Information on the IRB
What is the IRB?
IRB is an acronym for Institutional Review Board for Human Use. UAB has two IRBs. Together, they review all research conducted at UAB or by UAB faculty, staff and students research procedures that involves human subjects.
The IRB also has jurisdiction over research involving UAB data on human subjects. The IRB can approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.
The aim of the IRB review is to ensure that research involving human participants is conducted in an ethical manner. This includes ensuring that risks to participants are minimized, the selection of participants is equitable, and participants are informed fully of what their participation will entail and of the potential risks and benefits.
For purposes of human subject protection, how is research defined?
Research is defined by the regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” If you are conducting a study that you expect to publish or report in a public forum, you should consider it research and subject to IRB jurisdiction if it involves human subjects. If you are collecting data only for internal use, for example to improve customer service in your department, you are not doing research.
Who must obtain advance approval if humans are proposed as subjects of research?
Faculty, staff, postdoctoral fellows, and students (undergraduate or graduate) must obtain IRB approval before involving humans (or data collected about or from humans) as subjects of research. If you are unsure whether your research needs approval, contact the IRB for clarification. If you are a student, your advisor may have obtained IRB approval for the study that you are conducting. If you think that this is the case, it is important to verify it before you start.
Ultimately, who is responsible for all research activities that are part of a project?
As stated in federal regulations and UAB policy, the Principal Investigator of the study is responsible for all activities relating to the research study. Delegation of authority does not delegate responsibility.
How can the CCTS Regulatory Knowledge and Support component assist investigators who are new to human subject research?
The Research Subject Advocate (RSA) office can assist investigators with questions related to IRB submissions and the consent process, the development of appropriate data safety monitoring plans, and compliance with regulatory reporting requirements.
The RSA office is available to meet with research participants to review “participant’s rights,” observe the consent process, and assess participant’s understanding of the consent process.
To request assistance, please contact Kathleen Powell, PhD at 205-975-6023 or by email kpowell@uabmc.edu.
PubMed Redesign
The NLM® has implemented the redesign of the PubMed interface. The previous version is no longer available. According to the NLM®, the interface was simplified to make it easier to use while promoting scientific discovery. Please note that search processing, including Automatic Term Mapping, has not changed. For more information about the changes, please see:
http://www.nlm.nih.gov/pubs/techbull/so09/so09_pm_redesign.html and
http://www.nlm.nih.gov/pubs/techbull/so09/so09_pm_now_redesign.html
For assistance using PubMed, please contact Lister Hill reference:
IM Chat or email https://www.uab.edu/lister/qpask
Phone 934-4821
NIH Public Access Policy Workshop
On October 20 from 10am to 12pm in the LHL Electronic Classroom (LHL G-40) there will be a “how-to” workshop on the NIH Public Access Policy and manuscript deposit requirements. Attendees who bring manuscripts can receive assistance with submission during the second half of the workshop. No registration is required. For more information, please contact me at lvucovi@uab.edu
UAB Center for Clinical and Translational Science 1st Annual Scientific Symposium
The CCTS 1st Annual Scientific Symposium began with Katherine Klinger, PhD, Senior Vice President & Presidential Fellow in Genetics and Genomics at Genzyme Corporation, who presented Translational Medicine: How do we Walk the Walk? Dr. Klinger emphasized the importance of accelerating the pace of moving fundamental discoveries into practical applications that enhance health. The typical length of time to move a small molecule drug or protein from bench to beside is 10-15 years – very costly and very risky. Even though it takes so long to go through the process, there is a less than 5% success rate that small molecule drugs and proteins will actually be approved. Most compounds fail due to lack of efficacy (46%); other reasons for failure include animal or human toxicity, adverse events, or pharmacokinetics. Dr. Klinger proposed an opportunity to improve the odds by optimizing disease models and developing valid markers to accelerate trials in man.
Two speakers were funded in the inaugural round of the Translational Research Intramural Grant Program (CCTS Pilot Program) in 2008 and presented their work.
Hyunki Kim, PhD presented his research on Physiologic MRI for Early Therapy Assessment in Pancreatic Adenocarcinoma. Diffusion-weighted imaging (DWI) or dynamic-contrast enhancement MR imaging (DCE-MRI) were used to measure early physiologic changes in orthotopic pancreatic tumor xenografts following chemotherapies and/or targeted therapies in SCID mice. DWI was used to evaluate a novel anti-DR5 antibody TRA-8 with and without gemcitabine. DCE-MRI was used to evaluate an anti-EGFR antibody cetuximab with and without irinotecan. Both studies showed a decrease in tumor size with the most dramatic changes in the antibody and drug combinations.
Raegan Durant, MD presented PUSSH: The Pilot for Understanding Social Support and Hospital Use for Heart Failure. Dr. Durant compared the psychometric properties of three existing social support scales to examine their reliability and validity in a population of heart failure patients. The three scales were the Medical Outcomes Study Social Support Survey (MOS-SSS), the Personal Resource Questionnaire 85 (PRQ-85), and the Multidimensional Survey of Perceived Social Support (MSPSS). Surveys were given in person at the hospital and 2 weeks later by telephone. MOS-SSS had the highest internal validity and test-retest reliability, was informative regarding emotional and tangible support, and assessed distinct aspects of social support. Future plans include studies to examine relationships among social support, self-management and heart failure outcomes.
