Lessons From Coast IRB
Some of you know that I've been teaching Research Process & Methodology one night a week this semester at NYU's M.S. program in Public Relations and Corporate Communications. One of the concepts we discuss is confidence - what it means to have confidence in results, how to achieve it, how to measure it, how to determine the amount you actually need. The first thing we started out with, however, was ethics. Indeed, all of the students must pass a test given by NYU's University Committee on Activities Involving Human Subjects - the school's Institutional Review Board (IRB).
Special treatment on the subject of ethics in public relations? Yes, we're serious about this. The fact that some think it oxymoronic is, in fact, a crisis in confidence. With less than solid ethics, we risk creating a false or negative impression of ourselves, our business and our clients.
Ethics and confidence. Everyone knows that they exist in proportional units - the more the ethical behavior, the higher the confidence we have in the message, product, person, whatever. It's all part of the corporate reputation equation. Yet, each day we find new ways to rip ethics and confidence apart.
This is where we come back to the IRB. If there's ever a place where ethics and confidence should be at their most high, it's with research involving human beings. Unfortunately, such was not the case with Coast IRB of Colorado Springs. Federal investigators from the Government Accountability Office (GAO) concocted a fictitious clinical trial for a made-up medical device and attempted to get several IRBs to approve the study. Coast was the one that got out its rubber stamp.
Coast's press release last month said the Company had uncovered a "Congressional 'Sting' Operation." And, in testimony last week to Congress, Coast's CEO, Dan Dueber, complained of "extensive fraud" by the government. But the tune has changed. Now on their web site, Dueber says, "Coast IRB is cooperating fully with the Food and Drug Administration," and that efforts are underway to change "everything" and revamp "every aspect of the company."
Fortunately, no one was harmed although this episode called into question the hundreds of other studies Coast had approved. Those studies are continuing though Coast is banned from approving any new studies or adding patient volunteers to existing studies until the company can be brought into compliance.
Some of the key points I see are:
- Follow through on your promise. Coast IRB says its mission is "to protect the rights and welfare of subjects in clinical trials by providing and ethical and thorough review in a timely and efficient manner." Mr. Dueber, please review.
- Take responsibility. The Company's first reaction was to shift the blame - to the GAO, no less. If you're a company built on ethics, stick to the code.
- We need ongoing monitoring and reporting. Ethical codes stand only as long as there is a commitment to the enforcement of those standards.
- What's best for your audience, your customer, is what's best for you. James Grunig put it succinctly in his Symmetrical Communication model: the organization must consider the public interest to be at least as important as its own.
- Attempt to reassure and apologize. I did not observe any effort to address the hundreds of investigators and thousands of patients participating in Coast-approved trials. Try showing some empathy.