- What steps can I take to help to facilitate Office of Research processing?
When submitting contracts for Office of Research review, please review the Negotiations pages for a listing of the documentation required for each type of contract.
When inquiring about the status of a contract under review by the Office of Research, please remember to include the MyFunding or the MyRA ID as well as the PI's name and the other party with whom our University is contracting in your e-mail or phone inquiry.
- The submission forms required by the Clinical and Corporate Contract team have many compliance-related questions and I know I have seen references in some of my contracts. Where can I find information about these compliance areas?
- Use of human subjects
- Use of animals
- Use of hazardous materials and select agents
- Use of ionizing radiation
- Use of recombinant DNA
- Conflict of Interest
- Human Stem Cell Research Oversight Committee
- Export Controls
- Internet-Based Studies in Education and Research modules
- Committee for Oversight of Research and Clinical Training Involving Decedents (CORID)
- Office for Investigator-Sponsored IND and IDE Support (O3IS)
- What does "key personnel" mean?
The meaning of the term "Key Personnel" can vary depending upon whether the context is a contract or a grant. However, in general it refers to employees of the awardee who are engaged in the awarded project, listed in the award application, progress report, or any other report submitted to the sponsor and who are considered by the sponsor as essential resources in the work performance. (The sponsor may review the qualifications of any substitution of these individuals and require prior approval for replacement of said personnel.)
For the Clinical and Corporate Contract Team, Key Personnel refers to individuals who are specifically and uniquely important to the study. Key Personnel typically includes the principal investigators and coinvestigators, but is dependent upon the individual award. Departments may include lab technicians, research coordinators, etc. as Key Personnel if these individuals have a unique skill set that is required for the study. Please note that Key Personnel are required to complete the appropriate Conflict of Interest Faculty/Researcher filing at least annually (and during the year if they accrue new outside interests), as well as CITI modules relevant to the project.
- What Conflict of Interest disclosures and training do I need to complete before the Office of Research will endorse my award?
While the Office of Research has been closely involved in the implementation of the requirements for disclosure and training, it is important to understand that those requirements were created by other University offices in response to mandated changes from the federal government. Information on disclosures can be found on the Conflict of Interest homepage.
The COI training page also has extensive information on the training requirements applicable to the type of research being performed which is often determined by the funding source (PHS or non-PHS). There are distinct differences in the requirements dependent upon the type and source of funding. The COI Training page has comprehensive information that will assist in making both disclosure and training determinations.
The Research Conduct and Compliance Office is instrumental in providing updated information on training in conjunction with the COI Office. The RCCO has compiled a Research Training Requirements chart which nicely outlines the training requirements dependent upon the source of funding.
- What should be included in a Collaborator’s Scope of Work/Statement of Work (SOW) in an outgoing Subaward/Subcontract?
When preparing a request for an outgoing Subaward/Subcontract, one of the most critical elements is the Scope of Work (SOW). The SOW should provide a full and detailed explanation of the work to be conducted, including project goals, deliverables, reporting requirements, investigator responsibilities, as well as materials, drugs or devices to be exchanged between the University and the sites. It is typically one or two paragraphs and contains simple, non-scientific terms explaining what research will be performed at the Subrecipient site. The Scope of Work should not be the budget justification or the listing of specific aims from the proposal.
- Should a CDA cover the conduct of a research study?
No. A CDA should not be used to cover the actual conduct of research, as it would restrict the University and investigator's ability to publish or otherwise disseminate the results and knowledge gained by the research. In addition, the University may lose its ability to claim a fundamental research exemption from US Federal Export Control regulations if the results of research are restricted from dissemination. Appropriate provisions regarding confidentiality in the conduct of the research project shall appear in the sponsored research agreement itself.
- Should my disclosure agreement be two-way or one-way?
Use a "mutual" or two-way CDA when both you and the other party to the agreement exchange confidential information that should not be disclosed to third parties. Use a one-way CDA when only one party is disclosing confidential information and the other party is receiving that information.
- Is the Office of Research the only University of Pittsburgh Office that signs CDAs?
No. The Office of Research is the appropriate business office to sign confidentiality agreements that relate to research activities, but many other University offices sign agreements that pertain to their functional areas. For example, the Innovation Institute signs confidentiality agreements related to licensing and commercialization negotiations, and the Purchasing Department signs confidentiality agreements relative to negotiating the purchase of equipment and services.
- Should an investigator just sign his/her own CDA as the sole University signature?
