FY09 - 5-4-09

							                                Institutional Review Board
                                   Kennesaw State University
                                         May 4, 2009

Present: Dr. Annette Bairan, Dr. Joy Bell, Dr. Gaia Marchisio, Dr. John McLester, Dr. Jonathan
McMurry, Dr. David Mitchell, Dr. Alice Terry, Dr. Jo Williamson, Dr. Ginny Zhan, Dr.
Christine Ziegler

Excused: Dr. Estella Chen, Dr. Teresa Joyce, Dr. Beverly Maddox

Absent: Rev. Doris Graf Smith

1. The meeting was called to order by Dr. Zhan, IRB Chair, at 9:30 a.m. in the Hospitality Suite
of KSU’s Convocation Center.

2. The minutes from the April 2009 meeting were reviewed. Following a motion by
Dr. Bairan, with a second by Dr. McLester, the minutes were approved by a vote of 9 for and 0
against.

3. Review of Expedited Reports

Activity Report of Expedited and Administrative Activities (4/3/09 through 4/27/09)

    Summary of discussion: None

    Action: No changes

4. Review of New Studies

    Summary of discussion: None

    Action: None

5. Continuing Review of Studies

Study #09-140, HIV Prevention for Young Adults 18-24 Years of Age, Substance Users, and
Men Who Have Sex with Men

    Summary of discussion: Revisions to this study, requested by the board during the April
    2009 meeting, were submitted by Dr. Barbara Blake for additional review. Dr. Blake’s
    documentation revealed that the Youth Pride organization was removed from the study as a
    source of participants. The Paulding and Gwinnett County detention centers will be part of
    the study and parents, who in fact do not sign over parental rights to children placed in the
    centers, will be asked to give signed consent. No monetary incentives will be given.



KSU IRB Retreat
May 4, 2009
    Action: After a motion by Dr. Bairan, with a second by Dr. McMurry, the study revisions
    were approved by a vote of 9 for and 0 against.

6. Other Business:

IRB Exemption Review Application

    Summary of discussion: After reviewing three examples of exemption application forms
    presented by Paula Strange, a format was selected from which to model KSU’s form. The
    new form will ask researchers to provide project identification information, select the exempt
    category in which the study falls, give a brief description of the proposed project, and address
    six additional questions regarding why the study should be granted an exemption.
    Researchers will be required to electronically submit the exemption review application along
    with a copy of survey questions, consent documents (if required), interview scripts, etc., for
    review by Dr. Zhan and Paula Strange. If the study is deemed to be exempt, no further
    review will be required, and a letter of exemption will be issued. If it is determined that the
    study is not exempt, the researcher will be asked to submit an IRB Approval Request, and an
    additional board member will be assigned to complete an expedited review along with Dr.
    Zhan.

    All forms and information regarding the change in the submission process will be publicized
    on the IRB website as soon as the form is approved. At that time, board members will
    announce the changes in the process to their departments/college through an in-person
    presentation or by sending a blanket email regarding the changes, ensuring a link to the IRB
    website is included.

    Dr. Maddox’s email correspondence with Ms. Freda Yoder of the OHRP, regarding
    publication or presentation of data on studies that are categorized as exempt, was discussed
    once again. Dr. Zhan reiterated that if a study including human subjects falls within an
    exempt category, and the researcher decides to present or publish data that yields
    generalizable knowledge from that study, the study would still maintain its exempt
    classification. It was also noted that when data is de-identified, a study may be classified as
    exempt as long as it falls completely within one of the exempt categories.

    Action: Paula Strange, working with Dr. Zhan, will prepare a final draft of the Exemption
    Review Application form with board review and approval following.

Bagwell College of Education (BCOE) Student Researchers in Educational Settings Policy

    Summary of discussion: The current policy relating to student researchers in educational
    settings was discussed. It was determined that the policy is unclear and all aspects of the
    policy are in need of revision.

    The section regarding student-researchers carrying out course-based research is problematic.
    At present, students are required to forward copies of all documents submitted to and issued
    by the school district in which the study is to be conducted. It has been determined that a


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May 4, 2009
    very small percentage of students are adhering to this policy as there is no formal follow-up
    procedure in place in BCOE. Dr. Terry stated that the students are assigned a research
    project in class, but due to a lag in IRB review by the school district, the research project is
    not approved until after the semester ends. By this time, the instructor is no longer in contact
    with the student. A number of board members stated that as faculty advisor on a research
    project, it continues to be the instructor’s responsibility to ensure students submit required
    paperwork even after a class ends. Some members felt it should be the responsibility of the
    student, not the faculty advisor, to complete the requirements.

    Action: Drs. Bell, Terry, and Williamson volunteered to work together to revise the policy.
    They will consider input and suggestions from the BCOE Graduate Dean and Dr. Zhan and
    will present a draft at the August 2009 meeting.

Community Membership

    Summary of discussion: The board is in need of continued representation by individuals
    from the local community. No particular background is deemed necessary for this type of
    membership, but the individual, nor his/her immediate family, should be affiliated with KSU.
    All members were requested to ask personal contacts within their various communities to
    consider such an appointment.

    Action: Board members will submit names and contact information of community members
    found willing to commit to a three-year appointment to the board to Dr. Zhan as soon as
    possible. Dr. Zhan will work with Dr. Joyce to ensure appropriate appointments are made.

7. The meeting was adjourned by Dr. Zhan at 1:00 p.m.

Minutes submitted by Paula Strange on May 20, 2009




KSU IRB Retreat                                                                                    3
May 4, 2009