|
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 – Tania Ghani!
In this issue, we’ll help you get to the “Yes” with tips and tricks for avoiding common noncompliance.
In this issue, we highlight our recent presentation on Research Café, where we answered the question “What does the ORC do?”.
In this special article, we discuss compassion fatigue: what it is, how to identify if you may be experiencing it, and what to do to prevent or mitigate it.
Find all of the meeting and deadline dates for the next three months of Board and Committee meetings.
|
|
What’s Happening in the ORC?
Here is the latest news from the ORC:
Alyson Stearns, one of our beloved IRB Compliance Managers, left the university in June and we wish her all the best. We have appropriately transitioned her projects to other IRB team members and are actively recruiting new IRB Compliance Managers. If you are (or know someone) interested in research compliance, please see our posting.
The IACUC has officially transitioned out of GRAMS and has implemented new protocol and amendment forms. The new forms can be found on the IACUC forms page. In addition to these new forms, you can also watch a quick training video on completing and submitting the new protocol form.
On May 21st, the North Texas Regional IRB hosted a booth at the annual JPS Research & Quality Symposium. As in previous years, this event allowed researchers to connect directly with the NTR IRB, and also allowed the IRB a chance to see the results of the researchers’ hard work and research successes!
In the continued efforts for accreditation of the Human Research Protection Program (HRPP) and the NTR IRB, the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) will be conducting a site visit on August 6th – 7th. In support of this, there will not be an IRB meeting during the month of August. You can read more about this on our NTR IRB website, and we will be sure to keep you updated with additional information as we receive it.
As a general reminder, the HSC RCOI Campaign for 2024 will commence on September 1st. Please stay tuned for further announcements from the ORC/RCOI office closer to the start of the campaign.
back to top
Employee Spotlight – Meet Tania Ghani
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 have worked in the Office of Research Compliance since March 2018, so almost 6 ½ years now! Time flies when you are having fun. 😊 I started off as an IRB Compliance Manager, then moved into the Director of Research Compliance role in October 2019. There are several things I enjoy about this role, but mostly, I love the opportunity to work with people both within and outside of the institution to truly fulfill our University’s mission – creating solutions for a healthier community. While I know compliance is not one of the more popular areas of research, I know many of the people our office works with agree that it’s especially important to not only follow the rules, but also to conduct research in an ethical manner. Working in and overseeing the ORC has given me the opportunity to be a part of so many successful research projects, and to see the benefits that research has both in the local community and in the greater society makes me truly proud! I’m also honored to regularly work alongside so many incredibly talented people (both my team members/colleagues and researchers alike!) – every day, we have the chance to collaborate and learn new things.
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!) I am a strong believer in displaying all of these values on a day-to-day basis, but if I had to pick which values I feel I exemplify most, it would be Courageous Integrity, We Care, and Better Together. As leader of a Compliance office, integrity must be first and foremost for me, for without it, our office wouldn’t be able to support ethical research. Additionally, I believe that when people care for one another, it helps us to be our best selves and in turn, allows us to do our best work each day. Finally, while one person can certainly be successful on their own, experience has taught me that I’m able to accomplish so much more when working alongside a strong team.
What is something we would be surprised to find out about you?I love to perform and used to be in choir and musical theater! I took voice lessons and was in choir through most of my childhood, and also spent several years doing musical theater. My husband and I were also part of a guitar group a few years ago, and while I certainly need MANY more of years of practice to even be proficient, having another creative outlet is a great way to help keep some balance in my life. 😊
back to top
How to Get to the Yes
Tips and tricks for avoiding common noncompliance
There’s nothing worse than the feeling of finding out you violated your protocol, missed completing a process/procedure, or misunderstood a policy or SOP. What do you do? Could this have been avoided? Noncompliance with a protocol or process arises when a deviation from an approved IRB or IACUC protocol takes place or when a procedure for international travel is missed. While nobody wants noncompliance to occur, they happen to even the most experienced and meticulous researchers. In this article, we’ll cover some of the common types of protocol violations/noncompliance, tips to keep them from occurring in the first place, and what steps you should take if they do happen.
For IACUC Protocols:
Including certain flexibilities within your Animal Use Protocols could help avoid protocol noncompliance. When writing your protocol, consider the following:
- Providing a dose range for substances administered: Regardless of the source type, the name of the funding source must be identified/provided in the protocol.
- Providing an alternative euthanasia method: There are times when the study endpoint euthanasia method is not going to work as a humane endpoint euthanasia method. Providing alternative euthanasia methods will keep you in compliance with your protocol if you need to euthanize an animal quickly due to humane reasons.
- Listing a range for the animal model’s age or weight: Animals tend to age and grow while they are on a protocol. To ensure the animal does not age out of the protocol, it is recommended that age and weight be listed as a range.