Two speakers funded by the Alabama Drug Discovery Alliance (ADDA) and the CCTS Drug Discovery Component also presented their work.
Andrew West, PhD presented his project Discovery of LRRK2 Kinase Inhibitors. His research focuses on mutations in LRRK2, which are the most common known cause of Parkinson’s Disease and account for 1-5% of cases in many Western populations and up to 35% in certain ethnicities. Through in vitro assays, it has been demonstrated that mutations increase LRRK2 kinase activity, which is required to block neurotoxicity. Factors that mitigate kinase activity may represent novel therapeutics to block neurodegeneration in Parkinson’s. More research is being done on a three part screening for identification of small molecule inhibitors of LRRK2 with therapeutic potential.
Krister Wennerberg, PhD presented his research on Discovery and Development of Ect2 Inhibitors as Anti-cancer Drugs. During the phases in cell division, the molecular events during cytokinesis have not been actively pursued as anti-cancer targets. The Ect2 stands out as a particularly interesting anti-cancer target due to its essential role in cytokinesis; because it is commonly overexpressed in cancers such as gliomas, ovarian, and lung cancers; and because the overexpression is correlated with metastatic behavior and poor clinical outcome. The next steps will include high throughput screening and follow-up assays to identify specific inhibitors that will establish whether small molecule inhibitors of Ect2 can act as potent anti-cancer agents.
An afternoon poster session followed with thirteen posters. Presenters and their research included the following:
- Jessica Alvarez, MS, RD – Dietary Vitamin D and Calcium Are Differentially Associated with Insulin Sensitivity among African American and European American Premenopausal Women
- Elizabeth Brown, PhD, MPH – Molecular and Genetic Epidemiology (iMAGE) Study of Myeloma
- Nikki Bush, MS, RD – Maternal gestational glucose and offspring indices of insulin resistance and secretion
- David D. Chaplin, MD, PhD – Myeloid-Derived Regulatory Cells in the Airways of Patients with Asthma and COPD
- Nefertiti Durant, MD, MPH – Exercise in Young African American Women: Advancing Methods of Promotion of Physical Activity: WEBWALK
- W. Timothy Garvey, MD – Identifying Agonists of NR4A3 Orphan Nuclear Receptor for the Treatment of Insulin Resistance
- Kenneth Hoyt, PhD – On the potential of contrast-enhanced ultrasound for monitoring breast cancer response to antiangiogenic therapy
- Rajesh K. Kana, PhD – Structural integrity of White Matter in Autism: a diffusion tensor imaging (DTI) study
- Michal Mrug, MD – Timing of the development switch regulating cystogenesis in humans
- Lisa M. Schwiebert, PhD – The effect of aerobic exercise on asthma-related responses in adults
- Adrie JC Steyn, PhD – Role of Nitric Oxide and Carbon Monoxide in Active Pulmonary Tuberculosis
- David E. Vance, PhD– Speed of Processing Training in Adults with HIV: A Pilot Study
- Sadanandan E. Velu, PhD – Synthesis and Anti-Breast Cancer Activity of Novel Makaluvamine Analogs
Introducing Jean Lambert
Congratulations to Laurel Hitchcock on finishing her doctorate degree and pursuing her dream! We wish her the very best in her career. Laurel has left me with some large shoes to fill.
My name is Jean Lynch Lambert and I have been in and out of the UAB system for years. While in high school and during the summer, I helped my mother, Murrill Lynch, in the Departments of Cardiology and OB/GYN. I received a BS in Secondary Education with an emphasis in Biology and Earth Science from UAB School of Education. While getting my degree, I taught labs in the Departments of Geology and Biology. After teaching 8th graders science and math, I returned to student life at UAB and received a MA in Secondary Education with an emphasis in Biology. While in school and tutoring on the side, I worked in the Department of Biology researching invertebrates from the Gulf of Mexico under James McClintock, PhD and worked some with Stephen Watts, PhD. After finishing my MA, I worked in the Department of Pathology researching osteoporosis under Harry C. Blair, MD. I have also worked with Steven Carroll, MD, PhD in that department running GeneChips and researching nerve sheath tumors. Outside of UAB, I worked at the Birmingham VA in the Department of Pathology with Harry C. Blair, MD, the Department of Rheumatology with Warren Blackburn, MD and Radiation Safety with Kathy Boyd. Antarctic Support Associates hired me to work in Antarctica to assist researchers with their projects and making sure they had what they needed in the field. I have worked with Veterinarians in their personal practices in Alabama and Mississippi doing everything from lab tests and assisting in exams to assisting in surgery. Also, I worked for TransMoleculer, Inc., a company started by Harold W. Sontheimer, PhD, researching the drug TM-601 for glioblastomas. Most recently, I was with Southern Medical Association working meetings for doctors receiving CME credits. Some may call me a jack of many trades, and a master of a few, but it has been an experience that I would not change. Every position has given me insight into the wonderful world of science and medicine, and for a science junkie like me, it’s been great!
I look forward to working at the UAB Center for Clinical and Translational Science (CCTS). Please feel free to contact me if you have any questions regarding the CCTS. I may not know the answers right away, but I promise to find the answer and help you in any way possible.
