PI Roles and Responsibilities

Cheryl Dykstra-Aiello: Okay, I’m going to get started. Thanks for joining this information session about PI Roles and Responsibilities. My name is Cheryl Dykstra-Aiello. I am a research development specialist in Advancement and Strategy in the Office of Research.

Cheryl Dykstra-Aiello: So jumping right in, a PI’s role is a shared responsibility, when it comes to sponsored project award management.

Cheryl Dykstra-Aiello: But you can’t share that responsibility with your assisting admin staff. So you’re the, the primary responsibility still lies with the PI You are the, the primary, person responsible for achieving the project’s technical success and for remaining in compliance with all of the financial administrative policies and regulations that are associated with your award. The Office of Research, though, is here to, help you.

Cheryl Dykstra-Aiello: And we have resources on the Office of Research website for researchers, to stay in compliance. We have guidelines and policies and federal updates, on the site. The federal updates are obviously quite important in today’s environment. So if you are not aware of those pages, then please check them out. One thing I forgot to mention is that these slides will be available to you.

Cheryl Dykstra-Aiello: They’ll be sent out in an email, at some point, later today or this week. And they’ll be uploaded to our website so you can access them there. Support and Operations are, they support you beyond the submission of your proposal. So they provide you with a list of responsibilities on their website and that’s linked here.

Cheryl Dykstra-Aiello: So anything in these slides that’s in red font and underlined is actually a link to, a website. So when you get the slides you will have that, that information available at your fingertips. Support and Operations also has guidelines, policies and regulations on their website. They have data security requirements and data and publication, reporting information. So you can, check that out.

Cheryl Dykstra-Aiello: Research Assurances. They are the ones that oversee the safety committees. And they, oversee the IRB and IACUC, they look after, making sure that you’re in compliance when you are dealing with hazardous materials and with export control. And then, they also, through IACUC they are also involved with the campus veterinarian. So these are some of the guidelines and policies that you can find on the Office of Research website.

Cheryl Dykstra-Aiello: And they are there for your information. I encourage you to check them out. Each one of these is a link to, to those guidelines and policies, specifically, you’ll be interested in the research integrity and misconduct. I’ll go over that today. But you can also find information there about generative generative AI, etc.. Do I have a question?

Cheryl Dykstra-Aiello: Lisa.

Lisa: Hi, Cheryl. This is Lisa. I just, I’ve been encountering a lot of, situations lately where the, faculty have not realized that surveys, require IRB. So if you, I’m hoping you’ll be addressing that today.

Cheryl Dykstra-Aiello: Well, I was not, but thank you very much for mentioning that, and, I it will definitely be covered next week.

Cheryl Dykstra-Aiello: I’m just kind of giving an, a general overview of PI responsibilities, and, and, Assurances our assurance office will be definitely covering that in next week’s information session. But thank you for mentioning that, Lisa. And I hope everyone heard that that surveys definitely fall under the IRB.

Cheryl Dykstra-Aiello: So one of the items that you can find on the course or website is this research administration process. They will give you, a listing of, the responsibilities and who is responsible for what. And it it is actually a really good resource. Today I’m going to cover award acceptance, set up subrecipient monitoring, award management and maintenance and the compliance issues.

Cheryl Dykstra-Aiello: And again, I’ll just be giving a broad overview of those, research Assurances are your contact for that. And I do encourage you to attend the the information session next week. I’m not going to be going over pre award. First four items on this list have been covered under the information sessions that have been previously given this semester on the the the grant process here at WSU.

Cheryl Dykstra-Aiello: And so and I’ll also touch briefly on preparing and submitting the technical reports. So award review and acceptance. It mainly falls under ORSO. ORSO does the negotiation of the award terms and conditions. But they do that in conjunction with the PI. So and as well as the department, the dean, and SPS, and they make sure that everybody is in agreement with any changes that are made.

Cheryl Dykstra-Aiello: We have information about the regulations and policies for sponsored projects. Those come, from the federal government, the state, and WSU, and these are just some resources, that you can, look at to find more information on these, policies.

Cheryl Dykstra-Aiello: There are some problematic contract clauses that you should be aware of, including, limitations as a state agency, confidentiality, liability issues, any clauses surrounding intellectual property and technology transfer. I will touch a little bit on technology transfer and PI responsibilities here, but they can be problematic in the clauses. So be aware of that.

Cheryl Dykstra-Aiello: And then of course data rights and security obligations and publication restrictions can also be problematic in, in awards and contracts. So when, when that comes back to you, be sure that you’re looking at those. Also, only an authorized signatory can sign and accept a sponsored project award on behalf of the university. And those are listed here.