- Don’t list the room location for housing or procedure rooms within the animal facility: As the rooms within the vivarium could change based on DLAM’s needs, there is no need to list the specific room number within the protocol. However, do list the room number for the laboratory location used for animals outside of the vivarium.
- List the restraint duration in a range: Sometimes there are slight variations in how long it takes for an animal to acclimate to the restraint device – providing a range accounts for those variations.
- Including a buffer in animal numbers: Calculating animal numbers can be a challenge. There’s always the question, do I have enough animal numbers calculated to complete this project? This is especially true for studies which have the potential for losing animals early due to humane endpoints. Additional animal numbers are okay to include in the protocol; however, an explanation is needed of how this number was determined.
- Including enough animals for breeding: There are many things to consider when calculating animal numbers for breeding. Not only do you need to justify the number of animals for the experiment, but you also need to account for the number of breeder dams and bucks needed to generate enough pups for the experiment. Remember to include refresher breeders to discourage genetic drift. And don’t forget about the surplus animals generated that cannot be used due to not having the right genotype or not fitting the parameters of the experiment. Feel free to set up if you need assistance in calculating animal numbers for breeding experiments.
More tips to consider for avoiding protocol noncompliance:
- Always check your animals when they arrive, to guarantee the right animals arrived and ensure the cage card information is correct.
- Review the protocol with the protocol team members before starting an experiment, to make sure that everything is in place when you’re ready to begin. If there are any adjustments needed to the protocol, please submit an amendment.
- Check the cage card of the animals before performing the experiment to ensure you have the right animals and that they are on the correct protocol.
- Contact the DLAM office for any questions concerning the animals, or the IACUC office for any questions concerning the protocol. We are always happy to help.
|
|
|
For IRB Protocols:
Below are some common (or “trending”) protocol violations/deviations that have been reported to the NTR IRB (either through the Post-Approval Monitoring program or self-reported by researchers) and ways to avoid them.
- Lapsed IRB Training (e.g. Human Subject Protection and Good Clinical Practice Trainings):
- Importance of Training: It’s crucial that all researchers engaged in human subject research maintain current IRB training. Although it may be daunting to track training of all involved on a protocol, consider the following options to assist:
- Maintain a spreadsheet of expiration dates for all team members’ training.
- Set calendar reminders for upcoming expiration dates (15, 30, and/or 60 days in advance).
- Discuss the importance of staying current with IRB training during research team meetings.
- Remove inactive research team members from the protocol by submitting an IRB amendment.
- Irregularities with Documenting Informed Consent:
- Importance of Signatures: Missing signatures on informed consent documents are a common issue. Collecting the participant’s signature is a regulatory requirement (and demonstrates consent actually occurred). Consider implementing the following when consenting participants:
- Use “sign here” tabs to highlight where signatures are needed.
- Review the informed consent document with the participant before they leave.
- Have a second reviewer check the document for completeness.
- Provide reminders and training on the importance of obtaining signatures during team meetings.
- Minor Deviations from the Study Protocol:
- Sometimes research does not go as planned, and adjustments to the day-to-day implementation of research activities/procedures may be needed. Non-compliance often occurs when the protocol does not allow for flexibility, or the protocol has not been appropriately modified (and approved by the IRB) to address a change in procedure. Some common examples include but are not limited to the following:
- Recruiting more participants than specified
- Not following study timelines
- Including additional data variables
- Best practices to mitigate minor violations to the protocol:
- Review the IRB-approved protocol regularly to ensure compliance.
- Contact the IRB before making changes to the protocol.
- Report any immediate changes made to the IRB for review.
-
For International Travel:
By following these guidelines, you can ensure that your international travel for University-related purposes complies with export control regulations and avoids any potential delays or complications.
- Your destination is important!
- Before traveling, make sure to check the country’s “Travel Advisory” you plan to visit. (Hint: The ORC obtains data from www.Travel.state.gov regarding risks on traveling to areas outside of the U.S.).
- If the Travel Advisory has a level of 3 or higher get in touch with the Export Control Officer well ahead of your planned travel for guidance and advice on ways to mitigate risks with travel to that particular area. Additionally, each country has its own specific laws and regulations for technology and encryption, so the guidance you need may differ. You can find the listings of embargoed countries here.
- Plan ahead
- Submit your international travel request in Concur in advance to allow adequate time for the export control compliance review process as well as all other University and/or System approvals that may be required. This review is mandatory for all international travel.
- Preparing for Travel
- Don’t forget to complete and send an International Travel Device Checklist and upload it into Concur for any international travel requests. This is necessary to make sure that all electronic devices, equipment, and technology being taken outside of the United States comply with export control regulations.