No. In addition to the fact that an investigator is not authorized to sign a contract on behalf of the University, doing so puts the investigator in a position of potentially being held personally (and solely) responsible for any legal or business issues related to the agreement. Requiring the University to sign on behalf of the investigator, or in addition to the investigator, is the safest way to proceed. If the CDA is formatted by the other party to depict only an investigator as the party with only the investigator's signature, the Office of Research will alter the agreement as needed to include an institutional signature.
- When should I consider asking another party to complete a CDA?
You should consider the need for such an agreement any time you are disclosing information that is not generally available to the public, and which you wish to limit the other party's use or dissemination of. Examples might be sending a study of your design, or a protocol, to a pharmaceutical company, giving a lecture to a pharmaceutical company that discusses your unpublished research, or sharing a potentially patentable idea with a collaborator outside the University in the context of a grant proposal. It is always safest to complete a CDA anytime the disclosure involves information not already in the public domain. Just contact the Office of Research if you are not sure. In addition, if you are reducing the non-public information to written form, you should ensure that any of your hand-outs, PowerPoint presentations, emails, even the diagrams or notes generated in the course of the confidential meeting distributed by you to an outside party during a meeting or invited lecture are clearly marked "Confidential" on each page.
- Should a CDA cover issues like publication pre-review and intellectual property?
Typically these areas should not be addressed in a CDA, as a CDA should typically only allow use of provided information for evaluation purposes. The actual conduct of the project should be covered in a separate contract, like a clinical trial agreement or a sponsored research agreement. Accepting these kinds of clauses in a CDA can restrict the investigator or University from freely pursuing their research and results.
- If I receive information under a CDA, can I give it to other University of Pittsburgh employees?
Possibly, depending upon the terms of the CDA. It is always a good idea to check first, because some agreements limit disclosures strictly to the point of contact referenced in the agreement- usually the primary investigator. In this case, post doctoral fellows, students in the lab, and even other faculty collaborators would not be permitted to see the confidential information. A good rule of thumb to protect yourself and the University is to read your contract and even if a release is permitted, to limit exposure as much as possible. Do not allow anyone to access the confidential materials unless they absolutely must.
- Does the Office of Research sign CDAs for confidential information an investigator will receive in connection with outside employment or research as an independent consultant?
No. The University can only sign CDAs for University research purposes for an investigator who is acting in his/her role as a University employee. For activities related to outside employment, please refer to Outside Employment.
- Why sign a DUA?
DUAs address important issues such as limitations on use of the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data. The understanding established by the DUA can help avoid later issues and will ensure the appropriate use of data for a specific research project, protecting both the provider and the recipient.
Establishing a Data Use Agreement Achieves the Following:
- Protects the investment and reputation of both the investigator and the University
Access to important data makes an investigator more competitive in publications and grants; sharing of this data helps to foster collaboration with other leading scientists
- Ensures that the investigator and University receive academic credit for their work
Appropriate acknowledgement of the data's source in academic publications and presentations can be addressed in the DUA, although any determination of appropriate designation must be based on actual contribution of the research, and cannot be agreed upon in a DUA.
- Prevents the inappropriate use of intellectual property or protected or confidential information that could cause harm to research subjects, the investigator or the University
- Helps to shelter the investigator and University from any liability or loss arising from a recipient's use of University data
- Assures that the recipients are using the data in accordance with applicable law
Contractually obligates the recipient to use the data only for the purpose described in the DUA
Where data may be subject to HIPAA, ensures that appropriate restrictions on use are maintained
- Protects the investment and reputation of both the investigator and the University
- Who signs DUAs?
The University of Pittsburgh's Office of Research is authorized to enter into research agreements, including DUAs, on behalf of the University. Researchers are not authorized to negotiate or sign agreements on behalf of the University. When a researcher signs such an agreement on behalf of the University, the researcher could be subjected to legal and financial risks. It is important for the researcher to read the terms of the DUA before forwarding it to the Office of Research for signature. The Office of Research assumes that a researcher who submits a DUA has read it and agrees to conform to those terms, whether or not the researcher's signature is required on the DUA itself (Rights, Roles and Responsibilities of Sponsored Research Investigators). The Office of Research will confer with the Office of University Counsel and IRB or other pertinent compliance offices as required in the evaluation of DUAs.
- What are examples of data that might be exchanged under a DUA?
- Records from government agencies or corporation
- Human Research Subject Data
- A De-identified or Limited Data Set of Protected Health Information (PHI)
- Genetic sequences
- Proprietary or valuable information or material that does not fit the profile of a tangible physical material
- When do I need a DUA?
