Clinical research is one of the most exciting activities at OU-COM. The College's highest priority, however, is to ensure that patients participating in research studies are guaranteed the highest standards of safety and confidentiality. A previous newsletter article (Fall 1997) discussed requirements of the Ohio University Institutional Review Board (IRB), which must approve any Ohio University study involving human beings. Before the IRB approval process, however, an additional review takes place for all human research proposals at OU-COM.
In 1996, a Human Subjects Sub-Committee (HSSC) of the Research and Scholarly Affairs Committee (RSAC) at OU-COM was established. Members include Jack Brose and Al Pheley from the Office of Research & Grants, the RSAC Chair (currently Ed Rowland), and all clinical faculty members of RSAC. HSSC reviews human subjects research proposals BEFORE submission to the OU Institutional Review Board.
Protocols must receive approval from HSSC if they involve either:
HSSC scrutinizes research methodologies for:
Generally, HSSC takes 7-10 days to review a proposal. Every effort is made to move the approval process forward expeditiously. Some protocols, such as survey research, may pose little or no risk to patients. These proposals can sometimes receive a facilitated review by Jack Brose and Al Pheley. Other proposals are sent to the full HSSC for review. If there is any questionregarding the three review criteria, a formal meeting with the Primary Investigator is scheduled. After approval by HSSC, the proposals are sent to the OU-IRB for consideration.
Current members of HSSC are:
Submission of projects to HSSC is a simple procedure. Application materials, information, and assistance can be obtained from Judi Rioch at740-593-2336 or rioch@ohiou.edu.
Physicians routinely order a hemoglobin A1C (Hb A1C) test to determine the average blood glucose level of a diabetic patient over the last 60 to 120 days. Currently, the result of the blood test arrives several days after the office visit. New equipment is now available that provides results within six to ten minutes.
The Primary Care Associates, working with Jack Brose, D.O., have developed a research project utilizing the new analyzer. The study will determine if results of Hb A1C testing received during the office visit improve diabetic control compared to results received several days after the visit. A group of 150 Type II diabetics will be divided equally between rapid results and results three business days after the visit. Participants will be monitored over a six-month period. After six months, the two groups will be compared.
Type II diabetics who participate in the trial must sign an informed consent form before participating. The Hb A1C testing, which normally costs $153, is free to the study participants. Active recruitment of participants is ongoing in Parks Hall only. Approximately 30 patients have been enrolled thus far. Over 120 more participants are needed for this project to be successful. A finder's fee of $10 will be paid to referring staff members for each patient who completes the trial. To enroll potential patients, please page Lori Arnott, R.N., at 592-8063 .
In 1996, the OU-COM Office of Research received a grant from the 1804 Fund and the Research Challenge program to organize and implement interdisciplinary clinical research projects at Ohio University. Thus far, ten projects have been funded. This fall, a final call for proposals will be issued by the Clinical Research Steering Committee to support the creation of research focus teams to address specific clinical problems. These interdisciplinary teams will identify a fundable research area, recruit personnel and collect pilot data as necessary, and will be expected to submit proposals to external granting agencies.
We are soliciting proposals for clinical or health services research with an interdisciplinary approach. The Clinical Research Steering Committee will review the proposals based on:
We can provide up to $10,000 for costs associated with the project. Since the success of the program will be judged primarily upon the ability to attract external funding, each team must agree to prepare and submit at least one external grant proposal within one year of the initiation of the project.
We are particularly interested in developing new projects that involve CORE sites and other colleges within Ohio University. If you have a project in mind but need help in identifying collaborators, feel free to contact the Office of Research for assistance.
Instructions for the preparation of proposals will be sent out in early September. The due date for submission of proposals will be October 23, 1998. If you have any questions, contact Judi Rioch at 740-593-2336 or rioch@ohiou.edu.
This summer, fourteen Phase II medical students worked with COM faculty mentors in various research endeavors through the Research and Scholarly Advancement Fellowship program. For ten weeks during the summer quarter, the fellows worked on their research projects and attended research related seminars.
Listed below are the faculty and students who participated in the program:
Poster displays of these research projects will be exhibited in Irvine Hall throughout the school year. If you would like more information about the fellowship program, please contact Judi Rioch, Program Director, at 740-593-2336 or rioch@ohiou.edu.
by Al Pheley
This month we will take a look at research funding programs that are supported by the American Osteopathic Association. Each year, the AOA makes research money available for training, fellowships, independent research, and career development.
According to the 1997 Osteopathic Research Handbook, the specific aims of the programs are to:
Osteopathic research is defined by the AOA as "research done under osteopathic sponsorship that is directed toward answering questions traditionally or currently associated with the osteopathic profession and its particular philosophy or practice."
The award programs include:
To find out more about these programs, including deadlines, eligibility, application instructions and help with developing applications, please contact Al Pheley at 740-593-2411 or pheley@ohiou.edu.
by John Dooley
In the last issue, we discussed the Student t-test, which evaluates differences between two, and only two, study groups. Here, we will examine the Pearson and Spearman correlation coefficients.
The correlation coefficient ("r") is used to determine the degree of association between two variables of interest. It is important to remember that "r" estimates only the relationship of these variables and provides no information related to causality.
Two aspects of the relationship between the variables of interest are indicated by the correlation coefficient -- namely, magnitude and direction. Magnitude pertains to the strength of the relationship, or how tightly changes in one variable correspond to changes in another. Direction pertains to whether the relationship is positive (as one variable increases in value, so does the other) or negative. The correlation coefficient may vary between -1.0 (perfect negative association) and +1.0 (perfect positive relationship). A "r" of zero suggests random or no relationship.
Imagine that you have information on the age of each child in your school diestrict and the grade that he or she was in at the beginning of the year. If you plotted this data with year in school on the y axis and age on the x axis, you would expect to see a fairly strong relationship between these two pieces of information. The data points would fit tightly along a straight-diagonal line that began in the lower-left and ended in the upper-right segment of the graph. The "r" for this information would be in the neighborhood of 0.8 to 0.9.
On the other hand, Rosner (1990) gives an example of the association between the cholesterol levels of 100 spouse pairs, an analysis where we might expect some positive relationship because of common nutritional and environmental exposure, although tempered by genetics. Indeed, the authors report a moderate relationship of 0.25.
The most common type of "r" is the Pearson correlation coefficient, which is used when both variables of interest are measured on continuous scales. There are also nonparametric alternatives to Pearson's correlation. Spearman's rho, also known as the rank difference correlation, and Kendall's tau are similar to Pearson's, but are used only when one or both variables are nominal or ordinal. A nonparametric statistic could be used to assess how rankings of medical students in Microbiology correlate with rankings in Behavioral Science.
Caution must be exercised when using the correlation coefficient. As with all statistics, it is important to first plot the data and make sure that there are no underlying relationships that will distort the statistics. For example, if the plot is U-shaped, the correlation coefficient would suggest no association, where in fact there is. A simple transformation of the data would allow the investigator to more accurately estimate the true relationship between the study variables.
If you have any questions related to these or other statistics, please call John Dooley (330-468-4508 ext.224 or dooley@ohiou.edu) or Al Pheley (740-593-2411 or pheley@ohiou.edu).
Contact Judi Rioch at 740-593-2336 or rioch@ohiou.edu for details
Supports research activities broadly related to cardiovascular function and diseases, stroke, or related to basic science, clincal and public health problems.
Grant-in-Aid
Beginning Grant-in-Aid
Postdoctoral Research Fellowship
1999 Research Training Fellowships for Medical Students
1999 Postdoctoral Research Fellowships for Physicians
1998 Fall Cycle
