February 2006

IRB approval is a hard‑won but remarkable honor

by Dr. Terry A. Rondberg

When David Jackson, DC, CEO of Research & Clinical Science (RCS) told me that not only was the project "IRB approved," but that every RCS Authorized Clinical Investigator would be "IRB approved" as well, I was astonished.

Having done my homework before endorsing RCS, I knew that, according to the FDA, "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."

I was also aware that it was an achievement for any project to earn approval by an Independent Review Board, since these boards are extremely stringent in their investigation into every aspect of a research project.

There is good reason for their attention to detail. Their job is to protect of the rights and welfare of human research subjects. They have to make sure every clinical research project meets high standards for its scientific protocol as well as professional ethics.

As described in a paper published in Clinical Researcher (March 2004), before approving any human subjects research project, government regulations call for IRBs to make sure that:

***  risks to subjects "are minimized"

***  risks to subjects are "reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result"

***  selection of subjects is "equitable"

***  informed consent is sought from each prospective subject or the subject's legally authorized representative

***  informed consent is "appropriately documented"

***  the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects (where appropriate)

***  there are "adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data" (where appropriate)

That's why they examine everything from privacy safeguards to financial arrangements before giving their stamp of approval on a project.

It's not easy to get an IRB approval for a research project and it's particularly difficult for non‑medical research to qualify. Attorney Michael A. Cohen, director of legal programs at Harvard Medical School's Division for Research and Education in Complementary and Integrative Medical Therapies commented: "I've heard horror stories at other institutions about IRBs taking a year or more to review a protocol simply because it involves chiropractic, acupuncture, or homeopathy... Research into safety, efficacy, and mechanism of CAM therapies raises several challenges, including typical lack of familiarity by IRB personnel with such studies; difficulty in evaluating risks and benefits, qualifying CAM co‑investigators, and/or meeting protocol requirements..."

The IRB that reviewed RCS recognized the scientific validity of the research and were impressed by the measures RCS took to safeguard the privacy and welfare of all volunteers, including the very detailed informed consent forms used to explain the research program to volunteers.

Obviously, for RCS to have received an unqualified IRB approval says a lot about the validity of its project. But it didn't stop there. It makes sure each one of the participating doctors ‑‑ the RCS Authorized Clinical Investigators who actually recruit volunteers and gather the data ‑‑ are all IRB‑approved as well.

Although the approval process is a complicated one, RCS helps facilitate the procedure and act as liaison between the IRB and the doctor. The result it that the doctor becomes part of a very small and select group of chiropractic researchers ‑‑ an honor worthy of praise from their colleagues and the public.

What many doctors may not realize beforehand is the effect their newly acquired "researcher" status will have on their professional credibility. When they send out the press release announcing their acceptance as an RCS researcher ‑‑ having successfully completed both the National Institutes of Health Office of Human Subjects training and an intensive RCS training program ... and earned IRB approval as well as a Fellowship in Health Outcomes Research ‑‑ members of their community sit up and take notice. They are looked upon as scientific chiropractors who provide evidence‑based care. Even medical doctors in the area mentally set them apart from their colleagues, giving them more respect and consideration.

Of course, no chiropractor is going to join RCS just to have bragging rights about his or her status as an IRB‑approved researcher, regardless of how much publicity that status generates. The real reason doctors are signing up with RCS is so they can be in the advance guard of the movement to demonstrate the far‑reaching, positive impact that we believe chiropractic has on health and wellness."

"They want to test the theory that chiropractic can help boost the immune system and aid the body in warding off the effects of stress‑related diseases. They don't want our profession to have to continue relying on the old "trust me ... it works" routine we've had to use up to now. They want the chance to compile standardized health data on as many people as possible and introduce them to chiropractic so we can also obtain "before and after" statistics that will demonstrate the extent of chiropractic's efficacy and safety once and for all."

Still, they can't be faulted for prominently displaying their IRB approval certificate! They have every reason to be proud of their accomplishment, and definitely deserve our respect and admiration.