November 12, 2019

 
Attendees: Eileen Curl, Vidisha Worley, Ruthie Robinson, Judi Mann, Emily Born, Beverly Kemp, Jerry Lin, Alan Moore

    I.        Call to Order: Dr. Curl called the meeting to order at 12:30pm.

   II.          Approval of Minutes: Dr. Curl asked if there were any corrections to the July 9, 2019 meeting minutes. Board members in attendance stated there were none. Dr. Curl stated by a show of approving nods, the minutes were approved.

   III.        Updates from the Office of Research and Sponsored Programs Administration (ORSPA):

               a.    Welcome to Dr. Jerry Lin - new Associate Provost for Research
                      Dr. Lin: I am excited to be here and looking to how I can serve and assist.
               b.    Emily Born, Compliance Officer:
                      Emily: There are several items listed further down in the agenda that we will discuss.
               c.     Beverly Kemp, Research Coordinator:
                      Some minor changes to the IRB webpage. Updated the Frequently asked questions section. Updated the Apply for Review page videos. Cayuse IRB performed upgrades and the information in the videos needed to be updated to match the new layout.

  IV.        Update on Approved Expedited Studies
Beverly provided the update of Expedited approved reviews for FY19 year (we did not have a September meeting) and for FY20. FY19 had 46 Expedited approved studies and FY20 currently had 6.

    V.        Recommendations for new members:

              a.    Replace Dr. Wendy Greenidge (Education) and Lynn Godkin (Business) are no longer on the board.   Dr. Greenidge has request to roll off now and Dr. Godkin is retiring. We will need to find replacements from their respective departments.

Dr. Curl: I would like for us to reach out to the department chair or dean and see if they can recommend a replacement.

Emily: I would like if possible, to replace Dr. Greenidge with someone from Kinesiology. We have quite a lot of reviews that rely on Dr. Moore as he is kind of our expert in in the Kinesiology. I don’t mind reaching out to the department chairs or deans for recommendations.

Beverly: When Dr. Godkin let me know of his retirement I asked him for recommendations for a replacement. I am waiting for his reply.

Dr. Moore: I believe that Shannon Jordan would be a good recommendation.

             b.    Add and replace external member

Dr. Curl: We currently need to replace our external board member. We will need a nonscientist and they cannot be related to anyone here on campus. Please reach out to Kneco Jones and see if she would like to continue as our external since her term has expired.

Emily: I have reached out to her several time and have not had any sort of response.

Dr. Mann, Beverly, and Dr. Worley: She has been to a few meetings in the beginning but has not been to any since.

Dr. Mann: She does work for the prison system and when they are on lock down, she cannot leave. She is has also moved up in position and she may no longer have the time to devote to the roll of external board member.

Dr. Curl: I would like to also add a community member to serve on this board.

Dr. Worley: I will reach out to my contacts and see if there is an additional community that would be available.

Dr. Lin: I have a few contacts that I can contact as well and see if they would like to serve as the additional community member.

Dr. Curl: Thank you all for the recommendations and again, Emily will contact the deans or department chairs for replacement recommendations.

  VI.        LU IRB Policies and Procedures on the Use of Human Subjects in Research

             a.    Blood draws – required experience and retraining
Dr. Curl: We are experiencing some items in our policies that need attention regarding blood draws. Should we need these list items in our policies regarding who will be conducting the blood draw? I get the impression that their experience is what they are using. Should we defer to the department procedures and refer them to the OSHA procedures as well? Environmental Health and Safety (EHS)  will be helpful with item as well.

Dr. Moore: Who is the lowest certified person who can draw blood and what certification should they be providing? Does it need to be a certified phlebotomist? I would think this might pose an issue.  

Emily: Usually certification is better but it’s not a federal requirement a phlebotomist conduct all blood draws. We do a case by case study currently. We also now have an IBC committee and this area falls under them which should be helpful.

Dr. Robinson: I think we should do a case by case as well, because do not have many.

              b.    Social media and research
Dr. Curl: I added the research to social media in our policy update because we currently do not have any items in our policies regarding social media and research. Because this is a new area and things are changing often, I think a review on a case by case basis would be appropriate. 

              c.     Other suggestions for changes: None at this time.

             d.    IRB policy changes need to be reviewed at two IRB meetings prior to implementation
Dr. Curl: I tried to look over the federal guidelines and we want to make sure the board has time to review all the changes. We will not take a vote today but I ask that you review the updates to the policy and have your input completed by the end of December 2019 so they are available for the January 14, 2020 meeting. Dr. Lin: I requested a check list and Emily has one she is currently revising, and it will eventually be on our website.

Dr. Curl: One thing I did not realize, the policy was so strong about was the number of participants. We need to ask for the number of maximum of participants for recruitment.

Emily and Dr. Moore: It would be better if we said estimated maximum number. This will allow for PI’s to continue the research in the event they placed a firm number they would need to submit a modification to increase the number if they had more. This has the potential to slow down the research which might be on a strict timeline.

Beverly: I made the change to the submission template and it states: estimated maximum number of participants as well as provide a justification for the chosen estimated number.

Dr. Moore: Once you have a person sign a consent form, they are a subject. I think it would be a good idea to clarify that. I am not sure how you would clarify that or if you even want to clarify that here or in another area. We can add participation begins when the consent form is signed. We might possibly add to the number of participation question.

 VII.        CITI

              a.    Class Projects
Emily: We have a lot of research methods courses, but they have a hard time because it is hard for them to work through CITI. We removed the student course as it only had two modules. If it is a class project and if they are going to use it for publication, then they must complete the IRB and complete the CITI training requirement. But if they are doing a class project and are not going to publish,/present/disseminate, they do not need to complete the CITI training requirement.

             b.    Reminder: Board members need to hold CITI certificates
Dr. Curl: Board members need to hold CITI training certificates in Social and Behavioral Research-Basic/Refresher (SBE), Biomedical Research – Basic/Refresher (Biomed), and IRB members – Basic/Refresher.  Submit electronic copies of CITI certificates to Beverly Kemp if you have not already done so. Beverly, please let me know if there are any board members who are still outstanding with this requirement.

VIII.        Other Items: Next meeting: Jan. 14, 2020 at 12:30 pm . IRB meetings start at 12:30 pm:
2020 meetings January 14, April 14, July 14, September 8, November 10

Dr. Curl adjourned the meeting at 1:32pm.