Research Compliance Newsletter: Quarter Four, January 2023
January 1, 2023 • Research Compliance
Find the latest updates on all areas of the ORC, including the IACUC, the NTR IRB, RCOI, and International Compliance.
This quarter we introduce our team member – Joycelyn Bryant!
In this issue, we’ll help you get to the “Yes” with a quick summary on collaborating with investigators from other institutions for both human and animal subjects researchers
In this issue, we answer questions about getting started as a new researcher at HSC and affiliated institutions. If you’re a new researcher, this Q&A is for you!
In this special article, we detail the recent external engagements that the IACUC and IRB have had the privilege to participate in, in order to leverage our knowledge to benefit external individuals.
Find all of the meeting and deadline dates for the next three months of Board and Committee meetings.
Happy New Year! Here is the latest news from the ORC:
Several of our team members participated in the “2022 Public Responsibility in Medicine and Research (PRIM&R) Annual Conference” in December! We are so excited that our talented ORC staff is able to represent HSC at this conference, and that we continue to have the opportunity to participate with the wider research compliance and research community across the country.
Additionally, our IACUC office just recently wrote an article for the Lab Animal Magazine – definitely an exciting accomplishment for our IACUC!
Please see our special article below for additional details on these presentations and the magazine article!
Traditionally, Conflict of Interest and Research Conflict of Interest Disclosure statements are completed on an annual basis between September 1st and October 1st. Due to unexpected technical issues with GRAMS, the deadline was pushed back indefinitely while we work on fixing it. Please note that there may still be some special cases in which a COI/RCOI disclosure form is needed, and those instances will be handled with communication from the appropriate offices.
International Compliance: If you are an HSC Faculty, Staff, or Student travelling internationally on university-funded or university-related business, field study, research, conference attendance, internship or study abroad program, be sure to register your HSC international related trip with the University of North Texas System.
After you have registered with the UNT international travel registry, please complete the International Travel Device Checklist. Email your completed checklist to Crystal Perez: firstname.lastname@example.org.
You may remember that our office has spent the past couple of years engaged in process improvement activities – and we are continuing on this path! In addition to providing guidance, training, and resources to our research community, we will begin rolling out specialized training programs in the future pertaining to all areas of our office. So stay tuned! We will provide additional updates and announcements as they develop.
Help us help you! Please click the below button to ask a question:
All questions, general or specific, about any of the Research Compliance areas are encouraged.
How long have you worked in the HSC Office of Research Compliance? What is your role, and what do you like best about it? I became the Senior Administrative Coordinator for the Office of Research Compliance in June of 2022. What I like best about my role is being a part of and being able to assist this amazing team! I have enjoyed learning the functions of the NTR IRB, IACUC and RCOI to help assist them in any way that I can, as well as equip me with the knowledge to assist all of our customers. I must admit there was a bit of pressure, at first, knowing that I would be the first point of contact for those that would be seeking assistance from the ORC. This amazing team immediately calmed any fear or anxiety with the support that they have offered from day one, it has made learning and growing in this role feel like a walk in the park.
Of the five HSC values, which one do you believe you exemplify the most, and why? Growing up respect and serving others first are values that my family instilled in me. Now that I am an adult they are values that I still uphold, “In everything, do to others what you would have them do to you” (Matthew 7:12) In other words, how could I ever look to someone to show me respect if I am not first willing to give it? Serving others first, I’ve always viewed as being afforded the opportunity to be the light in a person’s day, you truly never know what someone may be going through or dealing with and your simple act of kindness may be the one thing that turns their day around. “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel.” -Maya Angelou.
What is something we would be surprised to find out about you? My love for travel and cooking go hand in hand. I absolutely love traveling, seeing, and exploring new places and learning about their culture. When I return from traveling recreating cuisines I’ve had, allows me to share those experiences with my family and friends who may not have the opportunity to travel to these destinations.
A quick summary on collaborating with investigators from other institutions for both human and animal subjects researchers.
Human Subject Researchers:
For human subject researchers, the NTR IRB understands collaboration between researchers is important and often occurs across institutions on the local, national, or even international level. When collaborating with an investigator from another institution, there are several factors to consider, such as (but not limited to):
Which institutions are considered engaged in the human subject research? Which site is the primary site? What research procedures will take place at each institution (main intervention vs. data analyses)? Is the project funded? If so, what are the requirements of the sponsor (e.g., NIH single IRB requirement)?
Therefore, when working with external investigators, the NTR IRB highly encourages researchers to seek our guidance before initiating any research activities. Ultimately, when multiple institutions are engaged in research, a decision should be made whether the IRB of one institution will assume regulatory oversight of the research being conducted by all collaborating institutions. This decision is made (on a case-by-case basis) by institutional leadership after extensive discussions between the partnering regulatory offices and the collaborating researchers.
There are many different outcomes of those discussions. However, these collaborative arrangements ultimately fall within two main buckets –
Single IRB Review: One institution’s IRB has assumed regulatory oversight of the research project/activities occurring at multiple institutions (i.e., “IRB of record”). A reliance or reciprocity agreement is a legal contract between collaborating institutions [reviewing site and relying site(s)], and it is executed when the institutional official from each collaborating site signs said agreement. In addition to this, there may be other agreements/contracts (e.g., memorandum of understanding, material transfer agreement, etc.) as well as other local site requirements or context (e.g., local laws) for researchers to consider.
Independent IRB Reviews: Through discussion, it may be determined by the collaborating IRB(s) and institutional leadership that single IRB review is not appropriate or applicable (e.g., no funding requirement, unfavorable risk assessment, different research procedures occurring at each site, etc.) for a specific project. In this case, each collaborating institution conducts their own regulatory review of the research activities.
