be Careful When Recruiting Subjects in Other States Via Telehealth Visits

Although virtual study visits are increasingly common, there are restrictions on providing FDA-regulated medications and devices for clinical studies when research interactions are done entirely remotely, particularly for subjects in other states.  In addition, prescription of controlled substances to subjects in Pennsylvania visited exclusively online can be problematic.  Such restrictions are related to state-specific telemedicine and physician licensure requirements. Investigators who are contemplating an interventional clinical study that involves entirely virtual visits with subjects in other states, or for provision of a controlled substance, should contact the Human Research Protection Office for advice.

 

Clinical Investigators: A New University-Wide Agreement with Contract Research Organizations May Benefit Your Studies


Support from a Contract Research Organization (CRO) may be beneficial to Pitt clinical researchers, especially those doing multi-center trials involving investigational drugs and devices, to ensure regulatory compliance. Examples of CRO services include multi-center trial monitoring, project management, database development, data management and regulatory support.

To facilitate clinical investigators entering into a contract with a CRO, ORP, in cooperation with the University’s Purchasing Services Department, has executed three University-wide Contracted Suppliers Agreements with the following:

Details can be found at the Purchase, Pay & Travel website. Support for studies involving investigational drugs and devices can be obtained by emailing IIS@pitt.edu.

Hosting a Visitor this Summer? The Visitor Policy Ensures that Everyone is Protected

Compliance with the Visitor Policy ensures that both our guests and the University are protected. It is particularly important to properly onboard visitors who are working in laboratories to ensure they are adequately trained, receive required regulatory approvals, and are identified in the system of record as having the right to be on campus. A University member may be sanctioned if they host a visitation that is not properly approved.

Questions about the Visitor Policy should be directed to the Visitor Liaison by email or phone (412-624-2116).

 

Are You Leaving Pitt this Summer? Let Us Help Close Out Your Work Correctly!


Ending a research career at an institution, whether you are retiring or moving to another university, can be very complicated. Labs need to be decommissioned, data must be provided for retention, and grants may need to be transferred, amongst many other tasks. However, we can help!

If you are leaving Pitt, please refer to our Checklist for Investigators Leaving the University. Completing this online form will also alert relevant offices about your departure, and they will contact you to provide information.

Importing a Biologic for Your Lab? You Might Need a Permit

Incoming biologicals obtained via Office of Sponsored Programs material transfer agreements are screened by the University’s Import Permit Control program to determine federal permitting and/or documentation requirements. This is to ensure that shipments being received, both internationally and interstate, are not delayed in transit upon review by the carriers or Customs and Border Protection. Information and links on how to obtain a permit, if needed, will be provided to the investigators. Import Control can also be reached at tradecompliance@pitt.edu to proactively provide permitting information to investigators to ensure timely approvals of agreements. More information on the kinds of materials covered can be found here.

 

Reminders about Disclosures

Annual Disclosure Certifications were due by April 15th.  University employees who are required to disclose receive weekly email reminders from MyDisclosures with links to their certifications. If you are required to disclose but have not yet submitted your certification, please do so as soon as possible. 

Supervisor reviews of disclosures should be completed by June 15. 

As a general reminder, investigators in University research must disclose their financial interests in research associated with MyRA, ARO or PittPRO submissions. Following are two examples:

  • An investigator consults for a company and conducts University research sponsored by that company. The investigator must indicate a financial interest in the sponsored research agreement in MyRA.
  • An investigator creates a start-up company and conducts University animal research that will evaluate technology the start-up company has optioned from the University. The investigator must indicate a financial interest in the IACUC protocol.

Training videos for disclosers, supervisors and administrators are available here. Step-by-step instructions on how to complete disclosures, supervisor reviews and access MyDisclosures reports are available here. Guidance regarding disclosure requirements is available here.

If you have questions, please contact ORP’s Conflict of Interest Division at mydisclosures_support@pitt.edu.

 

ORP Support Service


Need help in ensuring that your research meets regulatory requirements and ethical standards?

Then use the ORP Support Service!

Just answer a few questions and we will put you in touch with the right professionals to help facilitate your research.

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