Texas Tech University
Protection of Human Subjects
Institutional Review Board
2010 Annual Report
Total of 1,602 proposals in 2010
including 396 terminated proposals
but not including 110 amendments to proposals
New
Extensions
Pending
Other
500
450
400
350
300
250
200
150
100
50
0
Full Board
Expedited
Exempt
Amendments
Terminated
External
About the IRB
The mission of the IRB is to protect the rights and welfare of human research subjects by
minimizing risks, ensuring that people are fully informed before they participate in research, and
promoting equity in research participation.
The Texas Tech University Institutional Review Board for the Protection of Human Subjects
(IRB) complies with the Federalwide Assurance registration guidelines through the Office for
Human Research Protections of the U.S. Department of Health and Human Services regulated by
45 CFR 46 under number FWA00001568. It is also identified by IORG 0000166 and IRB
00000276 codes. Registration is current and the FWA expires on September 16, 2012. The IRB
office is housed in Holden Hall. The IRB is supervised by Dr. Alice Young, Associate Vice
President for Research (Research Integrity), under the oversight of the Vice President for
Research.
People
Chair, Coordinator, and Assistant Coordinator
Dr. Rosemary Cogan continued as the Chair of the IRB. Dr. Cogan has completed a line of
research related to IRB consent forms. Ms. Donna Peters continued as the Coordinator of the
IRB. Ms. Peters continued pre-screening new IRB proposals before sending the proposals to
reviewers and continued to make presentations about the IRB to TTU classes and groups. She
continues to work toward a Master of Public Administration. Mr. Brian Piscacek joined the IRB
staff as an Assistant Coordinator in June, 2010. Piscacek has a MPA and brings relevant
community experience to the IRB.
Both Dr. Cogan and Ms. Peters have current certifications as Certified IRB Professionals (CIP).
Both attended the Public Responsibility in Medicine & Research (PRIM&R) meetings in
Nashville in November where each presented a poster (Cogan, McDonald, & Eaton, 2010;
Peters, Cogan, Barker, Carter, & Butler, 2010). Mr. Piscacek also attended the PRIM&R
meetings.
Members
In December 2010, one IRB member left the university. One IRB member changed jobs and
became Ex-Officio. We added three new alternate members. The Board consists of ten TTU
faculty members, two HSC faculty members, and three community members. Board members
serve on the IRB as a service to the university community. A current roster of the IRB can be
found in Appendix A. This is an exceptional group of people in terms of commitment, sensitivity
to the issues involved in protecting human subjects, and willingness to be helpful to members of
the university community.
Activities in 2010
Meetings
2010 Annual Report Page 2 The full IRB met seven times in 2010. IRB members discussed research articles and educational
materials at each meeting. The minutes of the IRB Full Board Meetings are available to the
public by contacting the IRB Coordinator at 806-742-3905.
Networking
Dr. Cogan and Ms. Peters worked by phone with PRIM&R Mentor Eric Allen, CIP, Director of
the Office of Research Compliance at the University of North Carolina at Greensboro. These
conversations focused on streamlining the work of the TTU IRB and on helping researchers with
specific issues.
Proposals
The number of proposals coming to the IRB continues to increase. We are taking active steps to
contain the work load within regulatory requirements. A related problem is the lack of a back-up
for the IRB Chair. We outline our recommended solutions below.
Of the active IRB protocols, 88 involve sponsored projects and 33 have grants pending.
Year
2005
2006
2007
2008
2009
2010
Active proposals
326
557
824
1,001
1,152
1,206
Budget
The IRB Budget includes the salary for the Coordinator and Assistant Coordinator and 25%
salary for the Chair. We have a half time undergraduate student assistant. The budget also allows
for professional memberships, travel to educational conferences, certification fees, and a modest
amount for relevant journals, books, and supplies.
Goals
We will continue to focus on the smoothest possible functioning of the IRB by helping
investigators with the least restrictive necessary level of IRB review, continuing to pre-screen
proposals before they are sent to reviewers, and continuing to help every IRB member with
training and educational opportunities.
