July 2005

RCS wins IRB approval

How many really know what that means?

by Dr. David A. Jackson

When RCS (Research & Clinical Science) was recently awarded IRB approval, I proudly announced the fact to a few colleagues.

I was met with polite but blank stares, and I was reminded once again how little we, as chiropractors, know about the arcane world of research.

I put myself in that category as well since, until I founded RCS with two "real" researchers ‑‑ Bob Blanks, PhD, and Matthew McCoy, DC ‑‑ I, too, was ignorant of all but the most basic research fundamentals.

This IRB approval thing for instance. I suppose, if I ever thought about it, I would have assumed that when researchers wanted to conduct research, they would come up with their protocol and go to work compiling the data they needed.

But I rapidly found out that this is not the case when you plan to conduct research using actual people (as opposed to analyzing existing data or literature). The government, understandably, has extensive regulations governing any research on human subjects and all proposed research projects must be approved by an Institutional Review Board ‑‑ IRB ‑‑ which comply with all US Food and Drug Administration (FDA) guidelines.

Under FDA rules, "an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects."

The FDA goes on to explain that, "The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research."

Large research facilities, like the Mayo Clinic or Duke University Medical Center, have their own IRBs to review their biomedical research proposals. Researchers who are not aligned with these facilities must apply to independent IRBs and undergo intensive scrutiny.

This is particularly difficult for chiropractic researchers, since most IRBs are dominated by medical professionals who, at best, do not understand chiropractic and, at worst, are antagonist toward our profession.

For RCS, it meant developing a comprehensive application for the proposed "Health Outcomes Study of Chiropractic."

In explaining the project to the IRB, Dr. Blanks detailed the purpose of the research, as well as the protocol we would be using. He noted that, "Public health surveillance strategies will be employed to sample: 1) incidence of clinical sign (vertebral subluxation), 2) primary and secondary benefits of chiropractic, 3) optimal duration and frequency of care, 4) health conditions benefitted by chiropractic, and 5) effects of age, sex, ethnicity and prior existing conditions... This comprehensive program permits a comparison of health outcomes and cost‑effectiveness across and between (co‑therapies) health disciplines. These strategies will ultimately improve the quality of health care service delivery, radically advancing the evidence‑based documentation of the fields under study, and promote the re‑establishment of a rationale, information technology‑based, national health policy."

The application also described the sophisticated electronic data entry and networking system that RCS developed. "The RCS Corporation has established an integrated, web‑based data entry, storage and electronic data capture network to provide: 1) automated record keeping and quality assurance, 2) mechanisms whereby patient data are de‑identified, coded to ensure privacy of protected health information and HIPAA compliance, 3) electronic filtering and encryption allowing data to be transmitted safely to and from a central server for preparation of reports and summary of findings back to the provider, and 4) a system for entering eligible data sets into a central data repository for research purposes. These integrated, but entirely segregated functions (electronic records for quality assurance vs. research data repository), have been brought together through a commercial website employing electronic data capture."

Every aspect of the program was described and examined in detail, from the way RCS member doctors will recruit volunteers (using ads and flyers similar to those developed by the Mayo Clinic, the Naval Medical Research Center, the University of Maryland School of Medicine, Massachusetts General Hospital, and the University of Kentucky Chandler Medical Center) to how volunteers will be handled as paying patients should they wish to receive chiropractic care from the research doctor.

The IRB reviewed information on the financial arrangements between RCS and the lead researchers, and even the actual informed consent forms to be used for volunteers. The IRB Committee examined everything with a figurative microscope to make sure RCS was in full compliance with all professional and ethical guidelines governing health care research.

After weeks of intensive inspection, RCS not only was awarded IRB approval, but generated a great deal of enthusiasm and excitement from the Board's committee members!

This is the same type of enthusiasm and excitement I hope our own colleagues will feel when they learn about this exciting development for chiropractic. It is going to be an incredible boost for our profession when we start producing the analysis of the data, the hard, scientific proof that chiropractic has a positive, far‑reaching impact on all aspects of health and wellness.

Of course, doctors won't have to wait until the research papers are published in peer‑reviewed scientific journals before they feel the impact of RCS on their own practice. The influx of new patients they'll enjoy almost immediately will convince them that RCS is not only the most powerful research program in the history of the profession ‑‑ it's an incredible practice‑building tool.

The inaugural RCS training session, held on the campus of the University of California‑Irvine in June, created the first group of RCS Authorized Research Sites. Member doctors were granted a Fellowship in Health Outcomes Research and returned to their offices able to proclaim to their communities that they are now scientific, evidence‑based research practitioners. They'll attract volunteers to their office and provide them with valuable services and information as part of their research participation. The volunteers ‑‑ who are already interested in health and wellness ‑‑ will learn how chiropractic care might help them lead healthier and more vital lives. They'll make the decision to receive regular care as paying patients ‑‑ without any overt "sales" effort by the doctor.

I'm very proud that RCS was awarded the IRB approval, but I'm even prouder of the fact that we'll be helping doctors achieve the success they so richly deserve, while at the same time paving the way for chiropractic to become the primary choice of health care for people everywhere.

(Dr. Jackson is chief executive officer of Research and Clinical Science ‑‑ RCS ‑‑ a private sector research program exploring issues of subluxation correction and chiropractic care as they relate to health and wellness. Previously, he served as president of the Chiropractic Leadership Alliance and Creating Wellness Alliance and was owner/operator of several private practice offices in California and Idaho that specialized in high‑volume, family wellness‑based care. For more information on RCS, call 800‑909‑1354 or 480‑303‑1694, or visit the RCS website at www.rcsprogram.com. Doctors of chiropractic may log on to a special limited‑access area of the site by using the username DC1 and password RESEARCH.)