Texas Tech University
Human Research Protection Program/
Institutional Review Board
Protection of Human Subjects
2012 Annual Report
About the IRB/Human Research Protection Program
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 November 29, 2017.
The Human Research Protection Program (HRPP) became the new name of the IRB office in
early 2012. The name change was approved by university administration to reflect a more
accurate description of the office functions and purpose. The HRPP carries out administrative
duties involved with the Institutional Review Board. In August, the HRPP Office and staff
moved to 357 Administration Building joining other offices and staff of the Vice President for
Research. The HRPP is supervised by Dr. Alice Young, Associate Vice President for Research
Integrity, under the oversight of the Vice President for Research.
People
Chair, Manager, Program Coordinator, Program Coordinator for Post-Approval Review
Dr. Rosemary Cogan continued as the Chair of the IRB in 2012. Donna Peters was promoted to
Section Manager in the role of Manager of the Human Research Protection Program. Ms. Peters
continued both pre-screening new IRB proposals before sending the proposals to reviewers and
reviewing Exempt proposals. She continued to make presentations about the IRB to TTU classes
and groups. She continues to work toward a Master of Public Administration. Both Dr. Cogan
and Ms. Peters have current certifications as Certified IRB Professionals (CIP).
Mr. Brian Piscacek provided support to the operations of the HRPP as Program Coordinator
through July 11, 2012, at which time he left TTU. Ms. Esther Lucey joined the HRPP staff on
September 1, 2012, as Program Coordinator. Mr. Rick Shupe joined the HRPP staff on
September 14, 2012, as Program Coordinator for Post-Approval Review (PAR). Mr. Shupe fills
a new position in the HRPP Office. Both Ms. Lucey and Mr. Shupe attended the Public
Responsibility in Medicine & Research (PRIM&R) conference in San Diego, California in
December, including the pre-conference fundamental training session for new members. Dr.
Cogan and Ms. Peters opted not to attend the conference this year to allow limited travel funds to
be granted to Ms. Lucey and Mr. Shupe for their professional development.
IRB Members
In 2012, one IRB member died and one member’s 3-year term ended. Three members were
active for the first six months of the year and then moved to alternate membership. One member
is on a sabbatical leave. Three new faculty members were trained under the HRPP/IRB mentor2012 Annual Report
Page 2
mentee training program early in 2012. Two of the trained people joined the IRB as proposal
reviewers. An alternate member agreed to return as a full IRB member. For the last six months of
2012, the IRB roster included 11 members down from 15 the previous year. A current roster of
the IRB can be found on page 6. 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 2012
Meetings
The full IRB met four times in 2012. 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 806-742-2064. The Chair and Coordinator attended
additional meetings involving relevant issues such as fMRI testing, genetic testing and electronic
data protection issues during the year.
Staff Development
Staff development is a critical component of the work of the HRPP. Ms. Peters, and staff
members attended the TTU Responsible Conduct of Research Conference, several webinars and
several short-courses offered by TTU and PRIM&R.
Protocols
The number of IRB protocols has tripled since 2005. In 2012, we continued to take active steps
to limit unnecessary IRB proposals and be within regulatory requirements. We asked each of the
47 department chairs about the names of faculty members who had left TTU. Sixty-two faculty
left, involving 83 protocols. We have closed fifty-four protocols and transferred the others to
new Principal Investigators. With these efforts, the number of IRB protocols remained stable this
year.
Year
2005
2006
2007
2008
2009
2010
2011
2012
Current protocols
at the end of the year
326
557
824
1,001
1,152
1,206
1,243
1,213
Of the active IRB protocols, 100 involve sponsored projects.
2012 Annual Report
Page 3
Budget
The HRPP budget includes salaries for the HRPP Manager, the two Program Coordinators, and
25% salary for the Chair. We also have a half time undergraduate student assistant. The budget
allows for some funds for professional memberships, travel to educational conferences,
certification fees, and a modest amount for relevant journals, books, and supplies.
Accomplishments and Goals
We will continue to focus on the smoothest possible functioning of the HRPP 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. In 2012, we began to implement the 5-10 year strategic
plan for the HRPP that we developed in 2011.
Achieved in 2012
1. Early in 2012, the office was reorganized and became the Human Research Protection
Program office. This reflected our 5-10 year strategic plan mentioned above and was
supported by Dr. Alice Young, Associate Vice President for Research as part of the broader
research integrity mission.
2. We gained approval for work load credit for IRB faculty reviewers, with the support of Dr.
Alice Young.
3. We had 15 complaints about possible adverse events. (This compares to one a year in recent
years.) After investigation, we closed one active research study, helped the investigators
modify two projects, and resolved the others.
4. To help resolve questions about the handling of human genetics research, we formed a subcommittee to consider the issues. We reviewed the literature and we will have a policy in
2013.
5. We made presentations to classes, groups, and administrative units.
6. We worked with others to further the goals and initiatives of the Office of the Vice President
for Research.
