“How To” Guide for Conducting Clinical Research
If you are interested in conducting a research study, no matter how small or large, this guide is designed to help you.
What is clinical research?
Quite simply, it is human-oriented research. This may involve communication or other interpersonal contact between an investigator and a human subject, Epidemiologic and/or behavioral studies, outcomes research, health services research or Community-based participatory research, as well as other study methods.
I have a research idea, but I don’t know what to do next. Where do I start?
1) First, you should speak with the Epidemiologist. An epidemiologist can help with developing appropriate research questions and study design. You may have many options, including in person or online surveys, chart reviews, or collaboration within the College of Osteopathic Medicine or other institutions for gathering additional biological data. You may contact Bhuma Krishnamachari, PhD, Director of Clinical Research to begin this process (516-686-7564, or firstname.lastname@example.org).
2) This should be followed by a meeting with the Epidemiologist and Biostatistician (Min-Kyung Jung, PhD, 516.686.1102 or email@example.com). You must know how you would like to analyze your data BEFORE implementing your study. This way, you can ensure everything is set up properly. The Biostatistician is instrumental in this process. Remember, once you have collected data, you will not be able to go back and change your study design to get data you are missing.
How will I pay for my research?
There are multiple methods of conducting funded and non-funded research:
It may be possible to conduct research with internal funding. Specifically, studies based on surveys or chart reviews may require minimal funding. You should check with your department for opportunities. Additionally, announcements are periodically sent out through email regarding additional funding opportunities.
Many smaller grants are available through foundations, such as Avon, or private charity groups.
Large grant funding
It may be helpful to visit the National Institute of Health (NIH) website.
*** It is often difficult or impossible to get a larger grant unless you have pilot data to show that you have a sound research question. Thus, it is good to pursue your ideas with internal funding first.
I have a study design in place. Can I begin my research?
No, you must first determine whether you need to submit an application to the Institutional Review Board (IRB).
What is the IRB and who needs to submit an application?
Any study that involves a human participant must be reviewed by the IRB. A human participant is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information. (Title 45 CFR, Part 46.102.f)
What if what I am doing does not count as “research?”
Research is defined as a "systematic investigation designed to develop or contribute to generalizable knowledge" (Title 45 CFR (Code of Federal Regulations) Part 46.102(d), Federal Register, 56, p.28013). Thus, most types of studies, however simple, will fall under the jurisdiction of the IRB. Non-compliance with the IRB can result in significant fines for the University, so it is always better to discuss your research with them prior to initiating any work. You may visit them at the following site:
As a clinical researcher, you must be aware of the Health Insurance Portability and Accountability Act (HIPAA) you plan on using any patient data. To maximize compliance with HIPAA, you must implement the same processes for security in your research that you would in clinic. Failure to comply with HIPAA carries severe personal penalties, as well as penalties for the University.
My study has been approved by the IRB, and I am ready to start. Am I ready to begin
You should have another conversation with the Epidemiologist. Your methods of data collection and storage can make a large difference down the road in terms of the ease of analyzing your data. The Epidemiologist has expertise in the best methods of electronic data collection and storage.
The Epidemiologist and Biostatistician will work with you to analyze your data. They can also discuss ideas for publication.
I haven’t had very much training in how to formulate a research idea, and how to write a research protocol. How can I learn more?
I would like to have Assistance with Clinical Research. How do I Request Assistance?
If you would like to request assistance with the design or analysis of your clinical research project, you must thoroughly complete the Research Services Assistance Form for our review. Forms that are incomplete or lacking in signatures will not be reviewed. Review of your request does not guarantee assistance by our research staff. Each project is reviewed individually by its merits, as well as the time commitment involved in assisting with the project. Completed forms may be faxed to the following number: 516.686.3834.