Research Compliance Newsletter: Quarter One, April 2023
April 6, 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 ORC member – Alyson Stearns!
In this issue, we’ll help you get to the “Yes” with your time-sensitive human subjects, animals subjects, or export-controlled activities.
In this issue, we answer questions about who can be the Principal Investigator or listed as Key Personnel on IRB and IACUC protocols.
In this special article, we’ll discuss tips and strategies for effective recruitment in your Human Subjects Research.
Find all of the meeting and deadline dates for the next three months of Board and Committee meetings.
Here is the latest news from the ORC:
How long have you worked in the HSC Office of Research Compliance? What is your role, and what do you like best about it? Well, this time around I have worked as an IRB Compliance Manager with the ORC since February of 2022, but because I worked here previously, you could say I am a repeat customer, ha. I first began my career at UNTHSC as a Research Compliance Manager in August 2019. Several months later, this tiny thing called the COVID-19 pandemic happened, which temporarily derailed all my carefully made plans; instead of reviewing research projects, I was suddenly attempting to teach my daughter second grade. However, I knew that I wanted to return to the ORC if I had the chance once the world stabilized. I was able to do just that in early 2022, and I haven’t looked back since.
This leads me to what I like best about my role here: my awesome team & our researchers. It is a wonderful feeling to come to work every day knowing that I’m part of a team that has integrity, is kind and supportive, and who really cares about our researchers and the work that we do. Those reasons are why I knew I wanted to come back to the ORC after my “COVID sabbatical.”
Of the following values, which one do you believe you exemplify the most, and why?(Courageous Integrity, Be Curious, We Care, Better Together, and Show Your Fire!) It’s kind of funny, actually… Several of my colleagues mentioned that they thought I should choose better together as soon as I was selected for this newsletter’s Employee Spotlight. They’re absolutely right, though; I truly believe that we are all better together, and that diversity of thought, experiences, cultures, and lifestyles enriches everything, especially in the workplace. Every person that we work with has a unique perspective from which we can learn. I view it as my personal mission to encourage my colleagues, to collaboratively find solutions to problems, and to be an ally to our researchers in their quest for compliant, ethical research with human subjects.
What is something we would be surprised to find out about you? My team already knows this, but I took classes at the Dallas Comedy House before it closed and performed improv on stage in front of a live audience. I also love plants and have given cuttings of the pothos in my office to fellow colleagues. And finally, I originally had six wisdom teeth instead of four, leading me to believe that my superhero name would be Jaws.
Time-sensitive human subjects, animals subjects, or export-controlled activities
Human Subject Research Projects:
If you have a time-sensitive submission (e.g. a new research project that has specific start date; a modification to an existing, IRB-approved project involving activities that need to occur by a certain date, etc.), there are some important steps you can take to help ensure your submission is reviewed and approved by the NTR IRB within the necessary timeframe.
While the NTR IRB cannot guarantee that a time-sensitive submission will receive IRB approval by a certain date, the NTR IRB strives to accommodate investigators’ deadlines whenever possible and reasonable.
Animal Research Projects:
Oftentimes, sponsor-initiated projects cause a time-sensitive concern for IACUC submissions, such as a new protocol, or an amendment to an approved IACUC protocol. Here are some helpful tips to help navigate receiving IACUC approval within the necessary timeframe.
A note in regard to amendments: Not all amendments need to go through full committee review, which may help in a quicker turnaround time for the review process.
While the IACUC Office cannot always guarantee that a time-sensitive submission will receive IACUC approval by a certain date, we will do our best to work with our researchers in hopes of meeting the identified time constraints of the project.
Compliance Review for Export Control Regulations on International Travel:
As we approach a new season of international travel, we would like to remind you of the requirements for all University-related travel outside of the United States. Here are some guidelines to keep in mind:
By following these guidelines, you can help ensure that your international travel for University-related purposes is in compliance with export control regulations, while also avoiding any potential delays or complications. Please do not hesitate to contact the Export Controls/International Compliance Office if you have any questions or concerns regarding the process.
Q: Who can serve as PI? (and who cannot serve as PI)
A: For the IRB: The term “PI” (Principal Investigator) implies specific responsibilities and interactions with a research project. The PI is responsible for all overall aspects of the research project (which include the scientific, technical, and administrative aspects), even when certain responsibilities have been delegated to their staff, students, or co-investigators. To be a Principal Investigator of a human subject research project, the individual must be:
For the IACUC: For protocols using animal subjects, HSC Faculty are eligible to serve as a Principal Investigator for an IACUC Protocol. However, individuals without HSC Faculty status may serve as a PI under the following conditions: (1) as a co-investigator with an individual who meets the eligibility requirements, or (2) receive written approval from the Executive Vice President for Research.
Q: Who can serve as key personnel? (and who cannot serve as key personnel – minors)
A: For the IRB: All research personnel who are actively involved with the project and anyone who will be interacting with human subjects or their data from a research perspective are considered “key personnel”. Key personnel do not have to be affiliated with the NTR IRB, but they are required to complete the necessary training (e.g., CITI Human Subjects Training, Good Clinical Practice) and to submit Conflict of Interest Statements if involved in an Expedited or Full Board protocol.
Minors cannot be named as key personnel in protocols. If undergraduate students (who are 18 years of age and over) will be involved in research protocols, please reach out to the NTR IRB for additional requirements.
For the IACUC: Anyone who will be working on the design, conduct, or reporting of the research for a specific project/activity must be listed in the “Protocol Team Members” section of the protocol (in the GRAMS system). This applies to individuals who are internal or external to the institution and includes faculty, staff, and students. In addition to the PI, all individuals listed on the protocol must first complete the Personnel Requirements, which include the completion of appropriate training and enrollment in our Occupational Health Program.
Researchers might wonder or ask themselves…Why is the IRB so interested in my recruitment materials? One may think study recruitment involves harmless informal interactions with potential research participants – however, recruitment is an important aspect of human subject research because it is considered part of the informed consent process. The information participants are given during the recruitment phase can make a huge impact on their decision to participate; thus, study recruitment should be approached with care. All recruitment efforts must respect personal rights to privacy and confidentiality, be compliant with the relevant regulations (Federal, HIPAA, FERPA) as well as institutional policies, and avoid possible coercion or undue influence (e.g., power differential between the researcher and the subject, therapeutic misconception, overly enticing incentives and false advertisements). For this reason, the IRB assesses study recruitment materials to ensure that the rights and welfare of potential participants are protected from the very first contact with the research team.
Of course, study recruitment strategies must be effective in attracting potential participants in addition to being accurate and ethical. When developing recruitment materials and strategies, make sure to give special considerations to the following areas to ensure potential research participants are appropriately receiving and understanding your message:
Individuals are more willing to participate in research when researchers carefully tailor the recruitment message to meet their unique needs and situations. In respecting participants and their circumstances, researchers build rapport with the intended subject pool and create strong relationships that translate into better research outcomes.
Because the IRB must review and approve all recruitment methods and materials for regulatory compliance and ethical considerations, it is important to submit appropriate documentation for each recruitment method to the IRB, including any scripts (oral, telephone, video, radio, etc.), flyers, advertisements, guides, handouts, and any other relevant materials. For a more thorough explanation about what must be submitted to the IRB for study recruitment, please visit the NTR IRB’s Recruitment Guidance document that is accessible from the Guidance and Sources page on our website.
Please note that the Principal Investigator is responsible for ensuring that study recruitment materials follow all institutional guidelines. As always, please contact the NTR IRB with any questions or suggestions at NorthTexRegIRB@unthsc.edu.