Executive Committee Minutes - February 18, 2004




Present:          Beck, Bradford, Fuller, Logan-Peters, Miller, Peterson, Shea, Spann, Whitt, Wunder


Absent:           Alexander, Buck, Fech


Date:               Wednesday, February 18, 2004


Location:        201 Canfield Administration Building


1.0       Call to Order

            Wunder called the meeting to order at 3:03 p.m.


2.0       Marcela Raffaelli and Shirley Horstman, Institutional Review Board

Raffaelli reported that the total number of protocols received by the IRB for 2003 was 1,130.  She noted that each submission, whether it is a new submission, a change in protocol, continuing reviews, or terminations must be reviewed and responded to.  She stated that there are currently 622 active protocols that are subject to federal oversight.  She pointed out that Horstman coordinates the Research Compliance Services but she has only one assistant and a part-time receptionist to help. 


Raffaelli stated that Vice Chanellor Paul wants to have UNL accredited with the Association for the Accreditation of Human Rights Protection Programs.   She stated that in order for this to occur, very comprehensive and specific information is required.   Wunder asked if this is required by the federal government.  Raffaelli stated that all information that is requested on protocols is required by the government. 


Wunder asked if the process for applying for IRB approval is on-line.  Raffaelli stated that the forms needed to submit a protocol are on line as well as guidelines to help people with the protocols.  She noted that they can be found on the Research Compliance Services web page (http://www.unl.edu/research/ReComp/main.html).  She stated that there are programs for on line processing of forms but they are very expensive and it requires a lot of work in the Compliance Office when a form is submitted on-line.


Raffaelli stated that IRB records are maintained by the Research Compliance Office.  She stated that UNL has not been audited in the past but it is possible that we could be audited at some time. 


Horstman stated that the Office for Human Research Protections (OHRP), a division of the Department of Health and Human Services of the federal government, is responsible for overseeing compliance with federal regulations.  She distributed an article reviewing the OHRP compliance oversight letters.  She pointed out that the article shows that 155 institutions were issued letters of citations for non-compliance and deficiencies.  She noted that in the 1990’s many institutions were shut down because of violations of non-compliance.  She pointed out that many of these facilities were involved in medical research. 


Wunder asked about the recent federal regulation which excludes history from the IRB requirements.  Raffaelli pointed out that this involves oral history.  She stated that a subcommittee, chaired by Assistant Professor McCollough, Anthropology & Geography and Ethnic Studies, is working on developing guidelines regarding the new regulation.   Raffaelli stated that these guidelines will be put on the web.  She pointed out that the subcommittee is getting further clarification regarding the regulation and hopes to move quickly on it.  Wunder noted that it is particularly important for graduate students working on dissertations to get this information as soon as possible.


Wunder stated that the Wasted Time Committee identified the process of submitting and getting approval for IRB protocols as an area that might be streamlined.  Raffaelli pointed out that not only does the IRB have to approve newly submitted protocols, it must also do continuing reviews on protocols that have been approved and are being worked on.  She stated that last year 226 continuing reviews were conducted.  She pointed out that when research is concluded a termination letter must be filed.   Wunder asked if the federal government wants the continual reviews.  Raffaelli stated that it is required by the government and for accreditation.  She noted that the government has tightened the regulations regarding IRB protocols in the last five years.  Horstman pointed out that of the 155 institutions cited for violations, 45 of them were due to violations of the continuing review process.  Beck asked how in depth the review must be.  Raffaelli stated that there is a two page document that must be completed. 


Logan-Peters asked how many people were on the Institutional Review Board.  Raffaelli stated that there are 12 members appointed by Vice Chancellor Paul.  She stated that the Board is made up of faculty members, graduate students, and outside community members. 


Peterson asked if the Board is divided into subcommittees to look at the proposals.  Raffaelli stated that some protocols require the full board to review.  She noted that these protocols typically deal with children or other vulnerable populations.  She pointed out that the federal government establishes the categories of protocols.  She noted that exempt proposals usually need more revisions.  She stated that the Compliance Services Office has been conducting more training recently.  Whitt noted that there is an on-line training course that people must take if they are submitting an IRB proposal or will be supervising a graduate student doing work that requires IRB approval.  He noted that the deadline for completing the course is March 1.  He stated that it takes approximately four hours to complete the course.  Horstman noted that the course is administered by the University of Miami.  Wunder asked if the federal government requires this course to be completed.  Raffaelli stated that Vice Chancellor Paul is requiring it because it is needed in order for UNL to receive accreditation.  She noted that it will take some time before UNL gets accredited. 


Horstman stated that the Research Complaince Services office is working on providing more hands-on-training for people.  She noted that there is a link on the website that deals with common protocol errors.  She stated that they are also holding IRB clinics where people can sign up and come in to receive help.  Raffaelli pointed out that diminishing the errors on the protocols would help reduce the workload of the Board. 