Cheryl Dykstra-Aiello: So at WSU, there are only three authorized signatories who can accept, the award on WSU’s behalf, President Cantwell, our Vice President for Research, Kim Christen, and the Associate Vice President for Research Operations, Maria Hernandez, are the only ones that can do that. Be aware that if you personally sign an award without the authority to do so, then you can become individually liable for any, damages that result.

Cheryl Dykstra-Aiello: So don’t do it. We do have some industry contracting vehicles, so, I’m not just talking about the federal government. At least on this slide. So the sponsored project agreement or SPA. That is a set of standard terms and conditions that are frequently utilized by the University, full F&A costs apply. And in under this agreement, WSU retains ownership of the intellectual property and any industry partner has access to the results and they can, actually obtain a license option.

Cheryl Dykstra-Aiello: There is a broad industry project agreement or BIPA. This is a non-negotiable one page agreement, and it provides any partners, with access to the, the results. There are no intellectual property, rights associated with this contract. There are no F&A charges. However, a 10% project fee is incurred, and 50% of that is to the lead PI.

Cheryl Dykstra-Aiello: This contract, usually has a maximum $40,000 for the project. And then the contract contracting acceleration program, or CAP`allows the choice of various upfront, intellectual property licensing options to industry sponsors and WSU researchers, and this is the best contracting vehicle for projects, that have expected outcomes that are specifically beneficial to a sponsor, or that improve or refine a sponsor’s product.

Cheryl Dykstra-Aiello: So, ORSO, is the unit in the Office of Research, that typically, looks after these contracts and they do that, usually in close association with our Commercialization team. We have some common non-monetary agreements. Again, this is ORSO and Commercialization. But if you have questions surrounding these and please do email, orso@wsu.edu for more information.

Cheryl Dykstra-Aiello: But these are not usually part of award acceptance. Although they might be necessary to, to actually facilitate the project. So, just be aware, some of these include, you know, non-disclosure agreements, material transfer agreements, equipment loan agreements, that kind of thing. You can find templates for these agreements on the ORSO website, but again, if you’ve got any questions do reach out to ORSO.

Cheryl Dykstra-Aiello: A word set up primarily that responsibility lies with sponsor program services in conjunction with ORSO they’re really trying to help reduce the administrative burden on SPS. And you can find again that the screenshot comes from the ORSO website. And you can see that it lists, the responsibilities for the different the various units and individuals there.

Cheryl Dykstra-Aiello: So it’s very helpful. And if you’re unsure of what your responsibility is, is surrounding a particular task, you know, check out the website because they’ve got it all listed there for you. So subrecipient monitoring, that is a shared responsibility between the PI, ORSO, SPS and the Department there. You can have hands on assistance between the department and the PI and, monitoring your subrecipient and then supporting operations and SPS both, ensure compliance with that.

Cheryl Dykstra-Aiello: When the Prime award is funded, the PI needs to work with the research administrator in your college to, set up the sub recipient. There is a sub award initiation form that can be found on the, ORSO website and that form needs to get completed between the PI and the research administrator and then submitted to ORSO with a copy of the proposal documents and then the PI in conjunction with the research administrator needs to facilitate communication.

Cheryl Dykstra-Aiello: So, between Support and Operations and the grants office at the sub recipient college.

Cheryl Dykstra-Aiello: We, the PI needs to follow, federal regulatory requirements. And the, the uniform guidance that’s listed there. There’s a link there for you to check out if you want more information about that. And then you can also see ORSO guidelines seven. The PI is responsible for reviewing the sub recipient’s progress on the tasks.

Cheryl Dykstra-Aiello: So you may even want to consider visiting the, the sub recipient’s lab or the site where the research is taking place. If there, you know, that seems appropriate. PI is responsible for approving the progress and the final reports that come from subrecipient and any invoices, that come through. So you need to work with, the research administrator in your college as well as, SPS. If, as you go along through the project, there are some changes that need to be made to the terms and conditions, you know, time it’s, extensions or something needs to be re-budgeted,

Cheryl Dykstra-Aiello: you need to work with ORSO on that. If there’s a deobligation, communicate with the Subrecipient PI before you make the change. You don’t just, don’t just arbitrarily make that change. It’s important that you talk to the Subrecipient PI first and then work with your research, administrator and ORSO to get that done.