It is important to note that in either scenario there are required IRB processes and administrative documents that must be completed before engaging in any collaborative research activity. Please consult with the NTR IRB (NorthTexRegIRB@unthsc.edu) for additional guidance on these processes. Our goal is to help your research collaboration succeed!
For animal research, collaboration with other institutions can get a little hairy. According to the Office of Laboratory Animal Welfare (OLAW) FAQ (D) (8), when collaboration occurs across institutions, a formal written understanding (i.e., Memorandum of Understanding (MOU)), to identify animal ownership and institutional responsibilities, such as protocol review and inspections, is required. To help clarify this process, the Institutional Animal Care and Use Committee (IACUC) has developed IACUC SOP 052: Institutional Collaboration. In summary, the IACUC will review/determine the ownership of the animals and the Performance site (where the animal work takes place). If the ownership and performance site match, no MOU is required. However, if the ownership is different from the performance site, a MOU is required.
There are many things to consider when the ownership of the animals differs from the performance site, therefore, we encourage any researcher wishing to collaborate with an external organization to seek guidance from the IACUC Office prior to initiating these activities.
When reaching out to the IACUC Office, be prepared to provide the following information:
Oftentimes, the institution that owns the animals initiates the MOU process. All MOUs are reviewed by the IACUC. For more information or guidance through this process, please reach out to the IACUC Office (IACUC@unthsc.edu), as we would like to help you succeed in your research collaborations.
1. Q: I am new to research and research compliance here at HSC – what do I do, who do I contact, and how do I get started???
A: The first thing to know is – the Office of Research Compliance (ORC) is here to help you and aid in the success of your research! Our staff of dedicated and talented research compliance specialists can guide you on your research journey!
Here are the areas with which the Office of Research Compliance can assist you:
A quick side note that the ORC/International Compliance office is also responsible for conducting risk assessment reviews for anyone who will be traveling internationally as part of their research or any HSC official/sponsored business. (Risk assessments are only conducted for travel to certain countries which meet certain criteria – it is up the to the ORC to make this determination). All individuals traveling internationally for HSC official business purposes should review information on the UNT System International Travel page, and also ensure their travel is registered in the Concur system.
We look forward to hearing from you!! 😊
Have a question you would like answered? Just click the link below to submit your question.
In addition to the daily tasks of ensuring the responsible conduct of research and compliance with federal regulations and institutional procedures/policies, our team continues to be involved in other scholarly and educational activities as well!
2022 PRIM&R Conference:
Our office was well represented at this year’s annual Public Responsibility in Medicine and Research (PRIM&R) conference with both a poster presentation and a speaking engagement. PRIM&R is a nonprofit and professional organization “that works to ensure the highest ethical standards in research by providing education, membership, and other professional resources to the research and research oversight community…”( https://primr.org/about-us). This year, PRIM&R combined the IACUC and IRB annual conferences and opted to host it virtually from December 12th through December 15th.
One of the platforms was a virtual poster wall, and Ms. Tania Ghani, Ms. Itzel Peña Pérez, and Dr. Brian Gladue, worked together with our colleagues at John Peter Smith Hospital, Dr. Melissa Acosta, Mr. Andrew Adorboe, and Ms. Carissa Jensen to present their poster titled Creating a Regional IRB: An Innovative and Collaborative Approach to Protect Research Participants, Serve the Community, and Enhance the Human Research Enterprise in the Same Geographical Area. This poster highlighted the functionality of creating a Regional IRB, including the following in their discussion section: “Establishment of a regional IRB provides many benefits… First, it satisfies the NIH single IRB review requirement for multi-site studies. Second, it allows for inter-institutional collaboration which provides the landscape for translational research, in turn creating partnerships which would not have otherwise occurred. Finally, these partnerships allow for an increase in research opportunities, with the ultimate goal of creating a healthier community.” To view the poster, you can access a copy here.
The NTR IRB was not the only team in our office that had the opportunity to present at the annual conference. Ms. Christina Aguilar, our Senior IACUC Administrator, co-presented the Breakout session titled Hitting the Mark: Best Practices for IACUC Administrators with two other IACUC-industry professionals, Ms. Tiesha Murray from Georgia State University, and Ms. Rachel Cameron from Janssen. This interactive session explored the best practices for IACUC administrators. Ms. Aguilar’s portion of the presentation focused on navigating difficult conversations, protocol review, and semi-annual inspections. Their presentation was one of the most viewed sessions, and held a very engaged and captivated audience who asked great questions and provided their own professional insights as well. The presentation truly captured the spirit of collaboration between IACUC professionals and other stakeholders as intended by PRIM&R hosting this annual conference.
Article in Lab Animal Magazine:
Ms. Christina Aguilar was also selected to write an article for the Lab Animal Magazine. Lab Animal is a monthly journal dedicated to the animal model with articles covering important news, business, and regulatory matters. Ms. Aguilar collaborated with fellow colleagues Dr. Nathalie Sumien (IACUC Chair) and Ms. Karina Garcia (IACUC administrator) to co-author a piece for the Protocol Review Column of the magazine. The Protocol Review Column is a scenario-based column exploring the various regulatory components of an animal care and use program and how to resolve ambiguous situations.
The team decided to tackle the issue of how many times an animal should be counted in a study. They chose to title the article, “Once Used, Once Counted” as they presented an argument for why an animal should only be counted once on study. The article should be published in the March 2023 edition of the magazine.