Spann asked if there has been an effect on research production because of all the federal regulations and the lengthy process.  Raffaelli stated that she has seen only one graduate student not receive IRB approval.  She does not think that research is being stifled.  She stated that the important thing is to make sure that we are protecting the rights of the subjects that are being researched.  She stated that the role of the Board is to make sure that the research being done is in compliance with the federal regulations.  She pointed out that having more staff to work on the protocols would help greatly in getting them processed.  Whitt pointed out that people need to be aware that the process needs to be done in order to conduct research on human subjects.  Raffaelli pointed out that if a professor wants to do research with a class during a semester, they need to submit a protocol before the semester begins. 


Whitt asked if UNL’s IRB is separate from UNMC’s.  Horstman stated that they separated in 1993. 


Logan-Peters asked if student surveys need IRB approval.  Raffaelli stated that it depends on how the data will be used.  She stated that if it is just for quality control issues than it does not need approval but if it is research that will be published it will need IRB approval.  Whitt asked whether census data needs approval.  Raffaelli stated that the major issue is whether there is a list that can be linked to particular individuals and data.  She pointed out that previously collected data is usually not an issue because a list is not provided that links the participants to the data. 


Raffaelli stated that they encourage people to talk with them if they need any assistance or have any questions.  The Research Compliance Services Office is located at 312 N.14th Street in the Alexander Building.  Phone number is 472-6965. 


3.0       Linda Crump – On-Line Sexual Harassment Course Demonstration

Crump stated that the campus is looking at an on-line sexual harassment course dealing with a college setting that would be required for all employees to take.  She noted that the course does not need to be done at one time but all sections must be completed before the quiz can be taken.  She stated that the tone of the course and the question and answer section can be tailored specifically to UNL.  She stated that the course is web based and people do not need to have access to email to complete the course. 


Crump reported that the course actually deals with other types of harassment as well as sexual harassment.  She noted that the quiz must be passed in order for a person to complete the course.  She stated that a refresher course can be developed each year.  She stated that UNL’s policy on harassment would be available for people to review. 


Crump stated that there are three different types of courses:  one is for supervisors, one is for non-supervisors, and one is for teachers and coaches.  She noted that the required course for non-supervisors takes about 60 minutes to complete.  She stated that the course for supervisors takes about 90 minutes and another 20 minutes for teachers and coaches.  She pointed out that each of the courses has different sets of scenarios. 


Beck asked if unprofessional conduct that is not considered illegal can be tailored into the course.  Crump stated that some examples in the course do a better job in dealing with this issue.  She stated that UNL can add things to the course but it will make it longer and more costly.  She pointed out that UNL will receive a copy of the entire script that can be tailored however changes cannot be made that will rewrite what is law. 


Fuller asked if the course was available for students to take.  Crump stated that at this time it is just for the workplace.  Logan-Peters asked if all employees will be required to take the course.  Crump stated that they would and that it would be done in cycles with refresher courses each year. 


Spann asked if the other campuses would be acquiring the course.  Crump stated that as of now, only UNL is getting it.  She stated that the University of Southern California is currently using the course. 


Bradford asked if the course was available in other formats for people who may be visually challenged.  Crump stated that it is and for other people who have other physical challenges as well. 


Spann asked what the timeline is for getting the course into place.  Crump stated that once the script is approved it would be 30 days before it is available for use.  She stated that the cost will be reduced if the campus does some of the work in  the changes made to the script.  Whitt asked about the cost.  Crump stated that it depends on the length of the course but typically it is anywhere from $5 - $8 per person. 


Beck asked who will be involved in the writing of the script.  Crump stated that this has not yet been determined.  She pointed out that whoever works on the script will need to be careful with the legal aspects and the length of it. 


4.0       Announcements

            No announcements were made.




5.0       Approval of 2/11/04 Minutes

Spann moved and Beck seconded approval of the minutes as amended.  Motion approved. 


6.0       Unfinished Business

6.1       Faculty Leadership Summit

Wunder asked if the press should be invited to attend the summit provided that they not interrupt the meeting with questions.  Spann asked if the meeting was open to the public or if is by invitation only.  Wunder stated that it is by invitation.  Spann pointed out that it would not be considered a public meeting and the press does not need to be invited.  Wunder stated that he would consider the press welcomed but that he would not specifically invite individual members of the press to the event.


6.2       ES/IS Proposal

Wunder stated that he believed an amendment needs to be made to the proposal dealing with the issue of the ratification process.  He stated that there needs to be clarification of the process on how the proposal will go forward.  The committee agreed to discuss this at its next meeting.


7.0       New Business

7.1       Senate Sponsoring Debate on US Patriot Act

Wunder reported that he has been contacted about the Academic Senate sponsoring a debate on the US Patriot Act.  He stated that it would be an evening event at the City Campus Union.  The committee agreed to discuss the issue further at its next meeting.


7.2       Legislative Bill

Wunder brought up concerns about the state legislature considering a bill to make the University Presidential search a secret search.  This will be discussed at a subsequent meeting.


The meeting was adjourned at 5:05 p.m.  The next meeting of the Executive Committee will be on Wednesday, February 25th at 1:30 pm.  The meeting will be held in the Academic Senate Office, 420 University Terrace.  The minutes are respectfully submitted by Karen Griffin, Coordinator and Shelley Fuller, Secretary.