Attendees: Srinivas Palanki, Eileen Curl, Emily Born, Judi Mann, Nandu Radhakrishnan, Clayton Jeffryes, Alan Moore, Diane Mason, Kaye Shelton, Vidisha Worley
I. Call to order by Dr. Curl at 12:30pm.
II. Approved minutes from Sept 11, 2018 and November 13, 2018 meeting.
Motion made to approve minutes, all in attendance approved minutes.
III. Updates by Dr. Palanki: Introduction of Emily Born, new Compliance Specialist and purchase of Cayuse SP.
IV. Emily Born: Compliance Officer ORSPA.
Update Federal Common Rule. Dr. Curl mentioned to leave the categories as they are unless affected by Common Rule changes.
Dr. Curl also made a recommendation to the board that Emily Born in the role of Compliance Specialist review all exempt IRB’s, and she be a non-voting member of the board.
Vidisha Worley made a motion that Emily Born, Compliance Specialist review all exempt IRB’s and she not be a voting IRB member.
Diane Mason seconded.
Motion unanimously approved.
V. Full Board IRB’s:
1. FY19-111 – LU Strong Media Outreach
PI Judi Mann
Discussion: Start date needs to be revised. Study description and what exactly the program is will also need clarification. This is a three-part grant. The grant is for one year and this part/study is for the media publication aspect of the program. Through this part people are made aware of the program and what it has to offer to those affected by Hurricane Harvey.
General population survey sample from all 5 colleges on campus. Proposed sample includes the following: Spring 2019 - 400 students, Fall 2019 – 400 students; LU Strong Center participants: Spring 2019 – 50 students Fall 2019 – 50 students; Focus Groups: Spring 2019 – 16 students.
Survey changes: Need to identify how to contact the PI and also add ORSPA as a contact. How to contact the PI is listed on the informed consent but not on the survey.
The study meets exempt category 5, so in the future does not require the full board review with the new federal Common Core changes.
Dr. Shelton made a motion to accept the FY19-111 IRB application with changes.
Dr. Radhakrishnan seconded the motion.
Motion unanimously approved.
2. FY19-89 - LU Strong Rebuild Texas
PI Judi Mann
Discussion: Dr. Mann: This is very much like LU Strong. This grant is for 2 million dollars and it is again to help students recover from Hurricane Harvey. This money will focus on students not only on campus but students transferring to ذكذكتسئµ, and our online students. It is a much broader audience than the previous LU Strong grant. This will also focus on resilience. The grant will enable LU to give money and services to students in need. The focus is to look at the effectiveness of the program through anonymous surveys.
Dr. Curl: The surveys will need to include contact information for the PI and the ORSPA.
Dr. Shelton made a motion to accept IRB FY19-89 with changes.
Dr. Radhakrishnan seconded the motion.
Motion unanimously approved.
3. FY19-99 – Susceptibility and Consequences of E Cigarette Smoking in 7th-9th Grade Students
PI’s: Cindy Pipkins and M.S.N. Student Alyson Epp
Discussion: Change the start date. Coding is based on class roster and is not anonymous, unless the order of the roster is mixed up. Recommend deleting religious status of the student on the survey. Also need to add the word “voluntary” to the parents’ letter. Recruitment information that will be shared with the parents needs to be stated.
Ms. Alyson Epps: What is a good start date or what should I use?
Dr. Curl: February 1st is a good date. Once the changes are made and approved you could begin your research study. If the changes are submitted by the end of the week you could begin next week as long as you have your approval letter.
Dr. Shelton made a motion to accept the IRB FY19-99 application with changes.
Dr. Worley seconded the motion.
Motion unanimously approved.
VI. Other Items:
Issues with Cayuse: Cayuse and Qualtrics survey issues. Qualtrics will let you send out 500 emails per week. In order to send out more requires approval from ORSPA. It was originally thought that 500 emails per survey is what would happen, but some have figured out that it is 500 per week. This is an issue within Qualtrics. We do not have any control over this other than when the PI notifies us they need more than 500 per week. We must approve this on a case by case study.
Webpage Update: Dr. Moore: Within the online submission form in Cayuse, there is a help section that still says CITI or NIH.
Beverly Kemp: I will get into the template and change it to just say CITI.
Next meeting is April 9, 2019.
Dr. Curl adjourned the meeting at 2:32pm.