For Human Subject Data
- Disclosure of data for research purposes and
- Individual authorization for disclosure to this recipient is not/has not been obtained (from human subject, as through use of a subject-signed informed consent authorization) and
- Disclosure is permitted under an IRB-approved protocol (for human subject research) or
- The researcher is disclosing or receiving a "De-identified or Limited Data Set of Protected Health Information (PHI)", as defined under HIPAA.
- Please note that when a University researcher is receiving a Limited Data Set for research purposes from UPMC through the use of an honest broker, UPMC has approved a form of DUA that is acceptable to the University (http://www.irb.pitt.edu/hipaa#Identify/Recruit)
For Non-Clinical Data
- When no other form of contract concerning the data transfer exists between the provider and the recipient and
- When the data is not in the public domain, and the disclosing party wishes to limit the further use or distribution of the data in some way, and
- The recipient intends to use the data for research purposes
- When don't I need a DUA?
- When data is exchanged that is not subject to a legal or other restriction on its use.
- If a research subject signs a consent authorization form that authorizes data sharing with the recipient, a DUA is not needed.
- When de-identified data is exchanged for research purposes under a subcontract or other form of agreement with the recipient. "De-identified data" as used here has the meaning attributed in HIPAA.
- Do I need to make a MyRA DUA submission for NCBI dbGaP requests?
Yes, in addition to completing the NCBI dbGaP Data Access Application, investigators must initiate Office of Research review of the Project by submitting a MyRA DUA request. In doing so, investigators should select “NCI dbGaP” when prompted to upload an agreement draft.
- What is required for an NCBI dbGaP Project Renewal or Project Closeout?
For Project Renewals and Project Closeouts, investigators will receive automatic messages from the dbGaP system prompting them to login and complete the necessary renewal or closeout procedure. Once the Investigator updates and completes the application, it should be submitted for SO approval. Additionally, a MyRA Amendment is required to initiate Office of Research review and approval of the request.
- Are there any data security requirements for NCBI dbGaP Projects?
Yes. First, all Investigators and Collaborators are required to complete an IT security awareness module and supply a certificate to the Office of Research. This can be satisfied by completing the “NIH Information Security Awareness for New Hires” module, publicly available via this link: https://irtsectraining.nih.gov/public.aspx.
Also, Departmental IT Personnel are required to work with CSSD to complete an approved Data Security Plan. A CSSD Security Officer can assist with and provide approval for an adequate Data Security Plan. To initiate this process, IT Personnel should contact the CSSD Help Desk.
- Why sign an MTA?
The University of Pittsburgh's Office of Research is designated as the office to enter into research contracts on behalf of the University, and this includes MTAs. When a researcher signs such an agreement on behalf of the University of Pittsburgh, the researcher could be subjected to legal and financial risks. MTAs, while usually not conveying funding, are still binding documents with possible legal penalties for violations of the terms. It is important for the researcher to read the terms of an MTA before forwarding it for University signature. The Office of Research assumes that a researcher who forwards an MTA has read and agrees to conform to those terms (Rights, Roles and Responsibilities of Sponsored Research Investigators). The Office of Research will confer with the Office of University Counsel and the Innovation Institute as required.
- I need to order some materials from a repository like the NIH AIDS Reagent program. Do I need to submit anything to Office of Research (OR)?
Some repositories require registrations and some require MTAs. Some require both. If you are registering to use a repository, or if you are ordering a specific material, and the repository says that an institutional signature is required, then you will need to submit that documentation to the OR. If no institutional signature is required, no submission needs to be made to the OR. Registrations and material requests must be submitted as separate requests. Registrations are processed as “other” and material requests are handled as MTAs to receive materials.
- I am ordering material from ATCC. Do I need to submit an incoming MTA to Office of Research (OR)?
Pitt already has a master MTA agreement in place with ATCC that governs purchases from their general collection. No separate MTA is needed for general items, but you should follow Purchasing’s process outlined here: http://cfo.pitt.edu/pexpress/ATCC.php
ATCC does have some special collections, like BEI, that require a separate institutional signature from OR. If that separate institutional signature is required, then you will need to submit it to the OR, as an MTA to receive materials.
- I am a Pitt researcher, and I have a material I want to send to a repository so the repository can distribute it to other researchers. How do I submit that to the Office of Research?
Deposits like this are agreements to send research materials outside of Pitt, so please complete a MyRA submission for an MTA with a direction of transfer = sending.
- Ordering material from KOMP (The Knockout Mouse Project) Repository:
Q1: Do I need to submit an incoming MTA to the Office of Research?
A1: No. To obtain KOMP materials, no MTA submission is required in the Office of Research.
Q2: Why does the Office of Research no longer need an MTA submission for KOMP materials?
