Texas Tech University Protection of Human Subjects Institutional Review Board Annual Report

Transcription

1 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 Full Board Expedited Exempt Amendments Terminated External

2 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 FWA It is also identified by IORG and IRB codes. Registration is current and the FWA expires on September 16, 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, 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

3 The full IRB met seven times in 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 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. Budget Year Active proposals , , ,206 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 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

4 Usability Lab will complete a formal assessment of the revised materials. 3. 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 We handled two adverse events, consulting with the Office of Human Research Protections (OHRP) for guidance on one. 5. 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, 6. 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. 7. We (DP) organized a meeting of all TTU/TTUHSC compliance office personnel. 8. We (staff) made 10 class presentations and one TLTC presentation. 9. We are gathering information about IRB work with social networking (DP) and reactions to research participation (fmri and sensitive topics RC). Goals for 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,, ABPP, CIP Donna Peters, CIP Brian Piscacek, MPA 2010 Annual Report Page 4

5 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 Annual Report Page 5

6 Appendix A MEMBER ROSTER September 2010 Name Term College/Dept. MS Phone Rosemary Cogan, (Chair) 2010 Arts & Sciences Psychology ext 253 r.cogan@ttu.edu Lillie Aguilar 2010 Jan Blackwell 2010 Bill Downing 2012 Lubbock Community Lubbock Community Lubbock Community Angela Eaton, 2010 English 3091 John Fowler, 2012 Sarah Kulkofsky, Lorenz Lutherer,, M.D. Susan Mengel, Kelly Phelan, 2012 Darcy Reich, 2012 Andreas Schneider, James L. Smith, Erin Snyder, 2012 TTUHSC Physiology HDFS TTUHSC Physiology Computer Science Nutrition, Hosp. Retailing Arts & Sciences Psychology Soc., Anthro., Social Work Industrial Engineering Student Counseling Ctr NA lillie.aguilar@mail.tmccentral.org NA NA jblackwell7@suddenlink.net NA NA brigadoon36@aol.com HSC HSC ext 229 angela.eaton@ttu.edu john.fowler@ttuhsc.edu ext 292 sarah.kulkofsky@ttu.edu lorenz.lutherer@ttuhsc.edu ext ext ext ext 231 susan.mengel@ttu.edu kelly.phelan@ttu.edu darcy.reich@ttu.edu andreas.schneider@ttu.edu james.smith@ttu.edu ext 247 erin.snyder@ttu.edu Eric Walden, 2012 Business eric.walden@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 # Annual Report Page 6

7 ALTERNATES Name Term College/Dept. MS Phone Nancy Bell, 2012 Patricia DeLucia, 2011 Kenneth DeMarree, HDFS A&S Psychology Psychology 2051 Doug Hamman, Education 1071 Sylvia Mendez-Morse, 2012 Education Comfort Pratt, 2013 Education ext ext # ext #367 nancy.bell@ttu.edu pat.delucia@ttu.edu ken.demarree@ttu.edu doug.hamman@ttu.edu sylvia.mendezmorse@ttu.edu c.pratt@ttu.edu Alan Reifman, 2012 HDFS ext 274 alan.reifman@ttu.edu JoAnn Shroyer, 2012 MDCE joann.shroyer@ttu.edu Jaeki Song, 2012 Business jaeki.song@ttu.edu Andy Young, Ed.D Behavioral Sciences, Lubbock Christian University NA andy.young@lcu.edu Ex-OFFICIO Name College/Dept. MS Phone Katherine Austin,, Asst Vice President Information Technology kathy.austin@ttu.edu Jennifer Horn, J. D. Office of Research Services jennifer.horn@ttu.edu Randy Nix, Managing Director Environmental Health/Safety randy.nix@ttu.edu Alice Young, Associate VP for Research (Research Integrity) Office of the Vice President for Research alice.young@ttu.edu 2010 Annual Report Page 7

8 Figure 2. Number of active proposals in each college Number AG A&S BA ED ENG HS MCOM VP Other College 2010 Annual Report Page 8

9 Figure 3. Number of active proposals in departments in Arts & Sciences Number 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 Number CUR EPSY Other APS DES HDFS NHR Other Education 2010 Annual Report Page 9