Cheryl Dykstra-Aiello: So the PI responsibilities for award management and maintenance, there are many. Touching first, on, expenses and funds, you need to make sure that the funds, that the funds that the funds you have are being used only for, purposes directly related to the project and make sure that they are reasonable, allowable and allocable per the union guidance, uniform guidance.

Cheryl Dykstra-Aiello: And then make sure that, all of the expenses that are being, submitted are consistent with the award terms, conditions and limitations. Make sure that you’re aware of that. If anyone is working with you, on reporting those expenses, you need to make sure that they are aware of all of the award special terms, conditions and limitations,

Cheryl Dykstra-Aiello: and make sure that they’re not more than what’s been authorized for the contracted period and know if there’s any, specific limits by budget, category or, line item on your budget. So, the PI is responsible for, for that. And you can usually do that in conjunction with your research administrator as well.

Cheryl Dykstra-Aiello: Obviously your responsibilities for the, management of this project, you are responsible for developing, designing and conducting the research. You are responsible for completing and submitting, all of the technical reports and any, continuation or renewal proposals that, come out of this project and you’re responsible for submitting the financial report, but you can work with your, research administrator and SPS on that. If you have modifications, work with your research administrator and, and ORSO. You need to oversee the project management.

Cheryl Dykstra-Aiello: You can delegate, but you are still the one who is ultimately responsible for, for what happens with your research project. You’re also responsible, of course, for disseminating the research results through publications and presentations.

Cheryl Dykstra-Aiello: Additionally, you’re responsible for making sure that anyone who’s working on your project has the appropriate training. That includes the responsible conduct research training that is required by NSF, NIH, and USDA. And that training needs to be done by everyone associated. So staff, postdocs, grad students, and undergrads, you need to make sure that, you maintain training on, safety, clinical, practices and anything, microbiological training needs to be done.

Cheryl Dykstra-Aiello: You are responsible for the safe, ethical, conduct of research, that also, is important, per the policies of the university and federal regulatory laws. And you can find that training on CITI. You are responsible for remaining in compliance with shipping requirements. So any, infectious substance or diagnostic specimens, any recombinant DNA molecules that you’re working with, know all of the regulations surrounding that.

Cheryl Dykstra-Aiello: And you need to make sure that your employees, know any, award terms and conditions. All of your, agreements that are associated with that, any deliverables that you are contracted, for and, yeah, ultimately the responsibility lies with you. It is not the responsibility of your, undergrads or your grad students or your postdocs to, to know those things on their own.

Cheryl Dykstra-Aiello: You need to make sure that they know that. I’m going to talk about compliance issues. There are several, issues that I’m going to be going over. Again, these can be found, on the ORSO so website, and specific tasks associated with these issues. I encourage you to look at them. And the Office of Research Assurances, really, most of what I’m going to be talking about falls under their jurisdiction.

Cheryl Dykstra-Aiello: With the exception of technology transfer that falls under the Office of Commercialization, Office of Research Commercialization Unit and conflicts of interest and misconduct are also part of the Office of Research, Human Resources, an equal opportunity under the Office of Compliance and Civil Rights and then public records under the Public Records Office.

Cheryl Dykstra-Aiello: So, training responsibilities, actually starts before proposal submission and this is a new, change to, the policies at WSU for research security. I’m sure that you, saw the notice that came out. I think this last week in the Research Radar. So before you submit your proposal, and then annually during the award period, you’ll be required to have, obtained the, completed the research security training that is offered through WSU.

Cheryl Dykstra-Aiello: It’s currently required for the Department of Energy. NSF requirement is effective October the 10th. The NIH requirement, they they did have a date, but they’ve since rescinded that. And they they say that that will be updated. So that date is is still to be determined, but eventually this is going to be required by all, federal agencies.

Cheryl Dykstra-Aiello: So, WSU then is proactively requiring that PIs do this training prior to submitting the eREX for any federal agency proposals. And that becomes effective on November the 3rd. The research security training now is on CITI. And, that’s so that it could cover additional information that’s required by the federal agencies. And you can access it by logging into your CITI account, select add, of course, and then select Research Security Combined.

Cheryl Dykstra-Aiello: If you’ve already done the Research Security Manager Mitigate Risks Training in Percipio, then you don’t need to retake this Research, Research Security Combined Training in CITI right now. But if you are awarded, your, your federal grant, then you’ll have to go into the CITI training, and, and update your training. You have to do that annually.

Cheryl Dykstra-Aiello: Responsible Conduct of Research is another mandatory training. You can find that, through MyResearch under mandatory training. Anyone credited on the grant has to have this this training, and it needs to be redone, every five years. It covers topics such as data acquisition, research misconduct, collaborations, animal use, research with humans, that kind of thing.