- While in Concur, upload the itinerary of your travel plans and conferences, including any planned activities that may require the temporary export of controlled items. This will help the Export Controls Officer determine the appropriate level of review needed for your travel.
If you have any questions or concerns regarding the process, please contact the Export Controls Officer. For more information on complying with HSC international travel requirements, visit our webpage. .
Regardless of the compliance unit involved, the important thing is to not panic once you’ve identified violations/noncompliance with protocols or procedures; reach out to our office and we will help you with next steps. Noncompliance can happen despite our best efforts, and we’re here to help you be successful in your research and research-related activities.
back to top
You’ve Got Questions, We’ve Got Answers!
If you’ve ever had the question “What IS the Office of Research Compliance?” or “What does the Office of Research Compliance actually DO?”, you’re in luck! This past April, our office had the opportunity to answer questions like these on Research Café with our presentation, “Getting to the Yes: How to Navigate the Research Compliance Regulatory Landscape”. In this introductory presentation we covered the scope of our office, including what each sub-area does and what investigators need to know about working with each section of the ORC.
To recap, our office includes the Institutional Animal Care and Use Committee (IACUC), Research Conflict of Interest (RCOI), the North Texas Regional Institutional Review Board (NTR IRB), Export Controls, Research Integrity, and Responsible Conduct of Research (RCR). If you missed the presentation, you can click here to watch a recording; or, for a more in-depth look at our office, check out our website.
Every month, Research Café virtually hosts a different speaker covering different topics relevant to researchers at all levels. You can find Zoom links for upcoming Research Cafés and watch recordings from previous months on their webpage!
Any other general questions or not sure where to start? You can visit our Office of Research Compliance webpage, call us at 817-735-0409, or email us at Research.Compliance@unthsc.edu.
We look forward to hearing from you!! 😊
Have a question you would like answered? Just click the link below to submit your question.
back to top
|
|
|
What to Know About the Condition of Caring Too Much: When Caring Leads to Compassion Fatigue
Compassion fatigue has been dubbed “the cost of caring” by traumatologist Dr. Charles Figley. In his book Compassion Fatigue in the Animal-Care Community, Dr. Figley writes that it is “the deep physical, emotional, and spiritual exhaustion that can result from working day to day in an intense caregiving environment.” Also known as Secondary Traumatic Stress, compassion fatigue can affect anyone working in a caregiving role. It can impact those who work with humans like healthcare professionals, teachers, or lawyers. It can also affect those who work with animals like veterinarians, zookeepers, and animal control officers. People who work in research, whether with humans or animals, are not immune to compassion fatigue.
Compassion fatigue can come about when the lines between work and personality become blurred. The sufferer will often wrap their self-worth in what they are doing in their career, often causing a struggle to remove who they are as a person from their career and especially from those in their care, leading to emotional exhaustion. This blending of personal and professional identities makes recognizing the symptoms crucial.
Learning to recognize the signs of compassion fatigue early will allow the sufferer to take steps towards improving their mental health. Identifying both mental and physical symptoms can be the first step towards seeking help. By understanding these warning signs, individuals can begin to implement strategies for self-care and seek professional support if needed.
Some mental symptoms include:
- Lowered Concentration
- Feelings of Helplessness
- Irritability or Anger
- Depression
- Feeling Detached
- Reduced Empathy
Some physical symptoms include:
- Physical Pain
- Exhaustion
- Poor Sleep
- Headaches
- Nausea
- Dizziness
Prevention and mitigation are incredibly important for helping those suffering from compassion fatigue. An early preventative step is workplace implementation of staff training to improve awareness of and the ability to identify compassion fatigue. Leadership taking an active role in teaching employees how to respond to trauma and burn out in healthy ways leads to a better work environment overall. Leadership should also be available for direct communication from employees who believe they are feeling the effects of compassion fatigue. Those feeling the effects of compassion fatigue can also take steps to alleviate the effects. Having a dedicated support network to talk with, whether that be a therapist, friends, coworkers, or support groups allows the sufferer to let out their negative feelings and get feedback on how to work through it.
The most important steps are the ones that those experiencing compassion fatigue take for themselves. Taking time to focus on themselves and what makes them happy and practicing mindfulness when symptoms start to manifest. While it may not be a be-all end-all solution to the problem, it can help the sufferer to feel better overall.
Compassion fatigue can affect anyone who is involved in the care of others, human or animal. Being aware of the signs and learning how to prevent and mitigate its effects is vital for the health and wellbeing of both the caregiver and the ones being cared for. Most importantly, having proactive strategies in place to deal with compassion fatigue will make navigating it a much less daunting endeavor.
back to top
|
Social media