7. This year the TTU IRB had authorization agreements with several universities and with the
Department of Defense. These agreements facilitate collaboration between TTU investigators
and others.
8. We continued a line of work on payment to research participants by carrying out a survey of
how payment issues are handled nationally.
9. We continued work on our self-study as background for a possible application for AAHRPP
accreditation.
Goals for 2013
1. We will begin a formal program of post-approval review of active IRB protocols.
2. We will actively work on our self-study as a background for a possible application for
AAHRPP accreditation.
3. To expand our communication to the TTU community about the IRB proposal preparation,
we will develop a set of video vignettes which we will post on the HRPP website.
2012 Annual Report
Page 4
4. We will train at least four new IRB members.
5. We will complete a template consent form for human research involving genetics.
6. We will complete a proposal for funding for an IRB Associate Chair.
7. We will continue research on payment to research participants at the national level and will
carry out research to assess our IRB training programs for members of the university
community.
8. We will need an increased budget to allow PRIM&R membership dues for HRPP personnel
and the IRB Chair and Co-Chair and travel to the national PRIM&R national meetings for all
five.
Long term goal
Our continuing long-term goal is AAHRPP accreditation.
Respectfully submitted,
Rosemary Cogan, Ph.D., ABPP, CIP
Chair, Institutional Review Board
Donna Peters, CIP
Manager, Human Research Protection Program
2012 Annual Report
Page 5
TEXAS TECH UNIVERSITY
INSTITUTIONAL REVIEW BOARD
PROTECTION OF HUMAN SUBJECTS COMMITTEE
September 2012
Name
Term
Department
Phone
Email
Rosemary Cogan, Ph.D.
(Chair)
2014
Psychology
MS 2051
742-3711
#253
r.cogan@ttu.edu
Lillie Aguilar
2014
Community
763-4187
lillie.aguilar@mail.tmccentral.org
Jan Blackwell
2014
Community
-
jblackwell7@suddenlink.net
Scott Burris, Ph.D.
2015
Ag Ed & Comm.
MS 2131
742-2816
Ext 234
scott.burris@ttu.edu
Ken DeMarree, Ph.D.
2013
Psychology
MS 2051
742-3711
ken.demarree@ttu.edu
Angela Eaton, Ph.D.
2013
English
MS 3091
742-2500
#229
angela.eaton@ttu.edu
John Fowler, Ph.D.
2015
Physiology
MS 6651
743-2083
john.fowler@ttuhsc.edu
Lorenz Lutherer, Ph.D.,
M.D.
2013
Physiology
MS 6651
743-2532
lorenz.lutherer@ttuhsc.edu
Shirley Matteson, Ph.D.
2015
Education
MS 1071
742-1997
Ext 270
shirley.matteson@ttu.edu
Education
MS 1071
742-1997
#237
c.pratt@ttu.edu
Industrial Engineering
MS 3061
742-3543
james.smith@ttu.edu
Comfort Pratt, Ph.D.
James L. Smith, Ph.D.
2015
2015
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
2012 Annual Report
Page 6
Ex-OFFICIO
Name
Alice Young, Ph.D.
Department
Associate Vice President for Research
Research Integrity
Email
alice.young@ttu.edu
Katherine Austin Beltz, Ph.D. Assistant Vice President
Information Technology
kathy.austin@ttu.edu
Jennifer Horn, J.D.
Associate Managing Director
Office of Research Services
jennifer.horn@ttu.edu
Cliff Harris
Interim Director
Environmental Health and Safety
cliff.harris@ttu.edu
ALTERNATES
Name
Term
Department
Email
Nancy Bell, Ph.D.
2015 Human Develop Family Studies
MS 1230
nancy.bell@ttu.edu
Elsa Bello-Reuss, M.D.
2015 Physiology
MS 6651
elsa.bello-reuss@ttuhsc.edu
Shannon Bichard, Ph.D.
2015 Media and Communications
MS 3082
shannon.bichard@ttu.edu
Doug Hamman, Ph.D.
2013 Education
MS 1071
doug.hamman@ttu.edu
Sylvia Mendez-Morse, Ph.D. 2015 Education
MS 1071
sylvia.mendezmorse@ttu.edu
Susan Mengel, Ph.D.
2015 Computer Science
MS 3104
susan.mengel@ttu.edu
Kelly Phelan, Ph.D.
2015 Nutrition, Hosp., Retailing
MS 1240
kelly.phelan@ttu.edu
Darcy Reich, Ph.D.
2015 Psychology
MS 2051
darcy.reich@ttu.edu
Alan Reifman, Ph.D.
2015
Andreas Schneider, Ph.D.
2015 Sociology, Anth., and Social Work andreas.schneider@ttu.edu
MS 1012
Andy Young, Ed.D.
2015 Behavioral Sciences, Lubbock
Christian University
2012 Annual Report
Human Develop Family Studies
MS 1162
alan.reifman@ttu.edu
andy.young@lcu.edu
Page 7
2012 Annual Report
Page 8
2012 Annual Report
Page 9