Office of Research Compliance - Introduction

ORC Introduction 

Hello, this is Kirk Lubick from the Office of Research Compliance. I am the Associate Vice President of Research Compliance at Montana State University.  

  
In this training, we'd like to introduce you to the Office of Research Compliance and the diverse realms of oversight essential to align with your specific research goals.  

We will guide you through the regulatory processes, ensuring that your research adheres to the standards set forth by the Federal, State and University policies and procedures. 

The Office of Research Compliance (ORC) oversees University Programs to ensure compliance with the many federal, state and local regulations for research. ORC facilitates an environment that furthers the ethical and responsible conduct of research.  

ORC is here to help you navigate through the complex research environment to ensure your research runs smoothly and meets safety and compliance requirements.   

We recognize the various responsibilities you juggle as a researcher, faculty member, and teacher. ORC’s role is to stay informed about compliance rules, to communicate with you and to provide necessary training. Your responsibility is to adhere to these rules and fulfill all requirements. ORC is available as a resource to support you in these research endeavors. 

This training introduces you to the following the life cycle of a compliance protocol MSU's compliance pathway.  

These steps include submission of a protocol, engagement of ORC, and securing relevant committee approvals, training requirements and resources, and finally your responsibilities as a principal investigator.  

2:00 

The protocol life cycle is a very dynamic process that begins with the identification of applicable funding to meet the needs of your research. Once funding is secured, a critical evaluation ensues to determine if the planned activities necessitate the establishment of a protocol. This initial assessment identifies relevant training requirements and prepares individuals with the necessary knowledge and skills.  

  
Next, efforts focus on the development of a protocol where careful attention to is paid to detail, ensuring alignment with ethical and regulatory standards. The subsequent phases involved the protocol's journey through the submission and review process.  

  
Once the protocol secures approval, the focus shifts to the management and completion of the projects. Regular reviews and assessments become integral, ensuring that the project remains on course as time progresses. The protocol undergoes a natural evolution, presenting the need for renewal or closures. Renewals are scheduled to keep pace with emerging knowledge or adapt to evolving circumstances, safeguarding the integrity of the research or project. Alternatively, the closure of a protocol indicates the conclusion of the activities.  

The protocol’s life cycle includes many stages, each contributing to the progression of a research endeavor from its inception to its eventual closure or renewal.  

 The protocol life cycle includes diligence, adaptability, and ethical considerations that support scientific and project-based research.  

 In research, certain research activities demand a structured approach to ensure safety, compliance, and ethical standards are met.  

The following programs necessitate the development and implementation of protocols.  

Biosafety involves the handling of biological agents or toxins, ensuring the safety of researchers and the environment. Protocols outline containment measures, waste disposal and emergency practices.  

Human subject research crucial for studies involving human participants. Institutional review of our protocols detailed informed consent, ethical considerations, and protection of participants rights.  

Radiation safety encompasses the use of radiological material, X-ray generating equipment and the use of Class 3B are for lasers in research. radiation safety protocols establish protective measures, exposure limits, and emergency response protocols.  

Animal care and use are essential for research involving animals. At Montana State University, we have two committees that oversee animal care and use, one being what we call the AACUC, the Agricultural Animal Care and Use Committee, which oversees all agricultural animals at Montana State University and the other committee is the IACUC, the Institutional Animal Care and Use Committee. This committee oversees Laboratory animal research and Teaching Activities. Protocols in these areas, address ethical treatment, housing conditions, and veterinary care.  

Protocols include essential methods, process descriptions, and safeguards ensuring that research activities adhere to the highest standards of safety, ethics, and regulatory compliance.  

By following these protocols, researchers contribute to the responsible advancement of knowledge safeguarding both human and environmental well-being.  

6:03 

The compliance pathway involves integrating sponsor grant proposals, rigorous research, compliance practices, and acquisition of essential compliance program or committee approvals.  

By following each step, researchers contribute to the ethical, legal, and responsible conduct of research, fostering a culture of compliance and integrity.  

  
Let's start with step one of this compliance pathway.  

  
6:29 

All MSU proposals submitted to funding agencies must be processed by the Office of Sponsored Programs, OSP. Regardless of sponsor requirements. Proposals must be reviewed and have university approval.  

OSP has developed the Electronic Proposal Clearance Form, also known as EPCF, which must be used when submitting proposals to OSP for review and approval.  

The form summarizes key administrative and fiscal information about the proposal that is needed by the MSU reviewer to approve to proceed. Note there is a training available on the OSP website on a topic of EPCF submission.  

  
In the EPCF, there's a tab called Compliance. This is a tab you will fill out in the EPCF that triggers the engagement of the Office of Research Compliance.  

In addition to overseeing programs that require protocol submissions, the Office of Research Compliance is also responsible for managing the export control program, conflict of interest, testing service agreements, and uncrewed aircraft systems. Although these programs do not need protocol approval, they do, however, have some sort of approval process. For example, export control requires that the export Control Officer at Montana State University signs off and approves of the work prior to engagement.  

