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Pitt Research
Office of Research Protections

Common Funding Agency Disclosure Forms for Other Support and Biographical Sketches

On August 7th, the National Science Foundation (NSF) released in the federal register a draft version of common disclosure forms for the Biographical Sketch and Current and Pending (Other) Support sections of an application for federal research and development (R&D) grants or cooperative agreements.  NSF is now seeking public comment on any potential flaws in the proposed common forms. 

The public has 30 days in which to submit comments, after which time the Office of Management and Budget (OMB) will approve a final version that must be adopted by federal agencies within their application processes.  The goal of these common forms is to obtain similar information across federal agencies in order to increase clarity and reduce administrative burden. 

All named senior key personnel on federal R&D applications will be required to complete the forms and certify that the information contained on the forms is current, accurate and complete.  Further, all named senior and key personnel must also certify that they are not a party in a malign foreign talent recruitment program.

What is a Malign Foreign Talent Recruitment Program?


Section 19232 of the CHIPS and Science Act of 2022 prohibits federal employees, contractors, and awardees—including institutions, individual investigators, and other key personnel—from participating in Malign Foreign Talent Recruitment Programs (MFTRPs).

MFTRPs are defined as any type of foreign program, position or activity containing financial or in-kind compensation that involves one or more of the following characteristics:

  • Unauthorized transfer of intellectual property (IP), materials or data developed through a federal R&D award,
  • Required recruitment of trainees or other researchers to enroll in such program, position, or activity,
  • Accepting appointments or employment in a foreign country that would conflict with federal R&D award terms and conditions,
  • Difficult termination clauses,
  • Confidentiality of foreign program participation and non-disclosure to one’s primary appointment institution and federal research sponsors,
  • Participation in program activities that would overlap directly with a federally funded R&D award,
  • Any program sponsored by a country of concern or entity therein (China, Russia, Iran, North Korea).

Pitt researchers, staff, and students who are—or plan to be—named as senior and key personnel on federal applications need to be aware of this expanding prohibition by following all federal agency and University disclosure practices. These include the University’s conflict of interest disclosure policy, outside employment policy and all federal agency disclosure rules addressing current and pending other support, biographical sketch, and foreign components. 

Onboarding New Investigators


We have found that connecting new investigators with relevant ORP representatives (such as from the IRB or IACUC) is helpful in jumpstarting their career. These meetings provide individualized assistance in protocol writing, regulatory compliance, and also establish a point-of-contact that is helpful in addressing questions in the future. New investigators have indicated that such initial, personalized meetings are highly useful. 

If you are interested in our onboarding services, please complete this short survey so we can determine your needs:

https://pitt.co1.qualtrics.com/jfe/form/SV_bHQXJH10KgtGTOe

Visit our site to learn more. 

Recap: Basic Biomedical Researcher Symposium

Earlier this month, ORP hosted its annual Basic Biomedical Researcher Symposium, which was an opportunity for new—and established—researchers to learn more about research-related offices and departments at Pitt. The symposium featured 10 speakers from across the University, who provided a comprehensive view of the resources and services available to Pitt researchers. 

The presentations can be viewed by clicking the links below:

 

New Directed or Sole Source Justification Form


Purchasing Services recently revised the Directed or Sole Source Justification Form, commonly known as the “DSSJF.” In accordance with University policy FN 08, Purchasing Services uses the DSSJF to document why a supplier is being utilized that was not selected through the University’s competitive bidding process or that was not the lowest bid.

Among other updates, the new DSSJF clarifies that the Requestor must be the person who is most intimately familiar with the product or service being used. Generally, this will be the Principal Investigator, scientist or department user. The Requestor will rarely be the department administrator. The Requestor’s Primary Supervisor, as identified in MyDisclosures, must sign the DSSJF to approve the request.

The DSSJF Requestor and their Primary Supervisor must be in compliance with University conflict of interest policies FN 06, ER 02, ER 03, and RI 01, including completion of current Annual Disclosure Certifications in MyDisclosures. Additionally, Requestors and their Primary Supervisors, in accordance with ER 02 and its definition of “Related Persons,” must inform Purchasing Services about any relationships they or a family member have with the recommended supplier, including their spouse, domestic partner, children, siblings, or parents.

Starting October 1, 2023, all directed or sole source requests must be submitted to Purchasing Services using the new DSSJF. For more information, visit the Purchasing Services website.

ClinicalTrials.gov - Enhanced Scrutiny of Reporting by NIH and FDA

ClinicalTrials.gov is a public database containing information about federally and privately supported clinical trials for an array of diseases and conditions, managed by the National Library of Medicine. Clinical trials registration and results reporting is required by law for all Applicable Clinical Trials, for clinical trials funded by the National Institutes of Health (NIH), and for investigators wishing to publish trial information in an International Committee of Medical Journal Editors (ICMJE) journal.

Scrutiny surrounding noncompliance with ClinicalTrials.gov results-reporting requirements continues to grow. The Food and Drug Administration (FDA) recently issued a notice of noncompliance to a pharmaceutical company, giving the company 30 days to respond. The FDA also threatened monetary fines and prosecution for failing to report results.

The NIH have also heightened their oversight of ClinicalTrials.gov reporting. In cases where investigators are not in compliance with reporting requirements, the NIH funding agency may send a letter to the institution, requesting a remediation plan. Noncompliance with ClincalTrials.gov reporting has the potential to impact current and future federal funding. 

If you receive a compliance enforcement letter regarding ClinicalTrials.gov reporting, please notify us immediately so that we can assist in resolving the issue quickly and efficiently. Further information about clinical trial registration requirements is summarized on the Clinical Trial Registration and Transparency Support website, and you may also contact us at CTgov@pitt.edu for directed guidance.

 

Moving Biological Materials to Pitt? You May Need an Import License


An import license, permit, or other certification may be required to import a biologic agent, including plant material, from another state or country.  The Office of Trade Compliance (OTC) partners with the Office of Sponsored Programs (OSP) to review Material Transfer Agreements (MTA) for biologic materials that include animals, viruses and vectors, cell lines, plasmids, bacterial agents and plant materials. In cases not involving an MTA, OTC works directly with the Pitt member to conduct import reviews to determine necessary permitting requirements.

Please contact the Office of Trade Compliance if you are importing a biologic agent, so they can assist you in determining permitting requirements. Contact them at: tradecompliance@pitt.edu.

Report Any Concerns through the Pitt Concern Connection

The Pitt Concern Connection enables our campus communities to elevate irregular or troublesome workplace, academic, and other issues so that they can be reviewed, addressed, and resolved.

You can report an issue online, by telephone or via text message.  Information on confidentiality and non-retaliation can be found here.

For more details about submitting a report, refer to this quick guide.

 
Make a Report to the Pitt Concern Connection

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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