Cheryl Dykstra-Aiello: So, important, to know that this is mandatory and it will pop up on the eREX if you haven’t done it. So what you need to know about, research misconduct. I hope that you already know this, but, I need to, reiterate that, fabrication is making up data or results recording or reporting them. That’s research misconduct. Falsification or manipulating research materials, equipment or processes or changing or omitting data, or results so that your research isn’t accurately represented in the research record is research misconduct, Plagiarism, appropriation of anybody else’s ideas or processes or results or words and not giving appropriate credit and any serious deviation from accepted practices.

Cheryl Dykstra-Aiello: And I’ve listed several of these here. So that includes abusing confidentiality. That’s research misconduct. If you steal, destroy or damaged research property, or if you encourage or knowingly allow someone else to engage in fabrication, you are you are, actually doing research misconduct and can be reported. Compliance and civil rights. I want to touch on this.

Cheryl Dykstra-Aiello: There is trainings available surrounding human resources, equal opportunity, discrimination and harassment. You can find that through this link. WSU employees with supervisory responsibility need to report all incidents of discrimination and discriminatory harassment to the compliance and civil rights Office. And these incidents, don’t necessarily have to involve sexual harassment or sexual, misconduct. Areas of compliance include equal employment opportunity and affirmative action,

Cheryl Dykstra-Aiello: the Americans with Disabilities Act and Title nine. So make sure that you know, that you need to be in compliance with those and take the trainings. You are responsible when you are conducting research, with humans, you are responsible for their protection. So you need to adhere to federal regulations, state and local laws, institutional policies and WSU procedures, regarding their safety and protection, refer to the, Business Policies and Procedures Manual 45.50 or on research involving human subjects and oversight of this is through the human Research Protection Program and the IRB.

Cheryl Dykstra-Aiello: If you’re working with animals, bottom line, as a PI you’re responsible for, their responsible use and care. You need to adhere again, as with, human subjects, to all federal regulations, you need to adhere to policy, state and local laws. And IACUC procedures, regarding their humane care and use and the authority of the attending veterinarian, is, listed in the Business Policy and Procedures Manual, Institutional Animal Care and Use Committee

Cheryl Dykstra-Aiello: IACUC oversees, animal welfare.

Cheryl Dykstra-Aiello: PIs are responsible for disclosing any significant financial interests, and financial conflicts of interest. You need to disclose this when you’re submitting a proposal to, Health and Human Services or any other agency that follows, these rules. If you check the conflict of interest box on the eREX form, you need to disclose this SFI. If you, acquire a new SFI, you need to report that it needs to be disclosed annually.

Cheryl Dykstra-Aiello: And or when it’s required by the sponsor. And if travel is reimbursed or sponsored, you need to also disclose this. Any changes to any financial relationships that affect your research have to be reported.

Cheryl Dykstra-Aiello: So, if you’re unsure of when this might apply, if you are engaging in intellectual property activities or, starting up, business, any entrepreneurial or startup efforts, any, inter industry collaborations, if you’re engaging in, sponsored agreements, subcontracts or facility use agreements where you’re an owner of a company that’s working with WSU. If you, have the grants from the public health services, and adopting sponsor grants, HHS , PHS, gifts greater than $50 from an outside entity, count as a significant financial interest.

Cheryl Dykstra-Aiello: Know what the institutional base salary and salary caps are. If you have any outside salary or payments, that overlap with institutional responsibilities for a service that you are providing, any consulting work or working at a startup company, or if you are membership on an advisory board, etc. If you have any overlap of, equity interest, if you have third party sponsor travel or if you have any family that are connected to activities that have been listed above, you should be in contact with ORSO or any Commercialization if you have any, questions surrounding this.

Cheryl Dykstra-Aiello: If you are unsure then please contact them to get verification and know what you need to do to stay in and compliance with this. I am mentioning this because it also popped up in, the research radar last week, but prior travel is, a prior approval is required for all travel that you do on behalf of WSU.

Cheryl Dykstra-Aiello: And that includes anything that’s related to your research and you’re using grant funds for that. This is very important, for, increasing federal oversight or due to federal oversight and know that the Office of Research needs to review, and ensure that plan travel meets federal and state requirements and follows WSU guidelines. So submit your, your request for approval, well, in advance of your travel so that you can get that.