Achieved in 2010
1. We hired an Assistant IRB Coordinator, Mr. Brian Piscacek.
2. We (DP) arranged for a usability assessment of our www materials by the TTU Usability Lab
(English 5388) and completed a major revision of the www site and materials. In 2011, the
2010 Annual Report Page 3 3.
4.
5.
6.
7.
8.
9.
Usability Lab will complete a formal assessment of the revised materials.
We developed a self-assessment of whether or not a project requires IRB review. This will be
on the web to be available to the TTU community early in 2011.
We handled two adverse events, consulting with the Office of Human Research Protections
(OHRP) for guidance on one.
We completed a thorough review of policies and procedures for Payment to Research
Participant. We interviewed staff members at TTU and HSC, the IRS and others. We (BP)
developed a series of decision charts to describe current practices, which require 1-2 hours of
staff time for processing small payments to research participants. We recommended revisions
of the guiding OPs and gave these to Alice Young, Ph.D.
After a careful review of federal regulations, and a survey of IRB reviewers, we approved a
test period during which the IRB Coordinator will approve Exempt proposals, sending only
problematic Exempt proposals to IRB members for further review. This will save time and
effort in the IRB office as well as reducing reviewers’ time demands.
We (DP) organized a meeting of all TTU/TTUHSC compliance office personnel.
We (staff) made 10 class presentations and one TLTC presentation.
We are gathering information about IRB work with social networking (DP) and reactions to
research participation (fMRI and sensitive topics – RC).
Goals for 2011
1. While staying within federal guidelines, we will continue work to reduce the number of IRB
proposals that need to be reviewed by IRB reviewers.
2. We will continue our self-study as background for a recommendation about national
accreditation of the TTU IRB, using the self-assessment materials from the Office for Human
Research Protections (OHRP). We are not yet prepared to make a recommendation about
whether or not TTU sets IRB accreditation as a goal. If such a goal is adopted it will take
several years to accomplish.
Long term goal
We recommend that an Assistant IRB Chair be added. This person should be encouraged to work
toward Certification and should be provided with summer support. This will also help ensure the
availability of IRB reviewers for summer.
__________________________________
Rosemary Cogan, Ph.D., ABPP, CIP
_________________________________
Donna Peters, CIP
________________________________
Brian Piscacek, MPA
2010 Annual Report Page 4 PRIM&R Presentations
Cogan, R., McDonald, B. & Eaton, A. (December, 2010). Retention of information from
written consent forms and reactions to research participation among university
students. Poster presented at meetings of Public Responsibility in Medicine & Research,
San Diego, CA.
Peters, D., Cogan, R., Barker, T., Carter, J., & Butler, K. (December, 2010). Usability
study of IRB website at Texas Tech University: A two-stage model. Poster presented at
meetings of Public Responsibility in Medicine & Research, San Diego CA.
2010 Annual Report Page 5 Appendix A
MEMBER ROSTER
September 2010
Name
Term
College/Dept.
Rosemary Cogan,
Ph.D. (Chair)
2010
Arts & Sciences
Psychology
Lillie Aguilar
2010
Jan Blackwell
2010
Bill Downing
2012
Angela Eaton,Ph.D.
2010
John Fowler, Ph.D.
2012
Sarah Kulkofsky,
Ph.D.
Lorenz Lutherer,
Ph.D., M.D.
Susan Mengel, Ph.D.
2012
2011
2012
MS
Phone
Email
2051
742-3711
ext 253
r.cogan@ttu.edu
NA
763-4187
lillie.aguilar@mail.tmccentral.org
NA
NA
jblackwell7@suddenlink.net
NA
NA
brigadoon36@aol.com
English
3091
742-2500
ext 229
angela.eaton@ttu.edu
TTUHSC
Physiology
Human Sciences
HDFS
TTUHSC
Physiology
Computer
Science
Nutrition, Hosp.
Retailing
Arts & Sciences
Psychology
HSC
6651
743-2083
john.fowler@ttuhsc.edu
1230
742-3000
ext 292
sarah.kulkofsky@ttu.edu
HSC
6651
743-2532
lorenz.lutherer@ttuhsc.edu
Lubbock
Community
Lubbock
Community
Lubbock
Community
3104
1240
742-3527
ext 224
742-3068
ext 2370
742-3711
ext 237
susan.mengel@ttu.edu
kelly.phelan@ttu.edu
Kelly Phelan, Ph.D.