A2: The KOMP Repository is located at the University of California Davis and Children’s Hospital Oakland Research Institute. The Office of Research has signed a University-wide MTA with KOMP, therefore, individual MTAs are no longer needed with KOMP for each individual order. Please see this link for details: https://www.komp.org/mta.php
The University-wide MTA that has been signed covers the following types of KOMP materials:
- Embryonic Stem Cells
- Targeting Vectors
- Knockout Mice (including, without limitation, Embryos)
Q3: How do I obtain materials from KOMP?
A3: Place KOMP orders online at https://www.komp.org/
- For-Profit vs. Nonprofit MTAs- How are they different?
The transfer of materials to or from a nonprofit institution should be as unencumbered as possible. Typically, most universities and nonprofit entities use a simple agreement with few restrictions and agreement is reached expeditiously.
The transfer of materials to or from the for-profit sector is usually more complex, as the corporate entity has an often aggressive interest in protecting its proprietary rights, a stance that can lead to restrictive language in the agreement that the University of Pittsburgh cannot accept. There are also a number of differing contractual formats for transfer of materials from industry, and MTAs can even be called by different names. Therefore, for incoming materials, we must evaluate each case individually and this takes time. For outgoing materials, all recipients must use our template form of contract.
- Do we still need a Cre-Lox license?
The University of Pittsburgh had a Cre-Lox license originally signed in 1997 and updated in 2007. Cre-Lox was a tool developed by DuPont for site-specific recombination of DNA in eukaryotic cells. It regulates the expression of engineered genes at Lox sites through activation of a regulatory sequence that controls the expression of the recombinase Cre gene. Cells can be grown, then turned on, to make the transcript of choice. We have been advised that the US patents for this technology have expired, and use no longer requires a license. Thus the license agreement is terminated.
- Who can sign a research contract?
The University of Pittsburgh's Office of Research is designated as the office to enter into research contracts on behalf of the University. This includes MTAs and other non-financial agreement which relate to research as well as those research contracts involving funding from a corporate entity. When a researcher attempts to sign such an agreement on behalf of the University of Pittsburgh, the researcher could be subjected to personal legal and financial risks.
- Should a PI or department staff member negotiate their own contract?
Never. The Office of Research is the only official office authorized to accept binding terms in research contracts on behalf of the University. The PI and department are certainly permitted (and are encouraged) to discuss the scope of work and the budget with a sponsor, but the rest of the contract terms are the purview of the Office of Research. Only those terms reflected in the final, executed contract are binding on the parties. Communications between the PI/department and the sponsor may lead to confusion over the contract terms.
It is important for the researcher to read the terms of all research agreements before transmitting it for University signature. The Office of Research assumes that a researcher who transmits a contract has read and agrees to conform to those terms (Rights, Roles and Responsibilities of Sponsored Research Investigators). Note: The Office of Research will confer with the Office of University Counsel and the Innovation Institute, or any necessary compliance office as required in the review and negotiation of any research contract.
- What is the role of the UPMC OSPARS and how do we work together?
The UPMC OSPARS handles a subset of corporate clinical trials under a formal agreement between the University of Pittsburgh and UPMC for the purpose of facilitating the implementation of industry-initiated and sponsored clinical trials being conducted by Physician Services Division (PSD) or UPMC investigators within the UPMC environment. The purview of the UPMC OSPARS with respect to corporate clinical trials is limited to industry-initiated and sponsored clinical trials of drugs and devices conducted within a UPMC or University of Pittsburgh Physicians (UPP) facility or conducted under the direction of a UPMC or UPP staff member in connection with his/her UPMC and/or UPP responsibilities, appointments and clinical privileges, as appropriate.
Checklist of Applicability for Corporate Clinical Trial Submission to UPMC OSPARS
- Was any University of Pittsburgh faculty or staff member involved substantially in the development of the clinical trial protocol?
- Does any University of Pittsburgh faculty or staff member serve as the investigator-sponsor of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) for the experimental drug or device being evaluated in the clinical trial?
- Is the conduct of this clinical trial being financially supported by any entity other than the industry sponsor and, possibly, the clinical department/division to whom the principal investigator reports?
- Will the clinical trial procedures be performed exclusively within a University facility without any use of UPMC patients, records, or facilities (i.e., this does not apply to University-owned buildings leased by UPMC)?
- Does the experimental drug or device being evaluated in the clinical trial 1) emit ionizing radiation; 2) involve a gene transfer intervention; or 3) involve a transgenic xenotransplant?
If the answer to ALL of the above questions is "NO", the clinical trial should be routed to UPMC OSPARS for processing. Connect the UPMC OSPARS office at (412) 647-4666 for details.