Cheryl Dykstra-Aiello: Foreign influence is a big thing right now coming out of the federal government. And disclosure of foreign support is a continuous PI obligation, particularly the Malign Foreign Talent Recruitment program. Certification needs to be done annually for NSF, whether or not you’re participating in the MFTP, you need to, report that. And anyone serving as a PI or Co-PI on an active NSF F award, needs to do that.

Cheryl Dykstra-Aiello: So it’s not just PI if you’ve got a Co-PI on that board. They also need to do it. NIH is also going to require this, but the exact details haven’t been posted yet, so.

Cheryl Dykstra-Aiello: The PI is responsible for being aware of all regulation requirements surrounding export controls. This is a complex set of federal regulations that govern the release of certain commodities and technologies and software to foreign nationals, in the U.S. and abroad. And knowing this, and having these controls promotes national security. National security is huge with the federal government right now.

Cheryl Dykstra-Aiello: And there is CITI training provided, surrounding this. When you need to think about export control, you need to ask yourself these questions. Are you going to be shipping for electronically transmitting any material or technical data outside of the U.S? Are you going to be collaborating with foreign persons or entities? Are you going to be traveling with your laptop?

Cheryl Dykstra-Aiello: That’s often forgotten. So, if any of these, things pertain to you, or if something else pops up and you’re just unsure, then you need you should be, contacting, research Assurances for clarification.

Cheryl Dykstra-Aiello: Biosafety is a responsibility of the PI. If you’re doing any research with recombinant or synthetic nucleic acid molecules, you have to comply with NIH guidelines if you have an NIH grant. And if you’re working with these molecules, if you’re working with human fluids or tissues, if you’re working with, any infectious agents with, potentially bio hazardous materials, then you need to register with the Institutional Biosafety Committee.

Cheryl Dykstra-Aiello: And that doesn’t matter where where your funding comes from. That is just mandatory, and you need to do that before you start conducting research.

Cheryl Dykstra-Aiello: The IBC actually verifies containment practices and facilities. And so that’s why it’s important that you contact them before you start doing your research.

Cheryl Dykstra-Aiello: If you are going to ship hazardous materials, you are responsible to know what, materials are actually considered hazardous or potentially hazardous. And some of those are listed here. So dry ice or lab chemicals, that includes preservatives. Any pathogens animal or human specimens fall under this category. Compressed gas cylinders, lithium batteries, whether they’re in or out of the equipment, any genetically modified organisms and radioactive materials.

Cheryl Dykstra-Aiello: You should be contacting the hazmat shipping unit and research Assurances. So call them or, contact them through email. The link here is on this slide.

Cheryl Dykstra-Aiello: PIs are responsible for disclosing any, use of radioactive materials when they submit their eREX form. And you are responsible for following safety procedures for radioactive materials. And please, look at the radiation safety officer’s website. The radio, the radiation safety program also provides services to users. Anybody who’s using a radioactive materials or radiation machines, so reach out to them, please.

Cheryl Dykstra-Aiello: Pi’s are responsible for maintaining, materials, handling, safety and standard operating, procedures. To maintain environmental health and safety, you’re responsible for making sure that your equipment remains safe and keeping up on maintenance. You’re, responsible for internal and external inspections. And you need to supervise any anyone, who’s using these, materials and equipment and anyone who’s working in your labs to ensure that they adhere to all required health and safety trainings, recordings and communications.

Cheryl Dykstra-Aiello: Environmental Health and Safety at WSU provides consultation and services. And those services, surround chemical waste management, lab safety, including chemical safety, public health and air and water quality and worker health and safety. So again, reach out to them.

Cheryl Dykstra-Aiello: We have an open government. And, that means that all data, including communication and hard drives, emails, texts, voicemails, notes, etc. are actually the property of the state.

Cheryl Dykstra-Aiello: And residents have a legal right to review public records. So, you, when you are requested, by, public records to release, data, you need to adhere to those policies. State ethics addresses, conflicts of interest, improper use of state resources, compensation for outside activities and gifts. And that, can fall under the request for, public and state records.

Cheryl Dykstra-Aiello: Technology transfer. PIs are responsible for submitting any invention, disclosures to Commercialization in the Office of Research, before you do any public, presentations of your research. So that includes, you know, published articles, poster presentations, anything, see thesis, presentations or submissions and any conferences, you’re responsible for preserving and maintaining the primary data that’s related to your inventions.

Cheryl Dykstra-Aiello: You need to secure and outgoing material transfer agreement before you transfer any research related materials to outside collaborators. And, you are responsible for completing the invention portion of any, continuing grant applications. And the final invention report, Commercialization is your contact for, technology transfer. So make sure you are, in contact with them, remain in contact with them.