2012
Darcy Reich, Ph.D.
2012
Andreas Schneider,
Ph.D.
2012
Soc., Anthro.,
Social Work
1012
742-2401
ext 231
andreas.schneider@ttu.edu
James L. Smith,
Ph.D.
2012
Industrial
Engineering
3061
742-3543
james.smith@ttu.edu
Erin Snyder, Ph.D.
2012
Student
Counseling Ctr
5008
742-3674
ext 247
erin.snyder@ttu.edu
Eric Walden, Ph.D.
2012
Business
2101
2-1552
eric.walden@ttu.edu
2051
darcy.reich@ttu.edu
Rosemary Cogan: Licensed Clinical Psychologist, State of Texas #3676; Board Certified in Clinical Psychology, American Board of
Professional Psychology; Board Certified in Psychoanalysis, American Psychoanalytic Association.
Lorenz Lutherer: Licensed Physician, Texas Medical Board #E8682
James Smith: Registered Professional Engineer-Texas; Certified Professional Ergonomist #577
2010 Annual Report Page 6 ALTERNATES
Name
Term
Nancy Bell, Ph.D.
2012
Patricia DeLucia, Ph.D.
2011
Kenneth DeMarree,
Ph.D.
2013
Doug Hamman, Ph.D.
College/Dept.
Human Sciences
HDFS
A&S
Psychology
MS
Phone
2-3000
ext 269
2-3711
ext 259
2-3711
242
2-1997
#367
2-1997
ext 367
1230
2051
Psychology
2051
Education
1071
Email
nancy.bell@ttu.edu
pat.delucia@ttu.edu
ken.demarree@ttu.edu
doug.hamman@ttu.edu
Sylvia Mendez-Morse,
Ph.D.
2012
Education -
1071
sylvia.mendezmorse@ttu.edu
Comfort Pratt, Ph.D.
2013
Education
1071
2-1997
#367
c.pratt@ttu.edu
Alan Reifman, Ph.D.
2012
Human Sciences
HDFS
1162
2-3000
ext 274
alan.reifman@ttu.edu
JoAnn Shroyer, Ph.D.
2012
Human Sciences
MDCE
1162
2-3050
joann.shroyer@ttu.edu
Jaeki Song, Ph.D.
2012
Business
2101
2-8036
jaeki.song@ttu.edu
Andy Young, Ed.D.
2012
Behavioral Sciences,
Lubbock Christian
University
NA
720-7830 andy.young@lcu.edu
Ex-OFFICIO
Name
College/Dept.
MS
Phone
Email
Katherine Austin, Ph.D.,
Asst Vice President
Information Technology
2008
2-5156
kathy.austin@ttu.edu
Jennifer Horn, J. D.
Office of Research Services
1035
2-3884
jennifer.horn@ttu.edu
Randy Nix,
Managing Director
Environmental Health/Safety
1090
2-3876
randy.nix@ttu.edu
Alice Young, Ph.D.
Associate VP for Research
(Research Integrity)
Office of the Vice President
for Research
1075
2-3905
alice.young@ttu.edu
2010 Annual Report Page 7 Figure 2.
Number of active proposals in each college
2005
2006
2007
A&S
BA
ED
2008
2009
ENG
HS
2010
600
Number 500
400
300
200
100
0
AG
MCOM
VP
Other
College
2010 Annual Report Page 8 Figure 3.
Number of active proposals in departments in Arts & Sciences
2005
2006
2007
2008
2009
2010
250
Number 200
150
100
50
0
BIO CHEM CMLL COMS ECO ENGL GEO HESS HIST MATH PHYS PHIL POLS
PSY
SOC
Departments in Arts & Sciences
Figure 4.
Number of active proposals in divisions in Education and Human Sciences
2005
2006
2007
2008
2009
2010
250
Number 200
150
100
50
0
CUR
EPSY
Other
APS
DES
HDFS
NHR
Other
Education Human Sciences
2010 Annual Report Page 9