  
Conflict of interest if deemed appropriate, the Conflict of Interest program will put a what we call a conflict of interest plan into place. This plan will outline safeguards that that need to be adhered to, to mitigate any potential issues with the conflict of interest. 

Testing service agreements must have assigned executed contract in place prior to engagement of any work. And for drones, there is an approval process in place at Montana State University. This approval process is all online and you can find it on the Office of Research Compliance website.  

 8:49 
The Office of Research Compliance has developed a comprehensive website designed to be your go-to hub, guiding you through the entire process. On the Office of Research Compliance main page, you will see five main areas: Committees and Programs, Research Ethics, Training, Topaz and About Us.  

  
I'm going to go on the About Us page first. On the About Us page you will see numerous different ORC team members ranging from myself to the program managers of the IACUC and IBC and down the line. You will also see the training and Topaz coordinator as well and then program officers of our specific areas of oversight. Please feel free to reach out to all of these individuals as they'd be happy to assist you.  

  
If we go back to the Office of Research Compliance main page, I want to direct you to the compliance or the Committees and Programs tab. On this you will see the different programs and committees that are overseen by the Office of Research Compliance. I am not going to click through every single one of these, but I would just want to click on one to show you kind of how they are all set up.  

  
I'm going to click on the biosafety program. On the Biosafety program web page, you're going to see numerous different areas ranging forms, manuals, regulations and policies, what we call pathogen safety data sheets, training and then our institutional biosafety committee.  

I'm going to click on the Forms and manual regulation policy tab. In here you will see two buttons. I'm going to click on the policies and then you can see the various policies that pertain to the biosafety program.  

 I'm going to go back to the main page and go to a very important tab, Training.  

  
10:49  
In the training tab, you will see different areas again as well as the CITI tab. CITI is, as I said earlier, CITI is our online training platform and this is directions on how to go through and log into the CITI Training at Montana State University.  

Again, this could be overwhelming when you first start, so please reach out to us if you have any questions or you hit a stumbling block.  

  
Again, back to the main page. I'm going to hit one last main area, the Topaz. As I we described earlier in this training, Topaz is our centralized online protocol system for numerous different research compliance areas and office research compliance. And here you'll see a login to Topaz.  

I'm going to click that and you will need a net ID and a password to get on there. There's also how-to videos on main areas of navigation of the toolpath system. There's FAQs as well as tips for Topaz.  

  
Topaz is a very nice system, but it also sometimes it needs some subject matter expertise to help guide you through that process. And I just want to point out if you do get stuck in that process of Topaz, either when you're filling out a protocol or when you're renewing it, please do not hesitate to reach out to your program manager or the Office of Research Compliance, Topaz coordinator.  

  
So in summary, that is a very, very quick overview of the Office of Research Compliance website. Please reach out to us if you have any questions, as you navigate this system.  

We have a lot of information on here, but we're always refining our web pages.  

And if you have any questions or concerns, or you have an idea about how to make it a better web page, please reach out to us. Thank you.  

ORC serves as your compliance resource to streamline research efforts with applicable agencies and programs. We are tracking rules and regulations each of these agencies and many more.  

At Montana State University, we utilize the Topaz Elements database to manage the life cycle of protocols for programs requiring protocol approval.  

Upon the approval of your protocol, you can expect to receive an automated e-mail from Topaz providing details of their approval specifics. All information you will need about Topaz is on our website. Please note that completing training is required before gaining access.  

  
The ORC website has a page dedicated to programmatic training requirements and includes a direct link to CITI information and login.  

CITI stands for Collaborative Institutional Training Initiative, and this is our database of training modules also accessible on our website.  

The principal investigator is responsible for the conduct of research activities requiring oversight. To optimize the approval process, the PI can do the following:  

• Contact ORC to evaluate research needs and determine requirements.  
• Complete all required training. Incomplete training requirements are the most frequent item delaying approval.  
• Submit your protocol at least 30 days before you would like approval.  

• After securing approval, it is essential to adhere to the protocol and follow MSU policies.  

We recognize research needs change, and Topaz allows you to amend and update your protocol swiftly before any changes are implemented, MSU requires an interim or annual review to ensure the protocol is current and all staff are up to date on their training report.  

Adverse events safety issues and unanticipated pro problems to the ORC. We are here to assist you with your research needs and navigate regulatory reporting requirements.  

  
15:41  
In conclusion, we appreciate your time and attention during this presentation. Should you have any further questions or required guidance on the topics discussed, please don't hesitate to contact the ORC team. We are here to support you on your research journey.  

  
Additionally, be sure to explore our comprehensive website for additional resources and detailed guidance. Thank you. We look forward to assisting you in your research endeavors.